Hello, everyone. Thank you for joining us, and welcome to the Innate Pharma third quarter 2026 business update and financial results. 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. I will now hand the conference over to Stéphanie Cornen, Vice President, Investor Relations, Communication, and Commercial Strategy at Innate Pharma. Please go ahead.
Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma's third quarter 2026 business update and financial results conference call. The press release and today's presentation are both available on the IR section of our website. Before we begin, I would like to remind everyone that today's presentation includes forward-looking statements based on current expectations. These statements involve risks and uncertainties that could cause actual results to differ materially. To briefly cover today's agenda, our CEO, Jonathan Dickinson, will begin with a strategic overview and outlook. Markus Jensen, our Chief Medical Officer, and Yannis Morel, our Chief Operating Officer, will then take us through updates on lacutamab, IPH4502, monalizumab, and our preclinical ADC pipeline. Jonathan will return for our upcoming catalysts and closing remarks before we open the call for Q&A. With that, I will now hand it over to Jonathan.
Thank you, Stéphanie. Good morning to those joining from the U.S., and good afternoon to our European participants. Turning to slide five. Since our first half update, we have continued to advance our focused portfolio while strengthening our financial position. Starting with lacutamab, the TELLOMAK-3 phase III study has been initiated following the closing of our strategic partnership with Sobi, with first patient dosing expected in Q1 2027. The partnership is now effective, and the $ 75 million upfront payment has been received. For IPH4502, we will present phase I data at the EORTC-NCI-AACR Symposium on November 18, 2026. We will also host a hybrid virtual and in-person event in London on the same day at 4:00 P.M. GMT or 11:00 A.M. ET. Turning to monalizumab, the PACIFIC-9 phase III study led by AstraZeneca is now expected to read out in the first half of 2027.
Financially, our cash position as of September 30th, 2026 was EUR 96.8 million, with an anticipated cash horizon through the end of the first quarter of 2028. Taken together, these developments position Innate for several important near-term catalysts through year-end and into 2027. Let me start with lacutamab. Lacutamab is our anti-KIR3DL2 antibody, which is being developed in cutaneous T-cell lymphoma, or CTCL. Turning to slide seven. As I mentioned, our strategic partnership with Sobi to license lacutamab in T-cell lymphoma is now effective. TELLOMAK-3, our confirmatory phase III study in CTCL, has been initiated, with the first patient expected in the first quarter of 2027. Innate is conducting the phase III study, and we plan to file for accelerated approval in Sézary syndrome based on the existing phase II TELLOMAK data. Upon potential accelerated approval, Sobi will receive global rights to commercialize lacutamab.
Following positive phase III results, Sobi will be eligible to obtain full global development rights. Under the terms of the agreement, we received a $ 75 million upfront payment and are eligible for up to $ 40 million in near-term milestones connected to Sézary syndrome, and up to an additional $ 465 million related to Sobi's option to obtain full development rights and future regulatory and commercial milestones. The agreement also includes tiered double-digit royalties on future net sales. I will now hand it over to Markus, our CMO, to review the clinical and regulatory roadmap. Markus.
Thank you, Jonathan. From a clinical and regulatory perspective, this slide summarizes the projected roadmap for TELLOMAK-3. The phase III study has been initiated with first patient dosing expected in Q1 2027. TELLOMAK-3 includes a confirmatory cohort in Sézary syndrome and a registrational cohort in mycosis fungoides. For Sézary syndrome, we plan to file a BLA with the FDA in the second half of 2027, with potential accelerated approval in the first half of 2028. Primary progression-free survival analysis for Sézary syndrome and mycosis fungoides cohorts are projected 12 months after completion of enrollment, with potential regular approval thereafter. These milestones reflect our current expectations as we execute TELLOMAK-3 and advance the program together with Sobi. Turning to slide nine, I now move to IPH4502. I now turn to IPH4502, our differentiated Nectin-4 exatecan ADC in phase I development for advanced solid tumors.
Turning to slide 10, IPH4502 was designed to address some of the key limitations of first-generation Nectin-4 ADCs. The molecule combines an exatecan topoisomerase I payload with our proprietary stable linker and a high-affinity Nectin-4 antibody that binds a non-overlapping epitope compared with enfortumab vedotin. We believe these features provide an important point of differentiation as the Nectin-4 ADC landscape continues to evolve. Phase I dose escalation enrollment is complete. As previously disclosed, we have observed preliminary antitumor activity, including objective responses in heavily pretreated patients, together with a favorable safety profile observed to date. We look forward to presenting phase I data at the EORTC-NCI-AACR Symposium on November 18. We will also host a virtual event and webcast at 4:00 P.M. GMT or 11:00 A.M. ET to discuss the results. Turning to slide 11, I now move to monalizumab.
Monalizumab is our NKG2A antibody being co-developed with AstraZeneca in non-small cell lung cancer. Turning to slide 12, PACIFIC-9 is a randomized phase III trial in patients with unresectable stage III non-small cell lung cancer who have not progressed following definitive platinum-based concurrent chemoradiotherapy. The study enrolled 1,051 patients and compares durvalumab plus oleclumab, durvalumab plus monalizumab, and durvalumab plus placebo, with progression-free survival as the primary endpoint. The program is supported by three earlier phase II studies in early non-small cell lung cancer, including COAST, NeoCOAST, and NeoCOAST-2. With enrollment complete, phase III high-level data are now expected in the first half of 2027. The updated timing reflects the event-driven nature of the study. I now hand over to Yannis to briefly review the economics of our partnership with AstraZeneca.
Thank you, Markus. As a reminder, we have received $450 million to date under our partnership with AstraZeneca, and additional potential milestones in the agreements are up to $ 825 million, together with double-digit royalties outside of Europe and 50% of profit sharing in Europe. Turning to slide 14, I now move to our next-generation ADC pipeline. Slide 14. Beyond IPH4502, we are using the capabilities and technology we have developed internally to build a broader pipeline of differentiated ADC candidates. Turning to slide 15. Our next-generation ADC strategy is focused on addressing several limitations we see with current ADC approaches. The portfolio is built on a proprietary linker technology, whose stability in patients is supported by our emerging clinical data for IPH4502.
We are developing a portfolio of drug candidates around three approaches: dual-targeted bispecific ADCs to address tumor antigen heterogeneity and to expand addressable indications compared with single tumor antigen targeting, bispecific ADCs with enhanced internalization to unlock activity in low-expressing tumors, and finally, dual-payload ADCs using complementary mechanisms of action to overcome resistance. I'll now hand the call back to Jonathan.
Thank you, Yannis. Moving to slide 17 and turning to our key near-term catalysts. For lacutamab, TELLOMAK-3 has been initiated, with first patient dosing expected in the first quarter of 2027, followed by a planned accelerated approval filing in Sézary syndrome in the second half of 2027. For IPH4502, phase I data will be presented at the EORTC-NCI-AACR Symposium on November 18, and we will host a hybrid event the same day with an in-person event in London and a webcast at 4:00 P.M. GMT or 11:00 A.M. ET. For monalizumab, PACIFIC-9 enrollment is complete, with the phase III readout now expected in the first half of 2027. We have several important near-term catalysts across our focused portfolio, together with a strengthened financial position that supports continued execution of our key priorities.
Before we conclude, I would like to acknowledge the departure of Frédéric Lombard, our Chief Financial Officer, who will be leaving Innate at the end of December to pursue a new career opportunity. We thank Frédéric for his significant contributions over nearly six years, including the strong teams and capabilities he has helped build. The search for his successor has been initiated, and we wish him every success in this next chapter. With that, operator, we are ready to open the call 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. 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 open. Please go ahead.
Hey. Morning, everyone. Phil on for Daina. Thanks for the question. I guess going into the triple meeting, can you just help set up some expectations for your poster? How many patients are you going to see and, I guess, what degree of follow-up? Secondly, just curious what your thoughts are on the head and neck opportunity given recent successes with EGFR and bispecifics. Thank you.
Thank you for the question. Maybe Markus, you can take that question.
Okay. It looks like Markus has lost his connection, so maybe I'll have a stab at answering your question. In terms of expectations for the ENA meeting, we have a phase I dose-finding study, so we recruited 76 patients. This was a basket tumor type, so there were over 10 different tumors within the study. What you should expect to see is the data regarding the safety profile of the product. I think with 76 patients, you see a pretty nice profiling of the safety. What you will also see is the totality of the data across those 10 tumor types, which I think we can draw some conclusions from an efficacy perspective. I think as we previously communicated, you would expect to see responses across a number of different tumor types.
We previously communicated that we've seen activity post-PADCEV in urothelial cancer, and we've also seen responses in non-small cell lung and head and neck cancer. I'm not going to go into the details of what you'll see. You'll have to wait for the poster presentation in Barcelona on November 18 for the specific details. I think that's probably it in terms of what you should expect to see. In terms of head and neck, we basically have, I would say, a limited dataset across each individual tumor type. You've got to remember that you will see data across different doses at each of those tumor types, so it's very difficult to draw specific conclusions on any one specific tumor type. I will stop there, but we have Markus now back on board, so maybe if Markus wants to add anything to that, he can. Markus?
Now I'm back, yes. Thank you. My button for unmuting was frozen, but this is fixed now. I think you said the essential things in a very comprehensive way. We are going to present our dataset as announced on the ENA meeting on the 18th, and it is important then to have a look on the entirety of data to see the full potential of the drug.
Got it. Thank you.
Your next question comes from the line of Jeet Mukherjee with BTIG. Your line is open. Please go ahead.
Great. Good morning, and thanks for taking the question. Two from us. First, just any thoughts on the delay behind PACIFIC-9 and what implications that may have on active and control arm performance? The second being, following the triple meeting for IPH4502, what can we expect as next steps for the program? Thanks.
Okay. Maybe I will start off and maybe give some high-level thoughts on PACIFIC-9, and maybe Markus can add to that, or Yannis as well. I think it is very difficult to draw any conclusions from the delay. As you know, this is an event-driven analysis, so the events are coming in more slowly. But that could mean a number of things. It could mean that the experimental arms are overperforming, or it could mean that the control arm is overperforming. So, I think it would be very difficult to speculate and try and draw any conclusions from the fact that there is a delay at this particular stage. I do not know, Markus or Yannis, if you want to add anything to that.
Yeah, just to reiterate, it is a blinded study conducted by AstraZeneca, and it is the nature of these kind of studies that at the end, there is a waiting for the trigger event. So what we see here is something many other studies have seen before. It is really not a signal to draw any conclusion out of it.
Markus, I do not know if you want to take the question on next steps following the ENA presentation for IPH4502.
Yeah. We have, of course, a clear picture where we want to go with the drug and with the next steps in the protocol. There will be more information around that released on the day of the poster presentation, and there will, in the afternoon, be the KOL event, where we can also answer questions.
As a reminder, if you would like to ask a question, press star one to raise your hand. It looks like there are no further questions at this time. We have reached the end of the Q&A session. I will now turn the call back to Jonathan Dickinson, CEO, for closing remarks.
Okay. Thank you, everyone, for joining us today. We look forward to updating you further as we continue to progress through our important near-term catalysts. Thank you, and I wish you a great rest of the day.
This concludes today's call. Thank you for attending. You may now disconnect.