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. All lines have been placed on mute to prevent any background noise. After the speaker remarks, there will be a question- and- answer session. If you would like to ask a question during this time, simply press star followed by number one on your telephone keypad. If you would like to withdraw your question, please press star followed by number two. I will now introduce to Mr. Henry Wheeler, Head of Investor Relations. Please, Mr. Wheeler, go ahead.
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 2022 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 two, 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 three, 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. We will also have our CFO, Frédéric Lombard, on phone Q&A. Mondher, I'll now hand over to you.
Thank you, Henry. Good morning, good afternoon, everyone, and thank you for joining this call. Please move to slide four and let me first start by reminding you our strategy. Our strategy centers around three key priorities, where we look to drive value from our early R&D efforts through later stage partnerships whenever 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. We did open an all comers cohort in mycosis fungoides in the TELLOMAK trial, and also initiated two trials in the larger indication of peripheral T-cell lymphoma.
Second, we continue to fuel our pipeline and create longer-term value, leveraging our antibody engineering capabilities to develop innovative molecules with a primary focus on our multispecific antigen engagement platform called ANKET. Sanofi has the most advanced ANKET in the clinic, and we are nearing the clinic with the others. On the immune pathway, we have a phase I underway for anti-CD73 IPH5301, performed in partnership with the Institut Paoli-Calmettes, the anti-cancer center here in Marseille.
We are in further discussion 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 the various partnerships between Innate Pharma and industry, but also with academia. Our focus here is to leverage the value of our product 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.
This will not only validate our science, but also offer capital we can invest to advance our early portfolio. Building on this pillar, on this last pillar, if you can move to slide five, you can see the milestone summary from an annual view. We were very pleased to announce a couple of days ago that we had received a further milestone of $50 million for the dosing of the first patient in the phase III trial PACIFIC-9, which is AstraZeneca registration trial in phase III unresectable 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 milestones to come.
Before I hand over to Joyson, please move to slide six, which is an overview of the pipeline, and it shows how we have translated our science into a robust portfolio of proprietary and partnered 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 engagement ANKET platform. We are also beginning to see the progress throughout the portfolio with several clinical assets continuing to progress from phase I through to registration phase III trial.
We look forward to a series of potential clinical data results and catalysts in the upcoming 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 pass the call over to Joyson, who will review the progress made throughout our portfolio, starting with lacutamab, our most advanced proprietary asset. Joyson, over to you please.
Thank you, Mondher. On slide seven, 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 lymphomas. In the TELLOMAK trial, Cohort 1 recruiting Sézary 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-expressers and expressers of KIR3DL2 using the frozen companion diagnostic assay. As expected, our scientific hypothesis was confirmed in Cohort 2. High global response rates in comparison to the benchmark and the non-expressing cohort. 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 eight, 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 Sézary syndrome, where lacutamab was granted U.S. Fast Track designation and EU PRIME designation in 2020. We have expanded past Sézary syndrome to mycosis fungoides, where we have seen encouraging preliminary data from our phase II trial. For the Sézary 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 the monotherapy and combination trials in the relapse setting. On slide nine, I would like to update you on monalizumab. To remind you, monalizumab is an anti-NKG2A, which acts upon the checkpoint pathway to potentiate NK cell activation 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-PD-L1 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 3 non-small cell lung cancer setting that had not progressed after concurrent chemoradiation therapy.
For the phase II COAST study, the three arms evaluated the combinations 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 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 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 2-A to 3-A 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 I/O in December 2021 for the triplet of monalizumab plus durvalumab plus cetuximab in first-line head and neck cancer. The data demonstrated antitumor 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 in CPS greater than or equal to one and 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-1 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 new treatment.
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 as to 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 ANKET platform.
Thank you, Joyson. On slide 12, I wanted to highlight the latest updates from our proprietary multi-specific NK cell engager platform that we call ANKET. ANKET standing for antibody-based NK cell engager therapeutics. We are pleased to have presented our latest innovation at major scientific and medical conferences, including AACR annual meeting this year by our CSO, Professor Eric Vivier, as well as at ESMO and SITC last year. ANKET is a versatile fit-for-purpose technology made of various building blocks that is creating an entirely new class of tri- and tetra-specific engagers to induce synthetic immunity against cancer.
The technology platform, which is leveraging our expertise in the NK cell space, will be an engine for our pipeline, creating value via multiple drug candidates addressing multiple tumor targets. Our excitement for this ANKET platform is built on because of the preclinical data that we have to date. First, the ANKET platform allows for optimal harnessing of the NK cell effector function due to the unique engagement of both NK cell activating receptors, NKp46 and CD16.
Second, this preclinical efficacy can be further increased by the addition of an interleukin-two variant, which targets the IL-2 receptor beta gamma complex, which express on NK cells, inducing their proliferation within the tumor microenvironment. Overall, this platform demonstrates better preclinical anti-tumor efficacy than we have seen in tumor models with clinically approved benchmarked antibodies. Our most advanced ANKET program is a CD123 targeted tri-specific molecule, IPH6101, also called SAR443579, that we have generated in collaboration with Sanofi. It is now fully licensed to them and currently in phase I trial.
The second ANKET program of this collaboration with Sanofi, IPH6401, also continues in development. Our most recent generation of tetra-specific ANKET is also progressing toward the IND-enabling studies, with the first IND filing expected in 2023 for IPH6501. Now, I will turn to Mondher for a summary of the upcoming catalysts.
Thank you, Yannis. 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 and long-term value. Looking at our clinical program, we expect to achieve a number of milestones over the next two 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 pre-pivotal cohort in Sézary syndrome, as well as data in the mycosis fungoides in the second half of this year.
In addition, we are moving our anti-NKG2A program into the clinic, with initial data expected next year. Monalizumab in the head and neck trial is underway. Finally, we continue to advance the adenosine pathway in the clinic, where we look forward to data and next steps from the anti-CD39 in 2023. In parallel, we continue to develop our ANKET technology platform, and we are very encouraged by the preclinical results from our next generation NK cell engagers. We believe that this represents a natural evolution of our platform, with data presented at conferences 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 throughout 2022.
Let's move to slide 14. As you can see, we continue our exciting journey at Innate. We look to build our business to create value for patients and stakeholders. In summary, we have positioned Innate for the future with our strategy and made meaningful progress throughout 2021 across all three strategic pillars. We have carefully managed our resources so we can continue to invest in our progress in our pipeline. 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 31st, 2022. In addition, we have the EUR 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' interest. As such, we opened an at-the-market program last week on the Nasdaq. The ATM allows us to accept the request for purchase dependent on market dynamics. Collectively, we are driving value across our business and ultimately 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.
Thank you. At this time, I would like to remind everyone, in order to ask a question, please press star followed by number one on your telephone keypad. If you would like to withdraw your question, please press star followed by number two. We will pause for just a moment to compile the Q&A roster. Our first question comes from the line of Yigal Nochomovitz from Citi. Please, Yigal, your line is now open.
Hi, team. This is Ashiq Mubarack from Citi. Thanks for taking my questions. For the phase III INTERLINK-1 trial AstraZeneca is running in head and neck cancer, my understanding is that there will be an interim analysis prior to the full data in 2024. 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.
Absolutely. So, as I said, this is an AD cancer trial that we initiated, that was initiated back in 2020. The first patient was dosed in November 2020. At that time, we announced that there is an interim analysis that is planned to occur between 18-24 months after the first patient dose, which means that this interim analysis would occur in the second half of 2022, but the final analysis are expected in 2024. I hope it's clear.
Okay. Will you share any details?
Okay.
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.
AstraZeneca did not disclose or nor communicate any details about the threshold nor the statistical test for this interim analysis. We know that there is a an interim analysis to decide whether to pursue or to stop. This will, as I said, occur in the second half of this year. Of course, we will be informed by AstraZeneca once this analysis is performed. We'll share the outcome of the discussion.
Okay, great.
Yeah.
Thanks for taking my questions.
Sure.
Thank you.
Thank you.
Our next question comes from the line of Daina Graybosch from SVB Leerink. Please, Daina, the line is now open.
Thank you. Thank you guys for the question. Two for me. The first on COAST. 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.
Thank you, Daina. I'll take your second question, and then I will be back.
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 studies.
Absolutely. Thank you very much, Daina. I'm gonna hand over to Joyson. As you've heard in his remark, Joyson just referred to the biomarker analysis and probably is the right person to address your first question about what's the takeaway from this data. Of course, Yannis will address the question about IPH sixty-five, for which we did not disclose the target yet. Joyson, would you start, please?
Sure. 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 yeah and this should be taken with caution, considering the small numbers that were used in the subgroup analysis. We found that the combination of monalizumab and durvalumab in tumors that expressed high HLA-E and NKG2A expression appeared to favor this combination in this PFS subgroup analysis. It for us that helped to support the synergistic as well as mechanistic rationale that we initially had developed for the combination when it was first put into the clinic. I think I'll hand it over to-
Thank you.
Oh, go ahead.
Yannis.
Yeah. Hi, Daina. On the IPH65, so like Mondher said, we did not disclose the identity of the target, but what 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 variant. We perform, I would say, a very classical lead optimization work in order to select the best candidate, and we are underway to in IND-enabling study with the target to file an IND in 2023.
Thank you. Maybe one follow-up for Joyson. Do you think that there's any potential to use either HLA-E or NKG2A in the future as a diagnostic to enrich patients for the combination of monalizumab in any of the settings?
I think with the small numbers, at least in the COAST trial, it will help to supplement the data that we see, at least from the NeoCOAST study. I think right now, with the small numbers and exploratory nature of the analysis, it's definitely a hint that it's possible. I think that this will need to be supported with the NeoCOAST data that we get before kind of moving into a biomarker-driven approach.
Very helpful. Thank you.
Thank you. Our next question comes from the line of Olga Smolentseva from Bryan, Garnier. Please, Olga, your line is now open.
Good afternoon, everyone, and thank you for taking my questions. The first one would be, could you maybe discuss a bit, how you see positioning of lacutamab in evolving landscape of PTCL treatments? Maybe do you have data on overlap between expression of, for instance, CD30 and KIR3DL2?
Thank you, Olga. Welcome back. First of all, you know that the giant cell lymphoma program just started, as of today, we don't have data. Of course, any positioning should be and must be data-driven. I won't speculate, but if we assume that we have a level of activity that justifies further development of lacutamab giant cell lymphoma, it's definitely what we could call a game changer in the development of this program because so far it has been limited to a rare form of peripheral T-cell lymphoma. We look forward really to generate this data. As you know, we have two approaches.
One is a single agent monotherapy in the relapsed refractory setting, trying to detect a single agent activity in a difficult to treat patient population, for which of course it is important to provide alternative therapeutic approach given the persistent unmet medical need there. There is a second approach we are pursuing in collaboration with the LYSA, which is a non-Hodgkin lymphoma cooperative group in France and in some European countries where we are testing the combination of lacutamab with the chemotherapy. As you know, the combination of the GemOx and lacutamab is one of the between bracket standard of care.
It's a randomized comparative study, so it will also provide a hint to the contribution of component of 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 drug in this setting. This will be biomarker-driven, as you know, both in the single arm trial as well as in the combination trial. We are targeting KIR3DL2 positive large cell lymphoma. Now to your second question about the overlap in expression, I'm gonna ask Yannis to provide more color on this. Yannis, please.
Yeah, sorry. Yeah, in PTCL, there is no correlation of the KIR3DL2 expression with CD30. For example, you find expression across all different subtypes of PTCL with some variation depending on the subtype. I would say that there is a KIR positive PTCL patient both in the CD30 positive as well as in the CD30 negative.
Thank you.
That's clear. Thank you.
Yannis.
If I may, maybe
Oh, yeah.
A few words on the companion diagnostic. Yeah, sorry. I just I was wondering-
Please.
If you can share a few words on companion diagnostics for KIR3DL2 expressers and maybe how aligned it is with the standard diagnostic laboratory practices. Basically, would it be easy to kind of just add it to the current regimen for PTCL and maybe what additional steps, if any, are required to get it approved?
Absolutely. As you've heard in Joyson's remarks, we are working on further solidifying the package for this purpose. I'm gonna let Joyson answer the question knowing that we are still at the early phase of the development and that Sézary syndrome per se is not probably the best target indication for this since more than 90% of the patients fit the target. But pharmacologically from the data, it's definitely because we believe that this is still required there. Joyson, can you give more color on our CDx plan for lacutamab, please?
Sure. We had mentioned the initial results that we're seeing with CTCL was based on a frozen assay. I mean, a frozen assay. We are now using the all-comers cohort looking at an FFPE assay. 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. We are going through the necessary steps to ensure that not only for CTCL but also PTCL, the assay can be used in our later phase trials.
That's very helpful. Thank you.
Thank you. I will hand over back to Henry Wheeler now for any chat questions.
Hi. 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. You have negative experience with Lumoxiti. Still, you are holding all rights to 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 pre-marketing and market access. What avenues are you considering? When you say you have cash into 2024, what does that mean for lacutamab marketing-wise?
Thank you, Eric. Very important question. I would like to start maybe by reminding what I said in my intro when I described our strategy with, you know, the three pillars. One of the core pillar is about building really a strong and sustainable foundation for our business, leveraging the various partnerships across both industry and academia. We are, as you know, a company with a good track record of collaboration over the years that has been instrumental actually in just the growth and the development of our company. Clearly, we want to ensure that there is no restriction to that. In other words, if we can gain valuable competencies via partnership, even for lacutamab, we'll consider that in our development plan.
I think what is really important is to ensure we have medicine get into patients as quickly as possible. If there is an opportunity to do it in partnership with another company, we would consider that and would evaluate the benefits of partnering. Today, we are in a phase II stage generating data. Of course, the Sézary syndrome cohort has the potential to be pivotal based on a predefined level of activity that we discussed with the FDA. Overall, we are generating data that will guide and inform, of course, about phase stage and phase III.
We are far away from preparing for the launch of the market because you know how long it takes to deliver a phase III in this setting. We are not there yet. We are just focusing on executing on the TELLOMAK trial, making sure we can build on the Fast Track designation for the drug and have an accelerated approval in Sézary syndrome. At the same time, of course, consider all the options, including the partnership if we believe there is more value to create in partnering. Last but not least, I think the lomustine experience was, as you said, a tough one.
We launched the drug at the worst moment possible with the COVID, but nevertheless, it was an extremely useful. As you know, we learn a lot from our failures, and I think it was an extremely important step in the development of our company. It gave us the opportunity to refocus our energy and resources on R&D to continue to fill our pipeline and generate innovative medicine that can contribute to help cure cancer. That's our ambition, our mission at Innate Pharma. Thank you for your question.
Thank you. We continue with the questions on the phone lines. The next question comes from the line of Liisa Bayko from Evercore. Please, Liisa, your line is now open.
Hi. Thank you for taking our question. This is Gina Yang for Liisa. My first question is, what should we expect at the TELLOMAK data readout second half this year? My second question is, can you talk a little bit about what is your plan for lacutamab and Sézary syndrome and mycosis fungoides? Do you plan to file, go ahead and file Sézary syndrome alone, or will you wait for the mycosis fungoides data to file together? Thank you.
Thank you, Gina, for the question. Two question on lacutamab, and I think, you know, Joyson is the right person to update you on the readout, even though we had a slide in describing this, but he'll provide also more color about our registration strategy and regulatory approach. Hi, Joyson.
Thank you, Mondher. Thanks for the question. For your first question about the data readouts in the second half of 2022, the Sézary syndrome would be the first time that we're presenting that data, so that would be preliminary data on the Sézary syndrome pivotal cohort. In regards to the 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. That would be the two data readouts for the second half of 2022.
I think in regards to the second question around whether we would file for Sézary syndrome or mycosis fungoides, I think a lot of this will depend upon the data itself. When we look at both of these cohorts, you know, there is definitely the potential to file both of them together. Also in addition, we also have the ability to file for the Sézary syndrome as a pivotal cohort. We are already going in with the approach that in mycosis fungoides we would have to do a phase III. We're kind of looking at the entire package that we're able to get for both Sézary syndrome and mycosis fungoides, and then making a data-driven decision from there.
I see. Thank you. If I may, squeezing one more question. 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 12-18 months from, you know, dosing the first patient? And should we also expect a $50 million milestone from that potential readout?
Sorry to disappoint you, but this is really an off-label trial, and I won't speculate on any timing. They didn't provide any specific dates of whether there is an interim analysis or even for the final. This is lung cancer, okay? I know you are familiar with the lung cancer development and the timeline and how long it takes to accomplish these types of clinical trials.
Okay, thank you.
Thank you. I hand over back to Henry now for the questions on the chat.
We had another question from Liisa Bayko at Evercore. Do you see read-through from activity in the phase II head and neck to phase III l ung cancer?
Joyson, this is for you. It's your preferred question. I know. I'll let you address it.
Yes. Thank you for the question, Liisa. I think when we look at both of these trials, there's two main components. Number one is they're vastly different disorders. You know, lung cancer versus head and neck. Because of that, I think what you would see in head and neck would probably not translate over into lung cancer. I think that's the main takeaway. I mean, the answer to that question is I don't. Based on the oncologic indications, you would not expect to read through at least between head and neck and lung cancer.
That's also noting in the head and neck, as well as in lung cancer, we are seeing exploratory evidence that there is synergistic potential between monalizumab and durvalumab, as well as we've seen that with monalizumab and cetuximab. I think when you look at it in two different points mechanistically, there could be a mechanistic rationale that applies to both indications. Clinically, these two indications are vastly different tumor types.
Thank you, Joyson. I think we have more questions on the line.
Yeah. Thank you. We continue with the questions on the phone lines, and the next question comes from the line of Arthur He from H.C. Wainwright. Please, Arthur, your line is now open.
Hi, everyone. Thanks for taking my question. This is Arthur He from H.C. Wainwright. I just wonder, could you guys remind us the milestone payment could potentially related to the IPH64 with the Sanofi collaboration?
Sure. I'll hand over to Yannis to provide the answer on the financial terms of the deal with Sanofi.
We did not disclose the breakdown of the milestone that we have with Sanofi. What we disclosed that for both program, IPH61 and IPH64, we have in total up to EUR 400 million in milestones as well as high single-digit royalties.
Okay. Thank you for that.
Yeah. Thank you, Yannis.
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.
Thank you very much. Again, thanks all for joining this call. I know it's a busy time of year, so many of you are, let's say, busy with the various Q1 results. I wanted just to, in a conclusion, to say that, as you can see, we are consistent. We continue to execute against our strategic priorities. Looking ahead, we will continue to advance our lacutamab program, move our early R&D activity toward the clinic. As you've heard from Yannis, we are actively preparing the R&D package for IPH65, as well as of course, a collaboration and partnership around this platform.
Finally, for omalizumab, we are pleased with the development in early lung cancer, but also the head and neck cancer underway and the interim analysis planned in second half of the year are important milestones. Of course, it reinforces our strategy of building a sustainable business with a robust R&D engine. With that, I thank you very much, and I wish you a wonderful day.
This concludes today's call. Thank you so much for joining. You may now disconnect your lines.