Hello, everyone. Thank you for joining us, and welcome to the Innate Pharma webcast call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. If you have logged in via the webcast, please use the Q&A button to submit your questions. I will now hand the conference over to Stéphanie Cornen, Vice President of Investor Relations and Communication at Innate Pharma. Please go ahead. Good morning and good afternoon, everyone. Thank you for joining us for the conference call. Before we begin, I would like to remind everyone that today's presentation includes forward-looking statements based on current expectation. These statements involve risks and uncertainties that could cause actual results to differ materially. With that, I will now hand it over to Jonathan. Thank you, Stéphanie. Thank you, everybody, for joining us this morning in the U.S., this afternoon in Europe, to discuss this morning's announcement of Innate Pharma's EUR 30 million equity raise. This week has been a very busy and important week for Innate Pharma, putting in place the critical elements which allow continued advancement of the strategic agenda which we announced in September last year. As a reminder, this strategic agenda includes a number of items. First, advancing lacutamab into the confirmatory TELLOMAK-3, phase III study in cutaneous T-cell lymphoma, which has already been green-lighted by the FDA. Study initiation allows advancement towards the BLA filing for Sézary syndrome under the FDA Breakthrough Therapy Designation once patient recruitment is ongoing. The strategic partnership with Sobi, which was announced on Monday, allows initiation of the TELLOMAK-3 study. As a reminder, Innate will continue to run the study based on our extensive experience and expertise in CTCL. At closing, which is subject to conditions including antitrust clearance, Sobi will pay Innate a EUR 75 million upfront, as well as up to EUR 40 million in near-term milestones associated with the Sézary syndrome accelerated approval. There is subsequently an additional EUR 465 million of opt-in regulatory and commercial milestones, as well as double-digit tiered royalties on future lacutamab sales. Sobi will take on the full global commercialization following the accelerated approval. The Sobi partnership now allows Innate to proceed at full speed with lacutamab using the proceeds of the agreement. Second on the strategic agenda is the advancement of IPH4502, our second-generation differentiated Nectin-4 targeted ADC, which has shown preclinical activity in the PADCEV-resistant setting, as well as in tumor models of low Nectin-4 expression. We communicated on July 21st that we have completed enrollment in the dose escalation study with 76 patients. To date, we have seen preliminary clinical activity, including in the post-PADCEV urothelial cancer setting, where there is higher medical need and no standard of care, as well as in non-small cell lung cancer and head and neck cancer. We also observed a favorable safety profile to date with limited hematological toxicity, supporting the hypothesis that our proprietary linker minimizes the release of payload into the circulation. The dose escalation results will guide the next steps for development, and the data will be presented at a medical conference before year-end. The third part of our strategic agenda is the advancement of our ADC preclinical portfolio, building on the IPH4502 linker, which has shown stability in patients already. With the ADC preclinical portfolio, we're following three approaches. The first is a dual targeted bispecifics approach to address tumor antigen heterogeneity and expand addressable indications compared to single tumor antigen targeting. The second part of the approach is bispecific ADCs with enhanced internalization to unlock activity in tumors with low antigen expression. The third part is using novel dual payload ADCs using complementary mechanisms of action to overcome resistance. The EUR 30 million equity raise, which was announced this morning, allows Innate to progress this strategic agenda. Starting with seamless progression of IPH4502 into next development steps based on the data from the dose escalation phase I, and then progression of our next wave of preclinical ADCs towards candidate selection and IND-enabling studies. Also on our strategic agenda is next steps for monalizumab, our NKG2A-targeted antibody, which is being developed with AstraZeneca in stage III non-resectable non-small cell lung cancer. The primary completion date for the PACIFIC-9 study is the end of September, with data for the primary endpoint expected by year-end. This is important for Innate, and if positive, represents a significant future source of value for Innate, with up to $825 million of potential milestones, a 50% profit share for Europe, and double-digit royalties on sales outside of Europe, including the U.S. market. The EUR 30 million raised, together with the EUR 75 million upfront payment payable upon closing of the strategic partnership with Sobi, extends our projected cash runway through Q1 2028. The focus now is on execution and delivering against our highlighted strategic priorities. Thank you for your attention, and we can now open the line for questions. We will now begin the question and answer session. If you would like to ask a question, please press star-one to raise your hand. To withdraw your question, press star-one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. If you have logged in via the webcast, please use the Q&A button to submit your questions. Please stand by while we compile the Q&A roster. Your first question comes from the line of Daina Graybosch with Leerink Partners. Your line is now open. Please go ahead. Yeah, thanks for the question. I wonder for IPH4502, if you can give us any more guidance on how many patients in follow-up you will have in the three highlighted indications, so the post-PADCEV bladder, head and neck, and lung? And then I have a follow up after that. Maybe I can take that one, Daina. We have not given any guidance on the specific number of patients in each of the indications. What we have said is we expect to have 10- 15 patients at the go-forward pharmacological doses in each of those indications. In terms of the amount of follow-up, as you can imagine, the last patients were recruited in the middle of July, and we will need to follow those patients and have the first scans to be able to have efficacy data on all of the patients. So that leads us to a time point later in the year, and hence the guidance that we will be presenting at a medical conference later in the year. I think most people have deduced that is not ESMO, so a subsequent medical conference. Got it. We have had a lot of exatecan ADC readouts recently with, I would say, wildly different therapeutic indices. You have the Tubulis one that was at ASCO. You have a Lilly one at ASCO. You have a Sutro one this week. I wonder if you could speak to more about why you think there is differentiation in the therapeutic index across these ADCs and what we should expect, and why we should be excited about IPH4502? Maybe I will let Yannis take that one. Do we have Yannis on the line? I do not think we do, so maybe I will give it my best shot and maybe Stéphanie can jump in. I think what we have communicated, Daina, is that what we have seen so far is that our linker, I think, benchmarks with the best linkers that we have seen out there. We have also been able to achieve doses which are in line with other Topo I and exatecan-based payloads. So we are at that point where with other targets at the particular dose we are at, we have basically seen efficacy with those other products. So I think that gives us a good sense of where we are at. I think the other thing that we found very encouraging was the Lilly dataset, with their ADC with the camptothecin payload at ASCO, in terms of the fact that it validated the approach of coming with a Topo I-based ADC targeting Nectin-4 post-PADCEV. We took that as a validation. Of course, with the caveats of the Lilly ADC and the payload being metabolized through CYP2D6 and having this genetic variation and potential liability associated with that. If we pull all that together, I think we're feeling quite confident that we have a window here from a dosing perspective where IPH4502 will be effective. I think we've mentioned we have seen responses, including in the post-PADCEV setting. Basically every one of our urothelial cancer patients that's been treated in our study has had PADCEV, and I think all but one has also received pembrolizumab. These patients have had the best standard of care. I think when you see any level of activity in this particular patient group, take into account where we've recruited these patients, because the phase I sites are open with five sites in the U.S. and two sites in France. All of these patients have had the best standard of care and are progressing on therapy when they enter the study. When we see activity, we're genuinely seeing something real here. We continue to be excited about that. Hopefully that's answered part of your question. We have Yannis on the line now, so I don't know whether he wants to add anything to that. Yannis? You're on mute, Yannis. Okay. I'm sorry about that, Daina. It looks like Yannis is unable to speak. He's actually on vacation this week, somewhere where the internet connection is not great, and he was dialing in at the last minute. Hopefully I've addressed your question. Yeah. Okay. Thank you. Maybe Yannis can follow up when he's back from his vacation, too. Thank you. I'll get back in the queue. Thank you, Daina. I think we can follow up offline, maybe afterwards, with Yannis. Your next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright. Your line is now open. Please go ahead. Hello Please remember to unmute yourself locally. Thank you. Hello. Can you hear me? Yes, we can hear you, RK. Okay. Just trying to understand the impetus behind the raise today. Is this EUR 30 million, is this to be thought of as a bridging funding between now and the close? Or is this so that you can hasten up some of the work that you need to do on TELLOMAK-3 from here on? The rationale for the raise, RK, is basically to allow us to continue to move seamlessly into the next steps for IPH4502. What we didn't want to do is present the data later in the year and then have to go out and raise money to be able to go into the next steps. Having done this raise now, we can plan for the next steps for IPH4502, and dependent on what the data shows us, we can go seamlessly into those next steps. This is a competitive space, and I think based on where Lilly's recent presentation and some of the ambiguity around their program, we think now we're probably close to the front of the pack of at least Western-based Nectin-4 ADCs. We want to be able to continue the momentum and speed with IPH4502, and we also want to be able to take the next steps for our preclinical ADC portfolio. We have an exciting portfolio of preclinical ADCs, which we will reveal in due course at the appropriate time. Based on the fact that we have a linker that we believe is very effective now and has proven itself in the phase I study, we're in a good place to be able to take advantage of our antibody engineering capabilities, and produce bispecifics. But also to look at ways of improving internalization and also to look at novel dual payloads. I don't mean combining MMAE and Topo I. I mean some genuinely innovative approaches from a payload perspective that will bring something different to the table. The raise allows us to continue and to move those programs forward now that we have the resourcing in place to be able to take TELLOMAK-3 into the next steps and to move forward. This is really about making sure we can move fast on the rest of the portfolio. Thank you for that. A quick follow-up. Just following up on Daina's question. At what point, hopefully this year, would we get a good picture of where IPH4502 is in the development pathway and what are the different indications that you would certainly go into, and also reveal some of the pipeline molecules that you're talking about. Is this going to be happening sometime within the rest of 2026, or should we wait up to 2027? I think for the pipeline, it will be sometime in 2027. We would start to potentially communicate on those aspects. For IPH4502, we will get a better sense of the data when it is presented at the medical conference later in the year. I think that is basically the key piece here. The next steps will obviously be based on the data, and we have not seen the full data set yet. We need to see that data set, and that will dictate which tumor types we go into. What we have said is that we have seen activity in urothelial cancer post-PADCEV, and we have also seen activity in head and neck cancer and non-small cell lung cancer. I think they are likely candidates, but that, of course, has to be validated by the complete data set, which we will see later in the year. Thank you. Thanks for taking the questions, Jon. Thank you, RK. Your next question comes to the line of Jeet Mukherjee with BTIG. Your line is now open. Please go ahead and please remember to unmute locally. Thank you. Great. Thank you for taking the question, and congrats on the financing. One question from me. Any additional thoughts around expansion opportunities for monalizumab outside of oncology, such as IPF or other fibrosis-related indications? I am sure you saw the Science Translational Medicine article that came out a few months ago, highlighting monalizumab's potential in such indications. Was curious regarding your thoughts around going in that direction. Thanks. Thanks, Jeet. We were, of course, very happy to see that publication. I think it is another potential avenue for monalizumab. What I would say at this moment in time, we are really focusing on the readout from PACIFIC-9. That is our critical gating criteria here. I think if we see a positive study with PACIFIC-9 in non-small cell lung cancer, then I think that is the time to really further evaluate other potential opportunities. I think one thing just to remind of is that AstraZeneca have the license through the collaboration agreement for monalizumab for oncology and any additional indications. So the fibrosis indication would be a new indication that would not fall under the collaboration agreement. I think the bottom line is we will wait and see what PACIFIC-9 delivers, and then I think we will take some informed steps after that. And if you don't mind, one additional follow-up. Could you just remind us what would be due up front should PACIFIC-9 be positive? We have not basically disclosed the schedule of the milestones. I think what we've said is they're up to EUR 400 million of development and regulatory milestones, and they follow the standard type of criteria that you would see for these sorts of deals. So I think you can probably work out what they are quite easily. Great. Thanks for taking the questions. There are no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.
Loading workspace