Innate Pharma Q2 2025 Earnings Call Transcript

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Provided by Quartr
September 17, 2025

Key Takeaways

  • Positive Sentiment: Innate Pharma announced a strategic refocus to concentrate investment on their three high-value clinical assets—IPH4502, Lacutamab, and Monalizumab—and streamline the organization to deliver transformative cancer therapies.
  • Positive Sentiment: The next-generation NECTIN-4 ADC IPH4502 demonstrated differentiated preclinical activity in models resistant to enfortumab vedotin and those with low or heterogeneous NECTIN-4 expression; phase 1 enrollment is on track with data expected in H1 2026.
  • Positive Sentiment: Lacutamab received FDA Breakthrough Therapy designation for relapsed/refractory Sézary syndrome, with the phase 3 protocol nearly finalized and potential accelerated approval targeted in 2027 after strong phase 2 results.
  • Positive Sentiment: Monalizumab’s partner-led PACIFIC-9 phase 3 trial in unresectable NSCLC is fully recruited and set for primary completion in H1 2026; Innate Pharma remains eligible for up to $1.275 billion in milestones plus double-digit royalties.
  • Negative Sentiment: The company’s cash runway of $70.4 million provides funding only through the end of Q3 2026, highlighting the need for additional financing or partnerships to support upcoming clinical milestones.
AI Generated. May Contain Errors.
Earnings Conference Call
Innate Pharma Q2 2025
00:00 / 00:00

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Operator

Thank you. I'd now like to turn the call over to Stéphanie Cornen, Vice President, Investor Relations and Communications. You may begin.

Stéphanie Cornen
Stéphanie Cornen
VP - IR, Communications & Commercial Strategy at Innate Pharma

Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma H1 2025 Business and Financial Results Conference call. The press release and today's presentation are both available on the investor section of our website. Before we begin, I'd like to remind everyone that today's presentation includes forward-looking statements based on current expectations. These statements involve risks and uncertainties that could cause actual results to differ materially. I'll briefly cover today's agenda. Our CEO, Jonathan Dickinson, will discuss our strategic overview, fast forward, and commercial opportunity. Our COO, Yannis Morel, will provide an update on the scientific differentiation of our lead ADC. He will then hand over to our CMO, Sonia Quaratino, who will present clinical pipeline updates on IPH4502, Lacutamab, and Monalizumab. Afterward, our CFO, Frédéric Lombard, will review the financials. Jonathan will return with closing remarks and will open the call for Q&A. With that, I'll now hand it over to Jonathan.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Thank you, Stéphanie, and good morning to those joining from the U.S. and good afternoon to our participants in Europe. Moving to slide five, Innate Pharma's foundation is in leveraging our deep scientific expertise to advance life-enhancing cancer therapies. Through our years of pioneering work in antibody engineering, we have built a differentiated, high-value clinical pipeline supported by compelling data, and this positions us to deliver truly transformative treatments. Turning to slide six, during the first half of the year, we've made significant progress across our portfolio, and today marks an important new chapter for Innate Pharma. As you may have read in the press release for our half-yearly update that we issued earlier today, we have made the strategic decision to focus our investment where we believe we can deliver the greatest impact for both patients and our shareholders.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Therefore, going forward, our main investments will be centered on three high-value clinical assets: IPH4502, Lacutamab, and Monalizumab. These programs represent the strongest opportunities to transform care and create meaningful value, and they will form the focus of today's discussion. At the same time, we will concentrate on selecting and advancing our next ADCs towards clinical development. As a consequence of this prioritization and sharpened focus, we intend to streamline our organization to deliver on our strategic objectives and key near-term milestones. This is a pivotal moment for Innate Pharma. We are aligning our strategy, our science, our organization, and our investments to drive forward the programs that can truly make the biggest difference. I could not be more confident in the path we are taking, and I'm excited to share with you how we will execute on this vision in the coming presentation.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

As you will also have seen in this morning's announcement, our Chief Scientific Officer, Eric Vivier, has decided to return to full-time academic research. Eric has been a true driver of the scientific agenda within Innate Pharma, so we are extremely pleased that he will continue to support the company's innovation in the important role as an advisor to the R&D Committee of the Board of Directors. Our Chief Operating Officer, Yannis Morel, has always had responsibilities for preclinical research and development, and he will now also assume the Chief Scientific Officer responsibilities. With that, I will now hand it over to Yannis for a closer look at our lead ADCs and the potential. Yannis.

Yannis Morel
Yannis Morel
EVP & COO at Innate Pharma

Thank you, Jonathan. First, on slide eight, let me share with you why we think NECTIN-4 is an attractive target for a next-generation ADC and why our highly differentiated NECTIN-4 ADC has broad potential across many solid tumors. Even though NECTIN-4 is a validated ADC target, enfortumab vedotin (PADCEV®) carries some challenges and has several limitations. It is approved solely for patients with urothelial cancer, where NECTIN-4 expression is the highest. In addition, PADCEV-related toxicity often leads to treatment discontinuations, and relapses are frequently observed, creating a growing medical need in the post-PADCEV setting. Finally, even though NECTIN-4 is expressed at moderate to high level in several other tumor types, there is limited evidence showing that PADCEV is active beyond urothelial cancer. On the next slide, slide nine, I want to show you why we are so excited by our next-generation NECTIN-4 ADC program called IPH4502.

Yannis Morel
Yannis Morel
EVP & COO at Innate Pharma

As I said previously, this is a differentiated ADC that leverages a novel design to improve both safety and efficacy. IPH4502 is based on a proprietary humanized antibody that binds a unique epitope on the NECTIN-4 molecule. The linker used is stable, cleavable, and hydrophilic, ensuring high ADC exposure and low systemic release of free exatecan, which minimize potential side effects. The payload itself, exatecan, is a potent topoisomerase-1 inhibitor. It shows what's called bystander activity, which means it impacts neighboring tumor cells that do not express high level of NECTIN-4 and can therefore address tumors with heterogeneous expression of NECTIN-4. In addition, it remains highly active in enfortumab vedotin (PADCEV®) or MMAE-resistant models, allowing it to target tumors that have or became resistant to EV. In summary, the design of IPH4502 is purpose-built to overcome the limitations seen with existing therapies such as enfortumab vedotin (PADCEV®).

Yannis Morel
Yannis Morel
EVP & COO at Innate Pharma

On the next slide, slide 10, turning to preclinical data, during the period, we were also pleased to present at the AACR annual meeting our findings that highlight the differentiated potential of IPH4502. Starting from a PDX model of urothelial cancer, we generated a model of acquired resistance by exposing tumors to repeated cycles of enfortumab vedotin (PADCEV®). As anticipated, tumors that were initially sensitive became resistant to EV while keeping expression of NECTIN-4. What is remarkable is that in the same model, IPH4502 maintained its activity. While EV lost efficacy, IPH4502 continued to control tumor growth, underscoring its differentiated profile and the opportunity to address patients who no longer respond to EV. On the next slide, slide 11, our preclinical data also demonstrated anti-tumor activity in PDX models with low or heterogeneous NECTIN-4 expression from various tumor types, including, for example, triple-negative breast, esophageal, and NMN cancers.

Yannis Morel
Yannis Morel
EVP & COO at Innate Pharma

These results highlight the potential of IPH4502 to extend the reach of NECTIN-4 targeting beyond urothelial cancer into tumor types with significant medical needs. IPH4502 is currently in phase one development, and we are very excited about the potential of this novel and differentiated NECTIN-4 ADC to address high unmet medical needs, both in bladder cancer post-EV, but also in solid tumors with low or heterogeneous expression of NECTIN-4, representing a potentially broad market opportunity. I'll now hand over to Sonia, who will discuss the clinical progress of IPH4502, as well as our other clinical programs.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

Thank you, Yannis. Today, I will focus on three clinical assets that represent the potential to create the highest value for Innate: IPH4502, Lacutamab, and Monalizumab. In the next slide, starting with IPH4502, the ADC directed against NECTIN-4, this is a trial that is an asset that is currently investigated in a first-in-human phase one study. Enrollment in this dose escalation is going very well, and we are now on track to complete enrollment before the end of Q1 2026. The objective of the study is to assess the safety, tolerability, and preliminary efficacy of IPH4502 in advanced solid tumors known to express NECTIN-4. We are pleased to present this study in a trial-in-progress poster at the ASCO annual meeting in Chicago last June.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

The dose escalation is guided by an adaptive Bayesian design to determine the maximum tolerated dose, and once this is established, patients in one or two selected indications will be randomized across two dose levels to define the recommended phase two dose as per FDA guidelines. The anti-tumor activity of IPH4502 as a single agent will be further explored at RP2D in an expansion phase in selected indications in which signs of activity have been detected in the dose escalation. As well as confirming that the drug has a favorable safety profile and tolerability, the goal of this phase one trial is to generate efficacy data that will guide the path forward for IPH4502, such as a basket trial in combination with standard of care or expansion phase to help maximize its value for both patients and shareholders. In slide 14, we have the key milestones ahead for IPH4502.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

With enrollment progressing well, we expect to report preliminary safety and activity data in the first half of 2026. The preclinical data presented earlier by Yannis are guiding us towards two key hypotheses to be explored in the clinic. The first is in urothelial carcinoma 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 late-stage development is large. The second is to look for signals in other tumor types where NECTIN-4 expression may be low or heterogeneous, which could open an even broader opportunity. With this hypothesis, the clinical data will guide us towards the indication where IPH4502 can make the greatest impact. Now, turning on next slide on Lacutamab, we are close to completion of the phase three protocol following alignment with the FDA and EMA.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

To recap, Lacutamab is a first-in-class anti-KIR3DL2 antibody in development for the treatment of cutaneous T-cell lymphoma and peripheral T-cell lymphoma. In CTCL, Lacutamab has already generated strong long-term follow-up data, which we presented at ASCO earlier this year and which we'll summarize in the next slide. Importantly, the regulatory pathway is clear, supported by key designations that position Lacutamab for potential accelerated approval in Sézary syndrome. Our confidence in the program was further strengthened earlier this year when the FDA granted breakthrough therapy designation for relapsed or refractory Sézary syndrome based on the TELLOMAK phase two results. This designation is intended to accelerate both development and regulatory review of drugs that address serious conditions. Beyond CTCL, PTCL, peripheral T-cell lymphoma, represents a second indication. It's a group of aggressive lymphomas with poor prognosis and a significant life cycle management opportunity for Lacutamab.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

Importantly, KIR3DL2 correlates with worse clinical outcomes, and this is expressed in approximately 40% of PTCL patients. In PTCL, Lacutamab has previously demonstrated some objective responses as a single agent, reinforcing the relevance of the target and providing the rationale to pursue development in combination with chemotherapy. Building on these findings, Lacutamab is now being investigated in the KILT trial, a randomized phase two in combination with gemcitabine and oxaliplatin versus gemcitabine and oxaliplatin in relapsed refractory KIR3DL2 positive PTCL patients. When we move to the next slide and to recap the data in CTCL that we presented at ASCO 2024, the long-term follow-up data from the TELLOMAK phase two trial, here we see the results in Sézary syndrome, which is an aggressive subtype of CTCL, and post-Mogamulizumab, where there are no approved drugs, we have shown clinical efficacy.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

In heavily pretreated patients, all pretreated with MOGA, Lacutamab demonstrated a global overall response rate of 42.9% and a median progression-free survival of 8.3 months. Of note, the median duration of response was 25.6 months, underscoring Lacutamab's potential to deliver durable clinical benefit in this very aggressive and difficult-to-treat population. Turning in the next slide to mycosis fungoides, the long-term follow-up data from the TELLOMAK phase 2 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, with no difference between the two subgroups. Importantly, in both Sézary syndrome and mycosis fungoides, every patient who achieved a complete response remained in response at the time of the data cutoff, once again highlighting Lacutamab's ability to deliver durable benefit even in heavily pretreated patients.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

In both indications, Sézary and mycosis fungoides, Lacutamab was well tolerated, with an excellent safety profile that supports its potential use for long systemic therapy. Now, in the next slide, let's look at the potential positioning of Lacutamab in CTCL. The challenges in CTCL care are well known. The disease has a profound impact on quality of life, with patients suffering from itching, fatigue, and cutaneous lesions, with important psychosocial implications. Preventing progression to advanced stages is critical, as outcomes in stage IIB and beyond are poor. Yet, very few tolerable systemic options are currently available for early-stage patients, and this is where Lacutamab can make a real difference. Our data have shown deep anti-tumor activity, durable responses, and meaningful progression-free survival. Equally important, Lacutamab has shown an excellent safety profile, overcoming the tolerability concern of other systemic therapies in earlier stages of disease.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

Furthermore, Lacutamab addresses the symptoms that matter most to patients, with a positive impact on their quality of life. In the next slide, we see that the combination of strong efficacy with excellent safety makes Lacutamab a unique candidate for earlier use of systemic therapy in CTCL. This becomes particularly important in mycosis fungoides, where survival estimates deteriorate once patients progress to more advanced stages. As you can see, in stage IIB and beyond, the five-year survival is lower than 50%. Poor survival in late-stage MF highlights the need for systemic therapies that can be used earlier to change the course of the disease. Here is where Lacutamab could fill a critical gap, offering a tolerable systemic option that can be introduced at an earlier time point, with the potential to delay progression and improve patient outcomes.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

Altogether, we are on track to advance Lacutamab towards phase three in cutaneous T-cell lymphoma. As discussed, we are close to finalizing the phase three protocol following interaction with the FDA and EMA. Once financing is secure, we will be positioning to initiate the confirmatory phase three trial next year, with the potential for accelerated approval the following year as enrollment advances in Sézary syndrome, targeting approximately 2027. The key next step will be to determine the optimal path forward, whether through partnering or additional investor support, always with the goal of maximizing value for both patients and shareholders. In parallel, in peripheral T-cell lymphoma, the LISA-sponsored KILK trial continues to enroll patients, and we look forward to data from this study in 2026, which could further validate Lacutamab's potential across additional T-cell lymphoma.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

Now, switching gears in the next slide, we discuss another late-stage program, Monalizumab, with a great potential value creation for the company. As a reminder, Monalizumab is a first-in-class anti-NKG2A checkpoint inhibitor currently evaluated in phase three clinical trial in lung cancer by our partner AstraZeneca, in combination with durvalumab. Three phase two trials, COST, NEO-COST, and NEO-COST-II, demonstrated a strong rationale for this combination in unresectable non-small cell lung cancer and in the neoadjuvant setting. The phase three PACIFIC-9 trial aims to demonstrate efficacy of durvalumab in combination with either Monalizumab or the AstraZeneca anti-CD73 antibody, or LECLUMAB, in patients with unresectable stage three non-small cell lung cancer who have not progressed following classic platinum-based concurrent chemoradiation therapy. The study is now fully recruited, and it remains on track for primary completion at the end of the first half of 2026.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

This is an important catalyst for the program, with data expected in the second half of 2026. Now, I'm going to hand over to Jonathan again, who will walk through the commercial opportunity of these two late-stage assets, Lacutamab and Monalizumab.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Thank you, Sonia, for showing how Lacutamab has the potential to fundamentally reshape the care of CTCL patients. As you can see on slide 23, the opportunity for Lacutamab starts with Sézary syndrome, where following a potential accelerated approval in 2027, we see a clear launch pathway. In the past months, by assessing U.S. claims data, we have identified a significantly greater opportunity in Sézary syndrome than previously anticipated. It's been established that there are around 1,000 Sézary syndrome patients in the U.S., with approximately 300 new cases each year and a large pool of post-Mogamulizumab-treated patients. This represents a meaningful and de-risked first market opportunity for Lacutamab following an accelerated approval.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

After accelerated approval in Sézary syndrome, the opportunity expands into second-line plus setting for mycosis fungoides and ultimately into earlier stages of CTCL patients, where a tolerable systemic option is currently lacking and where Lacutamab has the potential to create a new market opportunity and change the course of the disease for patients through early intervention to stop or delay disease progression beyond stage IIA. It's been established through the same U.S. claims data that there are approximately 20,000 CTCL patients in the U.S., with an incidence of approximately 5,000 patients, suggesting a larger population than previously estimated based on publicly available data. These new dynamics, combined with the additional potential in PTCL, have led us to reconsider our strategy and the value we assign to Lacutamab.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

To maximize the opportunity for Lacutamab, we're currently planning to bring the product into phase three and submit a BLA in Sézary syndrome, either with the support of investors or with a partner, but with improved deal terms. Already at launch, Lacutamab has the potential to reach a substantial patient population, making it an interesting, profitable, and value-creating opportunity for Innate Pharma. We are actively collecting additional CTCL market data and conducting further analyses, leveraging claims data and market research to further define the market opportunity. We plan to share the new data and market insights at a Lacutamab-focused investor event by the end of the year. Turning now to slide 24 and to Monalizumab, our partnership with AstraZeneca for Monalizumab continues to represent a significant value driver for Innate.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

The total agreement is worth up to $1.275 billion, and we have already received $450 million in upfront and milestone payments to date under this partnership. Moving forward, Innate is eligible for up to an additional $825 million in development and commercial milestones. Outside of Europe, AstraZeneca records all sales, and Innate will receive double-digit royalties upon commercialization. In Europe, we retain co-promotion rights along with a 50% profit share while contributing to a portion of the phase 3 costs with a predefined cap. This structure ensures that Innate remains well positioned to benefit from Monalizumab's future success globally. That concludes the pipeline update for this presentation. I will now turn the floor to Frédéric Lombard, our Chief Financial Officer, to discuss the financials for the first half of the year. Frédéric.

Frédéric Lombard
Frédéric Lombard
SVP & CFO at Innate Pharma

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

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Thank you, Frédéric. Turning to slide 28, you can see our new flow for the near and midterm, which is fully aligned with the strategic refocus I outlined at the beginning of today's call. For IPH4502, our novel NECTIN-4 ADC phase one trial is progressing well, and we expect data in the first half of 2026, while our preclinical R&D continues to build a strong ADC pipeline to fuel our next wave of candidates, as shown by Yannis. Lacutamab has secured FDA breakthrough therapy designation, supported by long-term follow-up data presented at ASCO, and we are preparing the phase three protocol submission following our discussion with regulators, as indicated by Sonia. For Monalizumab, AstraZeneca's phase three PACIFIC-9 trial is fully recruited and remains on track for primary completion in the first half of 2026, with data expected in the second half of 2026.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Turning to slide 29, in summary, we are excited about the opportunities ahead and confident in our ability to deliver value for patients and shareholders. We are concentrating our investment on what we believe are our highest value clinical stage assets, IPH4502, Lacutamab, and Monalizumab, where we have multiple near-term catalysts, and we will right-size our organization to deliver on these strategic priorities. With $70.4 million in cash at the end of June, we are funded to the end of the third quarter of 2026, providing Innate Pharma the ability to execute on our focused strategic priorities. Thank you for your attention, and with that, operator, please open the line for questions.

Operator

Thank you. 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. If you would like to withdraw your question, simply press star one again. If you are listening via the webcast, you may submit questions via the Q&A box on your screen. Your first phone question today comes from the line of Dana Greybosch from Leerink Partners. Your line is open.

Daina Graybosch
Daina Graybosch
Senior MD - Immuno-Oncology at Leerink Partners

Hey, good morning, guys. You got Bill on for Dana. Thanks for the question. What should we take away on the potential of targeting NK cells now that ANKET® assets are not included in your prioritization today, as well as Eric Vivier sort of leading the company? Thank you.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Takeaways from Eric leaving the company, maybe that's the place to start off. Eric is leaving the company, but he will still play an important role with the company moving forward. He will be an advisor to the R&D committee of our Board of Directors, and we have an extended research collaboration with his lab. We basically will continue to benefit from any innovation which Eric can bring to the table. Moving back to NK cells and the reading, we are still working on NK cells. It's not our main priority today. We're focusing on what we believe are our highest value clinical assets, IPH4502, Lacutamab, and Monalizumab.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

We will be basing all future decisions on our NK cell engagers on clinical data and the relevance of that clinical data to markets, and we'll make the appropriate decisions on those assets when we have that clinical data and establish market relevance based on that data. It's not the end of NK cells, but it's not our priority today anymore. Can we move to the next question?

Operator

Yes.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Yeah.

Operator

We'll move on to our next question, and it comes from the line of Swayam Pekula, Remicont from HCW. Your line is open.

Swayampakula Ramakanth
Swayampakula Ramakanth
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

Thank you. Good morning. Good afternoon, Jonathan and team. Now that the ANKET® programs are out, at least as far as your development is concerned, any commentary on where Sanofi is with the assets that they currently are developing?

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Absolutely. I'd just like to say that it's not the end of the story for NK cells. We're still moving forward and completing the studies with IPH6501. We have a path to explore IPH6101 via investigator-initiated research and an interesting way forward. I wouldn't say it's the end of NK cells. It's just that it's been basically lowered in our current company priorities. From a Sanofi perspective, Sanofi continues to progress the BCMA-targeted ANKET®, and as I think we've communicated in the past, that's being explored in autoimmunity, in immunology, as part of Sanofi's focus as a company. We expect to have updates from Sanofi on that BCMA program in the near future.

Swayampakula Ramakanth
Swayampakula Ramakanth
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

Thanks for that. Regarding the phase three start for Lacutamab, should we still assume that unless you have a partner signed up ahead of the start of the study, it'll still be a wait and watch till you get a partner, or you have enough commitment from investors to go ahead and start that study?

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

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

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Yes, we're keeping the options open for both moving forward with investors and with potential partners.

Swayampakula Ramakanth
Swayampakula Ramakanth
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

Last question from me, Jonathan. This is on IPH4502. Based on the preclinical data that you have generated so far, what potential indications do you think IPH4502 will be effective? Since there are numerous NECTIN-4 ADCs in the clinic right now, how differentiated is IPH4502 against those?

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Yeah. Maybe Sonia can take the first part of that question. Sonia?

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

Yes, can you repeat the question, please?

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

Yeah. Based on the preclinical data that you have generated today, you know what indication do you think is where IPH4502 could be effective?

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

Right. As I mentioned before, we focus on any indication that expresses NECTIN-4 because we believe that we also can target those indications with a relatively small NECTIN-4 expression. We also very much focus on the urothelial cancer patients who became refractory or resistant to enfortumab vedotin. For these patients, there are no approved drugs. If we have good clinical data in these refractory relapsed patients, we really may have a very fast opportunity for an accelerated market approval in urothelial cancer post-enfortumab vedotin. We are exploring the classic path as well as some more defined area for a potential accelerated approval.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

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

Swayampakula Ramakanth
Swayampakula Ramakanth
MD & Senior Healthcare Analyst at H.C. Wainwright & Co.

Okay, thank you very much for taking the questions.

Operator

Your next question comes from a line of Justin Zelen from BTIG. Your line is open.

Justin Zelin
Justin Zelin
Director - Biotechnology at BTIG

Thanks for taking your questions. Maybe I'll continue the questioning on IPH4502. If you can just give us an update on how enrollment has been progressing here. I know you gave an update here on enrollment completion. Just was curious on how you could comment on how enrollment is going today, when we should expect the initial data, if it'll be sometime in the first half of next year, how many patients' worth of data we should expect, and any expectations from a safety or efficacy standpoint from that update.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Sonia, do you want to take it?

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

Of course, of course. As mentioned, the enrollment with IPH4502 is going extremely well. We always have, let's say, a list of patients to go in at the different dose levels. Also, with the Bayesian design that we have, we have the possibility to have a parallel enrollment in backfill cohorts. We do not have the classic 3+3 design with an extremely limited number of patients, but we can expand different dose levels as we go along. To your question, of course, you know we plan to finish the enrollment in the first quarter of 2026. The data in terms of at least the first CT scan can only occur, as you can understand, eight weeks later from the first dosing. It takes, let's say, another quarter to have the data of the clinical efficacy from the last cohort recruited.

Sonia Quaratino
Sonia Quaratino
EVP & Chief Medical Officer at Innate Pharma

Having said that, we are going to have probably a pool of data of 50, 60 patients by then.

Justin Zelin
Justin Zelin
Director - Biotechnology at BTIG

Great. Thanks for taking our questions.

Operator

There are no further phone questions at this time. I will now turn the call back over to management for any written questions.

Stéphanie Cornen
Stéphanie Cornen
VP - IR, Communications & Commercial Strategy at Innate Pharma

Thank you. Yes, we have one question on the line here from Rajan Sharma. The first question is, does the new strategic focus mean the ANKET® assets will not be progressed irrespective of clinical data, given that IPH6501 data are expected in the near term?

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

I think I answered this earlier, but I'll repeat it again. From an IPH6501 perspective, the study continues, and we expect to have data, I think, as we've communicated previously, towards the end of this year or very early next year. We will make any decisions on the next steps for IPH6501 based on that clinical data and the clinical relevance of that data to the marketplace.

Stéphanie Cornen
Stéphanie Cornen
VP - IR, Communications & Commercial Strategy at Innate Pharma

Okay. The next question, what is the financial impact of the strategic refocus and headcount reduction, and what proportion of current R&D expense are directed toward IPH4502 and Lacutamab?

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

The financial impact, we've not and we won't be communicating specific numbers on the impact of the financial reductions. We're in a legal process now, which is a French legal process to reduce the size of the organization, which gives us an obligation not to communicate on certain components. That would fall under that legal framework that we're operating within. We can't provide specific guidance there. In terms of R&D expenses, maybe Frédéric would like to comment on the proportion.

Stéphanie Cornen
Stéphanie Cornen
VP - IR, Communications & Commercial Strategy at Innate Pharma

What proportion of current R&D expenses are directed toward IPH4502 and Lacutamab?

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Yeah. We usually never communicate on the investment that we do in those two in the portfolio. Following up on the comment from Jonathan, we have a significant portion of our external expenditure which are on those assets.

Stéphanie Cornen
Stéphanie Cornen
VP - IR, Communications & Commercial Strategy at Innate Pharma

Okay. We have another question from Oussama Ben Gvir. With regard to financial visibility, does the estimate for the end of the third quarter of 2026 take into account the impact of the restructuring plan?

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

The answer to that is yes. The restructuring plan is fully embedded into the cash runway, which takes us to the end of Q3 2026.

Stéphanie Cornen
Stéphanie Cornen
VP - IR, Communications & Commercial Strategy at Innate Pharma

Last question, concerning phase 3 of Lacutamab, can you provide an initial estimate of the investment requirements if you decide to go to trial without a partner?

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

Again, this is something that we would not normally communicate on in terms of the cost. This is a standard phase 3 study, so I think you can draw your own conclusions. It's nothing too dissimilar from similar oncology phase 3 trials.

Stéphanie Cornen
Stéphanie Cornen
VP - IR, Communications & Commercial Strategy at Innate Pharma

Thank you, Jonathan. There is no further question.

Jonathan Dickinson
Jonathan Dickinson
CEO & Director at Innate Pharma

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

Operator

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

Executives
    • Stéphanie Cornen
      Stéphanie Cornen
      VP - IR, Communications & Commercial Strategy
    • Jonathan Dickinson
      Jonathan Dickinson
      CEO & Director
    • Yannis Morel
      Yannis Morel
      EVP & COO
    • Sonia Quaratino
      Sonia Quaratino
      EVP & Chief Medical Officer
    • Frédéric Lombard
      Frédéric Lombard
      SVP & CFO
Analysts
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