Earnings Call Transcript

Innate Pharma SA (IPHA)

Earnings Call Transcript 2022-03-31 For: 2022-03-31
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Added on April 09, 2026

Earnings Call Transcript - IPHA Q1 2022

Operator, Operator

Good morning, everyone. My name is Juan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Innate Pharma First Quarter 2022 Business Update. I will now introduce to Mr. Henry Wheeler, Head of Investor Relations. Please, Mr. Wheeler, go ahead.

Henry Wheeler, Head of Investor Relations

Thank you. Good morning and good afternoon and welcome everyone. This morning Innate issued a press release providing a business update for our first quarter '22 results. We look forward to highlighting the progress made during the quarter as well as addressing future goals and milestones. The press release and today's presentation are both available on the IR section of our website. On Slide 2, before we start, I would like to remind you that we will make forward-looking statements regarding the financial outlook, in addition to regulatory and product plan developments. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. On Slide 3, on today's call, we will be joined by Mondher Mahjoubi, our Chief Executive Officer who will then hand over to Joyson Karakunnel, EVP and Chief Medical Officer and Yannis Morel, EVP of Business Development and Product Portfolio Strategy. And we will also have our CFO Frederic Lombard on for Q&A. Mondher, I'll now hand over to you.

Mondher Mahjoubi, CEO

Thank you, Henry. Good morning, good afternoon, everyone. And thank you for joining this call. Please move to Slide 4 and let me first start by reminding you of our strategy. Our strategy centers around three key priorities where we look to drive value from our early R&D efforts for later sales partnership and it makes sense to do so. First, we look to create near-term value driven by our lead proprietary candidate, lacutamab, which is in development for T-cell lymphoma, which is opened in all-comers cohort in mycosis fungoides in the TELLOMAK trials, and also initiated two trials in the larger indication of peripheral T-cell lymphoma. Second, we continue to see our pipeline and create significant value, leveraging our antibody engineering capabilities to develop innovative molecules with a primary focus on our multi-specific NK cell engager platform called ANKET. Sanofi has the most advancing ANKET in the clinic, and we are nearing the clinic with the others. On the Adenosine pathway, we have a Phase I underway for our anti-CD73, IPH5301 performance in partnership with the Paoli-Calmettes Institute, the anti-cancer center in Marseille. And we are in further discussions with AstraZeneca on the next step for our anti-CD39, IPH5201. Last but not least, we continue to build a strong and sustainable foundation for our business, leveraging various partnerships between Innate Pharma and industry across academia. Our focus here is to leverage the value of our products as much as possible. We want indeed to make sure that if we can gain valuable competency via a partner agreement, we will consider that in our development plans for the product, which will not only validate our size but also offer capital we can invest to advance our early portfolio. And building on this pillar of the size pillar, if you can move to Slide 5, you can see the milestone summary for monalizumab. We were very pleased to announce a couple of days ago that we have received a further milestone of USD 50 million for the dosing of the first patient in the Phase III trial PACIFIC 9, which is AstraZeneca registrational trial in Phase III resectable lung cancer. This milestone further strengthens our company cash position. We remind you that we have potentially up to another $400 million in development and regulatory milestones, and $425 million in sales management milestones. Before I hand over to Joyson, please move to Slide 6, which is an overview of the pipeline, and this shows how we have translated our science into a robust portfolio of proprietary and patent assets. It also illustrates how we are executing against our strategy with our lead proprietary asset lacutamab, supported by partners and earlier stage products, in particular from our NK cell engager ANKET platform. We're also able to see the progress throughout the portfolio with several clinical assays continuing to progress from Phase I through to registrational Phase III trials. And we look forward to a series of potential clinical data results and catalysts in the outstanding couple of years as our R&D engine looks to leverage our scientific know-how in order to create sustainable business. I would like now to turn the call over to Joyson, who will review the progress made in our portfolio starting with lacutamab, our most advanced proprietary asset. Joyson, over to you, please.

Joyson Karakunnel, EVP and Chief Medical Officer

Thank you, Mondher. On Slide 7, let me start with our first-in-class humanized monoclonal antibody that targets immune receptor KIR3DL2. As you may remember, KIR3DL2 is an inhibitory receptor found in approximately 65% of patients across all cutaneous T-cell lymphoma. In the TELLOMAK trial, cohort 1 recruiting Sezary syndrome patients could potentially be a pivotal cohort. For mycosis fungoides, we have cohorts 2 and 3, which have been presented previously and are testing the hypothesis of non-expressors and expressors of KIR3DL2 using the frozen companion diagnostic assay. As expected, our scientific hypothesis was confirmed in cohort 2, which showed high global response rates in comparison to the benchmark and a low global response rate in the non-expressing cohort. Recently we opened the all-comers cohort to further evaluate our FFPE companion diagnostic, which is being considered for late-stage trials. This cohort is not expected to impact timelines for the readout of the trial, and the companion diagnostic data will aid further in the development of the program. On Slide 8, let me summarize the progress we are making with lacutamab. We are pursuing a fast-to-market strategy for lacutamab in the niche setting of Sezary syndrome where lacutamab was granted U.S. Fast Track designation and Prime designation in 2020. We have expanded past Sezary syndrome to mycosis fungoides, where we have seen encouraging preliminary data from our Phase II trial. For the Sezary syndrome cohort, enrollment is on track, and we will still expect to be able to report top-line preliminary data in the second half of 2022. For the mycosis fungoides cohort, enrollment is on track, and we still expect to be able to report top-line preliminary data in the second half of 2022. Finally, we are advancing into peripheral T-cell lymphoma in monotherapy and combination trials in the relapse setting. On Slide 9, I would like to update you on monalizumab. To remind you, monalizumab is an anti-NKG2A, which acts upon a checkpoint pathway to activate NK cells that we have licensed to AstraZeneca for oncology. There are currently two ongoing AstraZeneca-sponsored Phase III trials with monalizumab. One in combination with cetuximab in head and neck cancer, and one in combination with anti-PDL-1 durvalumab in lung cancer. On this slide, you can see an overview of the late-stage development plan for monalizumab in lung cancer. As mentioned, based on the AstraZeneca-sponsored Phase II COAST data, AstraZeneca commenced PACIFIC-9, a Phase III trial evaluating the combination of either monalizumab or oleclumab plus durvalumab in the unresectable Stage III non-small cell lung cancer setting that had not progressed after concurrent chemo-radiation therapy. For the Phase II COAST study, the three arms evaluated the combination of durvalumab plus monalizumab and durvalumab plus oleclumab, AstraZeneca's anti-CD73. As published recently in the Journal of Clinical Oncology by AstraZeneca, after a median follow-up of 11.5 months, the results of the interim analysis showed a hazard ratio of 0.42 for durvalumab plus monalizumab versus durvalumab alone. The results also showed an increase in the primary endpoint of confirmed ORR for durvalumab plus monalizumab over durvalumab alone of 36% versus 18%, respectively. Although the small numbers in a PFS exploratory subgroup analysis, monalizumab with durvalumab demonstrated a trend favoring the combination in tumors with high HLA-E and NKG2A expression and supporting the mechanistic rationale for the combination. We are also pleased to see that AstraZeneca-sponsored NeoCOAST data was presented at the AACR Annual Meeting with initial signals that led to AstraZeneca's decision to start the NeoCOAST-2 study. NeoCOAST-2 is a Phase II study in Stages IIA to IIIA non-small cell lung cancer that includes a treatment arm with monalizumab in combination with durvalumab and chemotherapy. On Slide 10, moving to head and neck cancer. We presented data from cohort 3 of the Phase II trial at ESMO-IO in December of 2021 for the triplet of monalizumab plus durvalumab plus cetuximab in first-line head and neck cancer. The data demonstrated anti-tumor activity in the first study to evaluate this chemo-free triplet combination in the first-line recurrent or metastatic head and neck cancer setting. As a reminder, the standard of care is based on the KEYNOTE-048 trial. The approval is for pembrolizumab monotherapy and CPS greater than or equal to one in pembro plus chemo in all-comer patients. We continue to collaborate with our partner, AstraZeneca, on potential next steps for this program. The Phase III INTERLINK-I trial of monalizumab plus cetuximab in IO-pretreated head and neck cancer is ongoing with final data expected in 2024. We look to work further with our partners, AstraZeneca, on this potential niche. On Slide 11, I would like to highlight the progress of our assets targeting the adenosine pathway, which is increasingly recognized as critical in tumor immune suppression and two approaches we at Innate are taking. Our anti-CD39 IPH5201 in collaboration with AstraZeneca has concluded the Phase I trial in solid tumors in combination with durvalumab, and we expect the data in 2023. In the meantime, we are in discussions with AstraZeneca on the next steps for this program. For our anti-CD73 IPH5301, an investigator-sponsored Phase I trial has started, where the IST is exploring a differentiated approach, combining our anti-CD73 with trastuzumab in HER2-positive cancers. We look forward to further updates from this clinical program next year. I will now hand over to Yannis to cover our NK platform.

Yannis Morel, EVP of Business Development and Product Portfolio Strategy

Thank you, Joyson. On Slide 12, I want to share the latest updates from our proprietary multi-specific NK engager platform, known as ANKET, which stands for antibody-based NK-cell-engager therapeutics. We have proudly showcased our latest innovation at significant scientific and medical conferences, such as this year's AACR Annual Meeting by our Chief Scientific Officer, Professor Eric Vivier, as well as at ESMO and SITC last year. ANKET is a flexible and purpose-built technology comprised of various components that is developing a new class of tri and tetra-specific engagers aimed at inducing synthetic immunity against cancer. This technology platform, drawing on our expertise in the NK cell field, will serve as a driving force for our pipeline, generating value through engagement with multiple tumor targets. Our enthusiasm for this ANKET platform is fueled by the preclinical data available thus far. Firstly, the ANKET platform effectively harnesses NK cell effector function through the unique engagement of both NK cell activating receptors, NKp46 and CD16. Secondly, the preclinical efficacy can be enhanced by incorporating an interlinking 2 variant that targets the IL-2 receptor beta gamma complex, which boosts NK cell proliferation within the tumor microenvironment. Overall, this platform shows superior preclinical antitumor efficacy compared to what we have observed in tumor models using clinically approved benchmark antibodies. Our most advanced ANKET program is a CD123 targeted bispecific molecule, IPH6101, also referred to as SAR443579, developed in collaboration with Sanofi. It is now fully licensed to them and is currently in Phase I trials. The second ANKET program from this collaboration, IPH64, is also progressing in development. Additionally, our latest tetra-specific ANKET is advancing toward IND-enabling studies, with the first IND filing anticipated in 2023 for IPH65. Now I will pass it over to Mondher for a summary of the upcoming catalysts.

Mondher Mahjoubi, CEO

Thank you. Please move to Slide 13. As you can see, we are working diligently to execute across all our strategic pillars and believe that we are laying the foundation to drive near long-term value. Looking at our clinical program, we expect to achieve a number of milestones over the next three years. First, as you've heard from Joyson, the Phase II TELLOMAK trial for lacutamab continues to progress. We continue to expect to report preliminary data from the potentially clinical cohort in Sezary syndrome as well as data in the mycosis fungoides in the second half of this year. In addition, we are moving our clinical investigation into the clinic with initial data expected next year. For monalizumab, the head and neck trial is underway. And finally, we continue to advance the adenosine pathway in the clinic, where we look forward to data and next steps from the anti-CD39 program in 2026. In parallel, we continue to develop our ANKET technology platform, and we are very encouraged by the treatment of the results from our one-generation ANKET cell engager. We believe that this represents a natural evolution of our platform with data updates expected last year. We are really excited to see the new tri-specific ANKET in the clinic with Sanofi and for updates on our proprietary ANKET for 2022. Let's move to Slide 14. As you can tell, we continue our exciting journey at Innate. We look to build our business to create value for patients and stakeholders. And in summary, we have positioned Innate for the future with our strategy and made meaningful progress throughout 2021 across all three pillars. We have carefully managed our resources, so we can continue to invest in progressing our pipeline. And I'm very pleased that we continue to have a very strong cash position through to 2024 with EUR 131.7 million as of March 31, 2022. In addition, we had the $50 million payment received from AstraZeneca we announced two weeks ago. We also want to allow opportunities for investors to buy the stock while trying to safeguard our existing stakeholders' interests. As such, we opened an at-the-market program last week on the NASDAQ. The ATM allows us to access the market depending on market dynamics. Collectively, we are driving value across our business and intimately advancing our goal to deliver innovative medicine to patients. We look forward to keeping you updated on our progress throughout the year. With this, we conclude our prepared remarks, and we now open the call to questions.

Operator, Operator

Operator Instructions. And our first question comes from the line of Yigal Nochomovitz from Citi.

Unidentified Analyst, Analyst

This is Ashiq Babar for Yigal. For the Phase III INTERLINK 1 trial, AstraZeneca is running for head and neck cancer. My understanding is that there will be an interim analysis prior to the full data in 2024. So just curious if that's still on track. And if you can share any color on when that might happen. And what, if anything, you might share from that interim analysis?

Mondher Mahjoubi, CEO

Absolutely. So as I said, this is an AZ-sponsored trial that was initiated back in 2020, the first patient was dosed in November 2020. And at that time, we announced that there is an interim analysis that is planning to occur 18 to 24 months after the first patient dose, which means that these interim analyses would occur in the second half of 2022 and the final analyses are expected in 2024. I hope it's clear.

Unidentified Analyst, Analyst

Okay. Will you share any details from that analysis? My second question is that I understand that there's a $50 million milestone payment associated with hitting some kind of threshold from that interim analysis. Is there any color you can share on what that threshold is? Is it a response or survival-based threshold? Any color would be great.

Mondher Mahjoubi, CEO

AstraZeneca did not disclose nor communicate any details about the threshold note of statistical performance analytics. We know that there is an interim analysis to decide whether to pursue or to stop. And this will, as I said, occur in the second half of the year. And of course, we will be informed by the analysis of this threshold. And we'll share the outcome.

Operator, Operator

Our next question comes from the line of Daina Graybosch from SVB Leerink.

Daina Graybosch, Analyst

Two for me. The first post, there was a recent full publication of COAST, and it had some additional biomarker cuts. I wonder whether you guys could discuss those cuts, especially any that you thought were relevant for monalizumab and any new interpretations you took from them?

Mondher Mahjoubi, CEO

Thank you, Daina. I'll take your second question, and then I'll dispatch.

Daina Graybosch, Analyst

So the second question is on ANKET. I wonder if Yannis could discuss any additional optimization of IPH65 that you are doing or planning as you go into IND study?

Mondher Mahjoubi, CEO

Absolutely. Thank you very much, Daina. I'm going to hand over to Joyson. And as you've heard in his remarks, Joyson has referred to the biomarker analysis and probably the right person to address the first question about what is the takeaway from this data. And then, of course, Yannis will address the question about IPH65 for which we did not disclose the target yet. Joyson, will you start please?

Joyson Karakunnel, EVP and Chief Medical Officer

Sure. So I think in reference to the JCO article that was published by AstraZeneca on the COAST study. There were PFS exploratory subgroup analyses that were done that, at least, should be taken with caution, considering the small numbers that were used in this subgroup analysis. We found that the combination of monalizumab and durvalumab in tumors that expressed high HLA and NKG2A expression appeared to favor this combination in this PFS subgroup analysis. So for us, that helped to support the synergistic and mechanistic rationale that we initially had developed for the combination when it was first put into the clinic. I kind of hand it over to Yannis now. Go ahead.

Yannis Morel, EVP of Business Development and Product Portfolio Strategy

Yes. On the IPH65, so like Mondher said, we did not disclose the identity of the target, but we can say that we have selected a validated tumor target to which we are applying our ANKET technology, which is a tetra-specific format, incorporating an IL-2 variance. Then we performed, I would say, a very classical lead optimization work in order to select the best candidate, and we are underway to our IND-enabling study with the targets to find an IND in 2023.

Daina Graybosch, Analyst

And maybe one follow-up for Joyson. Do you think that there's any potential to use either KIR3DL2 or NKG2A in the future as a diagnostic to enrich patients for the combination of monalizumab in any of the settings?

Joyson Karakunnel, EVP and Chief Medical Officer

I believe that the small sample size in the COAST trial will complement the data we are gathering from the NeoCOAST study. Currently, the limited numbers and the exploratory nature of this analysis suggest some potential, but we will need to validate this with the NeoCOAST data before considering a biomarker-driven approach.

Operator, Operator

Our next question comes from the line of Olga Smolentseva from Bryan Garnier.

Olga Smolentseva, Analyst

Could you discuss how you view the positioning of lacutamab in the changing landscape of PTCL treatment? Additionally, do you have data on the overlap between the expression of CD30 and KIR3DL2?

Mondher Mahjoubi, CEO

Thank you, Olga. Welcome back. So first of all, you know that the KIR3DL2 expression is being evaluated, and as of today, we don't have data. And of course, any position should be and not be data driven. So I won't speculate, but if we assume that we have a level of activity that justifies further development of lacutamab, definitely, what we could call it game changer in the development of this program because so far, it has been limited to a rare form of cutaneous T-cell lymphoma. So we look forward really to generating the data. And as you know, we have two approaches. One is a single-agent monotherapy in the relapsed factor setting trying to detect single-agent activity and a difficult to treat patient population for which, of course, it is important to provide an alternative strategic approach given the persistent unmet medical need there. And there is a second approach we are pursuing in collaboration with the LYSA group, which is a non-Hodgkin lymphoma cooperative group in France and in some European countries where we are setting the combination of chemotherapy. And as you know, the combination of the GEMOX and oxaliplatin is one of the standard regimens, and this is a randomized comparative study. So it will also provide insights into the contribution of components of the lacutamab in this setting. These data of course which we expect to start sharing and presenting next year will definitely drive the positioning of the closing and definitely, this will be biomarker-driven, as you know, both in the single-arm trial as well as in the combination trial, we are targeting Q3 positive patients. Now to your second question about the overlap and expansion, I'm going to ask Yannis to provide more color on this. Yannis, please?

Yannis Morel, EVP of Business Development and Product Portfolio Strategy

Yes. Sorry. Yes, in PTCL, there is no correlation of the KIR3DL2 expression with CD30. You find expression across all different subtypes of PTCL with some variation depending on the subtype. And there is no clear positive PTCL allocation, both in the service positive as well as in the CD30 negative.

Olga Smolentseva, Analyst

If I maybe a few words on the companion diagnostic. I was wondering one thing if you can share a few words on companion diagnostics for KIR3DL2 expression and maybe how aligned it is with the standard diagnostic proprietary practices. Basically, would it be easy to come and just add it to the current therapies for PTCL? And maybe what additional steps, if any, are required to get it approved?

Mondher Mahjoubi, CEO

Absolutely. And as you've heard in Joyson's remarks, we are working on further solidifying the package for this purpose. So I'm going to let Joyson answer the question, knowing that we are still at the early phase of the development, and that Sezary Syndrome per se is not probably the best target indication of testing more than 90% of the patients expressed target. So Joyson, can you provide more color on our plan for lacutamab, please?

Joyson Karakunnel, EVP and Chief Medical Officer

Sure. So as we had mentioned, the initial results that we're seeing with PTCL was based on a frozen assay. We are now using the all-comers cohort looking at an FFPE pathway. We are in discussions with regulatory agencies, and we're also looking at developing it not only in-house but also with a third-party companion diagnostic company. So we are going through the necessary steps to ensure that not only for CTCL, but also for PTCL, the assay can be used in our later-phase trials.

Operator, Operator

I will hand over back to Henry Wheeler now for any chat questions.

Henry Wheeler, Head of Investor Relations

Thank you. We have one question on the line, Eric Le Berrigaud at Stifel. The question goes more and more biotech companies are reevaluating strategy as to whether to go marketing, which is costly, burdensome and uncertain considering size and inexperience. Still, you are holding all right with lacutamab. And if everything goes well, you might be ready to market in the U.S. in 18 months from now. Regulatory activities will start earlier as well as premarketing and market access. So what avenues are you considering when you say you have cash into 2024? What does that mean for lacutamab marketing-wise?

Mondher Mahjoubi, CEO

Thank you, Eric. That's a very important question. I want to start by reminding you of my earlier comments about our strategy focused on three pillars. Today, we are building a sustainable foundation for our business by leveraging partnerships across both industry and academia. We have a solid track record of collaboration that has significantly contributed to our growth and development as a company, and we aim to maintain that momentum. If there are valuable competencies to gain from the partnership with lacutamab, we will take that into account in our development plan. It's crucial that we get medicine to patients as quickly as possible, and if partnering with another company can facilitate that, we will evaluate the benefits of such partnerships. Currently, we are in Phase II, and the Sezary syndrome cohort has the potential to be a pivotal point based on the level of activity we've discussed with the FDA. We are generating data that will inform our preparations for market launch, keeping in mind how long Phase III trials typically take. We are executing the TELLOMAK trial, aiming to build on the fast track designation for the drug and securing FDA approval for Sezary syndrome. We are also considering various options, including partnerships, as we believe there is more value to create in our pipeline. Lastly, while the marketing experience was challenging due to COVID, it was invaluable. We learned a lot from our setbacks, which has allowed us to refocus our energies on R&D and continue developing innovative treatments that contribute to cancer care. That remains our clear ambition and mission.

Operator, Operator

Thank you. We continue with the questions on the phone lines. The next question comes from the line of Liisa Bayko from Evercore.

Jingming Chen, Analyst

This is Jingming on for Liisa. My first question is, what should we expect at the TELLOMAK data readout second half this year? And my second question is, can you talk a little bit about what is your plan for lacutamab and Sezary syndrome and mycosis fungoides? Do you plan to file ahead and file Sezary syndrome alone? Or will you wait for the mycosis fungoides data to file together?

Mondher Mahjoubi, CEO

Thank you, Jingming, for the question. So I'll take the questions on lacutamab, and I think, Joyson, the right person to update you on the readout, even though we have a slide describing this, but will provide also more color about our value creation strategy and regulatory approach. Right, Joyson?

Joyson Karakunnel, EVP and Chief Medical Officer

Thank you. So thanks for the question. So when we look at the data readouts in the second half of 2022, the Sezary syndrome would be the first time that we're presenting that data, so that would be preliminary data on the Sezary syndrome pivotal cohort. In regards to mycosis fungoides, which is the second data readout we would have in 2022. We're anticipating updating some of the data that was seen at Lugano in 2021 with longer follow-up on those patients as well as additional patients that have enrolled. So that would be the two data readouts during the second half of 2022. I think in regards to the second question around whether we would file a Sezary syndrome or mycosis fungoides, I think a lot of this will depend upon the data itself. When we look at both of these cohorts, there is definitely the potential to file both of them together. In addition, we also have the ability to file the Sezary syndrome as a pivotal cohort. And we are already going in with the approach that in mycosis fungoides, we would have to do a Phase III. So we're kind of looking at the entire package that we're able to get for both Sezary syndrome and mycosis fungoides and then making a data-driven decision from there.

Jingming Chen, Analyst

Thank you. If I may squeeze in one more question. So in terms of timing for the PACIFIC-9 readout, is it fair to assume it will be similar to INTERLINK 1, which would be like interim readout for 18 to 24 months from dosing the first patient? Actually, we also expect a $50 million milestone from that potential readout?

Mondher Mahjoubi, CEO

Sorry to disappoint you, but this is really an AstraZeneca trial and I won't speculate on any timing. They didn't provide any specific dates or whether there is an interim analysis or even the modalities. This is lung cancer, okay? I know you are familiar with lung cancer development and the timelines and how long it takes to develop these types of drugs.

Operator, Operator

Thank you. I hand over back to Henry now for the questions on the chat.

Henry Wheeler, Head of Investor Relations

Yes, we had another question from Liisa Bayko at Evercore. Do you see a read-through from activity in the Phase II head and neck to Phase III lung cancer?

Joyson Karakunnel, EVP and Chief Medical Officer

Thank you for the question, Liisa. When considering both trials, it's important to note that they involve very different disorders: lung cancer and head and neck cancer. Therefore, the outcomes observed in head and neck cancer may not apply to lung cancer. This is the primary point to understand. Based on the oncologic indications, you wouldn't expect a direct correlation between head and neck and lung cancer. However, we are observing exploratory evidence indicating potential synergy between monalizumab and durvalumab, as well as with monalizumab and cetuximab in both cancer types. Mechanistically, there could be a rationale that connects both indications, but clinically, they are significantly different tumor types.

Henry Wheeler, Head of Investor Relations

Thank you, Joyson. I think we have more coming on the line.

Operator, Operator

Thank you. We continue with the questions on the phone lines. The next question comes from the line of Arthur He from H.C. Wainwright.

Arthur He, Analyst

This is Arthur in for RK. I just wonder, could you guys remind us of the milestone payment that could potentially relate to the IPH64 with the Sanofi collaboration?

Mondher Mahjoubi, CEO

I'll hand over to Yannis on the financial terms of the deal with Sanofi.

Yannis Morel, EVP of Business Development and Product Portfolio Strategy

We did not disclose the breakdown of the milestones that we have with Sanofi. What we disclosed is that for both programs, IPH6101 and IPH64, we have a total of up to $400 million in milestones as well as high single-digit royalties.

Operator, Operator

Thank you. We currently have no further questions on the phone line. So I hand over back to the management team for any final remarks.

Mondher Mahjoubi, CEO

Thank you for joining this call. I know it's a busy time of year with many of you focused on Q1 results. In conclusion, I want to emphasize that we are consistently executing our strategic priorities. Moving forward, we will continue to update our lacutamab external program and advance early R&D activities towards the clinic. As Yannis mentioned, we are actively preparing the R&D package for IPH65 and exploring collaboration and partnership opportunities around this platform. Additionally, we are pleased with the progress of monalizumab in early lung cancer, and the head and neck trial is also underway. The interim analyses scheduled for the second half of the year are important milestones and reinforce our strategy of building a sustainable business with a strong R&D focus. Thank you for your attention, and I wish you a wonderful day.

Operator, Operator

This concludes today's call. Thank you so much for joining. You may now disconnect your lines.