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Innate Pharma S.A. (IPHA)

Q2 2025 Earnings Call· Wed, Sep 17, 2025

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Transcript

Operator

Operator

Thank you for standing by, and welcome to the Innate Pharma First Half 2025 Business Update and Financial Results Conference Call. [Operator Instructions]. I'd now like to turn the call over to Stéphanie Cornen, Vice President, Investor Relations and Communications. You may begin. Stéphanie Cornen: Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma H1 2025 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'd 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. I'll briefly cover today's agenda. Our CEO, Jonathan Dickinson, will discuss our strategic overview, path forward and commercial opportunity. Our COO, Yannis Morel, will provide an update on the scientific differentiation of our lead ADC. He will then hand over to our CMO, Sonia Quaratino, who will present clinical pipeline updates on IPH4502, lacutamab and monalizumab. Afterwards, our CFO, Frederic Lombard, will review the financials. Then Jonathan will return with closing remarks and we'll open the call for Q&A. With that, I'll now hand it over to Jonathan.

Jonathan Dickinson

Analyst

Thank you, Stéphanie, and good morning to those joining from the U.S., and good afternoon to our participants in Europe. Moving to Slide 5. Innate Pharma's foundation is in leveraging our deep scientific expertise to advance life-enhancing cancer therapies. Through our years of pioneering work in antibody engineering, we have built a differentiated high-value clinical pipeline supported by compelling data, and this positions us to deliver truly transformative treatments. Turning to Slide 6. During the first half of the year, we've made significant progress across our portfolio, and today marks an important new chapter for Innate. As you may have read in the press release for our half yearly update that we issued earlier today, we have made the strategic decision to focus our investment where we believe we can deliver the greatest impact for both patients and our shareholders. Therefore, going forward, our main investments will be centered on 3 high-value clinical assets, IPH4502, lacutamab and monalizumab. These programs represent the strongest opportunities to transform care and create meaningful value, and they will form the focus of today's discussion. At the same time, we will concentrate on selecting and advancing our next ADCs towards clinical development. As a consequence of this prioritization and sharpened focus, we intend to streamline our organization to deliver on our strategic objectives and key near-term milestones. This is a pivotal moment for Innate. We are aligning our strategy, our science, our organization and our investments to drive forward the programs that can truly make the biggest difference. I could not be more confident in the path we are taking, and I'm excited to share with you how we will execute on this vision in the coming presentation. As you will also have seen in this morning's announcement, our CSO, Eric Vivier, has decided to return to full-time academic research. Eric has been a true driver of the scientific agenda within Innate, so we are extremely pleased that he will continue to support the company's innovation in the important role as an adviser to the R&D Committee of the Board of Directors. Our Chief Operating Officer, Yannis Morel, has always had responsibilities for preclinical research and development, and he will now also assume the Chief Scientific Officer responsibilities. With that, I will now hand it over to Yannis for a closer look at our lead ADCs and the potential. Yannis.

Yannis Morel

Analyst

Thank you, Jonathan. First, on Slide 8, let me share with you why we think Nectin-4 is an attractive target for a next-generation ADC and why our highly differentiated Nectin-4 ADC has more potential across many solid tumors. Even though Nectin-4 is a validated ADC target, PADCEV or enfortumab vedotin carries some challenges and has several limitations. It is approved solely for patients with urothelial cancer where Nectin-4 expression is the highest. In addition, PADCEV-related toxicity often leads to treatment discontinuations and relapse are frequently observed, creating a growing medical need in the post-PADCEV setting. Finally, even though Nectin-4 is expressed at moderate to high level in several other tumor types, there is limited evidence showing that PADCEV is active beyond urothelial cancer. On the next slide, Slide 9. I want to show you why we are so excited by our next-generation Nectin-4 ADC program called IPH4502. As I said previously, this is a differentiated ADC that leverages a novel design to improve both safety and efficacy. IPH4502 is based on a proprietary humanized antibody that binds a unique epitope on the Nectin-4 molecule. The linker used is stable, cleavable and hydrophilic ensuring high ADC exposure and low systemic release of free exatecan, which minimize potential side effects. The payload itself, exatecan, is a potent topoisomerase I inhibitor. It shows what's called bystander activity, which means it impacts number in tumor cells that do not express high level of Nectin-4 and can therefore address tumors with heterogenous expression of Nectin-4. In addition, it remains highly active in enfortumab vedotin or MMAE-resistant models, allowing it to target tumors that have or became resistant to EV. In summary, the design of IPH4502 is purpose-built to overcome the limitations seen with existing therapies of [indiscernible] enfortumab vedotin. On the next slide, Slide 10,…

Sonia Quaratino

Analyst

Thank you, Yannis. Today, I will focus on preclinical assets that represent the potential to create the highest value for Innate, IPH4502, lacutamab and monalizumab. In the next slide, starting with IPH4502, the ADC-directed against Nectin-4, this is a trial that is an asset that is currently investigated in a first-in-human Phase I study. Enrollment in this dose escalation is going very well, and we are now on track to complete enrollment before the end of Q1 2026. The objective of the study is to assess the safety, tolerability and preliminary efficacy of IPH4502 in advanced solid tumors known to express Nectin-4. And we are pleased to present this study in a trial-in-progress poster at ASCO Annual Meeting in Chicago last June. The dose escalation is guided by an adaptive [indiscernible] design to determine the maximum tolerated dose. And once this is established, patients in 1 or 2 selected indications will be randomized across 2 dose levels to define the recommended Phase II dose as per FDA guidelines. The antitumor activity of IPH45 as a single agent will be further explored at RP2D in an expansion phase in selected indications in which signs of activities have been detected in the dose escalation, as well as confirming that the drug has a favorable safety profile and tolerability, the goal of this Phase I trial is to generate efficacy data that will guide the path forward for IPH4502, such as a basket trial in combination with standard of care or expansion phase to help maximize its value for both patients and shareholders. In Slide 14, we have the key milestones ahead for IPH4502. With enrollment progressing well, we expect to report preliminary safety and activity data in the first half of 2026. The preclinical data presented earlier by Yannis, are guiding us…

Jonathan Dickinson

Analyst

Thank you, Sonia, for showing how lacutamab has the potential to fundamentally reshape the care of CTCL patients. As you can see on Slide 23, the opportunity for lacutamab starts with Sézary syndrome, where following a potential accelerated approval in 2027, we see a clear launch pathway. In the past months, by assessing U.S. claims data, we have identified a significantly greater opportunity in Sézary syndrome than previously anticipated. It's been established that there are around 1,000 Sézary syndrome patients in the U.S. with approximately 300 new cases each year and a large pool of post-mogamulizumab treated patients. This represents a meaningful and derisked first market opportunity for lacutamab following an accelerated approval. After accelerated approval in Sézary syndrome, the opportunity expands into second-line plus setting for mycosis fungoides and ultimately, into earlier stages of CTCL patients, where a tolerable systemic option that are currently lacking and where lacutamab has the potential to create a new market opportunity and change the course of the disease for patients through early intervention to stop or delay disease progression beyond Stage IIa. It's been established through the same U.S. claims data that there are approximately 20,000 CTCL patients in the U.S. with an incidence of approximately 5,000 patients suggesting a larger population than previously estimated based on publicly available data. These new dynamics, combined with the additional potential in PTCL have led us to reconsider our strategy and the value we assign to lacutamab. To maximize the opportunity for lacutamab, we are currently planning to bring the product into Phase III and submit a BLA in Sézary syndrome, either with the support of investors or with a partner, but with improved deal terms. Already at launch, lacutamab has the potential to reach a substantial patient population, making it an interesting, profitable and value-creating…

Frederic Lombard

Analyst

Thank you, Jonathan. So for the first half of 2025, we've reported total revenue of EUR 4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi as well as governmental funding for research expenditures. Operating expenses were reaching EUR 30.3 million with EUR 20.5 million in R&D and EUR 9.8 million in G&A expenses. R&D expenses decreased by 29% compared to the prior year, reflecting the phasing of certain clinical programs, while G&A expenses remained stable at EUR 9.8 million. At June 30, 2025, we had EUR 70.4 million in cash, cash equivalents and financial assets, providing a cash runway until the end of the third quarter of 2026. With that, I'm turning it back to Jonathan for closing remarks.

Jonathan Dickinson

Analyst

Thank you, Frederic. Turning to Slide 28, you can see our news flow for the near and midterm, which is fully aligned with the strategic refocus I outlined at the beginning of today's call. For IPH4502, our novel Nectin-4 ADC, the Phase I trial is progressing well and we expect data in the first half of 2026. While our preclinical R&D continues to build a strong ADC pipeline to fuel our next wave of candidates as shown by Yannis. Lacutamab has secured FDA breakthrough therapy designation, supported by long-term follow-up data presented at ASCO. And we are preparing the Phase III protocol submission following our discussion with regulators as indicated by Sonia. And for monalizumab, AstraZeneca's Phase III PACIFIC-9 trial is fully recruited and remains on track for primary completion in the first half of 2026 with data expected in the second half of 2026. Turning to Slide 29. In summary, we are excited about the opportunities ahead and confident in our ability to deliver value for patients and shareholders. We are concentrating our investment on what we believe are our highest value clinical stage assets, IPH4502, lacutamab and monalizumab, where we have multiple near-term catalysts, and we will rightsize our organization to deliver on these strategic priorities. With EUR 70.4 million in cash at the end of June, we are funded to the end of the third quarter of 2026, providing Innate the ability to execute on our focused strategic priorities. Thank you for your attention. And with that, operator, please open the line for questions.

Operator

Operator

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

Bill Ling

Analyst

You got Bill on for Daina. So I guess, what should we take away on the potential of targeting NK cells now that ANKET's are not included in your prioritization today as well as Eric Vivier sort of leaving the company?

Jonathan Dickinson

Analyst

So takeaways from -- I would like to say from Eric leaving the company, maybe that's the place to start off. Eric is leaving the company, but he will still play an important role with the company moving forward. He will be an adviser to the R&D Committee of our Board of Directors. And we have an extended research collaboration with his lab. So we basically will continue to benefit from any innovation, which Eric can bring to the table. Moving back to NK cells and the reading, we are still working on NK cells. It's not our main priority today. We're focusing on what we believe are our highest value clinical assets, IPH4502, lacutamab and monalizumab. We will be basing all future decisions on our NK cell engagers on clinical data and the relevance of that clinical data to markets, and we'll make the appropriate decisions on those assets when we have that clinical data and establish market relevance based on that data. So it's not the end of NK cells, but it's not our priority today anymore.

Operator

Operator

We'll move on to our next question, and it comes from the line of Swayampakula Ramakanth from HCW.

Swayampakula Ramakanth

Analyst

So now that the ANKET programs are out at least as far as your development is concerned. Any commentary on where Sanofi is with the assets that they currently are developing?

Jonathan Dickinson

Analyst

Absolutely. So I'd just like to say that it's not the end of the story for NK cells. We're still moving forward and completing the studies with IPH6501. We have a path to explore IPH61 via investigator-initiated research and an interesting way forward. So I wouldn't say it's the end of NK cells. It's just that it's been basically lowered in our current company priorities. From a Sanofi perspective, Sanofi continues to progress the BCMA-targeted ANKET. And as I think we've communicated in the past, that's being explored in autoimmunity, in immunology as part of Sanofi's focus as a company, and we expect to have updates from Sanofi on that BCMA program in the near future.

Swayampakula Ramakanth

Analyst

And then regarding the Phase III start for lacutamab, should we still assume that unless you have a partner signed up ahead of the start of the study, it will still -- it will be a wait and watch until you get a partner or you have enough commitment from investors to go ahead and start that study?

Jonathan Dickinson

Analyst

So we are actively working with investors at the moment to basically keep options open. So we're continuing discussions with partners, but we also have some very advanced discussions with investors who are very interested in lacutamab, now that we effectively have a derisked development program to move forward into Phase III. And we also see interest based now on the increased potential commercial opportunity. This also will reinvigorate discussions with partners. And we are also expecting next steps with respect to the finalization of the protocol for the confirmatory Phase III study, which is also an important step for partners. So we continue the discussions with partners. But at this stage, we see it as very important to keep our future options open to either go down the partner route, but with improved deal terms based on the significantly larger potential market opportunity, particularly with the first accelerated approval launch in Sézary syndrome. And so yes, we're keeping the options open with both -- for both moving forward with investors and with potential partners.

Swayampakula Ramakanth

Analyst

So last question from me, Jonathan. This is on 4502. Based on the preclinical data that you have generated so far, what potential indications do you think 4502 will be effective? And since there are numerous Nectin-4 ADC's in the clinic right now, how differentiated are you is 4502 against those?

Jonathan Dickinson

Analyst

Yes. So maybe, Sonia, you can take the first part of that question, Sonia?

Sonia Quaratino

Analyst

Yes. Can you repeat the question, please?

Swayampakula Ramakanth

Analyst

Yes. Based on the preclinical data that you have generated to date, what indication do you think is where 4502 could be effective?

Sonia Quaratino

Analyst

Right. As I mentioned before, we focus on any indication that express Nectin-4 because we believe that we also can target dose indication with a relatively small Nectin-4 expression, but we also very much focus on the urothelial cancer patients who became refractory or resistance to PADCEV. And for these patients, there are no approved drugs. And if we have clinical -- good clinical data in this refractory relapsed patients, we really may have a very fast opportunity for an accelerated market approval in UC post-PADCEV. So we are exploring, let's say, the classic path as well as some more defined area for an accelerated -- potential accelerated approval.

Jonathan Dickinson

Analyst

And then in terms of differentiation, RK, I mean, I think we believe that we'll be able to show differentiation here, particularly versus PADCEV or MMAE-based ADCs, due to the payload and the different resistance and toxicity profile, which we believe we'll be able to show meaningful differences between IPH4502 and MMAE-based ADCs.

Operator

Operator

Your next question comes from the line of Justin Zelin from BTIG.

Justin Zelin

Analyst

Maybe I'll continue the questioning on 4502. If you can just give us an update on how enrollment has been progressing here. I know you gave an update here on enrollment completion. Just was curious on how you could comment on how enrollment is going today. When we should expect the initial data, if it will be sometime in the first half of next year, how many patients' worth of data we should expect? And any expectations from a safety or efficacy standpoint from that update?

Jonathan Dickinson

Analyst

Sonia, do you want to take that one?

Sonia Quaratino

Analyst

Of course, of course. As mentioned, the enrollment with IPH45 is going extremely well. We always have, let's say, a list of patients to go in -- at a different dose level. And also with the [indiscernible] design that we have, we also have the possibility to have parallel enrollment in backfill cohorts. And so, we do not have the classic 3 plus 3 design with an extremely limited number of patients, but we can expand different to dose levels as we go along. To your question, of course, we plan to finish the enrollment in the first quarter of 2026. And of course, the data in terms of at least from the first CT scan can only occur as you can understand, 8 weeks later from the first dosing, so it takes another quarter to have the clinical efficacy from the last cohort recruited. Having said that, we are going to have probably a pool of data of 50, 60 patients by then.

Operator

Operator

And there are no further phone questions at this time. I will now turn the call back over to management for any written questions. Stéphanie Cornen: Yes, we have one question on the line here from Rajan Sharma. So the first question is, does the new strategic focus means, ANKET assets will not be progressed irrespective of clinical data, given that 6501 data are expected in the near term?

Jonathan Dickinson

Analyst

So, I think I answered this earlier, but I'll repeat it again. So from an IPH6501 perspective, the study continues, and we expect to have data, I think, as we've communicated previously, towards the end of this year or very early next year. And we will make any decisions on the next steps for IPH6501 based on that clinical data and the clinical relevance of that data to the marketplace. Stéphanie Cornen: Okay. And so the next question, what is the financial impact of the strategic refocus and head count reduction and what proportion of current R&D expense are directed towards IPH4502 and lacutamab?

Jonathan Dickinson

Analyst

So the financial impact, we've not -- and we won't be communicating specific numbers on the impact of the financial reductions. We're in a legal process now, which is a French legal process to reduce the size of the organization, which gives us an obligation not to communicate on certain components, and that would fall under that legal framework that we're operating within. So we can't provide specific guidance there. In terms of R&D expenses, maybe Frederic would like to comment on the proportion. Stéphanie Cornen: So the question was, what proportion of current R&D expenses are directed towards IPH4502 and lacutamab?

Frederic Lombard

Analyst

Yes, we usually never communicate on the investment that we do in those 2 in the portfolio. But following up on the comment from Jonathan, we have a significant portion of our external expenditure, which are on those assets. Stéphanie Cornen: So we have another question from Oussema Denguir. So with regard to financial visibility, does estimate for the end of the third quarter of 2026, taking into account the impact of the restructuring plan?

Jonathan Dickinson

Analyst

The answer to that is yes. So the restructuring plan is fully embedded into the cash runway, which takes us to the end of Q3 2026. Stéphanie Cornen: And last question, concerning Phase III of lacutamab, can you provide an initial estimate of the investment requirements, if you decide to trial without a partner?

Jonathan Dickinson

Analyst

Again, this is something that we would not normally communicate on in terms of the cost. This is a standard Phase III study. So I think you can draw your own conclusions. It's nothing too dissimilar from similar oncology Phase III trials. Stéphanie Cornen: Thank you, Jonathan. There is no further question.

Jonathan Dickinson

Analyst

Okay. So thank you for everybody's time and attention and for your interest in Innate Pharma, and we'll look forward to meeting with you in person in the near future or on one of our next calls. Thank you, and goodbye.

Operator

Operator

This concludes today's conference call. Thank you for your participation. You may now disconnect.