Good morning, everyone. My name is Juan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Innate Pharma First Quarter 2022 Business Update. [Operator Instructions] I will now introduce to Mr. Henry Wheeler, Head of Investor Relations. Please Mr. Wheeler, go ahead.

Thank you. Good morning and good afternoon and welcome everyone. This morning Innate issued a press release providing a business update for our first quarter '22 results. We look forward to highlighting the progress made during the quarter 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 2, before we start, I would like to remind you that we will make forward looking statements regarding the financial outlook, in addition to regulatory and product plan developments. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. On Slide 3, on today's call, we will be joined by Mondher Mahjoubi, our Chief Executive Officer who will then hand over to Joyson Karakunnel, EVP and Chief Medical Officer and Yannis Morel, EVP of Business Development and Product Portfolio Strategy. And we will also have our CFO Frederic Lombard on for Q&A. Mondher, I'll now hand over to you.

Thank you, Henry. Good morning, good afternoon, everyone. And thank you for joining this call. Please move to Slide 4 and let me first start by reminding you of our strategy. Our strategy centers around 3 key priorities where we look to drive value from our early R&D efforts for later sales partnership and it makes sense to do so. First, we look to create near-term value driven by our lead proprietary candidate, lacutamab, which is in development for T-cell lymphoma, which is opened in all-comers cohort in mycosis fungoides in the TELLOMAK trials. And also initiated 2 trials in the larger indication of peripheral T-cell lymphoma. Second, we continue to see our pipeline and create [Indiscernible] value, leveraging our antibody engineering capabilities to develop innovative molecules with a primary focus on our multi-specific NK cell engager platform called ANKET. Sanofi has the most advancing ANKET in the clinic, and we are nearing the clinic with the others. On the Adenosine pathway, we have a Phase I underway for our anti-CD73, IPH5301 performance in partnership with the Paoli-Calmettes Institute, the anti-cancer center in Marseille. And we are in further discussions with AstraZeneca on the next step for our anti-CD39, IPH5201. Last but not least, we continue to build a strong and sustainable foundation for our business, leveraging the various partnership between Innate Pharma and industry across academia. Our focus here is to leverage the value of our products as much as possible. We want indeed to make sure that if we can gain valuable competency via a partner agreement, we will consider that in our development plans for the product, which will not only validate our size but also offer capital we can invest to advance our early portfolio. And building on this pillar of the size pillar, if you…

Thank you, Mondher. On Slide 7, let me start with our first-in-class humanized monoclonal antibody that targets immune receptor KIR3DL2. As you may remember, KIR3DL2 is an inhibitory receptor found in approximately 65% of patients across all cutaneous T cell output. In the TELLOMAK trial, cohort 1 recruiting Sezary syndrome patients could potentially be a pivotal cohort. For mycosis fungoides, we have cohorts 2 and 3, which have been presented previously and are testing the hypothesis of non-expressors and expressors of KIR3DL2 using the frozen companion diagnostic assay. As expected, our scientific hypothesis confirmed -- was confirmed in cohort 2, high global response rates in comparison to the benchmark and the non-expressing cohort, a low global response rate in the non-expressing cohort. Recently we opened the all-comers cohort to further evaluate our FFPE companion diagnostic, which is being considered for late-stage trials. This cohort is not expected to impact timelines for the readout of the trial, and the companion diagnostic data will aid further in the development of the program. On Slide 8, let me summarize the progress we are making with lacutamab. We are pursuing a fast-to-market strategy for lacutamab in the niche setting of Sezary syndrome where lacutamab was granted U.S. Fast Track designation and Prime designation in 2020. We have expanded past Sezary syndrome to mycosis fungoides, where we have seen encouraging preliminary data from our Phase II trial. For the Sezary syndrome cohort, enrollment is on track, and we will still expect to be able to report top line preliminary data in the second half of 2022. For the mycosis fungoides cohort enrollment is on track, and we still expect to be able to report top line preliminary data in the second half of 2022. Finally, we are advancing into peripheral T-cell lymphoma in the monotherapy…

Thank you, Joyson. On Slide 12, I wanted to highlight the latest updates from our proprietary multi-specific NK engager platform, what we call ANKET, ANKET standing for antibody-based NK-cell-engager therapeutics. We are pleased to have presented our latest innovation at major scientific and medical conferences, including AACR Annual Meet in this year by our CSO, Professor Eric Vivier as well as at ESMO and SITC last year. ANKET is a versatile fit-for-purpose technology made of various building blocks that is creating an entirely new class of tri and tetra-specific engagers to induce synthetic immunity against cancer. The technology platform, which is leveraging our expertise in the NK cell space, will be an engine for our pipeline, creating multiple -- creating value via multiple combat addressing multiple tumor targets. Our excitement for this ANKET platform is both on because of the preclinical data that we have to date. First, the ANKET platform allows for optimal harnessing of the NK cell effector function due to the unique engagement of both NK cell activating receptors, NKp46 and CD16. Second, this preclinical efficacy can be further increased by the addition of an interlinking 2 variant, which targets the IL-2 receptor beta gamma complex, which is a [Indiscernible] NK cells, inducing their proliferation within the tumor micro environment. Overall, this platform demonstrates better preclinical antitumor efficacy than we have seen in tumor models with clinical -- with clinically approved benchmark antibodies. Our most advanced ANKET program is a CD123 targeted bispecific molecule, IPH6101, also called SAR443579 that we have generated in collaboration with Sanofi. It is now fully licensed to them and currently in Phase I trial. The second ANKET program of this collaboration with Sanofi, IPH64, also continues in development. Our most recent generation of tetra-specific ANKET is also progressing toward the IND-enabling studies with the first IND filing expected in 2023 for IPH65. Now I will turn to Mondher for our summary of the upcoming catalysts.

Thank you. Please move to Slide 13. As you can see, we are working diligently to execute across all our strategic pillars and believe that we are laying the foundation to drive near long-term value. Looking at our clinical program, we expect to achieve a number of milestones over the next 3 years. First, as you've heard from Joyson, the Phase II TELLOMAK trial for lacutamab continues to progress. We continue to expect to report preliminary data from the potentially clinical cohort in Sezary syndrome as well as data in the mycosis fungoides in the second half of this year. In addition, we are moving our clinical [Indiscernible] into the clinic with initial data expected next year. For monalizumab, the head and neck trial is underway. And finally, we continue to advance the adenosine pathway in the clinic, where we look forward to data and next steps from the anti-C59 in 2026. In parallel, we continue to develop our ANKET technology platform, and we are very encouraged by the treatment of the results from our one-generation and ANKET cell engager. We believe that this represents a natural evolution of our platform with data [Indiscernible] last year. We are really excited to see the new tri-specific ANKET in the clinic with Sanofi and for updates on our proprietary ANKET for our 2022. Let's move to Slide 14. As you can tell, we continue our exciting journey at Innate. We look to build our business to create value for patients and stakeholders. And in summary, we have positioned Innate for the future with our strategy and made meaningful progress throughout 2021 across all 3 pillar. We have carefully managed our resources, so we can continue to invest in our -- in progressing our pipeline. And I'm very pleased that we continue to have a very strong cash position through to 2024 with EUR 131.7 million as of March 31, 2022. In addition, we had the $50 million payment received from AstraZeneca we announced 2 weeks ago. We also want to allow opportunities for investors to buy the stock while trying to safeguard our existing stakeholders' interest. As such, we opened an at-the-market program last week on the NASDAQ. The ATM allows us to access the request for [Indiscernible] depending on market dynamics. Collectively, we are driving value across our business and intimately advancing our goal to deliver innovative medicine to patient. We look forward to keeping you updated on our progress throughout the year. With this, we conclude our prepared remark, and we now open the call to question.

[Operator Instructions] And our first question comes from the line of Yigal Nochomovitz from Citi.

This is [Ashiq Babar] for Yigal. For the Phase III INTERLINK 1 trial, AstraZeneca is running for head and neck cancer. My understanding is that there will be an interim analysis prior to the full data in 2024. So just curious if that's still on track. And if you can share any color on when that might happen. And what if anything you might share from that interim analysis?

Absolutely. So as I said, this is an AZ sponsored trial that was initiated back in 2020, the first patient was dosed in November 2020. And at that time, we announced that there is an interim analysis that is planning to occur 18 to 24 months after the first patient dose, which means that these interim analysis would occur in the second half of 2022 and the clear time analysis are expected in 2024. I hope it's clear.

Okay. Will you share any details from that analysis and -- all right. My second question is that I understand that there's a $50 million milestone payment associated with hitting some kind of threshold from that interim analysis. Is there any color you can share on what that threshold is? Is it a response or survival-based threshold? Any color would be great.

AstraZeneca did not disclose nor communicate any details about the threshold note of statistical perform analytics. We know that there is an interim analysis to decide whether to pursue or to stop. And this will, as I said, occur in the second half of the year. And of course, we will be informed by [Indiscernible] analysis of this threshold. And we'll share the outcome.

Our next question comes from the line of Daina Graybosch from SVB Leerink.

Two for me. The first post, there was a recent full publication of cost, and it had some additional biomarker cuts. And I wonder whether you guys could discuss those cuts, especially any that you thought were relevant for monalizumab and any new interpretations you took from them?

Thank you, Daina. I'll take your second question, and then I'll dispatch.

So the second question is on ANKET. I wonder if Yannis could discuss any additional optimization of IPH65 that you are doing or planning as you go into IND study?

Absolutely. Thank you very much, Daina. I'm going to hand over to Joyson. And as you've heard in his remarks, Joyson has referred to the biomarker analysis and probably the right person to address the first question about what is the takeaway from this data. And then, of course, Yannis will address the question about IPH65 for which we did not disclose the target yet. Joyson, will you start please?

Sure. So I think in reference to the JCO article that was published by AstraZeneca on the COAST study. There were PFS exploratory subgroup analysis that were done that at least and this should be taken with caution, considering the small numbers that were used in this subgroup analysis. We found that the combination of monalizumab and durvalumab in tumors that expressed high HLA and NKG2A expression appeared to favor this combination in this PFS subgroup analysis. So for us, that helped to support the synergistic as well as mechanistic rationale that we initially had developed for the combination when it was first put into the clinic. I kind of hand it over to Yannis now. Go ahead.

Okay, Yannis?

Yes. On the IPH65, so like Mondher said, we did not disclose the identity of the target, but we can say that we have selected a validated tumor target to which we are applying our ANKET technology, which is a tetra-specific format, incorporating an IL-2 variance. Then we performed, I would say, a very classical lead optimization work in order to select the best candidate, and we are underway to our IND enabling study with the targets to find an IND in 2023.

And maybe one follow-up for Joyson. Do you think that there's any potential to use either [Indiscernible] or NKG2A in the future as a diagnostic to enrich patients for the combination of monalizumab in any of the setting?

I think with the small numbers, at least in the COAST trial, it helps to -- it will help to supplement the data that we see at least from the NeoCOAST study. I think right now with the small numbers and the exploratory nature of the analysis, it's definitely a hint that it's possible. But I think this will need to be supported with the NeoCOAST data that we get before kind of moving into a biomarker-driven approach.

Our next question comes from the line of Olga Smolentseva from Bryan Garnier.

The first one would be, could you maybe discuss a bit how you see positioning of lacutamab in evolving landscape of PTCL treatment? And maybe do you see -- do you have data on overlap between expression of, for instance, CD30 and KIR3DL2?

Thank you, Olga. Welcome back. So first of all, you know that the KIR3DL [Indiscernible] and the program just a physical as of today, we don't have data. And of course, any position should be and not be data driven. So I won't speculate, but if we assume that we have a level of activity that justify further development of lacutamab, definitely, what we could call it game changer in the development of this program because so far, it has been limited to a rare form of cutaneous T-cell lymphoma. So we look forward really to generate the data. And as you know, we have 2 approaches. One is a single-agent monotherapy in the relapsed factor setting trying to detect single-agent activity and a difficult to treat patient population for which, of course, it is important to provide alternative strategic approach given the persistent unmet medical need there. And there is a second approach we are pursuing in collaboration with the LYSA group, which is non-Hodgkin lymphoma cooperative group in France and in some European countries where we are setting the combination of equipment of the chemotherapy. And as you know, the combination of the GEMOX and oxaliplatin is one of the [Indiscernible] and this is a randomized comparative study. So it will also provide into the contribution of components of the lacutamab in this setting. These data of course which we expect to start sharing and presenting next year will definitely drive the positioning of the closing and definitely, this will be biomarker reason, as you know, both in the single-arm trial as well as in the combination trial, we are targeting Q3 positive [Indiscernible]. Now to your second question about the overlap and expansion, I'm going to ask Yannis to provide more color on this. Yannis, please?

Yes. Sorry. Yes, in PTCL, there is no correlation of the KIR3DL2 expression with CD30. You find expression across all different subtype of PTCL with some variation depending on the subtype. And there is no -- I would say that there is a clear positive PTCL allocation, both in the service positive as well as in the CD30 negative.

If I maybe few words on the companion diagnostic. Yes, sorry. I just -- I was wondering one thing if you can share a few words on companion diagnostics for KIR3DL2 express and maybe how aligned it is with the standard diagnostic proprietary practices. Basically, would it be easy to come and just add it to the current [Indiscernible] for PTCL? And maybe what additional steps, if any, are required to get it approved?

Absolutely. And as you've heard in Joyson's remark we are working on further solidifying the package for this purpose. So I'm going to let Joyson answer the question, knowing that we are still at the early phase of the development, and that Sezary Syndrome per se is not probably the best target indication of testing more than 90% of the patient expressed target, but [Indiscernible]. So Joyson, can you give more color on our plan for lacutamab, please?

Sure. So as we had mentioned, the initial results that we're seeing with PTCL was based on a frozen assay. We are now using the all-comers cohort looking at an FFPE pathway. We are in discussions with regulatory agencies, and we're also looking at developing it not only in-house, but also with a third-party companion diagnostic company. So we are going through the necessary steps to ensure that not only for CTCL, but also PTCL, the assay can be used in our later phase trials.

I will hand over back to Henry Wheeler now for any chat questions.

Thank you. We have one question on the line, Eric Le Berrigaud at Stifel. So the question goes more and more biotech companies are reevaluating strategy as to whether to go marketing, which is costly, burdensome and uncertain considering size and un-experience. [Indiscernible] still you are holding all right with lacutamab. And if everything goes well, you might be ready to market in the U.S. in 18 months from now. Regulatory activities will start earlier as well as premarketing and market access. So what avenues are you considering when you say you have cash into 2024? What does that mean for lacutamab marketing-wise?

Thank you, Eric. Very, very important question. And I would like to start maybe by reminding what I said in my answer when I described our strategy with the 3 pillars. And remember the today is about building really under sustainable foundation for our business, leveraging the various partnerships across both industry and academia. And we are, as you know, a company with a good track record of collaboration over the years that has been instrumental actually in just the growth in the development of our company. And clearly, we want to ensure that there is no restriction to that. In other words, if we can gain valuable competencies the partnership is for lacutamab, we will consider that in our development plan. I think what is really important is to ensure we have medicine get into patients as quickly as possible. And if there is an opportunity to do it in partnership with another company, we would consider that and we will evaluate the benefit of part time. Today, we are in a Phase II stage generated to date. Of course, the Sezary syndrome cohort has the potential to be pivotal based on a predefined level of activity that we discussed with the FDA. But overall, we are generating data that will guide and inform, of course, [Indiscernible] really from preparing for the launch of the market because you know how long it takes to deliver Phase III in the settings we are not there yet. We are just taking on executing on the TELLOMAK trial, making sure we, of course, can build on the fast track designation for the drug and have an FDA approval in Sezary syndrome. And at the same time, of course, consider all the options including the partnership with -- we believe there is more value to create in pipeline. And last but not least, I think the [Indiscernible] experience was, as you said, the tough one, the launch of the drug in the rough moment possible with the COVID. But nevertheless, it was an extremely useful. And as we learn a lot from our failures, and I think it was an extremely important step in the development of our company. It gave us the opportunity to refocus our energy and resources on R&D to continue to fill our pipeline and generate negative medicine that can contribute to hike to cancer, and that's our ambition and our mission is intact.

Thank you. We continue with the questions on the phone lines. The next question comes from the line of Liisa Bayko from Evercore.

This is Jingming on for Liisa. My first question is, what should we expect at the TELLOMAK data readout second half this year? And my second question is, can you talk a little bit about what is your plan for lacutamab and Sezary syndrome and mycosis fungoides, do you plan to file go ahead and file Sezary Syndrome alone? Or will you wait for the mycosis fungoides data to file together?

Thank you, Jingming, for the question. So I'll take the questions on lacutamab and I think, Joyson, the right person to update you on the readout, even though we have a slide and describing this, but will provide also more color about our value creation strategy and regulatory approach. Right, Joyson?

Thank you. So thanks for the question. So when we look at the -- for your first question about the data readouts in the second half of 2022, the Sezary syndrome would be the first time that we're presenting that data, so that would be preliminary data on the Sezary syndrome pivotal cohort. In regards to the mycosis fungoides, which is the second data readout we would have in 2022. We're anticipating updating some of the data that was seen at Lugano in 2021 with longer follow-up on those patients as well as additional patients that have enrolled. So that would be the 2 data readouts during the second half of 2022. I think in regards to the second question around whether we would file a Sezary syndrome or mycosis fungoides, I think a lot of this will depend upon the data itself. When we look at both of these cohorts, there is definitely the potential to file both of them together. And also, in addition, we also have the ability to file the Sezary syndrome as a pivotal cohort. And we are already going in with the approach that in mycosis fungoides, we would have to do a Phase III. So we're kind of looking at the entire package that we're able to get for both Sezary syndrome and mycosis fungoides and then making a data-driven decision from there.

Thank you. If I may squeeze in one more question. So in terms of timing for the PACIFIC-9 readout, is it fair to assume it will be similar to INTERLINK 1, which would be like interim readout for 18 to 12 months from dosing the first patient. Actually, we also expect a $50 million milestone from that potential readout?

So sorry to disappoint you but this is really an AstraZeneca trial and I won't speculate on any timing. They didn't provide any specific dates or whether there is an interim analysis or even the [Indiscernible] -- this is lung cancer, okay? I know you are familiar with lung cancer development and the time line and how long it takes to [actually push in] these types of [Indiscernible]

Thank you. I hand over back to Henry now for the questions on the chat.

Yes, we had another question from Liisa Bayko at Evercore. Do you see a read-through from activity in the Phase II head and neck to Phase III lung cancer?

Joyson, this is for you. It's your prepared question, I know. I'll let you.

Yes. So thank you for the question, Liisa. So I think when we look at both of these trials, there's 2 main components. Number one is they're vastly different disorders. So lung cancer versus head and neck. And so because of that, I think what you would see in head and neck would probably not translate over into lung cancer. I think that's the main takeaway. I mean, the answer to that question is, I don't -- based on the oncologic indications, you would not expect to read through at least between head and neck and lung cancer. But that's also not saying in the head and neck as well as in lung cancer, we are seeing exploratory evidence that there is synergistic potential between monalizumab and durvalumab as well as we've seen that with monalizumab and cetuximab. So I think when you look at it in 2 different points, mechanistically, there could be a mechanistic rationale that applies to both indications. But clinically, these 2 indications are vastly different tumor types.

Thank you, Joyson. I think we have more coming on the line.

Thank you. We continue with the questions on the phone lines. And the next question comes from the line of Arthur He from H.C. Wainwright.

This is Arthur in for RK. I just wonder, could you guys remind us the milestone payment could potentially related to the IPH64 with the Sanofi collaboration.

I'll hand over to Yannis on the financial terms of the deal with Sanofi.

We did not disclose the breakdown of the milestone that we have with Sanofi. What we disclosed that for both programs, IPH61 and IPH64, we're having total up to $400 million in milestones as well as high single-digit royalties.

Thank you. We currently have no further questions on the phone line. So I hand over back to the management team for any final remarks.

Thank you very much. So again, thanks all for joining this call. I know it's a busy time of year, so many of you are, let's say, busy with the various Q1 results. I want to just -- in a conclusion to say that as you can see, we are consistent to continue to execute against our strategic priorities. And looking ahead, we will continue to update our lacutamab external program. Move on early R&D activities towards the clinic. And as you heard from Yannis, we are actively preparing the R&D package for IPH65 as well as, of course, a collaboration and partnership around this platform. And finally, for monalizumab, we are pleased with the development in early lung cancer, but also the head and neck trial is on the way. And the interim [Indiscernible] in the second half of the year are important milestone. And of course, it reinforces our strategy of building a sustainable business with a robust R&D action. With that, I thank you very much, and I wish you a wonderful day.

This concludes today's call. Thank you so much for joining. You may now disconnect your lines.