Earnings Call Transcript - IPHA Q2 2021

Operator, Operator

Good day, and thank you for standing by, and welcome to the Innate Pharma Half Year Results Conference Call. For your information, the conference is being recorded. Now, I would like to hand the conference over to your speaker, Mondher Mahjoubi. Please go ahead.

Mondher Mahjoubi, CEO

Thank you. Good morning, good afternoon, and welcome, everyone. It's a real pleasure to be here with you today. This morning, we issued a press release providing a business update for the first half of 2021. I look forward to explaining the progress we’ve made during the year-to-date 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. And before we start, on Slide 2, I would like to remind you that we will make forward-looking statements regarding the financial outlook in addition to regulatory and product plan development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. On today's call, I'm delighted to be joined by Dr. Joyson Karakunnel, EVP and Chief Medical Officer; and our CFO, Frederic Lombard, who will present an update followed by the Q&A section. On Slide 4, you have the classic intro slide of Innate Pharma. As you know, we are pioneers in the field of innate immunity, and in particular, in NK cells. We follow the science to develop innovative therapeutics for patients, leveraging our know-how and antibody generation platform. We are using this expertise to develop a robust pipeline of novel medicines for cancers. Please move to Slide 5. Our pipeline shows how we have translated our scientific leadership into a robust portfolio of both proprietary and partnered assets. It also illustrates how we are executing against our strategy with our lead asset, lacutamab, supported by partners and also earlier-stage products. Additionally, we have a rich pipeline, including the adenosine pathway with an anti-CD73 and an anti-CD39 in the clinic, along with a pool of preclinical projects, including our NK cell engager platform, which we will carefully select and bring forward to fuel our clinical pipeline. Please move to Slide 6. Our strategy centers around three core priorities. While we look to drive value from our early R&D efforts through later-stage partnerships where it makes sense to do so. First, we look to create near-term value driven by our lead proprietary product candidate, lacutamab, which is in development for T-cell lymphoma. Second, fueling our pipeline and creating longer-term value by leveraging our antibody engineering capabilities to develop innovative molecules with a primary focus on our multi-specific NK cell engager, delivered from our proprietary ANKET platform. And third, we are building a strong and sustainable foundation for our business by leveraging various partnerships across industry and academia. We will look to partner including late-stage, when it makes sense to do so. These will further validate our science and offer capital that we can reinvest to advance our early portfolio. During the first half of this year, we have worked diligently to execute against these three core priorities. Number one, we have continued to advance lacutamab as we pursue a broad development strategy across T-cell lymphoma. We are excited to showcase lacutamab data in mycosis fungoides, from the Phase 2 TELLOMAK trial, and we have progressed to Stage 2 earlier than anticipated. In addition, we announced our stepwise approach in developing lacutamab in PTCL with two clinical studies for KIR3DL2-expressing patients with relapsed peripheral T-cell lymphoma, including a randomized controlled trial in collaboration with our partner at the LYSA or Lymphoma Study Association. We have also worked hard to advance our R&D efforts with our early stage program, and we were pleased to announce earlier this year that Sanofi made the decision to progress IPH6101, our lead NK cell engager, into IND-enabling studies. This is the first candidate to emerge from our multi-specific NK cell engager platform, and we are excited about the prospect of this technology, which we believe will fuel our pipeline well into the future. Lastly, we look forward to further updates on our monalizumab collaboration with data from the randomized Phase 2 COAST trial in Stage 3 non-small cell lung cancer which will be presented at ESMO this week. I would like now to pass the call over to Joyson, who will review the progress made with our portfolio starting with lacutamab, our lead proprietary asset. Joyson?

Joyson Karakunnel, Chief Medical Officer

Thank you, Mondher. On Slide 7, let me start with lacutamab. It's a first-in-class humanized monoclonal antibody that targets the immune receptor KIR3DL2. As you may remember, KIR3DL2 is an inhibitory receptor found in approximately 65% of patients across all cutaneous T-cell lymphomas and even more in certain aggressive subtypes, but with limited expression in healthy tissue. To date, data from lacutamab have shown promise, demonstrating compelling single-agent activity and offering immense potential in lymphomas historically associated with poor prognosis for which there are few therapeutic options at an advanced stage. On Slide 8, I just wanted to remind you of our development strategy for lacutamab and T-cell lymphoma. We are pursuing a fast to market strategy with a potentially pivotal trial underway in a niche setting of Sézary Syndrome, where lacutamab was granted US Fast Track designation and EU PRIME designation last year. We are also looking to potentially expand past Sézary syndrome to mycosis fungoides, where we have encouraging preliminary data from our Phase 2 trial, which I'll cover in a minute. Finally, we are advancing into peripheral T-cell lymphomas with a couple of recently announced trials. On Slide 9, let me highlight the great progress we have made this year in our ongoing Phase 2 TELLOMAK study for Sézary syndrome and mycosis fungoides. In mycosis fungoides, firstly we moved the KIR3DL2 expressing cohort from Stage 1 to Stage 2, clearing a pre-determined threshold before 50% of the cohort was enrolled. The KIR3DL2 MF data was also presented with the next MF data due in 2022. For the Sézary syndrome cohort, enrollment is on track, and we expect to be able to report top line data in 2022. On Slide 10, we have a summary of the Cohort 2 mycosis fungoides data in KIR3DL2 expressers. Here we see the preliminary results Cohort 2, which showed an overall response rate of 35% in these late line patients with limited treatment options. You see the median follow-up is still short at 4.8 months. It is important to consider that there are quite a lot of confirmed responses, and we now have six confirmed responses out of 17. And you see that some patients have quite a long duration of follow-up in this Cohort 2. If we look at the response by compartment in the skin, you see that the responses are quite high. Now with 11 confirmed responses out of 17. These skin results are extremely interesting because skin is very important for the quality of life of the patient. And so it is interesting to see that the majority of patients had represented a very good complete or partial response in the skin. We are encouraged by the data and look forward to further proof points in 2022. On Slide 11, as mentioned, we are working to advance our recently announced clinical development plan for peripheral T-cell lymphoma, which will initially focus on the relapse setting where the unmet medical need is most significant. We are initiating our Phase 1b trial evaluating lacutamab as a monotherapy by midyear. The study will enroll approximately 20 patients and will evaluate safety and characterize clinical outcomes. First data are expected in 2022. Separately, our partner, LYSA, are initiating an investigator-sponsored Phase 2 study to evaluate lacutamab in combination with the chemotherapy GEMOX. This study will be a multicenter, randomized trial with approximately 60 relapsed/refractory patients outside the U.S. We believe that this stepwise approach will prove efficient in identifying the optimal regimen for lacutamab in the relapsed PTCL setting. Depending upon the data generated in these initial studies, we will consider initiating a separate trial in combination with another standard of care treatment and eventually we would look to move lacutamab into earlier lines of treatment, including as potential combination in the CHOP regimen in frontline PTCL or as a consolidation therapy following standard first-line treatment. Moving on to Slide 12. We are pleased to have presented our latest innovation to our proprietary multi-specific NK cell engager platform that we call ANKET, which Eric Vivier presented at the FOCIS meeting in June, and for which an oral presentation has been accepted for ESMO this week. ANKET stands for antibody-based NK cell engager therapeutics. These multi-specific molecules are made of various building blocks, as illustrated here. The reason why we are so excited about the ANKET is because we are announcing two breakthroughs. First, a technological breakthrough and second an efficacy breakthrough. This is leading to the harnessing of NK cell effector function against cancer and also provides proliferation. So on the technological breakthrough, as you can see on this slide, ANKET is very versatile, fit for purpose technology that is creating an entirely new class of tri- and tetra-specific molecules to induce strategic immunity against cancer. On the efficacy breakthrough, this unique NK cell engager engages for the first time to activating NK cell receptors, namely NKp46 and CD16. But also the combination of receptors for IL-2, IL-2R beta and IL-2 gamma with the IL-2 variant and tumor antigen in a single tetra-specific molecule. Overall, it demonstrates a better anti-tumor efficacy than clinically approved antibodies within the limits of preclinical models. On Slide 13, is a summary of the data on our recent generation of tetra-specific ANKET, which is made of four components. In yellow, an antibody fragment that recognizes the tumor antigen. In green, an antibody fragment that recognizes NKp46. And then red, an FC portion that will interact with CD16. And then in blue, a variant of the IL-2v variant. On the left side of the graph, we show you the contribution of the tetra-specific ANKET with the IL-2 variant. The black graph on the far left is the vector. The green graph is the tetra-specific ANKET. The red graph on the right is a tri-specific ANKET with the IL-2 variant separately. You can see the benefit from the green graph in the middle of including the tetra-specific ANKET with the IL-2 variant. On the right, you can see the benefit of tetra-specific versus the vehicle obinutuzumab in lung mouse models. On the top, you have the vehicle; in the middle, tetra-specific ANKET and on the bottom, the CD20 obinutuzumab. Activity is seen with the tetra-specific model that is not seen with obinutuzumab. We look forward to updates on ANKET this year at ESMO and other Scientific Congresses and look forward to progressing our partnership with Sanofi. Finally, on Slide 14, we have our third pillar of our strategy of building a sustainable business. I wanted to highlight the latest developments for monalizumab which we have outlined since the AstraZeneca deal and received $400 million in milestones to date, with further potential milestones to come. To remind you, monalizumab is an anti-NKG2A, which acts upon the checkpoint pathway to potentiate NK cell activation. This is being trialed in combination with cetuximab in head and neck cancer, and also in combination with the anti-PD-L1 immunotherapy durvalumab in lung cancer. In head and neck cancer, the Phase 3 INTERLINK-1 trial of monalizumab plus cetuximab in IO-pretreated head and neck cancer is underway. In addition, we are expecting data from Cohort 3 as a Phase 2 trial later this year for the triplet of monalizumab plus durvalumab plus cetuximab in first-line head and neck cancer. As mentioned previously, the Phase 2 data in Stage 3 non-small cell lung cancer COAST trial for monalizumab in combination with durvalumab will be presented at ESMO this week by AstraZeneca. In summary, we look to work further with our partners at AstraZeneca.

Frédéric Lombard, CFO

Thank you, Joyson, and good day everyone. So moving to the finance, Slide 15, we start with our key metrics as usual, our cash position. Our cash and cash equivalents amounted to €159.4 million as of June 30 this year, down from €181.7 million at the end of Q1 2021. We are in a strong financial position with cash to fund planned operations to at least 2022. In addition, as you can see, we are efficiently managing our resources and actively seeking opportunities to accelerate our impact by nimbly following data to explore strategic and opportunistic indications. We believe this approach ensures that we remain in a position to strategically invest in our vision for Innate. Now, going into the P&L. We will only comment on the main and most significant lines. You have very detailed comments in the appendix of the press release that you can refer to for more information. I will start with our revenue from collaboration. Our revenue and other income amounted to €15.7 million, primarily resulting from revenues from collaboration and licensing agreements, and to a lesser extent from governmental funding. This revenue mainly resulted from the spreading of the upfront and opt-in payments received from AstraZeneca for monalizumab, which remain recognized based on the percentage of completion of the work performed by the company. I also remind you that it has no impact on cash. On operating expenses, for the first half of 2021, they amounted to €41.1 million, a reduction of 11% from the first half of 2020. R&D expenses decreased by €9.7 million to €21.8 million, representing just over half of our operating expenses. This change mainly results from a decrease in depreciation and amortization expenses allocated to R&D, following the end of the transition period with AstraZeneca in September 2020. Also, the return of commercialization rights in the U.S. and Europe for Lumoxiti, as well as the end of recruitment in trials evaluating avdoralimab in oncology. Turning to SG&A expenses, they increased by €4.8 million to €19.3 million for the period primarily due to the provision for charges booked related to the payment of US$6.2 million to be made to AstraZeneca in April 2022 under the Lumoxiti transition and termination agreement. This is less than the company reported up to US$12.8 million contingent liability at the end of 2020, linked to the split of certain manufacturing costs. As such, net income from distribution agreements was new following the end of the transition period relating to the commercialization of Lumoxiti in the U.S. The company recognized US$1 million in excess of Lumoxiti for the first half of 2021. With that, I will turn back to Mondher.

Mondher Mahjoubi, CEO

Thank you, Frédéric. Thanks to Joyson. So please move to Slide 16. 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 for our patients and our shareholders. Moving on to our clinical program, we expect to achieve a number of milestones over the next 18 months. As you've heard from Joyson, our Phase 2 TELLOMAK study for lacutamab continues to progress, and we expect to report potentially pivotal data in Sézary syndrome and in mycosis fungoides in 2022. In addition, we are moving our PTCL program into the clinic with initial data expected as well in the next year. For monalizumab, we look forward to the Phase 2 COAST data at ESMO this Friday, which builds on the hypothesis of adding monalizumab to the anti-PD-L1 durvalumab. Later this year, as you've heard from Joyson, we will present the data from Cohort 3 of the Phase 2 head and neck cancer study, just in the combination of monalizumab with cetuximab and durvalumab in IO naive patients with advanced neck cancer. We are further advancing the adenosine pathway agents in the clinic, where we are starting a new Phase 1 trial for IPH5301, the anti-CD73, and we look forward to data from the anti-CD39 IPH5201 due in 2022. 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, illustrating the potential for all NK cells. And the fact that they could become the next generation of cancer immunotherapy with more to come as Joyson said; this Saturday is an oral presentation at ESMO. We look forward to further updates on the progress of our ANKET platform in the second half of this year. Please move to the conclusion slide, Slide #17. So as you can tell, we have an exciting journey ahead at Innate. We continue to build our business to create value for patients and stakeholders. And in summary, we have positioned Innate Pharma for the future with a solid strategy and made meaningful progress throughout the year. Just to recap, in summary, with lacutamab we moved forward with our MF trial and presented encouraging data. Next year we will have data on MF and potentially pivotal data in Sézary syndrome, and we will start with PTCL products. Second, our R&D engine was further validated as Sanofi chose to progress IPH6101 into IND-enabling studies. We will continue to leverage this antibody capability to develop innovative molecules with a primary focus on our next-generation ANKET NK cell engager molecules, as demonstrated at FORCE and ESMO this year. And finally, as you heard from Joyson, we continue to be a sustainable business by balancing our portfolio with partnered assets that provide substantial revenue streams to support our continued investment in early R&D. Collectively, we are driving value across our business and ultimately advancing our goal to deliver innovative medicines to patients. We look forward to keeping you updated on our progress. With that, I conclude the prepared remarks and I will now open the call to questions. Operator?

Operator, Operator

We're taking our first question from the line of Daina Graybosch. Please go ahead.

Daina Graybosch, Analyst

Hi. Thank you for the question. Two for me. One, just thinking ahead for the monalizumab data to be presented on Saturday. I wonder if you could remind us how much overlap in efficacy and read through from concept to proof-of-concept study? Do you believe there is a new combination of monalizumab with durvalumab versus cetuximab? Does either of these therapeutic combinations or mechanisms have activities at CD8 cells or NK cells? And then in addition, keeping alive my question could we see NeoCOAST data this half? I noticed it's not on your milestone slides, so maybe you don't have specific visibility, just wondering about the possibility.

Mondher Mahjoubi, CEO

Thank you, Daina. I'm going to repeat the question because the line was not great. So to make sure that I got it right and everyone also can hear them. So you ask question on the NeoCOAST data, when this data will be public. And the first question was about the potential read across or read through from the COAST data to the INTERLINK trial and the combination of monalizumab with cetuximab. AM I repeating correctly?

Daina Graybosch, Analyst

Correct.

Mondher Mahjoubi, CEO

Okay, perfect. So I will start with the second question very quickly to say that as you know, the NeoCOAST data is run by AstraZeneca, it's sponsored and run by AstraZeneca. We have really no further information than what is publicly available on the AZ side, which is that the data are expected in the second half of 2021. So we will hear more problems from AZ in the near future. With regard to your first question, I think this is an excellent opportunity also for us to remind you our strategy from the basic research and the slide that Joyson showed to illustrate his remarks on monalizumab, you have two mechanism of action that were the blockers in our labs. The first one is a way to enhance the activity of antibodies that, like cetuximab could have a synergistic effect when combined with monalizumab. And that's what led to the head and neck program and the Phase 3 trial that was started last year. The second piece of information and piece of data that was published already in 2019 was basically the technical package that supported the clinical program of the combination of monalizumab and anti-PD1 or PD-L1 showing the clear synergy, coming from the fact that NKG2A is not only expressed on NK cells, but also on a subset of CD8 positive T cells. So, first of all, I think the two trials and the two settings and the two types of combinations are supported by strong scientific rationale. Now, as you know better than me, these are two different tumor types and two different settings and it's really premature to speculate on the data before the COAST data is presented and of course, I would be very cautious not to have cross trial comparisons or read across, but I'll hand over to Joyson who can maybe complete this answer.

Joyson Karakunnel, Chief Medical Officer

Yes. So I think Mondher summed it up very nicely. I think the strength of the preclinical data that supported these trials, both with cetuximab as well as with durvalumab, have two different mechanisms of actions that we look for, that the combination potentials. We've already kind of seen some of that with head and neck. And we'll have to wait for the data to see what happens with COAST. I think second, I think Mondher pointed it out very nicely, which is, these are two different indications, two very different settings; one adjuvant, the other metastatic. And it would be hard to read across the trials or read from across trial comparisons, not only because we try not to do that, but also just because of the differences of indications, settings as well as mechanisms of action.

Mondher Mahjoubi, CEO

Thank you, Joyson. Does it answer your question, Daina?

Daina Graybosch, Analyst

Thank you. Yes, it does. Thank you very much.

Mondher Mahjoubi, CEO

Thank you.

Operator, Operator

We are taking our next question from the line of Yigal Nochomovitz at Citigroup.

Yigal Nochomovitz, Analyst

Thanks, Mondher. I just had a few questions. So first, I know obviously, you can't disclose the data yet on the ORR and PFS proposed ahead of the later-breaking presentation. But that said, to the extent that you can comment generally, what percent improvement in ORR and PFS would you view as clinically meaningful benefit for monalizumab plus durvalumab combo over the durvalumab monotherapy? Thanks.

Mondher Mahjoubi, CEO

Thank you, Yigal. Again, we look forward to seeing the full data presented at ESMO as this will be an oral later-breaking abstract. This was detailed by the curtain raiser. They will report ORR, but they also present PFS data for both arms, durvalumab plus monalizumab and durvalumab monotherapy. I think the design of the trial is well-known. It has been already publicly disclosed. It's a well-controlled phase randomized Phase 2 trial. They have not, to my knowledge, publicly disclosed the details of the statistical hypothesis. But I believe what is interesting to have in mind is that these are patients who finished their chemotherapy and radiation therapy and are randomized within six weeks, if they do not progress. And they are being treated with durvalumab mono or durvalumab for up to 12 months. The response rate is certainly a very important endpoint and is the primary endpoint for this trial. But the quality of the response and in particular, the disease-free survival or the progression-free survival is certainly something to look at as well. So I believe the response rate is certainly important to assess, and we look forward to seeing the data, but I think PFS is something crucial to keep in mind.

Yigal Nochomovitz, Analyst

Okay, got it. Thank you. And then a second question I had on lacutamab. Can you talk a bit about how you're planning to identify Sézary syndrome and mycosis fungoides patients, given that in the major pharma markets, U.S., Europe, and Japan, there are only 200 Sézary patients and about 3,000 mycosis fungoides patients according to the database?

Mondher Mahjoubi, CEO

Yes, just to make sure I get your question, is it vis-à-vis the commercial opportunity, or talking in general about how we are designing and implementing or executing our clinical trials?

Yigal Nochomovitz, Analyst

No, more about the commercial opportunity.

Mondher Mahjoubi, CEO

Thank you for the great question, which allows me to discuss our strategy. The Sézary syndrome indication serves as a prototype to validate our mechanism of action, as most patients express KIR3DL2. In the Phase 1 trial, we observed that targeting the tumor antigen KIR3DL2 resulted in significant tumor shrinkage and improved quality of life. This symptom marks the first step in our fast-to-market strategy, aimed at achieving brand recognition and engaging with the FDA and EMA to expedite clinical development. Our goal is to expand beyond this indication, as mycosis fungoides represents a substantial portion of peripheral T-cell lymphoma. Mycosis fungoides accounts for approximately 3,500 to 4,000 new patients each year in the U.S., Europe, and Japan, alongside 4,000 patients with other non-mycosis fungoides cutaneous T-cell lymphoma. This totals around 8,000 patients with cutaneous T-cell lymphoma, with half expected to express KIR3DL2. The mycosis fungoides segment is only part of the larger picture, which presents a more compelling business case. A key milestone from the Lugano meeting was demonstrating that lacutamab is effective outside of Sézary syndrome in T-cell lymphomas expressing KIR3DL2, thus laying the scientific foundation for expanding into T-cell lymphoma, where we see a commercial opportunity with over 18,000 new cases annually. KIR3DL2-expressing T-cell lymphoma presents an even more attractive market potential. However, our approach remains stepwise: we must validate the mechanism of action and confirm that lacutamab is effective beyond Sézary syndrome, which we are currently doing, before proceeding with KIR3DL2-expressing T-cell lymphoma. Overall, this move transforms our business perspective from a niche indication to a significant market opportunity.

Yigal Nochomovitz, Analyst

Got it. Thanks. And just I had one final question. This one might be good for Eric or Joyson. I'm just curious about the ANKET platform and the course of combining NKp46, CD16, and IL-2R. So is the thought that this tetra-specific asset would be better suited to solid tumors or to hematologic malignancies, or are both categories under consideration?

Mondher Mahjoubi, CEO

Yes. That's another excellent question. That, of course, we debate internally and I'll hand over to Joyson to sum up the thoughts behind the selection of the tumor antigen for these multi-specific antibodies.

Joyson Karakunnel, Chief Medical Officer

Thank you for the question, Yigal. I want to revisit the ANKET platform. The remarkable aspect of the ANKET platform is its versatility. As you mentioned, it involves NKp46 and CD16 attachments to the NK cells with the IL-2 variant. The tumor antigen can be changed, which provides flexibility. As Mondher indicated, we are currently engaged in extensive discussions internally to identify the optimal approach. We are examining both solid tumors and hematologic tumors. The platform's versatility enables us to have these discussions to determine the best opportunities in either category.

Yigal Nochomovitz, Analyst

Thank you very much.

Operator, Operator

Thank you. We're taking our next question from Graig Suvannavejh at Goldman Sachs. Please go ahead.

Graig Suvannavejh, Analyst

Hey, good afternoon. Good morning. Thanks for taking my questions. I've got a couple. First is actually on 5301. Certainly will be interested to see what the lacutamab data is for the AstraZeneca compound. But could you remind us how to think about differences that you are aware of between their asset and your asset? That's my first question about 5301. And then secondly, as it relates to the COAST data, anything at least from a scientific or biological rationale that would help us think about how to think about monalizumab and the efficacy and safety that we might see relative to a CD73 targeted asset such as lacutamab. So that's the second question. And then maybe just a question on the P&L. How should we think about trending over the next several quarters, just given the many moving parts. And in that context as we think about your current cash balance where you say you have cash at least until 2022, I mean, we're right around the corner. So how is the company thinking about financing options? What kind of options are available and what's the strategy? Thanks.

Mondher Mahjoubi, CEO

Thank you, Graig. Those are very important and insightful questions, as usual. I will begin with the first question and then hand it over to Joyson to discuss the COAST and the mechanistic approach we are considering, especially in relation to the potential combination with CD73. After that, I will let our new CFO, Frédéric, address your question about financing moving forward. Briefly on the 5301, we are eager to see the lacutamab data. Aside from that, I am not aware of any other public randomized data in this field. Everyone recalls the BMS and DAG Phase 1b data presented about two years ago at ASCO and AACR, which showed some trends of activity, but there hasn’t been anything since. Therefore, the results of the COAST trial regarding lacutamab are of significant interest to us and to other companies in this area. Additionally, I want to remind you that we published data and presented findings at AACR back in 2019, if I recall correctly, comparing our anti-CD73 with the BMS asset and others. It’s clear that our antibody has superior enzymatic activity in blocking anti-CD73. Of course, we need to translate those preclinical trials into clinical benefits for patients, which is why we were somewhat waiting to see data to learn from others. Over the last few months, we have been working on transforming the IND we filed at the end of last year into a clinical trial, which is set to begin soon. This will be our first clinical trial evaluating IPH5301. We have a plan in place regarding the combination approach we should take. We are looking forward to the COAST trial data to further refine and maximize the opportunities surrounding anti-CD73. Now, Joyson, regarding the question about COAST, how do we consider the extent across -- while I don’t want to speculate on the data, we are looking at the mechanism of action and potential compatibility with anti-CD73 if both arms are influenced?

Joyson Karakunnel, Chief Medical Officer

Yes. I want to emphasize that the mechanisms of action here are clearly different. One involves anti-CD73 and anti-NKG2A. We have preclinical data suggesting ADCC synergy. Monalizumab operates through a redundant pathway in combination. So, as we analyze this, we recognize two different tumor types in the same setting, each with distinct mechanisms of action that have different potentials. We'll need to wait for the COAST data to see what it reveals about the clinical outcomes. Both mechanisms focus on relieving immune suppression. My earlier mention of cetuximab was inaccurate; my reference was to CD73, which is involved in breaking down tumors by reducing the amount of adenosine present, thereby decreasing immune suppression. One mechanism focuses on decreasing adenosine, while the other targets two pathways: anti-NKG2A and PD1. Thus, we will wait for the clinical data to learn what unfolds.

Graig Suvannavejh, Analyst

Thank you.

Frédéric Lombard, CFO

Yes. Thank you, Mondher. Yes, as I said before, the cash position is quite robust at the moment with €159 million. We constantly monitor our financial needs and we provide an update when needed. We cannot communicate at this stage. In terms of the plan, for sure, if you look at the cash burn for this first half versus last year, we see a big decrease, but it's not following a disinvestment on the outside; we keep our plan as planned. Let's say, last year was having some special cash burn related to Lumoxiti and special payments that we had at the same time. So today you will see a slight increase in the second half due to the delivery of some studies that we are having in the pipeline.

Mondher Mahjoubi, CEO

Yes. So, Graig, long story short, we have a solid cash position. We have a good track record of ensuring that our cash covers the various catalysts and milestones ahead of us, as we constantly monitor our financing needs and provide updates when necessary. Thank you.

Operator, Operator

We are taking our next question from the line of an audience member. Please go ahead. Your line is open.

Mondher Mahjoubi, CEO

Hi. Good morning.

Unidentified Analyst, Analyst

Hey, good afternoon, Mondher, and greetings to the gentlemen. Thanks for taking my question. So I just wonder one question on the monalizumab data is going to be reported for the IO naive patients later this year. So could you remind us what kind of data set we could expect? And how many patients we could look into the data? Thank you.

Mondher Mahjoubi, CEO

Yes. Joyson, would you like to answer or I can take it? Okay.

Joyson Karakunnel, Chief Medical Officer

No, go ahead, Mondher.

Mondher Mahjoubi, CEO

Thank you for the question. To remind everyone, this is a single-arm study that tests the triplet combination. As I mentioned earlier, we have two mechanisms of action. Monalizumab could work synergistically with the antibody that operates within ADCC, which is the combination with cetuximab. Additionally, monalizumab is also synergistic with anti-PD-L1. The triplet is simply the combination of both cetuximab and durvalumab aimed at increasing response rates and improving response quality in terms of durability. This study was designed primarily to evaluate the safety of the triplet, marking it as potentially the first triplet used in a non-cytotoxic or chemo-free regimen for head and neck cancer. The safety results were promising with the first 20 patients, prompting us to expand the trial to 40 patients, although it remains a single-arm trial involving advanced relapsed or metastatic patients with squamous cell carcinoma of the head and neck, some of whom may have undergone prior chemotherapy or radiation but have not been previously treated. We plan to present the data at the end of the year, looking at the overall results to determine the platform. The competitive landscape is changing, and it's crucial to assess the specific unmet needs to position this triplet effectively. Currently, the standard of care is cetuximab, with or without chemotherapy, depending on the CPS level. The results we present at the end of the year will also be examined from this perspective, comparing CPS more than one versus CPS low or PD-L1 negative, and we look forward to sharing this data towards the end of the year.

Unidentified Analyst, Analyst

Thank you for that and congratulations on the progress.

Mondher Mahjoubi, CEO

Thank you very much. Thank you. Operator?

Operator, Operator

Thank you. There are no further questions on the phone.

Mondher Mahjoubi, CEO

Okay. Henry, do we have questions on the webcast?

Henry Wheeler, Analyst

No more questions, Mondher. Thank you.

Mondher Mahjoubi, CEO

Okay. So if there are no more questions, I would like, again, to thank everyone for dialing in this morning, this afternoon. I'm very excited with, again, the progress we are making with our strategy. As I said, we have encouraging data with lacutamab. Our R&D is progressing nicely with the new data from our ANKET platform, and we also look forward to the continued progress, including the upcoming monalizumab presentation at ESMO this Friday. With that said, I look forward to talking to you in the near future. Thank you very much, and have a great day.

Operator, Operator

That concludes the conference for today. Thank you for participating. You may all disconnect.

Henry Wheeler, Analyst

Thank you. Bye-bye.