Half Year 2024 Innate Pharma SA Earnings Call
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Please wait the conference will begin shortly.
[music].
Swayampakula Ramakanth: Swayampakula Ramakanth, Ashiq Mubarack, Arvind. Thank you for standing by and welcome to the Innate Pharma first tab, 2024 financial result and business update. All lines have been placed on mute to prevent any background noise.
Speaker Change: Thank you for standing by and welcome to the a neat pharma first half 2024 financial results and business update all lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you'd like to ask a question. During this time simply press star followed by the number one on your telephone keypad.
Operator: After the speaker's 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 the number one on your telephone keypad. If you would like to withdraw your questions, simply press star one again. Thank you.
Speaker Change: He would like to withdraw your question simply press Star one again.
Henry Wheeler: I'd now like to turn the call over to Henry Wheeler, Vice President, Investor Relations and Communications. You may begin.
I'd now like to turn the call over to Henry Wheeler, Vice President Investor Relations and Communications you may begin.
Henry Wheeler: Good morning. Good afternoon and welcome, everyone. This morning, Innate issued a press release for our Each One business update and financial results. We look forward to highlighting the progress majoring near-to-date, as well as addressing future goals and milestones. The press release in today's presentation is both available on the IR section of the website.
Speaker Change: Thank you good morning, good afternoon, and welcome everyone. This morning, <unk> issued a press release for our <unk> business update and financial results. We look forward to highlighting the progress 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 the web site.
Henry Wheeler: On slide two, before we start, I'd like to remind you that we're making some forward-looking statements regarding the financial outlook, in addition to regulatory and product and development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
Speaker Change: On slide two before we start I'd like to remind you that I'll be making some forward looking statements regarding the financial outlook. In addition to regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
Henry Wheeler: On slide three, on today's call, we will be joined by Erbe Brey, our interim Chief Executive Officer, who we will then hand over to Sonio Correntino, a Chief Medical Officer who will cover updates on the QTSMAB and IPH65, who will then hand the call to Janis Morrell, a Chief Operating Officer who will discuss Ankebt and the ADC platform.
our library: On slide three on today's call, we will be joined by our library, our interim Chief Executive Officer.
our library: We will then hand over to Sonya Contino, and Chief Medical Officer, who will cover updates on the kid's mouth, and 65, who will then hand the call to your honest Morrell and Chief operating officer, who will discuss and kit and the ADC platform.
Henry Wheeler: Fredrick Lombard, a CFO, will cover the financials, and Arvind, sued at EVP US operations, will wrap up and close.
Speaker Change: Critical about our CFO will cover the financials and oven suit EVP U S operations will wrap up and close are they I now hand, the call over to you.
Erbe Brey: Erbe, I now hand the call over to you. Thanks, Henry. So, turning to slide five, I'd like to remind you of its almost strategy. So now, as an early stage clinical stage strategy, all business model centers around three priorities, where we look to run value from early R&D efforts through latest stage partnerships where it makes sense to do so. Our ambition is to develop innovative drug candidates with a strong pipeline of differentiated antibodies. So first, we look to create near-term value, driven by our lead proprietary asset, the QTSMAB, in development for Tissel Informa, with top-line CTCL data that were presented at ASCO this year on Ash in December. With those latest data in hand, we will now assess the best path forward to maximize the potential of 7.
Thanks Henry.
Sonya Contino: Turning to slide five I'd like to remind you also need pharma strategy.
Speaker Change: And early stage clinical stage.
Speaker Change: <unk> okay.
Speaker Change: The sensor is around three priorities, where we look to drive value from our early R&D efforts through the latest stage partnerships, where it makes sense to do so.
<unk> is to develop innovative drug candidates with a strong pipeline of differentiated antibody. So first we'll look to create near term value driven by our lead proprietary I said like Kitimat and development for T cell lymphoma with topline CTC data that were presented at the high school this year on <unk>.
Speaker Change: December was dues lasers that are in hand, we'll know assess the best path forward to maximize the potential of this asset.
Erbe Brey: We continue to fuel our pipeline and create longer-term value by leveraging on our antibody engineering capabilities to develop innovative molecules with a primary focus on our multi-specific end-case and engagement platform on KET. We are pleased to see continued progress with Sanofi, presenting various updates for the lead on KET candidate, 43579, which are recently transitioned from phase 1 to phase 2 in monotherapy. On more recently, it has started a new combination Phase 1 to trial. We're also pleased to see our lead on KET IPH6501 continuing in Phase 1. As we develop on tibaly targets, we'll recognize some of these targets might be very suitable for ADC technology, and we have some further details in our ADC pipeline today with our lead ADC effect IPH445 progressing through phase 1.
Speaker Change: We continue to fuel our pipeline and create longer term value by leveraging on the antibody engineering capabilities to develop nobody's molecules with a primary focus on the multi specific NK cell on gateway platform. Okay.
Speaker Change: We are pleased to see continued progress with Sanofi presenting various of days for the lead candidate.
Speaker Change: For 3579.
Speaker Change: Recently transitioned from phase one to phase II in mono therapy on more recently it has started a new combination phase one two trial.
Speaker Change: So pleased with your lead candidate I'll get IP age 60, 501, continuing phase one as we develop antibody targets.
Speaker Change: Recognize some of these targets might be very suitable for ADC technology.
Speaker Change: Some further details.
Speaker Change: Pipeline today with our lead ADC I think IP is 45 progressing through phase one.
Erbe Brey: Finally, we're building a strong foundation for business by key partnership across industry. On a key example, there is Munali Jamab, where we saw some further data, phase 2 data, presented last week at WCMC, which is partner, as you know, with AstraZeneca, on his advancing in its developing learning concept. The next slide, that is slide 6. Slide 6 summarizes actually where we stand with our pipeline and shows how we continue to translate our science into a robust portfolio of proprietary and partner assets. It also illustrates how we are executing against our strategy with our lead proprietary assets, like the map on KET, on emerging ADCs, supported by partner product with a further concern of E from late to early stage development.
Speaker Change: Finally, we are building a strong foundation for our business by a key partnership across industry.
Speaker Change: Key example, there is literally if you map, where we saw some further debt phase two data presented last week at <unk>, which is partnered with Astrazeneca.
Speaker Change: <unk> is advancing and it's developing in lung cancer.
Speaker Change: Next slide that is slide six.
Speaker Change: Six summarizes actually where we stand with our pipeline and shows how we continue to translate our science into a robust portfolio of proprietary and partnered asset. It also illustrates how we are executing against our strategy with our lead proprietary assets, let's say, Matt I'll get on emerging adcs supported by positive.
Speaker Change: Product without further Atkinson of heat from late two early stage development.
Erbe Brey: We actually anticipate the series of potential clinical data redounds on catalysts in the upcoming couple of years, as our R&D engine looks to leverage our scientific know-how to create a sustainable business.
Speaker Change: Anticipated series of potential clinical data Readouts and catalysts in the upcoming couple of years as our R&D.
Speaker Change: R&D engine looks to lever age our scientific knowhow to create sustainable business, we'd like no one to pass the call over to Sonya will review the progress made with our portfolio starting with <unk> almost headwinds proprietary asset.
Sonia Quaratino: We'd like now to plan the call over to Sonia, who will review the progress made with our portfolio, starting with Lekita Maths, almost advanced proprietary assets. Thank you, Arve. On a slide 8, I want to recapitulate the progress we are making with Lakutamab and in particular, with the Taloma trial in Kutainus, Tissel in Phoma. Lakutamab is a monoclonal antibody that targets K3DL2, and was shown to deplete the cells that express the receptor. Just a reminder, the K3DL2 is apparently expressed as a tumor-associated antigen in CTCL, in particular, in more than 90% of patients with sensory syndrome, and approximately 50% of patients with mycosis from gorillas.
Sonya Contino: Thank you.
Speaker Change: Slide eight.
Speaker Change: Doesn't recapitulate, the progress, we're making with <unk> and in particular with the Palomar trial in cutaneous T cell lymphoma.
Speaker Change: <unk> is a monoclonal antibody that targets <unk> and.
Speaker Change: And was shown to deplete the cells that express the receptor.
Speaker Change: Just a reminder, the Q3 deals two is that directly express as a tumor associated antigen in <unk> in particular in more than 90% of patients with <unk> syndrome, and approximately 50% of patients with Microsystems Oh, yes.
Sonia Quaratino: The Taloma trial is a phase 2 single arm study, investigating Lakutamab monotherapy in CTCL, in patients with sensory and metosis from gorillas, who received at least 2 prior systemic therapies. The FDA granted an orphan drug designation for Lakutamab in the treatment of CTCL, and the first drug designation for the treatment of all patients with refractory relapse, sensory syndrome, who have received at least 2 prior lines of systemic therapies. The key results of the trial and salary were presented last year at Ashiq and at ASCO this year, we presented the key results in Mikosa Fungoida's cohorts.
Speaker Change: The Palomar trial is a phase two single arm study investigating.
Speaker Change: Monotherapy in CPL in patients with temporary and make us a stronger well received at least two prior systemic therapies.
Speaker Change: Actually I think granted an orphan drug designation for <unk> in the treatment of CDC out.
Speaker Change: And the fast track designation for the treatment of all patients with refractory relapse, that's already syndrome, who have received at least two prior lines of systemic therapies.
Speaker Change: The Q is out of the Trialing salary were presented last year.
Speaker Change: And of course this year, we presented the key results in makeup is from Gary the cohorts.
Sonia Quaratino: We are going to present other secondary results at other conferences this year. A better than the expression of key 3DL2 is often detected also in peripheral crystalline trauma and in this indication in PTCL. Lakutama is investigated in combination with Jamsaidabhin and Noksalibladhin. The tilt faced to trial is currently ongoing and recruiting, and we believe this combination with chemotherapy may offer additional benefit to patients with PTCL. In the next slide, I would like to summarize the key results in MS which were presented at ASCO Unwell meeting in June. In this heavily-prereated patient population with four median prior lines of therapy of systemic therapy and 11.8 months of follow-up, at the data cutoff of October 2023, we observed a global objective response rate of 16.8% and the median PSS of 10.2 months.
Speaker Change: I'm going to present, the other secondary results.
Speaker Change: Colton.
Speaker Change: Yeah.
Speaker Change: Our bedroom expression of Q3 deals to us often.
Speaker Change: Tested also increased their out of T cell lymphoma.
Speaker Change: And in this indication in PCL La Quinta Mamba is investigated in combination with German cytarabine in selling flatten.
Speaker Change: The <unk> phase two trial is currently ongoing and recruiting and we believe this combination with chemotherapy may offer additional benefit to patients with PCL.
Speaker Change: In the next slide.
Speaker Change: I would like to summarize the key results in MF, which were presented at our school enrollment meeting in June.
Speaker Change: In this heavily pre treated patient population with four median prior lines of therapy of systemic therapy and 11.8 months of follow up.
Speaker Change: The data cutoff of October 2023, we observed a global objective response rate of 16.8% and the median PFS of 10 two months.
Sonia Quaratino: It is interesting to stress that objective responses have been observed not only in the sub-agulation expressing more than 1% of target but also in the population expressing less than 1% of the key 3DL2. This suggests that Lakutamaid may produce clinical benefit in MS regardless of the key 3DL2 expression, and you can see it on the water plot on the right-hand side. In keeping with previous results, also in MS, a very favorable safe profile was observed. On the next slide, we can see the opportunity for Lakutamaid in the treatment landscape. With potentially no need for a companion diagnostic, we believe that the number of PTCL patients that could benefit from Lakutamaid expands from 1,500 to 3,500 in the 2-plus line of therapy.
Speaker Change: It is interesting to stress that the objective responses have been observed not only in the subpopulation expressing more than 1% of the target, but also in the population expressing a less than 1% of the <unk>.
This suggests that <unk> may produce clinical benefit in that.
Regardless of the Q3 deal to expression and you can see it is on the water plot on the right hand side.
Speaker Change: In keeping with previous results also had and that's a very favorable safety profile was observed.
Speaker Change: On the next slide we can see the opportunity for <unk> in the treatment landscape with potentially no need for a companion diagnostic we believe that the number of <unk> patients that could benefit from <unk> expanded from one five.
Speaker Change: <unk> hundred 3000 Python dress in the two plus line of therapy.
Sonia Quaratino: And this figure may even increase 5,000 in an early-align setting. Now our aim is to ensure that Lakutamaid gets to patients who need it as quickly as possible and to maximize the value not only in surgery, but also in the larger population of micosis formgoiders. We believe that there remains a critical and man need for additional treatment options, in particular for wraps and refractory surgery, and also in macosis formgoiders. Based on the strengths of our data from the telematrial, we are engaged with the FDA on a proposed registration strategy that could enable a fast market approval.
Speaker Change: And this figure may even increased five Thomson in an earlier line setting.
Speaker Change: No. Our aim is to ensure the lockwood, our math gets to patients who need it as quickly as possible and to maximize the value not only in Calgary, but also in the largest population of ecosystem from Reuters.
Speaker Change: We believe that there remains a critical unmet need for additional treatment options in particular for relapse and refractory February and also in Mycosis <unk>.
Based on the strength of our data from the stellar trial, we are engaged with the FDA on our proposed registration strategy, but could enable a faster market approval.
Sonia Quaratino: On the next slide, we would like now to switch gear to our most advanced property asset, IPH65, the Tetris-Pacific antibody base anti-anguages therapeutic, the antithemolical, which is the first anti-cell-anguages to engage the tumor via a tumor-associated antigen and on the anti-side, engaged to activating receptor, the anti-P46 and CD-16, as well as the interlooking to the receptor via an IL-2 variant, he called IL-2V. The innovative mechanism of action includes the IL-2 variant in the aim to induce activation and proliferation of anti-cells in the tumor microenvironment. IPH65 is the first of the second-generation antiet targeting CD-20, and we were pleased, as the have already mentioned, to announce earlier in the quarter that IPH65 entered the clinic and the first inhuman stardust with the patient being those early in March.
Speaker Change: On the next slide.
Speaker Change: We would like now to switch gear to our most outbound appropriately asset IV age 65, the tetra specific antibody base and try to engage with therapeutics the untracked molecule.
Which is the first NK cell engage us to engage the tumor.
Speaker Change: Tumor associated antigen and on the NK side.
Speaker Change: H two activating receptor the <unk> 46 in CD 16.
Speaker Change: As well as the interleukin two receptor by an iOS, providing yeah called IL two week.
Speaker Change: The innovative mechanism of action includes the IL two variant.
Speaker Change: The aim to induce activation and proliferation of NK cells in the tumor microenvironment.
Speaker Change: I page 65 is the first of the second generation <unk>.
Speaker Change: Targeting CD 20.
Speaker Change: And we were pleased.
Speaker Change: Ray already mentioned.
Speaker Change: It's early in the quarter that IP age 65 entered the clinic and the first in human study has started with.
When the patient being dosed early in March.
Sonia Quaratino: The trial is enrolling patients with reflaps and refractory B-cell, non-orchestral lymphoma, and the study is running in the U.S., Australia, and France.
Speaker Change: Trial is enrolling patients with relapsed and refractory b cell non Hodgkin lymphoma, and the study is running in the U S Australia unprompted.
Sonia Quaratino: There are a few points here that I would like to highlight about this Tetris-Pacific Antiet. The elimination of the CD-20 positive cancer cells by a profound activation and proliferation of the anti-cells. By stimulating the anti-natal function via the IL-2 variant, IPH65 has a bystander effect and can also call the elimination of the CD-20 negative tumor cells, thereby overcoming the tumor heterogeneity or loss of tumor antigen, which is sometimes reported in patients. The IPH65 format also addresses the common challenges of antibody associated with loss of CD-16 by ensuring activation of intra-tumoral anti-cells via the anti-P-46.
Speaker Change: There are a few points here that I would like to highlight about this that are specific to unpick.
Speaker Change: The elimination of the CD 20 positive cancer cells by profound activation and proliferation of NK cells.
Speaker Change: By stimulating the uncanny natural function by two variant.
Speaker Change: At the age 65 has a bystander effect and you can also cause the elimination of the <unk> 20 negative tumor cells.
Speaker Change: Thereby overcoming the tumor heterogeneity or loss of tumor antigen, which is sometimes reported in patients.
Speaker Change: The IP age 65 formats also addresses the common challenges of antibody associated with loss of <unk> 16 by ensuring activation of intra tumoral NK cells via the N type <unk> 46.
Sonia Quaratino: By the moment, this asset differs from allogeneity and cell anti-cell therapies, including car-anti, as it is an off-the-shelf therapy that drives the proliferation of the patient's own anti-cells and does not require any lymphodiblation as cell therapy. We have presented the proclinical data at the ASCO meeting this year showing that IPH65 depletes a polar with CD-20 b-cells from L-T donor, with greater efficacy and lower induction of pro-inflammatory cytokines that assist with when T-T-cell engages. IPH65 also effectively and preferentially stimulates N-K-cell proliferation from P-V-N-C of relapse, refractory, non-ochkanal information.
Speaker Change: Furthermore, this asset differs from allogeneic and sale.
Speaker Change: Cell therapies, including car NK as it is an off the shelf patter IP that drives the proliferation of the patient's own NK cells and does not require any even for depletion as cell therapy.
Speaker Change: We have presented the preclinical data of the ethical maintain this year showing that the IV age 65 depletes until all of the CD 20, b cells from healthy donor with greater efficacy and lower induction of pro inflammatory cytokines that the CFPB 'twenty T cell engagement.
Speaker Change: At the age 65 also effectively and preferentially stimulates NK cell proliferation from PV and <unk> of relapsed refractory non hodgkin lymphoma patients and last but not least the trial and progress of the phase one two study.
Sonia Quaratino: Last but not least, the trial and progress of the Phase I study has been presented at the European Hematology Association Congress and ASCO in 2024.
Speaker Change: <unk> presented at the European Hematology Association Congress and obstacles in 2024.
Sonia Quaratino: On the next slide, I would like to very briefly give an overview of the next steps for IPH 65. Throughout the year, we plan to complete the dose escalation, and we look forward for initial safety data, PK and pharmacodynamics three doubts, as well as preliminary efficacy signals. Throughout 626 and beyond, we will open the dose optimization part of the study to select the optimal dose and expansion cohort in non-autical informa.
Speaker Change: On the next slide I would like to very briefly give an overview of the next steps for IP age 65.
Speaker Change: Throughout the year, we plan to complete the dose escalation and we look forward for initial safety data PK and pharmacodynamics readouts as well as preliminary efficacy signals.
Speaker Change: Throughout <unk> 26, and beyond we will open the dose optimization part of the study to select the optimal dose and the expansion cohort.
Speaker Change: <unk> lymphoma.
Yannis Morel: And now, I will turn to Yannis Tukoga, other anchors, and the A.D.C. Thank you, Sonia. I will know I like the two classes of next generation antibody therapeutics on which we are focusing all our research activities, the anchors and the A.D.C. On slide 14, I draw your attention to our portfolio of anchors, which has made significant progress during the last quarter. As you remember, our proprietary first-in-class anchors and anchors platform is a multi-specified plug-and-play technology made of antibody-derived building blocks aiming at engaging anchors toward tumor cells by triggering the most stable, activating anchors and surface receptors called NKP46.
Speaker Change: And now I'll turn to <unk> to cover other anchors in the ADC.
Speaker Change: Thank you Sonya I will know highlight the two class of next generation antibody therapeutics on which we are focusing all our research activities.
Speaker Change: I think you said on gauge of homecare and the ADC.
Speaker Change: On slide 14, I'd call your attention to our portfolio of owned kit, which has made significant progress during the last quarter.
Speaker Change: As you'll remember.
Speaker Change: Hopefully it'll it first in class and I guess I don't get it off that's all in the multi space you can plug and play technology.
Speaker Change: <unk> antibody device breeding blocks aiming at some engaging in T cells to walk to ourselves.
Speaker Change: By targeting the most stable activating NK cell surface receptor called.
Speaker Change: And keep in 46.
Yannis Morel: The interesting feature of this platform is that by swapping the tumor by the proportion of the anchors molecule, it can produce multiple drug candidates, addressing a variety of targets in oncology, but also, it can potentially harness NK cells to kill pathogenic cells in other areas like A.N.I. Last quarter, Sanofi advanced the most advanced NKETS 3579 to phase 2 on the back of initial efficacy data showing single-agent activity with durable complete responses in relapse-refactory AML patients. In addition, Sanofi started the new phase 1 trial in front light AML in combination with other cytodine and venetoclax. We are looking forward to seeing further updates from Sanofi.
Speaker Change: So enticing feature I'll discuss falls in that by swapping the <unk> portion of the <unk> molecule.
Speaker Change: Can produce multiple dark comedy.
The value to your targets in oncology, but also it can potentially ominous NK cells to kill pathogens itself in other disease areas like Eni.
Speaker Change: Last quarter southern.
Speaker Change: <unk> advanced the most advanced.
Speaker Change: Southside 79, two phase II on the back of any short adjacent data showing single agent activity with durable complete responses.
Speaker Change: Effectively AML patients.
Speaker Change: In addition, <unk> started a new phase one two trial in frontline AML in combination with Azacitidine and <unk>.
Speaker Change: We are looking forward to seeing further updates from Sanofi.
Yannis Morel: Also, as mentioned by Sonya, we are very pleased to have our proprietary second-generation anchors in the clinic with the first patient dose with IPF 651 in March.
Speaker Change: Also as mentioned by Saudi out we are very pleased to have our hopefully that's a second generation <unk> in the clinic with the first patient dosed with <unk> hundred one in March.
Yannis Morel: Last but not least, we are putting a lot of effort to further extend this portfolio to additional tumor targets, including in solid tumors. Slide 15, I liked our growing portfolio of ADC drug candidates. As we continue to develop next-generation antibody therapeutics, we find that for some tumor targets, we can generate antibodies with good internalizing properties that are therefore more suitable for ADC. On slide 16, I will no cover updates on our least proprietary ADC, IPF 45, which is targeting next in four. The preclinical characterization of this drug candidate has been presented at a normal session at AACR in San Diego earlier this year, and I liked the key differentiation, like the feature of this product.
Speaker Change: But we.
Speaker Change: We are putting a lot of effort to further expand this portfolio two additional targets, including in solid growth.
Speaker Change: Slide 15 highlights our growing portfolio of ADC candidate.
Speaker Change: As we continue to develop next generation antibody therapeutics, we find that's awesome qunar targets, we can generate antibodies with good internalizing pulp elkins.
Speaker Change: Therefore more suited for ADT.
Speaker Change: On slide 16, I will now cover updates on our new appropriately agency <unk> 45, which is targeting mixing full.
Speaker Change: The quick clinical characterization of this drug candidate has been presented at the normalization at ACR and some legal area of Israel and highlighted the Tv's onstage differentiation feature of this product.
Yannis Morel: Based on this data, we feel that we have a novel and differentiated ADC to target next info in a broad panel of human education on top of bladder cancer by overcoming the challenges associated with next info MMAE ADC, including unfortibaldedotine. Here on the slide, we highlight the opportunity for IPH-45 in next info expressing tumors, especially in low-to-moderate expression of beyond bladder, like breast, lung, prostate, and pancreas, where efficacy reported by PADSF is so far limited. Slide 17 is a summary of some of the data presented at ASER. In a nutshell, we show that IPH-45 has strong anti-tumor efficacy in a variety of preclinical models, including one that are refractory to PADSF because of high expression of MDR1, which is a Netflix transporter, a non-mechanism of resistance to MMAE.
Speaker Change: Based on these data we feel that we have been novel and differentiated ADC target mix in full in the Board's final Hakim organization on top of Black Duck Enzo.
Speaker Change: Overcoming the challenges associated with Mitsui.
Speaker Change: The agency, including <unk>.
Speaker Change: Here on the slide we highlight the opportunity for <unk> 45 victim for expressing tumors.
Speaker Change: Specialty in low to moderate takes place so beyond bladder.
Speaker Change: Lung prostate and bulk sale.
Speaker Change: Reported by <unk> is so far limited.
Speaker Change: Slide 17 is a summary of some of the data presented at ACR.
Tom: In a nutshell, we show that <unk> 45, as Tom Antitumor efficacy in a variety of preclinical models, including one that are refractory to Pat says because of high expression MDF, one which is a netflix constructor no mechanism of resistance to women.
Yannis Morel: Also, it has strong efficacy in patient-DIF PDX model with low expression of NX-4, as shown in the graph in the middle of the slide, where PADSF does not work. With a favorable developmentity profile, including high yields of productivity, high interstability, and encouraging PKTOPs data in animal studies, we are progressing IPH-45 towards the phase 1 this year. On slide 18, we summarize the next step of the program. As we are progressing towards phase 1 this year, we are looking forward to generating preliminary phase 1 safety data in 25, and then to establishing activity in NX-4, expressing tumor types with low and high expression levels.
Speaker Change: Also.
Speaker Change: It does.
Based on the IPD exploded with low expression of mixing pool as shown in the graph in the middle of the slide where passive does not work.
Speaker Change: With the fact that with the broker community profile, including yields.
Speaker Change: Yields of productivity heightening, just stability and encouraging PK tox data in animal studies, we are progressing.
Speaker Change: 45 towards the phase one this year.
Speaker Change: Okay.
On slide 18, we summarize the next step of the program.
As we are progressing towards phase one this year, we are looking for work with generating preliminary phase one safety data in 'twenty five.
Speaker Change: Then two established activity Mickey for expressing tumor types with low and high expression level.
Unknown Executive: On slide 19, I would like to remind you of Monolidumab.
Speaker Change: On slide 19.
I would like to remind you of our new model.
Yannis Morel: The entire NKG2A we have licensed to AstraZeneca for oncology. On this slide, you can see another view of the late-stage development of monolidumab in lung cancer. Days on the phase 2 cause data, AstraZeneca started in May 22, Pacific Nine, a phase 3 trial evaluating the addition of azurmonolidumab, or olexumab to diorelumab, in an respectable stage 3 lung-small cell lung cancer patient, who have not progressed after computer cancer therapy. We are encouraged to announce in two days' press release that, over summer, the independence data monitoring committee recommended the continuation of the phase 3-Pacific Nine based on the pre-planned analysis.
Speaker Change: <unk>, we have licensed to Astrazeneca for oncology.
Speaker Change: On this slide you can see another view of the late stage development of <unk>.
Speaker Change: Lung cancer.
Based on the phase II data as President got started in May 'twenty two specific line a phase III trial evaluating the addition of XOMA nitrogen level or literally Matt to Joe <unk>.
Speaker Change: <unk> stage III non small cell lung cancer patients, who have not progressed at the controller.
Chemo radiation therapy.
Speaker Change: We're encouraged we're not in today's pricing that's.
Speaker Change: Although some of the independents.
Currently we commended continuation of the phase III Pacific nine based on the pre planned analyses.
Yannis Morel: The AstraZeneca sponsor Neocos II phase 2 study is also underway in an earlier lung cancer setting, evaluating the addition of novel agents, including monolidumab to diorelumab and chemo, in the perioperative setting. Priminary data was presented last week at Wardleung, supporting the activity of monolidumab in this setting, with 26.7% of pathological promptly prespenses, and 53.3% of major pathological responses observed in 60 patients, which are numerically higher than the currently approved regions. Together with the cost and near cost, these near cost to data provide a third proof points in the control phase to study that plan the map provide an additional anti-tumor activity on top of general map in early learning.
Speaker Change: I'll, probably take as Consol Niarchos two phase II.
Speaker Change: He is also underway.
Speaker Change: Lung cancer 15 Division evaluating the addition of novel agents, including <unk>, <unk> and chemo in the <unk> setting.
Speaker Change: Preliminary data was presented last week at toward loan supporting the activity of <unk> in this setting with $26 seven 4% of technological from key presences and 50 crippling pre books of major pathological complete pathological responses.
Speaker Change: With 60 patients, which are numerically idea than the currently approved regimen.
Speaker Change: Together with of course, and Niarchos, there's no cost to data providers.
Speaker Change: Proof points and the control phase two study that but anything that provides an additional entrepreneurial activity on top of <unk>.
Frederic Lombard: I will now end over to Frederic.
Speaker Change: Doug.
Speaker Change: I will know Andover two priorities.
Frederic Lombard: Thanks, Janice. Today, I will cover the highlights on the financial details table, so I include it in the press series we issued today. The key elements of Innate financial position and results for the six months period ending June 30, 2024 are as follows. Revenue and other income amounted of 12.3 million in the first half of 2024, and mainly comprised of two elements: first, revenue from collaboration and licensing agreements, which mainly resulted from the partial and entire recognition of the proceeds received from AstraZeneca and Sanofi; and, second, a governmental funding for research and expenditure for 4.1 million for the first half of 2024.
Speaker Change: Thanks Shannon.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Today I will cover the highlights on the financials. The detailed tables are included in our press release, we issued today.
Speaker Change: The key elements of <unk> financial position and results for the six months period ending June 32024.
Speaker Change: <unk>.
Speaker Change: Revenue and other income amounted of $12 3 million in the first half of 2024 and mainly comprised of two elements first revenue from collaborations and licensing agreements, which mainly resulted from the partial an entire recognition of the proceeds received from astrazeneca incentive sheet.
Speaker Change: And so Glenn governmental funding for research in expenditure for pulpwood $4 1 million for the first half.
Speaker Change: Of 2024.
Frederic Lombard: On the operating expenses size, we are reaching 38.7 million for the first half of 2024, with 75% related to R&D and decreasing by 5%. R&D expenses decreased by 2.4 million to 29.1 million for the first half of 2024. This decrease is mainly due to lower personal and other R&D expenses. On the GNS side, expenses having increased slightly by 0.4 million to 9.6 million for the first half of 2024.
On the operating expense your size.
Speaker Change: We are reaching $38 7 million for the first half of 2024 with 75%.
Speaker Change: Related to R&D and decreasing by 5%.
Speaker Change: R&D expenses decreased by $2 4 million to $29 1 million.
The first half of 2020 for this decrease is mainly due to lower personnel and those R&D expenses on.
Speaker Change: On the G&A side expenses have increased slightly by <unk> 4 million to $9 6 billion for the first half of 2024.
Frederic Lombard: Lastly, cash equivalent short term investment and financial assets amounted to 102.1 million as of June 13, 2024, sufficient to fund operations until the end of 2024, five, sorry. All right.
Speaker Change: Lastly, cash cash equivalents short term investments and financial assets amounted to $602 1 million as of June 32020 for sufficient to fund operations until the end of 2024 five sorry.
Speaker Change: Okay.
Operator: Now on over to Arvind. Arvind, are you there? Yes, can you hear me now? Yes, go ahead. Okay. Okay, excellent. Thank you, Fredrick.
Speaker Change: Now I hand over to Avi.
Speaker Change: Are you done.
Speaker Change: Yes can you hear me now.
Avi: Yes go ahead.
Avi: Okay excellent. Thank you fredrik.
Arvind Sood: A key value driver for any bi-parma company is upcoming R&D catalyst that can contribute to long-term growth. And we have a number of them. Near term, we are looking forward to engaging with the regulatory bodies over next steps for lecutum abs. Programs coming out of our ANCAP platform continue to advance as IPA 6101 targeting CD123 in hematologic malignancies, and as part of the Canopy has recently progressed to phase 2. Our proprietary tetra-specific ANCAP that goes by IPA 6501 is now in clinical development, and as Janus pointed out, by ADC targeting Nectum 4 is rapidly progressing towards the R&D catalyst.
Speaker Change: A key value driver for any Biopharma company as upcoming R&D catalysts that can contribute to long term growth and we have a number of them near term. We are looking forward to engaging with the regulatory bodies over next steps for <unk>.
Speaker Change: Programs coming out of our <unk> platform continue to advance as IP 60, 101 targeting CD 123 in hematologic malignancies and is partnered with Sanofi has recently progressed to phase two.
Speaker Change: Our proprietary tetra specific and kit that goes by IP 65, or one is now in clinical development and as John just pointed out our <unk> ADC targeting <unk> four is rapidly progressing towards the clinic.
Arvind Sood: So, I would like to leave you with a few thoughts. Yes, we are a small care biotechnology company, but we have a differentiated pipeline with several first-in-class opportunities. We have seven products in clinical development with three that are proprietary and four that are partnered. Within the first half of this year, we have made significant pipeline progress as outlined on this slide. Our cash position, as Fred Rick pointed out, 105 million euros through the end of June, will enable us to fund operations well through the end of 2025.
Speaker Change: So I would like to leave you with a few thoughts.
Yes, we are a small cap biotechnology company, but we have a differentiated pipeline with several first in class opportunities. We are selling products in clinical development with three that are proprietary and four that are partnered.
Speaker Change: Within the first half of this year, we have made significant pipeline progress as outlined on this slide.
Speaker Change: Our cash position as Rick pointed out 105 million euros through the end of June will enable us to fund operations through the end of 2025.
Arvind Sood: This is also, in many ways, a very special year for Innate Pharma. It's our 25th year anniversary to commemorate this special occasion. We will host an investor meeting in New York on October 3rd, beginning at 8 a.m. each time in collaboration with Anne at the Mount Sinai School of Medicine. I, together with the rest of the Executive Management team, will be there and look forward to discussing our advancing pipeline and strategy for growth and value creation. We hope to see you all there.
Speaker Change: This is also in many ways a very special year for any pharma, it's our 25th year anniversary.
To commemorate this special occasion, we will host an investor meeting in New York on October 3rd beginning at eight PM Eastern time in collaboration with and at the Mount Sinai School of Medicine, I together with the rest of the executive management team would be there and look forward to discussing our advancing pipeline.
Speaker Change: And strategy for growth and value creation, we hope to see you all here so buildup, Rob I'd like to turn the call back over to you and we can open the call for Q&A and if you can please review the procedure for asking questions. Thank you.
Operator: So, with that, Rob, I'd like to turn the call back over to you, and we can open the call for Q&A. If you can, please review the procedure for asking questions. Thank you. Certainly, we will now begin the question and answer session. If you would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again.
Speaker Change: Certainly we will now begin the question and answer session. If you would like to ask a question. Please press star one on your telephone keypad to raise your hand and joined the queue. If you would like to withdraw your question simply press Star one again.
Rochelle Sharma: Your first question comes from the line of Rochelle and Charma from Goldman Sachs. Your line is open.
Speaker Change: Our first question comes from the line of Richard Sharma from Goldman Sachs. Your line is open.
Rochelle Sharma: Hi, thanks for taking my questions. Just on the near-coast two-day tour, we saw a conference for lung cancer. There obviously looked to be a graphic of signal with Monolithumab. As you pointed out, but optically, at least it looked like the DataDxDM in that trial showed higher response rates.
Speaker Change: Hi, Thanks for taking my questions just on the Neocart to data we saw at Royal Conference for lung cancer. There, obviously look to be a good efficacy signal with monetizing them up.
Speaker Change: As you pointed out the optimally at least it looks like the Doctor Dxd arm in that trial showed higher response rates. So I just wanted to get your perspectives on monetizing amounts of potential role in the SaaS Inc.
Rochelle Sharma: So, just wanting to get your perspectives on Monolithumab's potential role in the setting and why there may be a reason for it to coexist with DataDxD and potentially the PD1 CTAA4 by specific, but also in that trial that were yet to see DataDxD for.
Speaker Change: Why there may be a reason fritsch coexist with Dr <unk> and potentially the PD one <unk> four by specific Thats also not sure all that we're yet to see data for.
Rochelle Sharma: And then on kind of CEO kind of appointment, could you just maybe talk about internal timelines there and then related to that kind of absent permanent CEO to what extent are you able to make key strategic decisions going forward, such as the strategy with the queue to map.
Speaker Change: And then on kind of.
Speaker Change: Kind of appointment could you just maybe talk about internal timelines.
Speaker Change: And then related to that kind of absent permanent CEO to what extent are you able to make key strategic decisions going forward such as the strategy within the <unk> and then if I could just squeeze one in on that Takeda termination.
Rochelle Sharma: Then, if I could just squeeze one in on that to cater termination, just wondering there if there is any data generated that could be informative to your development of the ADC program. Thank you. Thanks for all those questions.
Speaker Change: Just wondering there if there is any data generated that could be informative to your development of the ADC program. Thank you.
Speaker Change: Central oldest question I will leave the first one.
Operator: I will leave the first one on Monolithumianis, then the EO and on the Lekita map too. Ervee, I don't know if you can hear us, but we lost the sound. We're a bit, can you hear us? Ladies and gentlemen, we are experiencing some technical difficulties. Please stand by. Your lines will just be on musical for a very short time. Please wait; the conference will begin shortly. Ladies and gentlemen, thank you for standing by. We will now continue. Thanks for doing the three questions. I will leave Yannis on the first question of Manali Jumab on the Newcastle trial.
Speaker Change: Lunar two units.
Speaker Change: <unk>.
Speaker Change: I don't know if you can hear us, but we lost the sound.
Speaker Change: I don't see any tightening.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Can you hear us.
Speaker Change: Ladies and gentlemen, we are experiencing some technical difficulties. Please standby your lines will just be on music hold for a very short time.
Speaker Change: Please wait the conference will begin shortly.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: No.
Speaker Change: Yes.
[music].
No.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Thanks.
Speaker Change: [music].
Speaker Change: Ladies and gentlemen, thank you for standing by and we will now continue.
So thanks, Paul Luther three.
Speaker Change: Three questions, So I will leave.
Speaker Change: Yes on the first question on the Immunology lab.
Speaker Change: On the <unk> trial.
Yannis Morel: Dan Sonia will give more color on where we stand with that item up.
Speaker Change: And then Sonya will give more color on where we stand with regulatory matters.
Yannis Morel: I will say the third question about the CEO recruitment of Yannis. I, Rajan, can you hear me? I can hear you. Yannis speaking, like you mentioned, the nail cause data are really encouraging for Manali Jumab and they really show superiority, numerical superiority of the PCR and MPRI compared to what is known for agents, for example. The study is run by ASI, and obviously we cannot comment on the next steps. You may know also that only sick patients have been reported; the trial enrolls 72 patients, so we are really looking forward to see the final data.
Speaker Change: Collyn I would just say to your question, but to see or a quick inventory units.
Speaker Change: Hi.
Speaker Change: Can you hear me, yes, I can hear you.
Speaker Change: Yes, hi.
Speaker Change: Yes, so I mean.
Speaker Change: Like you mentioned.
Madame Delphine: The local data really encouraging for LNG Madame Delphine sure.
Speaker Change: And real quick just Iot of the ERP CRM MTR rate compared to what is known for our agent for example.
Speaker Change: The study is owned by AZ and obviously, we cannot comment on the year on the next steps.
Speaker Change: You May note, although that's only 60 patients have been reported the tile and all 72 patients. So we are really looking for a while to Cvs.
Speaker Change: The final data note also that as these are cleanly.
Speaker Change: The confidence in cell Intel votes.
Speaker Change: Overall lighting.
Yes.
Speaker Change: As of today I would say the main message from this data that you'd see in processing with confidence that Mona is hanging in here and add on activity Yoga mat.
Speaker Change: Are you done.
Speaker Change: Yes.
Yannis Morel: Yeah. Right, around Lakutama, we, as I mentioned in our discussion previously, are engaged with the FDA on a proposal registration strategy to pursue a faster market approval. And as you know, the FDA operates a variety of programs to expedite approval since serious conditions and pending feedback from the FDA. We believe Lakutama could benefit from one of these expedite approvals. And we will of course provide an update in your course when this is available. In regard to the next step, you mentioned we are actively looking for different options, including partnership; we do not exclude any possible development for Lakutama in CTCL.
Speaker Change: Yes, absolutely.
Speaker Change: Right.
Lockwood amount.
Speaker Change: As I mentioned an hour.
Speaker Change: Discussion previously we are engaged with the FDA on our proposed legislation strategy to pursue a hospital not get approval and as you know FDA operates a variety of programs to expedite approval since serious condition and pending feedback.
Feedback from the FDA, we believe lack of demand but could benefit from.
Speaker Change: One on this.
Speaker Change: Expedite approval.
Speaker Change: We'll of course provide an update in due course when this is available.
Speaker Change: In regard to the next step.
Speaker Change: Mentioned, we are actively looking for different options.
Speaker Change: <unk> partner shifts, we do not exclude any.
Speaker Change: Any possible development for a good amount, but in in seat Tcl.
Yannis Morel: Our hope has addressed your plan. Yeah, Rajan, and with regard to your question on Pakeda, you may remember this, this was a very early stage deal with Pakeda where we based on the practical data package. We licensed them a panel of antibody, which were really at the research stage. So it was a very early stage deal. This determination is really related to a strategic review on their side and the closing on of the research site where the research was performed with this technology in this therapeutic area. So, yeah, there is really nothing to, I would say, to over interface about this determination or the data generated during this initial work.
Speaker Change: Yes.
Speaker Change: Our whole path.
Speaker Change: Yeah go ahead.
Speaker Change: Yes, yes.
Speaker Change: With regard to your question on.
Speaker Change: <unk>.
Speaker Change: You May remember this was a very early stage deal with Takeda, where we based on the preclinical data package, we license them a panel of antibody, which we have any idea pizza off stage saw.
Speaker Change: It was a very early stage deal.
Speaker Change: This termination is really related to AR.
Speaker Change: Strategic review on their side and the closing of the.
Speaker Change: There is upside throughout the research was that from.
Speaker Change: This technology and visa therapeutic area.
Speaker Change: So yes, there is really nothing to add.
Speaker Change: I would say it will go into place about this.
Speaker Change: In Asia, nor the data generated during this initial work.
Okay.
Yannis Morel: On to your question on the permanent field, so the process is still ongoing, but we should be able to come back and inform the market in a reasonable time about where we stand with progress in this direction.
Speaker Change: On to your question on the.
Speaker Change: From an Seo so the processes.
Speaker Change: It's still ongoing but we should be able to come back on informed.
Speaker Change: The market recently.
Speaker Change #100: Recently, Volvo talking about where we stand with the progress in <unk>.
Dana Graybosch: Okay, Rob, let's take the next question, please. Your next question comes from a line of Dana Graybosh from Lering Partners.
Speaker Change #100: Yeah.
Speaker Change #100: Okay, Rob let's take the next question please.
Speaker Change #101: Your next question comes from the line of Dana <unk> from Leerink Partners. Your line is open.
Dana Graybosch: Your line is open. Hi, thank you guys for the question. On Pacific 9, can you give us any more details about what this interim analysis was, by which the IDMC decided to go ahead and continue?
Speaker Change #102: Alright. Thank you guys for the question on Pacific Nine can you give us any more details about what this interim analysis was.
At AMC decided to go ahead and continue.
Dana Graybosch: Hi, hi, Dana. Hi, and it's speaking. Yeah, no, unfortunately, we cannot tell anything more than what we said, and neither is, you know, us. I mean, we, there's been, there was an interim pre-plan analysis. The IDMC looked at the data, and we basically get information; AC and us, that's the triangle is continuing.
Yes, hi.
Dana: Dana This is speaking.
Speaker Change #104: Yes, Unfortunately, we cannot.
Dana: Anything.
Speaker Change #105: More than what we say it in Asia.
Speaker Change #105: I mean, there's been there was.
Speaker Change #105: The A&P penalizes.
Speaker Change #106: <unk> looked at the data and we can get information.
Speaker Change #106: That's the plan is continuing.
Dana Graybosch: So that's basically it.
Speaker Change #106: So.
Speaker Change #106: That's basically it.
Dana Graybosch: And maybe could I, could you help us pen down timing when we might, when you might come to the next interim or final analysis of Pacific 9. And also help us on timing of the regulatory interactions with Lakuda Mab. And I think we've been asking, you know, the same sort of regulatory questions many quarters now. So, you know, which quarter should we really expect to have a more concrete plan from an eight? Yeah, so with regard to the timing of the Pac-9, no, we cannot comment. I mean, you know what is public? The 26th is mentioned on the CT.gov.
Speaker Change #106: And maybe could.
Speaker Change #106: Could you help us and down timing.
Speaker Change #106: We might.
And you might come to the next interim or final analysis of specific nine and also help us on timing of the regulatory interactions with lacuna Mab, but I think we've been asking the same set of regulatory questions. Many quarters, now, so which quarter should we really expect to have.
Speaker Change #106: A more concrete plan for M&A.
Speaker Change #107: Yes, so with regard to the tightening of the back nine.
Speaker Change #108: No we cannot comment on India.
Speaker Change #109: What you.
Speaker Change #108: So they can use the <unk>.
Speaker Change #108: <unk> mentioned on the on the <unk> Gov.
Dana Graybosch: If you use the original Pacific as a benchmark, you know that the time between the final analysis and the first patient was three years. But again, A.D. has not communicated any updates on the timing for the validity of the final data. And with regard to the Twitter map, we are going to have the interaction during the fourth quarter of this year. Wait, you put it in the interaction in the fourth quarter. Did I hear that correctly? Yeah, Q.Pro. Do not appreciate your patience in this. As you know, it takes time to prepare for Type-C meetings.
If you use.
Speaker Change #108: The original PTC as a benchmark that's due at the time between the final analyses and the first patient with <unk>.
Speaker Change #108: But again no.
Speaker Change #108: As communicated in year.
Speaker Change #108: On the on the tightening favia of each of the final data.
Speaker Change #110: And with regard to <unk>, we are guiding towards production during the fourth quarter of this year.
You put into interactions.
Speaker Change #111: Fourth quarter did I hear that correctly, yes Q4.
I appreciate your patience in this as you know it takes.
Speaker Change #112: Time to prepare for type C meetings and also the <unk>.
Dana Graybosch: And also, you know, the FDA has the time.
Speaker Change #112: Actually I have that time.
Dana Graybosch: But I would say that in our next discussion, we may provide a bit more clarity.
Speaker Change #112: And our next discussion we may provide a bit more.
Speaker Change #112: Clarity.
Dana Graybosch: Very helpful. Thank you.
Speaker Change #112: Very helpful. Thank you.
Yigal Nochomovitz: Your next question comes from a line of Yagal Nakamobits from City. Your line is open.
Speaker Change #114: Your next question comes from the line of Yigal <unk> from Citi. Your line is open.
Ashiq Mubarack: I think this is Ashok Mubarak on the Yagal. Thanks for taking my question. Just a couple on the early stage pipeline. For the CD-20 and that's the time on early development. I believe you said you have some timeline today. I think you said next year.
Speaker Change #114: Hi, Tim This is Oscar Mubarak on for Yigal. Thanks for taking my questions. Just a couple on the on the early stage pipeline.
Speaker Change #114: The C D C. The 20th Cutoffs.
Speaker Change #115: Pylon early development I believe you said, you'll have some timeline for that I think I think you said next year can.
Ashiq Mubarack: Can you give us a little color on what sort of signal you're looking for to warrant, you know, for their advancement there and maybe what specific types of patients you're enrolling. And then a similar question on the netted for development plan. It's a plan to enroll primarily post-pads of patients given, you know, the potential to treat MMA resistant patients any color that would be helpful. Thanks. So, yeah. You're right. On the IPH65, the CD-20 anchored. We are currently in dose of collation during this year. We open all the sides and we are progressing with the escalation next year.
Speaker Change #116: Could you give us a little color on what sort of signal you're looking for to warrant further advancement there maybe what specific types of patients you're enrolling and then a similar question on the on the method for development plan.
Speaker Change #116: <unk> enrolled primarily post paths of patience given.
Potential to treat MMA resistant patients any color there would be helpful. Thanks.
Speaker Change #116: Okay.
Speaker Change #116: Yes.
Speaker Change #116: Right.
Speaker Change #116: On the IP age 65, the CD 20 <unk>.
Speaker Change #117: We are currently in dose escalation during each year, we open all the time and we are progressing with the dose escalation next tier what we intend to see it.
Ashiq Mubarack: What we intend to see is the completion of the dose escalation and moving to the dose optimization. I brought a project optimist, which is, let's say, a mandatory stat in the development of early stage programs. And we are looking, of course, at generating the safety or safety profile for this asset. Mind you that the first generation anchored developed by Sanofi had demonstrated a remarkably favorable safety profile. And we hope to confirm the same level of, let's say, the same type of safety profile for with the second generation anchored, which include this extra aisle to variant.
Speaker Change #117: Completion of the dose escalation and moving towards.
Speaker Change #117: Those optimizations.
Speaker Change #117: At quarter of planned project Optimus.
Speaker Change #117: Which is.
Scott: Yes, hi, and mandatory Scott in the development of early stage programs.
Speaker Change #119: And we are looking of course at generating the safety.
Speaker Change #120: Safety profile for this asset mind, you that the first generation.
Speaker Change #121: Developed by <unk> demonstrated that.
Speaker Change #121: A couple of the tolerable safety profile and we hope the tool confirm the same lateral of.
Speaker Change #122: Let's say.
Speaker Change #122: The same type of.
Speaker Change #122: Safety profile with the cycle generation.
Speaker Change #122: Which include the extra IL two variant.
Ashiq Mubarack: And we, of course, are looking for pharmacodynamic markers, and therefore we are looking at the level of B cell depletion at different dose levels. We are looking at how much the anchors are stimulated, and ultimately we are looking at preliminary signs of antipumoractivity. And so anything that has the classic preliminary activity that is demonstrated in phase one trials. At the moment, we recruit non-orgically informed mainly the LBCL, but we are open to many other, let's say, some group of CD20 positive non-orgically informed.
Speaker Change #122: Of course are looking for Pharmacodynamic.
Speaker Change #123: And therefore, we are looking to the lateral also b cell depletion of different dose levels. We are looking at all much that NK cells are stimulated.
Speaker Change #123: And ultimately we are looking at preliminary signs of anti tumor activity and so anything that as let's say the classic.
Speaker Change #123: Preliminary activity.
Speaker Change #123: That is.
Speaker Change #123: Amongst traded in phase one trials at the mall.
Speaker Change #124: <unk>, we've accrued non hodgkin lymphoma, mainly DLP CLO, but we are open to <unk>.
Sam: Hi, Sam.
Speaker Change #126: Our group of <unk>.
Speaker Change #126: <unk> positive non Hodgkin lymphoma.
Ashiq Mubarack: And for the ADC, in terms of a clinical development plan, we are moving forward to the initiation of the phase one by the end of the year. And our aim, again, this is going to be a first in human dose escalation. And we are recruiting indications that generally express, let's say, moderate level of 194. And these are, let's say, not only blood or breast, but also non-small lung cancer, esophageal, GJ tumor, and so forth. And the dose escalation will be done in this, in this indication. And we, of course, expect to see preliminary signs of efficacy, as alongside the safety profile and pharmacokinetic and pharmacodynamic markers.
Speaker Change #127: And for the ADC in terms of our clinical development plan.
Speaker Change #128: We are moving forward to the initiation of the phase one by the end of the year and.
Speaker Change #129: Our aim again this is going to be a first in human dose escalation and we are.
Speaker Change #129: Fruiting indication.
Speaker Change #129: <unk>.
Speaker Change #129: And generally expressed that.
Speaker Change #129: Hi, there.
Our collateral of negative four in Bihar.
Not only bladder breast, but also non small cell lung cancer.
Speaker Change #129:
So for Gilles.
Speaker Change #129: GJ tubular.
Speaker Change #129: And so forth and the dose escalation will be done in this in this.
Speaker Change #129: Yeah.
Speaker Change #129: In this indication and we of course.
Speaker Change #129: Back to see preliminary signs of efficacy alongside the.
Speaker Change #129: Safety.
Speaker Change #129: Profile and pharmacokinetic and Pharmacodynamic markers.
Operator: I hope I addressed your questions. And you expect seeing an enrollment of patients protruded with parts of, or we don't know how many they may be, but definitely this is not an exclusion criteria. Understood, thank you. Again, if you'd like to ask a question, press star one on your telephone keypad.
Speaker Change #129: I hope I addressed your questions.
Speaker Change #129: Do you expect significant enrollment.
Speaker Change #129: Patients treated with <unk> or.
Speaker Change #130: Thanks, Brian.
Speaker Change #130: Yeah.
Speaker Change #131: We don't know maybe they may be but definitely this is not an exclusion criteria.
Understood. Thank you.
Speaker Change #132: Again, if you'd like to ask a question fresh start wondering your telephone keypad. Your next question comes from the line of Graham for cooler Ram <unk> from H C. W. Your line is open.
Bampakula Remacomph: Your next question comes from a line of Bampakula Remacomph from HCW. Your line is open. Thank you. So, I'm just trying to understand what's the progress in the PTCL indication for the CUDA map. If you can give us an idea of when you could expect some data from the Kiltra. This is a yes.
Speaker Change #132: Thank you.
Speaker Change #132: So I'm just trying to understand what's the progress there.
Speaker Change #132: P Tcl indication for.
Speaker Change #132: For the Kitimat, which you can.
Speaker Change #132: Can give us.
Speaker Change #132: And the idea right.
Speaker Change #132: We could expect some data from that trial.
Speaker Change #134: This is <unk>.
Speaker Change #132: Yes.
Bampakula Remacomph: Thank you for the question. As you know, this is an IST that is, let's say, sponsored by the Liza Group. And we can say that the study is ongoing and recruiting. You know, the study is not really on our direct control, but we can see that, you know, the study is on track for a termination late next year. Okay. Thank you.
Thank you for the question.
Speaker Change #132: You know this is Ed.
Speaker Change #132: Yes that is.
Speaker Change #132: Hi.
Speaker Change #132: Yes.
Speaker Change #135: Sponsored by the lifestyle group and we can say that the study is ongoing and recruiting.
Speaker Change #136: The study is not really under our direct control we can see that.
Speaker Change #136: The study is on track for 10 elimination late next year.
Speaker Change #136: Okay.
Speaker Change #136: Okay. Thank you.
Speaker Change #136: Yes.
Rajan Sharma: Hey, we have a follow-up question from the line of Rajan Sharma from Goldman Sachs.
Speaker Change #137: And we have a follow up question from the line of Rishon Sharma from Goldman Sachs. Please go ahead.
Rajan Sharma: Please go ahead. Hi. Yeah, thanks for taking the follow-up. Just wanted to come back on one of my initial questions.
Rishon Sharma: Hi, Thanks for taking the follow up I just wanted to come back on one of my initial questions and if I could just ask a question around CEO and strategy in a different way.
Rajan Sharma: And if I could just ask the question around CEO and strategy in a different way, just wanted to be clear kind of to what extent can you make strategic decisions on things like the CUDA map, absent the CEO, or will these things be on hold until you've made an appointment there? Thank you. Yeah. For sure, we prepare a scenario on where we have different options that we are contemplating for the next steps in the programme, and the decision will be made by the board with the board.
Speaker Change #139: Just wanted to be clear kind of to what extent can you make strategic decisions on things like <unk>.
Speaker Change #140: Absent the CEO or will these things be on hold until you've made an appointment that thank you.
Speaker Change #140: Yes.
Speaker Change #140: So we.
Speaker Change #140: Scenario.
Speaker Change #140: Although we have a <unk>.
Speaker Change #140: Given the options that we are contemplating for the next steps in the program.
Speaker Change #140: A decision would be made by the board with <unk> in place.
Yes.
Speaker Change #140: Okay.
Thanks.
Operator: We are actually out of question, so I will now conclude our question and answer session. And I would like to thank everyone for joining us today.
Speaker Change #140: We're actually out of questions. So I will now.
Speaker Change #141: Conclude our question and answer session and I would like to thank everyone for joining US today. This concludes today's conference call. Thank you for your participation and we know now disconnect.
Operator: This concludes today's conference call. Thank you for your participation. We know it now.
Operator: Disconnect.
Operator: Please wait; the conference will begin shortly.
Please wait the conference will begin shortly.
[music].
Speaker Change #141: Okay.
Speaker Change #141: Sure.
Speaker Change #141: Okay.
Speaker Change #141: Okay.
Speaker Change #141: Okay.
Speaker Change #141: Okay.
Speaker Change #141: Yes.
Speaker Change #141: Yes.
Speaker Change #141: Okay.
Speaker Change #141: Yes.
Speaker Change #141: [music].
Speaker Change #141: Yes.
Speaker Change #141: [music].