Ladies and gentlemen, thank you for standing by. My name is Brent and I will be your conference operator today. At this time, I would like to welcome everyone to the Innate Pharma Full year 2022 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks there will be a question-and-answer session. [Operator Instructions] It's now my pleasure to turn today’s call over to Mr. Henry Wheeler, Vice President of Investor Relations and Communications. Sir, please go ahead.

Thank you. Good morning. Good afternoon. And welcome everyone. This morning, Innate issued a press release providing a business update for our full year '22 results. We look forward to highlighting the progress made during the year as well as addressing future goals and milestones. The press release and today's presentation are both available on the IR section of the website. On Slide 2, before we start, I would like to remind you that we will be 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. Turning to 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. He will cover updates on lacutamab and monalizumab. Yannis Morel, EVP of Business Development and Product Portfolio Strategy will then cover some updates on partnering and ANKET; who will then turn the call over to our CFO, Frederic Lombard [indiscernible] later on our financials. Mondher, I will now hand the call over to you. Sorry, Mondher, I think you might be on mute.

Sorry, I’m on mute. Thank you, Henry. Yes, thank you, Henry. Please move to Slide #4. Let me start by demanding you our strategy. As an early clinical stage company, our business model centers around three key priorities where we look to drive value from our early R&D efforts through later stage partnership where it makes sense to do so. Our ambition is to develop innovative drug candidates that contribute to transform cancer care for a strong pipeline of differentiated antibodies. First, we look to create near-term value driven by our lead proprietary product candidate lacutamab, which is, as you know, in development for T cell lymphoma with final CTCL readouts expected happening in the second half of this year, early PTCL data are underway. Second, we continue to fuel our pipeline and create longer term value by leveraging our antibody engineering capabilities to develop innovative molecules with a primary focus on our multi-specific NK cell engagers platform called ANKET. As we develop targeted antibodies for our ANKET platform, we recognize some of these binders may be more applicable for ADC technology and we look to further reinforce our expertise in this setting. Last, but not least, we are building a strong and sustainable foundation for our business with various partnerships across industry and academia. Here, our AstraZeneca partnership with monalizumab is continuing in early stage lung cancer. Our focus remains to leverage the value of our products as much as possible. We want to ensure if we can gain valuable competencies via our partner agreement, we will consider that in our development plans for our product. This will further validate our signs and offer capital that we can reinvest to advance our early R&D engine. Please move to Slide #5. 2022 was a year of clinical and partnership validation…

Thank you, Mondher. On Slide 7, let me summarize the progress we are making with lacutamab. We are pursuing a faster market strategy for lacutamab in the niche setting of Sézary syndrome where lacutamab was granted U.S Fast Track designation in EU prime designation in 2020. We have expanded past Sézary syndrome to mycosis fungoides, where we have been -- seen encouraging preliminary data from our Phase 2 trial in both cohorts. For the Sézary syndrome and mycosis fungoides, enrollment is on track with final data due for both cohorts in half -- the second half of 2023. Finally, we are continuing to enroll into peripheral T cell lymphoma in the Phase 1b and 2 monotherapy and combination trials in the relapse setting with initial data expected later this year. On Slide 8, let me remind you the design of the TELLOMAK trial. Cohort 1 is recruiting Sézary syndrome patients that could potentially be a pivotal cohort. For mycosis fungoides, we have Cohorts 2 and 3 where we are testing the hypothesis of non-expressors and expressors of KIR3DL2 using the frozen companion diagnostic assay. We now have an [indiscernible] cohort where we will further evaluate our diagnostic assay. On Slide 9, we have the data published at the ASH Annual Congress 2022 in December. The presentation shows that in heavily pretreated, post-mogamulizumab patient pool with a median prior line of therapy of 6 and 10.9 months of median follow-up. The ORR in the ITT population was 21.6% with an ORR of 35.1% in the skin and 37.8% in the blood. It was very encouraging to see activity replicated in the larger Phase 2 trial in these late line patients. A favorable safety profile was also seen. We look forward to further interactions with the regulators as we get the final…

Thank you, Joyson. So let's move on Slide 12 where there is a summary of our monalizumab agreement with AstraZeneca. To date, we have cashed in $450 million, including $50 million last year with the start of the PACIFIC-9 Phase 3 trial in lung cancer. The total milestone package sign was up to $1.275 billion with royalty on net sales outside Europe, plus 50% of the profit share Europe with the option to co-promote the drug in this region. We look forward to continuing our relationship with AstraZeneca on the monalizumab as well as our -- on our anti-CD39 IPH5201. Indeed IPH5201 has moved into Phase 2 in early lung cancer with [indiscernible] trial in a neoadjuvant and adjuvant setting, which trigger a $5 million milestone payment last year. Now moving to Slide 13, I wanted to highlight our proprietary multi-specific NK cell engager platform that we call ANKET. ANKET standing for antibody-based NK cell engager therapeutics. ANKET is a versatile fit-for purpose technology made of various building blocks that is creating an entirely new class of tri or tetra-specific engager to induce synthetic immunity against cancer. This technology platform, which is leveraging our scientific expertise in the NK cell space, will be an enzyme for our pipeline creating value via multiple drug candidates addressing multiple tumor target. The backbone of this ANKET platform is based on the unique engagement of the activating NK cell receptors NKp46 and CD16 on the NK cells, which allows for the optimal harnessing of the NK cell effector functions, which can be further increased by addition of [indiscernible] variant that induce their proliferation. Now moving to Slide 14, I wanted to share our enthusiasm for this platform in the context of the growing interest in the NK cell space. Our expertise in antibody engineering…

Thank you, Yannis, and good day, everyone. So moving to the finance Slide 16, I will start with one of our key metrics as usual, our cash position. Our cash and cash equivalents amounted to €136.6 million as of December 31, 2022. Cash and cash equivalents as of December 31, 2022 does not include the €25 million of payment received from Sanofi in March 23. In addition, as you can see, we are efficiently managing our resources so that we can best capitalize on progress on data readouts to explore development pathways in different indications. We believe this approach ensures that we remain in position to strategically invest in our vision for Innate. Now, going into the P&L, I will only comment on the main and most significant lines, and you have very detailed comments in the appendix of the press release that you can refer to for more information. I'll start with our revenue and other income, which amounted to €57.7 million. It mainly resulted from revenues from collaboration and licensing agreements and governmental fundings. The revenue line is characterized by the spreading of the funds and opt-in payments received from AstraZeneca for monalizumab and from Sanofi, which I remind you are recognized on the basis of the percentage of completion of the growth platform by the company. I also remind you this has limited impact on cash. Operating expenses amounted to €74.1 million, an increase of 1% compared to 2021. R&D expenses were €51.7 million, an increase of 10% compared to 2021. The increase was mainly due to clinical and nonclinical research and development expenses. We took a full impairment on avdoralimab intangible assets of €41 million, which I'll remind you is a non-cash expense following the company's decision to stop the development of the molecule in the bullous pemphigoid indication in inflammation. To recap, we have a strong cash and cash equivalent position with €136.6 million at the end of the year with €25 million from Sanofi, still to add to this. We estimate that we have enough cash to fund planned operation to at least mid 2025. I will now turn to Mondher, for a summary of the catalyst and close.

Thank you, Frederic. As you can see on Slide 17, we are really working diligently to execute across all our strategic pillars and we believe that we are laying the foundation to drive near long-term value. Looking at our clinical program first, we expect to achieve a number of milestones over the next 2 years. As you heard from Joyson, our Phase 2 TELLOMAK study for lacutamab continues to progress with final data due at the end of this year. In addition, we look forward to initial PTCL data later in the year. [Indiscernible], we continue to develop our ANKET technology platform further reinforced by our partner Sanofi, and we are very encouraged by the preclinical results from the next generation of NK cell engager and the progress in the clinic. We believe that this represents a natural evolution of our platform with data presented at conferences last year. For monalizumab, the lung cancer trials are underway, and we continue to advance the adenosine pathway agents in the clinic where the Phase 2 for IPH5201 in early non small cell lung cancer is starting. Let's move to the conclusion slide now. Slide 18, please. As you can tell we continue our exciting journey at Innate. We look to build our business to create value for patient and stakeholders. In summary, we have positioned Innate Pharma for the future with our strategy and made meaningful progress throughout the year-to-date across all three strategic pillar. With our R&D engine and antibody engineering expertise, our science is producing more candidates to progress into the clinic. Some we are developing alone and some partnered. We have a focus on our NK cell engager platform, ANKET, as well as on ADCs. In parallel, our late stage portfolio continues to advance as we look to maximize the late stage portfolio assets of lacutamab and monalizumab. Number two, our partnership strategy continues to evolve with Sanofi doubling down on the ANKET platform with the second deal announced in December last year, and several programs now in early development. A later stage development, we continue to work with AstraZeneca for monalizumab and IPH5201 in lung cancer. Last but not least, we have carefully managed [indiscernible] so we can continue a sustainable business to invest in progress in our pipeline. I'm very pleased that we continue to have a strong cash position with the runway into mid 2025. Collectively, we are driving value across our business and ultimately advancing our goal to deliver innovative medicines to patient. We look forward to keeping you updated on our progress. That concludes our prepared remarks. We will now open the call to questions.

[Operator Instructions] Your first question comes from the line of Yigal Nochomovitz with Citi. Your line is open.

Hi team, This is Carly on for Yigal. Thanks so much for taking our questions. We have two. First on lacutamab. Can you elaborate on how you're thinking about the registrational pathway for mycosis fungoides, and I guess what you expect the comparator would be for a future Phase 3. And then the second question is, is on the ADC program that you disclosed. Just curious where the linker payload technology that you're using comes from, and how far those programs are from IND. If you can comment. Thank you.

Yes, sure. Thank you, Carly, for the question. I'm going to maybe ask Joyson to start with the lacutamab registrational pathway, and then hand over to Yannis to provide an update on where we are with the ADC technology platform. So maybe, Joyson, if you can briefly remind the goal, our strategy for lacutamab in cutaneous cell lymphoma overall and in Sézary, in particular.

Yes. So definitely, so just as a reminder, the TELLOMAK study has Cohort 1, which is with Sézary syndrome, and that itself can serve as a pivotal cohort. When looking at the registration strategy for mycosis fungoides, we're keeping all our options open, including a complete registration trial on mycosis fungoides alone, or even a combination of mycosis fungoides with Sézary syndrome. We are ensuring that we're continuing our conversations with regulators to make sure we are aligned with them in regards to the comparator as well as the design of the study. Yannis?

Thank you, Joyson. Yannis on the ADC.

[Indiscernible] question. So we indeed have an ADC program called IPH4501, for which we have selected a development candidate and that we are moving forward. And we will provide, obviously more update later during the year.

Okay. Thank you.

Thank you, Yannis. And maybe let me anticipate any further question on, as I said in my introductory remarks, we are an NK cell oriented and driven company. The ANKET platform technology is the center of our strategy, but as we develop targeted antibody, we develop binders, and some of those binders are more fit for an ANKET type of antibodies. Others could be used for other technology, in particular the ADC technology and how -- that's how we have been opportunistic in trying to develop those binders. So we'll provide more data as we progress and certainly join the upcoming months. Thank you. Next question.

Your next question is from the line of Daina Graybosch with SVB Securities. Your line is open.

Thank you. I also have two questions. The first one is on Sézary, lacutamab and the TELLOMAK study. You mentioned that there have been in the community some changes and how in the guidance for how outcomes are measured in CTCL. I wonder if you could describe the changes and what options you have with TELLOMAK, given those changes that you're deciding and discussing with regulators? And then the second question is one on the ANKET. I noticed that the BCMA program that Sanofi has is a mix of ANKET and their technology CROSSODILE. I wonder if you could describe what CROSSODILE is and is there back and forth sharing, could you use that technology in your own ANKET, so do you anticipate them using that in their other programs?

Sure. Thank you Daina. Same distribution to question one. The first one for Joyson. So you can update on the ERTC guidance for measurement of the anti-tumor activity in cutaneous T cell lymphoma. And then, Yannis, provide an answer on the BCMA IPH64 and CROSSODILE technology. Joyson, first you.

Thanks, Mondher. So looking at the new guidance, it is a clarification of the prior guidance, and we want to go a little bit more into detail. So in the upcoming calls, we will describe in detail: number one, the different aspects of the guidance that are different, but number two is also our strategy going forward in how we're going to approach the guidance, not only internally looking at the responses, but also in discussions with the regulators. Mondher?

Yannis?

Yes. Hello, Daina. Yes, the BCMA candidate is actually the molecular format is using what Sanofi is using, calling CROSSODILE, which is their commercial name for their, what you can find the literature as CODV for Cross-Over-Variable-Domain. So this is, I would say, the difference between ANKET and this is the special arrangement of the domains is a bit different. What we call ANKET at Innate are what co-creator [ph] re-molecular format plus our NKp46 proprietary binders. But we can actually plug in this NKp46 binder in our own proprietary format, but also on other, we can plug them in more generic format this [indiscernible] including this CODV from Sanofi.

Daina, does -- this address your question?

Great. Thank you very much.

Okay. Thank you.

Your next question is from the line of Arthur He with HCW. Your line is open.

Hi, everyone. This is Arthur on for RK [ph]. Thanks for taking my question. I had one question regarding the lacutamab. So for the PCTL study, could you give us more color on the inclusion, exclusion criteria for the monotherapy you guys sponsored in the COMBO therapy? Is there any difference in term of that?

Sure. Nothing really -- what to say, unique to this trial. But I'll let, Joyson maybe remind you the criteria. As you know, there are two trials. There is a Phase 1b trial testing, lacutamab monotherapy in relapse refractory PTCL patient. And there is a second trial, which is in collaboration with the [indiscernible], which is testing the combination of chemotherapy, namely, gemcitabine, oxaliplatin in combination with lacutamab. And this is a randomized trial testing chemo versus chemo plus lacutamab. Joyson, can you provide a little bit more color on the monotherapy trial, which we are sponsoring.

Yes, so the monotherapy trial specifically is KIR3DL2 positive patients, it is looking at relapse refractory line patients with no maximum lines of therapy. So, it is a general signal seeking trial and looking at the different subtypes also within it.

How about for the COMBO study? Is there any difference between the patient?

Yes, the COMBO study is also, as Mondher had mentioned, the COMBO study has a comparator arm. So it does have a gemcitabine, oxaliplatin comparator, in addition to the combination arm. So in this, we are also recruiting KIR3DL2 positives, and then enrolling all relapse refractory with no maximum lines of therapy.

Thanks for that. My second question is, so first of all, congrats on the expanding collaboration with Sanofi. My question is for the -- those two additional targets. Is there focus on the tri-specific, or it could target to the tetra-specific?

Yes, Yannis, we got this question previously when we announced the deal with Sanofi, so maybe you can clarify what is disclosed at least on the two options.

Yes, maybe it's a good -- thank you for the question to give me the opportunity to clarify this point. Actually, in our deal with Sanofi, we are licensing to them or giving them an option on the technology as it is today, meaning that we can and they can at some point decide to move under tri-specific format or tetra-specific format.

Okay, great. Thanks. Thanks for taking my question.

Thank you, Arthur.

Your next question is from the line of Rajan Sharma with Goldman Sachs. Your line is open.

Hi, thanks for the questions. I've got two as well. So one is on financials and the second is on the pipeline. So on financials, just thinking about costs in 2023, and how we should think about that, given that you have MATISSE, and also the IND for the CD20 tetra-specific. Would it be fair to assume kind of a similar level of growth that we saw in '22 versus '21? And then secondly, just on the pipeline and on the CD20 tetra-specific, again, what sort of profile would you be looking for in the initial Phase 1 data to kind of continue development there? And can you just provide a little bit more clarity on timelines for when we could potentially see the data? I know it's kind of dependent on the R&D, but on the side it says '24 plus, so could that be in 2024? Thanks.

Yes, thank you, Rajan. Two questions. The first one for Frederic, to give some colors on our burn rate for 2023 and would that be in line with what we have in the budget or not, given that we have two new studies entering into Phase 1 -- two new products enter into Phase 1, sorry, two new major trial, the randomized Phase 2 MATISSE, and the Phase 1 IPH6501. And then maybe Joyson, you can provide some colors on the final touch on the IPH6501 protocol and patient population.

Yes, [indiscernible] it's okay. Thanks, Mondher. Yes, coming to the cash burn, actually given the difference in some maturity of the trials, some ending, some starting, which are mostly offsetting the cash burn for the year to come, it will be in the same range or even a little bit lower. So we will be able to fund these additional studies without adding more cost to the current cash burn.

And maybe adding that to the MATISSE trial is, partnership [multiple speakers].

Also -- yes, also for the MATISSE trial, don't forget we share also some of the costs with AstraZeneca. And also something important to be able to finance all this strategy and we disclose this also is that we do have a careful approach on our resources and have some efficiency measures to make sure that we can finance our strategy. So …

Okay. Joyson, on the education and the selection criteria for IPH6501?

Yes. So as mentioned, the IPH6501 is CD20 targeted [indiscernible] molecule. So the population that we will be looking at is initially is the CD20 positive lymphoma. We're in the process of getting the protocol together as well as discussing with the FDA and we'll give more details as time goes on.

Okay. Thank you, Joyson. I think -- sorry, do you have additional questions?

No, that's everything. Thank you.

Thank you.

[Operator Instructions]

Okay. We, we have a question offline from Olga Smolentseva at Bryan Garnier. So if possible, could you provide a bit more color on IPH4501 and when we might see it entering the clinical Stage?

Yes, I already gave some colors on this, but maybe an opportunity for Yannis to, again, summarize the ADC approach and the progress of IPH45.

Yes, yes. Thank you, Mondher. And sorry if it's a repeat for some of you. Like Mondher say, we have an antibody engineering platform, out of which the -- which is the main output and the main focus is to generate binders against tumor antigen to apply it to our ANKET technology. But some of the binder that we're generating are more fit-for-purpose for ADC approach. And it's a field that we are exploring for several years now. But now with this IPH4501, we have made the decision to select one development candidate and as I also said previously, we -- we'll give more update on the next step of development later this year.

Thank you, Yannis. Any offline question, additional offline questions?

Not from this stage. Operator, over to you for any further questions on the line.

Yes. Your next question comes from the line of Jingming Chen with Evercore ISI. Your line is open.

Hi. This is Jingming on for Liisa. Thanks for taking our questions. So, we are just wondering for your first ANKET, the IPH6101 CD123, when shall we expect to see the Phase 1 data and what should we expect from the readout? Thank you.

Thank you for the question. As you know, this is a Sanofi asset. It's a Sanofi trial, and we, of course, cannot speculate or communicate on their behalf. Sanofi is progressing well. And they mentioned in their full year results, early February that the program is progressing well. And of course we will wait for the data that they can provide the study, Phase 1 study started about 15 months ago, and we do not have any additional update to share with you at this [indiscernible].

Got it. Thank you.

Yannis -- okay. Yannis, anything to add from your side?

No, nothing to add.

Okay. Thank you.

There are no further audio questions at this time.

Okay. So if there are no further question, I would like ladies and gentlemen, to thank you all for attending this call. And maybe, let me quickly remind you our key take homes and there are three. First of all, as you see, we stay focused on our strategic priorities to adventure lacutamab maximizing the NK platform and building strategic partnership. Number two, clearly we have important readouts from our proprietary and partnered portfolio programs that are expected over the next 24 months. And last but not least, we have a strong financial position as we are well funded into mid 2025. We'll keep you posted, and thank you again for participating to this call. Bye-bye.

Ladies and gentlemen, thank you for participating. This concludes today's conference call. You may now disconnect.