Q1 2024 Innate Pharma SA Earnings Call
Operator: Thank you for standing by, and welcome to the Innate Pharma first quarter 2024 financial results and business update call. All lines have been placed on mute to prevent any background noise.
Thank you for standing by and welcome to the innate pharma first quarter 2024 financial results and business update call. 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. If you would like to withdraw your question again prestige Star one. Thank you I'd now like to turn the call over to Henry Wheeler, Vice President Investor Relations and Communications you may begin.
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 the star followed by the number 1 on your telephone keypad. If you would like to withdraw your question, again press the star 1. Thank you. I'd now like to turn the call over to Henry Wheeler, Vice President, Investor Relations and Communications. You may begin.
Henry Wheeler: Thank you. Good morning, good afternoon, and welcome everyone. This morning, Innate issued a press release for our Q1 2024 business update and financial results. We look forward to highlighting the progress made during the quarter to date, as well as addressing future goals and milestones. The press releases in today's presentation are both available in the IR section of the website. On slide 2, before we start, I'd like to remind you that we'll make forward-looking statements regarding our financial outlook in addition to regulatory and product plan developments. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
Henry Wheeler: Thank you good morning, good afternoon, and welcome everyone. This morning, <unk> issued a press release for Q1, 2024 business update and financial results.
Henry Wheeler: We look forward to highlighting the progress made during the year to date during the quarter to date as well as addressing future goals and milestones. The press release and today's presentation are both available on the last section of the website.
Henry Wheeler: On slide two before we start I'd like to remind you that we'll make forward looking statements regarding our financial outlook. In addition to regulatory and product planned developments.
Henry Wheeler: 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'll be joined by Herve Brailly, Interim Chief Executive Officer. Then we have Sonia Quarantino, Chief Medical Officer, who will cover updates on Kutumav and IPH6501. We'll then hand the call to Yannis Morel, Chief Operating Officer, who will then discuss our ANCET and ADC platform update. Arvind Sood, EVP, US Operations, will wrap and close. We also have Frederic Lombard on the call for Q&A. Are they? I now hand the call over to you.
Henry Wheeler: On slide three on today's call, we'll be joined by Brian Interim Chief Executive Officer, then we have Sonya currency note, our chief Medical Officer, who will cover updates on the kits map and IP, aged 65, or one who will then hand the call to gannett's morale Chief operating officer, who will then discuss our <unk>.
Henry Wheeler: And ADC platform updates Arvind Sood EVP U S operations will wrap in place. We also have Frederik lunde bottle Nicole for Q&A.
Brian: I'll now hand, the call over to you.
Herv Brailly: Turning to slide 4, I'd like to remind you of our strategy. Our ambition is to develop innovative drug candidates that contribute to transform cancer care through a strong pipeline of differentiated antibody-derived drug candidates. We look to derive value from our early R&D efforts through later-stage partnerships where and when it makes sense to do so. Our business model is centered around three key priorities.
Henry Wheeler: Thank you Henry.
Henry Wheeler: Turning to slide four.
Henry Wheeler: To remind you of our strategy.
Henry Wheeler: Our ambition is to develop innovative drug candidates that contribute to transform concept.
Henry Wheeler: So a strong pipeline of differentiated antibody on the ultra but did you write drug candidates.
Henry Wheeler: We look to drive value for.
Henry Wheeler: Early R&D efforts through later stage partnerships, where and when it makes sense to do so.
Henry Wheeler: All business model is centered around three key priorities. Firstly, we'll look to create near term value driven by our lead proprietary product candidate <unk>.
Herv Brailly: Firstly, we look to create near-term value driven by our lead proprietary product candidate, LaCutaMav, which as you know is in development for T-cell lymphoma, and with top-line data from MF that are coming at ASCO DCIA. As a reminder, our focus remains to leverage the value of our products as much as possible, which will further validate our science and offer capital that we can reinvest to advance our proprietary With the latest data in hand, we will assess the best path forward to maximize the potential of this asset, LaCutaMav.
Henry Wheeler: Which as you know is in development for T cell lymphoma, and with top line data.
Henry Wheeler: That are coming at the ESMO Asia as a reminder, our focus remains to leverage the value of our products as much as possible, which will further value data science, although for capsule that we can reinvest to advance.
Henry Wheeler: Terry products and R&D in June with.
Henry Wheeler: With the latest data in hand.
Henry Wheeler: Assess the best path forward to maximize the potential of <unk>.
Henry Wheeler: This asset.
Herv Brailly: Second, we continue to fuel our pipeline and create longer-term value by leveraging our antibody engineering capabilities and our expertise in biology to develop innovative molecules with a primary focus on our multi-specific NK-Cell Engager. That's the platform called NK-Cell.
Henry Wheeler: So then we continue to fuel our pipeline and create longer term value by leveraging our antibody engineering capabilities on though.
Henry Wheeler: Our expertise in biology to develop innovative molecules with a primary focus on the specific NK cell engagement. That's the platform called <unk>. We are pleased to see continuous progress with our partner Sanofi presenting various updates for the lead candidate.
Herv Brailly: We are pleased to see continuous progress with our partner Stanofi presenting various updates for the lead ONCAT candidate, which has recently been transitioned from Phase 1 to Phase 2. We are also pleased to see our lead proprietary ONCAT IPH6501 starting the Phase 1 trial. As we develop antibody targets for our ONCAT platform, we recognize some of these targets might be more applicable for ADC technology, and we have further details in our ADC pipeline today presented by Yannis.
Henry Wheeler: Which has recently been transition to from phase one to phase two we also pleased to see our lead proprietary market IPA 65 away starting in phase one trials as we develop antibody targets will get vessel, we recognize some of these targets might be.
Henry Wheeler: More applicable for ADC technology, and we have a further details.
Henry Wheeler: Pipeline to date presented by these.
Henry Wheeler: Finally, while building a strong and sustainable foundation for our business with.
Herv Brailly: Finally, we are building a strong and sustainable foundation for our business with various partnerships across industry and academia. Obviously, our AstraZeneca partnership is of utmost importance with Monalizumab continuing development in lung cancer. Slide 6 illustrates the variety of approaches that we have. I will now move to slide 6 on the portfolio, sorry.
Henry Wheeler: Various partnerships across industry and academia on obviously your I suppose any cup off the ship is of utmost importance with Linda lithium that continuing development in lung cancer next slide.
Henry Wheeler: The slide six illustrates the various geos approaches that we have I will not I will now move to slide six to the portfolio sorry on slide six is a summary of our pipeline, which shows how we continue to translate the science into a robust portfolio of proprietary and partnered assets.
Herv Brailly: Slide six is a summary of our pipeline, which shows how we continue to translate our science into a robust portfolio of proprietary and partner data. It also illustrates how we are executing against our strategy with our lead proprietary assets like Lactamab and Onket and with the emerging assets ADCs supported by partner products with AstraZeneca, Sanofi, and Takeda from late to early stages, who anticipate a series of potential clinical data readouts 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
Henry Wheeler: Also illustrates how we are executing against our strategy with our lead proprietary asset <unk> wont get in with the emerging.
Henry Wheeler: Asset to ADC supported by bumped up products with Astrazeneca, Sanofi and take it out from late two early stage roughly.
Henry Wheeler: We anticipate a series of potential clinical data readouts and catalysts in the upcoming couple of years as our R&D engine looks to leverage our scientific knowhow to create a sustainable business.
Herv Brailly: In ASCO, we will have, in ASCO 2024, an important abstract being published. This summarises the top-line data from the Laputamab-Telumac trial in Mycosis fungoides. IPH 65-01 will be published with two posters, one in trial-in-progress on a preclinical assessment of IPH 65-01, and eventually two monality map posters with updated Phase II course results in Stage III unrespectable in SLC on the Phase II in an extensive stage SCLC trial. I would now like to pass the call over to Sonia, who will review the progress made with the portfolio, starting with Lepidomab and the most advanced proprietary effects.
Henry Wheeler: Let's move to slide <unk>.
Henry Wheeler: <unk> will have a nice 2024.
Henry Wheeler: An important important abstracts.
Henry Wheeler: Being published.
Henry Wheeler: Comprise.
Henry Wheeler: The topline data from the Lucky to have Matt Taylor Mac.
Henry Wheeler: Trial in <unk> disease from Bouygues.
IPA 60, 501 will be published with two doses one then.
Henry Wheeler: And progress on a preclinical.
Henry Wheeler: Assessment of $5 65.
Henry Wheeler: Eventually to modality map clusters with updated phase II <unk> results in stage, III Unresectable and SFC on the phase II in extensive stage SCLC trial, I would like now to pass the call over to Sonya.
Sonya: Review, the progress made with our portfolio starting with <unk>, our most advanced proprietary asset.
Sonia Quaratino: On slide seven, let me summarize the progress we are making with Lacutamab. Lacutamab has been developed in cutaneous T-cell lymphoma as the target Kir3DL2 is expressed in more than 90% of patients affected by Cesare's syndrome and approximately in 50% of patients with mycosis fungoides. The TELOMAC trial is a phase two single-arm study including both cesarean and mycosis fungoides. And last year, we presented the top line result for cesarean syndrome at ASH.
Sonya: Thank you.
Sonya: Like Kevin Let me summarize the progress, we're making with liquid amount I put them on that has been developed in cutaneous T cell lymphoma is the target Q3 deal too.
Sonya: In more than 90% of patients affected by <unk> <unk> syndrome, and approximately 50% of patients with me causes from going to the.
Sonya: Hello, Mike trial is a phase two single arm study, including both salary and make us a stronger and last year, we presented the topline results in <unk> syndrome at Ash.
Sonia Quaratino: We have now analyzed the top line results of the mitosis fungoides cohort, where we have seen encouraging preliminary data in patients with KIR3DL2 expression levels above and below 1%. The top line results in mycosis fongoides were accepted for a poster presentation at the ASCO annual meeting.
Sonya: We have now annualized the topline results of the meat of this from Lloyd cohort, while we have seen encouraging preliminary data in patients with <unk> <unk>, two expression level above and below 1%.
Sonya: Top line results in ecosystem behind US were accepted for a poster presentation of the optical annual meeting and we look forward to share the data with you then.
Sonia Quaratino: And we look forward to sharing the data with you then. We are pursuing a fast-to-market strategy for Lakutamab in Caesarean syndrome, where it was granted the U.S. Fast-Track designation and EU Prime designation in 2020. And we look forward to discussing the data with the FDA to define the next step. In PTCL, we continue to enroll patients in a phase two combination trial with chemotherapy, GEMOX, where we believe the combination will offer additional benefits to patients.
Sonya: We are pursuing a fast to market strategy for like with I Mab in says that he syndrome, where la <unk>, but was granted us fast track designation and EU Prime designation in 2020.
Sonya: And we look forward to discuss the data with the FDA to define the next steps.
Sonya: In <unk>, we continue to enroll patients in phase II combination trial with chemotherapy Jam.
Sonya: We believe the combination will offer additional benefits to patients.
Sonia Quaratino: On slide 9, we now switch gears to our most advanced proprietary asset, IPH65, the tetraspecific antibody-based anti-engager therapeutic, or ANKET, molecule, which is the first anti-engager to engage by a single molecule, two activating receptors, NKP46 and CD16, a tumor antigen, in this case, CD20, and an interleukin-2 receptor via an IL-2 variant IPH 65 is the first of the second generation ANCET vaccines targeting CD20.
Sonya: On slide nine we now switch to our most advanced proprietary asset.
Sonya: 65.
Sonya: Specific antibody based <unk> engage our therapeutic or uncapped molecule, which is the first anti engage us to engage via single molecule to activating receptor and KC 46, and CD 16, a tumor antigen in this case in 'twenty.
Sonya: And then interleukin two receptor via an IL 12, Orient or IL two.
Sonya: IL two <unk> is aimed to induce activation and proliferation of NK cells in the tumor microenvironment.
Sonya: IP age 65 is the first of the second generation <unk> targeting <unk>.
Sonia Quaratino: We were pleased to announce earlier in the quarter that IPH 65 has entered the clinic. And the first in humans has started with the first patient, those in the March trial with enrolled patients with relapsed refractory B-cell non-ortical lymphoma, and the study will run in the US, Australia, and France.
Sonya: We're pleased to announce earlier in the quarter that IP age 65 and to the clinic.
Sonya: And the first in human as highlighted with the first patient dose in March.
Sonya: The trial will enroll.
Sonya: All patients with relapsed refractory b cell.
Sonya: Non hodgkin lymphoma, and the study will run in the U S, Australia and France.
Sonia Quaratino: IPH 65 eliminates CD20 positive cancer cells via profound activation and proliferation of the NK cells. And by stimulating NK cells' natural function by the variant IL-2, IPH-65 evokes a bystander effect, affect, and can also cause the elimination of CD20-negative tumor cells, overcoming tumor heterogeneity or loss of tumor amplitude. The IPH format also addressed the common challenge associated with loss of CD16 by ensuring activation of intratumoral NK cells by the engagement of NKAP46.
Sonya: <unk> hundred 65, eliminate CD 20 positive cancer cells via profound activation and proliferation of NK cells.
Sonya: In my tenure lighting NK cells natural function by a desire to IL two.
Sonya: At the age 65 evokes a bystander effect effect and can also cause the elimination of CD 20 negative tumor cells, overcoming tumor heterogeneity or lots of tumor antigen.
Sonya: H format to also address the common challenge associated with lots of CD 16 by ensuring activation of intra tumoral NK cells by the engagement of NK B 46.
Sonia Quaratino: The asset also differs from allogeneic NKI cell therapy, including CAR-NKI, as it is an off-the-shelf therapy that drives the proliferation of the patient's own NKI cells in B-cell non-Hodgkin lymphoma and does not require lymphodepletion as for cell therapy. IPH 65 is going to be presented at the ASCO annual meeting with two posters, one as a trial-in I will now hand over to Yannis to cover the early pipeline.
Sonya: The assets also differed from Allergan, a car NK cell therapy, including car NK as it is an off the shelf therapy that drives the proliferation of the patient on NK cells in B cell non hodgkin lymphoma, and does not require lean for depletion for cell therapy.
Sonya: Ivy age 65 is going to be present.
Sonya: Ethical annual meeting with to bolster one trial in progress and the other outlining the preclinical disrupted making these gulf auction.
Sonya: I will now hand over to Janice to cover the early pipeline.
Thank you Sonya.
Yannis Morel: On slide 10, I wanted to draw your attention to our portfolio of on-cadre candidates, which has made significant progress during the last quarter. As you recall, NCCAT molecules are produced through our proprietary First-in-Class and Kessel Engager classes. It is a multi-specific plug-and-play technology made of antibody-derived breathing blocks aiming at engaging NK cells towards tumor cells by triggering the most stable activating NK cell surface receptor called NKP14. The interesting feature of this platform is that by swapping the tumor-binding portion of the ANKET molecule, it can produce multiple drug candidates addressing a variety of targets in oncology, but it can also potentially harness NK Last quarter, TANOTI advanced SAR579 to Phase II on the back of initial efficacy data showing single-agent activity with durable complete responses in relapsed refractory IML patients. We are looking forward to seeing further updates from Sanofi.
Janice: On slide 10, I wanted to draw your attention to our portfolio of <unk> candidates, which has made significant progress during the last quarter.
As you remember and gas molecules are produced through our hopefully it'll be first in class and gets elongated a festival.
Janice: This is a multi specialty plug and play technology made of antibody device reading apps aiming at engaging NK cells towards two methods.
Janice: In the most stable activating NK cells.
Janice: God and KC 46.
Janice: The interesting feature of this platform is that by sweating. The Gmail binding portion of the youngest molecule. It can produce multiple drug candidates, although we've seen a variety of targets in oncology, but also it can potentially on this NK cells to kill pathogens sales, although he's already like autoimmunity inflammation.
Janice: <unk>.
Janice: Last quarter <unk>.
Janice: Key advance <unk> 579, two phase II on the back of insured education. These are showing single agent activity with Julie bolt complete responses in the relapsed refractory AML patients.
Janice: Looking forward to seeing several updates by incentives.
Yannis Morel: Also, as just mentioned by Sonia, we are very pleased to see our proprietary second generation Anket IPF6501 entering the clinic with a first patient dose in March. Next month, two ATF 6501 posters will be presented at ASCO, one on the Phase 1-2 trial design and the other one on the 65-01 technical characterization. Last but not least, we are making a lot of effort to further extend this portfolio to additional tumor targets, including in solitude.
Janice: Also as just mentioned by soon yes, we are very pleased to see our appropriately second generation okay.
Janice: If I go one entering the clinic with our first patient dose in March next month's two ATI 501 pushback.
Janice: What will be presented at ash.
Janice: One on the phase one two trial design and the other one on the 60 501 clinical characterization.
But.
Janice: We are pushing a lot of it falls to further extend this portfolio traditional tumor targets, including in solid tumors.
Yannis Morel: Slide 11 highlights 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 and therefore more suited to antibody drug conjugate development than for oncogenes. Our agreement with Takeda in the field provides validation for this approach and highlights our capability to generate differentiated ADTs.
Janice: Slide 11 highlights our growing portfolio of ADC candidates.
Janice: As we continue to develop next generation antibody therapeutics, we found that saw some tumor targets, we can generate antibodies with good internalizing product.
Janice: And therefore more cities for antibody drug conjugate development.
Janice: When it gets.
Janice: I think he meant we started out in the field provides a validation to this approach and highlights our capability to generate differentiated ADC.
Yannis Morel: Now, I will cover updates on our Lead Proprietary ADC Program, IPH45, which is targeting Nexin 4 and which was presented at an oral session at AACR in San Diego last week. Slide 12 highlights IPH45's overall punch. First, it is composed of a proprietary antibody with a differentiated epitope, which is non-overlapping with N-fortumab, the parenteral antibody of PAD. Then, we selected a validated cleavable and hydrophilic linker that counterbalanced the hydrophobicity of the payload and allowed the use of a high drug-antibody ratio of 8.
Janice: Now I will cover updates on that well hopefully, Italy ADC program, <unk> 45, which is targeting Nixon for and which has been presented at an oral session at ACR in San Diego last month.
Janice: Slide 12 highlights Ips 40 sites overall culture.
Janice: It is composed of a popular antibody with a differentiated AAV, which is non overlapping with and talking about the <unk> antibody.
Janice: We selected a validated keyboard and looking at kimco.
Janice: Our balance and also the city of the payload and Hello.
Janice: The use of the high <unk> with the ratio of <unk> eight.
Yannis Morel: Finally, we selected Exatican, a topoisomerase I inhibitor with a strong bystander effect, allowing to bypass MMI-related resistance mechanisms and address tumors with low to heterogeneous Nectin-4 expression. All together, these elements create a novel and differentiated ADC to target Nectin-4 in a broad panel of tumor indications on top of bladder cancer by overcoming the challenges associated with Nectin Slide 13 is a summary of some of the data presented at AACR.
Janice: Finally, we selected exactly Ken the <unk> inhibitor with strong bystander effect, allowing to bypass MMA related resistance against them and address two modes with slow to adopt it.
Janice: Origin is making for expression.
Janice: Altogether these elements create a novel and differentiated ADC target net inflow in the broad panel of tumor indication on top of bladder cancer.
Janice: Overcoming the challenges associated with making sure it maybe ADC, including and functionality.
Janice: Thanks.
Janice: Slide 13 is a summary.
Janice: Some of the data presented at ACR.
Yannis Morel: In a nutshell, we showed that IPH45 has strong anti-tumor efficacy in a variety of preclinical models, including ones that are refractory to PADCEB because of high expression of the MDR-1 air flux transporter, a known mechanism of resistance to MMAE. Also, we found very good efficacy in patient-derived PDX models with low expression of NECTINFO, as shown on the graph This data provides a rationale to target, in addition to bladder, tumor types with medium to low expression or heterogeneous expression of nectin forms, like breast, lung, prostate, head and neck, and pancreas, where efficacy reported with PAD-CEV is so far limited.
Janice: In a nutshell, we showed that IPX fortified as tongue antitumor efficacy in a variety of preclinical models, including ones that topic factor into <unk> <unk>.
Because of high expression of the Mds, one FX on spot, though no one Mackenzie demo for instance to Amy.
Janice: Also we saw very good efficacy in patients.
Janice: Next Monday with low expression of victims.
Janice: As shown on the graph in the center of the slide with that said does that work either.
Janice: These data provide the arsenal to targets. In addition to bladder tumor type with mid <unk> to low exploration well at <unk>.
Janice: During this expression of nicotine salt life.
Speaker Change: Postpaid and then Nick and Fantastic if you can.
Speaker Change: You reported respectively is so far limited.
Yannis Morel: With a favorable developability profile, including high yield productivity, drug stability, and encouraging PK-tox data in animal studies, we are looking forward to filing the IND this year. On slide 14, I would like to remind you of Monalizumab, the anti-NKG2A antibody that we have licensed to AstraZeneca for oncology. On this slide, you can see an overview of the late-stage development of monalizumab in lung cancer. Based on the Phase II CAUSE data, AstraZeneca started on May 22, Pacific 9, a Phase III trial evaluating the addition of either monalizumab or olecumab to durvalumab in unreflectable Stage III non-small cellulite lung cancer patients who have not progressed after concurrent
Speaker Change: With the fact that I bought the profitability profile, including high yield productivity.
Speaker Change: Stability and <unk> PK Tox data in animal studies.
Speaker Change: Looking forward to filing.
Speaker Change: This year.
Yannis Morel: The AZ-sponsored MioCost-2 Phase 2 study is also underway in an earlier lung cancer setting, namely in Stage 2a to 3b non-small cell lung cancer patients, and is evaluating the addition of monalizumab to durvalumab and chemo in the perioperative agent-like setting. As mentioned by Hervé at the beginning, Mona Lisa UMAB will have two poster presentations at ASHCorp, one being an update of the cost results, and the other one being a presentation of the investigator-sponsored Mozart trial in the first-line treatment of extensive stage small cell lung cancer. I will now hand it over to Arvind.
Speaker Change: On slide 14, I would like to remind you of Malaysia Mab.
And getting to that we have licensed to astrazeneca for oncology.
Speaker Change: On this slide you can see another view of the late stage development of when they're using that in lung cancer.
Speaker Change: Based on the phase II data as doesn't make US started in May 'twenty two specific nine a phase III trial evaluating the addition of the element that is market related.
Speaker Change: Matt to Joe very Matt in analytics devoted stage III non small cell lung cancer patients, who have not progressed as a concurrent chemo radiation therapy.
Speaker Change: The AZ sponsor Niarchos two phase II study is also underway in an earlier, our lung cancer setting, namely in stage, two 8% to <unk> non small cell lung cancer patients and is evaluating the addition of Malaysia mapped to Joe. Thank you, Matt and chemo in the video about agent light fittings.
As mentioned by every at the beginning when they need you Matt will have two poster presentations at ash.
Speaker Change: One being an update of the cost figures and the other one the presentation of the investigator of stem cell Mozart hired in the first line treatment of extensive stage small cell lung cancer.
Speaker Change: I will note Andover to Albion.
Arvind Sood: Yannis, thank you. So, just a few comments as we close out our prepared comments. Let me just highlight a few of the milestones that are expected over the next couple of years. We expect to achieve a number of milestones over the next two years for both our proprietary and partnered assets. Just a few weeks ago, we presented preclinical data on IPH45 that Yannis alluded to earlier, which, of course, is our nectar for targeting ADC at the recently held AACR.
Speaker Change: Yes. Thank you so just a few comments.
Andover: We close out our prepared comments.
Albion: Let me just highlight a few of the milestones that are expected over the next couple of years, we expect to achieve a number of milestones over the next two years for both our proprietary and partnered assets just a few weeks ago, we presented preclinical data on IP, It's 45 debt beyond as alluded to earlier.
Albion: Which of course is our <unk> targeting ADC at the recently held AAC arm.
Arvind Sood: We also expect the upcoming ASCO to be a busy one for us, as we expect to present the final data from the TELEMEC trial with our proprietary product, Lecutamab, in MF or mycosis fungoides. This, combined with data on SESRI syndrome that Sonia alluded to, that has been previously communicated, will form the basis of our interactions with regulatory bodies as we map out next steps. We are also making very good progress with our ANCAT platform, and we will present some data at the upcoming ASCO conference.
Albion: We also expect the upcoming ask her to be a busy one for us as we expect to present the final data from the telematic trial with a proprietary product <unk> and MF four mic closest <unk>.
Albion: This combined with data and sensory syndrome. That's the one you alluded to and that has been previously communicated both formed the basis of our interactions with regulatory bodies as we map out next steps. We're also making very good progress with our anchored platform, but some data coming at the upcoming <unk> conference two abstracts on IP.
Arvind Sood: Two abstracts on IPH-65, our second generation ANCAT targeting CD20 for the treatment of relapsed refractory NHL or non-Hodgkin's lymphoma. Two abstracts will also be presented by our partner, AstraZeneca, and Molilizumab, phase two clinical trials for the treatment of lung cancer. If we can, then we can move to the last slide.
Albion: 65, our second generation and kept targeting CD 20 for the treatment of relapsed refractory NHL or non Hodgkin's lymphoma. Two abstracts will also be presented by our partner Astrazeneca on moly Lindsay Mab.
Albion: Phase two clinical trials for the treatment of lung cancer.
Albion: If we can then move to the last slide So let me just conclude with the key a few key takeaways will continue to leverage our expertise in immuno pharmacology and I hope it <unk> that we have just provided the upcoming catalyst with <unk> and the anchor platform. It provides a strong affirmation or.
Arvind Sood: So let me just conclude with a few key takeaways. We'll continue to leverage our expertise in immunopharmacology. And I hope the examples that we have just provided of upcoming catalysts with Lecutumab and the Ankit platform provide a strong affirmation. Our pursuit of ADCs is based on developing differentiated, potentially best-in-class assets, and I hope the presentation of our data with IPH 45 at AACR provides added clarity on our efforts there.
Albion: Pursuit of Abc's is based on developing differentiated potentially best in class assets and I hope the presentation of our data with IP. It's 45 at ACR provide added clarity on our efforts there.
Arvind Sood: Lastly, with about 115 million euros in cash on our balance sheet as of the end of March 2024, we are in a strong cash position for operations through the end of 2025. So, with that, let me turn the call over to you, back to you, and then we can open it up for questions.
Albion: Lastly, with about 115 million yours in cash on our balance sheet as of the end of March of 2024, we are in a strong cash position.
Albion: Operations at the end of 2025, so with that I turn the call over to you back to you and then we can open it up for questions.
Operator: Yeah, thank you. We'll go straight to questions. Please operate that.
Speaker Change: Yes, Thank you well go straight to questions. Please operator.
Operator: Thank you. We will now begin the question and answer session. If you would like to ask a question, press star 1 on your telephone to raise your hand and join the queue. If you would like to withdraw your question, again, press star 1. Your first question comes from the line of Daina Graybosch from Leering Partners. Your line is open. Hi.
Speaker Change: Thank you we will now begin the question and answer session. If you'd like to ask a question press star one on your telephone to raise your hand and joined the queue. If you would like to withdraw your question again press Star one.
Speaker Change: Your first question comes from the line of Dana <unk> from Leerink Partners. Your line is open.
Daina Graybosch: Hi, thank you for the questions and the update. The first on the MS data in the tele-mech study, if I remember correctly, part of doing that arm was to define a potential biomarker threshold by going broad and more narrow and tier 2 DL3 expression. I wonder if you could talk about if that's still the intent and how you're going to go about picking a potential threshold for a biomarker going forward. And then the second question is about IPH6501. I wonder if you have thought about potentially taking this engagement forward in autoimmune diseases in addition to oncology. Thank you.
Dana: Hi, Thank you for the question and the update the first of all on the MLS data and the Telemark study.
Remember correctly part of doing that are in west as you sign a potential biomarker threshold going broad and more.
Speaker Change: Our narrow and.
Dana: <unk> a question for you.
Dana: Could talk about if that's still the intent and how youre going to is all about taking a potential threshold.
For a biomarker going forward and then the second question is on <unk>.
Dana: One I wonder if you've thought about potentially taking this engage our forward in autoimmune diseases. All of this is oncology.
Dana: Yeah.
Unknown Executive: Thank you, Daina. These are both great questions.
Speaker Change: Thank you Diana.
Speaker Change: Both great questions.
Unknown Executive: Let's start with lacutama. Since the expression level of KIR3DL2 in mycosis fungoide is relatively modest compared to cesarean, and it is also expressed in roughly 50% of patients, we have made three different cohorts in telomax trials for mycosis fungoides, where we prospectively screen patients for the expression of KIR3DL2, and we have a cohort of patients who express more than 1%, And we have been working alongside the trial on a companion diagnostic.
Speaker Change: <unk> talked with <unk>.
Speaker Change: So the expression level.
Q3, VL two in may cause it to go into it.
Speaker Change: Relatively modest compared to surgery and it is also expressed.
Speaker Change: In roughly 50% of patients. So we have made three different cohorts in parallel.
Speaker Change: Oh sure the ecosystem the latest well we.
Speaker Change: Prospectively screening patient, Florida expression of the.
Speaker Change: Q3, two and we had a cohort of patient expressing more than 1% less than 1% and all commerce.
Speaker Change: And we have been working.
Speaker Change: Long side, the Tri alone a companion diagnostic.
Unknown Executive: But at the ASCO annual meeting, you will see the results for Tier 3 positive tumors more than 1% or Tier 3 less than 1%, and there will be interesting data in both subsets. Now, for IPH 65. I will hand over to Yannis on this question because this is something that is very key to the business of Innate.
Speaker Change: At the <unk> annual meeting you will see the results in both tier three.
Speaker Change: Sure.
Speaker Change: Positive tumors more than 1% or.
Speaker Change: Q3 less than 1%.
Speaker Change: And that will be interesting data in both.
Speaker Change: Seth.
Speaker Change: Now for the <unk> 65.
Speaker Change: I will now hand over to Janice.
Janice: On this question because this is something that is.
Janice: Very key to the business solve and Nate.
Yannis Morel: Yeah, hi Daina. Yeah, of course, it's something that we are following. As you know, there have been several attempts to use C-Cell Engager and CAR-NK to deplete pathogenic B-cells. It's something that we could potentially contemplate at some point with IPH-6501, but for the moment, it's a bit early. Like Sonia mentioned, we just started the dose escalation. We really need to first establish the safety and the dose and really characterize the pharmacodynamic effect of the drug in B-cell depletion before considering expansion to other therapeutic areas. But in theory, it's something that we could contemplate in the mid to long term. Yeah, if I can compliment you.
Janice: Yes, Hi, Dana.
Janice: Yes of course, it's something that we are following.
Janice: As you know there have been several attempts to us.
Janice: Use.
T cell engaging <unk>, but also car NK to DP photogenic.
<unk>.
Janice: That we could potentially contemplate at some boats.
65, <unk> for the moment, it's a bit early.
Janice: So as I mentioned, we just started the dose escalation, we really needs to first establish the safety.
Janice: And the dose.
Janice: And to really characterize the pharmacodynamic effect of the drug in the B cell depletion and before considering.
Janice: Pension to other therapeutic areas, but in theory, it's something that we could contemplate on the mix rockdale.
Unknown Executive: Yeah, if I can add here, we do believe that with the ONCAT platform, we have an interesting tool to address alternative therapeutic fields beyond tumor immunology and tumor treatment, thanks to the very good safety profile that we see with ONCAT 3, and that we're going to document with ONCAT 4, and with the reported efficacy data that we have in various preclinical models. So it's a bit early to anticipate there or make any strong statement on the future direction, but we strongly believe that we have a platform of very high value to address a number of pathological conditions beyond.
Janice: Yes.
Speaker Change: If I can complement here.
We do believe that with the <unk> platform, we have an interesting tool to address alternative.
Speaker Change: But the field beyond.
Speaker Change: Tumor.
Speaker Change: Immunology tumor treatment.
Speaker Change: Thanks to the very good safety profile that we see we don't get three on that we're going to document we don't get four onwards, the reported efficacy data that we have in various preclinical models. So it's a bit early to anticipate they'll make a strong statement on the future direction, but we strongly believe that we have.
Speaker Change: Form a very high value.
Speaker Change: To address a number of pathological conditions beyond comes down.
Speaker Change: Great. Thanks.
Operator: Thank you. Our next question comes from the line of Yigal Nochomovitz from Citigroup.
Speaker Change: Our next question comes from the line of Yigal <unk> from Citigroup.
Yigal: Your line is open.
Yigal Nochomovitz: Hi, thanks. So with the MS data at ASCO, can you just talk about what we expect to discuss there and how that will impact the filing strategy? Is it pretty much consistent with what you've already outlined? You're going to be speaking with the FDA. Well, based on that data that you've recently seen, are you going to make any changes to the way you're thinking about crafting a label for the drug? And then what are the timelines associated with the discussions with the FDA as well as the likely timelines for filing the application?
Yigal: Hi, Thanks, so with CMS data at Ash, So could you just talk about.
Yigal: That's fair.
Yigal: How will that impact the filing strategy is it pretty much consistent with what you've already outlined.
Yigal: With the FCA.
Yigal: Based on that data.
Yigal: Are you going to.
Yigal: On this one just to the way you're thinking about.
Yigal: Crafting a label for the drug and then what what are the timelines associated with the discussions with the FDA as well as licensed timelines for filing the application.
Unknown Executive: I think I can take the question. I'm very sorry if I'm missing something from your question because the line was not ideal, and correct me if I'm wrong.
Speaker Change: I think I can tell you the question I'm very sorry.
Speaker Change: If I'm missing something from your question because the line was.
Speaker Change: Uh huh.
Speaker Change: Not ideal and correct me if I'm wrong.
Unknown Executive: You're asking around; your question is around the regulatory path forward for LACUTAMAP after the presentation of the MS data at ASCO. And our aim here is to ensure that LACUTAMAP gets to patients who need this drug as quickly as possible. And our aim is really to maximize the value of the drug, not only in cesarean but also in the larger population of mycosis fungoides, so capturing the whole CTCL space. And after the data are presented at ASCO, our priority is really to progress the regulatory strategy with the FDA. Please let me know if I missed some point.
Speaker Change: And you were asking around on your question is around the regulatory path forward for a good amount of I'll start the presentation of the <unk>.
Speaker Change: Less data at Ash and.
Speaker Change: Our aim aim here is to ensure that like what amount, but gets to patients who need this drug as quickly as possible and our aim is really to maximize the value of the drug not only <unk>, but also in the larger population of me cause it's from Lloyd.
Speaker Change: Central.
Lloyd: Capturing the Bel CPC AD space and.
Lloyd: After the data will be presented that to ask call, where our priority is really to progress our regulatory strategy with the FDA.
Speaker Change: Please let me know.
Lloyd: If I missed pointed question.
Unknown Executive: The goal would be to file with the FDA; there wouldn't be any other study. That would be the registrational study.
Speaker Change: The goal would be to file the file with the FDA there wouldn't be any other studies.
FDA: That would be the Registrational study.
FDA: Yeah.
Unknown Executive: Well, it is now mandatory to have a registrational trial. Also, Mogabulism has opened the field by having a randomized controlled study in CTCL. And this is very likely what the regulators, and in particular the FDA, expect from us. But we will discuss with the agency different options.
Speaker Change: Well it does say it is.
Speaker Change: Now mandatory to have a renewed energy.
Speaker Change: <unk> trial.
Speaker Change: No I believe the number is open.
Speaker Change: The field by having a randomized controlled study in <unk> and this is very likely what the regulators in particular, the SBA expect from us, but we will discuss with.
SBA: The agency different options.
Unknown Executive: Okay, and then regarding the health of the financial situation, you have runways until the end of 2025. Are there milestones from Sanofi or AstraZeneca that you're expecting between now and the end of 2025 that would send the cash?
Speaker Change: Okay, and then regarding the.
Speaker Change: Hello.
Speaker Change: Financial situations you have runway until the end of 2025.
Speaker Change: Are there milestones from Sanofi or.
Speaker Change: Yes.
Sanofi: We are expecting if we know any more into 2025.
Sanofi: Okay.
Sanofi: Yes.
Unknown Executive: The cash position and the projection of cash until the end of 2025 do not include and do not take into account any potential milestones from existing agreements nor potential other new agreements.
Sanofi: The cash position and projection of cash until the end of 'twenty.
Speaker Change: Does not include and does not take into account any potential milestones.
Speaker Change: Existing agreements no potential new adjuvant.
Operator: Okay, thank you.
Speaker Change: Okay. Thank you.
Swayampakula Ramakanth: Your next question comes from the line of Swayampakula Ramakanth from HCW. Your line is open. Thank you.
Speaker Change: Your next question comes from the line of swam Pakula Ram <unk> from H C. W. Your line is open.
Speaker Change: Thank you.
Yannis Morel: So my question is about the collaborations that have been going on with Sanofi on some of your earlier-stage molecules. I want to see what commentary you have on that. And then, in terms of monolizumab, what do you think your partner is planning to do once after the data presentation at ASCO?
Speaker Change: So.
Speaker Change: My question is on the collaboration that's been going on with Tennessee.
Speaker Change: On some of your earlier stage molecules I wanted to see what commentary you have on that and then in terms of our model isn't lab.
Speaker Change: Hum.
Speaker Change: Sure.
Tennessee: Where do you think your partner is planning to do ones that.
Speaker Change: After the data presentation at <unk>.
Speaker Change: Yes.
Yannis Morel: Yeah, so, hi RK, Yannis speaking. Not sure to understand your point on the Sanofi collaboration. Just to remind you that we have two; Sanofi is currently developing two ONCAT molecules, which are the trispecific ones, the third generation in the clinic, in HIM, with the CD123 that was presented last year at ASCO and ASH, and the BCMA, which entered the clinic also last year. And we are really looking forward to potentially seeing updates on these two programs this year. With regard to the early stage ones, as you know, both of them are in solid tumors. One is targeting B7H3, and the other one is targeting another undisclosed solid tumor.
Speaker Change: Yes, so hi.
Hi, Nisha speaking not sure to get your point on the Sanofi collaboration.
Nisha: Just to remind you that we are having to Sanofi as theyre looking currently.
Nisha: Ill get molecule with chop the tight strategic ones the third generation in the Clinique in him with a PD one therapy that has been presented last year at school.
Nisha: <unk>.
Speaker Change: And the <unk>, which has entered the Clinique also last year.
Sanofi: And we are really looking forward to potential updates on these two programs.
Speaker Change: Joe.
Speaker Change: Regarding the early stage was.
Joe: Both of them are in solid tumors.
Joe: One is disadvantaged targeting b cell NHL and the other ones targeting another undisclosed thirty-twomo.
Yannis Morel: We are progressing them at the preclinical stage, but we can unfortunately not comment on the timing when this molecule will reach the clinic. What I can say is that our collaboration with Sanofi is very active. You may have also seen during the last month that Sanofi has also refocused its oncology pipeline, and clearly, the NKCEL engagers that we are having with them are on the priority list for their oncology pipeline. Yes, so... Yeah, and then on MONA, as you can see by the title, and fortunately, we cannot disclose more for the moment. The COST presentation at ASCO will be a poster with updated results from the COST.
Joe: Operating them.
Speaker Change: Equal stage, but we can unfortunately not to comment on the timing of when these 42 realizations.
Speaker Change: But.
Speaker Change: What I can say that the collaboration with Sanofi is very active you may have seen also.
Sanofi: During the last months that.
Sanofi: So the focus is oncology pipeline and clearly India NK cell engaging <unk>, that's where I think with them on the priority list on their on the oncology pipeline.
Sanofi: Yes.
Sanofi: Yes, and then on the Mona.
Sanofi: As you can see by the titer and unfortunately, we cannot disclose more for the moment.
Mona Lisa: The cost presentation at <unk> will be a poster with updated results from the coast Joe It has been.
Yannis Morel: You know, it was published in GCO and presented at ESMO a couple of years ago, and now it's longer-term and updated data, but we cannot comment on what ASI will do after this data disclosure, but so far, the Pacific Nine trial is ongoing, and that's the only thing that we can say.
Speaker Change: Published in GTO and presented at ESMO couple years ago and now.
GTO: It's a more.
Joe It: non-GAAP them and updated data.
Speaker Change: We can note.
GTO: Comment on on what.
Speaker Change: We do have service that that disclosure, but so far the.
Speaker Change: Pacific not entirely is ongoing.
Speaker Change: And that's the only thing that we can say.
Operator: Thank you. Thanks for taking my question.
Speaker Change: Thank you thanks for taking my question.
Speaker Change: Again, if you would like to ask a question press star one on your telephone keypad.
Operator: Again, if you would like to ask a question, press star 1 on your telephone keypad. Your next question comes from Rajan Sharma from Goldman Sachs. Your line is open. Hi, thanks for taking my call.
Speaker Change: Next question comes from the line of Rishon Sharma from Goldman Sachs. Your line is open.
Rajan Sharma: Hi, thanks for taking my question. So firstly, just on IPH45, how should we think about the initial development plan now? Is it likely to be in PADSev-resistant or PADSev-experienced patients with bladder cancer?
Rishon Sharma: Hi, Thanks for taking my question. So firstly just on IP H 45, how should we think about the initial development plan that is it likely to be in pods.
Unknown Executive: And could you also just talk about your expectations longer term for the profile there? Do you think there's an opportunity to differentiate both on efficacy and on safety? And if so, on safety, how do you think that may work mechanistically? And then, just secondly, on Lecutumab and Cesare, you mentioned the potential for exploring a faster market strategy. Could you just kind of walk us through the potential passing market there, and is that predicated on MS? Thank you.
Rishon Sharma: <unk> resistant parts of experience patients in bladder cancer.
Speaker Change: Could you also just talk about your expectations longer time.
Speaker Change: For the profile of that do you think there's an opportunity.
Speaker Change: Differentiate based on efficacy and safety and zero and safety, how do you think that may work Mechanistically.
Speaker Change: And just secondly on the <unk> on <unk>.
Speaker Change: Mentioned potential exploring a fast to market strategy could you just kind of walk us through the potential.
Speaker Change: Passive market, there and is that predicated on MF. Thank you.
Unknown Executive: Rajan, thanks for the questions. Around IPH45, of course, we have some ideas based on the preclinical data on how to better position this asset. Of course, the initial trial will be a dose escalation study to assess the safety, tolerability, and signs of antitumor activity of this asset. And based on the characteristics shown in the trial, we will, of course, refine the clinical development plan for this asset. It may not only be in parts of refractory patients, but, for instance, there is a strong possibility based on the preclinical data that we recently published at AACR.
Speaker Change: Hello.
John: John Thanks for the question.
John: At around the IPA 245 of course, we have there some based on the preclinical data out to better position this asset.
John: Of course of that initial trial will be a dose escalation study tool.
John:
Speaker Change: To access the safety Tolerability and signs of antitumor activity of this asset and based on the characteristics shown in the trial, we will refine of course clinical.
Speaker Change: Clinical development plan for this type of this asset may not only be in test.
unknown: Refractory patients for a sensor that is a possibility strong of the preclinical data that we.
unknown: Recently.
Unknown Executive: Also, in all those tumors that express a low level of nectin force that at present are not captured by other Nectins for ADC, and so, of course, all this is purely speculative at the moment, and only the data will confirm it. Now regarding Lakutamab, Do you mind repeating your question?
Scott ACR: Probably Scott ACR.
Scott ACR: And also in.
Scott ACR: All of those tumors that express and low level of nicotine for that.
Adar: Spreads have not captured by Adar.
Scott ACR:
Scott ACR: Next thing for ADC and so of course all of this said purely speculative at the moment and only the data.
Scott ACR: We'll confirm.
Speaker Change: Now regarding <unk>.
ADC: The crude demand.
Speaker Change: Do you mind repeating your question.
Rajan Sharma: Yeah, sure. So I think you talked about a faster market strategy for Cesare syndrome. Could you just maybe walk us through how you're thinking about that and what the potential options could be? And then, just from a commercialization perspective, is that predicated on also getting an approval in MS?
Speaker Change: Yes, sure. So I think you talked about a fast to market strategy in salary.
Speaker Change: Yes.
Speaker Change: Would you just maybe walk us through how you're thinking about that and what the potential options could be and then just from a commercialization perspective is that predicated on also getting an approval in MF.
Unknown Executive: Right. Well, there are different options, of course.
Unknown Executive: And as I also thought previously, the option of asking for accelerated approval remains open. And as you know, we need the 12-month durability of response and a registrational trial ongoing in order to obtain accelerated approval in the niche indication of cesarean where we obtained the SBA fast-track designation. But of course, with the registrational trial, we'd also aim to bring LacutaMab on the market for the NF patients as well. And let's not forget that we remain committed to PTCL. It's still behind in terms of development, but this is also an indication that it is still ongoing. And it's very much on our radar, to your next question.
Speaker Change: Right.
Speaker Change: They're not a different option of course and <unk>.
Speaker Change: Yes.
Speaker Change: Also thought previously the option of asking for accelerated approval.
Speaker Change: It remains open.
Speaker Change: And as you know we need.
Speaker Change: 12 month durability of response and.
Speaker Change: And it used traditional trial ongoing in order to obtain accelerated approval in the niche indication.
Speaker Change: All the phase <unk>, where we obtained.
FDA: FDA fast track designation.
FDA: Of course that would that Registrational trial with also aim to.
Speaker Change: Bring them.
Speaker Change: The map on the market the Florida.
PTC al: Ah patients as well and let's not forget that we remain committed also to PTC al.
Speaker Change: Behind in terms of development, but this is also an indication that is still ongoing and is very much on our radar.
Speaker Change: Thank you.
Liisa Bayko: Your next question comes from a line from Liisa Bayko from Evercore ISI. Your line is open. Hi.
Lisa <unk>: Thank you. Our next question comes from the line of Lisa <unk> from Evercore ISI. Your line is open.
Lisa <unk>: Hi, Thanks for taking our questions Christmas stemming out from what you saw so our question is for Cuda map.
Lisa <unk>: What was the.
Lisa <unk>: Benchmark for PTC all data next year, what's your expectation for that readout. Thank you.
Unknown Executive: Hi Lisa, very interesting question. Now, PTCL, of course, is a very crowded space, cough cough Apologies. It's a very crowded space.
Lisa <unk>: Hi, Lisa very interesting question now PTC and of course, it's a very crowded space.
Lisa <unk>: Right.
Lisa <unk>: Yeah.
Speaker Change: My apology.
Lisa <unk>: It's a very crowded space.
Unknown Executive: On the other hand, it remains a largely unmet medical need for these patients, and Lakutamab has the advantage of having an extremely good safety profile, as shown in the Telomac study. compare, and that basically sets it in front of many other therapies that have a less tolerable profile. And this could also be an advantage for the patient population that has quite different comorbidities and cannot accept harsher therapy. The combination with chemotherapy, you know, should bring the efficacy, of course, to what other competitors are with other drugs in the same space. It's a balance between efficacy and tolerability.
Speaker Change: On the other hand.
Speaker Change: It remains quite unmet medical need for these patients and.
Speaker Change: Last quarter.
Speaker Change: Has the advantage of having an extremely.
Speaker Change: Good.
Speaker Change: <unk> profile.
Paloma tardy: As shown in the Paloma tardy.
Speaker Change: And that basically.
Paloma tardy: Got it in front of many other therapies that have.
Speaker Change: Less tolerable profile and this could also be an advantage for them.
Paloma: The patient population.
Speaker Change: That has quite different co morbidities.
Paloma: Cannot accept.
Speaker Change: Sure therapy, the combination with the chemotherapy.
Paloma: Sure.
Speaker Change: Bringing the secrecy of closer to.
Speaker Change: To want to other competitors.
Speaker Change #100: The other drug in the same in the same space.
Speaker Change: It's a balance between.
Speaker Change #101: <unk> and.
Speaker Change: <unk> ability.
Speaker Change: Got it thank you.
Operator: And this concludes our question and answer session and does conclude today's conference call. Thank you for your participation. You may now disconnect.
Operator: Got it. Thank you. And this concludes our question and answer session and does conclude today's conference call.
Speaker Change #102: And this concludes our question and answer session and does conclude today's conference call. Thank you for your participation you may now disconnect.
Speaker Change: Please wait the conference will begin shortly.
Speaker Change: [music].
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Operator: www.youtube.com.uk www.youtube.com.uk
Speaker Change: Okay.
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Speaker Change: [music].
Speaker Change: No.
Speaker Change: <unk>.
Speaker Change: Thanks.
Speaker Change: [music].
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Speaker Change: [music].
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