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Earnings call · FY2026 Q1
Executive readout · one minute
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Net tone +53 · moderate hedging
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Ladies and gentlemen, thank you for joining us and welcome to the Nate Pharma First Quarter 2026 Business of Aid and Financial Results. After today's remarks, we will host a question and answer session. If you'd like to ask a question, please press start one on the telephone keypad to raise your hand. I will now hand the conference over to Stephanie Cornen, Vice President of Investor Relations, Communication and Commercial Strategy at Nate 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 risk 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 Cuaratino, our chief medical officer, and Yanis Morel, our chief operating officer, and I will then provide updates on lacutamab, IPH 4502 and Next Generation ADCs, as well as AstraZeneca partner program, including Monalizumab and IPH 5201. Jonathan will then return with closing remarks. Frédéric Lombard, our CFO, will join us for the Q&A. With that, I will now hand it over to Jonathan.
Thank you, Stephanie. Good morning to those joining from the US and good afternoon to our European participants. Turning to slide five, we continue to execute against our strategy, which is focused on our three priority assets with discipline, and we're pleased with the strong progress we are seeing today. Starting with lacutamab, our anti-CUR3-DL2 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 TELEMAT-3 phase 3 trial for Locutumab 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 Locutumab, including potential pharma partnerships and royalty-based structures. From a commercial perspective, we believe that lacutumab 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 anti-tumor activity in heavily pretreated patients, including in urophilial cancer patients previously treated with EV. We believe that IPH4502 may represent a differentiated opportunity, both in the post-PADCEF urophilial cancer setting and potentially across a broader range of solid tumors. And finally, turning to monoluzumab, our AstraZeneca-partnered anti-NKG2A monoclonal antibody, which is being developed in non-small cell lung cancer. The ongoing Pacific 9 phase 3 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 a NAIT, including potential milestones, profit sharing in Europe and royalties in the United States and the rest of the world. Overall, we believe these three assets provide a NAIT 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 Telomac 3 confirmatory phase 3 trial and the potential accelerated approval pathway in Caesary syndrome. As a reminder, the phase 2 telomax study has demonstrated clinical meaningful and durable activity in both mycosis fungoidus and caesary syndrome, including improvement in quality of life with a favorable safety and tolerability profile supporting potential for long-term treatment. Based on this data, lakutamab has received breakthrough therapy designation from the FDA in relapsed or refractory cesare 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 2 data from the Telomac trial also support the potential accelerated approval filing in Caesary syndrome once the confirmatory phase 3 trial is underway. In the next slide, the PLAN-TELOMAC-3 is an open-label, multicenter, randomized comparative study to demonstrate the efficacy and safety of LACUTAMAP in two separate cohorts of patients with cutaneous distal lymphoma who have failed at least one prior systemic therapy. In cohort 1, patients with any stage Cesar syndrome who have failed at least one prior line of systemic therapy, including mogamolizumab, will be randomized one-to-one to either lacutamab or romidepsin. In cohort 2, patients with MF ranging from stage 1b to 4 who have failed at least one prior line of systemic therapy will be randomized one-to-one to either lacutamab or mugamulizumab. Both cohorts will be randomized one-to-one 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 cesare cohort is overall survival, whilst the key secondary endpoints for the MF cohort are quality of life and pruritus. The Telomac-3 study is designed to serve as the confirmatory trial for caesareous 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 three initiation expected in the second half of 2026. Stephanie will now go through the commercial opportunity.
Thank you, Sonia. So we continue to believe lacutamab represents an attractive commercial opportunity supported by a focused and efficient commercial food space. Starting with cesarean syndrome, based on recent real-world data analysis, we estimate approximately 300 incident patients per year in cesarean 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. Mycosis fungoides represents a significantly larger opportunity with approximately 3,000 incident patients per year and a prevalence of around 12,000 patients in the US. This data from an analysis conducted by ZS Associates are now available in the EHA 2026 online abstract book. 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 institutions. This concentration enables a targeted commercial approach with limited infrastructure. At the same time, cesare 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 cesare syndrome is not a stand-alone opportunity, but a direct entry point into the broader CTCL market. Importantly, when looking at the current market, Mogamulizumab generated approximately 300 million in annual sales in 2025, as planned, and is projected to reach 350 million in 2026 with strong adoption in cesary syndrome and more limited penetration in mycosis fungoides. This provides a relevant benchmark for the market opportunity and highlights the potential for a therapy able to capture share across both cesarean syndrome and mycosis fungoitis. 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. Taken together, this supports a stepwise commercial strategy, starting with an initial opportunity of up to 150 million in cesare syndrome, expanding to over 500 million across cesare syndrome and mycosis vangoides in the second-line 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 Yanis to start the update on IPH4502.
Thank you, Stephanie. IPH4502 is our novel and differentiated Nectin-4-Exatecan ADC, which is in Phase 1. Turning to slide 11, IPH4502 has been designed to overcome the limitation of the first-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, non-overlapping epitope persucenfortumab on the Nectin-4 target. It is combined with a stable, cleavable, and hydrophilic linker, which supports high systemic exposure of the ADC while minimizing the release of free exatican in circulation and therefore reducing the risk of off-target toxicity. The payload, Exaticam, 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 PADCEP. Next slide shows how IPH4502 is positioned within the evolving N4 ADC landscape. The first wave of N4 ADCs largely relied on the MMAE payloads, including Enfortumab Velotin. While EV has validated N4 as an important ADC target, other MMAE-based approaches will most likely face similar limitations than EV, such as MDR1-magneted resistance and peripheral neuropathy. IPH4502 is designed to address these limitations through its topoisomerized payload and differentiated linker design. We believe this creates a potential opportunity in bladder cancer, particularly in the POT and fortumal velotin setting, as well as across multiple tumor type with low or moderate N4 expression. Overall, we believe IPH4502 has the potential to be best in class topo1 N4 ADC 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 IPH4502 as a topo1 NEC4-ADC. You can see that in both high and low NEC4-expressing models, IPH4502 demonstrates robust antitumor activity. However, the key differentiation versus other topogram NEC4 clinical ADCs appears in models with low NEC4 expression. IPH4502 maintains meaningful antitumor efficacy, while the other clinical ADCs show a clear loss of activity. This is really important as it highlights the unique ability of IPH-2502 to remain active in tumors with lower target expression. Overall, across multiple in vivo models, we constantly observe better efficacy for IPH-2502, 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, Yanis. Turning to slide 14, we see the outline of the clinical design of the phase one of IPH4502 study. We are currently evaluating this asset in a first in human phase one 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 evaluate the netting for expression retrospectively. The study started in January 2025 and runs at specialized cancer sites in the US and in France. This first in-human study is guided by an adaptive Boeing designed with backfill cohorts with the objective to assess safety, tolerability, and preliminary anti-tumor 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, PQ, efficacy at a given dose level. Enrollment in the dose escalation part of the study has progressed well, and Phase 1 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 unheavily pre-treated patients with advanced solid tumor, including urothelial cancer patients who have progressed after infortumab venotin. Turning to the next slide, we see that we highlight the growing therapeutic gap in bladder cancer after progression on EV plus Pembro. Despite the advancement of unfortunate vedotin that has introduced in neurothelial cancer patients, Two-thirds of these patients still experience disease progression within two 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 Pembroke, 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 PEMBRO 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 tumour opportunities. In bladder cancer, we see an opportunity to address the growing population of metastatic urothelial cancer patients who progress after EV-based therapies, where neptin-4 expression appears to remain stable in tumour from patients who progress after EV. Over time, we also see potential to move to early alliance, including in combination with anti-PD-1 therapy. Beyond blood cancer, we believe IPH4502 may also have potential across multiple solid tumours with low to medium nectin for 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 and met need populations and expanding into early alliance 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 stability in patients is clearly demonstrated by our emerging clinical data, we are developing a drug candidate a portfolio around three approaches. First, dual-targeted bispecific ADCs to address tumor antigen heterogeneity and to extend addressable indications compared to single tumor antigen targeting. Then, bispecific ADCs with immense internalization to unlock the activity in the low-expressing 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 and ending studies. Now, turning to Sonia.
Turning to slide 19, we now provide an update on our AstraZeneca partner programs, Monalizumab and IPH5201. In the next slide, let's start with Monalizumab. The PACIFIC-9 is a major phase 3 randomized double-blind study to demonstrate that dual immunotherapy can significantly increase the survival rate of patients with unresectable stage 3 non-small cell lung cancer who have not progressed following definitive concurrent chemoradiotherapy. The rationale for this trial is supported by three phase 2 studies in early stage non-small-cell lung cancer, including COST, NEO-COST and NEO-COST II studies. These studies reinforce the potential of targeting the NKG2A pathway to enhance the innate immune response alongside PDI1 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 co-developed with AstraZeneca, IPH5201 that blocks CD39, an enzyme that converts ATP into adenosine, which suppresses the immune system. By preventing this conversion, the therapy is re-energizing the immune system within the tumor microenvironment. IPH5201 is currently evaluated in the MATIS phase 2 trial in combination with durvalumab and neoadjuvant platinum-based chemotherapy in patients with resectable non-small cell lung cancer. The recent pre-planned interim data presented at the ACR annual meeting on April 21st 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. CD39 positive cell density in tumors is warranted to be further investigated as an emerging biomarker for predicting pathological complete response in IPH5201 plus turvalumab treatment. Overall, this encouraging early findings support continued investigation of IPH5201 in non-small cell lung cancer.
Turning 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. In case Monalizumab is approved, AstraZeneca will book sales and Innate Pharma will receive double-digit royalties on sales in the US and the rest of the world. In Europe, since Innate Pharma is contributing to 30% of the funding for the phase 3 trial, we will get 50% of the profit and have the option to co-promote the drug. For IPH 5201, the agreement is worth up to 885 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 one, Innate Pharma has also the option to co-form phase 3 trials in order to get 50% of the European profit and co-promotion rights. otherwise innate pharma will receive royalty in europe like in the us and rest of the world together this partner program provides innate with meaningful potential non-delutive cash through future milestones royalties and profit sharing economies i will now hand over to jonathan for closing remarks thank you janice sonia and stephanie so turning to our upcoming milestones Over the coming quarters, we expect several important catalysts across our priority assets.
For Locutumab, we remain focused on initiating the TeleMAC3 confirmatory phase 3 study in the second half of 2026, subject to financing. For IPH 4502, the study is progressing very well, and we have observed preliminary anti-tumor activity with a favorable safety profile to date, including in patients with urophilial cancer, relaxed 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 monoluzumab, the phase three Pacific nine 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 three programs provide a clear set of value-driving catalysts across our portfolio. With a cash position of 25.4 million euros as of March 31st, 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.
We will now begin the question and answer session. If you would like to ask a question, please press start one on your telephone keypad to raise your hand. That is start one on your telephone keypad to raise your hand. To withdraw your question, press start one again. Please stand by while we compile the Q&A roster. Your first question comes from the line of Dana Graybosh with Leering Partners. Your line is now open. Please go ahead.
Hi, guys. I have a question on Matisse and CD39 since that was presented recently. The discussant at ACR pointed out that while the triplet compares quite favorably to prior outcomes with Dervalumab plus chemotherapy. It looks pretty similar to prior outcomes with the PD-1s 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 MATISE trial, is there a certain threshold of activity or biomarker finding that AZ and you are looking forward to take it forward into phase three i think janice and sonia between the two can answer i know you want to start sonia and then janice can fill in on the second piece sure um of course you you you are right to say that um this interim data show that the rate the The PCR 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 over 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 also seen that, for instance, in PCR high expression, this PCR rate goes even higher. Of course, we cannot predict where this trial may materialize in a phase three, but so far the data looks very promising.
Yeah, hi, Dana, Yanis is speaking. Yeah, like Sonia says, I mean, this trial has basically, is providing two levels of information. First, that when you add CD30D 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 patient really validating the targeting of this of this checkpoint in the adenosine pathway, plus targeting the, I would say, the efficacy of our drug candidate, then whether AZ will decide to take the license on this one and move it into phase three. that's another question that is more actually for AZ. But from an innate perspective, it's very important to confirm and to establish that the blocking of CD39 can be effective in that setting.
Okay, thank you.
Your next question comes from the line of Christopher Liu with Lucid Capital Markets. Your line is now open. Please go ahead.
Thanks for the question. 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? um thanks for the question uh at this moment we can only say we have seen some efficacy readouts in a different dose level within a therapeutic window and we will be a bit more specific around both those levels as well as potential indications to bring forward at a clinical conference this year.
Got it. Thanks.
Your next question comes from the line of Swayam Pakula Ramakant with HC Wainwright. Your line is now open. Please go ahead.
Thank you. This is RK from H.A. Wainwright. You know, regarding the Nectin 4 ADC, you know, you're – it's just Lily's products, which are in phase one, and bicycles, you know, recently deprioritized their product.
So how do you see the competition going forward, and, you know, what sort of data uh would you be able to release in the next six months or so so we have an understanding of how you are poised against the competition well um thanks for the question in fairness we don't know much about um lily so far and we can only speculate that perhaps the asset that was deprioritized because it doesn't look as good as the other Vectim IV 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.
Sorry for not adding more color, but we don't have details yeah and then in terms of the data I think Sonia mentioned earlier we expect to present the data in the medical conference sometime later later in the second half of the year and I think at that point you will see you will see go forward indications and the data in urethelial cancer and, yeah, and next steps for the program.
Thank you. And then on the collaboration with AstraZeneca, you know, have you elected for the 30% funding on the Pacific 9? And what's, you know, is there any residual cash obligations between you and them? I mean, between now and the positive readers.
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.
Thanks for taking my question.
Your next question comes from the line of Yid Mukherjee with BTIG. Your line is now open. Please go ahead.
Thank you for taking our question, too, from our side. Just any further color perspective on the status of the Likudamab 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 two PTCL data from Lucutamab this year as well?
So maybe on the partnerships, maybe I can start off and Yanis 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 two 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 BDE partnership or a royalty financing partnership. we would be running the phase three confirmatory study. So that would be in our control where we could utilize our expertise that we've developed in the CTCL area from the TeleMAC2 study. So we'll make that decision in the coming future, basically based on what's best for the company in terms of the MPVs of the two different approaches. So, something coming in the future. Yanis, I don't know if you want to.
Short answer is yes. We are confident that we can execute something before Q3.
And just a second question around phase two.
Yeah, but PTCL, as you know, is run by the Lysarc 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. Yeah, and we have no further visibility on this study.
Yeah, as this is an IST, it's under control of the LISARC group, so this is not a place where it's independent where we can have control of the timelines. We know that the least our 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 timeline on that.
Thank you.
There are no further questions at this time. I will now turn a 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 Locutumab, the initiation of the confirmatory phase three program for IPH 4502, 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 monoluzumab, we have the results from the primary endpoint of the Pacific Nine 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.