Full Year 2023 Innate Pharma SA Earnings Call
Operator: Please wait. The conference will begin shortly. Good day, ladies and gentlemen. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the Innate Pharma full year 2023 financial results and business update. Today's conference is being recorded, and all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. To ask a question during that time, simply press the star key followed by the number one on your telephone keypad.
Please wait the conference will begin shortly.
[music].
Okay.
Abby: Good day, ladies and gentlemen, my name is Abby and I will be your conference operator today.
Abby: At this time I would like to welcome everyone to the innate pharma full year 2020 financial results and business update call.
Abby: Today's conference is being recorded and all lines have been placed on mute to prevent any background noise.
Abby: After the Speakers' remarks, there will be a question and answer session.
Abby: I'd like to ask a question during that time simply press the star key followed by the number one on your telephone keypad.
Operator: If you would like to withdraw your question, press star one a second time. Thank you, and I will now turn the conference over to Henry Wheeler, Vice President of Investor Relations. Mr. Wheeler, you may begin. Thank you. Good morning, good afternoon, and welcome everyone.
Abby: If you would like to withdraw your question Press Star one a second time.
Abby: Thank you and I will now turn the conference over to Henry Wheeler, Vice President of Investor Relations. Mr. Wheeler you may begin.
Henry Wheeler: Thank you good morning, good afternoon, and welcome everyone.
Henry Wheeler: This morning, Innate issued a press release for our full year 2023 financial results and business opportunities. 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 in the IIS section of our website. On slide two, before we start, I'd like to remind you that we'll be making forward-looking statements regarding the financial outlook in addition to regulatory and product plan developments. These statements are subject to risk and uncertainty that may cause actual results to differ from those forecasted.
Henry Wheeler: This morning, <unk> issued a press release for a full year with 53 financial results and business update.
Henry Wheeler: We look forward to highlighting the progress made during the year to date.
Henry Wheeler: It's addressing future go lower than that.
Henry Wheeler: Recent data presentation, both are available on the IR section of our website.
Speaker Change: On slide two before we start I'd like to remind you that we will be making forward looking statements regarding our financial outlook. In addition to regulatory and product development.
Speaker Change: These statements are subject to risks and uncertainties that may cause actual results to differ from this forecast.
Henry Wheeler: On slide three of today's call, we will be joined by Urbe Brahi, our Interim Chief Executive Officer. Then we will hand over to Sonia Quaratino, our Chief Medical Officer, who will cover updates on the group's map and ICH65, who will then hand over to Yannis Morel, our Chief Operating Officer, who will then discuss ANCET and ADC platform updates. Frederic Lombard, our CFO, will cover the financials, and we're very pleased to welcome Arvind Sood, EVP, US Operations, who will wrap up and close, and I have a hand call with you. Thanks, Henry. Good morning and good afternoon, everyone.
Speaker Change: On slide three on today's call, we will be joined by Ed <unk>, Our interim Chief Executive Officer, then we will kind of Sonya Branco, our chief Medical Officer, who will cover updates on our model.
Speaker Change: 65.
Ed: He will then hand.
Speaker Change: And now Chief operating officer.
Speaker Change: We will then discuss and.
A couple of months.
Speaker Change: Yes that will cover the financials and we are very pleased to welcome oven seats Edp Europe.
Speaker Change: Operations, who will wrap up.
Aloha.
Edp Europe: Thanks Henry.
Edp Europe: Good morning, good afternoon, everyone.
Edp Europe: Just.
Urbe Brahi: Just first to recall that Innate Pharma is a very important player in the field of NK-cell pharmacology and innate immunity and manipulation. We address that through different mechanisms of action where we have corresponding products. It's first about engaging NK cells by trying to affect those tumor cells. And that's the approach that we use with the Ankit platform but also with the anti-toxic antibody Lactamab. We've also been pioneering the field of checkpoint inhibitors for NK-cells with Monalizumab, which is a checkpoint that is shared by different classes of NK-cells, on G-cells, and eventually through addressing suppression of the anti-toxic immune response through IPH 62 and 63, which address the adenosine pathway. So that's what the Innate Pharma strategy is. Well, firstly, it's about creating near-term value, and that's what we want to achieve with our most advanced proprietary asset, Lactamab, which is in development for T-cell lymphoma. Actually, final PTCL and early PTCL data will be released by the end of 2023 at ASH.
Speaker Change: Just to recall that e-commerce is a very important play.
Speaker Change: Ian Bell for HSN pharmacology on the ninth.
Speaker Change: Do you have any position on that.
Speaker Change: Through a different mechanism.
Actually its way out with have correctly products.
Speaker Change: First about engaging NK cells toxic effective.
Speaker Change: Okay.
Speaker Change: The foods that they.
Speaker Change: Implement ways.
Speaker Change: Okay.
Speaker Change: So with the stock antibody.
Speaker Change: We'll still be pioneering.
Speaker Change: The checkpoint inhibitor of NK cells with Navy do badly cheaply.
Speaker Change: Checkpoints with chat, which is targeting the Chicago with GTO by.
Speaker Change: You can catch it up.
Speaker Change: Okay.
Speaker Change: In Chile, Peru addressing suppression.
Speaker Change: Yeah.
Speaker Change: I'll take immune response.
Speaker Change: Great.
Speaker Change: Chip.
Speaker Change: I think the impact.
Speaker Change: With me.
Speaker Change: E Commerce packaging what first.
Chip: Firstly, it's about creating need near term value and thats, what we want to achieve.
Chip: Our most advanced the corporate sorry asset.
Chip: Which.
Chip: Of which which is in development.
Chip: T cell lymphoma.
Chip: Actually.
Speaker Change: Hi, Noah.
Speaker Change: That being released by the end of 'twenty three.
Speaker Change: At Ash.
Urbe Brahi: And here, we do look forward to the next step, which will be data on mycosis fungoides, and that will inform the future of this program for late-stage development. Second, we continue to fuel our innovative portfolio with both Ankit and antibody drug conjugates. Ankit is really a core asset.
Speaker Change: Yeah.
Speaker Change: We do look forward to the next decade.
Speaker Change: The desktop on the <unk> on that will inform the future of this program.
Speaker Change: <unk>.
Speaker Change: Our late stage development.
Speaker Change: We continue to cure or.
Speaker Change: <unk> portfolio with both okay on the antibody drug conjugates.
Speaker Change: <unk> is already a core.
Urbe Brahi: It's a platform that has generated several molecules, and as you know, the first molecule in the clinic has been advanced by our partner, Sanofi, who published important first clinical data in 2023. We'll come back to that, of course, in greater detail for ACR 443579.
Speaker Change: That format, which has generated several of the well.
Speaker Change: Our molecule as you know.
Speaker Change: First what are your Q&A.
Speaker Change: Being advanced by our partner Sanofi.
Speaker Change: <unk> 23.
Speaker Change: Important for us.
Speaker Change: Clinical data.
Speaker Change: We come back to that in greater detail all the ACR.
Speaker Change: 3579.
Speaker Change: Thanks.
Speaker Change: Okay.
Urbe Brahi: But the Ankit portfolio is now expanding with other assets that have been further licensed by Sanofi, but also with a proprietary program that was recently announced, and this is a second-generation Ankit, which has now been brought to a clinic in phase one in lymphoma. And beyond Ankit, we also have a second class of agents which are active as a single agent, potentially in tumors, with antibody drug conjugates, the first one being brought to, and we work on bringing it to IND in 2024. Eventually, in this phase two partnership, we have Monalizumab, the checkpoint inhibitor, in phase three on AstraZeneca is pursuing this late-stage asset, which will deliver very important data in the next years. So that translates into the portfolio, which is a combination of proprietary products on the partner's asset. I will now, before, I will now leave it to Sonia to detail the clinical stages or the clinical progress with those assets, especially first with Laputamab. Sonia?
Speaker Change: Portfolio, expanding our way say, although our FX.
Speaker Change: Yes.
Speaker Change: Reluctance by.
Speaker Change: But also with the appropriate Tory program.
Speaker Change: We referenced the unknown.
Speaker Change: No. This is a second generation now which has no.
Speaker Change: Through our Clinique.
Speaker Change: In the well.
Speaker Change: In lymphoma.
Speaker Change: And beyond that we'll get.
Speaker Change: We also had great.
Speaker Change: A second class of agent, which are active as a single agent.
Potentially at <unk>.
Speaker Change: <unk> drug conjugate the profile being growth.
Speaker Change: <unk>.
Speaker Change: We work on bringing it to.
Speaker Change: In the 2012.
Speaker Change: Inventory.
Speaker Change: Who the shipper, we have when that easy math.
Speaker Change: The checkpoint inhibitor in phase III.
Speaker Change: All right.
Speaker Change: Posturing.
Speaker Change: Asia I think.
Speaker Change: Sure.
Speaker Change: Regarding next year, it's very important.
Speaker Change: So that translates into the.
Speaker Change: Portfolio, which is a combination of proprietary products.
Speaker Change: Yes.
Speaker Change: The partnership.
Speaker Change: On them.
Speaker Change: I will note.
Speaker Change: Before.
Speaker Change: I will leave it to Sonya.
Sonia Quaratino: The <unk>.
Sonia Quaratino: Clinical features or the PD call it progress.
Sonia Quaratino: Thank you very much, Herve. When we look at slide seven, I would like to summarize the progress we are making with Laputamab. And on this slide, we are pursuing a fast-to-market strategy for Laputamab in the niche setting of cesarean syndrome, where it was granted the U.S. contract designation and EU prime designation back in 2020. We have then expanded post-Cesarean syndrome to mycosis fungoides, where we have seen encouraging preliminary data from the Phase II Telomax trial in patients that have a key trivial to expression level above as well as below the threshold of 1%.
Ethical, especially on Pepsi.
Sonia Quaratino: Thank you very much Kevin.
Sonia Quaratino: Robert I would like to summarize the progress we are making with absolute amount.
Sonia Quaratino: Yes.
Robert: Record fueling the faster market strategy.
Robert: In the niche snacking also estimates that a syndrome when I put the hammer would grant from the U S contractor retention and EU Prime designation.
Robert: Wendy.
Speaker Change: We went back.
Speaker Change: Victor.
Segment income to Nicole this is where.
Speaker Change: Well, we haven't seen an encouraging preliminary data from the phase two trial in <unk>.
Speaker Change: Sure.
Yes.
Speaker Change: Perhaps you can elaborate.
Speaker Change: They know the pressure of about 1%.
Sonia Quaratino: And we expect to present this data at one upcoming conference later this year. Now, the data in MS, together with the data in SS, will be shared with regulators to align on a path forward to maximize the value of lacutamab in CPCL, building on the existing fast track and orphan designation. Now, if we move to the PPCL phase, today we have announced that we are not going to reopen the recruitment for the phase one testing lacutamab in monotherapy in PPCL because the number of observed objective responses did not meet the pre-specified threshold for activity with lacutamab as a single agent.
Speaker Change: Yes.
Speaker Change: These data excellent upcoming conference later this year.
Speaker Change: No.
Together with the data.
Speaker Change: Will be shared related to align with the path forward to maximize the value of your equity.
Speaker Change: In that building.
Speaker Change: Building off the existing term.
Speaker Change: The information.
Speaker Change: Now if we move to the right.
Speaker Change: Today, we have announced.
Speaker Change: Going to reopen the recruitment of the phase one is up.
Speaker Change: Without robbing monotherapy in PD.
Speaker Change: That's the number.
Speaker Change: Objective response.
Speaker Change: Okay.
Speaker Change: Chris This is Mike tax shield for activity, we'd like with our model as a single agent.
Sonia Quaratino: However, based on the data presented at ASH last year demonstrating the synergism between lacutamab and chemotherapy in preclinical models of PDTL, we remain committed to the development of INP-PDTL and continue to enroll patients in the Phase 2 combination trial with chemotherapy, gemcitabine and doxaliplatin, where we believe the combination can offer additional benefits to patients. On the next slide, slide A, we have a summary of This is a heavily-pretreated post-imogamulizumab patient pool with at least five million prior systemic lines of therapies, including Imoga, and the global overall response rate was an encouraging 37.5%. I would like to note the deepness of the partial responses that you can see on the waterfall plot on the slide.
Speaker Change: However, based on the data presented at Ash.
Speaker Change: Demonstrating the synergies between.
Speaker Change: Good luck Marvin chemotherapy.
Robert.
Speaker Change: We remain committed to the development of <unk> and continue to enroll patients in the phase II combination trial.
Speaker Change: Yeah.
Speaker Change: And part of it.
Lastly, while we believe the combination of these channels.
Speaker Change: Thanks to patients.
Speaker Change: On the next slide slide <unk>, we have a summary.
Speaker Change: On the final phase III.
Speaker Change: Yes.
Speaker Change: That means that were presented.
Speaker Change: Yes.
Speaker Change: In an oral presentation, we did that have any cost.
Speaker Change: So that leaves about patient pool.
Speaker Change: The five median prior.
Speaker Change: Hi.
Speaker Change: Including AGA.
Speaker Change: The global.
Speaker Change: Right.
Speaker Change: And encouraging 57, 5%.
Speaker Change: I would like to note the deepness of the proper response perspective.
Speaker Change: Wonderful.
Speaker Change: Decline.
Sonia Quaratino: We have also reported in this patient population an overall response rate of 46.4% in the team and 48.2% in the blind, and overall, a clinical benefit rate of 87.5% and the medium PFS of 8 months with a durability of 12.3 months. A favorable safety profile was also observed, and we look forward to sharing this data set along with the final data in the Cossis-Fungordis cohort with the regulator later on. Now on slide 9, we can switch gears to our most advanced proprietary anchor, which includes a detuned variant IL-2 to include activation and proliferation of anti-cells in the tumor microenvironment. We were pleased to announce earlier this month that IPH 65, the first of this second generation anchor, which targets CB20, has entered the clinic, and the first in humans has started with the first patient windows in March.
Speaker Change: We have also reported in these patient population or no barrels.
Speaker Change: 46 declined.
Speaker Change: That's key.
Speaker Change: Yes.
Speaker Change: Hello, cleaning or a benefit rate of 87.
Speaker Change: And the median PFS of eight months with a durability.
Speaker Change: Also at 1.3 months.
Speaker Change: Our profitable the safety profile was also.
Speaker Change: And we look forward to sharing these data along with the final data ecosystem for this cohort with the regulator.
Later on.
Speaker Change: Yes.
Speaker Change: Now on the line design, we can switch to our most of our profit.
Speaker Change: Which includes a detailed design and pilot to include activation and proliferation of NK cells in the.
Speaker Change: Tumor microenvironment.
Speaker Change: We're pleased to announce there yet.
Speaker Change: That is.
Speaker Change: It's fine.
Speaker Change: Second generation.
Speaker Change: We're starting to see the 'twenty one to the.
Speaker Change: And the first in human.
With the first patient being dosed in March.
Sonia Quaratino: The trial will enroll patients with relapsed refractory and non-articulate lymphoma, and we will run it in the US, Australia, and France. In B-cell non-archivim informa Compared to recent therapies including CAR-T and T-cell engagers, IPH65 has a disruptive mechanism of action that eliminates cancer cells by a profound activation and proliferation of the ANCI cells. And IPH65 differs from allogeneic ANCI therapies, including CAR-ANCI, and it is an off-the-shelf therapy that drives the proliferation of the patient's own ANCI cells in non-archivim informa and does not require any immunodeficiency as for other cell therapies. Now, the IPH65 format also addresses the common challenges associated with the loss of CD16 by ensuring the activation of intratu Finally, by stimulating the anti-cell natural function, IPH65 has a bystander effect that can cause the elimination of CD20 negative tumor cells, overcoming tumor heterogeneity or loss of tumor antibodies. Now I will turn to Yannis.
Speaker Change: The trial will enroll patients with relapsed or refractory non hodgkin lymphoma, and we will run in the U S, Australia and France.
Speaker Change: In B cell non op in meaningful amount compared to.
Speaker Change: Including car T and T cell engagement.
Speaker Change: 65.
Speaker Change: The mechanism of action eliminates conflict.
Speaker Change: Buying a profile relation and proliferation of NK cells.
Speaker Change: IC H.
Speaker Change: These are from our G&A.
Speaker Change: Including car and try and this is an off the shelf therapy.
Speaker Change: Drives the proliferation of the patient.
Speaker Change: Okay.
Speaker Change: In non Hodgkin lymphoma, and thus will not require being critically.
Speaker Change: Rob.
Speaker Change: Okay.
Speaker Change: No I agree.
<unk> pharma also addresses the complex challenges associated with the loss of CVC by ensuring that the duration of intra tumor alone.
Speaker Change: Yes.
Speaker Change: Activation of <unk> 46.
Speaker Change: Finally by stimulating the entire Nash.
Speaker Change: Natural function.
Speaker Change: At the age 65.
Speaker Change: On the gasoline caused elimination of CD 19 negative.
Speaker Change: <unk>, two will add third G&A or loss of <unk>.
Speaker Change: Now I'll turn to Jan.
Yannis Morel: Thank you, Sonia. On slide 10, I wanted to highlight our proprietary first-in-class NK-State Long-Ager platform, which we call NK. And Kemp is a versatile technology made of antibody-derived building blocks that is creating an entirely new class of multistatistic engagers to induce synthetic immunity against cancer. Let us begin our scientific expertise in the antiseptic phase. This platform is designed for producing a series of drug candidates addressing multiple tumor targets, both in skin and solid tumors. The activating NK cell receptor called NKP46 is the backbone of our technology, and since it has a stable expression at the NK cell surface, even in the tumor microenvironment, it produces an optimal activation of the NK effector format.
Jan: Thank you Sonya.
Jan: On slide 10.
Jan: I wanted to highlight our hopefully SLE.
Jan: And then on the.
Jan: Well, let's be clear.
Jan: And get the versatile technology made of.
Jan: Building up.
Jan: Adding an entirely new class of medicines.
Jan: E comm gateways to induce.
Speaker Change: Again, Ken.
Speaker Change: Yes.
Speaker Change: Our base.
Speaker Change: And do you anticipate.
Speaker Change: This therefore, reducing theories.
Ken: As I said, Mexico target.
Ken: And 32 minutes.
Ken: Activating.
Speaker Change: I think Tom and KC 46 is the backbone of our success.
Speaker Change: And it has a stable patient base.
Speaker Change: And then the genomic fun environment.
Speaker Change: And optimal activation of the NK effector function.
Speaker Change: We have also developed a second daenerys investment of the technology.
Speaker Change: By incorporating a balance of 2002.
Speaker Change: Okay.
Speaker Change: <unk>.
Speaker Change: As you can see our pipeline of molecules significantly growing our license for mortgages too.
Yannis Morel: We have also developed a second generation version of the technology by incorporating a variant of Interleukin-2 in order to induce N-K-7 proliferation. As you can see, our pipeline of ANCAT molecules is significantly growing, with Sanofi having now licensed four molecules. Two are in the clinic in the team, and two are at the technical stage in solid tumors, including IPF67, which is the program for which Sanofi chose in December last. We are also very pleased to see our proprietary portfolio of on-cash progressives.
Speaker Change: And two.
Speaker Change: H in 30, chemo, including 67, which is the Pocahontas four weeks.
Speaker Change: Did it in December.
Speaker Change: We are also very pleased to see as well.
Speaker Change: Hopefully it'll be thoughtful you up on that.
Speaker Change: The second generation <unk>.
Speaker Change: <unk> is now in the teens and we continue to fuel our pipeline.
Speaker Change: Click and collect program.
Speaker Change: Again, let me back up.
Speaker Change: On slide 11, you can see.
Speaker Change: Our view of the clinical data presented by Sanofi last ash.
Speaker Change: At 61 to one also named stopped by 79.
Speaker Change: In these dose escalation, we were encouraged to see any shortcuts.
Yannis Morel: The second generation on-cash, IPF 6501, is now in the clinic, and we continue to fuel our pipeline with new preclinical programs against multiple targets. On slide 11, you can see an overview of the clinical data presented by Sanofi Lass and Gerard Ash for AMCAT IPH 6101, also named SAR 579. In this dose escalation, we were encouraged to see initial preliminary single agent activity and safety of SAR579 in relapsed recurrent animalization. At the one mixed-archive dose, five complete responses were observed out of 15 patients, with three responders remaining in remission at data cut-off at over 7, 12, and 14 months of treatment. SAR579 was well-related to 6 mixed carcines with no dose-limiting toxicity observed and 2 grade 1 CRS observed out of 43 patients.
Speaker Change: The activity and safety of stockpiled 79.
Speaker Change: Amortization.
And the one week document.
Speaker Change: I can keep it functioning well itself.
In patients with Thunder remaining in the Venetian and better capital at all.
Speaker Change: And 14 months.
Speaker Change: <unk>.
Speaker Change: <unk> 500, and 982 6 million sake.
Speaker Change: Those meetings toxicity ourself and to guide one of.
Our top 43 patients.
Speaker Change: While the phosphate 79.
Speaker Change: <unk>.
Speaker Change: And we look forward to seeing sales are based on <unk> in Europe.
Speaker Change: Yes.
Speaker Change: On slide 12, you can see a similarly about wealth diagnosing elegant.
Speaker Change: In 2016, we signed an insurance payment.
Speaker Change: Got it.
400 million.
Speaker Change: In milestone.
Speaker Change: Among which were announced 16 million to date.
Speaker Change: This program stopped by seven nine and stopped booking applegate in two phase one clinical clients.
Speaker Change: In December we signed a signal in that event.
Speaker Change: I hope the license.
Speaker Change: Okay.
Speaker Change: David.
Speaker Change: A solid tumor target.
Speaker Change: And again <unk> to adopt targets.
Speaker Change: It will depend on that yes, the uptick linked a lot of the call.
Speaker Change: 67, <unk> growth target.
Speaker Change: So getting a 15 million year old milestone and making all of.
Speaker Change: The total of statements.
Speaker Change: Single negative.
Speaker Change: Altogether altogether.
Payment we are eligible for a total maximum package of up to $1 75 billion that's why it.
Yannis Morel: The FDA award is FAR-579, a fast-tracking designation in May, and we look forward to seeing further updates from Sanofi in June. On slide 12, you can see a summary of our Sionofi alliance. In 2016, we signed an initial agreement for two ANCAC molecules worth up to 400 million euros in milestones plus royalties, among which we announced 16 million today. Most programs, SAR-579 and SAR-14, have progressed into phase one clinical trials. In December 2022, we signed a second agreement whereby Sanofi licensed the IPF62 Enquete Program targeting B7H3, a solid tumor target, and again optioned for two other targets. In December last year, they opt in for one of these programs called IPL67, targeting an undisclosed tumor target in solid tumors, calculating a 15 million euro milestone and making 40 million euros the total of payments received for this second agreement
Speaker Change: Slide 13 highlights our growing antibody conjugate pipeline as we continue to develop next generation therapeutics.
Speaker Change: And agenda.
Speaker Change: <unk>, our antibody that book.
Speaker Change: We find that bottom.
Speaker Change: We can generate antibodies with good <unk>.
Speaker Change: Part of that.
Speaker Change: Therefore, outweighed 64 ADC development.
Our agreement with <unk>.
Speaker Change: Well that makes sense.
Speaker Change: This is our approach and our.
Speaker Change: Our capability to begin with.
Speaker Change: Jason ADC candidate.
Speaker Change: I will now call the update on that well.
Speaker Change: So the agency program.
Speaker Change: 45 on the next slide.
Speaker Change: Slide 14.
Speaker Change: Yes, 40 sites, which is our appropriately next move both Tommy ADT with a total of one eight.
Speaker Change: We managed to create a differentiated product in multiple component.
Speaker Change: We generated <unk> antibody.
Speaker Change: Non overlapping with our bottler, Matt young somebody backbone.
Speaker Change: Sure.
Speaker Change: Then we collected the valuation capabilities designed to look at it.
Speaker Change: The <unk>.
Speaker Change: And to our low power high <unk> ratio.
Speaker Change: Finally, we typically the way it took one detail we'd like them.
Yannis Morel: Altogether, configuring these two agreements, we are eligible for a total milestone package of up to 1.75 billion BCH. Slide 13 highlights our growing antibody drug conjugate type. As we continue to develop next-generation therapeutics, having single-agent activity, utilizing our antibody engineering platform, we find that for some tumor targets, we can generate antibodies with good internalizing properties that are therefore well-suited for ADC development.
Speaker Change: Allowing to bypass.
Speaker Change: Like any of them and two I'd like to note.
Next question.
Speaker Change: Altogether this element.
Speaker Change: Nick will grow ADC, so even if you get infected nickel Monday, including <unk>.
Speaker Change: As well as on glad indicator.
Speaker Change: In the non human primates.
Speaker Change: These technical data have been selected for presentation at the north based on that.
Speaker Change: In the coming in the coming couple of weeks.
Speaker Change: We are looking forward to presenting them into <unk> for this product this year.
Speaker Change: On slide 15, I would like to remind you of.
Speaker Change: The entire entity to a checkpoint inhibitor that we have access to adequate capital oncology.
Speaker Change: In this slide you can see another view of the late stage development platform.
Yannis Morel: Our agreement with Sakeda in the field provides validation for this research approach and highlights our capability to generate differentiated ADT conditions. I will now cover updates on our lead proprietary ADC program, ICH45, in the next section. Slide 14 highlights ITH45, which is our proprietary Lexin for Darmatic ADC with a topo1 inhibitor payload. We have managed to create a differentiated product for multiple components. First, we generate the proprietary antibody with the differentiated epithelium, non-overlapping with infortimab, the antibody backbone of PET. Then we select a validated cleavable linker designed to be hydrophilic in order to counterbalance the aerophobicity of the payload and to allow for a high drug antibody rate.
Speaker Change: Non cancer.
Speaker Change: <unk> is currently being investigated in the basically higher competition Tonight.
Speaker Change: At closing the gap.
Speaker Change: In aggregate from the combination of in that mode.
Thank you Matt.
Speaker Change: I think the better phase III notebook the lung cancer setting.
Speaker Change: Not at all.
Speaker Change: John.
Understood.
Speaker Change: Based on the feedback of that phase II trial.
Because they thought were published in the journal of clinical oncology in 2002 and.
Speaker Change: Input.
Speaker Change: 11, five months PFS data.
Speaker Change: Our ratio of <unk> 42 in favor of <unk>.
Speaker Change: Vessels debate.
Speaker Change: The results also showed an increase in the primary endpoint of conceal although all of it but it's just recognition.
Speaker Change: 36% versus eight in Boston.
Yannis Morel: Finally, we selected a well-validated topo-1 inhibitor with Bicelder FX, allowing to bypass MMAE-related resistance mechanisms and to address tumors with heterogeneous NXIV expressions. Altogether, these elements result in a differentiating mechanism for ADC showing strong efficacy in preclinical models, including in fast-step refractory PDX, as well as encouraging TK-stopped profiles in non These preclinical data have been selected for presentation at an oral session at ACR in the coming couple of weeks. We are looking forward to presenting them and to filing the IND for this product this year. On slide 15, I would like to remind you of Monalizumab, the anti-NKG2A checkpoint inhibitor that we have licensed to AstraZeneca for oncology. On this slide, you can see an overview of the late stage development plan for Mona Lisa Lab at Namkens.
Speaker Change: Yes.
Speaker Change: Nucor's. Two study is also underway in an already updating of lung cancer evaluating <unk> with chemo in the new adjuvant non small cell lung cancer patients.
Speaker Change: On phase II data from the new cost.
Speaker Change: Which also evaluate manav.
Speaker Change: Our mission of delivering that.
Speaker Change: Okay.
We know down to put Eric for the financials.
Speaker Change: Thank you Jenny.
Speaker Change: On slide 16, the key elements of <unk> financial position financial results as of the year.
Speaker Change: Andy.
Speaker Change: The first of December 'twenty three is.
Speaker Change: Cash cash equivalents short term investments and financial assets amongst where other than two 3 billion as of the end of last year, including financial distress amounting to $9 8 million.
Speaker Change: This number does not include the 15 million payment received pumps policy in January 24.
Speaker Change: Revenue and other income from continuing operations amounted to 61 6 million and 20 Street, which mainly comprises revenue from collaboration and licensing agreements received pursuant to the agreements with us other than cap set of <unk>.
Yannis Morel: Mona is currently being investigated in a phase 3 trial called Pacific 9. AstraZeneca started this phase 3, evaluating the combinations of either Mona or Olecumab plus Gerbalumab in unresectable stage 3 non-Folxalian cancer patients who have not progressed after concurrent chemo-radiotherapy based on the results of their phase two cold trials. Cause data were published in the Journal of Clinical Oncology in 2022, and after a median follow-up of 11.5 months, PFS data showed a hazard ratio of 0.42 in favor of MONA versus Gervalumab alone. The results also showed an increase in the primary endpoint of confirmed overall response for MONAF and ZURBA combination over ZURBA alone of 36% versus 18%, respectively. The AstraZeneca-sponsored Neocost 2 study is also underway in an earlier setting of lung cancer, evaluating Monarch-Lazurvalumab with chemo in the neoadjuvant non-small cell lung cancer patient, based on phase two data from the NEARCORE study, which also showed superiority of the MONAB plus GeoValueMAP combination over GeoValueMAP in this new Agile study
Speaker Change: And $9 7 million in research tax credits.
Speaker Change: Operating expenses from continuing operations amounted to $74 3 million in 'twenty. Three we then now making up 75% of the Opex.
Speaker Change: Research and development expenses from continuing activities amounted to $56 million and 23 up eight 4% a year ago.
Speaker Change: The increase in their hands the menu results from an engaging directly serve some development expenses, both clinical and preclinical.
Speaker Change: General and administrative expenses amounted to $18 3 million down by <unk>, 5% on prior year due to dedicated and personnel expenses.
Speaker Change: These areas.
Speaker Change: Fees and other expenses many of his team.
Speaker Change: On efficiency measures applied by the company.
Speaker Change: The table in the press can be summarized yes go ahead.
Speaker Change: <unk> financial statements as of and for the year ended the first of December 'twenty, three including 2022 comparative information.
Abbvie: I will now handover to Abbvie.
Abbvie: Thank you for the rig.
Abbvie: I won't go through all the catalysts that we have listed on slide 17, but I'll spend a few minutes on some of the key clinical catalysts that we have noted on this slide.
Abbvie: And then we will provide a summary before we turn to your questions.
Abbvie: We're expecting the final data for our proprietary antibody like <unk> and <unk> on board is eminent.
Abbvie: And we look forward to presenting this data in detail at an upcoming medical meeting.
Abbvie: Concurrent with that we've also commenced in our accident with the global regulatory agencies as we map out the next steps in its development.
Yannis Morel: I will now turn to Frederic for the final. Thank you, Yannis. On slide 16, the key elements of Innate Financial's position and financial results as of the year ended 31st December 23 are as follows. Cash, cash equivalent, short-term investment, and financial assets amount to 102.3 million as of the end of last year, including financial risk amounts amounting to 9.8 million.
Abbvie: Our antibody therapeutic NK cell engagement program that was earlier referred to as the anchored program continues to evolve.
Abbvie: This program has received broad validation to the licensing of four programs to Tennessee.
Abbvie: We have recently taken a proprietary program emanating from the anchored platform into the clinic ourselves by dosing the very first patient.
Abbvie: This program known as IP 60, 501 is targeting 80, 20, and B cell non Hodgkin's lymphoma.
Abbvie: For modern lithium out of our antibody targeting <unk>.
Abbvie: <unk>.
Frederic Lombard: This number does not include the 15 million payment received from Sanofi in January 2020. Revenue and other income from continuing operations amounted to 61.6 million in 2019, which mainly comprises revenue from collaboration and licensing agreements received from the agreements with AstraZeneca, Sanofi, and Tecate, and 9.7 million in research tax credits. Obeiding expenses from continuing operations amounted to 74.3 million in 2020.
Abbvie: Sweet prior called Pacific minus underway.
Abbvie: The study is looking at monetizing that go bad and that in non small cell lung cancer. The.
Abbvie: The thinking here is that the dual targeting of the PDL, one and the MTA G to a pathway through the combination will lead to enhanced antitumor activity versus any delays on therapy with <unk>.
Abbvie: Continue to advance other reasons targeting the adenosine pathway.
Abbvie: An example is <unk> 201, which is currently in phase II in combination with <unk> and chemotherapy in treatment naive patients with respectable early stage non small cell lung cancer.
Abbvie: So just to conclude over the years, we have established a strong expertise in immuno pharmacology.
Abbvie: The definitive phase II data in hand, we are mapping up a regulatory next steps for an acute event.
Frederic Lombard: With R&D now making up 75% of the company's operations, Research and development expenses from continuing activities amounted to 56 million in 2020, of which 8.4% was from clear use. The increase in R&D mainly results from an increase in direct research and development expenses, both clinical and non-clinical. General and administrative expenses amounted to 18.3 million, down by 18.5% on the prior year due to the decrease in personal expenses, non-significance advisory fees, and other expenses mainly resulting from efficiency measures applied by the. The table in the press release summarizes the IFRS consolidated financial assessment as of and for the year ended 31st of December 2023, including 2022 comparative informal.
Abbvie: Our proprietary NPS that engage our platform.
Abbvie: Has the potential of addressing both hematologic malignancies and solid tumors.
Abbvie: We are pursuing adcs with a focus on differentiation with Icf's 45. This is our <unk> ADC targeting <unk> for being a key example of our approach.
Abbvie: Lastly, we continue to retain a strong cash position to fund our operations relative to the end of 2025.
Speaker Change: We are excited about our prospects for the future and before I close I would also like to thank the many employees.
Speaker Change: We worked very hard on developing therapies for the potential benefit of patients.
Speaker Change: With that we can open it up for questions.
Speaker Change: Thank you.
Speaker Change: At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad.
Speaker Change: We will pause for just a moment to compile the Q&A roster.
Speaker Change: Sure.
Speaker Change: So we will take our first question from Yigal <unk> with Citi. Your line is open.
Speaker Change: Hi, this is on for Yigal. Thank you for taking our questions.
Unknown Attendee: We now hand over to Anne. Thank you, Frederic. I won't go through all the catalysts that we have listed on slide 17, but I'll spend a few minutes on some of the key clinical catalysts that we have noted on this slide, and then we'll provide a summary before we turn to your questions. We are expecting the final data for proprietary antibody lecudimab in mycosis fungoides to be imminent, and we look forward to presenting this data in detail at an upcoming Concurrent with that, we'll also commence interactions with the global regulatory agencies as we map out the next steps. Our antibody therapeutic NK-Cell Engager program, which was earlier referred to as the ANCET program, continues to evolve. This program has received broad validation through the licensing of four programs to Santa Barbara.
Yigal: We have a couple first on the PTC program.
Speaker Change: But you are not planning to we opened the phase one monotherapy trial can.
Speaker Change: Can you walk us through your thought process, there and give us more than that details on that.
Speaker Change: What was the internal bar for efficacy there.
And then.
Speaker Change: Ken.
Again that could come out.
Speaker Change: Various spending within the past of finding a partner for commercialization and development of the program.
Speaker Change: Are you expecting the upcoming data.
Speaker Change: For MF to catalyze the partnership there.
Right.
Speaker Change: Let me try that.
Speaker Change: We have <unk>, we have enrolled 20 patients.
They talk about.
Speaker Change: Safety from 10 patients from lab event.
Yes.
Speaker Change: Our goal we have included four model.
Speaker Change: Right.
Unknown Attendee: We have recently taken a proprietary program emanating from this ANCIP platform into the clinic ourselves by dosing the very first. This program, known as IPH 6501, targets CD20 in B-cell non-Hodgkin's lymphoma. For Monolizumab or an antibody targeting NKG2A, a phase 3 trial called Pacific9 is underway. This is a study looking at monolizumab plus govalumab in non-small cell lung cancer.
Phil: Manav, it's Phil.
Phil: We defined a meaningful number of objective responses that needed to be.
Phil: Prior to continue the recruitment and despite.
Phil: Objective response, <unk>, we'd like with the Hopper.
Phil: <unk>.
Phil: The number of objective responses did not meet a meaningful number pre tax by the profitable and Youll understand ECL Gras many different.
Phil: In our beauty option.
Phil: Manny we are ready to provide is y.
Unknown Attendee: The thinking here is that the dual targeting of the PD-L1 and the MKG2A pathway through this combination will lead to enhanced anti-tumor activity versus single-age. We continue to advance other agents targeting the adenosine pathway in the clinic. An example is IPH5201, which is currently in Phase 2, in combination with Dervalumab and chemotherapy, in treatment-naive patients with respectable early-stage non-small So just to conclude, over the years, we have established a strong expertise in immunopharmacology. With definitive Phase II data in hand, we are mapping out the regulatory next steps for Leucudimab. Our proprietary NKITS platform, NKITS, has the potential to address both hematologic malignancies and solid tumors. We are pursuing ADCs with a focus on differentiation with IPH45.
Phil: Robust phenomenon of objective responses from their core hour.
Phil: Our traction.
Phil: We're quite high too much we remain committed to the Bcl two the phase two.
Phil: Bonnie in combination with chemotherapy, well, we expect to see from <unk>.
Manny: Let me begin with our mob.
Manny: And chemotherapy and therefore provide.
Manny: Some meaningful clinical benefit to patients.
Manny: The second question was around.
Manny: Mark.
Manny: Is that correct.
Manny: The second question was on.
Manny: On partnership.
Manny: Partnership.
Manny: Ownership of all.
Manny: We are actively looking for.
Manny: Different options too.
Speaker Change: Thank you the next.
Speaker Change: Page with luck was I'm, hoping the CPM.
Speaker Change: Our partnership allows patent Vantiv option.
Speaker Change: Okay got it that makes sense.
Speaker Change: Just one quick follow up do you expect this discussing yourself monotherapy.
Speaker Change: <unk>.
Speaker Change: Impact your plans on the on the partnership for this molecule.
Speaker Change: Yes.
Unknown Attendee: And lastly, we continue to retain a strong cash position to fund our operations well through the end of 2025. We are excited about our prospects for the future. And before I close, I would also like to thank the many employees at Innate who work very hard to develop therapies for potential. With that, we can open it up for questions. Thank you.
Speaker Change: Not really I mean.
Speaker Change: The data on <unk> will have no impact.
Speaker Change: Neither on the phase two in the Etfs in combination with chemo, but definitely not on the <unk>.
Speaker Change: <unk> already have the data in house.
Speaker Change: Okay got it great. Thank you very much for taking our questions.
Speaker Change: And we will take our next question from Dana <unk> with Leerink partners. Your line is open.
Dana: All right I'm going to ask a follow up on the one just asked on the single agent activity.
Dana: It's hard because we can't see it and so is this you had one before.
Operator: At this time, I would like to remind everyone in order to ask a question, press star and then the number one on your telephone keypad, and we will pause for just a moment to compile the Q&A roster. And we will take our first question from Yigal Nochomovitz with Citi. Your line: This is Amin on for you, Yigal. Thank you for taking our questions. We had a couple.
Dana: Yet a lot of shrinking staple disease or did you have three.
Dana: Did it meet your bar and so I wonder if you could give us any more specific detail, particularly because I think we'd like to.
Dana: What should make us confident clinically.
Dana: This is going to prove out and gem ox could be something more meaningful for patients and the unmet need compared to the therapeutic options here.
Dana: Okay.
Operator: And this is the operator I apologize.
Unknown Attendee: First, on the PT-SEAL program, that you are not planning to reopen the phase one monotherapy trial. Can you walk us through your thought process there and give us more details on that? And what was the internal bar for efficacy there? And then on the second, Again, I'm like the Kutumab.
Speaker Change: Our presenters go on mute.
Speaker Change: Yes.
And ladies and gentlemen.
Operator: Please standby we are experiencing technical difficulties.
Speaker Change: Ladies and gentlemen, I will put music back on while we wait for our speakers to reconnect. Thank you.
Speaker Change: Please wait the conference will begin shortly.
Unknown Executive: Where are you standing within the process of finding a partner for your commercialization and development of the program? Are you expecting the upcoming data or MS to catalyze the partnership there? Right. Let me say that in PTTL, we have enrolled 20 patients, and data around safety from 10 patients were presented at ASH last year. But per protocol, we included a formal, let's say, interim analysis where we defined a minimum number of objective responses that needed to be observed prior to continuing the recruitment. Our threshold was quite high, too much.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Thanks.
Speaker Change: [music].
Speaker Change: And ladies and gentlemen, thank you for your patience, while we managed our technical difficulties Ms. Grey box do you mind asking your question again please.
Speaker Change: Okay.
Daina Graybosch: And that came from city, which is.
Daina Graybosch: Wonder if you could give us any more details on the specific responses or any correlation with tier three D. L. Two activity.
Unknown Executive: We remain, however, committed to PTCL through the Phase 2 study in combination with chemotherapy where we expect to see some synergism between lacutamab and chemotherapy and therefore provide some meaningful clinical benefit to patients. The second question was around the partners. Is that correct?
Daina Graybosch: And the clinical data could we hang on to be confident that we're going to see synergy in combination with chemotherapy next year.
Daina Graybosch: Okay.
Daina Graybosch: I suspect you are talking about the PTC rather than ecosystem Reuters, yes.
Unknown Executive: The second question was about partnership, yes. Partnership. And around the partnership for LAKUTAMAB, we are actively looking for different options to pursue the next stage with LAKUTAMAB in the CPCL, either via partnership or alternative options. Okay, got it. That makes sense.
Daina Graybosch: Yes.
Speaker Change: Right Okay.
Speaker Change: Basically in this study we have.
Speaker Change: Recruited patients to have.
Speaker Change: Our next question level of tier three deals two that is equal our above 1%.
Speaker Change: We did not.
Speaker Change: E a streak to do any type of PTC L.
Unknown Executive: And just one quick follow-up. Do you expect this discontinuation of monotherapy to impact your plans for the partnership for this molecule? Not really. I mean the...
Speaker Change: And.
Speaker Change: And.
Speaker Change: We hope to present the data later on this year.
Speaker Change: Even if we.
Speaker Change: We are not going to reopen the Saudi and the sample size is relatively small because this is around <unk>.
Unknown Executive: The data on PTCL has no impact, neither on phase two in PTCL in combination with chemo, but definitely not on CTCL, where we already have the data in-house. Okay, I got it. Great. Thank you very much for taking our questions, and we will take our next question from Daina Graybosch with LeRink Partners. Your line is... Hi, I'm going to ask a follow-up on the one just asked about the single agent activity. It's hard because we can't see it.
Speaker Change: Intubation.
Speaker Change: So then what gives you confidence in the gym market combo will prove successful.
Speaker Change: No.
Speaker Change: This is an investigator sponsored trial and the date of completion is predicted to be towards the end of 2025.
Speaker Change: Okay.
Speaker Change: And yes, but why do you think that this will be successful why why continue with that.
Speaker Change: Because.
Speaker Change: Chuck.
Speaker Change: Last year, we have presented.
Speaker Change: Some data that diamond trade to come CNET GSM in preclinical model.
Daina Graybosch: And so, is this you had one response and every yet another shrinking staple disease, or did you have three, and they just didn't meet your bar? And so I wonder if you could give us any more specific details, particularly because I think we'd like to. What should make us confident clinically that this is going to prove out and jam ox to be something more meaningful for patients and the unmet need compared to the therapeutic options here? Thank you, presenters go on mute, and ladies and gentlemen, and many more. Ladies and gentlemen, I will put music back on while we wait for our speakers today. Please wait.
Speaker Change: Lockwood, our mob and chemotherapy.
Speaker Change: Okay. Thank you for that.
Speaker Change: Okay.
Speaker Change: So operator I'll ask an offline question and then maybe we can go back to the online questions.
Speaker Change: So I have an offline question from Justin <unk> at Kepler Chevron.
On the Coos, Matt regarding the potential progress made with the regulatory authorities and sensory syndrome can you give us an update and also at what points are you regarding design partner, which I think you covered already.
Speaker Change: So regulatory interactions.
Speaker Change: We are working now that we have the data in MF and these data are.
Speaker Change:
Speaker Change: And as data.
Speaker Change: These preliminary data.
Operator: The conference will begin shortly. Ladies and gentlemen, thank you for your patience while we worked out our technical difficulties. Ms. Graybosch, do you mind asking your question again?
Speaker Change: <unk>.
Speaker Change: Promising.
Speaker Change: We are.
Speaker Change: <unk>.
Speaker Change: We are working to before a basketball was.
Speaker Change: Alongside the SaaS and MF and plan to maximize the.
Operator: And then the next question that came from Citi, which is, I wonder if you could give us any more details on the specific responses or any correlation with CARE3DL2 activity. You know, what in the clinical data could we hang on to be confident that we're going to see synergy in combination with chemotherapy next year? I suspect you are talking about PTCL rather than mycosis fungoides data. Oh, yes.
Speaker Change: The value of Lockwood Omar there is going to be discussed with the regulators.
Speaker Change: Okay.
Speaker Change: Operator next question please.
Alright. Thank you. Our next question comes from Arthur He with H C. Wainwright. Your line is open.
Speaker Change: Okay.
Arthur He: Hi, good morning.
Arthur He: Also any.
Arthur He: Thanks for taking my question. So I just wanted to follow up on the regulatory question on that could've met.
Unknown Executive: Right. Okay. Basically, in this study, we have recruited patients who have an expression level of KIRT3DL2 that is equal to or above 1%. We did not, let's say, restrict ourselves to any subtype of PTCL, and we hope to present the data later this year. Even if we are not going to reopen the study and the sample size is relatively small because it's around 20 patients, what gives you confidence that the gem mark and combo will prove successful?
Arthur He: So.
Arthur He: Guys to go to the agents.
Arthur He: Data both with the city.
Arthur He: As you are seeing in MFS.
Speaker Change: Rather go for this.
Speaker Change: This is <unk> syndrome data alone to talk to the agent to file the BLA.
Speaker Change: Just wanted to clarify that.
Speaker Change: Sure.
Speaker Change: Regionally, we when we had the data.
Speaker Change: Sorry that was the option of going to the regulators with the sensory data alone.
Unknown Executive: This is an investigator-sponsored trial, and the date of completion is predicted to be towards the end of 2025. And yeah, but why do you think that this will be successful? Why continue with the IIT?
Speaker Change: We had fast track designation and.
Prime.
Speaker Change:
Speaker Change: Now we can really.
Speaker Change: Hmm.
Speaker Change: Plan to merge the data as I say it to maximize the value of Lockheed amount, but not only in treasury that is.
Unknown Executive: Because at ASH last year, we presented some data that demonstrated some synergism in a preclinical model with lacutamab and chemotherapy. Okay, thank you for that. So, operator, I'll ask an offline question and then maybe we can go back to the online world. So I have an offline question from Justine Telliez at Capital Chevro. On Kutumab, regarding the potential progress made with the regulatory authorities in Cesare syndrome, can you give us an update? And also, at what point are you regarding a desired partner, which I think, and regulatory interactions?
Small sub group of the CTC Io maximize the value of of the drag in the hall of CTC al.
Together of course with Nicolas <unk> of course.
Speaker Change: The option of.
Speaker Change: Asking for accelerated approval.
<unk> remains and as you know in order to get accelerated approval or any way, we need 12 months durability of response.
Unknown Executive: We are working now that we have the data in MS, and these data are promising. We are working to, for a fast forward, alongside SS and MS, and a plan to maximize the value of Lakutamab is going to be discussed with the regulators. All right, the next question, please. All right. Our next phone question comes from Arthur He with H.C. Wainwright. Your line is... Good morning, everyone. This is Arthur in for RK.
Speaker Change: That.
Speaker Change: It's needed for this and of course.
Speaker Change: We need to align on what the range is.
Speaker Change: Rational trial could look like.
Speaker Change: Thanks, Thanks for that.
Speaker Change: Helpful.
Speaker Change: Quick one.
Speaker Change: And Keds program, it's great to see the progress at all and the expanding of the portfolio.
Speaker Change: Specifically on the.
Arthur He: Thanks for taking my question. So I just want to follow up on the regulatory question about Cudemat. So you guys go to the agent with the data both for the Caesarean syndrome and the MF, or rather go for the Caesarean syndrome data alone to talk to the agent about filing the BLA? Just want to clarify. Sure, originally, when we had the data for cesarean, there was the option of going to the regulators with the cesarean data alone where we had fast track designation and prime.
Speaker Change: 65, Oh lung.
Speaker Change: I'm just curious for the trial.
Speaker Change: <unk> initially.
Speaker Change: With deep CD 20, Colo for the patient inclusion.
Speaker Change: And how about the dosing strategy.
Speaker Change: Can give additional color I appreciate it.
Speaker Change: Sure.
Speaker Change: In the study are going to be recruited the CD 20 positive non Hodgkin lymphoma again in every subtype and this is a classic first in human trial and therefore, we are.
Unknown Executive: Now we can really, plan to merge the data, as I said, to maximize the value of lacutamab, not only in cesarean, that is a small subgroup of the CTCL, but maximize the value of the drug in the whole of CTCL, together of course with mycosis fungoides and of course you know the option of asking for accelerated approval still remains and as you know in order to get accelerated approval anyway we need the 12 months durability of response that is needed for this and of course we need to align on what the registrational trial could look like, Thanks for that, really helpful. Just a quick on the... NCAT program. It's great to see the progress along and the expanding of the portfolio. Specifically on the 6501, I'm just curious for the trial you got to evaluate initially, is there a CD20 color for the patient inclusion? And how about the dosing strategy there? If you can give an additional color.
Speaker Change: First cohort as you can imagine as the first patient was enrolled in March.
Speaker Change: It is a dose escalation study with expansion.
Speaker Change: Thanks, and how about the dosing wise whats the dosing interval.
Speaker Change: The strategy for the dosing escalation when the dose escalation is guided by the safety signals that we see and of course.
Speaker Change: Hi.
Speaker Change: Statistical consideration and the appetite of.
Speaker Change: The investigators depending on the safety and exposure that we observed at each cohort.
Speaker Change: Alright, thanks, Thanks for the additional color.
Speaker Change: Okay.
Speaker Change: Operator are there any more questions.
Speaker Change: We have no further phone questions at this time.
Speaker Change: I would now like to turn the call back to Mr. <unk> for any closing remarks.
Speaker Change: Yes. Thanks, Thanks, a lot for your questions. We're looking forward to the next.
Speaker Change: <unk> on the next.
Unknown Executive: Appreciate it. Sure. In the study are going to be recruited the CD20 positive non-Hodgkin lymphomas, again, in every subtype. And this is a classic first in human trial.
Speaker Change: In Bolton steps will be the presentation of the oral presentation at the ACR to present the features so for AGC OCD.
Speaker Change: The IP is 45% and then of course the.
Unknown Executive: And therefore, we are the first cohort, as you can imagine, as the first patient was enrolled in MART. It's a dose escalation study with expansion. Thanks. And how about dosing-wise? What's the dosing interval and the strategy for the dosing escalation? Well, the dose escalation is guided by the safety signals that we see and, of course, by statistical considerations and the appetite of the investigators, depending on the safety and the exposure that we observe in each cohort.
General meeting taking place on May 21st So we're looking forward to reconnecting with you all on those two opportunities.
Speaker Change: A very good day.
Speaker Change: Looking forward to the next steps.
Speaker Change: Great. Thank you everybody.
Speaker Change: And ladies and gentlemen, this concludes today's call and we thank you for your participation you may now disconnect.
Speaker Change: Please wait the conference will begin shortly.
Speaker Change: [music].
Unknown Executive: All right, thanks. Thanks for the additional information, Carter. Thank you. We have no further phone questions at this time, and more. Thanks a lot for your questions.
Unknown Executive: We're looking forward to the next meetings. The next important steps will be the presentation, the overall presentation at the ACR to present the features of AGC, CD, and IPH45, and then, of course, the general meeting taking place on May 21st. So we're looking forward to reconnecting with you all on those two opportunities. And I wish you a very good day, and the next year's, great. Thank you, everybody. And ladies and gentlemen, this concludes today's call, and we thank you for your participation. Please wait.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Sure.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yes.
Okay.
Speaker Change: Sure.
Speaker Change: [music].
Operator: The conference will begin shortly. The conference will begin shortly. The conference will begin shortly. The conference will begin shortly. The conference will begin shortly. The conference will begin shortly. The conference will begin shortly.
Speaker Change: Okay.
Speaker Change: Okay.