Innate Pharma S.A. (EPA:IPH)
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Earnings Call: Q2 2021
Sep 15, 2021
Good day and thank you for standing by and welcome to the Innate Pharma Half Year Results Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. For your information, the conference is being recorded. Now I would like to hand the conference over to your speaker, Manda Majubi.
Please go ahead.
Thank you. Good morning, good afternoon, and welcome, everyone. Really pleasure to be here with you today. This morning, we issued a press release providing a business for the first half of twenty twenty one. I look forward to explaining the progress we have 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'll 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 forecasts. On today's call, I'm delighted to be joined by Doctor. Jason Carconeau, EVP and Chief Medical Officer and our CFO, Frederic Lambert, who will present an update followed by a Q and A session. 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 cancer. Please move to Slide 5. Our pipeline shows how we have translated the scientific leadership into Rubber's portfolio of both proprietary and partnered assets.
It also Illustrate how we are executing against our strategy with our lead asset, lequipamab, supported by partnered and also earlier stage product. Additionally, we have a rich pipeline, including the adeline pathway With an anti CD73 and an anti CDF-thirty nine in the clinic and the pool of preclinical projects including our Enkit NK cell engager platform, which we will carefully select and bring forward and fuel our clinical pipeline. Please move to Slide 6. Our strategy centers around 3 core priorities, Well, we look to drive value from our early R and D efforts through later stage partnerships where it makes sense to do so. 1st, we look to create near term value driven by our lead proprietary product candidate, lakutumab, which is in development for T cell lymphoma.
2nd, fueling our pipeline and creating longer term value By leveraging our antibody engineering capabilities to develop innovative molecules with the primary focus on our multi specific NK cell engager platform delivered from our proprietary NK cell engager platform. And third, we are building A strong and sustainable foundation for our business, leveraging various partnerships across industry and academia. We will look to partner including a late stage when it makes sense to do so. This will further validate our size 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 3 core priorities, number 1, we have continued to advance lequipamab As we pursue broad development strategy across T cell lymphoma, we are excited to showcase leukitamab data in microdispondroides from the Phase 2 telemat approach in developing lakutamab in PTCF with 2 clinical studies for Q3 DL2 expression patient with relapsed peripheral T cell lymphoma, including a randomized controller trial in collaboration with our partner at the laser of This is Lamp Fromaster, the SCCH.
We have also working hard to advance our R and D efforts with Our early stage program moving forward. And we were pleased to announce earlier this year that Sanofi made the decision to progress APS-six thousand one hundred and one, our lead NK cell engagers into IND enabling studies. This is the first candidate to emerge from our multi specific NK cell engager platform and we are very excited by the prospect of this technology, which we believe will fuel our pipeline well into the future. We look forward to telling you more about our progress here later in this call and in the near future. Lastly, we look for further updates on our monolizumab collaboration with data from the randomized Phase 2 COAST trial in Stage 3 unresectable 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 lekitharmab, our lead proprietary asset. Joyson?
Thank you, Mandeir. On Slide 7, let me start with lelucudumab, our 1st in class humanized monoclonal antibody that targets the immune receptor, Cure III DL2. As you may remember, Cure III DL2 is an inhibitory receptor found in approximately 65 percent of patients across all cutaneous T cell lymphomas and even more uncertain aggressive subtype, but with limited expression in healthy tissue. To date, Data from glukutumab have shown promise demonstrating compelling single agent activity and offering immense potential On Slide 8, I just wanted to remind you of our development strategy for lacunumab in T cell lymphoma. We are pursuing a fast to market strategy with a potentially pivotal trial underway in the niche The setting of Cesare syndrome where lekutumab was granted U.
S. Fast track designation, EU Prime designation last year. We are also looking to potentially expand PAS Sezary 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 TELLAMAX study for Caesare syndrome and mycosis fungoides.
In mycosis fungoides, firstly, we moved the Cure III DL2 expressing cohort From Stage 1 to Stage 2, clearing a predetermined threshold before 50% of the cohort was enrolled. The Cure III DL2 MF data was also presented at Lugana with the next MF data due in 2022. For the Sezary 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 Mycocea sponguides data in Cure III BL2 Expressors. Here we see the preliminary results of 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, 4.8 months. It is important to consider that there are quite a lot of confirmed responses and we now have 6 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 quality of life of the patient. And so it is interesting to see that the majority of patients and 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 20 On Slide 11, as mentioned, we are working to advance our recently announced clinical development plan for peripheral T cell lymphoma, which will focus initially on the relapse setting where the unmet medical need is most significant. We are initiating our Phase 1b trial evaluating leukutumab as a monotherapy by midyear. The study will enroll approximately 20 patients and will evaluate safety and characterize clinical outcome.
First data are expected in 2022. Separately, our partner, Liza, We are initiating an investigator sponsored Phase 2 study to evaluate lacutumab in combination with the chemotherapy genmox. 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 lacutumab 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 lacutumab into earlier lines of treatment, including as potential combination in the CHOP regimen in the frontline PTCL or as a consolidation therapy following standard first line treatment. Moving on to Slide number 12. We are pleased to have presented our latest innovation to our proprietary multi specific NK cell engager platform that we call NCAT, which Eric Vivier presented at the Phosys meeting in June and for which an oral presentation has been accepted for ESMO this week. MCAT stands for antibody based NK cell engager therapeutics.
And these multispecific molecules are made of various building blocks as is illustrated here. The reason why we are so excited about the NCAT is because we are announcing 2 breakthroughs. 1st, A technological breakthrough and second, an efficacy breakthrough. This is leading to the harnessing of NK cell effector function against So on the technological breakthrough, As you can see on this slide, MCAT 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 break This unique NK cell engager engages for the first time to activating NK cell receptors, namely, NKP-forty six and CD16, but also the combination of receptors for IL-two, IL-two R Beta and IL-two R Gamma.
With the IL-two variant and tumor antigen in a single tetra specific molecule, overall, it demonstrates a better antitumor efficacy And clinically approved antibodies within the limit of preclinical models. On Slide 13 is a summary of the data on our recent generation of TETRA specific MCAT, which is made of 4 components. In yellow, an antibody fragment that recognizes the tumor antigen. In green, an antibody fragment that recognizes MKP-forty six and in red an Fc portion that will interact with CD16 And then in blue, a variant of the interleukin-two IL-two variant. On the left side of the graph, We show you the contribution of the tetra specific NCAP with the IL-two variant.
The black graph on the far left is the vector. The green graph is the TETRA specific NCAT and the red graph On the right is a tri specific NCAT with the IL-two variant separated. You can see the benefit from the green graph in the middle of including the tetraspecific specific end cap with the IL-two variant. On the right, you can see the benefit of Tetrispecific versus the vehicle of binetuzumab in lung mouse models. On the top, you have the vehicle in the middle, TETRA specific NCAT 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 NCAT this year at ESMO and other scientific congresses and look forward to progressing our partnership with Sanofi. Finally, on Slide 14, we have our 3rd pillar of our strategy of building sustainable business. I wanted to highlight the latest developments for monalizumab, which we have out licensed to AstraZeneca and received $400,000,000 in milestones to date, With further potential milestones due, to remind you, monalizumab is an anti NKG2A, which acts upon the point pathway to potentiate MK 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 III INTERLUNK 1 trial of menolizumab plus tatuximab in IO pretreated head and neck Cancer is underway. In addition, we are expecting data from Cohort 3 of the Phase 2 trial later this year for the triplet of monalizumab plus durvalumab plus tatuximab 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 monolizumab 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. I will now hand over to Frederic to cover the financials for the half.
Thank you, Joyceann, and good day, everyone. So moving to the finance Slide 15. I will start with one of our key metrics as usual, our cash position. Our cash and cash equivalents amounted to €159,400,000 as of June 30 this year, down
from €181,700,000
at the end of Q1 2021. We are in a strong financial position with cash to fund planned operation to at least 2022. In addition, as you can see, we are efficiently managing our resources and sizing opportunity to accelerate Our impact by nimbly following data to explore strategic and opportunistic indications. We believe this approach ensures that we remain in position to strategically invest in our vision for Innate. Now going into the P and L, We only comment on the main and most significant lines and you have very detailed comments in the appendix of the press release that you can refer to for more information.
I'll start with our revenue for collaboration. So our revenue and other income amounted to EUR 15,700,000 and Domain resulted from revenues from collaboration and licensing agreements and to a lesser extent from Governmental Funding. This revenue mainly results from the spreading of the upfront and opt in payments received from AstraZeneca for monalismab, which I remind are recognized on the basis of 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, so for the first half of 2021, they amounted to €41,100,000 a reduction of 11% from the first half of twenty twenty.
R and D expenses decreased by €9,700,000 to €21,800,000 representing just over half of our operating expenses. This change mainly results from a decrease in depreciation and amortization expenses allocated to R and D following the end of the transition period with It's September 2020. Also, the return of commercialization rights in the U. S. And Europe for Lumoxiti as well at the end of the recruitment in trials evaluating avdoharlimab in oncology, sorry.
Turning to SG and A expenses, they increased by €4,800,000 to €19,300,000 for the period primarily as a result of the provision for charges booked relating to the payment of USD6.2 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 USD 12 €8,000,000 contingent liability at the end of 2020, which was linked to the split of certain manufacturing costs. As such, net income from distribution agreements was nil following the end of the transition period relating to the commercialization of Lumoxiti in the U. S. The company recognized USD 1,000,000 net sales of Lumoxiti for the first half of twenty twenty one.
With that, I will turn back to Mondhert.
Thank you, Frederic. Thanks, Jericen. 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. Looking at our clinical program, we expect to achieve a number of milestone over the next 18 months.
As you've heard from Joyceann, our Phase 2 telomex study for lequitamab continues to progress. And we expect to report potentially Pivotal's data in Sezary Syndrome and in Mycosis 400iS in 2022. In addition, we are moving our PTG health program into the clinic with initial data expected as well in the next year. For monalizumab, we look forward to the Phase 2 course data at ESMO this Friday, which built on the hypothesis of adenmonolizumab to the anti PD L1 givolumab. Later this year, We will present the data from Cohort 3 of the Phase 2 in head and neck cancer study, testing the combination of monolizumab We are further advancing the adhesin pathway agents in the clinic, where we are starting A new Phase I trial for APH5301, the anti CD73 and we look forward to data from the anti CD39, APH5201 In parallel, we continue to develop our EnCase technology platform and we are very encouraged by the preclinical results Next generation and insulin agents, we believe that this represents a natural evolution of our platform illustrating the potential for all of NK6.
And the fact that they could become the next generation of the shelf cancer immunotherapy. With more to come, as Jason said, this Saturday is an oral presentation of SMOBI ERIC TPA. We look forward to further updates on the progress for 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 patient and stakeholders. And in summary, we have positioned Innate Pharma for the future with the surface strategy and made meaningful progress throughout the year. Just to recap in summary, like L'Estama, we moved forward with our MF trial and presented in correlation data to GANU. Next year, we will have data on MF and potentially proven data in Sezary Syndrome and we will start the PTTL trial. 2nd, our R and D engine was further validated as Sanofi chose to progress APS-six thousand one hundred and one into R and D enabling studies.
We'll continue to leverage this antibody capability to develop innovative molecules with a primary focus on our next generation NKAT NK cell engager molecules As also demonstrated at Fosseal and ESMO this year. And finally, as you heard from Jason, we continue to build the sustainable business by balancing our portfolio with That provides substantial revenue stream to support our continued investments in early R and D. Collectively, we are driving value across our business and ultimately advancing our goals 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?
Thank We're taking our first question from the line of Daina Graybosch.
Please go ahead.
Hi, thank you for the question. 2 for me. 1, just thinking ahead for the monolizumab I wonder if you could remind us how much overlap in efficacy And read through from that particular concept study, do you believe there is when you combine monalizumab, durvalumab Versus cetuximab. Does either of these therapeutic combinations or mechanisms bias the activity to CD8 And then in addition, keeping alive mitremedin, could we see NEO COAST data this past? I noticed it's not on your milestone slides, but maybe you don't have specific visibility, just wondering if it's a possibility of it to come.
Thank you, Dana. I'm going to repeat the question because the line was not so great. So I'll make sure that I got it right and everyone also can hear them. So you asked question on the Neocost data, when this data will be public. And your first question was about the potential read across or read through from the Crossdated to the EntaLink trial and the combination of monolizumab, bussetuximab.
Am I repeating correctly? Okay, perfect. So I'll start with the second question very quickly To say that, as you know, the Neopasc data is run by AstraZeneca. It's also been run by AstraZeneca. We have Really no further information.
Then what is publicly available on the AD side, which is that the data are expected in the second half of twenty twenty one. So You will hear more probably from Azeem 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 Joseon showed to illustrate his remarks on monalizumab. You have 2 mechanisms that were developed Now what happens, the first one is a way to enhance the ADTC of antibodies that like cepiximab could Have a synergistic effect when combined with monolizumab, and that's What led to the head and neck program and the Phase III trial that was started last year. And the second Piece of information and piece of data that was published already in Cell in 2019 was basically the preclinical package that supported the clinical program of the combination of monalizumab and anti PD-one or PD L1 showing the clear synergy Coming from the fact that, as you know, 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 setting and the two type of combination are supported by strong scientific rationale. Now as you know better than TB, These are 2 different tumor types in 2 different settings, and it's really premature to, first of all, speculate on the data before Because data are presented, and of course, I would be very cautious not to have cross trial comparison or But I'll hand over to Joyce and who can maybe complete this answer.
Yes. So I think, Mandeir summed it up very nicely. I think the strength of the preclinical data that supported these Both with cetuximab as well as with durvalumab have 2 different mechanisms of actions that we look for 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 Mandir pointed it out very nicely, which is these are 2 different indications, 2 very different settings, One, adjuvant, the other, metastatic.
And
it would
be hard to Kind of read across the trials or read across trial comparisons, not only because We try not to do that, but also just because of the differences in indications, settings as
well as mechanisms of action. Thank you, Jason. Does it answer your question, Diane?
Yes, it does. Thank you very much.
Thank you.
We're taking our next question from the line of Yigal Nochomovitz at Citigroup.
Thanks, Mandar and Tim. 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 late 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 monaluzumab plus durvalumab combo over durvalumab monotherapy? Thanks.
Thank you, Yigal. Again, we look forward to seeing the full data presented at ESMO, As you know, there's an oral late breaking abstract. This was detailed by Bayer Prodynica and Bayer Curtin Reza. They will report ORR, but they also present PFS data for both arms, I think the design of the trial is well known. It has been Already publicly disclosed it.
It's a well controlled Phase randomized Phase 2 trial. They I 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 chemo radiation therapy and are randomized within 6 weeks If they do not progress and they are being treated with Durva, Durva Mona or Durva or Leclimab 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 those data, but I think the clear face is something Kohl should keep in mind.
Okay, got it. Thank you. And then a second question I had on lacutumab. Can you talk a bit about how you're planning to identify Sezary Syndrome and Lycosis Given that in the major pharma markets, U. S.
Europe5 and Japan, there are only 200 Cesri patients And about 3,000 microsfungoidis patients according to the SEER database.
Yes. Just to make sure I get your question, is it vis a vis the commercial opportunity or talking in general about how we are Designing and implementing or executing our clinical trial.
Now more about the commercial opportunity and how you
will find Yes. Okay. Yes. Thank you. This is, of course, a great question and gives me the opportunity to go back to our strategy.
I think The Caesare syndrome indication came as a prototype indication, if I can say, To validate the mechanism of action, since the majority of these patients are expressed in Q3, DL2, and we have Seeing in the Phase I, basically from the first dose level that when you target this tumor antigen, K3DL2, you get Significant tumor shrinkage and even an improvement in quality of life. I think the systemic symptom itself is the, I would say the first step, and I should say the Fast to market strategy in order to really get those Fast Track Designation and Prime Designation and Exchange with the FDA and with the EMEA in order to accelerate the clinical development. The Intent, of course, is to expand beyond that. And the microcystronvidez is half of the PTCL. As you know, You are right.
I mean, MycoCyspondroles accounts for about 3.5 to max 4,000 new patient every year in the U. S. And in Europe and Japan. And there are about 4,000 non mycosis foundryas, cutaneous T cell lymphoma. So all in all, we're talking about up to 8,000 Patient with the cutaneous disease element.
Half of them would express the K3 GL2. And again, the Mycosis fungalides Segment is not the end of the story. It's certainly much more attractive and much more competing business case. But of course, the I think the most important milestone Of the Lugano meeting was that we have been able to show that lacretinab works outside the dialysis syndrome and it works In T cell lymphoma, which expressed the KCL2, which of course solidify, if I may say, The scientific rationale to expand now to peripheral T Cellinform where the business case stands, of course. With more than 18,000 new case every year, That's healthy cell lymphoma has a much more attractive commercial prospect.
But again, the stepwise approach is Validate the mechanism of action, check that this is not a Sezary Syndrome drug, but it works Outside Stell syndrome, which we are exploring and validating SVT and Telemat and then go into FRC and pharma. And then when you look at the totality of The business case, it's no longer niche indication, it's a significant market opportunity.
Got it. Thanks. And just I have one final question. This one might be good for Eric or Joyson. I'm just curious about the ENKAT platform and the combining MKP-foursix, foursix, CD16 and IL-two are.
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?
That's another excellent question that, of course, we debate internally. And I'll hand over to Joyce To sum up, the thought behind the selection of the tumor antigen for these multispecific Thank you, guys.
Yes. Thanks, Yigal, for the question. So yes, I mean, so I'm going to kind of call Go back and talk a little bit about the NCAP platform. And the amazing thing about the NCAP platform is it's very versatile. So As you were stating that the MKP46 CD16 attachments to the MK cells with the IL-two variant in the same, But the tumor antigen is what I call as removable.
You could kind of put different tumor antigens in there. This allows for that flexibility. And as Mandehr said, there's heavy debates going on internally to determine sort of what is the best approach. We are looking at both solid tumors as well as hematologic tumors. So the versatility of the platform allows for us To kind of really have those debates internally to see which would be the best opportunity either in solids or hematologic malignancies.
Thank you very much.
Did that Okay.
Thank We We're taking our next question from the line of Greg Suvannavejh at Goldman Sachs. Please go ahead.
Hey, good afternoon. Good morning. Thanks for taking my questions. I've got a couple. First is actually on 5,301 certainly will be interested to see what the alectimab 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 assets, that's my first question around 5,301. And then 2nd of all, as it relates to the COAST data, anything at least from a scientific or biological Rationale that will help us think about how to think about monolizumab and the efficacy and safety That we might see relative to a CD73 targeted asset such as oleclinab? So that's the second question. And then maybe just a question on the P and 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.
Thank you, Greg. Very important and good questions as usual. I'll start with the first one, Then hand over to Joyce for the cost and the mechanistic Approach you're thinking about in particular with regard to the potential combination with Enanti C23 And then I'll give the opportunity to our new CFO, Frederic, to address your question about the financing moving forward. Very briefly on 5,301. So as you said, I mean, we do really look forward to Seeing the oleclinib data, I remind you, other than those data actually, I'm not aware we are not aware of other public randomized data in this field.
Everyone remember the BMS and DAG Phase 1b The data presented about 2 years ago at ASCO and AACR showing some trend of activity, but nothing since then. So clearly, The results of the cost trial with regard to oleklimab are of major interest for us and for The other company that are playing in this field. Number 2, I remind you that we published that data And again, we have even presented those data at AACR back in 2019, if my memory It's correct comparing our anti CDM entity with the BMS and the AZ-one. And clearly, when it comes to the anti matic activity, our antibody is much better. It's superior in doing the job of blocking the anti VCD73.
Of course, We have to translate those preclinical strength into clinical benefit for patient, and that's why We were, to some extent, waiting to see some very data emerge In order to try to learn from others and we have been working over the last couple of months in Transforming the IND that we filed at the end of last year into a clinical trial, which It is about to start. So that would be our 1st clinical trial testing and assessing API-five thousand three hundred and one, we have a plan on what combination approach we should do. And of course, we look forward to Seeing the data from the CORE trial to further fine tune and also maximize the opportunity around our That's my answer for your first question. Now, Jason, the question around cost, How do we think to the extent of course, I don't want to speculate of the data, but the mechanism of action and the potential
Yes. So I think I'll go back and kind of also State that the mechanisms of action here clearly are as we know are different. So ones in anti-seventy three and ones in anti NKG2A. One, we're looking to see I mean, we have preclinical data that has supported ABCC So synergy and then finally with molylizumab, it's sort of non redundant pathway mechanism of action in combination. So I think when we look at this, we See 2 once again 2 different tumor types, I mean 2 different, I mean same setting, but 2 different mechanism of actions that Do have different potentials.
I think when it comes to the clinical data, I think we'll have to wait to see what the COSE data shows. But I would just say these are 2 very distinct mechanism of actions operating in 2 different ways. 1, Sorry, both of them relieving immunosuppression. And sorry, I just messed up the cetuximab question, But this was CD73. So with CD73, it's basically relieving of the tumor, the amount of adenosine that's present, so Really decreasing immune suppression.
So decreasing adenosine is 1, the other one is decreasing In 2 different pathways, 1, anti NKG2A and the other one, with PD-one. So I think with that, we'd have to wait for the clinical data to see what's happening. I know that was a little roundabout messed up I'm happy to repeat it.
Because I think in my head
I had cetuximab and I was like,
oh gosh, this is cetuximab.
So clearly, I'm excited about both of these and I'm like sitting here going, okay. But yes, In short, the CD73 is adenosine. You're really stopping adenosine synthesis and so because of that relieving the immune suppression. The other is 2 pathways, one acting on T cells, the other one on NK cells. And so I think the clinical data will speak for at least which pathway may be better.
I think that last answer is the one I would kind of go into versus my first.
Okay. Thank you, Jason. Frederic, would you want to take the question Question on what's the plan and the financing of the company moving forward?
Yes. Thank you, Mondher. Yes, as I said before, the cash position is quite robust at the moment with €159,000,000 We constantly monitor our financial needs and we provide an update when needed. We cannot communicate at this stage. In terms of plan, for sure, if you look at the cash burning for this For the 1st August just last year, we see a big decrease, but it's not following these investments on our side.
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 There will be some studies that we are having in the pipeline.
And then
just in terms of how you're thinking about potential options to extend the cash runway?
At the moment, first of all, we Mondher, you want to
yes, please go ahead. Yes, okay.
So the different options are we look at the market for sure. We look at Financing options also with some banks as well. But more than ever, we look at progressing the way we operate and see what we can get out of those partnerships.
Yes. So Greg, long story short, we have a Solid cash position. And we've been actually we have a pretty good track record on making sure that our cash Cover the multiple catalysts and milestones that we have ahead of ourselves because we constantly monitor our financial needs and We'll provide an update when needed. Thank you.
Thank you.
Operator, do we have More question on the line.
Yes. We have one question from Harto Hee from HCB. Please go ahead. Your line is open.
Hey, good morning. Hey, good afternoon and greetings to the gentlemen. Thanks for taking my question. So I just wonder one question on the monolizumab for the data 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.
Jason, would you like to answer? I can take it.
No, Yes, go ahead, Monter.
Go ahead. Yes, okay. Thanks, Antoine, for the question. So first of all, to remind everyone, this is a single arm study that tests the Triplet combination. And again, we as I said in my answer to the first question, we have those 2 mechanism of action.
We know that Monalizumab could be synergistic with antibody that have or acts within ADCC and that's the combination with septiczema. We know that monalizumab is synergistic IPD L1 and the Co's data were built based on that rationale. I think the triplet is simply the combination of both cepiximab and durvalumab to see whether we can have an increase in response and in quality of response In terms of durability, so the study was designed really first of all to assess the safety of the triplet because this I remind you, this is the first I believe ever Triplet, are you to be developed or triplet of non cytotoxic KEYMOFULLY regimen to be developed in head and neck cancer. The safety was good for the first 20 patients. So we expanded the trial to 40 patients, but yet it's still a single arm trial in advanced relapsed or metastatic A patient with squamous cell carcinoma of the head and neck who might have been pretreated with chemotherapy or radiation therapy, but Who are naive of any PDX treatment.
The data will be presented At the end of the year, we are looking at the totality of the data with AG to really determine what's the path forward. As you know, the competitive landscape is evolving and it's important to take into consideration actually the specific unmet need and where we can position this triplet. And again, I insist on the fact that today the standard of care is temporal plus or minus chemo dependent on the level of CPS and The results that we are presenting at the end of the year will be looked at also from that perspective, CPS more than 1 versus CPS
Thank you for that and congratulations on the progress.
Thank
you very much. Thank you.
Thank you for your question. There are no further questions on the phone.
Okay. Henri, do we have question on the webcast?
No more questions, Wanda. Thank you.
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 lekutumab. Our R and D is progressing nicely with the new data from our Ion Cat platform and We also all look forward to the continued progress, including the upcoming monolizumab 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.
That concludes the conference for today. Thank you for participating. You may all disconnect.