Full Year 2024 Innate Pharma SA Earnings Call
Operator: Hello and welcome to the Innate Pharma full year 2024 financial results and business update.
Hello, and welcome to the full year 2024 financial results and business update all lines have been placed on mute to prevent any background noise. After.
Operator: All lines have been placed on mute to prevent any background After the speaker's remarks, there will be a question and answer session. If you would like to ask a question, please press star 1 on your telephone.
After the Speakers' remarks, there will be a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
Henry Wheeler: I would now like to turn the conference over to Henry Wheeler, Vice President, Investor Relations and Communications. You may begin. Thank you.
I would now like to turn the conference over to Henry Wheeler, Vice President Investor Relations and Communications you may begin.
Okay.
Thank you good morning, good afternoon, and welcome everyone. This morning, <unk> issued a press release for a full year 2024 business update and financial results. We look forward to highlighting the progress made during the year to date as well as addressing future goals and milestones.
Operator: Good morning, good afternoon and welcome everyone.
Operator: This morning Innate issued a press release for our full year 2024 business update and financial results. We look forward to highlighting the progress made during the year to date as well as addressing future goals and milestones. The press release and today's presentation are both available on the IR section of our website.
Press release and today's presentation are both available on the IR section of our website.
Operator: On slide two, before we start, I would like to remind you that we will be making forward-looking statements regarding the financial outlook in addition to the regulatory and product plan development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecast.
On slide two before we start I would like to remind you that we will be making forward looking statements regarding the financial outlook. In addition to the regulatory and product planning development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
Operator: On slide three, quickly cover today's agenda.
On slide three quickly cover to today's agenda. After an introduction from Johnson Dickinson CEO.
Jonathan Dickinson: After an introduction from Jonathan Dickinson, CEO, Yannis Morel, COO, will then discuss our preclinical ANCET platform and ADC updates.
Speaker Change: Yeah honest morale CLO will then discuss our preclinical anchored platform in ADC updates. He will then hand over to Sonya Dakar, Tino and Chief Medical officer to cover the clinical updates on the Kitimat I P. H 60, 501, and <unk> 45, or two he will then hand, so fredrik to cover the financials our CFO.
Yannis Morel: He'll then hand over to Sonia Quaratino, our Chief Medical Officer, to cover the clinical updates on the GutaMab IPH6501 and IPH4502.
Sonia Quaratino: He'll then hand to Frederic to cover the financials, our CFO. who will then hand to Jonathan who will then wrap and close.
He will then hand to Jonathan who will then wrap and close.
Operator: Thank you.
Jonathan Dickinson: Jonathan, over to you. Thank you, Henry. And good morning to our US participants and good afternoon in Europe. I'm happy to have the opportunity today to update you all on the latest developments at Innate Pharma.
Jonathan: Jonathan over to you.
Jonathan: Thank you Henry and good morning to all U S participants and good afternoon in Europe.
Speaker Change: Happy to have the opportunity today to update you on the latest developments at <unk> pharma.
Jonathan Dickinson: Turning to slide five, which illustrates our significant achievement. As we look back at 2024 and what we have achieved so far in 2025, I'm excited to share the progress made in advancing our innovative therapies and the key milestones we are expecting. IPH 65 remains a key focus for Innate, and we're pleased that the first patients were recruited into the phase one dose-finding trial in the first half of 2024. This represented a critical step in the product's clinical development, and we are now focusing on progressing the trial rapidly through the next dosing cohorts so that we're able to share data towards the end of this year or early next year.
Speaker Change: Turning to slide five which illustrates our significant achievements.
Speaker Change: As we look back at 2024, and what we have achieved so far in 2025 I'm excited to share the progress made in advancing our innovative therapies and the key milestones we are expecting.
Speaker Change: IP H 65 remains a key focus for an eight and we are pleased that the first patients were recruited into the phase one dose finding trial in the first half of 2024. This represented a critical step in the product's clinical development and we are now focusing on progressing the try.
Speaker Change: We'll rapidly through the next dosing cohorts, so that we're able to share data towards the end of this year or early next year.
Jonathan Dickinson: We are highly committed to this program and optimistic about its potential to address unmet needs in oncology and potentially autoimmune diseases.
Speaker Change: We are highly committed to this program and optimistic about its potential to address unmet needs in oncology and potentially auto immune diseases.
Jonathan Dickinson: We are thrilled with the progress of our Nectin-4 targeted ADC, IPH45, with the first patients dosed in January 2025, following the IND clearance in September 2024. This is an exciting milestone and we are confident that this therapy will make a meaningful impact for patients. Our team is dedicated to moving this program forward rapidly and delivering the next generation of treatment for patients in need.
Speaker Change: We are thrilled with the progress of our <unk> four targeted ADC <unk> 45, with the first patients dosed in January 2025.
Speaker Change: Following the <unk> clearance in September 2024. This is an exciting milestone and we are confident that this therapy will make a meaningful impact for patients.
Speaker Change: Our team is dedicated to moving this program forward rapidly and delivering the next generation of treatments for patients in need.
Jonathan Dickinson: Finally, we turn to Lecutumab, which has made good progress recently on the path to commercialization. We are incredibly excited about the breakthrough therapy designation granted to Lecutumab by the FDA. This brings Lecutumab one step closer to a potential accelerated approval following the productive feedback received from FDA last year. This achievement is based on the strong data we have seen to date and reinforces the potential Lecutumab has to significantly help patients in need. As we continue our interactions with the FDA to finalize the confirmatory phase 3 in the coming months, we also look forward to sharing updated long-term follow-up data via publications at key scientific media.
Speaker Change: Finally, we turn to Likuta map, which has made good progress recently on the path to commercialization. We are incredibly excited about the breakthrough therapy designation granted to <unk> by the FDA. This brings the <unk> one step closer to a potential.
Speaker Change: A rated approval following the productive feedback received from FDA last year.
Speaker Change: This achievement is based on the strong data we have seen to date and reinforces the potential likuta map has to significantly help patients in need.
Speaker Change: As we continue our interactions with the FDA to finalize the confirmatory phase III in the coming months. We also look forward to sharing updated long term follow up data via publications at key scientific meetings.
Jonathan Dickinson: We also continue to look for the best path forward for Lakutamab with partnership discussions advancing well. We also continue to advance our early pipeline with the expectation to discover new ANCETs and ADCs. As we look ahead to 2025, we are confident that we are building momentum across our pipeline with significant achievements in IPH65, IPH45, and LacutaMap.
Speaker Change: We also continue to look for the best path forward for Roku to map with partnership discussions advancing well.
Speaker Change: We also continue to advance our early pipeline with the expectation to discover new and kits and adcs.
Speaker Change: As we look ahead to 2025, we are confident that we are building momentum across our pipeline with significant achievements in IPA 65, <unk> 45.
Jonathan Dickinson: We remain dedicated to delivering breakthrough therapies to patients in need and are excited about the opportunities the next years will bring.
Speaker Change: And the Q Tomorrow, we remain dedicated to delivering breakthrough therapies to patients in need and are excited about the opportunities. The next years will bring.
Jonathan Dickinson: As we reflect on our strategic focus for 2025, I want to take a moment to remind you of the updated strategic focus we shared during our presentation at the JPMorgan Healthcare Conference in January, which is illustrated on slide six. Our strategy is focused on three key growth pillars that we believe will drive long-term value for Innate Pharma, our shareholders, and importantly, for patients. The first pillar is our NK cell engagement. The ANCA platform continues to be a critical component of our strategy. We're advancing three key programs. IPH-65, our CD20 anchor, is currently in phase one.
Speaker Change: As we reflect on our strategic focus for 2025 I want to take a moment to remind you of the updated strategic focus we shared during our presentation.
Speaker Change: J P. Morgan Healthcare conference in January which is illustrated on slide six.
Speaker Change: Our strategy is focused on three key growth pillars that we believe will drive long term value for our night pharma, our shareholders and importantly for patients.
Speaker Change: The first pillar is our NK cell engagements.
Speaker Change: <unk> platform.
Speaker Change: Platform continues to be a critical component of our strategy. We are advancing three key programs.
Speaker Change: Age 65, or <unk> 20 on kit is currently in phase one we're excited about IPA 65 potential to address hematological malignancies, and potentially autoimmune diseases.
Jonathan Dickinson: We're excited about IPH-65's potential to address hematological malignancies and potentially autoimmune disease. IPH 61, our CD123 targeted anchor, is progressing in Phase 2, with Phase 1 data already presented by our partner, Sonota. Fast Track designation was awarded for the treatment of acute myeloid leukemia. We believe that this asset has the potential to significantly impact patients lives. IPH64, our BCMA anchor is in a phase one trial in myeloma in partnership with Sanofi and will be transitioned into autoimmune diseases. These three assets continue to bolster our leadership in NK cell engager therapy.
Speaker Change: <unk> 61, a CD 123 targeted on cat is progressing in phase III with phase one data already presented by our partner Sanofi.
Speaker Change: Fast track designation was awarded for the treatment of acute myeloid leukemia. We believe that this asset has the potential to significantly impact patients lives.
Speaker Change: IPX 64, our BC MAA and kit is in a phase one trial in myeloma in partnership with Sanofi, and we will be transitioned into autoimmune diseases.
Speaker Change: These three assets continue to bolster our leadership in NK cell engaging therapies.
Jonathan Dickinson: The second strategic pillar is our antibody drug conjugate. We are particularly enthusiastic about IPH45, our Nectin-4-targeted ADC. The IND cleared last year and the first patients were dosed in January 2025. This differentiated TOPO1 ADC targets high, moderate and low overexpressing Nectin-4 tumours. With Nectin-4 being overexpressed at varying levels in a range of large tumor types, IPH45's ability to bind low, moderate, and high-expressing tumors preclinically significantly expands the potential product opportunity. We also have IPH43, our MIC-A-B targeted ADC program, in research, further advancing our capabilities in ADC.
Speaker Change: The second strategic pillar is our antibody drug conjugates.
Speaker Change: I'm, particularly enthusiastic about <unk> 45 on net thing for targeted ADC.
Speaker Change: <unk> created last year and the first patients were dosed in January 2025, this differentiated toper, one ADC targets high moderate and low over expressing nexium for tumors.
Speaker Change: We are connecting for being over expressed varying levels in a range of launch tumor types.
Speaker Change: 45 is the ability to bind low moderate and high expressing tumors pre clinically significantly expands the potential product opportunity.
Speaker Change: We also have <unk> 43, Mick <unk> targeted ADC program in research further advancing our capabilities in ADC.
Jonathan Dickinson: The third pillar is our current late-stage assets. We're committed to advancing our late-stage programs, particularly Lecutumab. With positive phase two data and the FDA feedback on next steps, we are actively progressing partnerships. Lakutumab has also been awarded U.S. FDA Breakthrough Therapy designation, which underscores its potential in treating cesarean syndrome patients with high unmet medical need. Additionally, monolizumab continues to progress well with AstraZeneca in the Pacific Nine Phase III trial, and we're optimistic about its future potential.
The third pillar is our current late stage assets, we are committed to advancing our late stage programs, particularly likuta map.
Speaker Change: With positive phase II data and the FDIC back on next steps.
Speaker Change: We're actively progressing partnership discussions Likuta Mab has also been awarded U S. FDA breakthrough therapy designation, which underscores its potential in treating <unk> syndrome patients with high unmet medical need. Additionally, Mona Lisa map continues to progress well with Astrazeneca in the <unk>.
Speaker Change: <unk> <unk> phase III trial, and we are optimistic about its future potential.
Jonathan Dickinson: Slide 7 highlights our impressive pipeline. We are advancing a robust pipeline with eight innovative assets currently in the clinic. The highlights include our proprietary asset, IPH-65, for B-cell lymphomas. Our Sanofi partner assets, IPH-6101 for AML, and IPH-6401 now for autoimmune diseases, and our proprietary ADC, IPH-45, targeting nekton-4-expressing tumors. In phase two, we have our proprietary CUR3DL2 target antibodies, Lecutamab, for CTCL and PTCL. And finally, we have our AZ-parnidacid monolizumab, which is being studied for neoadjuvant non-small cell lung cancer.
Speaker Change: Slide seven highlights our impressive pipeline.
Speaker Change: We are advancing a robust pipeline with eight innovative assets currently in the clinic.
Speaker Change: The highlights include our proprietary asset IPA $2 65 for B cell lymphomas, our Sanofi partners assets IPA 60, 101 for AML and IPX 60 401.
Speaker Change: Now for auto immune diseases, and our proprietary ADC IPX 45 targeting next foreign expressing tumors.
Speaker Change: In phase two we have a proprietary care three <unk> targeted antibody likuta map policy Tcl and <unk> and finally, we have our AZ partnered asset Mello Roos map, which is being studied for new adjuvant non small cell lung cancer and in a phase III study for Unresectable <unk>.
Jonathan Dickinson: and in a phase 3 study for unresectable stage 3 non-small cell lung cancer. These assets demonstrate the productivity of our R&D organization and our commitment to delivering breakthrough treatments across a range of cancer.
Speaker Change: <unk> III non small cell lung cancer. These assets demonstrate the productivity of our R&D organization and our commitment to delivering breakthrough treatments across a range of cancers.
Jonathan Dickinson: Slide 8 illustrates our Q4 conference activity at CIDSE and ASH last year. At the CIDSE meeting, we presented further preclinical data on our Next Generation CD20 Targeting Anchor IPH-65, as well as extensive preclinical data on our Nectin-4 Targeted ADC IPH-45.
Speaker Change: Slide eight illustrates our Q4 conference activity at <unk> and Ash last year.
Speaker Change: At the <unk> meeting, we presented further preclinical data on our next generation CD <unk> targeting <unk> IPA 65, as well as extensive preclinical data on our netting for targeted ADC <unk> 45.
Jonathan Dickinson: At ASH last year, we were pleased to present Leucutumab quality of life and pruritus data in an oral presentation. This oral presentation showcased the consistency between the clinical and quality of life data and the important impact of Leucutumab on patient well-being. There was also a poster presentation of translational data from the TELIMAC trial.
Speaker Change: At Ash last year, we were pleased to present <unk> quality of life and pruritus data in an oral presentation. This oral presentation showcased the consistency between the clinical and quality of life data and the important impact of Youku to map on patient wellbeing there was <unk>.
Speaker Change: Also a poster presentation of translational data from the Telemark trial.
Yannis Morel: I would like to now pass the call to Yannis who will review the preclinical rationale of our key strategic pillars in ANCETs and ADCs. Thank you, Jonathan. I will now highlight the two exciting next-generation antibody therapeutic classes on which we are focusing, the NKTL Engagers, NKET, and Antibody Drug On slide 10, I draw your attention to our portfolio of... Enquete is our proprietary first-in-class NKCEL engager platform. It is a multi-specific plug-and-play technology aiming at engaging NK cells towards tumor cells by triggering the most stable activating receptor expressed on NK cells called NKP14. The interesting feature of this platform is that, by swapping the tumor-binding portion, it can produce multiple drug candidates, addressing a variety of targets in oncology, but it can also potentially harness NK cells to eliminate pathogenic cells in other diseases, like in autoimmune diseases.
Speaker Change: I would like to now pass the call to <unk>, who will review the preclinical rationale of our key strategic pillars in and cuts in ADC.
Speaker Change: Thank you Jonathan and I will now highlight the two exciting next generation antibody therapeutic class on which we are focusing the NK cell <unk> and get an antibody drug conjugate.
Speaker Change: On slide 10, I draw your attention to our portfolio on kit.
Speaker Change: And that is our hopefully it's a first in class NK cell on gateway platform.
Speaker Change: It is a multi specific plug and play technology aiming at engaging NK cells towards cheer yourself by triggering the most stable activating I think Paul I think Tau expressed on NK cells called <unk> 46.
Speaker Change: The interesting feature of this platform in that by swapping the <unk> binding function. It can produce multiple drug candidates addressing a variety of targets in oncology, but it can also potentially honest NK cells to eliminate <unk> itself in other disease like in autoimmune disease.
Yannis Morel: In 24, Sanofi progressed the most advanced enquete, TAR579, to phase 2 on the back of initial efficacy data showing single-agent activity with durable complete responses in relapsed refractory AML patients, and started also a new phase 1-2 trial in frontline AML in combination with venetoclax and azithroxine.
Speaker Change: In 2004, Sanofi programs, the most advanced and get South 579, two phase II on the back of initial efficacy data showing single agent activity with durable complete responses in relapsed refractory AML patients and started the also a new phase 1% with higher <unk>.
Speaker Change: In combination with <unk>.
Speaker Change: Dean.
Yannis Morel: For the BCMA targeting inquest, IPH6401, the Phase 1-2 study led by Sanofi for the treatment of patients with relapsed or refractory multiple myeloma will be stopped early and the product will now be pursued in autoimmune indication.
Speaker Change: For the DTA may targeting and get it get 64, one the phase one two study led by Sanofi for the treatment of patients with relapsed or refractory multiple myeloma will be stopped early and the product will now be tough showed in autoimmune indication.
Yannis Morel: As will be covered by Sonia, our Lead Proprietary Enquete, IPH 65, is now in the clinic. It's a second-generation molecule which incorporates a variant of IL-2 to induce the expansion of patients' own NK cells, and for which we presented new supporting preclinical data at the CICI conference at the end of last year.
Speaker Change: As will be covered by Sonya our lead proprietary on kit I guess 65 is now in the clinic, it's a second generation molecule, which incorporates a valiant of IL two to induce the extension of patient's own NK cells and for which we presented new supporting preclinical data at the Citi Conference.
Speaker Change: At the end of last year.
Yannis Morel: On slide 11, I'd like to highlight the structure of IPH 6501, which is our Lead Proprietary Anchor. It's a novel CD20-targeted tetra-specific MK-cell engager that's specifically designed to target B-cells. The unique design of IPL6501 involves several key components, each of which enhance its therapeutic potential. First, we have an AFAB targeting the tumor-associated antigen, here CD20, in a monovalent way. Second, like in a regular antibody, we have an FC portion that activates the NK cell receptor. Then, the third and key component of the molecule is the NKP46 bind. It targets this NTP4C6-activating receptor, which is the most specific marker of human NK cells, and which expression is stable on tumor-infiltrating NK cells.
Speaker Change: On slide 11, I'd like to highlight the touch of ITI <unk> 65 for one which is our lead proprietary on kit.
Speaker Change: It's a novel <unk> targeting specific NK cell <unk> thats, specifically designed to target detail.
Speaker Change: The unique design of <unk> 65, a one involve several key components each of which and then its therapeutic potential.
Speaker Change: First we have an ACB targeting the tumor associated antigen <unk> 20 in the monovalent weight.
Speaker Change: Like in a regular antibody we have enlisted portion that activate the NK cell is a tough 2016.
Speaker Change: Then the sales and key component of the molecule.
Speaker Change: And kept 46 bind though.
Speaker Change: At target. This NTP 46, activating receptor, which is the most specific markdown of human NK cells, and which expression is stable on tumor infiltrating NK cells.
Yannis Morel: Finally, the IL-2 variant portion provides the proliferation signal that is directed towards NK cells, helping to boost their activity and enhancing the immune response against cancer. IPF6501 represents a significant innovation in our NK cell engager platform, and we are excited about the potential it holds for patients with B-cell magnesium. As we continue to advance this asset, we believe it could pave the way for a new class of immunotherapies targeting solid and hematologic tumors and potentially autoimmune disease.
Speaker Change: Finally, the IL two variant functioned provides a proliferation signal that is directed towards NK cells, helping to boost their activity and enhancing the immune response against cancer cells.
Speaker Change: <unk> 65 for one represents a significant innovation in our NK cell <unk> <unk> off platform and we are excited about the potential it all for patients with B cell malignancies.
Speaker Change: As we continue to advance these assets, we believe it could pave the way for a new class of immunotherapy targeting solid and hematologic tumors and potentially autoimmune disease.
Yannis Morel: On slide 12, I will now highlight IPH 4502, our lead proprietary ADP. We are very excited by this novel and differentiated Nektin-1, Topo-1, Exotican ADC that is currently in Phase 1 of development. This asset is built with a proprietary humanized anti-nectin-for-antibody which binds with high affinity to nectar. With an active FC, it's inducing, as well, ADCC and CDC, enhancing its immune response potential. The linker used is hydrophilic, stable, and cleavable, ensuring high ADC exposure and low release of free hexaticam, which minimizes potential side effects. And Payload, Exoticam, is a potent topoisomerase-1 inhibitor and has demonstrated bystander activity as well as strong activity in the MMI resistance model, allowing it to target tumors that may be resistant to previous ADC therapies.
Speaker Change: On slide 12, I will now highlight <unk> 45, or two our lead polyethylene ADT.
We are very excited by this novel and differentiated making one top one exactly Ken ADC that is currently in phase one of development.
Speaker Change: This asset is built with appropriate re unionized antigenic <unk>, four antibody, which bind with ire affinity to net inflow.
Speaker Change: With an active FC and Youre seeing as well <unk> and CDC and then seeing immune response potential.
Speaker Change: The linker is stable.
Speaker Change: Stable and capable ensuring ADT exposure and lowering needs of three exits again, which minimized potential side effects.
Speaker Change: Payload exactly Ken is a potent topoisomerase one inhibitor.
Speaker Change: As demonstrated by tender activity as well as strong activity in MMA registrants per day.
Speaker Change: Its to target tumors that may tend to produce ADC therapies.
Yannis Morel: Slide 13. As presented at AACR and CIDC last year, IPH4502 has demonstrated superior efficacy to amphotumab vedotine in bladder cancer preclinical models. especially in tumors with low Nektin-4 expression or in models resistant to EV.
Speaker Change: Slide 13.
Speaker Change: Dented at ACR and <unk> last year, it's 45 or two as demonstrate shipyard gassy to optimize <unk> in bladder cancer clinical model.
Speaker Change: Especially in tumors with low <unk> expression all in model resistance to EG.
Yannis Morel: Its unique design translates into high internalization and strong bystander effect, making it effective even in acting for low tumors. This could position IPH4502 as a potentially valuable therapy for a broad range of solid tumor, including breast cancer or lung cancer, but also with strong combination potential with PD-1 targeting agents. As we continue advancing IPH45.02 through clinical development, we are excited by its broad therapeutic potential and look forward to the data we'll generate in the coming months.
Speaker Change: Its unique design conflate into internalization and strong bystander effect, making it effective even in making for low tumors.
Speaker Change: This could position <unk> as a potentially valuable therapy for a broad range of solid tumors, including breast cancer or lung cancer, but also with concomitant potential with PD one targeting agents.
Speaker Change: As we continue advancing Ikea 45 of total clinical development.
Speaker Change: We are excited by its both therapeutic potential and look forward to the data we generate in the coming months.
Sonia Quaratino: I would like now to hand over to Sonia, who will cover the progress of our clinical program. Thank you very much, Yannis. I will now cover the proprietary clinical programs IPH-65, the second generation NK cell engager, targeting CD20-positive B-cell lymphomas, IPH-45, the Nectin-4-ADC, to be developed in solid tumor, and Lakutamab, developed in CTCL and PTCL.
Sonya: I would like now to end over to Sonya.
Sonya: I'll cover the progress of our packing of our clinical program.
Sonya: Thank you very much and I will now cover the.
Sonya: Proprietary clinical programs IP age 65 in the second generation NK cell engagement targeting CD 20 positive b cell lymphoma.
Sonya: <unk> 45 for the next 10 core ADC to be developed in solid tumor and liquid mob developed in CPC and PTC al.
Sonia Quaratino: Now, in slide 16, we present an overview of timelines for IPH6501. If we continue with the current fast-paced recruitment, we plan to complete the dose escalation by the end of this year. And we may have initial safety data, PK, and pharmacodynamic readouts, as well as any preliminary efficacy signals. As a next step, we will open the dose optimization part of the study to select the optimal dose for subsequent studies and then open expansion cohort in non-Hodgkin lymphoma subtypes. The emerging safety profile and therapeutic window from phase one will also indicate if this asset may also be safely and effectively positioned in the autoimmune field, in particular in B cell mediated autoimmune diseases where rituximab is used as a standard of care.
Sonya: Now in slide 16, we present another view of timelines for IP age 60 501.
Sonya: We continue with the current fast paced recruitment we plan to complete the dose escalation by the end of this year and we might have initial safety data PK and Pharmacodynamic readouts.
Sonya: Well as any preliminary efficacy signals.
Sonya: As a next step we will open the dose optimization part of the study to select the optimal dose for subsequent studies and then open expansion cohorts in non Hodgkin lymphoma subtypes.
Sonya: The emerging safety profile and therapeutic window from phase one will also indicate <unk> asset may also be safely and effectively position in the auto immune field in particular in B cell mediated autoimmune diseases, where it took some of the issues.
Sonya: As a standard of care.
Sonia Quaratino: Moving to the next program, in slide 17, we summarize the next steps of our highly differentiated ADC, IPh45.02 targeting Nectin-4. Following the IND clearance at the end of September, the first patient was dosed in January in the U.S., and the first cohort was dosed within a week. We are swiftly proceeding with the dose escalation in this trial. And we may have also and we have already received health authority authorization in France. And the first site in France will be open soon. We are actively working to progress this dose escalation as fast as possible, and we are looking forward to generating preliminary phase 1 safety data by the end of the year, and then to establish activity in tumors expressing different levels of Nekin-4 from low to moderate and high.
Sonya: Moving to the next program in Slide 17, we summarize the next steps of our highly differentiated ADC IP age $45 two targeting netting for.
Sonya: Following the IMD clearance at the end of September.
Sonya: First patient was dosed in January in the U S and the first call. It was those within a week.
Sonya: We are swiftly proceeding with the dose escalation in this trial and we might have also and we have already received.
Sonya: Al protein characterization in France, and the first site in France will be open soon.
Sonya: We are actively working to progress this dose escalation as fast as possible and we are looking forward to generating preliminary phase one safety data by the end of the year and then to establish activity in tumor expressed in different levels of net Q4 from low to moderate and high.
Sonia Quaratino: This study will be presented at ASCO this year.
Sonya: This study will be presented at ash could ECS.
Sonia Quaratino: Finally, in slide 18, I'm excited to share the progress of lacutamab, our first-in-class anti-gift 3DL2 antibody that kills those tumor cells expressing this tumor-associated antigen. This asset is under development for the treatment of cutaneous T-cell lymphoma, an indication with high and medical need, and via an investigator sponsored trial in peripheral T-cell lymphoma, PTCL. The results from the Phase II in CTCL in Caesaree Findron and Mycosis Fungoides were presented at ASH 2023 and ASCO 2024, and they've been highly encouraging, showing that Lakmuta Maba has the potential to make a significant impact on this patient population. Based on these results, we are thrilled to have received FDA breakthrough therapy designation for cesarean syndrome, in addition to the previous regulatory milestones, such as FDA FASTRAC, EMA prime designation for SS patients who have failed at least two prior systemic therapies.
Sonya: Finally slide.
Sonya: Slide 18, I'm excited to share the progress of <unk>, our first in class <unk> two antibody that kills those tumor cells expressing his tumor associated antigen.
Sonya: This asset is under development for the treatment of cutaneous T cell lymphoma, and indication with high unmet medical need and via an investigator sponsored trial in peripheral T cell lymphoma PCL.
Sonya: The results from the phase two in <unk>.
Sonya: In terms of Athene and May cost us from riders were presented at the Ash 2023, and asked for 2024 and they've been highly encouraging showing that <unk> has the potential to make a significant impact on this patient population.
Sonya: Based on these results we are thrilled to have received FDA breakthrough therapy designation for <unk> syndrome. In addition to the previous regulatory milestones such as FDA fast track EMA Prime designation for SaaS patients who have failed at least two.
Sonya: Prior systemic therapies.
Sonia Quaratino: These designations pave the way for a faster path to approval and also are a testament to the strength of the data. Additionally, LAKUTAMAB has been granted Orphan Drug Designation for CTCL in the U.S., further emphasizing the critical role it could play in treating rare and challenging cancer. We are incredibly excited about the ongoing development of Lagutamab and its potential to provide significant benefit to patients with these difficult to treat cancers.
Sonya: This designation paved the way for a faster path to approval and also are a testament to the strength of the data.
Sonya: Additionally, <unk> has been granted orphan drug designation for <unk> in the U S.
Sonya: Further emphasizing the critical role it could play in treating rare and challenging cancers.
Sonya: We are incredibly excited about the ongoing development of like bottom up and its potential to provide significant benefit to patients with this difficult to treat cancers.
Sonia Quaratino: And we are actively preparing the regulatory packages for the FDA and for EMA to receive authorization to proceed with the phase three trial.
Sonya: And we are actively preparing the regulatory packages for the FDA and EMA to receive Alto organization to proceed with the phase <unk> trial.
Sonia Quaratino: In slide 19, I would like to discuss The path forward, where do we stand in terms of business case? And the data generated from the TELOMAC trial confirm clinical benefit, not only in cesarean, but also in MF, regardless of the expression of the target KIR3DL2, highlighting the opportunity for the CTCL space without a companion diagnosis. Therefore, the number of CTCL patients that could potentially benefit from Lacutamab expands to 3,500 in the second prior line of therapy and to 5,000 should we move in an earlier line setting as discussed with the FDA.
Sonya: In the slide 19 outlines two.
Sonya: <unk> costs.
Sonya: The path forward, where do we stand in terms of business case.
Sonya: And the data generated from the Telemark trial confirm clinical benefit not only in <unk>, but also in a mess.
Sonya: Regardless of the expression of the target tier three deals two highlighting the opportunity for the <unk> space.
Sonya: Without a companion diagnostic.
Sonya: Therefore, the number of <unk> patients that could potentially benefit from local demand expands to 3500 in the second prior line of therapy.
Sonya: And two five times and should we move in an earlier line setting with the FDA.
Sonia Quaratino: With the strong MS data presented at ASCO and the data in SESARE at ASH 2023, the BTD and the supporting long-term follow-up data that we will present at ASCO this year, there is an increased confidence in the potential of lacutamase. Our aim is to ensure that LakotaMap gets to patients who need it as quickly as possible and to maximize the value via an accelerated approach.
Sonya: With the strong MF data presented at <unk> and.
Sonya: <unk> has already at Ash 2023, the BTT and supporting long term follow up data, we will present at <unk>. This year. There is an increased confidence in the potential of local demand.
Sonya: Our aim is to ensure that luck with <unk> to patients who need it quickly as possible and to maximize the value via an accelerated approval.
Frederic Lombard: And I will hand over to Frederic. Good morning. The key elements of Innate's financial position and financial results as of and for the year ended December 31st, 2024 are as follows. Revenue and other income from continuing operations amounted to $20.1 million in 2024. It mainly comprises revenue from collaboration licensing agreements at $12.6 million and a resource tax credit for $7.5 million. Avenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuing the agreements with AstraZeneca. Operating expenses from continuing operations amounted to $71.7 million in 2024 with 73% of expenses related to R&D.
Frederic: And I will hand over to Frederic.
Sonya: Yeah.
Sonya: Sure.
Sonya: Good morning.
Sonya: The key elements of <unk> financial position and financial results as off and for the year ended December 31, 2020 for Australia.
Sonya: Revenue in other income from continuing operations amounted to $20 1 million in 'twenty four it mainly comprises revenue from collaboration licensing agreements at $12 6 million and the research tax credit for $7 5 million.
Sonya: Revenue from collaboration and licensing agreement, mainly resulted from the partial or entire recognition of deposits received pursuant to agreements with astrazeneca incentive fee.
Sonya: Operating expenses from continuing operations amounted to $771 7 million in 2024 with 73% of expenses related to R&D.
Frederic Lombard: General and administrative expenses from continuing activities amounted to $19.7 million in 2024, showing an increase of $1.4 million versus prior year. This variation results cumulatively from a reduction in personal expenses, a one-off increase of non-scientific fees, and an increase in other expenses mostly driven by R&D tax credit financing. R&D expenses from continuing activities amounted to $52 million in 2024 and a reduction of $4 million versus prior year. Half of this decrease was due to a decrease in direct research and development expenses in line with the maturity of clinical development. The other half of the decrease was due to depreciation and amount.
Sonya: General and administrative expenses from continuing activities amounted to $19 7 million in 2012 before showing an increase of $1 4 million versus prior year.
Sonya: This valuation results converted results.
Sonya: Cumulatively from a reduction in personnel expenses.
Sonya: One of increase of nonscientific fees and an increase in other expenses, mostly driven by R&D tax credit financing costs.
Sonya: R&D expenses from continuing activities amounted to $52 million in 2024.
Sonya: Reduction of 4 million versus prior year.
Sonya: Also this decrease was due to a decrease in direct research and development expenses in line with the maturity of clinical development programs.
Sonya: So half of the decrease was due to depreciation and amortization.
Frederic Lombard: Cash, cash equivalent, short-term investments and financial assets amounting to $91.1 million as of December 31st, 2024. Financial liabilities amount to $31 million, down from $39.9 million from the end of 2020. This chain is mainly due to the loan repayment. So based on that, and based on our calculations, this gives us sufficient cash to fund operation through the mid-2020s.
Sonya: Cash cash equivalents short term investments and financial assets amounting to $91 1 million as of December 31, 2024.
Sonya: Financial liability amount to <unk> 1 million down from $39 9 million from the end of 2023.
Sonya: This change is mainly due to the loan repayments.
Sonya: So based on that and based on our calculations. This gives us sufficient cash to fund operations through the mid 2026.
Jonathan Dickinson: So I'll now hand over to Jonathan. Thank you Frederic. We have several upcoming R&D catalysts that can be meaningful to our long-term growth. I would draw your attention particularly to the ones that are bolded in this slide. Programs coming out of our ANCET platform continue to advance as IPH 6101 targeting CD123 in hematological malignancies and partnered with Sanofi progressed to phase 2 last year. Our proprietary tetraspecific ANCET that goes by IPH 65 is now in clinical development. We're also looking forward to the first data from our ADC targeting Nectin-4 in phase 1. Near term, we're looking forward to the next steps for Lacutumab now that we have positive FDA feedback and BTD designation.
Jonathan: So I'll now hand over to Jonathan.
Jonathan: Thank you Fredrik.
Jonathan: We have several upcoming R&D catalysts that can be meaningful to our long term growth I would draw your attention, particularly to the ones that are bolded in this slide.
Jonathan: Programs coming out of our anchor platform continue to advance.
Jonathan: The <unk> 61 to one targeting CD 123 in Hematological malignancies.
Jonathan: Partnered with Sanofi progressed to phase two last year, our proprietary tetra specific and kit that goes by <unk> 65 is now in clinical development. We're also looking forward to the first data from our ADC targeting <unk> four in phase well near term, we're looking forward to the next steps for <unk>.
Jonathan: <unk> now that we have positive FDA feedback and BTT designation.
Jonathan Dickinson: and of course partnering discussions underway.
Jonathan: And of course partnering discussions underway.
Operator: Turning to slide 25.
Jonathan: Turning to slide 25.
Operator: So that's the conclusion and we'd like to hand over to the operator for Q&A. Thank you.
Jonathan: So thats the conclusion.
Jonathan: We would like to hand over to the operator for Q&A.
Jonathan: Thank you.
Operator: If you would like to ask a question, please press star 1 on your telephone keypad. Please ensure you are not on speakerphone and that your phone is not on mute when called upon. Thank you.
Jonathan: I'd like to ask a question. Please press star one on your telephone keypad. Please ensure you are not on speaker phone and that your phone is not on mute when called upon thank you.
Daina Graybosch: Your first question comes from Daina Graybosch of Lyrinc Partners. Your line is open. Hi, guys. Thank you for the question. I want to ask one about NHL and your expectations for IPH6501. I think that some of the recent therapies, the CD19 targeted therapies, for instance, have underperformed some of the STREETS expectations. And I wonder if you have a hypothesis on why and what gives you confidence there's a market for IPH6501. And do you have confidence as a single agent, or do you think that we will need to get to combinations?
Dana <unk>: Your question comes from Dana <unk> of Leerink Partners. Your line is open.
Dana <unk>: Alright, guys. Thank you for the question.
Dana <unk>: Wanted to ask one about NHL and your expectations for IP 60 501.
Dana <unk>: I think that some of the recent therapies.
Dana <unk>: CD 19 targeted therapies for instance have underperformed some of the sort.
Dana <unk>: Great expectations and I Wonder if you have a hypothesis on why and what gives you confidence that the market for IP 60, 501, and then do you have confidence as a single agent or do you think that we will need to get the combinations. Thank you.
Jonathan Dickinson: Thank you, Daina, for the question. As you know, the non-Archiclinian pharma space, you know, it's a highly crowded space. And we acknowledge that, of course.
Dana <unk>: Thank you Dana for the question.
Dana <unk>: As you know the non Hodgkin lymphoma space.
Dana <unk>: It's a highly crowded.
Dana <unk>: Python, we acknowledge that of course on the other hand.
Jonathan Dickinson: On the other hand. We expect to see some efficacy based on the data that we obtained from preclinical model, especially as the CD20 is a target that is not downregulated in the disease, similarly to the CD19, for instance. and um And in particular, the safety profile that we expect to see, and it's so far confirmed, is very benign. And that could also be a differentiating factor for other ongoing therapies that are in the space, considering that patients in this trial are particularly frail and have pre-treated with already an extensive number of drugs.
Dana <unk>: We expect to see some efficacy based on the data that we obtained from preclinical model.
Dana <unk>: Especially as.
Dana <unk>: The CD <unk>.
Dana <unk>: To get to that is not down regulated.
Dana <unk>: In the disease.
Dana <unk>: Similarly to the CD 19 for instance.
Dana <unk>: And.
Dana <unk>:
Dana <unk>: And in particular.
Dana <unk>: The safety profile that we expect to see and it's so far confirmed.
Dana <unk>: Uh huh.
Dana <unk>: That is benign.
Dana <unk>: And that could also be a differentiating factor for other ongoing therapies that are in this space.
Dana <unk>: Considering that.
Dana <unk>: Patients in this trial, particularly frail.
Dana <unk>: Pre treated with already.
Dana <unk>: Extensive an extensive number of drugs.
Jonathan Dickinson: For the time being, we focus on the monotherapy. We cannot exclude that this could also be used in combination with the standard of care. Of course, yeah.
Dana <unk>: For the time being we focus on the monotherapy, we cannot exclude that this could also.
Dana <unk>: Be used in combination with the standard of care.
Dana <unk>: Of course.
Dana <unk>: <unk>.
Dana <unk>: Yes.
Jonathan Dickinson: and only emerging data will confirm. Thank you very much.
Dana <unk>: Only emerging data will confirm.
Dana <unk>: Okay.
Dana <unk>: Okay. Thank you very much.
Operator: There are no further questions at this time.
Dana <unk>: There are no further questions at this time.
Eric Le Berrigaud: I've got some offline-submitted questions. So first question from Eric Le Berrigaud at Stiefel. On IPH6401, is the understanding correct that Sanofi is not adding autoimmune diseases as a new space where to investigate the candidate, but is switching focus from MM, where development is terminated, into autoimmune disease?
Speaker Change: I've got some offline submitted questions. So first question from Eric Liberty go.
Speaker Change: Stifel on IPA 60, 401 is the understanding correct that Sanofi is not adding autoimmune diseases as a new space where to investigate the candidates, but its switching focus from mmm, where development is terminated into autonomy autoimmune disease.
Yannis Morel: At first glance, it looks disappointing, not only because BCMA is well-established in multiple myeloma, and Sanofi is a player in the space, but also because BCMA looks much more speculative and uncertain in autoimmune disease. It looks highly exploratory. Any chance you can share what type of autoimmune diseases would be prioritized, and if any evidence has emerged associating BCMA with any?
Speaker Change: At first glance, it looks disappointing not only because of the CMA is well established in multiple myeloma and Sanofi as a player in this space, but also because <unk> it looks much more speculative uncertain in autoimmune disease.
Speaker Change: It looks highly export any chance you can share what type of autoimmune diseases would be prioritized.
Speaker Change: Evidence has emerged associating PMA with any.
Yannis Morel: Yes, Yannis speaking. Yes, Eric, your understanding is correct.
Speaker Change: Yes.
Speaker Change: Generally speaking yes.
Speaker Change: And after <unk> is correct.
Yannis Morel: The ITH-64-01, so the BCMA-targeted NK-Cell Engager, will now be refocused from multiple yellow moths towards autoimmune disease. We see that rather as a given the strategic focus and the very strong capabilities of our partner Sanofi in I&I, we see that as a positive signal. We didn't see any data for the moment from the ongoing phase one, but we assume that the data are supporting this transition, and we really look forward to seeing which indications Sanofi will progress this asset in I&I.
Speaker Change: 64 wall to the CMA targeted in gets <unk>, we know the refocused palm.
Speaker Change: <unk>.
Speaker Change: I mean disease.
Speaker Change: See that.
Speaker Change: Given the year.
Speaker Change: Strategic focus and really strong capabilities of our partner Sanofi in Eni, which is a positive signal we didn't see any data on the momentum from the ongoing phase one, but we assume that the data are supporting this condition.
Speaker Change: And we really look forward to two.
Speaker Change: C in which indications and a few will progress this asset in Eni.
Operator: The next question comes from.
Speaker Change: The next question coming from.
Speaker Change: Slab pakula Obamacare.
Swayampakula Ramakanth: Swayampakula Ramakanth of H.C. Wainwright.
Speaker Change: Wainwright Your line is open.
Swayampakula Ramakanth: Your line is open. Thank you.
Speaker Change: Thank you.
Swayampakula Ramakanth: A quick question on the ongoing partnering discussions regarding Locutumab.
Speaker Change: Yes.
Speaker Change: Quick question on the partnering discussions ongoing partnering discussions.
Speaker Change: Regarding the quarter Matt.
Yannis Morel: I apologize, I was not on the call as I was trying to dodge between earnings calls. So at least if you can highlight what's going on in that realm.
Speaker Change: I apologize I was not on the call.
Speaker Change: Dodge between earnings calls.
Speaker Change: Users can highlight what.
Speaker Change: What's going on in that.
Speaker Change: Alan.
Speaker Change: Okay.
Yannis Morel: Hi RK, Yannis speaking. We are having like several parallel discussions with potential partners that are progressing well. We have a data room open and people are looking into it and so far I cannot really tell you more about it, but just that it's progressing well. Okay, thank you.
Speaker Change: Yes.
Speaker Change: And this is sticky.
Speaker Change: We are adding like Sudan.
Speaker Change: Parallel discussion with potential partner progressing well.
Speaker Change: With that I'll open and people are looking into it and so far I cannot tell.
Speaker Change: Can you more about it but just that progressing well.
Speaker Change: Okay. Thank you and then on the.
Swayampakula Ramakanth: And then on the on the ANCET programs, you know, in both with the 6101 and 6401, do you, do you see any one of them moving into the next stage of development? You know, either in late 25, early 26? Or what do you think is How do you think those two programs are progressing in Sanofi's hands? And what sort of indications would they be going after? you know, in the next, in the next stage of development. For the IPH 6061 to the SAR 579, actually, Sanofi already transitioned from phase 1 to phase 2 last year.
Speaker Change: On the anchor programs.
Speaker Change: But with the.
Speaker Change: 101060 401.
Speaker Change: Do you.
Speaker Change: Do you see any one of them moving into the next stage of development.
Speaker Change: Either in late 'twenty early 'twenty six are.
Speaker Change: What do you think.
Speaker Change: <unk>.
Speaker Change: Yes.
Speaker Change: Or how do you think that those two programs are progressing incentive fees hands.
Speaker Change: And what sort of indications we're going after.
Speaker Change: And the next.
Speaker Change: Late stage development.
Speaker Change: Okay.
Speaker Change: Firstly I get <unk> 61 for the SaaS 579.
Speaker Change: Actually Sanofi OLED transition from phase one to phase two last year.
Yannis Morel: We get a milestone for that, and now they are really in this confirmation phase in relapse refactoring IML setting. So they need to first complete that before transitioning to a later stage of development.
Speaker Change: We get a nice one for that and now they are really in this.
Speaker Change: <unk> consolidation phase.
Speaker Change: Relapsed refractory AML setting.
Speaker Change: So they need to first complete that before transitioning to a less later stage of development.
Yannis Morel: For IPH 6401, as I just said, the development is now repurposed into an INI. We don't know yet in which indication will be targeted. We will know more when Sanofi will start the clinical development of it, but you can guess that it will be in B-cell-mediated disease because the target is BCMA, so the purpose is to deplete cells that are producing antibodies because they are expressing BCMA, but for the moment, we still need to have more information from Sanofi to really understand in which indication it will be developed. Okay, thanks.
Speaker Change: I did 64 one.
Speaker Change: I just said.
Speaker Change: Development is no he built those into our.
Speaker Change: Ini.
Speaker Change: Don't know, yet in which which indication will be targeted we will know more when Sanofi will start the clinical development of it.
Speaker Change: You can.
You can get.
Speaker Change: It will be in the cell mediated disease, because the target is <unk> to deplete.
Speaker Change: Sales at our producing antibodies because they are exciting the CMA.
Speaker Change: But for the moment, we still need to have more information on Sanofi too to really understand in which indication it will be developed.
Speaker Change: Okay. Thanks, Thanks for taking the questions.
Swayampakula Ramakanth: Thanks for taking the questions.
Speaker Change: Okay.
Speaker Change: Okay I'll take another one.
Operator: Sorry, Operator, go ahead.
Speaker Change: Sorry, operator go ahead.
Daina Graybosch: Sorry, we have a follow-up question from Daina Graybosch with Lerink Partners. Your line is. I wonder if you could update us on potential confirmatory trial strategies or plans that you're considering going to with FDA that could support the accelerated approval of lacutumab.
Dana <unk>: Sorry, we have a follow up question from Dana <unk> with Leerink partners. Your line is open.
Dana <unk>: I Wonder if you could update us on potential confirmatory trial strategies or plans that you are considering.
Dana <unk>: Going through with FDA.
Dana <unk>: That could support the accelerated approval, but couldn't add thank you.
Sonia Quaratino: Hi, Daina. We are, let's say, currently working to align with both the FDA and EMA around the confirmatory trial. And this is going to be in the CTCL space, so SS, as well as MS. um This is going to be, let's say, a global trial and. Yeah, it needs to be really finalized, the details with the health authorities. And you can't give us any details on various design elements that you're considering different options for. Well, this is going to be a randomized controlled study, and we need really to have an agreement with the FDA before we can really discuss more details.
Dana <unk>: Hi, Dana.
Dana <unk>: We are.
Speaker Change: Hi, currently working to align with both the FDA and EMA around the confirmatory trial.
Dana <unk>: And.
Dana <unk>: This is going to be in the <unk> play.
Dana <unk>: Okay.
Dana <unk>: As well as EMS.
Dana <unk>: This is going to be let's say, a global trial and.
Dana <unk>: It needs to be really.
Dana <unk>: Finalized.
Dana <unk>: The details with the health authorities.
Speaker Change: And you can't give us any details on various design elements that you are considering different options for.
Dana <unk>: Yeah.
Dana <unk>: Well if this is going to be a randomized controlled study and we need really to have an agreement with the FDA before we can really.
Dana <unk>: Discuss more details.
Sonia Quaratino: You can you can imagine that the primary endpoint may be PFS. And, you know, in terms of the comparator to be used for this study, this is something we really need to align and have the buy in from the health authorities before we can discuss it on this forum.
Dana <unk>: You can imagine the primary endpoint might be PFS and in.
Dana <unk>: In terms of the comparator to be used for this study. This is something we really need to align and have the buy in from the health authorities before we can discuss it.
Dana <unk>: This forum.
Operator: All right, thank you.
Dana <unk>: Alright. Thanks.
Eric Le Berrigaud: Hi, so another question received offline from Eric Le Merigo at Stifel. I'm unclear whether you've made a decision to move forward with Leucutumab in Cesare's syndrome to regulators or if it is yet dependent on Phase III formal start in CTCL and or upon finding of a partner more globally for the drug across all indications. Thanks for clarifying.
Dana <unk>: So another question received offline from Erik <unk> Stifel I'm unclear, whether you have made a decision to move forward with <unk> in <unk> syndrome to regulators or if it is yet dependent on on phase III formal start in Cte cell undo upon finding of a partner more globally for the drug across all indications.
Dana <unk>: For clarifying.
Sonia Quaratino: I presume that this question refers to the accelerated approval that we have discussed in with the FDA in our type C meeting at the end of last year. And if so, the accelerated approval can only be obtained when the phase three is up and running and recruiting. So in that respect, going back to the question that Dina made before, our plan is to have a phase three in MF and in SS. And only then we can go back to the FDA with a pre-BLA meeting and submit the package to obtain an accelerated approval while the phase three is up and running.
Dana <unk>: I presume that this question refers to the accelerated approval.
Dana <unk>: That we have discussed with the FDA in our type C meeting.
Dana <unk>: At the end of last year and so on.
Dana <unk>: The accelerator approval can only be obtained when the phase III is up and running and recruiting so in that respect going back to the question that Dino made before our plan is to have the phase III in MF and in.
Dana <unk>: And only then we can go back to the FDA with the pre BLA meeting and.
Dana <unk>: Meet the package to obtain an accelerated approval.
Dana <unk>: While the phase III is up and running I hope that.
Sonia Quaratino: I hope that I've addressed The question.
Dana <unk>: Address.
Dana <unk>: The question.
Dana <unk>: Maybe I can add something.
Jonathan Dickinson: It's Jonathan here. We are very actively working at this point in time to finalize that phase three program, clinical trial confirmatory study. So we're working on the premise that we're moving forward with that phase three confirmatory study. And in due course, once that study is up and and the recruitment is well underway, and there's a good cadence of recruitment in the study, will be the time point at which we can then go back to FDA and potentially have a discussion about when exactly the BLA could be filed. But the company is working on the premise that this will be moving forward, ideally with a partner, which I think was part of the question.
Dana <unk>: It's Jonathan here.
We are very actively working at this point in time to finalize that phase III.
Dana <unk>: Program clinical trial confirmatory study.
So we're working on the premise that we're moving forward.
Dana <unk>: With that phase III confirmatory study and in due course once that study is up and running.
Dana <unk>: <unk>.
Dana <unk>: The recruitment is well underway and there's a good cadence of recruitment in the study will be the time point at which we can then go back to FDA and potentially have.
Dana <unk>: Have a discussion about when exactly the BLA could be filed by the company is working on the premise that this will be moving forward.
Dana <unk>: Daily with a partner, which I think was part of the question.
Jonathan Dickinson: But if we can't find a partner with a good deal, which I think is important from our perspective, it has to be a good deal that makes sense from an innate perspective, then we are working on a plan B to be able to take this forward. Thank you.
Dana <unk>: But if we can't find a partner with a good deal, which I think is important from our perspective. It has to be a good deal that makes sense from a night perspective than we are working on a plan b to be able to take this forward ourselves.
Dana <unk>: Okay.
Frederic Lombard: Another question offline again from Eric Liberigo at Stiefel. Lastly, considering that 91 million euros of available cash provides runaway into mid-26, is it fair to expect cash burn to be circa 60-70 million per year? Or are you including in the calculation any cash inflow over the period that goes beyond tax credit? Thanks for the question. So, as usual, we do not plan in the cash burn anything which is not under our control. any potential proceeds from potential coming partnership or equity is not included because the probability is until it's signed it's 50-50 let's say so it's not included and we have a small cash inbound of 6 million which is a financing which is absolutely under our control with more than 95 percent and which is very limited so as usual no measure in flow which is not already public and the cost is as expected based on the strategy.
Dana <unk>: Thank you another question offline again from Erika <unk> with Stifel Lastly, considering the $91 million of available cash provide us runway into mid 2000, <unk> is it fair to expect cash burn to be circa $60 million to $70 million per year.
Dana <unk>: Or are you, including in the calculation of any cash inflows over the period that goes beyond tax credits.
Dana <unk>: Thanks for the question so as usual, we do not plan in the cash burn.
Dana <unk>: Anything which is not under our control so any potential proceeds from potential coming partnership or <unk>, which is not included because the probability is until it's signed it's 50 50, let's say so it is not included and we have.
Dana <unk>: Small cash inbound of $6 million, which is a financing which is absolutely under control with more than 95%, which is very limited so as usual no measure of inflow.
Dana <unk>: Which is not already public and the cost base as expected based on the strategy.
Frederic Lombard: Thank you Frederic.
Fredrik: Thank you Fredrik.
Oussama Dengueir: Another question received offline from Oussama Dengueir at Odo. A quick question on working capital variation maybe I've missed something in the release can we have more color on the trade receivables variation? So this one, it's a particular year for sure.
Speaker Change: Another question received offline from some angry at Boto.
Speaker Change: Quick question on working capital variation, maybe I've missed something in the release came we have more color on the trade receivables variation.
Speaker Change: So this one.
Speaker Change: The particular year for sure we have communicated on that last year. We did enjoyed the repayment of 2019 and 2020 research tax credits in 2024 for about $30 million with us.
Frederic Lombard: We've communicated on that last year. We did enjoy the repayment of 2019 and 2020 research tax credit in 2024 for about 30 million. provided an inflow in cash of 30 million, but the corresponding trade receivable decreased. And also, as explained before, we have decided to finance the cash, the resource tax credit of 2023, instead of waiting for 2027 to have the cash in. So it has also generated 8.5 million of trade receivables decreased in the year. So in this year, we had more than, in a range of nearly 40 million of trade receivables decreased, which is one-off relative to the resource tax credit.
Speaker Change: <unk> added a new flow and cash of <unk> million, but a corresponding receivable decrease and also as explained before we have decided to finance.
Speaker Change: The cash.
Speaker Change: So as tax credits of 2023.
Speaker Change: Instead of waiting for 2027 to have the cash in so it has also generated $8 5 million of.
All of this the case.
Speaker Change: So in this year, where you had more.
Speaker Change: Nearly $2 million.
Speaker Change: Receivables decreased which is one off related to the actual leasing payments.
Speaker Change: Okay.
Operator: Thanks Operator, no further questions offline unless there are any more on the call. There are no questions at this time. This will conclude. Today's conference call. Thank you for joining.
Speaker Change: Thanks, operator, no further questions offline unless there are any more on the call.
Speaker Change: There are no questions at this time.
Speaker Change: Thank you very much.
Speaker Change: Today's conference call. Thank you for joining you may now disconnect.
Speaker Change: Please wait the conference will begin shortly.
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