Innate Pharma S.A. (IPH) Earnings Call Transcript & Summary

Hello, everyone. Thank you for joining us, and welcome to the Innate Pharma webcast call. [Operator Instructions] I will now hand the conference over to Stephanie Cornen, Vice President of Investor Relations and Communications 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 expectations. 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, Stephanie, and 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 greenlighted 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 USD 75 million upfront as well as up to USD 40 million in near-term milestones associated with the Sézary syndrome accelerated approval. There is subsequently an additional USD 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 resistance setting as well as in tumor models of low Nectin-4 expression. We communicated on July 21 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 high unmet 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. And 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. So -- with the ADC preclinical portfolio, we're following 3 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. And 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 raise, together with the USD 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.

[Operator Instructions] Your first question comes from the line of Daina Graybosch with Leerink Partners.

I wonder for IPH4502, if you can give us any more guidance on how many patients in follow-up you'll have in the 3 highlighted indications, so the post-PADCEV, bladder, head and neck and lung. And then I have a follow-up after that.

So maybe I can take that one, Daina. So we've not given any guidance on the specific number of patients in each of the indications. What we've said is we expect to have 10 to 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's not ESMO, so a subsequent medical conference.

Got it. And then we've had a lot of exatecan ADC readouts recently with, I'd 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's 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 don't think we do. So maybe I will give it my best shot and maybe Stephanie can jump in. So I think what we have communicated, Daina, is that what we've seen so far is that our linker, I think, benchmarks with the best linkers that we've seen out there. We've also been able to achieve doses which are in line with other Topo I and exatecan-based payloads. So we're at that point where with other targets at the particular dose we're at, we've basically seen efficacy with those other products. So I think that gives us a good sense of where we're at. I think the other thing that we found very encouraging was the Lilly data set with their ADC with the [ camptothecin 98 ] payload at ASCO in terms of the fact that it validated the approach of coming with a TOPO1-based ADC targeting Nectin-4 post-PADCEV. So we took that as a validation, of course, with the caveats of the Lilly ADC and the payload being metabolized through 2D6 and having this genetic variation and potential liability associated with that. So if we pull that together, I think we're feeling quite confident that we have a window here from a dosing perspective where IPH4502 will be effective. And I think we've mentioned we have seen responses, including in the post-PADCEV setting. And 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 pembro. So really, 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 in -- with 5 sites in the U.S. and 2 sites in France. So all of these patients have had the best standard of care and are progressing on therapy when they enter the study. So when we see activity, we're genuinely seeing something real here. And 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 are 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. So hopefully, I've addressed your question.

Maybe Yannis can follow up when he's back from his vacation.

Thank you. 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.

Can you hear me?