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Investor releaseQuarter not tagged2026-05-14Innate Pharma Q1 Earnings Call Highlights
MarketBeat
Innate Pharma Q1 Earnings Call Highlights
Interested in Innate Pharma S.A. Sponsored ADR? Here are five stocks we like better. Lacutamab is Innate Pharma’s top near-term clinical focus, with FDA clearance for the confirmatory Phase 3 TELLOMAK-3 trial in cutaneous T-cell lymphoma. The company expects to start the study in the second half of 2026, subject to financing, and is pursuing non-dilutive funding options. IPH4502, Innate’s Nectin-4 ADC, is showing early antitumor activity in a Phase 1 dose-escalation study in advanced solid tumors, including patients previously treated with enfortumab vedotin. The company says it has reached the maximum tolerated dose and plans to share more data, including urothelial cancer results, in the second half of 2026. Monalizumab, partnered with AstraZeneca, remains a major value driver with Phase 3 PACIFIC-9 enrollment completed and data expected in the second half of 2026. Innate also highlighted continued progress on IPH5201, another AstraZeneca-partnered program, which showed encouraging interim response rates in resectable non-small cell lung cancer. Innate Pharma (NASDAQ:IPHA) said its first-quarter 2026 business update centered on three priority clinical assets: lacutamab in cutaneous T-cell lymphoma, the Nectin-4 antibody-drug conjugate IPH4502 in advanced solid tumors, and the AstraZeneca-partnered monalizumab program in non-small cell lung cancer. Chief Executive Officer Jonathan Dickinson said the company is continuing to execute “with discipline” and pointed to several expected catalysts in the second half of 2026, including the planned initiation of a confirmatory Phase 3 trial for lacutamab and a Phase 3 readout for monalizumab. He also said the company ended the quarter with a cash position of EUR 25.4 million as of March 31, 2026. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Lacutamab, Innate’s anti-KIR3DL2 monoclonal antibody, is being developed for cutaneous T-cell lymphoma, including Sézary syndrome and mycosis fungoides. Dickinson said the company has received FDA clearance to proceed with TELLOMAK-3, a confirmatory Phase 3 trial, and expects to initiate the study in the second half of 2026, subject to financing. Chief Medical Officer Sonia Quaratino said prior Phase 2 TELLOMAK data showed “clinically meaningful and durable activity” in both mycosis fungoides and Sézary syndrome, along with quality-of-life improvement...
Investor releaseQuarter not tagged2026-05-13Innate Pharma Reports First Quarter 2026 Business Update and Financial Results
Business Wire
Innate Pharma Reports First Quarter 2026 Business Update and Financial Results
Lacutamab TELLOMAK-3 confirmatory Phase 3 trial in cutaneous T-cell lymphoma (CTCL) remains planned for initiation in H2 2026, subject to non-dilutive financing options currently under negotiation, including pharma partnering and royalty structures IPH4502 (Nectin-4 ADC) continues to show preliminary anti-tumor activity with favorable safety profile to date; the maximum tolerated dose has been reached and enrollment in the Phase 1 dose escalation and cohort enrichment is nearing completion PACIFIC-9 Phase 3 trial, which includes monalizumab and is led by AstraZeneca, continues to advance toward a planned H2 2026 data readout IPH5201 (anti-CD39 antibody), developed in collaboration with AstraZeneca, showed encouraging early results presented in a Clinical Trials Plenary Session at AACR 2026, supporting continued investigation in the MATISSE Phase 2 study in non-small cell lung cancer (NSCLC) Cash position of €25.4 million1 as of March 31, 2026, with an anticipated cash runway until the end of Q3 2026 Conference call to be held today at 1:30 p.m. CEST / 7:30 a.m. EDT MARSEILLE, France, May 13, 2026--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today reported its business update and consolidated financial results for the quarter ending March 31, 2026. "We have continued to make solid progress across our priority clinical assets during the first quarter. We are approaching completion of enrollment in the Phase 1 dose escalation and backfill cohorts for IPH4502. In parallel, we have advanced the negotiations for non-dilutive financing options to allow initiation of the lacutamab confirmatory Phase 3 TELLOMAK-3 trial in CTCL. Finally, the Phase 3 PACIFIC-9 trial with AstraZeneca is planned for data readout in the second half of 2026. Separately, we were pleased to see encouraging results from the MATISSE Phase 2 trial presented at the AACR Annual Meeting 2026. It is exciting to see the continued advancement of our differentiated immunotherapy pipeline for patients with high unmet medical need," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. Pipeline highlights: Lacutamab (anti-KIR3DL2 antibody): Cutaneous T-Cell Lymphoma The planned confirmatory Phase 3 TELLOMAK-3 trial is an open-label, multi-center, randomized, comparative study evaluating lacutamab in patients with Sézary...
TranscriptFY2026 Q12026-05-13FY2026 Q1 earnings call transcript
Earnings source - 61 paragraphs
FY2026 Q1 earnings call transcript
Ladies and gentlemen, thank you for joining us. Welcome to the Innate Pharma First Quarter 2026 Business Update 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 star one on your telephone keypads to raise your hand. I will now hand the conference over to Stéphanie Cornen, Vice President of 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 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 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, Stéphanie. Good morning to those joining from the U.S., 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-KIR3DL2 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 TELLOMAK-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 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 Innate, including potential milestones, profit-sharing in Europe, and royalties in the United States and the rest of world. Overall, we believe these three 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 Stéphanie for a more detailed review of the lacutamab program.
Thank you, Jonathan. Turning to slide seven. Lacutamab continues to progress towards initiation of the TELLOMAK-3 confirmatory phase III trial and the potential accelerated approval pathway in Sézary syndrome. As a reminder, the phase II TELLOMAK study has demonstrated clinical meaningful and durable activity in both mycosis fungoides and Sézary 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 Sézary 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 two separate cohorts of patients with cutaneous T-cell lymphoma who have failed at least one prior systemic therapy. In cohort one, patients with any stage Sézary syndrome who have failed at least one prior line of systemic therapy, including mogamulizumab, will be randomized 1-to-1 to either lacutamab or romidepsin. In cohort two, patients with MF ranging from stage 1B to four who have failed at least one prior line of systemic therapy will be randomized one-to-one to either lacutamab or mogamulizumab. 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 Sézary cohort is overall survival, whilst the key secondary endpoints for the MF cohort are quality of life and pruritus. The TELLOMAK-3 study is designed to serve as the confirmatory trial for Sézary syndrome while also supporting full approval in mycosis fungoides. 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. Stéphanie will now go through the commercial opportunity.
Thank you, Sonia. We continue to believe lacutamab represents an attractive commercial opportunity supported by a focused and efficient commercial footprint. Starting with Sézary syndrome. Based on recent real-world data analysis, we estimate approximately 300 incident patients per year in 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. Mycosis fungoides represent a significantly larger opportunity with approximately 3,000 incident patients per year and a prevalence of around 12,000 patients in the U.S. 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, 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 standalone opportunity but a direct entry point into the broader CTCL market. Importantly, when looking at the current market, mogamulizumab generated approximately EUR 300 million in annual sales in 2025 as planned and is projected to reach EUR 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 able 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. Taken together, this supports a stepwise commercial strategy starting with an initial opportunity of up to EUR 150 million in Sézary syndrome, expanding to over EUR 500 million across Sézary syndrome and mycosis fungoides 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 Yannis to start the update on IPH4502.
Thank you, Stéphanie. IPH4502 is our novel and differentiated Nectin-4 exatecan ADC, which is in phase I. 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 distinct non-overlapping epitope versus enfortumab 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 exatecan in circulation and therefore reducing the risk of off-target toxicity. The payload, exatecan, is a potent topoisomerase I 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 MMAE, allowing to address patients who have been pre-exposed to PADCEV. Next slide shows how IPH4502 is positioned within the evolving Nectin-4 ADC landscape. The first wave of Nectin-4 ADCs 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-mediated resistance and peripheral neuropathy. IPH4502 is designed to address this limitation through its topoisomerase payload and differentiated linker design. We believe this create a potential opportunity in bladder cancer, particularly in the post-enfortumab vedotin setting, as well as across multiple tumor type with low or moderate Nectin-4 expression. Overall, we believe we believe IPH4502 has the potential to be best in class Topo-1 Nectin-4 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 Topo-1 Nectin-4 ADC. You can see that in both high and low Nectin-4 expressing models, IPH4502 demonstrate robust antitumor activity. However, the key differentiation versus other Topo-1 Nectin-4 clinical ADCs appears in model with low Nectin-4 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 IPH4502 to remain active in tumors with lower target expression. Overall, across multiple in vivo models, we consistently observe better efficacy for IPH4502, 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 evaluate the Nectin-4 expression retrospectively. The study started in January 2025 and runs at specialized cancer sites in the U.S. and in France. This first-in-human study is guided by an adaptive BOIN design 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. Phase I dose escalation and cohort enrichment are nearing to completion. 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 an heavily pretreated patients with advanced solid tumor, including urothelial cancer patient who have progressed after enfortumab vedotin. Turning to next slide, we see that we highlight the growing therapeutic gap in bladder cancer after progression on EV plus pembro. Despite the advancement of enfortumab vedotin that has introduced in urothelial cancer patients, two-third of these patients still experience disease progression within two years. 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 enfortumab pembrolizumab. Several strategies are utilized based on patient-specific factors. For patients who received first-line enfortumab plus pembrolizumab without prior platinum exposure, platinum-based chemotherapy, cisplatin or carboplatin with gemcitabine, is the preferred subsequent option. Real-world data indicates a modest efficacy with a median real-world time to next therapy of approximately three to 4.7 months. Due to the limited efficacy of current second-line options, enrollment in clinical trials is strongly prioritizing 2026 guidelines to investigate novel mechanism of action and combination therapies. This creates a significant unmet need in the post-enfortumab plus pembrolizumab 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 therapies, 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 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. Bispecific ADC with enhanced internalization to unlock the activity in the low-expressing tumors. 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 partner 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 three non-small cell lung cancer who have not progressed following definitive concurrent chemoradiotherapy. The rationale for this trial is supported by three phase II studies in early-stage non-small cell lung cancer, including COAST, NeoCOAST, and NeoCOAST-2 studies. These studies reinforce the potential of targeting the NKG2A pathway to enhance the innate immune response alongside PD-L1 inhibition in early-stage lung cancer. 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 suppress the immune system. By preventing this conversion, the therapies is re-energizing the immune system within the tumor microenvironment. IPH5201 is currently evaluated in the MATISSE Phase 2 trial in combination with durvalumab and neoadjuvant platinum-based chemotherapy in patients with resectable non-small cell lung cancer. The recent preplanned interim data presented at the AACR 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 one or two. CD39 positive cell density in tumors is warrant to be further investigated as an emerging biomarker for predicting pathological complete response in IPH5201 plus durvalumab treatment. Overall, these 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 EUR 1.275 billion of milestones. We have already received EUR 450 million and remain eligible to additional EUR 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 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 profit and have the option to co-promote the drug. For IPH5201, the agreement is worth up to EUR 885 million in milestones. To date, we already received EUR 60 million and remain eligible to EUR 825 million.
This agreement, having a similar structure than the monalizumab one, Innate Pharma has also the option to co-fund 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 world. Together, this partner program provide Innate with meaningful potential non-dilutive cash through future milestone royalties and profit-sharing economics. I will now hand over to Jonathan for closing remarks.
Thank you, Yannis, Sonia, and Stéphanie. 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 TELLOMAK-3 confirmatory phase III study in the second half of 2026, subject to financing. For IPH4502, 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. For monalizumab, 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 three programs provide a clear set of value-driving catalysts across our portfolio. With a cash position of EUR 25.4 million 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 star one on your telephone keypad to raise your hand. That is star one on your telephone keypad to raise your hand. To withdraw your question, press star one again. 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 now open. Please go ahead.
Hi, guys. I have a question on MATISSE and CD39 since that was presented recently. The discussant 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-1s plus chemotherapy in the neoadjuvant setting. I wonder what gives you confidence given, in given that sort of range of broader benchmarks? And in the next part of the MATISSE trial, is there a certain threshold of activity or a biomarker finding that AZ and you are looking for to take it forward into phase III?
I think Yannis and Sonia between the two can answer. I know you want to start Sonia, and then Yannis can fill in on the second piece.
Sure. Of course, you, you are right to say that this interim data show that the rate, the pCR rate that we observed at this interim analysis may be comparable to what has been seen in other trial 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. In that respect, this has definitely produced an increase of pathological complete response that is not matched by an increase of toxicity. 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 III, but so far the data looks very promising.
Hi, Daina. Yannis speaking. Like Sonia says, I mean, this trial has basically is providing two levels of information for that. When you add CD39 on top of an active PD-1 blocker, it's increasing the pCR rate. For us, it's clearly, if the signal is confirmed on the additional patient, really validating the targeting of this checkpoint in the adenosine pathway, plus targeting the, I would say, the efficacy of our drug candidate. Whether AZ will decide to take the license on this one and move it into phase III, that's another question that is more actually for AZ. But from a 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.
Hey, thanks for the question. Maybe just two for me about IPH4502. For the first question, are there any additional details you can give us on the profile of the drug at the go-forward dose? 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 a therapeutic window. And we will be a bit more specific around both dose levels as well as potential indications to bring forward at a clinical conference this year.
Yep. Got it. Thanks.
Your next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright. Your line is now open. Please go ahead.
Thank you. This is RK from H.C. Wainwright. You know, regarding the Nectin-4 ADC, you know, you're, it's just Lilly's product which are in phase I, where and Bicycle, you know, recently deprioritized their product. How do you see the competition going forward? You know, what sort of data would you be able to release in the next six months or so we have an understanding of how you are poised against the competition?
You need to take that?
Well, thanks for the question. In fairness, we don't know much about Lilly so far. 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, you know, the data because they've not been shared. We can only see when the abstract will be available on the 21st of May. Yeah, sorry for not adding more color, but we don't have details.
Yeah. In terms of the data, I think Sonia mentioned earlier.
Yeah.
That we expect to present the data at a medical conference sometime.
Later in the year.
Later in the second half of the year. I think at that point you will see go-forward indications and the data in urothelial cancer. Yeah, next steps for the program.
Okay. Thank you. On the collaboration with AstraZeneca, you know, have you elected for the 30% funding on the PACIFIC-9? What, you know, is there any residual cash obligations between you and them? I mean between now and a positive readout?
I mean, just to qualify a couple of things. 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. There are actually minimal contributions required between now and the data readout.
Okay. Thanks. Thanks for taking my questions.
Your next question comes from the line of Jeet Mukherjee with BTIG. Your line is now open. Please go ahead.
Great. Thank you for taking our question. 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? The second question, are we expecting any phase II PTCL data from lacutamab this year as well? Thank you.
Maybe on the partnerships, maybe I can start off and Yannis can fill in any gaps. We are very confident that we will execute a, 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. 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.
That would be in our control, where we could utilize our expertise that we've developed in the CTCL area from the TELLOMAK-2 study. 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 two different approaches. Something coming in the future. Yannis, I don't know whether you want to.
The short answer is yes, we are confident that we can execute something before Q3.
Just the second question around phase II. Yeah.
Yeah. The PTCL, as you know, is run by the LYSA group, and we are towards the completion of this study. 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. This is an IST. It's under the control of the LYSA group. This is not a place where, as it's independent, where we can have control of the timelines. We know that the LYSA group are quite excited about lacutamab in combination with the GemOx chemo regimen, where they're studying this in late stage patients. 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 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. 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. 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.
Investor releaseQuarter not tagged2026-04-18Innate Pharma to Present MATISSE Phase 2 Interim Results of IPH5201 in Clinical Trials Plenary Session at AACR 2026
Business Wire
Innate Pharma to Present MATISSE Phase 2 Interim Results of IPH5201 in Clinical Trials Plenary Session at AACR 2026
Encouraging early results catalyze continued investigation in the MATISSE Phase 2 study evaluating IPH5201, a first-in-class anti-CD39 monoclonal antibody, in combination with durvalumab and chemotherapy in resectable NSCLC; these results will be presented at the Clinical Trials Plenary Session at the AACR Annual Meeting 2026, on April 21 MARSEILLE, France, April 17, 2026--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company"), today announced that interim results from the MATISSE Phase 2 study evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in resectable non-small cell lung cancer (NSCLC) will be presented in one of the Clinical Trials Plenary Sessions at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22, 2026 in San Diego, California. The MATISSE study (NCT05742607) is a single arm Phase 2 clinical trial evaluating perioperative IPH5201, an anti-CD39 blocking antibody, in combination with perioperative durvalumab (anti-PD-L1) in addition to neoadjuvant platinum-based chemotherapy in previously untreated patients with resectable NSCLC. The trial is designed to assess whether dual inhibition of the CD39 and PD-L1 pathways, together with chemotherapy, can enhance anti-tumor immune responses and improve clinical outcomes in early-stage lung cancer. These results follow a pre-planned interim analysis on 40 patients. The combination of IPH5201 with durvalumab and chemotherapy demonstrated higher pathological complete response (pCR) rates compared with the benchmark set by durvalumab plus chemotherapy alone. Notably, pCR was 35.7% and 50% in patients with tumors expressing PD-L1 ≥1% and PD-L1 ≥50%, respectively. Based on these results, the study continues to recruit patients with tumors expressing PD-L1≥1%. "Patients with resectable NSCLC remain at significant risk of recurrence, underscoring the need for novel perioperative treatment strategies. Disrupting the adenosine pathway through CD39 inhibition with IPH5201, in combination with PD-1 blockade and chemotherapy, could enhance anti-tumor immune responses—particularly in patients with PD-L1 positive tumors, where we observed up to 50% pCR rate in the MATISSE trial. This signal will be further investigated as we complete enrollment of the study in the PD-L1-positive popul...
Investor releaseQuarter not tagged2026-03-27Innate Pharma SA (IPHA) Full Year 2025 Earnings Call Highlights: Strategic Advances and ...
GuruFocus.com
Innate Pharma SA (IPHA) Full Year 2025 Earnings Call Highlights: Strategic Advances and ...
This article first appeared on GuruFocus. Release Date: March 26, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Innate Pharma SA (NASDAQ:IPHA) has received FDA clearance to proceed with the Telemax 3 phase 3 trial for lacutamab in CTCL, with initiation expected in the second half of 2026. IPH 4,502 is showing early signs of anti-tumor activity in heavily pretreated patients, including those with urothelial cancer, and has a favorable safety profile. Monalizumab, in partnership with AstraZeneca, is progressing with the Pacific 9 phase 3 trial data readout expected in the second half of 2026. The company has streamlined its organization to support efficient decision-making and disciplined capital allocation. Innate Pharma SA (NASDAQ:IPHA) has a cash position of 44.8 million, providing funding visibility until the end of the third quarter of 2026. Operating expenses were 63 million, with a significant portion related to R&D, reflecting high costs associated with ongoing studies. Revenue and other income amounted to only 9 million, indicating limited income generation from current operations. The company is still in the process of evaluating financing options for the phase 3 study of lacutamab, indicating potential funding challenges. The collaboration revenue from the monalizumab program has dropped significantly, reflecting a shift in project management to AstraZeneca. There is a significant therapeutic gap in the post-EV setting for urothelial cancer, highlighting unmet needs that IPH 4,502 aims to address. Warning! GuruFocus has detected 7 Warning Signs with IPHA. Is IPHA fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide additional specifics regarding the IPH 4,502 program and how it stands against competitors in the nectin 4 ADC space? A: Jonathan Dickinson, CEO: We are very excited about the IPH 4,502 program. The study is progressing well with significant interest. Recent competitive developments reinforce our positioning. As a Topo1 ADC, IPH 4,502 has a unique opportunity in the post-PAD setting, which was not available to MMAE-based ADCs. Sonia Quaratino, CMO: We have established the maximum tolerated dose and are encouraged by preliminary activity at therapeutic doses across different tumor types. Q: Regarding the Matisse interim data presentation at AACR, what s...
Investor releaseQuarter not tagged2026-03-26Innate Pharma Reports Full Year 2025 Financial Results and Business Update
Business Wire
Innate Pharma Reports Full Year 2025 Financial Results and Business Update
Lacutamab TELLOMAK-3 confirmatory Phase 3 trial in cutaneous T-cell lymphoma (CTCL) is planned for initiation in H2 2026, subject to non-dilutive financing options currently under negotiation, including pharma partnering and royalty structures IPH4502 (Nectin-4 ADC) shows preliminary anti-tumor activity with favorable safety profile to date; Phase 1 cohort enrichment ongoing at active dose levels Monalizumab PACIFIC-9 Phase 3 trial, partnered with AstraZeneca, continues to advance toward a planned H2 2026 data readout IPH5201 (anti-CD39 antibody), partnered with AstraZeneca - Interim results of MATISSE Phase 2 trial in non-small cell lung cancer (NSCLC) have been selected for an oral presentation in one of the Clinical Trials Plenary Session Sessions at the AACR Annual Meeting 2026, on April 21 Cash position of €44.8 million1 as of December 31, 2025 with an anticipated cash runway until the end of Q3 2026 Conference call to be held today at 2:00 p.m. CET / 9:00 a.m. EDT MARSEILLE, France, March 26, 2026--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today reported its business update and consolidated financial results for the year ending December 31, 2025. The consolidated financial statements are attached to this press release. "2025 has been a year of strong execution across our portfolio. With the TELLOMAK-3 design finalized and FDA clearance in hand, lacutamab is planned for confirmatory Phase 3 initiation in H2 2026, dependent on current negotiations with pharma partners and royalty structures. IPH4502, our Nectin-4 exatecan ADC, is progressing rapidly, with early signs of anti-tumor activity in heavily pre-treated patients, including in urothelial cancer post-enfortumab vedotin, where we aim to validate our preclinical hypothesis supporting a differentiated profile versus MMAE-based approaches. We continue to enrich cohorts at pharmacologically active dose levels, and explore activity in tumors with low to moderate Nectin-4 expression, where we believe IPH4502 has best-in-class potential among Topo I-based Nectin-4 ADCs. We look forward to the PACIFIC-9 readout in H2 2026, which remains a key catalyst for Innate Pharma," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. Pipeline highlights: Lacutamab (anti-KIR3DL2 antibody): Cutaneous T Cell Lymphoma The planned confi...
TranscriptFY2025 Q42026-03-26FY2025 Q4 earnings call transcript
Earnings source - 117 paragraphs
FY2025 Q4 earnings call transcript
Ladies and gentlemen, thank you for joining us, and welcome to the Innate Pharma full year 2025 earnings call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. I will now hand the conference over to Stéphanie Cornen, Vice President of Investor Relations, Communications, and Commercial Strategy at Innate Pharma. Please, Stéphanie, go ahead.
Thank you. Good morning and good afternoon, everyone, and thank you for joining us for Innate Pharma's full year 2025 business update and financial results conference call. The press release and today's presentation are available on the investor relations section of our website. Before we begin, I would like to remind everyone that today's presentation includes forward-looking statements based on current expectation. These statements involve risk and uncertainties that could cause actual results to differ materially.
I will briefly cover today's agenda. Our CEO, Jonathan Dickinson, will begin with a strategic overview and outlook. We will then share updates on our three priority program, lacutamab, IPH4502, and monalizumab, as well as IPH5201 in partnership with AstraZeneca. Speakers will be our CMO, Sonia Quaratino, our COO, Yannis Morel, and I. Frédéric Lombard, CFO, will comment our financial results. Jonathan will return with upcoming catalyst and closing remarks before we open the call for Q&A. With that, I'll now hand it over to Jonathan.
Thank you, Stéphanie. Good morning to those joining from the U.S., and good afternoon to our European audience. Turning to slide five, Innate Pharma is a focused oncology company with a clear ambition to deliver high-value differentiated therapies for patients with significant unmet medical need. Our strength lies in our deep expertise in antibody engineering and our ability to translate this into innovative therapeutic approaches, particularly in immuno-oncology and antibody-drug conjugates.
Over the years, we have built a pipeline of highly differentiated assets built on targets we believe have high potential to deliver meaningful clinical benefit. Today, we're focused on advancing these assets through late-stage development, combining smart, agile execution with a clear line of sight to key clinical and regulatory milestones. Turning to slide six. Over the past year, we have taken important steps to deliver on our strategic priorities with an execution-driven organization.
As we announced previously, we made the decision to prioritize investment on what we believe are our three highest value clinical assets, IPH4502, lacutamab, and monalizumab. This strategic focus allows us to concentrate our resources where we see the greatest potential to generate clinical impact and long-term value. In parallel, we continue to leverage our internal expertise and platform capabilities to advance the next generation of ADCs.
At the same time, we have streamlined the organization to ensure we are fit for purpose, with a more agile structure that supports efficient decision-making and disciplined capital allocation. As previously communicated, we implemented a redundancy plan, which is expected to be completed by the end of April. Turning to slide seven. We continue to execute against our strategy with discipline across our core programs and are pleased with the strong progress we are seeing.
First, as you remember, we received the FDA clearance to proceed with the TELLOMAK 3 phase III trial with lacutamab in CTCL, and we expect to be able to initiate it in the second half of 2026. In parallel, we are actively advancing discussions with ongoing negotiations on several fronts, including potential pharma partnerships and royalty-based structures. We believe these approaches provide a disciplined path forward to support late-stage development while preserving shareholder value.
Second, we're advancing IPH4502, our novel Nectin-4 ADC, where we see the potential to deliver a differentiated profile and address significant unmet needs across multiple tumor types. IPH4502 is progressing rapidly with early signs of antitumor activity in heavily pretreated patients, including in urothelial cancer previously treated with EV, and a favorable safety profile seen to date. We are starting to validate our preclinical hypothesis, which supports a differentiated profile versus MMAE-based approaches.
We are currently enriching cohorts at pharmacologically active dose levels in urothelial cancer post EV, and selected additional tumor types, and are excited by the progress we are seeing to date. Third, monalizumab, in partnership with AstraZeneca, represents an important late-stage asset with the PACIFIC-9 phase III trial data readout expected in the second half of 2026.
Across these programs, we remain focused on driving value, prioritizing key milestones, and ensuring that we are well-positioned to deliver multiple catalysts over the near and medium term. With that, I will now hand it over to Sonia.
Thank you, Jonathan. Now, moving to slide nine and starting with lacutamab, our late-stage asset in cutaneous T-cell lymphoma. As a reminder, the phase II TELLOMAK study has demonstrated a clinically meaningful and durable activity in both mycosis fungoides and Sézary syndrome, including improvement in quality of life with a favorable safety and tolerability profile, supporting potential for long-term treatment.
Building on this data, first, we have established a strong regulatory foundation, obtaining Breakthrough Therapy designation in relapsed or refractory Sézary syndrome, as well as Fast Track, PRIME, and Orphan Drug Designation. Second, this data support the potential accelerated approval path in Sézary syndrome, the most aggressive CTCL subtype characterized by high unmet medical need and no standard of care after treatment with mogamulizumab.
Lastly, we have received FDA clearance to proceed with the TELLOMAK 3 study, which intends to be a confirmatory study for Sézary syndrome and the registrational study for mycosis fungoides. The initiation of TELLOMAK 3 is planned for the second half of 2026 as we evaluate financing options. In slide 10, I will now walk you through the phase III trial design.
The proposed phase III study, TELLOMAK 3, is an open-label, multicenter, randomized comparative study to demonstrate the efficacy and safety of lacutamab in two separate cohorts of patients with cutaneous T-cell lymphoma who have failed at least one prior systemic therapy. In cohort one, there will be patients with any stage SS who have failed at least one prior line of systemic therapy, including mogamulizumab. Patients will be randomized 1:1 to either lacutamab or romidepsin.
In cohort two, patients with MF from stage Ib to stage IV who have failed at least one 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 PFS by blinded independent central review. The secondary key endpoint for the SS cohort is overall survival, while the key secondary endpoint for mycosis fungoides are quality of life and pruritus.
As the Sézary syndrome and mycosis fungoides study subpopulation are considered as independent cohorts answering to distinct objectives, two sample size are estimated to meet the primary endpoint in both SS and MF cohorts independently.
As such, the study's power to demonstrate superiority of lacutamab effect on PFS as compared to romidepsin in patients with SS who received at least one prior line of systemic therapy, including mogamulizumab, and that's compared to mogamulizumab in patients with MF who received at least one prior line of systemic therapy. From a regulatory standpoint, we have received FDA clearance to proceed with this clinical trial protocol, and we are now progressing towards phase III initiation expected in the second half of 2026.
Slide 11 outlines the projected regulatory timelines for lacutamab in Sézary syndrome and mycosis fungoides. As previously presented, the phase II TELLOMAK data in Sézary syndrome are intended to support a potential accelerated approval once the confirmatory phase III trial is underway.
In this context, the TELLOMAK 3 study is designed to serve as a confirmatory trial for SS, while also supporting full approval in mycosis fungoides. In the MF cohort, the primary endpoint of progression-free survival is expected to support full approval in both U.S. and Europe. Importantly, given the larger patient population in mycosis fungoides, we expect enrollment in this cohort to be faster, which may enable an earlier completion of the primary analysis in this indication.
From a regulatory standpoint, this represent a stepwise development approach, starting with Sézary syndrome with the highest medical need, and then expanding into broader CTCL population.
From a commercial perspective, we see a focused and attractive opportunity for lacutamab in CTCL, starting with Sézary syndrome. Based on recent real-world data analysis, we estimate approximately 300 incident patients per year in 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.
Importantly, 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, 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 standalone opportunity, but a direct entry point into the broader CTCL market.
Mycosis fungoides represents a significantly larger opportunity with approximately 3,000 incident patient per year and the prevalence of around 12,000 patient in the U.S. 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 Sézary syndrome and more limited penetration in mycosis fungoides.
This provide a relevant benchmark for the market opportunity and highlight the potential for a therapy able to capture share across both Sézary syndrome and mycosis fungoides. From a value perspective, the key driver include treatment duration, supported by the durability of response, 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 EUR 150 million in Sézary syndrome, expanding to over EUR 500 million across Sézary syndrome and mycosis fungoides in the second-line setting, with additional upside as lacutamab moves into earlier lines of therapy and broader patient segments over time. With that, Yannis and Sonia will now walk you through IPH4502.
Thank you, Stéphanie. Turning to slide 14. On this slide, I would like to highlight why we are particularly excited about our next-generation Nectin-4 ADC program called IPH4502. As mentioned earlier, IPH4502 is a differentiated ADC built to improve both safety and efficacy through a novel design. This molecule is based on a proprietary humanized antibody that bind on the Nectin-4 target to a distant and non-overlapping epitope versus enfortumab.
It is combined with a stable, cleavable, and hydrophilic linker, which supports high systemic exposure of the ADC while minimizing the release of free exatecan in the circulation, and therefore reducing the risk of off-target toxicity. The payload, exatecan, is a potent topoisomerase I inhibitor with strong bystander activity, enabling it to target not only Nectin-4 expressing tumor cells, but also neighboring cells with lower or heterogeneous expression.
Importantly, IPH4502 has demonstrated activity in models resistant to enfortumab vedotin, supporting its potential to address tumors that are either refractory to or progress after current standard therapies. Overall, the design of IPH4502 is intended to overcome key limitations of third-generation Nectin-4 ADCs and to deliver a more favorable therapeutic profile. Slide 15. Here, we position IPH4502 within the current Nectin-4 ADC landscape and highlights its key differentiating feature.
As you can see, the majority of Nectin-4 ADCs currently in clinical development, including approved and late-stage assets, are based on MMAE payloads such as enfortumab vedotin or PADCEV. While these therapies have demonstrated clinical activity, they are also associated with certain limitations, particularly in terms of safety and resistance mechanism.
In contrast, IPH4502 is based on topo I payload, exatecan, which we believe offers a differentiated mechanism of action. Importantly, this allows us to potentially overcome some of the limitations observed with MMAE-based conjugates, including activity in tumors that are resistant to or have progressed following enfortumab vedotin.
Indeed, MMAE-based ADCs are largely developed in bladder first-line setting in direct competition with the approved standard of care, when the trial of IPH4502 includes patients relapsing after enfortumab vedotin. In addition, as mentioned earlier, the strong bystander effect associated with exatecan may enable activity in tumors with low or heterogeneous Nectin-4 expression, thereby broadening the potential addressable patient population.
Taken together, we believe that IPH4502 combines a differentiated design with a competing mechanism, positioning it as a potential best-in-class topo I-based Nectin-4 ADC. Turning to slide 16.
Here, we present new preclinical data supporting the profile of IPH4502 as a potential best-in-class topo I Nectin-4 ADC. Starting on the left-hand side of the slide, in a CDX model with high Nectin-4 expression, IPH4502 demonstrates strong antitumor activity as other topo I ADCs do.
However, the key differentiation emerges in models with low Nectin-4 expression, where IPH4502 maintains meaningful antitumor activity, while other topo I ADCs in clinical development show a clear loss of efficacy. This is particularly important as it highlights the unique ability of IPH4502 to remain active in tumors with lower target expression.
Overall, across multiple in vivo models, we consistently observe a differentiated antitumor profile for IPH4502, supporting its potential as best-in-class agent, particularly in low to moderate Nectin-4-expressing tumors.
We believe this profile is driven by the combination of a high-affinity antibody with a unique epitope, a stable and hydrophilic linker, and a strong bystander effect of exatecan. Now, handing over to Sonia, who will present to you the IPH4502 phase I trial.
Thank you. Now let's turn to slide 17. IPH4502 is currently being evaluated in a first-in-human phase I study in patients with selected advanced solid tumor known to express Nectin-4. The trial is guided by an adaptive BOIN design with backfill cohorts with the objective to assess safety, tolerability and preliminary antitumor activity. The study runs at specialized cancer sites in the U.S. and in France. Enrollment in the dose escalation part of the study has progressed well.
The maximum tolerated dose is currently explored, and we are enriching cohort at pharmacologically active dose levels, including patients with urothelial cancer, relapsed or refractory to enfortumab vedotin, as well as selected additional tumor types. We've started to observe preliminary antitumor activity in this heavily pretreated patient population. Importantly, the safety profile to date remains favorable.
As the next step, we will build the package necessary to support the rationale for the dose optimization and selection of the recommended phase II dose. Now turning to slide 18. Based on the promising preclinical data we have generated that suggests that IPH4502 has robust activity in UC models resistant to EV, and we are focusing on patients with UC who progressed after EV treatment.
Despite the significant progress EV has delivered in treatment of urothelial cancer, and most notably by nearly doubling survival rates when combined with pembrolizumab, challenges regarding resistance, side effects, and long-term remission persist. In the first-line setting, the majority of patients progress within two years, with approximately 63% experiencing disease progression within 24 months.
On the right-hand side of the slide, we can see a fragmented treatment landscape and limited effective option for this patient, and this treatment landscape is still dominated by platinum-based therapies. This real-world data show that the outcomes in this setting remain poor, with time to next treatment of around three-five months and an overall survival in the range of seven-eight months with chemotherapy-based regimens.
Taken together, this defines a clear therapeutic gap in the post-EV setting, and IPH4502 is designed to address the significant unmet need in this patient population. Turning to slide 19. Based on the profile of IPH4502 and the data generated to date, we see a clear opportunity to develop the program across multiple solid tumors.
In particular, in metastatic urothelial carcinoma, we are initially focusing on the post-EV setting, where, as shown on the previous slide, there remains a significant and growing unmet need. In this context, IPH4502 has the potential to provide a new treatment option for patients to progress after EV-based therapies. Beyond this initial setting, we also see the opportunity to move earlier in the treatment paradigm, including into first-line setting, in combination with anti-PD-1 therapies.
In parallel, we believe IPH4502 has the potential to be explored across multiple solid tumors beyond bladder cancer in tumors with low to moderate Nectin-4 expression. Overall, our objective is to build a broad and modular clinical development strategy, starting with high unmet need population and expanding into earlier lines of therapy and additional tumor types over time, depending on the emerging data.
In slide 20, I will now turn to monalizumab and IPH5201. Starting with monalizumab, the anti-NKG2A antibody co-developed with AstraZeneca. We remain focused on the progress of the phase III PACIFIC-9 trial in non-small cell lung cancer, a trial led by AstraZeneca, which represent the next key step in the development of monalizumab.
The next slide, we see that this double-blind phase III PACIFIC-9 trial is designed to evaluate durvalumab in combination with either oleclumab, an anti-CD73 antibody, or monalizumab, an anti-NKG2A, compare to durvalumab alone in patients with resectable stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy. This study builds on a strong scientific rationale supported by controlled phase II studies in early lung cancer, including COAST, NeoCOAST, and NeoCOAST-2.
PACIFIC-9 is a large global trial that has now completed enrollment with approximately 999 patients randomized in a 1:1:1 ratio across the three treatment arms. The primary endpoint is progression-free survival with efficacy comparisons of both combinations versus durvalumab monotherapy. We now look forward to the data expected in the second half of 2026.
Let's now briefly touch IPH5201 in the next slide. This is a first-in-class humanized blocking monoclonal antibody that targets CD39, an enzyme that plays a key role in suppressing the immune system within the tumor microenvironment. The ongoing MATISSE phase II trial is a multicenter, open label, single-arm study evaluating the combination of IPH5201 and durvalumab plus standard chemotherapy in patients with early stage lung cancer. The study is conducted by Innate in collaboration with AstraZeneca.
We are happy to share that the results of a pre-planned interim analysis of this study have been selected for an oral presentation in a clinical trial plenary session at the AACR Annual Meeting in April in San Diego.
Turning to slide 23, I would like to remind you the financial terms for both monalizumab and IPH5201, as our partnership with AstraZeneca represents an important upside for Innate. For monalizumab, the agreement amounts up to $1.275 billion of milestones. We 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 U.S. and rest of the world. In Europe, as Innate Pharma is contributing to 30% of the funding for the phase III trial, we will get 50% of the profit and have the option to co-promote the drug. The agreement regarding IPH5201 is worth up to $885 million in milestones.
To date, we already received $60 million and remain eligible for $825 million. This agreement, having a similar structure to the monalizumab one, Innate has also the option to co-fund phase III trials in order to get 50% of the profits in Europe and co-promotion rights. Otherwise, Innate Pharma will receive royalties in Europe, like in the U.S. and rest of the world. With that, I will now hand it over to Frédéric to walk you through the financial results.
Thank you, Yannis. Now turning to slide 25, I will walk you through our 2025 financial highlights. Revenue and other income amounted to EUR 9 million this year. It includes EUR 2.8 million from licensing and collaboration agreements, primarily related to recognition of proceeds from our partnerships with AstraZeneca and Sanofi. As well as EUR 6.2 million in governmental funding for research expenditures.
Operating expenses were EUR 63 million, of which 73% were related to R&D. R&D expenses were EUR 43.6 million, decreasing by 16% year-over-year, reflecting the study's maturity as well as decrease in indirect R&D expenses, primarily due to lower staff costs and reduced scientific consulting and IP cost.
Partially offset by restructuring charges following the workforce restoring plan execution. G&A expenses were EUR 19.4 million, broadly stable year-on-year, with a decrease in non-scientific consulting fees and reduced insurance expenses, partially offset by the workforce restructuring plan impacts. Turning to our cash position, we ended the year with EUR 44.8 million in cash equivalents and financial assets as of December 31, 2025.
Based on our current operating plan, this provides funding visibility until the end of the third quarter of 2026. With that, I will now hand it back to Jonathan for the closing remarks.
Thank you, Frédéric. Turning to the next slide. As we close, I would like to highlight the strength of our focused portfolio built around three high-value assets, which are positioned to drive innate value. Starting with IPH4502, we are making strong progress in phase I. The study is progressing very well with high interest, and we are enriching cohorts at the pharmacologically active dose levels.
We have observed preliminary antitumor activity with a favorable safety profile to date, including in patients with urothelial cancer, which are relapsed or refractory to EV, which is a signal that we're starting to validate the preclinical hypothesis. We believe IPH4502 has the potential to address the significant unmet need in the post-PADCEV setting, as well as the opportunity to expand beyond bladder cancer in low and moderate Nectin-4 expressing tumors where IPH4502 could be best in class versus other topo I Nectin-4 ADCs.
With lacutamab, we are preparing for confirmatory study initiation in the second half of 2026 based on non-dilutive financing options, which are currently under negotiation with pharma partners and royalty structures. For monalizumab, 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 three programs provide a clear set of value-driving catalysts across our portfolio. Importantly, with a cash position of EUR 44.8 million at the end of 2025, we have funding visibility until the end of the third quarter of 2026, allowing us to continue executing on our key development priorities. Overall, we remain focused on advancing our pipeline and delivering on these upcoming milestones. With that, we're happy now to open for questions.
We will now begin the question and answer session. If you would like to ask a question, please raise your hand now. If you have dialed in to today's call, please press star nine to raise your hand and star six to unmute. That is star nine to raise your hand and star six to unmute. Please stand by while we compile the Q&A roster. Your first question comes from the line of Swayampakula Ramakanth with H.C. Wainwright. Your line is now open. Please go ahead.
Good morning or good afternoon, Jonathan and team. Thanks for doing this call. A couple of quick questions. Just to get started with IPH4502, you know, you are reporting some preliminary anti-tumor activity in the ongoing trial. You know, can you provide us some additional specifics regarding the program?
And also, you know, with the changes going on within Nectin-4 ADCs, you know, among some of the competitors, you know, how do you see your program in terms of strength? And also, you know, how much outside interest is there for that specific program?
Yeah. Maybe I can start off and address that, and maybe Sonia can hit some of the specifics, okay? I mean, we continue to be very excited by the IPH4502 program. Clearly the study is progressing very well, and there is a very significant amount of interest. We've been following the competitor activity here and what's been happening. If anything, we think that reinforces the competitive positioning of IPH4502. We're clearly focusing with the initial indication on the post-PADCEV setting.
As a topo 1 ADC, we think we have a very good opportunity there, which was never open to MMAE-based ADCs. We think some of the recent developments are, will actually potentially help us and really show the clear differentiation in positioning that we have with IPH4502. Maybe, Sonia, you want to add something?
Sure. We have established the MTD and this is going to be, let's say, at an expected level according to what we know for other exatecan-based assets. It is very encouraging to see this preliminary activity at the therapeutic dose in different tumor types. We're going to eventually explore even further this clinical activity.
Okay. Thanks for that. On the MATISSE interim data presentation at AACR, you know, I'm glad that you got an oral presentation slot at the conference. You know, I'm not asking you to reveal the abstract or the details of the study, but in general, how should we think about the program itself and you know, what would we potentially be walking away from that oral presentation regarding that program?
We're taking Yannis.
Hi, R.K. Yannis Morel speaking. We are having this MATISSE clinical trial in collaboration with AstraZeneca, so Innate is running it. As you may remember, this program is under an option with AstraZeneca. Basically they, AZ has an opt-in point before starting any phase III. I would say my expectation is that this phase II is really dedicated to generate a sufficient data package to validate the target and to show if there is a path forward for the development in lung cancer. In terms of data, as you know, there is an embargo on the data until the meeting, as it is a clinical abstract.
The design of the trial has been shown at the Trial in Progress poster at ESMO in 2023. It was disclosed at that point in time that there will be some interim analysis for efficacy. What will be presented at AACR is the interim on the first 40 patients, knowing that the trial is including up to 70 patients, and today the trial is continuing.
Well, thank you for that, Yannis. Last question from me. You know, regarding the collaboration revenue from monalizumab program, you know, or, you know, in the recent filing, it looks like that it's dropped almost to zero at this point, having met all the obligations. Do you foresee any additional milestones, especially with the upcoming, you know, second half, PACIFIC-9 readout?
With regards to revenue, you have to be careful because in fact it relates to the old agreement where we were co-developing the early stage of development. This is the very leftover, and those projects are over. Now the project is completely in the hand of AstraZeneca, so the accounting treatment is slightly different.
It's not going through the revenue, it's through collaboration liability, so the balance sheet. You don't see it in revenue, it doesn't mean that we don't work actively together. The future development of the program will depend also on the upcoming results expecting on the second half of the year.
Okay. Thank you. Thanks for taking all my questions.
Your next question comes from the line of Daina Graybosch with Leerink Partners. Your line is now open. Please go ahead.
Can you guys hear me? Can you hear me?
Loud and clear.
Sorry, I dialed in and it was a little confusing on Zoom. Thank you for the question. Another one on MATISSE going into the AACR presentation. If I recall, the initial data that Astra generated was in relapsed refractory lung cancer. I wonder if you could remind me of what you saw there with this program and why that gave Astra confidence to move this into the early stage setting.
Hi, Daina. Yannis speaking. I think that one of the key takeaway from the phase I is that, if you may remember, we presented that at a poster at ESMO IO two years ago. Well, that we managed to identify a dose that was able to actually block the enzymatic activity in the patient of CD39.
So as it was tested as a single agent and in combination with durvalumab in order to really define the dose to be explored in phase II. But what was really the key learning was that at the dose that we are using, we are really able, based on explants from patients, to block the pathway in the patients.
That's why we are exploring this setting where there is also expression of CD39. It's something that again, we have published in a previous poster in this early lung cancer. It really gave us the opportunity to test the ability of by removing this adenosine pressure. We know that the antibody can do it. It's not the case of all the antibody that we have tested.
We know that this one, IPH5201, can do it, to test whether it will translate into an increase of activity of durvalumab in setting where we know also based on the NeoCOAST trial, that durvalumab is active in this setting.
Because maybe we haven't thought about CD39 in a while, can you just remind us how that fits in relation to CD73, which Astra has with oleclumab as another sub-study in PACIFIC-9? Just how they all fit together and whether CD39 alone is sufficient to block the adenosine inhibition.
Inhibition. Yeah. Just to remind you, CD39 is the enzyme that is upstream in the pathway of degradation of ATP. ATP is sequentially degraded into ADP and then finally into adenosine, I would say, sequential degradation going through CD39 and then into CD73. CD73 is the downstream enzyme. By blocking CD73, you potentially decrease the quantity of adenosine within the tumor microenvironment, but you do not prevent the degradation of ATP.
Whereas by blocking CD39, and it's something that we have published also in Cell Reports a few years ago, when you block CD39 upstream, you not only limit the accumulation of adenosine, but you also induce the accumulation of ATP, which is known to be immune-stimulating through the P2X receptor.
It's something that we have shown in preclinical models that it's of particular interest, especially when you combine with an inducer of apoptosis like chemotherapy. That is also why it makes this neoadjuvant setting in the MATISSE trial so appealing because it's a combination of both with durvalumab, again, which is approved in this setting, in this perioperative setting in operable lung cancer, but also there is chemo, which is an important inducer of ATP that can be blocked and accumulated by the blockade of CD39.
Thank you very much.
Your next question comes from the line of Jeet Mukherjee with BTIG. Your line is now open. Please go ahead.
Yes. Hi, can you hear me?
We can hear you loud and clear, yes.
Great. Thank you so much for taking the question. Maybe just starting with lacutamab, just any, color or updates you can share in terms of how those partnership discussions are going, and are there any particular, deal structures or outcomes that you feel best aligns with, Innate Pharma? I have a follow-up question.
I think if we look at lacutamab and how we're moving forward, and I think this is alluding to the financing question, I think the most important thing here is that we get lacutamab on the market for patients in the fastest way possible. The timelines for approval from our perspective look similar for either a BD option or a royalty financing option.
We also know that in either of those scenarios, we will be running the phase III studies. We will control the timelines and the regulatory interactions, and we'll be able to leverage our expertise and the networks that we've already established in CTCL.
At the end of the day, our decision then is really based around what will bring the most value for shareholders in terms of the long-term value. That's what we're currently evaluating and looking at both the potential of the BD partnership or a royalty financing structure. Watch this space, and we should hopefully make a decision in the not too distant future.
Great. Thanks for that. As my follow-up question, just coming back to IPH4502, in terms of the initial update that you'll disclose, is this one that'll come as perhaps, an investor webcast or perhaps at a medical conference? Are you able to say now if you've seen antitumor activity in other tumor types outside of urothelial carcinoma? Thank you.
Maybe I can start off and then Sonia can give them the details. I mean, I think we're moving very well with this program. It's moving very fast. We have seen antitumor activity in both post-EV, but also in other tumor types. Maybe Sonia can fill us in on the details.
I mean, of course, this is a work in progress, and, you know, it is always very difficult to say, be more specific on an ongoing trial. But definitely, yes, we had also some durable clinical activity in some individuals heavily pretreated.
As Jonathan said, the data that we currently have show that our path forward in the EV, in the urothelial post EV may be plausible and supported by data. And also it was nice to see other clinical activity in other indication, and forgive me for not being too specific on this. We are aiming, of course, to present at a medical conference as soon as the data get mature, then we are obtaining all the, let's say, data around this phase I trial.
Your next question comes from the line of Christopher Liu with Lucid Capital Markets. Your line is now open. Please go ahead. A reminder to unmute yourself locally when speaking. To unmute yourself, please press star six on your telephone keypad, or if using Zoom, just click on unmute.
Hello. Can you guys hear me?
hear you now, Christopher.
Okay, perfect. Apologies. I disconnected before, so I had to rejoin the call. I apologize if I ask something that's already been asked. I just was wondering, you know, for the ADC, what can we expect to see from the upcoming data readouts? And then for lacutamab, what kind of sales infrastructure are you looking to build and, you know, how much are you looking to spend on something like that?
You wanna take the first question, Sonia?
In terms of study readout, what we are going to focus is to get the full safety profile. The PK that is also quite relevant in the ADCs and also show the level of free payload that may be of importance and influencing also the safety profile. Of course, all the efficacy readouts that we have from these patients, including the expression of Nectin-4 in their tumors because we collect tumor biopsies at screening to identify the expression of Nectin-4.
This is done retrospectively and not prospectively in the study. We already know that some of the subjects we have enrolled had a negligible level of Nectin-4. This is done, of course, in batches.
This is what we aim to have out of this phase I trial, and we intend to present to a medical conference.
Addressing the second part of your question, Christopher, in terms of sales infrastructure. Just to reiterate that we've not made a decision yet whether we would do this ourselves or whether we would go through a potential B, BD partner. If we were to do this ourselves, what we have established is that CTCL, both mycosis fungoides is treated in a relatively small number of centers in the U.S. It's predominantly treated in academic centers.
The majority of the patients are treated in 50 centers in the U.S., and pretty much all of the patients within 100 centers. You need a relatively small commercial infrastructure to be able to fully realize the associated commercial opportunity.
Our estimate is a sales team, probably of around 20 people, a medical affairs team to support that of probably five or six people and a handful of access people. That's the sort of investment that you would actually be looking at if this was something that we ultimately decided to do ourselves.
Got it. Thank you very much.
There are no further questions at this time. I will now turn the call back to Jonathan Dickinson, CEO, for closing remarks.
Okay. I'd like to thank everybody for attending the conference call today. Just to reiterate that it's an exciting year ahead for the company. We're very clearly on a path with lacutamab to initiating the phase III confirmatory study and unlocking the potential for the accelerated approval, a path to creating near-term revenue, which is important for Innate Pharma.
With IPH4502, we're progressing very nicely, and we're expecting to approach some catalysts as we go through this year as we develop the dataset and develop a dataset that is robust and meaningful to patients, to shareholders, to investors, potential investors.
Obviously that will generate some inflection points, which would allow us to look at in terms of how we could further fund that further development of IPH4502. Of course, finally, we have monalizumab, which is approaching a very important inflection point for the company. Thank you for your time and attention, and we look forward to interacting with you over the coming weeks and months. Thank you.
This concludes today's call. Thank you for attending. You may now disconnect.
Investor releaseQuarter not tagged2026-03-19Innate Pharma Announces Conference Call and Webcast for Full Year 2025 Financial Results
Business Wire
Innate Pharma Announces Conference Call and Webcast for Full Year 2025 Financial Results
MARSEILLE, France, March 19, 2026--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company"), today announces that the Company will hold a conference call on Thursday, March 26, 2026 at 2 p.m. CET / 9 a.m. EDT, following the release of its financial results for the full year ending December 31, 2025. Participants during the call will be: Jonathan Dickinson, Chief Executive Officer Sonia Quaratino, Executive Vice President, Chief Medical Officer Yannis Morel, Executive Vice President, Chief Operating Officer Stéphanie Cornen, Vice President, Investor Relations, Communication and Commercial Strategy Frédéric Lombard, Senior Vice President, Chief Financial Officer Details for the Virtual Event The live webcast will be available at the following link: https://events.q4inc.com/attendee/704730270 Participants may also join via telephone using the following registration link: https://events.q4inc.com/analyst/704730270?pwd=usHLLD39 This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its expertise on antibody-engineering and innovative target identification, Innate Pharma is developing innovative and differentiated next-generation antibody therapeutics. Innate Pharma is advancing a portfolio of differentiated potential first and/or best-in-class assets, focused on areas of high unmet medical need, including IPH4502, a differentiated Nectin-4 ADC developed in solid tumors, lacutamab, an anti-KIR3DL2 antibody developed in cutaneous T cell lymphomas and peripheral T cell lymphomas, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer. Innate Pharma has established collaborations with leading biopharmaceutical companies, including Sanofi and AstraZeneca, as well as renowned academic and research institutions, to advance innovation in immuno-oncology. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on...
Investor releaseQuarter not tagged2025-11-13Innate Pharma Reports Third Quarter 2025 Business Update and Financial Results
Business Wire
Innate Pharma Reports Third Quarter 2025 Business Update and Financial Results
Following FDA clearance for confirmatory Phase 3 trial TELLOMAK-3, lacutamab is progressing toward Phase 3 initiation in H1 2026 and potential accelerated approval in Sézary syndrome IPH4502 Nectin-4 ADC Phase 1 enrollment continues to progress well - pharmacologically active dose reached Monalizumab PACIFIC-9 on track to deliver data in H2 2026 Cash position of € 56.4 million1 as of September 30, 2025, anticipated cash runway until end Q3-2026 Conference call to be held today at 2:00 p.m. CET / 8:00 a.m. ET MARSEILLE, France, November 13, 2025--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today announced its business update and financial results for the first nine months of 2025. "This quarter highlights strong execution across our key programs," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "With FDA clearance to initiate TELLOMAK-3, we are advancing lacutamab toward its confirmatory Phase 3 and potential accelerated approval in Sézary syndrome. We remain on track for dose-escalation data, from IPH4502, our Nectin-4 ADC, in the first half of 2026, followed by monalizumab PACIFIC-9 results in the second half of 2026. Together, these milestones position us well to deliver meaningful value for patients and shareholders as we continue to advance our differentiated portfolio." Pipeline highlights: Strategic focus As previously announced, Innate Pharma is prioritizing its investment on what it believes are its highest-value clinical assets, IPH4502, lacutamab, and monalizumab (partnered with AstraZeneca); and advancing the next Antibody Drug Conjugates (ADCs) toward development, leveraging its pipeline of innovative targets. Lacutamab (anti-KIR3DL2 antibody): Cutaneous T Cell Lymphoma The Company announced on November 10 that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed. The planned confirmatory Phase 3 trial, TELLOMAK-3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome p...
TranscriptFY2025 Q32025-11-13FY2025 Q3 earnings call transcript
Earnings source - 26 paragraphs
FY2025 Q3 earnings call transcript
Ladies and gentlemen, thank you for joining us, and welcome to the Innate Pharma Third Quarter 2025 Business Update and Financial Results. [Operator Instructions] I will now hand the conference over to Stephanie 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 Q3 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. To begin, I briefly cover today's agenda. Our CEO, Jonathan Dickinson, will discuss our strategic priorities and path forward. Then our CMO, Sonia Quaratino, will present clinical pipeline updates on IPH4502, monalizumab, and lacutamab. Afterwards, I will present the commercial opportunity for lacutamab before turning back to Jonathan with closing remarks, and we'll open the call for Q&A. With that, I'll now hand it over to Jonathan.
Thank you, Stephanie. Good morning to those joining from the U.S., and good afternoon to our European audience. Turning to Slide 5. I would like to start with the strong momentum around lacutamab, supported by meaningful regulatory progress and new commercial opportunity insights. A few days ago, we received FDA clearance to initiate the TELLOMAK-3 Phase III trial in cutaneous T-cell lymphoma. This is a major milestone for the program, positioning lacutamab to advance towards potential accelerated approval in Sezary syndrome, supported by robust Phase II data. We expect the study to initiate in the first half of 2026, with filing anticipated following achievement of key enrollment milestones. Our CMO, Sonia Quaratino, will provide additional color on the Phase III trial and the regulatory path. In parallel, we hosted a well-attended lacutamab KOL event in October, featuring leading experts in CTCL. The discussions highlighted the continued unmet medical need for new, effective, and well-tolerated therapies in this space and reinforced lacutamab's unique positioning. During the event, we also presented new real-world claims data underscoring the commercial opportunity in both CTCL, which we believe further strengthens the value proposition for this program. Stephanie Cornen, our Vice President of Investor Relations and Commercial Strategy, will review the real-world evidence-based commercial opportunities for lacutamab towards the end of our call today. Moving to Slide 6. As you know, Innate Pharma's core strength lies in applying 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, positioning us to deliver treatments with truly transformative potential for patients and for all our stakeholders. Moving to Slide 7. As we look ahead, our path forward is clear and focused. As you remember, at our half-year results, we announced the strategic decision to focus our investment on what we believe are our highest value clinical assets, including IPH4502, lacutamab, and monalizumab, to maximize impact and value creation. In parallel, we are advancing our next generation of ADC programs through research, building the foundation for future innovation. Finally, we are streamlining the organization to ensure we remain fit for purpose and aligned with our strategic objectives. I'll now hand over to Sonia, who will take us through the clinical pipeline progress. Sonia?
Thank you, Jonathan. In this update, I would like to highlight the 3 clinical programs we believe hold the strongest potential to create significant value for Innate, IPH4502, monalizumab, and lacutamab. Starting with IPH4502, our differentiated ADC directed against Nectin-4. As a reminder, I would like to pinpoint the preclinical model where IPH4502 has demonstrated the 2 major feature of differentiation to an approved drug such as enfortumab vedotin. The first one is related to the payload of IPH4502, which is exatecan, a potent topoisomerase 1 inhibitor. Exatecan can induce a bystander effect, a phenomenon where it kills neighboring cancer cells in addition to the targeted cells. The exatecan is released from the antibody drug conjugate in the tumor and diffuses into nearby cells. This is beneficial for treating heterogeneous tumors where cancer cells may not all express the target antigens. The second point of differentiation is that in preclinical models, we have demonstrated that IPH4502 can induce potent tumor regression in PADCEV MMAE-resistant models, allowing us to target tumors that are or have become resistant to PADCEV. We have, therefore, built the study design of the first-in-human trial on the basis of these preclinical findings. First, we look for signals in tumor types where Nectin-4 expression may be low or heterogeneous, opening to a very broad opportunity. Second, we enriched the study of urothelial cancer patients in the post-EV setting, where IPH4502 may overcome resistance to EV. This represents an area of high unmet need with no approved drugs and the potential to move rapidly into later-stage development. With this hypothesis, the emerging clinical data will indicate the indication where IPH4502 can make the greatest impact. The first-in-human trial is guided by an adaptive design, and the main objective of this study are to assess the safety, tolerability, and preliminary efficacy of IPH4502 in patients with advanced solid tumors known to express Nectin-4. Enrollment in the dose escalation part of the study is progressing very well. We started the trial in January, and we have now reached already a pharmacologically active dose, and we have started to see early signs of clinical activity. We remain on track to complete the dose escalation by the first quarter of 2026. And after that, the dose optimization part of the study should commence. Now let's turn to Slide 10 to provide an update on monalizumab, which continue to advance in collaboration with AstraZeneca. The double-blind PACIFIC-9 Phase III trial aims to demonstrate improved progression-free survival of durvalumab in combination with either oleclumab or monalizumab as compared to durvalumab with placebo in patients with unresectable Stage III non-small cell lung cancer who have not progressed after platinum-based chemo radiotherapy. The PACIFIC-9 study builds on very strong scientific rationale, supported by earlier studies such as COAST, NeoCOST and NeoCOST-2 trials. This is a large global study that has fully completed enrollment with 999 patients randomized 1:1:1 across the 3 treatment arms. The primary endpoint is progression-free survival with efficacy comparisons for both combination arms versus durvalumab monotherapy. The study is fully recruited, and the independent data monitoring committee recently recommended continuation of the trial following a preplanned analysis, an important validation of the program progress. And we look forward to the data expected in the second half of 2026. Now moving to Slide 11 and to lacutamab. As we highlighted during our KOL event last month, our development strategy is designed to enable a stepwise approach, beginning with Sézary syndrome, an indication with the highest unmet medical need, especially in patients who have progressed after mogamulizumab, then progressing with a larger opportunity in mycosis fungoides, and finally, expanding to peripheral T-cell lymphoma. We are preparing a confirmatory Phase III study in an FNSS, which, once underway, opens the door for our filing of the biologics license application for Sézary syndrome post mogamolizumab based on the existing Phase II TELLOMAK data. This represents a potential path to accelerated approval with a key milestone expected in 2027. The confirmatory Phase III will also include patients with mucosis fungoidis, the largest CTCL subtype, where there remains a clear need for disease-modifying therapies. These results of the confirmatory Phase III trial will support a full approval in 2029 in NF and then full approval for Sézary and help establish lacutamab as a game changer in the therapeutic landscape across CTCL. Our goal is to position lacutamab within the NCCN guidelines as a preferred systemic therapy, not only for late-stage Sézary and mucosis fungoides, but ultimately for earlier-stage CTCL patients who continue to face limited treatment options. Now beyond CTCL, we are also advancing development of lacutamab in peripheral T-cell lymphoma, a particularly aggressive lymphoma subtype with few effective treatment options, and an ongoing Phase II study will help defining lacutamab role in this patient population. Turning to Slide 12. I would like to remind the data that will form the basis for the accelerated approval in Sézary post mogamulizumab. They are the long-term follow-up data from the TELLOMAK Phase II trial that was presented at ASCO 2025. Sézary is an aggressive subtype of CTCL. And post-mogamulizumab, there are no approved drugs that have demonstrated clinical efficacy. In heavily pretreated patients, all pretreated with mogamolizumab, lacutamab demonstrated an impressive global overall response rate of 42.9% with a median duration of response of 25.6 months. The median progression-free survival for the whole population was 8.3 months. Of note, lacutamab was very well tolerated with very favorable safety profile, underscoring lacutamab potential to deliver a meaningful clinical benefit in this aggressive and difficult-to-treat population. Turning now to mycosis fungoides. Long-term follow-up data from the TELLOMAK Phase II trial showed that lacutamab achieved a global overall response rate of 19.6% with consistent activity observed regardless of KIR3DL2 expression level. The median duration of response was 13.8 months, and median progression-free survival was 10.2 months, again, with no difference between the 2 subgroups. Also in MF, lacutamab was very well tolerated with an excellent safety profile that supports its potential use for long-term systemic therapy at an early-stage disease. Turning to the clinical development plan for the confirmatory trial. This is an open-label multicenter randomized comparative Phase III trial evaluating lacutamab in patients with cutaneous T-cell lymphoma who have failed at least one prior line of systemic therapy. In alignment with the FDA, the study includes 2 independent cohorts with distinct statistical analysis plans, one for Sézary syndrome and the other for mycosis fungoides. In the Sézary syndrome cohort, patients who have failed at least one prior systemic treatment, including mogamulizumab, will be randomized 1:1 to receive either lacutamab or Romidepsin, which is currently the only FDA-approved option for patients who progress after mogamulizumab. The primary endpoint is progression-free survival assessed by blinded independent central review, and the key secondary endpoint is overall survival. In the mycosis fungoides cohort, patients with Stage Ib to Stage IV disease will also be randomized 1:1 between lacutamab and mogamulizumab, which represent the current standard of care for this population. Here again, the primary endpoint is PFS, weak pruritus, and quality of life as a secondary endpoint. As the Sézary syndrome and MF study subpopulations are considered as independent cohorts, answering to distinct objective sample sizes are estimated to meet the primary endpoint in both SS and MF cohorts independently. From a regulatory standpoint, we have received clearance from the FDA about this clinical trial protocol. And therefore, we are well placed to initiate the Phase III trial in the first half of 2026. And with that, I will now hand over to Stephanie Cornen, who will walk us through the commercial opportunity for lacutamab and how we plan to unlock its full value across CTCL and beyond.
Thank you, Sonia. Now looking at commercial opportunity an important parameter is about eligible population. CTCL is aware of this diseases and assessment incidence and prevalence remain a challenge, potentially underestimating its true burden. During the occurring event, associates presented the most up-to-date source based on U.S. TELLOMAK data Versus CTCL Patient population, which highlights the higher incidents and prevalence than previously described. So if we look into each of these opportunities, starting with Sézary syndrome, as discussed it should release near-term in U.S. based on the Phase II TELLOMAK data. Sézary syndrome may affect around 3x more patients than previously believed, with an annual incidence was around 300 patients, prevalence around 1000 overall Sézary patients. And according to U.S. TELLOMAK data, approximately 300 patients treated with mogamulizumab annually. Importantly, these opportunities clearly define and actual of approximately concentrating in special and referral centers which accessible with a focused commercial footprint. Our launch strategy will therefore target specialized centers already managing these patients, allowing for a near-term and derisk opportunity in the U.S. Now moving to mycosis fungoides, which represents a larger opportunity. Here again, the TELLOMAK data shows a higher incidence than previous reported with approximately 3,000 U&M patients diagnosed each year in the U.S., and about one in four of these patients received systematic therapy. The goal of our Phase III, TELLOMAK-3, is to establish lacutamab as the new second standard of care, and our primary market research supports the view that physicians would adopt lacutamab as a second line of treatment base. And again, importantly, Sézary syndrome enable a seamless expansion into mycosis fungoides since both indications are managed by sustainable network of prescribers. So in summary, we see Sézary syndrome as our first focused entry point into the CTCL market in the U.S., a manageable and concentrated launch opportunity that will also serve as the foundation for a broader commercial in MA. Turning to Slide 17. This slide illustrates the market potential for lacutamab in CTCL and how we plan to expand over time through a stepwise strategy that Sonia previously described. We expect an initial opportunity of up to $150 million in the U.S. with accelerated approval in Sézary syndrome, where the patient population is small but highly concentrated and addressable through a focused commercial footprint. As lacutamab moves into mycosis fungoides and secures full approval the opportunity could expand to around $500 million across the U.S. and Europe. And beyond that, we see additional upside as part of our life cycle management strategy. Lacutamab offers important standard care for early-stage patients, a segment where systemic treatments are less used today. And the unique profile of lacutamab that combines tumor targeting activity, improved quality of life, and a favorable safety profile makes it a compelling candidate to unlock earlier use of systemic therapy. While the Phase III trial is designed to support registration across all stages of Innate in the second-line setting, we see a broader opportunity in addressing the Innate medical need of patients who are currently managed only with skin therapy and may benefit from lacutamab. In short, lacutamab offers a clear derisk path to commercialization starting with Sézary syndrome, expanded into larger CTCL segment over time, and then an even larger opportunity in PTCL. And now I'll hand the mic to Jonathan for closing remarks.
Thank you, Stephanie. As part of our focused strategy, we are advancing 3 high-value clinical assets that form the core of Innate's portfolio. Starting with IPH4502, our novel and differentiated Nectin-4 ADC, we see a significant opportunity in bladder cancer, particularly in the post-PADCEV setting, as well as across other solid tumors with low to medium Nectin-4 expression. Enrollment in the ongoing Phase I trial is progressing well, with completion expected by late 2025 or early 2026. We've now reached a pharmacologically active dose level where we're beginning to see encouraging early signs of clinical activity. Monalizumab, partnered with AstraZeneca, continues to advance in Phase III for unresectable non-small cell lung cancer, where enrollment in the PACIFIC-9 trial is now complete. Top-line data are expected in the second half of 2026, and this collaboration remains a key value driver with up to $825 million in total milestones and $450 million already received to date. And with lacutamab, our anti-KIR3DL2 antibody for cutaneous T-cell lymphoma, long-term follow-up from the TELLOMAK Phase II study has demonstrated meaningful and durable clinical benefit in both mycosis fungoides and Sézary syndrome, leading to breakthrough therapy designation in Sézary syndrome. As you know, we've now received FDA clearance to proceed with the confirmatory Phase III TELLOMAK-3 trial, and we're on track to initiate in the first half of 2026, supporting the potential for accelerated approval in Sézary syndrome. To wrap up today's call, I'll remind you that we have several value-driving catalysts ahead across Innate's portfolio. In the first half of 2026, we expect Phase I data from IPH4502, our Nectin-4 ADC program. This will be followed in the second half of 2026 by data from the PACIFIC-9 Phase III trial of monalizumab in collaboration with AstraZeneca. Looking beyond to 2027 and onward, we anticipate multiple milestones, including a potential accelerated approval for lacutamab in Sézary syndrome, the monalizumab BLA filing, and IPH4502 expansion phase data. Finally, we ended the third quarter of 2025 with a cash position of EUR 56.4 million, providing runway through the end of Q3 2026 to deliver on these key milestones. Operator, we can now open the Q&A session. Thank you.
[Operator Instructions] Your first question comes from the line of Christopher Liu with Lucid Capital Markets.
So I have 2. For the first one, what would you need to get done in the near term for the potential lacutamab commercial launch in Sézary syndrome? And for the second question, for IPH4502 and the upcoming data set, could you give us a little bit more color on what we can see at that readout?
Okay. Christopher, I can take that. So from a commercial perspective, I think one of the key things that we would need to get done prior to Sézary launch is the work to ensure that lacutamab will be included in the NCCN guidelines. So what we're aiming to be able to do, and we've already started the discussions on this with KOLs, is to ensure that when the BLA is approved for Sézary, that we basically already have lacutamab included in those NCCN guidelines for Sézary syndrome, but also for mycosis fungoides. So that will be one of the key pieces of work that we believe we will need to have in place prior to the BLA. And then IPH4502, in terms of what we hope to have next year, I think we've communicated this on a number of occasions, but what we're aiming to have is a cohort of patients in the PADCEV resistant setting, probably 10-plus patients where we will hopefully see an interesting response rate and be able to show clinical activity as well as safety data. We also hope to have data in 1 or 2 other tumor types in a similar perspective. So 10-plus patients in 1 or 2 tumor types. What we're doing with the study, and I think Sonia mentioned this earlier, is we've set up the study in a way where we can basically chase signals. We can backfill cohorts. So when we see a signal in a particular tumor type, our objective is to backfill and to substantiate that signal. So hopefully, then in 1 or 2 other tumor types, you would have 10-plus patients. And again, hopefully, an interesting response rate that allows us to then move forward into the next stages for the development of the product. Thank you for the question, Christopher.
Your next question comes from the line of Justin Zelin with BTIG.
You've indicated that FDA views an accelerated approval pathway here for lacutamab as viable once the Phase III study is underway. Could you just expand whether FDA is looking for any additional supplementary analyses beyond the existing Phase II data set as part of that accelerated approval package? And then just second, based off of the feedback from the October KOL event. Do you have a sense of growing momentum from the KOLs for lacutamab to become the preferred second-line option here? And should we expect mogalizumab to naturally move later in the treatment paradigm?
Okay. So addressing the first part of your question, Justin. So from an FDA perspective, they have not given us an indication that we would require any further substantial analysis. So basically, the BLA approval will be based off the data we have in hand today from the TELLOMAK study and the results that we've already presented that led to the breakthrough therapy designation. So we see that as reasonably straightforward. The key thing to unlocking the BLA submission here is having the confirmatory study up and running and to have established an enrollment trajectory into that study that would satisfy FDA that this study will complete and will deliver the confirmation of the accelerated approval. So that's something that we're obviously working very hard to be ready to do that ASOP because that counts down the -- it's the countdown to the submission of the BLA. We hope to be able to initiate the confirmatory Phase III study sometime around the middle of 2026. We would anticipate potentially a 6-month enrollment period to get the right trajectory to satisfy FDA requirements. And then that would allow us to submit the BLA sometime in early 2027, leading to FDA approval of the BLA, hopefully, sometime in the second half of 2027. So yes, so that hopefully answers the first part of your question. Then in terms of KOL feedback, we do see very good KOL feedback on lacutamab, and we do sense a building momentum around that. I think if you were attending the KOL event, and I think the KOL used the word game changer, which was, I think, something that summarizes what lacutamab can potentially bring not only to Sezary syndrome, but also to mycosis fungoides. I think there's particular excitement around basically what can happen in MF. If we look at the 5-year survival, of patients with MF, we do see a dramatic decrease in 5-year survival when patients progress from Stage 2a to Stage IIb, it drops from 78% to 47%. And we know that physicians want to be able to prevent that progression. And lacutamab, based on its tolerability profile and the excellent quality of life data for patients, is incredibly well placed to be able to slot into that area and be able to treat those patients at Stage b, Stage 2a, and hopefully prevent that progression of the patients to Stage Ib when you see the reduction in 5-year survival. So that's clearly, I think, factoring into the thinking of KOLs and how they will use this drug. So I think particularly in MF, we anticipate that lacutamab will be used ahead of Moga. In Sezary, we're studying post-Moga. So our expectation is that the product will be used post-Moga. Based on the excellent safety profile, I think some physicians may choose to use it in the first-line setting off-label as well. But our main assessment and where we're targeting for positioning the product is post Moga and initially in the Sezary syndrome indication. Hopefully, I've answered your question.
If I could just fit in a quick question with a potential near-term approval here, could you just comment on your CMC readiness as far as commercial scale manufacturing, PPQ run stability work for lacutamab?
Yes, I can comment on that. I think the answer is we're in a good place. We're basically ready to go. That won't be on the critical path to submission of the BLA. So we've ticked that box, and we're ready to go from that perspective.
Your next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright.
So I appreciate your comments on how you plan to file the accelerated approval application by the end of 2026. So what -- does this mean you're still hoping to get a partner on board? And in your previous conversations with potential partners, how much stress was there in terms of getting a clear signal from the FDA and a protocol blessed by the FDA?
Thank you for the question, RK. So in terms of partner discussions, having FDA acceptance of the protocol was an important consideration. It was potentially one of those boxes that we needed to tick for a number of them for us to be able to progress with those discussions. So yes, it was an important clearing event to be able to move forward with some of those partnering discussions. In terms of partnering, commenting on partnering, I think what the company is looking to do is basically to keep our options open. We basically were continuously evaluating a variety of financial options to ensure we're appropriately positioned to support our growth initiatives and create long-term shareholder value. And we remain disciplined and opportunistic in our approach to capital management, and we'll pursue the opportunities that basically support where we're going here. So I think it's important that we keep the options open at this particular stage, particularly with the exciting news that we've seen more recently with lacutamab and the great path that we have forward.
Can I ask 2 quick follow-ups, one on 4502? What specific safety signals would you be looking out for, especially when you would like to see this differentiated against other TOPO1 inhibitor ADCs? And the second question is, so what's the thought process now for the ANKET platform, especially them taking a little bit of a backseat? What's the long-term plan for that platform?
So maybe I can take the first question, and then I will ask Sonia to take the question on the safety signals that we're looking out for. So -- on the ANKET platform, we are basically waiting -- we're actually finalizing the study for IPH6501. I think we mentioned previously that we've completed the dose escalation phase of the study, and we were basically exploring the MTD at this stage. We're still in the process of doing that. And we'll basically make any future decisions based on -- for IPH6501 based off clinical data. And that clinical data should come sometime in the first half of next year, and then we will be able to make the evaluations and the next steps. In relation to IPH6101, we have now basically have most of the clinical data for the Phase I and Phase II returned to us from Sanofi. So we're now in the process of evaluating that data and trying to understand what next steps could be for the ANKET platform. What I would really like to clearly emphasize, though, is from a prioritization perspective, we're putting most of our time and effort behind IPH4502, behind lacutamab and behind monalizumab, and making sure that we advance those 3 assets as quickly as possible because we believe we have the highest chance to win for those 3 assets. Sonia, if you can take the question on the safety signals we're potentially looking out for?
Well, in terms of signal for IPH45, we try to establish a very well-tolerated and relatively safe drug. And in particular, we try to, of course, avoid all the MMA-specific adverse events like peripheral neuropathy, that is very often not reversible, and ocular toxicity. And so far, we did not see many adverse events or a specific trend in that respect. So the plan is to provide clinical efficacy in, let's say, unusual indication or indications where the Nectin-4 expression is not as high as urothelial cancer, with a very good benefit-to-risk ratio matched by a favorable safety profile. It's difficult to say a prior what you want to see, yes.
Your next question comes from the line of Diana Graybosch with Leerink Partners.
Yes, Bill on for Dana. I change it up a little bit, just asking about monalizumab. So I guess I'm just curious, can you just give us some, I guess, expectations for the readout in the second half of '26? Sort of what gives you the confidence that monalizumab, I guess, and durva can actually win out against durva?
Yes. So maybe I can take that question. So basically, we have good expectations for the PACIFIC-9 study. And what that is based on really is the COAST study, which was the Phase II study, a randomized Phase II study that was replicating the PACIFIC-9 setting. If you look at the results and the Kaplan-Meier curves from that study, they are very interesting. When you added monalizumab to durva, you basically added 12 months median PFS on top of durva. So if we retain a proportion of that effect size going into the PACIFIC-9 study, there's a very high chance that we will have a positive study. So that gives us a, I would say, a relative sense of confidence that this will be a positive study. Hopefully, that addresses your question.
There are no further questions at this time. I will now turn the call back to Jonathan Dickinson, CEO, for closing remarks.
Okay. I'd like to thank everybody for attending our quarterly earnings call. Thank you for your time and attention, and I wish you a great rest of the day. Thank you very much.
This concludes today's call. Thank you for attending. You may now disconnect.
Investor releaseQuarter not tagged2025-11-05Innate Pharma Announces Conference Call and Webcast for Third Quarter 2025 Results and Business Updates
Business Wire
Innate Pharma Announces Conference Call and Webcast for Third Quarter 2025 Results and Business Updates
MARSEILLE, France, November 05, 2025--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today announced that the Company will hold a conference call on Thursday, November 13, 2025, at 2 p.m. CET / 8 a.m. ET, to give an update on business progress during the third quarter of 2025. Participants during the call will be: Jonathan Dickinson, Chief Executive Officer Sonia Quaratino, Executive Vice President, Chief Medical Officer Yannis Morel, Executive Vice President, Chief Operating Officer Stéphanie Cornen, Vice President, Investor Relation, Communication and Commercial Strategy Frédéric Lombard, Senior Vice President, Chief Financial Officer Details for the Virtual Event The live webcast will be available at the following link: https://events.q4inc.com/attendee/424851735 Analysts may also join via telephone, click here to register. This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its antibody-engineering expertise, the company has developed innovative therapeutic approaches, including monoclonal antibodies (mAbs), Antibody Drug Conjugates (ADC) and multi-specific NK Cell Engagers through its proprietary ANKET® (Antibody-based NK cell Engager Therapeutics) platform. Innate’s portfolio includes lacutamab, an anti-KIR3DL2 mAb developed in advanced forms of cutaneous T cell lymphomas and peripheral T cell lymphomas, IPH4502, a differentiated Nectin‑4 ADC in development in solid tumors, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as renowned research institutions, working together to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X. Information about Innate Pharma shares Disclai...
Investor releaseQuarter not tagged2025-09-17Innate Pharma Reports First Half 2025 Business Update and Financial Results
Business Wire
Innate Pharma Reports First Half 2025 Business Update and Financial Results
Pipeline highlights: Strategic focus Innate Pharma plans to prioritize its investment on what it believes are its highest-value clinical assets, IPH4502, lacutamab, and monalizumab (partnered with AstraZeneca); its preclinical research and development (R&D) efforts will focus on advancing the next Antibody Drug Conjugates (ADCs) toward development, leveraging its pipeline of innovative targets. IPH4502 (Nectin-4 ADC, proprietary): IPH4502 is Innate’s novel and differentiated topoisomerase I inhibitor ADC targeting Nectin-4. The first patient was dosed in a Phase 1 study in January 2025. The Phase 1 study will assess the safety, tolerability, and preliminary efficacy of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients. A Trial in Progress Poster was shared at the ASCO Annual Meeting in June 2025. Enrollment is in progress and expected to be completed at the end of 2025 or in the first quarter of 2026. New preclinical data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. IPH4502 demonstrated superior preclinical anti-tumor activity compared to enfortumab vedotin (EV) in urothelial carcinoma (UC) models with low or heterogeneous Nectin-4 expression, as well as in models resistant to EV. Beyond UC, IPH4502 also exhibited anti-tumor activity in preclinical models of triple-negative breast cancer, head and neck squamous cell carcinoma, and esophageal cancer, suggesting broader potential clinical applicability. Lacutamab (anti-KIR3DL2 antibody, proprietary): Cutaneous T Cell Lymphoma In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome (SS) based on TELLOMAK Phase 2 results demonstrating efficacy and a favorable safety profile in patients with advanced SS, heavily pretreated, post-mogamulizumab. Breakthrough Therapy Designation is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition. At the 2025 ASCO Annual Meeting, updated long-term data from the Phase 2 TELLOMAK trial reinforced the clinical activity and durability of lacutamab in relapsed/refractory SS and mycosis fungoides (MF). In...

