Innate Pharma S.A. (IPHA) Q1 2026 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for joining, and welcome to the Innate Pharma First Quarter 2026 Business Update and Financial Results. [Operator Instructions] I will now hand the conference over to Stephanie Cornen, Vice President of Investor Relations, Communications and Commercial Strategy at Innate Pharma. Please go ahead.

Good morning, and good afternoon, everyone. Thank you for joining us for Innate Pharma's Q1 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. Sonia Quaratino, our Chief Medical Officer; and Yannis Morel, our Chief Operating Officer and I will then provide updates on lacutamab, IPH4502 and next-generation ADCs as well as AstraZeneca partner program, including monalizumab and IPH5201. Jonathan will then return with closing remarks. Frederic Lombard, our CFO, will join us for the Q&A. With that, I will now hand it over to Jonathan Dickinson.

Thank you, Stephanie. Good morning to those joining from the U.S., and good afternoon to our European participants. Turning to Slide 5. We continue to execute against our strategy, which is focused on our 3 priority assets with discipline, and we're pleased with the strong progress we are seeing to date. Starting with lacutamab, our anti-CIR3DL2 monoclonal antibody, which is being developed in cutaneous T-cell lymphoma or CTCL. As you remember, we received the FDA clearance to proceed with the TELLOMAT-3 Phase III trial for lacutamab in CTCL, and we expect to be able to initiate the study in the second half of 2026. We have made progress in negotiating non-dilutive financing options for lacutamab, including potential pharma partnerships and royalty-based structures. From a commercial perspective, we believe that lacutamab represents a meaningful opportunity in CTCL in both the United States and Europe with additional life cycle expansion opportunities in peripheral T-cell lymphoma. Moving to IPH4502, our differentiated Nectin-4 ADC, which is being evaluated in advanced solid tumors. The Phase I study is ongoing and approaching completion of enrollment in the dose escalation phase and backfill cohorts. As highlighted on the slide, we continue to observe preliminary antitumor activity in heavily pretreated patients, including in urothelial cancer patients previously treated with EV. We believe that IPH4502 may represent a differentiated opportunity, both in the post-PADCEV urothelial cancer setting and potentially across a broader range of solid tumors. And finally, turning to monalizumab, our AstraZeneca partnered anti-NKG2A monoclonal antibody, which is being developed in non-small cell lung cancer. The ongoing PACIFIC-9 Phase III study remains on track for a planned readout in the second half of 2026. From a financial perspective, the partnership also continues to represent a potentially important source of future value for Innate, including potential milestones, profit sharing in Europe and royalties in the United States and the rest of world. Overall, we believe these 3 assets provide Innate with a focused portfolio of differentiated clinical stage opportunities spanning both proprietary and partnered programs. I'll now hand over to Sonia and Stephanie for a more detailed review of the lacutamab program.

Thank you, Jonathan. Turning to Slide 7. Lacutamab continues to progress towards initiation of the TELLOMAK-3 confirmatory Phase III trial and the potential accelerated approval pathway in Sezary syndrome. As a reminder, the Phase II TELLOMAK study has demonstrated clinical meaningful and durable activity in both mycosis fungoides and Sezary syndrome, including improvement in quality of life with a favorable safety and tolerability profile supporting potential for long-term treatment. Based on this data, lacutamab has received breakthrough therapy designation from the FDA in relapsed or refractory Sezary syndrome. It has previously received Fast Track designation from the FDA, prime designation from EMA and orphan drug status in both United States and Europe. The Phase II data from the TELLOMAK trial also support the potential accelerated approval filing in Sézary syndrome once the confirmatory Phase III trial is underway. In the next slide, the planned TELLOMAK-3 is an open-label multicenter randomized comparative study to demonstrate the efficacy and safety of lacutamab in 2 separate cohorts of patients with cutaneous T-cell lymphoma who have failed at least 1 prior systemic therapy. In Cohort 1, patients with any stage Sezary syndrome who have failed at least 1 prior line of systemic therapy, including mogamulizumab, will be randomized 1:1 to either lacutamab oleclumab. In Cohort 2, patients with MS ranging from Stage Ib to 4 who have failed at least 1 prior line of systemic therapy will be randomized 1:1 to either lacutamab or mogamulizumab. Both cohorts will be randomized 1:1 and randomization will be stratified according to disease stage and region. The primary endpoint for both cohorts is progression-free survival assessed by blinded independent central review. The secondary endpoint for the secondary cohort is overall survival, while the key secondary endpoints for the MS cohort are quality of life and pruritus. TELLOMAK-3 study is designed to serve as the confirmatory trial for Sezary syndrome while also supporting full approval in mycosis fungoides. And from a regulatory standpoint, we have received FDA clearance to proceed with this clinical trial protocol, and we continue towards Phase III initiation expected in the second half of 2026. Stephanie will now go through the commercial opportunity. Stéphanie Cornen: Thank you, Sonia. So we continue to believe lacutamab represents an attractive commercial opportunity supported by a focused and efficient commercial foot syndrome -- based on recent analysis, we estimate 30 Sézary syndrome in the U.S. with a prevalence of around 1,000 patients, the majority of whom are treated in a limited number of specialized academic centers. Mucositides larger 3,000 incident patients and the prevalence of around 12,000 patients in the U.S. from an analysis conducted by Associates are now available in the EHA 2026 online -- this is a highly concentrated treatment landscape with over 85% of patients managed in academic centers and a large proportion treated within approximately 50 key institution. This concentration enables a targeted commercial approach with limited infrastructure. At the same time, Sézary syndrome and mycosis fungoides share the same prescriber base, which is a critical point from a commercial perspective. This means that an initial launch in Sézary syndrome is not a stand-alone opportunity, but a direct entry point into the broader CTC Importantly, when looking at the current market, moamizumab generated approximately $300 million in annual sales in 2025 as planned and is projected to reach $350 million in 2026 with strong adoption in Sézary syndrome and more limited penetration in mycosis fungoides. This provides a relevant benchmark for the market opportunity and highlights the potential for our therapy to capture share across both Sézary syndrome and mycosis fungoides. From a value perspective, key drivers include treatment duration, which is supported by durability of responses, pricing and market share across a broader eligible patient population. Sézary syndrome, expanding to over $500 million across Sézary syndrome and mycodungoid in the second setting with additional upside as lacutamab moves into earlier lines of therapy and broader patient segments over time. I will now hand it over to Yannis to start the update on IPH4502.

Thank you, Stephanie. IH4502velntiated ADC, which is in Phase I. Slide 11, IH450 has been designed to overcome the limitation of the third-generation Nectin-4 ADCs and to deliver a more favorable therapeutic profile across multiple solid tumors. The drug candidate is based on a proprietary humanized antibody that binds to a distant nonoverlapping epitope on the Nectin-4 target. It is combined with a stable cleavable and heroinic linker, which supports high systemic exposure of the ADC while minimizing the release of freeexotican in circulation and therefore, reducing the risk of off-target toxicity. The payload is a potent topoisomerase 1 inhibitor with strong bystander activity enabling to target not only Nectin-4 expressing tumor cells but also neighboring cells with lower or heterogeneous expression. Moreover, it is not sensitive to the mechanism of drug resistance related to MMA, allowing to address patients who have been pre-exposed to PDC. Next slide shows how IPH4502 is positioned within the evolving Nectin-4 ADC landscape. The first wave of Nectin-4 ADC largely relied on the MMAE payloads, including enfortumab vedotin. While EV has validated Nectin-4 as an important ADC target, other MMAE-based approach will most likely face similar limitation than EV, such as MDR1 resistance and peripheral neuropathy. IPH4502 is designed to address these limitations through payload and differentiated linker design -- we believe this creates a potential opportunity in bladder cancer, particularly in the post setting as well as across multiple tumor types with low or moderate Nectin-4 expression. Overall, we believe ITH4502 has a potential to be best-in-class TPO1ectin-4ADC driven by its differentiated design. On the next slide, we show newly generated preclinical data that continue to reinforce the best-in-class potential of ITH4502 as a T1 Nectin-4 ADC. You can see that in both high and low Nectin-4 expressing models, ITH4502 demonstrates robust antitumor activity. However, the key differentiation versus other TO1ectin-4 clinical ADCs appears in model with low Nectin4 express H502 maintains meaningful antitumor efficacy, while the other clinical ADC show a clear loss of activity. This is really important as it highlights the unique ability of IPH2502 to remain active in tumors with lower target expression. Overall, across multiple in vivo models, we constantly observe better efficacy for IPH2502, supporting its best-in-class agent potential, particularly in low to moderate Nectin-4 expressing tumors. Now turning to Sonia for the clinical update.

Thanks, Yannis. Turning to Slide 14. We see the outline of the clinical design of the Phase I of IPH4502 study. We are currently evaluating this asset in a first-in-human Phase I open-label multicenter study in patients with advanced solid tumors known to express Nectin-4. We collect tumor biopsies at baseline from these patients and evaluated the Nectin-4 expression retrospectively. The study started in January 2025 and runs a specialized cancer sites in the U.S. and in France. This first-in-human study is guided by an adaptive Bing designed with backfill cohorts with the objective to assess safety, tolerability and preliminary antitumor activity. Cohorts are backfilled at lower doses during the dose-finding trial while prioritizing the dose escalation cohort to explore a higher dose. These backfills help to generate more data in terms of safety, PK, efficacy at a given dose level. Enrollment in the dose escalation part of the study has progressed well and Phase I dose escalation and cohort enrichment are nearing to completion and the maximum tolerated dose has been reached. We have defined a clear therapeutic window with a favorable safety profile to date and see preliminary efficacy at different dose level within the defined therapeutic window in heavily pretreated patients with advanced solid tumor, including urothelial cancer patients who have progressed after mabenitin. Turning to next slide. We see that we highlighted the growing therapeutic gap in bladder cancer after progression on EV plus pembro. Despite the advancement of unfortunate vedotin that has introduced in urothelial cancer patients, 2/3 of these patients still experience disease progression within 2 years and the management of patients who progress to this regimen has become a critical challenge. As of 2026, there is no single established gold standard for second-line therapy after EV pembro, but several strategies are utilized based on patient-specific factors. For patients who received first-line EV plus pembro without prior platinum exposure, platinum-based chemotherapy, cisplatin or carboplatin with gemcitabine is the preferred subsequent option. Real-world data indicates modest efficacy with a median real-world time to next therapy of approximately 3 to 4.7 months. Due to the limited efficacy of current second-line options, enrollment in clinical trials is strongly prioritized in 2026 guidelines to investigate novel mechanism of action and combination therapies. This creates a significant unmet need in the post EV plus pro setting, and we believe IPH4502 is well positioned to potentially fill this therapeutic gap. In the next slide, we'll see our development vision for IPH4502, which includes both bladder cancer and broader solid tumor opportunities. In bladder cancer, we see an opportunity to address the growing population of metastatic urothelial cancer patients who progress after EV-based therapy, where Nectin-4 expression appears to remain stable in tumor from patients who progress after EV. Over time, we also see potential to move to earlier lines, including in combination with anti-PD-1 therapy. Beyond bladder cancer, we believe IPH4502 may also have potential across multiple solid tumors with low to medium Nectin-4 expression, and we intend to consolidate the signals observed in the dose escalation study. Overall, our objective is to build a broad and modular clinical development strategy, starting with high unmet need populations and expanding into earlier lines of therapy and additional tumor types over time, depending on the emerging data.

Now before we move ahead with our partner program, this slide highlights how we have built a comprehensive ADC discovery platform to develop a portfolio of next-generation ADCs designed to overcome the limitation of the current ones. Building on the IPH4502 linker, which is -- which stability in patients is clearly demonstrated by our emerging clinical data, we are developing a drug candidate portfolio around three approaches. Dual targeted bispecific ADCs to address tumor antigen heterogeneity and to expand addressable indications compared to single tumor antigen targeting. Then bispecific ADC with enhanced internalization to unlock the activity in the low expressing tumors. And finally, dual payload ADCs using complementary mechanism of action to overcome resistance. Our next wave of ADC is currently progressing towards candidate selection and then IND-enabling studies. Now turning to Sonia.

Turning to Slide 19. We now provide an update on our AstraZeneca partnered programs, monalizumab and IPH5201 -- in the next slide, let's start with monalizumab. The PACIFIC-9 is a major Phase III randomized double-blind study to demonstrate that dual immunotherapy can significantly increase the survival rate of patients with unresectable Stage III non-small cell lung cancer who have not progressed following definitive concurrent chemo radiotherapy. The rationale for this trial is supported by 3 Phase II studies in early-stage non-small cell lung cancer, including COAST, NeoCOAST and NOCOST-2 studies. These studies reinforced the potential of targeting the NKG2A pathway to enhance the innate immune response alongside PD-L1 inhibition in early-stage lung cancer. And enrollment in PACIFIC-9 has been completed, and now we look forward to the data expected in the second half of 2026. Now in the next slide, let's move to another asset this time in the adenosine pathway that is also codeveloped with AstraZeneca, IPH5201 that blocks CD39 an enzyme that converts ATP into adenosine, which suppress immune system. By preventing this conversion, the therapy is really driving the immune system within the tumor microenvironment. IPH5201 is currently evaluated in the MATIS Phase II trial in combination with durvalumab and neoadjuvant platinum-based chemotherapy in patients with resettable non-small cell lung cancer. The recent preplanned interim data presented at the ACR Annual Meeting on April 21 during a clinical trial plenary session has significantly strengthened the case for this anti-CD39 antibody. The interim analysis of 40 patients demonstrated that the combination of IPH5201, durvalumab and chemotherapy is achieving pathological complete response rates that compare very favorably to the current benchmark. The primary endpoint of pathological complete response showed a strong correlation with PD-L1 expression level. Based on the robust 35.7% PCR rate in PD-L1 above 1% and 50% PCR rate in patients with tumor with PD-L1 expression of at least 50%. The study is now moving forward by focusing recruitment exclusively on patients with PD-L1 positive tumors. No new or unexpected safety signals were identified. The combination was generally well tolerated with most adverse events being grade 1 or 2. CD3 cell density in tumors is warrant to be further investigated as an emerging biomarker for predicting pathological complete response in IH5201usurvalumab treatment. Overall, this encouraging early findings support continued investigation of IPH5201 in non-small cell lung cancer.

Coming to Slide 22. Slide 22 summarizes the financial highlights of our AstraZeneca partnerships. For monalizumab, the agreements amount up to $1.275 billion of milestones. We have already received $450 million and remain eligible to additional $825 million of potential payments AstraZeneca will book sales and Pharma will receive double-digit royalties on sales in the U.S. and rest of the world. In Europe, since Innate Pharma is contributing to 30% of the funding for the Phase III trial, we will get 50% of the profits and have the option to co-promote the drug ForX5201, the agreement is worth up to $85 million in milestones. To date, we already received $60 million and remain eligible to $825 million. This agreement having a similar structure than the monalizumab Innate Pharma has also the option to Phase III trial in order to get 50% of the European profit and co-promotion rights. Otherwise, Innate Pharma will receive royalty in Europe like in the U.S. and rest of the Together, this partner program provides IM with meaningful potential nondilutive cash through future milestones, royalties and profit sharing economics. I will now hand over to Jonathan for closing remarks.

Thank you, Yannis, Sonia and Stephanie. So turning to our upcoming milestones. Over the coming quarters, we expect several important catalysts across our priority assets. For lacutamab, we remain focused on initiating the TELLOMAT-3 confirmatory Phase III study in the second half of 2026, subject to financing. For IPH-4502, the study is progressing very well, and we have observed preliminary antitumor activity with a favorable safety profile to date, including in patients with urothelial cancer relapsed or refractory to EV, which is a signal that we're starting to validate our preclinical hypothesis. We look forward to continued maturation of the emerging clinical data set following completion of dose escalation and cohort enrichment. And for monalizumab, the PACIFIC -- the Phase III PACIFIC-9 trial in non-small cell lung cancer has completed enrollment with data expected for the primary endpoint in the second half of 2026. Taken together, these 3 programs provide a clear set of value-driving catalysts across our portfolio. With a cash position of EUR 25.4 million as of March 31, 2026, we remain disciplined in our execution and focused on advancing programs that we believe have the potential to deliver meaningful value for both patients and shareholders. With that, operator, we're now ready to open the call for questions.

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

I have a question on MATIS and CD39 since that was presented recently. The discussion at AACR pointed out that while the triplet compares quite favorably to prior outcomes with durvalumab plus chemotherapy, it looks pretty similar to prior outcomes with the PD-1 plus chemotherapy in the neoadjuvant setting. And I wonder what gives you confidence given that sort of range of broader benchmarks? And in the next part of the MATIS trial, is there a certain threshold of activity or biomarker finding that AZ and you are looking for to take it forward into Phase III?

I think Sonia between the two of you. I know you want to start and then Jan can fill in on the second.

Sure. Of course, you are right to say that this interim data show that the rate -- the PR rate that we observed at this interim analysis may be comparable to what has been seen in other trials using pembrolizumab. But when you are benchmarking, of course, with the same PD-L1 backbone that is durvalumab, you have to admit that there is a significant uplift this therapy as a single agent. And so in that respect, this has definitely produced an increase of pathological complete response. That is not matched by an increase of toxicities, which is remarkable. We've also seen that, for instance, in PCR high expression, this PCR rate goes even higher. Of course, we cannot predict where this trial might materialize in a Phase III. But so far, the data looks very promising.

Yes, like Sona said, I mean, this trial has basically is providing 2 level of information. So that when you add CD39 on top of an active PD-1 blocker, it's increasing the PCR rate. So for us, it's clearly if the signal is confirmed on the additional patients really validating the targeting of this checkpoint in the adenosine pathway plus targeting the, I would say, the efficacy of our drug candidate. Then whether will decide to take the license on this one and move it into Phase III, that's another question that is more actually for A. But from a perspective, it's very important to confirm and to establish that the blocking of CD39 can be effective in that perspective.

Your next question comes from the line of Christopher Liu with Lucid Capital Markets.

Maybe just two for me about 4502. So for the first question, are there any additional details you can give us on the profile of the drug at the go-forward dose? And for the second question, what do you see as the most compelling indications outside of bladder cancer for the asset considering market opportunity and potential competition?

Thanks for the question. At this moment, we can only say we have seen some efficacy readouts in a different dose level within the therapeutic window. And we will be a bit more specific around both dose levels as well as potential indications to bring forward at clinical conference this year.

Your next question comes from the line of Swayampakula Ramakan with H.C. Wainwright.

This is RK from H.C. Wainwright. Regarding the Nectin-4 ADC... You -- it's just Lilly's product, which are in Phase I and Bicycle recently deprioritized their product. So how do you see the competition going forward? And what sort of data would you be able to release in the next 6 months or so, so we have an understanding of how you are poised against the competition?

Well, thanks for the question. In fairness, we don't know much about Lilly so far. And we can only speculate that perhaps the asset was deprioritized because it doesn't look as good as the other Nectin-4 program that they also have in clinical development. We do not have the data because they have not been shared, and we can only see when the abstract will be available on the 21st of May. Yes. Sorry for not adding more color, but we don't have... details.

Yes. And then in terms of the data, I think Sonia mentioned earlier that we expect to present the data at a medical conference sometime Later in the second half of the year. And I think at that point, you will see go-forward indications and the data in urothelial cancer and yes, and next steps for the program.

Okay. And then on the collaboration with AstraZeneca, have you elected for the 30% funding on the PACIFIC-9? And what's -- is there any residual cash obligations between you and them?

I mean, between now and a positive readout... I just to qualify a couple of things. So the agreement that we have with AstraZeneca, it's capped at a certain level, and we are actually very close to the cap of the contribution. So there are actually minimal contributions required between now and the data readout.

Your next question comes from the line of Jeet Mukherjee with BTIG.

Two from our side. Just any further color or perspective on the status of the lacutamab partnership discussions? Do you anticipate or feel confident that a deal can be finalized before the third quarter of this year? And the second question, are we expecting any Phase II PTCL data from lacutamab this year as well?

So maybe on the partnerships, maybe I can start off and Yannis can fill in any gaps. So we are very confident that we will execute either a BD partnership or a royalty financing partnership for lacutamab. The discussions are quite advanced, and we would expect to be able to conclude one of those 2 types of partnerships moving forward in the relatively short term. And from our perspective, it doesn't really matter which way we go with either a BD partnership or a royalty financing partnership. We would be running the Phase III confirmatory study. So that will be in our control where we could utilize our expertise that we've developed in the CTCL area from the TELLOMAK-2 study. So we'll make that decision in the coming future, basically based on what's best for the company in terms of the NPVs of the 2 different approaches. So something coming in the future. Yannis, I don't know if you want to.

Short answer is yes, we are confident that we can execute something before Q3...

And just the second question around Phase II.

Yes. PTCL, as you know, is run by the LARC group, and we are towards the completion of this study, but I don't think that this data will materialize before the end of this year. Yes. And we have no further visibility on this study.

Yes. This is an IST, it's under the control of the LSA group. So this is not a place where -- it is independent where we can have control of the time lines. We know that the LSR group are quite excited about lacutamab in combination with the GEMOX chemo regimen, where they're studying this in late-stage patients. And we're optimistic that there will be data at some point in the future, but we can't put a very specific time line on that.

There are no further questions at this time. I will now turn the call back to Jonathan Dickinson, CEO, for closing remarks.

Okay. Thank you, everybody, for attending the earnings call today. We're at a point in time where I think we have some very exciting catalysts coming over the coming months. So just to remind you, on lacutamab, the initiation of the confirmatory Phase III program. For IPH4502, we're expecting to be releasing data on the first-in-human studies at a medical conference before the end of the year. And then on monalizumab, we have the results from the primary endpoint of the PACIFIC-9 study coming before the end of the year. So thank you, everybody, for attending, and we look forward to giving you some updates in the very near future. Thank you.

This concludes today's call. Thank you for attending. You may now disconnect.