Half Year 2023 Innate Pharma SA Earnings Call
Speaker 1: Hello and welcome to the Innate Forum of First Half 2023 Financial Results and Business Update Conference Call. I would like to advise all participants that this call is being recorded. I'd now like to welcome Henry Wheeler to begin the conference. Henry, over to you.
Hello, and welcome to the innate pharma first half 2023 financial results and business update conference call I would like to advise all participants that this call excuse me Corey good I'd now like to welcome Henry Wheeler to begin your conference Henry over to you.
And welcome everyone. This morning, <unk> issued a press release, providing a business update well H one switch to slide three financial results and business update.
Speaker 2: Welcome everyone. This morning, Enate issued a press release providing a business update for our H1 2023 financial results and business update.
Speaker 2: We look forward to highlighting the progress made during the year to date, as well as addressing future goals and marks.
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 websites on.
Speaker 2: press release from today's presentation are both available on the IELTS section of our webinar.
Speaker 2: On slide two, before we start, I'd like to remind you that we will be making forward-looking statements regarding the financial outlook in addition to regulatory and product planning.
On slide two before we start.
I'd like to remind you that we will be making forward looking statements regarding financial outlook. In addition to regulatory and product development.
Speaker 2: These statements are subject to risk and uncertainties that may cause actual results to differ from their
These statements are subject to risks and uncertainties that may cause actual results to differ lewisville passage.
On slide three today.
Speaker 2: On slide three, on today's call, we will be joined by Monda Bajoubi, a Chief Executive Officer, who will then hand over to Joyce and Cara Canale, Interim Chief Medical Officer, who will cover updates on the CUTA Map and Monolith Map. Yanis, Murali, Evie, Phoebe, and product portfolio strategy will then discuss our Anket and ABC platform.
Today on today's call, we will be joined by most of the JV are Chief Executive Officer, who will then hand over to Joseph talked now interim Chief Medical Officer.
Total opex on the acute.
Yes.
Yes, morale EVP of BD and Bard full credit strategy will then discuss inkjet and ADC platforms.
Speaker 2: And then we have our CFO Frederick Lombard to cover the financials. Wanda and I have a go at you.
And then we have our CFO fredrik lamaze cover financials, Wanda and Avalon team.
Thank you Henry.
Speaker 3: Thank you, Henry. Good morning, everyone. Please move to slide four. Let me start by welcoming Dr. Sonia Karatini to Inay Pharma as chief medical officer as we announced this morning. We are looking forward to Sonia joining the team next month with her wealth of expertise in the field of oncology drug development.
Good morning, everyone.
Let's move to slide four.
Let me start by welcoming desktops, Sonya car T to pharma as Chief Medical Officer, as we announced at the small Rob.
We're looking forward to Sonya joining the team next mall with her wealth of expertise in the field of oncology drug development.
Looks like Allergan, who joins it at an exciting time of clinical momentum for in a pharma and we look forward to working together to advance in this pipeline and you'll have the opportunity to meet with the stock out at our next quarterly earnings call.
Speaker 3: Dr. Caratino joins us at an exciting time of clinical momentum for innate pharma, and we look forward to working together to advance innate pipelines, and you will have the opportunity to meet with Dr. Caratino at our next quarterly round of group meetings.
Speaker 3: I would, of course, like to extend a great thanks to Jordan for all his contribution over the last years and wish him well in his next.
Of course like to extend a great. Thanks to Georgia for all his contribution over the last years and wish him well in these next steps.
Speaker 3: Jolson will ensure a smooth transition period at Sonia Campbell.
<unk> will ensure smooth transition theory as Soviet chemical involved.
Turning to slide five I would like to remind you.
Speaker 3: Turning to slide five, I would like to remind you of our strategy.
Of our strategy.
As an early stage company, our business model centered around three key priorities, where we look to drive value from our early R&D efforts to later stage partnerships, where it makes sense to do so.
Speaker 3: As an early clinical stage company, our business model centers around three key priorities where we look to drive value from our early R&D efforts to later stage partnerships, where
Speaker 3: Our ambition remains to develop innovative drug candidates that contribute to transform cancer care through a strong pipeline of differentiated antibodies.
Our ambition remains to develop innovative drug candidate that contribute to pulse for cancer care. So a strong pipeline of differentiated antibodies.
Speaker 3: Firstly, we look to create near-term value driven by our heat proprietary product Comidate, like with a map, which is in development for T-cell diploma, with final CTCS and early TCL readouts expected by the end of the year.
Firstly, we Luther King near term value driven by our proprietary.
Operator: Hello and welcome to the Innate for a month's first half, 2023 Financial Results and Business Update Conference call. I would like to advise all participants that this call is being recorded.
The comedy like with them as.
Which is in development for T cell lymphoma with final.
Early PTC had readout expected by the end of.
Speaker 3: As a reminder, our focus remains to leverage the value of our product as much as possible, which will further validate our science and offer capital that we can reinvest to advance our early R&D engine.
As a reminder, our focus remains to leverage the value of our product as much as possible, which released further validate our science and offer capital if we can reinvest.
Henry Wheeler: I'd now like to welcome Henry Wheeler to begin the conference. Henry, over to you.
Henry Wheeler: Welcome everyone. This morning, Innate issued a press release providing a business update for our H1 2023 financial results and business updates.
Early on the engine.
Speaker 3: We want to ensure that if we can gain valuable competence via a partner agreement, we will consider that in our development plan for the product, as we look to later stage, as we have done in the past, for other partners.
We want to ensure that if we can gain valuable competence.
No I came and political Magoo unfortunate event and our development plans for the product as we look to later stage side as we have done in the past for other partnered assets.
Henry Wheeler: [inaudible] On slide three, today, on today's call, we will be joined by Wanda Bajubi, a chief executive officer. He will then hand over to George and Carick Nell, Interim Chief Medical Officer. He will collect updates on Puku's map and Wanda Bajub map. Yann's morale, EVP and BD in the product portfolio strategy will then discuss our NKET and APC platforms. And then we have our CFO Frederick Mombard to cover the financials.
Speaker 3: Second, we continue to fuel our pipeline and create longer-term value by leveraging our antibody engineering capabilities in order to develop innovative molecules with a primary focus on our multi-specific N-casein-engager proprietary platform we call N-CASE.
Second we continue to shoot our pipeline and create longer term value by leveraging our antibody engineering capabilities.
Obviously developed innovative monitor this is a primary focus on our multi strategic interests and engage a proprietary platform we call it and we are.
Speaker 3: We are pleased to announce today that our lead proprietary anchors, APS65, has passed IMD and progressed towards phase one trials.
Im pleased to announce today that our lead proprietary and get it get 65 has started <unk> and progress towards phase one trial.
Speaker 3: As we develop antibody targets for our NCATS platform, we recognize that some of these binders may be more applicable for ADC technology, as we announced from advancement in our ADC pipeline today.
As we develop antibodies as targets for our <unk> platform, we recognize that some of these binders may be more applicable for ADC technologies, and we announced some advancement in our ADC pipeline today.
Last but not least we are building a strong and sustainable foundation for our business with various partnerships across industry and academia.
Speaker 3: Last but not least, we are building a strong and sustainable foundation for our business with various partnerships across industry and academia. Here, our AstraZeneca partnership with Monami Genavi continues in Lancashire.
Unknown Executive: Wanda and Avalodium.
Wanda Bajubi: Thank you, Henry.
Wanda Bajubi: Good morning. I'm going to turn everyone. Please move to slide four.
Our Astrazeneca partnership with one of the dynamics continue in lung cancer.
Wanda Bajubi: Let me start by welcoming Dr. Sonia Carick Nell to innate pharma as chief medical officer, as we announced this month. We are looking forward to Sonia joining the team next month with her wealth of expertise in the field of oncology for development. Dr. Carick Nell joins us at an exacting time of clinical momentum for innate pharma and group forward to working together to advance innate pipeline.
Please move to slide six and before I hand over to Jonathan I would like to share with you an overview of our <unk>.
Speaker 3: Please move to slide six and before I hand over to Joyce and I would like to share with you an overview of our pipeline, which shows how we continue to translate our science into the robust portfolio of proprietary and partner.
Pipeline, which shows how we continue to formulate our size into the robust portfolio of proprietary and partnered assets.
Speaker 3: also illustrates how we are executing against our strategy with our need for quality assets like PitaMap but also AMCAT and the emerging API.
Also this page how we are executing against our strategy with our need for a variety of asset light pick them up but also <unk> adcs supported by partnered products with Astrazeneca Sanofi and now Takeda from late two early stage development.
Wanda Bajubi: And you will have the opportunity to meet with Dr. Carick Nell at our next quarterly learning course. I would, of course, like to extend a great thanks to Jordan for all his contribution over the last years and wish him well in his next step. Jordan will ensure a smooth position theory at Sonia's camp on board.
Speaker 3: Supported by partner products with AstraZeneca, Sanofi, and now Tequila, from late to early stage development.
Speaker 3: 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 know-how in order to create a sustainable new vaccine.
We anticipate the series of potential clinical data readouts and catalysts and that can be a couple of years as our R&D engine looks to leverage our scientific knowhow in order to create a sustainable business.
Wanda Bajubi: Turning to slide five, I would like to remind you of our strategy. As an early clinical stage company, our business model centers around three key priorities, where we look to drive value from our early on in the effort to lay the stage partnerships, where it makes sense to do so. Our ambition remains to develop innovative drug candidates that contribute to transform, can take it to a strong pipeline of differentiated entry value.
Speaker 3: I would like now to pass the call over to Joyce, who will review the progress made with our portfolio, starting with Lekki Dammar, our most advanced proprietary asset. Joyce, over to you.
I would like now to pass the call over to Jason who will review the progress made with our portfolio starting with record demand for our most advanced proprietary assay Jason over to you.
Speaker 4: Thank you, Mondaire. On slide seven, let me summarize the progress we are making with Lakuta.
Thank you <unk> on slide seven let me summarize the progress we are making with <unk>.
We are pursuing a fast to market strategy for <unk> in the niche setting of surgery syndrome, where lucrative mab was granted us fast track designation and EU Prime designation in 2020, we have expanded past surgery syndrome to mycosis, <unk>, where we have seen encouraging preliminary data from our phase II trial in both cohorts.
Speaker 4: We are pursuing a fast-to-market strategy for Leucutumab in the niche setting of Cesare's Syndrome, where Leucutumab was granted U.S. Fast-Track designation and EU Prime designation in 2020. We have expanded past Cesare's Syndrome to mycosis fungoides, where we have seen encouraging preliminary data from our Phase 2 trial in both cohorts.
Wanda Bajubi: Thirdly, we look to create near the end value driven by our his property, the company date, like it's a map, which is in development for teaching and trauma, with finals. And early to see a redout expected by the end of the year. As a reminder, our focus remains to leverage the value of others as much as possible, which will further validate our science and offer capital that we can reinvest to advance our early on the end.
Speaker 4: for the Cesare's syndrome and mycosis fungoides. Final data is due for both cohorts in the second half of 2023.
For the surgery syndrome in Mycosis <unk> final data is due for both cohorts in the second half of 2023.
Speaker 4: Finally, we are continuing to enroll into peripheral T cell lymphoma in the phase 1b and 2 monotherapy and combination trials in the relapse setting with initial data expected later this year.
Finally, we are continuing to enroll into peripheral T cell lymphoma, and the phase one b and two monotherapy and combination trials in the relapsed setting with initial data expected later this year.
Wanda Bajubi: We want to ensure that if we can gain valuable competence via partner agreement, collect it and that we will consider that in our development plans for the product, as we look to let the stage trial as we have done in the past for other partners.
On slide eight.
Speaker 4: We have the preliminary phase 2 data published last year in cesarean syndrome and mycosis fungoides.
We have the preliminary phase two data published last year in salary syndrome in mycosis <unk> on the top half of the slide and sensory syndrome at the Ash annual Congress 2022 in December the presentation showed that in heavily pretreated post <unk> mab patient pool with the <unk>.
Wanda Bajubi: Afe. Second, we continue to shoot our pipeline and create longer than value by leveraging our antibody-engineering capabilities in order to develop innovative molecules with a primary focus on our multi-species increase and engage of proprietary platform we call ANCAT.
Speaker 4: On the top half of the slide in cesarean syndrome at the ASH Annual Congress 2022 in December , the presentation showed that in heavily pre-treated post-mulgammalizumab patient pool with a median prior line of therapy of six.
Indian prior line of therapy of sex the or are in the ITT population was 21, 6% with an hour or 35, 1% in the scan and 37, 8% in the blood.
Speaker 4: The ORR in the ITT population was 21.6%, with an ORR of 35.1% in the skin and 37.8% in the blood.
Wanda Bajubi: We are pleased to announce today that our lead proprietary ANCAT, EGS-65, has spastic IMD and progress towards 3-1 tribes. As we develop at the latest targets for our ANCAT platform, we recognize that some of these binders may be more applicable for agency technologies as we are now from adventurers in our agency pipeline today.
Speaker 4: It was encouraging to see activity replicated in larger phase 2 trials in these late-line patients. A favorable safety.
It was encouraging to see activity replicated in larger phase II trials in.
These late line patients a.
A favorable safety profile was also seen.
Speaker 4: We look forward to further interactions with the regulators as we get the final data later this year.
We look forward to further interactions with the regulators as we get the final data later this year.
Speaker 4: The lower half of the slide summarizes the preliminary cohort 2 and 3 data in mycosis fungoides where we presented updated data based on the revised Olson criteria at ICML this year.
A lower half of the slide summarizes the preliminary cohort two and three data in Mycosis, <unk>, where we presented updated data based on the revised Olson criteria at <unk> This year.
Wanda Bajubi: Last but not least, we are building a strong and sustainable foundation for our business with various partnerships across industry and academia. Here, our AstraZeneca partnership with one of the cannabis continues in Lancashire. This moves to slide six and before I hand over to Joyson, I would like to share with you an overview of our pipeline, which shows how we continue to formulate our science into the robust portfolio of proprietary and partner assets.
Speaker 4: In the updated data presentation based on the Olsen 2022 criteria in the Cure 3D L2 expressing cohort, we were encouraged to see that in these late line patients with the median of four prior treatments, Lecudemab demonstrated a 42.9% ORR and nine responses.
In the updated data presentation based on the Olson in 2022 criteria in the Q3 D L to.
Expressing cohort we were encouraged to see that in these late line patients with the media announced four prior treatments Likuta Mab demonstrated a 42, 9% over our nine responses.
Wanda Bajubi: It also illustrates how we are executing against our strategy with our lead proprietary asset, the Kitamab, but also NGET and the emerging APC. Supported by partners products with AstraZeneca-Sanurthi and Nautakila from late to early stage development.
We are participant, particularly encouraged by the responses in the skin, where we saw 57, 1% or and 12 responses. A reminder, that our skin response is important response in this disease.
Speaker 4: We are particularly encouraged by the responses in the skin where we saw 57.1% ORR and 12 responses. A reminder that a skin response is an important response in this disease.
On slide nine.
Speaker 4: On slide nine, I would like to update you on monolizumab. To remind you, monolizumab is an anti-NKG2A, which acts upon the checkpoint pathway to potentiate NK cell activation that we have licensed to AstraZeneca for oncology. On this slide, you can see an overview of the late stage development plan for monolizumab in lung cancer.
I would like to update you on <unk> to remind you modal as a mab as an anti <unk>, which acts upon the checkpoint pathway to potentiate NK cell activation that we have licensed to Astrazeneca for oncology on this slide you can see an overview of the late stage development plan for mental as Mab in lung cancer.
Wanda Bajubi: We anticipate the series of potential clinical data redouts and catalysts in that coming couple of years as our only engine looks to leverage our scientific know-how in order to create a sustainable business.
Joyson Karakunnel: I would like now to fetch the call over to Joyson, who will review the progress made with our portfolio, something reflected in the map, or most advances, provides the action. Joyson, over to you. Thank you, Mondair. On slide seven, let me summarize the progress we are making with Lakutamab. We are pursuing a fast-to-market strategy for Lakutamab in the niche setting of Cesare syndrome, where Lakutamab is granted U.S, fast-track designation and EU prime designation in 2020.
Speaker 4: Based on the AstraZeneca-sponsored Phase 2 COAST data, AstraZeneca commenced Pacific 9, a Phase 3 trial, evaluating the combinations of either monolizumab or oliculumab plus dervalumab in the unresectable Stage 3 non-small cell lung cancer setting who have not progressed after concurrent chemoradiation therapy.
Based on the Astrazeneca sponsored phase two coast data Astrazeneca commenced Pacific nine a phase III trial evaluating the combination of either mono is a mab or <unk> cluster value map in the Unresectable stage III non small cell lung cancer setting.
Who have not progressed after concurrent chemo radiation therapy.
Speaker 4: For the phase two co-study, the three arms evaluated the combination of duralumab plus nonalizumab and duralumab plus oliculumab, AstraZeneca's anti-CD73.
For the phase II <unk> study the three arms evaluated the combination of <unk> plus model as a mab undervalue Mab plus Silicula Mab Astrazeneca is anti CD 73.
Joyson Karakunnel: We have expanded past Cesare syndrome to mycosis fungoides, where we have seen encouraging preliminary data from our phase two trial in both cohorts. For the Cesare syndrome and mycosis fungoides, final data is due for both cohorts in the second half of 2023. Finally, we are continuing to enroll into peripheral T-cell lymphoma in the phase one B and two monotherapy and combination trials in the relapse setting with initial data expected later this year.
Speaker 4: As published in the Journal of Clinical Oncology by AstraZeneca after a median follow-up of 11.5 months, the results of an interim analysis showed a hazard ratio of 0.42 for Dervalumab plus monolizumab versus Dervalumab alone. The results also showed an increase in the primary endpoint of confirmed ORR for Dervalumab plus monolizumab over Dervalumab alone of 36% versus 18% respectively.
As published in the journal of clinical oncology by Astrazeneca. After a median follow up of 11 five months. The results of an interim analysis showed a hazard ratio of 0.42 for <unk> plus model is a map versus your value amount below.
The results also showed an increase in the primary endpoint of confirmed or are for der value Mab personal isn't lab overdue value member loan of 30.
Joyson Karakunnel: On slide eight, we have the preliminary phase two data published last year in Cesare syndrome and mycosis fungoides. On the top half of the slide in Cesare syndrome at the Ash annual Congress 2022 in December, the presentation showed that in heavily pre-treated post-mogamelism ab patient pool with a median prior line of therapy of six, the ORR in the ITT population was 21.6 percent, with an ORR of 35.1 percent in the skin and 37.8 percent in the blood.
6% versus 18% respectively.
The Astrazeneca sponsored Neo Coast II study is also underway and an earlier lung study evaluating <unk> Mab undervalue Mab with chemo.
Speaker 4: The AstraZeneca-sponsored Neocose 2 study is also underway in an earlier lung setting, evaluating monolizumab and drivalumab with chemo in neoadjuvant non-spot cell lung cancer patients.
<unk> non small cell lung cancer patients I will now hand over to <unk> to cover our Endcap an ADC platform.
Speaker 4: I will now hand over to Yanis to cover our NCAT and ADC platform.
Thank you <unk> on slide 10, I wanted to highlight our hopefully SME NPA stayed on gauge our basketball as before thank you Sandy.
Speaker 3: Thank you, Joyce. On slide 10, I wanted to highlight our proprietary NCCEL-Engager platform that we call NCCET. NCCET stands for Antibody-Based NCCEL-Engager Therapy.
Joyson Karakunnel: It was encouraging to see activity replicated in larger phase two trials in the these late line patients. Favourable Safety Profile was also seen. We look forward to further interactions with the regulators as we get the final data later this year. The lower half of the slide summarizes the preliminary cohort 2 and 3 data in mycosyfunguides where we presented updated data based on the revised Olsen criteria at ICML this year. In the updated data presentation based on the Olsen 2022 criteria, in the Q3DL2 expressing cohort, we were encouraged to see that in these late-line patients with the median of four prior treatments, Lecutomab demonstrated a 42.9% RR and nine responses. We are particularly encouraged by the responses in the skin where we saw 57.1% RR and 12 responses, a reminder that a skin response is an important response in this disease.
Spending both antibody base, if they don't get out of it.
And get divested direct feedback.
Speaker 3: Nketch is a versatile feed-for-purpose technology made of various building blocks that is creating an entirely new class of multi-specific engagers to induce synthetic immunity against cancer.
Energy made values building blocks that is taking an entirely new class of medicines basically some gauges to induce immunity against cancer.
Speaker 3: The technology platform, which is leveraging our scientific expertise in the NPTEL space, will be an engine for our pipeline, creating value via a series of select candidates addressing multiple human targets.
Operating cash flow, which leveraging our fence.
And yet it will be an enzyme for our pipeline safety and value their series outside accommodate atlassian much Becky.
Speaker 3: The backbone of our ONCAT platform is based on the unique engagement of the activating NK cell receptor NCP46, NCP16 on NK cells, which allows for optimal harnessing of NK cell effector functions, which can be further increased by addition of a NIL2 variant to induce NK cell proliferation.
I'll get that ball is based on the unique engagement of activating it.
And KC 46, and <unk> our anti.
Empty itself, which allows for keyboard Odyssey of MTS that EBITDA functions, which can be further increased by addition of <unk> to induce an effect.
On slide 11.
Speaker 3: On slide 11, I wanted to share our enthusiasm for this N-CAT platform. As you can see, our pipeline of N-CAT molecules is significantly growing, with Sanofi having now licensed three molecules, with two in the clinic, and having an option on two other undisclosed targets.
I wanted to share our enthusiasm bargains and gifts as well as you can see our pipeline of quality was significantly growing with specialty I think no license issues, we saw in the clinic and having an open on Florida.
Joyson Karakunnel: On slide 9, I would like to update you on monolizamab. To remind you, monolizamab is an anti-NKG2A, which acts upon the checkpoint pathway to potentiate NK cell activation that we have licensed to AstraZeneca for oncology. On this slide, you can see an overview of the late-stage development plan for monolizamab in lung cancer. Based on the AstraZeneca sponsored Phase II Coast data, AstraZeneca commenced Pacific 9, a Phase III trial, evaluating the combinations of either monolizamab or Elicula Mab plus Dervalumab in the unresectable Stage III non-small cell lung cancer setting, who have not progressed after concurrent chemo radiation therapy.
Targets.
Speaker 3: Also today, we disclosed that our most advanced proprietary anchor, ITH65, which is targeting CD20, has cleared IME, and we look forward to start the payload.
So to date, we disclose at while most adverse okay. Okay, Icf's 65, which you started 2020 as P M.
And we look forward to stop the phase one.
In addition, we have completed a technical report loss against Blacksburg targets on.
Speaker 3: In addition, we have proprietary technical programs against multiple targets.
Speaker 3: On the right panel, you can see the detailed mechanism of action of the AMCET molecules, which we have recently published in a couple of articles in IDPAC journals.
The iPad you can see the sustained Mckenzie of action of you'll get what issues, which we have recently started leasing the portfolio adopters.
Journals.
Joyson Karakunnel: For the Phase II Coast study, the three arms evaluated the combination of Dervalumab plus monolizamab and Dervalumab plus Elicula Mab AstraZeneca's anti-CD 73. It has published in the Journal of Clinical Oncology by AstraZeneca after a median follow-up of 11.5 months, the results of an intraminalysis showed a hazard ratio of 0.42 for Dervalumab plus monolizamab versus Dervalumab alone. The results also showed an increase in the primary endpoint to confirmed ORR for Dervalumab plus monolizamab over Dervalumab alone of 36% versus 18% respectively.
Our industrial Biotechnology Beta Division engineering as Jeff described the joint work with centers on the city wants to PMT.
Speaker 3: Our natural biotechnology paper, published in January this year, describes the joint work with Sanofi on the CD163 and T-cell engager, IPF6101, also called SAR579.
<unk> also called <unk>.
<unk> I'm sorry.
Speaker 3: SARS-CoV-2 is co-engaging NCC46 and CD16 on NK cells, and therefore triggers potent antigen-dependent killing of IML tumors, as well as production of K-cytokine for the anti-tumor response, but without inducing systemic cytokine release, which is a dose limiting for NK cell engager, for a T cell engager.
<unk> nine is call engaging and $54 six and 2016 on NK cells, and therefore figure with epogen dependent killing of tumors as well as prediction of case type of guidance. Thanks to my baseball, but without inducing.
Right.
Which is a dose limiting book if they don't get Joe.
I don't get this.
Moreover, we have shown that in our physical medicine based on a unique operation of a 92 volume into announced yet induce effector shoulder and get that installation within the tumor microenvironment exiting therefore, the number of any chemo I think of that.
Speaker 3: Moreover, we have shown that in our self-reported medicine papers, that the incorporation of an IL-2 variant into a NAM-K induced a preferential NK-cell proliferation within the tumor microenvironment, increasing, therefore, the number of anti-tumor effector cells.
Joyson Karakunnel: The AstraZeneca sponsored Neo-Coast II study is also underway in an earlier lung site, evaluating monolizamab and Dervalumab with chemo in neo-adjuvant non-small cell lung cancer patients.
Yannis Morel: I will now hand over to Janice to cover our NCAT and ADC platform. Thank you, Joyce. On slide 10, I wanted to highlight our proprietary anti-cellongator that we call NCAT, NCAT standing for anti-body base anti-cellongator service. NCAT is a versatile piece of proposed technology made of various building blocks that is creating an entire new class of multi-stetricongator to induce strategic immunity against cancer. The technology platform, which is leveraging our same 6.13 in the anti-cell space, will be an enzyme for our pipeline, creating value, their series of platform dates, addressing multi-partimal time. [inaudible] of anti-T-406, anti-15 on anti-cells, which allows for optimal armacing of anti-cell effector functions, which can be further increased by addition of an ideal to variant to induce anti-cells polyperation.
On slide 12.
You can see another view of the clinical data presented this year as well I guess, if you want to.
Speaker 3: You can see another view of the clinical data presented this year at ASCO for ITH6101 on-campus program, also named SAR579.
101 on Cat Cora also named soft 579.
Speaker 3: In this dose escalation, we were encouraged to see initial preliminary single-agent activity and safety for SARS-CoV-2 in relapsed recurrent AML patients.
In these dose escalation, we were encouraged to see any short term email <unk> single agent activity and safety stock by Tonight.
Amy.
<unk>.
Speaker 3: At the one-mix-per-trip dose, three complete responses were observed out of eight patients, with two responders remaining in remission at the data cutoff at 6.7 and 7.6 months of treatment.
At the one one.
One Mitch they'll keep those three complete responses, while wholesale out of eight patients with two <unk>, we maintain remission at epitope at.
$6, seven and seven six months of treatment.
Speaker 3: SAR579 was well-tolerated, with no dose units in toxicity observed, and only one grade 1 CRS observed out of 23 patients.
<unk> signed 79 was well tolerated.
No.
Yourself and only one Canadian one yeah that's itself also.
These patients.
Speaker 3: The FDA awarded SARS-CoV-2 579 past vaccination in May, and Sanofi plans to evaluate further those labels. We look forward to further updates from Sanofi in due course.
The FDA awarded 579 pass by recognition in May and Sanofi plans to evaluate some of those levers we look forward to further updates on several key vehicles.
Yannis Morel: On slide 11, I want you to share our answer to the other for this anti-platform. As you can see, our five-line of anti-small ideals is significantly growing, with some analyses having no license premature, with two in the clinch, and having an option on two other anti-score targets. Also, today we disclose that our most advanced proprietary anti-HTH-65, which is targeted in 3D20 as clear IME, and we look forward to start the phase one.
On Slide 13, you can see some of you have outside Australia.
Speaker 3: On slide 13, you can see a summary of our Sanofi Alliance.
Speaker 3: In 2016, we signed an initial agreement for two AMCET molecules worth up to 400 million milestones, among which we announced 16 million today.
In 2016, we signed an initial agreement up to August 22.
Two 4 million milestone, among which we announced 16 million to date.
Speaker 3: Both programs have progressed with SARS-579 and SARS-514 in phase one trials. In December last year, we signed a further agreement, whereby Sanofi licensed the ICF62 Enquette program, targeting D7H3, a solid tumor target, with an option on two other undisclosed targets. Sanofi paid 25 million upfront, with 1.35 billion in potential microbes and RNAs.
This program Applegate with soft by 79 and stopped by.
<unk> is based on fire.
Remember last year, we signed a further argument whereby <unk> license the <unk> 60 to <unk>.
<unk> solid tumor targets.
Yannis Morel: In addition, we have proprietary technical programs against multiple targets. On the right panel, you can see the same mechanism of action of the anti-platform ideals, which we have recently published in a couple of articles in IME.5 journals. Our Matthew and biotechnology painter, published in Gen.1, which describes the joint work with Sanofi on the 3123 anti-cylong gager, IPF6101, or also called Star by 79. Star 79 is co-engaging anti-T-406 anti-16 on anti-cells, and therefore, pre-girls, potent anti-zendipenemic healing of IMEs tumors, as well as protection of anti-cylokines of the anti-stream arrestome, but results in using systemic cytokine release, which is a dose-reliking for anti-cylongager, for anti-cylongager.
And that's enough for the undisclosed targets.
We paid $25 million.
One.
175 billion in potential milestones in wireless.
This now takes a total mice and package up to $1 $75 billion. That's why you.
Speaker 3: This now takes the total milestone package up to 1.75 billion plus royalties.
Speaker 3: We look forward to working with Planopty as we bring these molecules to the clinic.
We look for what we sell.
As we bring these molecules to the clinic.
Slide 14.
Our ongoing ADC pipeline.
Speaker 3: As we continue to develop next-generation therapeutics utilizing our antibody engineering platform, we find that for some tumor targets, we can generate antibodies more suited for ADCs and for ENCKEs, especially when they show good internalizing properties.
As we continue to develop next generation democracy.
I think our antibody engineering basketball, we find that for some small targets, we can generate antibodies more 54, ADC, therefore market, especially when they show good internalizing Papa.
Speaker 3: Our recent agreement with Takeda in the field is providing a validation to this research approach and highlights our capability to generate differentiated adequate conditions.
Our recent agreement with <unk>.
Yannis Morel: Moreover, we have shown that, in our technical medicine paper, a new corporation of a naive two-variant into an object, induced a paternal soul anti-tank proliteration within the tumor recombinant, increasing the record number of anti-tumor effectors. On flight 12, you can see another view of the clinical data presented this year at ASCO or ITH-211 on the program, also named Star by 79. In this dose-excalation, we were encouraged to see initial preliminary single agent activity and safety for Star by 79 in relapsed recurrent IMEs patients.
Providing a validation with this approach and our capabilities.
These projected ADC candidates.
Speaker 3: Today, we disclose that our lead proprietary LSA program, LCH45, is targeting Nexin4. We look forward to further updates on this molecule as we prepare for R&D 5. In addition, we have several other targets in early AD series.
To date, we disclose at least qualitatively at least.
<unk> 45, starting mixing bowl.
We look forward to further updates on this molecule as we prepare for <unk> bye.
In addition, we have similar targets in early.
<unk>.
Slide 15.
Speaker 3: Slide 15 highlights the terms of the recent deal with Takeda. We entered into an agreement whereby Takeda gained exclusive license to a panel of selected antibodies against an undisclosed target to develop ABCs with a primary focus in celiac disease, which is outside of our oncology focus.
The sales of the recently respectively.
We entered into an agreement whereby Takeda gain excuse me license with panel of safety to antibody against an undisclosed targets to develop adcs with a primary focus and key activity, which is outside of our oncology focus.
Yannis Morel: At the one list of the one list of those, three concrete responses were observed out of eight patients with two responders remaining in remission at the data cutoff at 6.7 and 7.6 nons of treatment. Star by 79 was well tolerated with no dose-reliking toxicity of cells and only one grade-one tier-res observed out of 23 patients. The FDA awarded Star by 79 past five years in May and Sanofi plans to evaluate further dose levels. We look forward to further update on Sanofi EDU course.
Speaker 3: The terms include 5 million upfront and up to 410 million in milestone and royalties on net.
<unk> included a 5 million upfront and up to $407 million in milestone and <unk> next stage.
Speaker 3: This deal also demonstrates our ability to monetize pipeline assets in therapeutic areas outside of our area of expertise.
This deal also demonstrates our ability to predict.
To monetize assets.
Ali ads outside of our area of exceptions.
Speaker 3: I will now hand over to Frédéric for a summary of the time I'm short.
Are we now and developed subsidiary while external view of the financials.
Thanks Renee.
Speaker 3: On slide 16, as usual, you can find the consolidated financial statements for the first half of 2023 in our press release for further information. I will cover the highlights on this slide.
On slide 16 as usual you can find the consolidated financial statements for the first half of <unk>.
'twenty three now as it is for further information.
We cover the highlights on this one.
Yannis Morel: On flight 13, you can see the tsunami of our Sanofi Alleya. In 2016, we signed an initial agreement for two anti-smolitude works of two four-on-vis million milestone among which we announced 16 million today. Both programs have progressed with Sarpite 79 and Sarpite 14 in place on fire.
Speaker 3: Cash, cash equivalents, short-term investment and financial assets amounted to 124.7 million as of June the 30th.
Cash cash equivalent and short term investment of financial assets amounted to.
$124 7 million.
June 30.
Speaker 3: It does not include the expected $39 million of Bit of Stack credit due in H2 2023.
Not include the expected <unk> 9 million sufficient credit jewelry niche.
324.
Speaker 3: We believe this cash position is sufficient to fund our version into H2 2021.
We believe this cash position is sufficient to fund our operations into HQ2020.
Yannis Morel: In December last year, we signed a federal agreement whereby Sanofi Lighten, the ITF 62-on-page program, started in 2017, the Solicime of Target, with an option on two other industrial targets. Sanofi pays 25 million up on with 1.1.35 million in potential milestones and royalties. This now takes a total milestone package up to 1.75 million plus royalties. We look forward to working with Sanofi as we bring this molecule to the finish.
And when you add those earnings come from continuing operations amounted to $40 million in the first half of the year.
Speaker 3: Revenue and other income from continuing operations amounted to $40 million in the first half of the year compared to $45.6 million in the first half of last year.
$2045 6 million in the first half of last year.
Speaker 3: I mainly provide revenue from collaboration and licensing agreements.
Combined revenue from collaborations.
Ration on licensing.
Speaker 3: These many initiatives form the partial or entire recognition of the proceeds strictly pursuant to the agreements with AstraZeneca and Sanofi, and which are recognized on the basis of the percentage of completion of the work performed by the company under such agreements.
These menu is a deposit that show.
The completion of the proceeds to keep the CMT agreements with other new gas ft, and which are recognized on the basis of the best data completion of the words baffled by the company.
<unk> agreements.
Governmental funding for research expenditure were $4 9 million in the first half of the year.
Speaker 3: Governmental funding for research expenditure were $4.9 million in the first half of the year.
Yannis Morel: Slide 14, highlights our growing ADC pipeline. As we continue to develop net generation democracy, utilizing our antibody engineering platform, we find that for some tumor targets, we can generate antibodies more suited for ADC than for ANCAP, especially when they show rules in analyzing proper. Our Christians' agreement with the Kedai in the field is providing a validation to the Scripture approach and highlights our capabilities to generate differentiated ADC candidates.
Speaker 3: Operating expenses from continuing operations were 40.6 million in the first half of the year, of which 77.5% or 31.5 million are related to ARM.
<unk> expenses from continuing operations were $46 million in the first half of the year of which 77, 5% or $71 5 million our ability to add.
<unk> expenses from continuing operations increased by $6 5 million.
Speaker 3: And then the expenses from continuing operations increased by 6.5 million.
This change.
The change mainly results from an increase in direct R&D expenses related to four months.
Speaker 3: This changed many results from an increase in direct R&D expenses related to programs, notably for our first antibody drug-conjugated spaghetti mix.
Yannis Morel: Today, we disclose that our lead proprietary ADC program LCH45 is targeting next in four. We look forward to further update on this molecule as we prepare for IND pipeline. In addition, we have several other targets in early ADC research.
For our first antibody drug conjugate targeting <unk>.
General and administrative expenses from continuing operation decreased by <unk> 3 million $9 1 billion in the first half of the year. This is mainly results from efficiency measures.
Speaker 3: General and administrative expenses from continuing operations decreased by 3 million to 9.1 million in the first half of the year, this decreased many results from efficiency measures. I will now turn to Mondeo for summary.
Yannis Morel: Slide 15, highlights the terms of the written deal with Kedai.
I will now turn to modem or similar.
Thank you for that.
Yannis Morel: We enter into an agreement for our Kedai game, exclusive license to a panel of select identity bodies, again, anonymous close targets to develop ADC with the primary focus in CLIADD, which is outside of our oncology focus. The terms include a five-million upfront and up to 410 million in my stone and YSG on next stage. We deal also demonstrates our ADC to the two-minitized pipeline assets in therapeutic areas outside of our area of expertise.
Move to slide 17.
Speaker 5: As you can see, we are working diligently to execute across all our strategic pillars.
As you can see we are working diligently to execute our cost or our strategic pillars.
Speaker 5: and believe that we are laying the foundation to drive near and long-term value for the company and the shareholders.
And believe that we are laying the foundation to drive near and long term value for the company and the shareholders.
Speaker 5: Looking at our clinical program, we expect to achieve a number of milestones over the next two years.
Looking at our clinical program, we expect to achieve a number of milestones over the next two years.
Speaker 5: As you heard from Jason, Lactamab Phase II telomere final data is due at the end of this year, in addition to initial PTCL data readouts.
As you heard from Jason lithium up phase II Telematic final data if you at the end of this year. In addition to initial <unk> data readout.
Frederic Lombard: I will now end over on Kedai for a summary of the title shows. Thank you, name, Yanis. On slide 16, as usual, we can find the consolidated financial statements for the first hour of 2023 in our press release of our information. I will cover the highlights on this slide. Cash equivalent short term investment on financial assets amounted to 124.7 million out of June the 30s. This does not include the expected stock in 9 million out of its stock credit due in H22023 and in 24.
Speaker 5: In parallel, we continue to develop our iCAPE platform, further enforced by our.
In parallel we continue to develop our Iga platform.
Further <unk> by our partner Sanofi.
Speaker 5: And we are very encouraged by the initial clinical data at ASCO and the IMD clearance from our proprietary anchors and the POVs in the clinic.
And we are very encouraged by the initial clinical data at <unk> and the IND clearance from our proprietary NK and the progress in the clinic.
Speaker 5: We believe that this represents a natural evolution of our Black community.
We believe that this represents a natural evolution of our platform.
Speaker 5: Finally, for monolismab, the lung cancer trials are well underway, and we continue to advance the adrenosine pathway in the clinic where the phase 2 for APH5201 in early lung cancer is underway.
Finally for modeling is above the maintenance of trials are well underway and we continue to advance the adenosine pathway.
The clinic, where the phase III for Avs particular, one the earlier cancer is underway.
Frederic Lombard: We believe this cash position is sufficient to fund our operations into H22025. Avenue and other income from continuing operations amounted to 40 million in the first hour of the year compared to 25.6 million in the first half of last year. [inaudible] exchanges for continuing operations were 40.6 million in the first half of the year of which 77.5% or 31.5 million are related to end. And the exchanges for continuing operations increased by 6.5 million.
Let's move now to the concluding slide.
Slide 18, as you can tell we continue our exciting journey a journey, we look to build our business to create value for patients and stakeholders and.
Speaker 5: So as you can tell, we continue our exciting journey.
Speaker 5: We look to build our business to create value for patients and stakeholders.
Speaker 5: In summary, we have positioned the company for the future with our strategy and made meaningful progress across all three strategic pillars.
In summary, we have positioned the company for the future with our strategy and made meaningful progress across our three strategic pillars.
Speaker 5: With our R&D engine and antibody expertise, our science is producing more candidates to progress to the clinic. Some we are developing alone, and some are fast.
With our R&D engine and antibody expertise, our science is producing more candidates to progress through the clinic somewhere development alone and some our partner.
Speaker 5: We have a focus on our NKCN Engager platform, NK, as well as ADC.
We have a focus on our efficacy and engage a platform and K as well as ABC.
Speaker 5: In parallel, our late-stage portfolio continues to advance as we look to maximize the late-stage portfolio assets of Laxitomar and Monavut.
In parallel our <unk> portfolio continues to advance as we look to maximize the late stage portfolio asset <unk> and Monovisc.
Speaker 5: Our partnership strategy continues to evolve, with the recent Takeda deal adding to those of AstraZeneca and Sanofi.
Our partnership strategy continues to evolve with the recent <unk> deal, adding to those of Astrazeneca and Sanofi.
Speaker 5: And we have carefully managed our resource so we can continue a sustainable business to invest in progress in our pipeline and very pleased that we continue to have a very strong cash production with a runway into the second half of 2025. Collectively, we are driving value across our business and ultimately advancing our goal to deliver innovative medicine to patients.
And we have carefully managed our also so we can continue our sustainable business to invest in progressing our pipeline and very pleased that we continue to have a very strong cash position with a runway into the second half of 2025.
Frederic Lombard: This change, this change many leaders from an increase in direct arrange in the exchanges related to programs looked at these for our first and cheaper need or a co-jugate targeting network. General and non-expective exchanges from continuing operations decreased by 3 million to 9.1 million in the first half of the year.
Secondly, we are driving value across our business and ultimately advancing our goal to deliver innovative medicines to patients.
Speaker 5: We look forward to keeping you updated on our progress. And that concludes our prepared remarks. We will now open the call to questions.
We look forward to keeping you updated on our progress and that concludes our prepared remarks, we will now open the call to questions.
Frederic Lombard: These decreased many results from efficient emitters.
Of our 60 volt question you'd like to ask any questions.
Speaker 1: Operator, if you'd like to ask any questions.
Mondher Mahjoubi: I will now turn to Mondher or Sonia. Thank you, Frederic. Please move to slide 17.
Mondher Mahjoubi: As you can see, we are working diligently to execute a course or our strategic pillars and believe that we are laying the foundation to drive near and long-term value for the company and the shareholders. Looking at our clinical programs, we expect to achieve a number of milestones over the next two years. As you heard from Joyce and Lekid Amartre is to tell you my final data is you at the end of this year.
When you get the call to questions. Please.
Speaker 1: Thank you. If you'd like to ask any questions, please press star and number one on your telephone keypad. Our first question comes from Miguel Muchomovich from Citi. Your line is now open.
Thanks, Nick if you'd like to ask any questions. Please press star and number one on your telephone keypad. Our first question comes from Macau Mitchell mortgage from Citi. Your line is now open.
Hi, Tim This is Akshay Kumar on for Yigal, Thanks for taking my questions.
Speaker 6: Hi, team, this is awesome. Thanks for taking my questions. My 1st, 1 is on the choice of rationale for. Connecting for, I guess, where do you think the unmet need with pads of is, or how do you think this molecule could be differentiated or approved? And do you think you'll be focused on 2 more types? Like, your field, your field cancer, bladder cancer, or perhaps some, some more novel indications next.
My first one is on the choice of rationale for the next four ADC I guess, where do you think the unmet need with Pat surface or how do you think this molecule could be differentiated or approved.
Mondher Mahjoubi: In addition to initial PDCL data reader. In parallel, we continue to develop our NK platform further enforced by our partners and we are very encouraged by the initial clinical data at ASCO and the IMG clearance from our proprietary entities and the progress in the clinic. We believe that this represents a natural evolution of our platform. Finally, for Mondher and MAP, the NKs are wet underway and we continue to advance the adenosine pathway into the clinic where the phase two for APH-501 in early and cancer is underway.
And do you think youll be focused on tumor types like you'll see your cereal cancer bladder cancer, where perhaps some more novel indications.
Speaker 5: Thank you for the question. I'm going to hand over to Yanis to provide the rational and the competitive position for our ADC target.
Thank you for the question I'm going to hand over to <unk> to provide an irrational.
Our competitive position for our ADC target indicate.
Speaker 3: Yeah, so as you know, Nexin4 is a validated target for the ADC mechanism of action, and through our antibody platform, we are able to generate potential best-in-class antibodies with unique properties. And we are following the field of ADC for several years now, and it came now to a point where we can really well understand which kind of payload and linker we can couple to our potential best-in-class antibodies.
Yes. So as you know next employs a validated target for the year and communicate these are those action.
Well our antibody platform.
We generate potential best in class antibody with unique properties and we are following the sale of ADC for several years now.
Mondher Mahjoubi: Let's move now to the concluding slide. As you can tell, we continue our exciting journey. We look to build our business to create value for patients and stakeholders.
<unk> been out to a point, where we can the U S on lockdown.
Just kind of.
<unk> Nikko, we can copel two our potential best in class antibodies.
Mondher Mahjoubi: In summary, we have positioned the company for the future with our strategy and made meaningful progress across all three strategic pillars. With our R&D engine and antibody expertise, our science is producing more candidates to progress to the clinic. Some we are developing alone and some are partners. We have a focus on our engaging engage of platform NK as well as ABC. In parallel, our A-Stage portfolio continues to advance as we look to maximize the late stage portfolio Our partnership strategy continues to evolve with the recent Takeda deal adding to the rules of Ashiq Mubarackanth and Arvind Sood.
Speaker 3: And we really see that, I mean, after bat cells or in other tumor types, as you know, making 4-degree broadly expressed across multiple tumor types, there is potential for next generation making 4-degree.
And we really see that in <unk>.
Other genotype as you know Mickey.
<unk> for the year 40 exploration cost.
There is potential for that next generation mix and volumes.
Okay.
Yes.
Speaker 6: Okay, got it. Maybe a similar question on IPH-65 to CB20, Ankit. I guess, what tumor types do you think make the most sense to target? Should we be thinking about this in the same, you know, subset of indications that Rituxan is approved for, or do you think you'll be targeting more broadly than that?
Okay got it and then maybe similar question on IP 65 to <unk> 20 I.
I guess, what tumor types, you think make the most sense to target should we be thinking about this is the same.
A subset of indications that we will touch on it as a proof or do you think youll be.
Or is it more broadly than that.
Mondher Mahjoubi: And we have carefully managed our ourselves so we can continue a sustainable business to invest in progress in our pipeline and very pleased that we continue to have a very strong cash position with the runway into the second half of 2025. Collectively, we are driving and value across our business and ultimately advance our goals to deliver innovative medicine to patients.
Okay.
Speaker 3: Yeah, so we actually, you know, the IP65, to remind you, is using the new version of the Oncad technology, which is incorporating the Allium 2 variant. So we decided to go after CD20 to test the potency and the efficacy of this new technology in patients in order to limit the variables.
Yes, so we actually.
<unk>.
I guess 65, just to remind you using the new version of the <unk> technology, which is incorporating the <unk>.
So we decided to go a subsidy 'twenty two.
Yes potentially.
Yes, yes, yes.
This new technology to patients who need the valuable and as you noted the swanky displacement UNH.
Mondher Mahjoubi: We look forward to keeping you updated on our progress and that concludes our prepared remarks.
Speaker 3: And as you know, CD20 is expressed in BNHL, and it has the advantage over other tumor antigens to be pretty stable across different types of treatments, even after rituximab, or after CAR-T, or after T-cell engager. So there is still an ultimate need after in this relapsing patient, and then depending on the efficacy and safety profile of the drug, we can then adjust the clinical development plan.
Operator: We will now open the cards to questions. Operating for questions. I'd like to ask any questions.
It does.
Advantage of the or the geology gets to be pretty stable across different lines of equipment Youre NAFTA Rituximab upsell cocky. After you said home gateway. So there is good investment need.
The <unk> mutation.
And then depending on the year.
Thank you Jackie and <unk> provide us with what we.
Operator: Would you have a poll of the questions please? Thank you. If you'd like to ask any questions please press star. The number one on your telephone p-pad.
We can then address.
Clinical development plan.
Okay, great. Thanks for taking my questions.
Ashiq Mubarackanth: Our first question comes from Miguel, Mutu Mubic from Sydney. Your line is now open. Hi team, this is Ashiq Mubarackanth, thanks for taking my questions. My first one is on the choice of rationale for the netting for ADC. I guess where do you think the unmet need with pad service or how do you think this molecule could be differentiated or approved? And do you think you'll be focused on tumor types like your field cancer or bladder cancer or perhaps some more novel indications? Thanks. Thank you for the question.
Our next question comes from visa.
Speaker 1: Our next question comes from Lisa Baker from Evercore ISI. Your line is now open.
From Evercore ISI. Your line is now open.
Hi, This is Jamie finally, Sam Thanks for taking our question.
Speaker 7: Hi, this is streaming on for Lisa. Thanks for taking our questions. My first question is, and what.
My first question is what shall we expect that that's what I'm asking about later it does yes.
Speaker 7: The data later this year, and do you expect to present it at a conference or just a press release? And then my 2nd question is, what do you expect to be the next steps for the map and for example, do you plan to go ahead and file with? If data is positive, do you plan to go ahead with the first or do you plan to conduct a combined trial phase 3 trial? Thank you.
Do you expect to close on that at our conference.
And then my second question is what do you expect to be the next step if I look at the map and TTC out for example, do you plan to go ahead and file with if data is positive.
Yannis Morel: I'm going to hand over to Yanis to provide the rational and the competitive position for our ADC target in the next four. Yeah, so as you know, netting core is a very easy target for the Alishimic individual election and for our antibody, who are able to generate potential basing gas antibodies with unique properties. And we are following the field of ADC for for several regions now and it came now to a point where we can really well understand which kind of field and nuclear we can co-pollue to our potential basing gas antibodies.
The plant is all I have to place that separation John first of all do you plan to.
Conduct a combined trial phase III trial.
Jim.
Yes.
Thank you.
Speaker 5: Thank you. I'm going to hand over to Jorgen to answer the two questions. You can understand for the first one that
Hand over to Jonathan.
To answer the two questions.
You can understand for the first one debt.
Don.
Speaker 5: We never communicated on a specific conference, there are multiple conferences happening in the second half of 2023.
We communicated on a specific conference multiple robust comprehensive in the second half of 2023 and of course, we will be in a position to communicate when we have certainty about.
Speaker 5: And of course, we will be in a position to communicate when we have certainty about, you know, the acceptance of the app. That's all. I'll keep it at this at this level. But clearly, the.
The acceptance of the asset.
Yannis Morel: And we really see that after battle or in other tumor types, as you know, netting core is really a broad way to express, of course, much more tumor types of potential for the net generation netting core industry. Okay, got it.
And this.
At this level, but clearly.
The best on the most appropriate I should say.
Speaker 5: or the most appropriate, I should say, forum to present this data in a medical conference.
Forum to present these data at medical.
Medical conferences.
Sure.
Speaker 5: Now, the second question is very important and I'm going to ask you to provide a high-level view on the regulatory path for Lakita maps, both in CPC-L but also in CPC-L.
Now the second question is this is very important.
Joseph.
Hi.
Yannis Morel: Maybe a similar question on IPH-65, the CG-20. Ankit, I guess what tumor types think you think make the most sense to target? Should we be thinking about this in the same set of indications that reduction is approved for, or you think you'll be targeting more broadly than that?
A high level view on the regulatory path for <unk>, but also as you said.
Get them all.
Speaker 5: and how we could see the full potential of this asset. Joyce? Thanks, Bander. So what are the next steps, basically, for Leucutumab? Our aim is to basically pursue clinical strategies that would support getting Leucutumab to patients who need it as quickly as possible while ensuring a good PTRS. Discussions with the FDA will enable us to firm up these Phase III plans in the context of the upcoming data readout.
See the full potential of this asset.
Thanks Bye there. So so what are the next steps basically for Likuta map. Our aim is to basically pursue clinical strategies that would support getting <unk> to patients who need it as quickly as possible.
Yannis Morel: Yeah, so we actually, you know, the IPH-65 is to remind you, you think the new version of the Tecron-Case technology, which is incorporated in the ALF to variant. So we decided to go after 3D-20 to test the potential and the efficacy of this new technology into patients in order to limit the variable. And you know, 3D-20 is actually the DNA shell and it has the advantage over other tumor antigens to be pretty stable across different lives of treatment to the native and future map, or actor-carpile, or actor-fisher-engueer. So there is still a net-mechanical actor in this relation. And then depending on the efficacy, in fact, it profile of the drug, we can then adjust the clinical development.
While ensuring a good <unk> discussions with the FDA will enable us to firm up these phase III plans in the context of the upcoming data readouts.
Unknown Attendee: Okay, great. Thanks for taking my questions.
Speaker 4: Ongoing dialogue with potential partners is also being explored to identify the perfect fit for the drug for innate and for patients that may benefit from this potential medicine.
Ongoing dialog with potential partners is also being explored to explore to identify the perfect fit for the drug.
And for patients that may benefit from this potential medicine.
Speaker 4: The ideal partner for Lacudamab is one that can realize the full potential of the drug for patients with T-cell lymphoma.
The ideal partner for <unk> is one that can realize the full potential of the drug for patients with T cell lymphoma.
Speaker 4: You know, as mentioned before, 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 early R&D engine. We want to ensure that if we can gain valuable competencies by a partner agreement for Lakutumab, we will consider that in our development plans for the product as we look to later stage trials. Thank you.
Yes.
As mentioned before 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 early R&D engine, we want to ensure that if we can gain valuable competencies by a partner agreement for the <unk>, we will consider that in our <unk>.
Daina Graybosch: Our next question comes from Liisa Bayko from Evercore ISI. Your light is now open. Hi, this is Daina Owens for Liisa. Thanks for taking our questions.
<unk> plans for the product as we look to later stage trials.
Got it thank you.
Speaker 1: Our next question comes from Diana Graybosh from the Ringed Partners. Your line is now open. Hi, thank you for the question.
Daina Graybosch: My first question is, and what key did we expect to look at a map data later this year and do you expect to descend at a conference or just a press release? And my second question is, what do you expect to be the next step for Luku the map in CTCL? For example, do you plan to go ahead and file with if data is positive? Do you plan to go ahead with the definition from first or do you plan to conduct a combined trial, phase three trial? Thank you.
Our next question comes from Diana Great Great push from Leerink Partners. Your line is now open.
Hi, Thank you for the question I have one on <unk>.
Joyson Karakunnel: I'm going to hand over to Joyson to answer the two questions.
I Wonder if you could talk about what you've learned from the preclinical data for the PD, one Tim three and cat on where the optimal dose maybe specifically how.
Speaker 8: I wonder if you could talk about what you've learned from the preclinical data for the CD123 NCAT on where the optimal dose may be. Specifically, if there is a bell-shaped dose curve, how much room do you have at the top of that bell for flexibility, or how much room could Sanofi have?
If there is a bell shaped dose curve how much room do you have at the top of that barrel for flexibility or how much room could to note behalf.
Speaker 8: And then more broadly, as you look across the other NCAT programs, how much work have you done optimizing affinity with ability to extend the plateau of a potential bell-shaped dose curve, and how difficult is that or different is that for the NCAT 4 versus the NCAT 3? Thank you.
Then more broadly as you look across the other end cap program. How much work have you John optimizing affinity with the ability to extend the plateau of potential bell shaped curve.
Joyson Karakunnel: You can understand for the first one that we never communicated on a specific conference. There are multiple of course conference happening in the second half of 2023. And of course, we will be in a position to communicate when we have certainly about the acceptance of the abstract tools. I'll keep it at this level, but clearly, the best or the most appropriate, I should say, form to present these data on medical conferences which you say.
How difficult is that our guess is that for the and kept for a person to end category. Thank you.
Yeah, Hi, Dana.
Speaker 3: Yeah. Hi, Dana. Yeah, actually, in.
<unk> speaking.
Yes actually.
<unk>.
Speaker 3: In vitro setting, it's something that we can observe, the benchmark curve, and it's, as you may know, it's not unique to NK-10 engager. It's something that.
In in vitro setting is something that we cannot sell the bench of general in the east as you May know expert's unique to HSN home gateways something that has been.
Speaker 3: It's something that can be modeled, and it's confirmed by experience. There are several parameters that are influencing the shape of the bell, notably the density of the antigen on one side, the density of activating receptor on the other side, and the affinity of the gold binder. So it's quite easy to build a model.
So we saw some disaggregated.
Something that can be model, then and is confirmed by experience the optical tommyto adopt influencing this.
Joyson Karakunnel: Now, the second question is very important and I ask Joyson to provide a high-level view on the real site path for like in the map, both in CTCL but also in CTCL and how we could see the potential of this aspect. Thanks, Fundair.
As the shape of the bed.
The density of the antigen on one side the density of existing assets on the other side and yes.
Both binder.
It's quite easy to build a model.
Joyson Karakunnel: So what are the next steps basically for Luku the map? Our aim is to basically pursue clinical strategies that would support getting Luku the map to patients who need it as quickly as possible while ensuring a good PTRS discussions with the FDA will enable us to firm up these phase three plans in the context of the upcoming data readouts. On-going dialogue with potential partners is also being explored to identify the perfect fit for the drug for innate and for patients that may benefit from this potential medicine.
Since it's pretty.
Speaker 3: So it's really confirmed by experimental assays in the fall. And it's really part of the, I would say, the lead optimization part of the candidate identification.
On film by excelling in Florida.
Based on the phase <unk>.
And it's really part of the.
I would say the lead optimization.
Based on the other.
The common data items mutation, so I didn't say that.
Speaker 3: So having said that, now it's more in the end of Sanofi. We're running the phase one, and we're also informing all these models with the PKP data that they will collect. And we may hear more or so at the SMO. As you know, they have an abstract on this topic for the CD123.
At the end of therapy.
And the phase one and also informing all this modem.
Safety data.
Correct and more.
Yes.
Yes.
As you know they have an abstract on this study further obviously you want to see.
Joyson Karakunnel: The ideal partner for Luku the map is one that can realize the potential of the drug for patients with CTCL and FOMA. As mentioned before, 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 early R&D engine. We want to ensure that if we can gain valuable competencies by a partner agreement for Luku the map we will consider that in our development plans for the product as we look to later stage trials.
Does that address your question.
Yeah, I think so let's.
Speaker 8: Yeah, I think so. So the CD123, I just wonder how you thought about it for the ones that follow, particularly your CD20 and how you're going to, what you expect and what we should expect with that one.
PD one secret I, just wonder how you thought about it for the ones that follow up, particularly FCB 'twenty and how youre going to yeah, what you expect and what we should expect a cat lines.
Speaker 3: It's something also that we have looked at in the candidate identification for the 65 program. But again, it's very experimental. And we are starting with the experiment, generating data, and it's part of the binder selection that we are doing. And we are testing multiple binders with different affinities, different epitopes.
It's something also that we have looked at.
<unk>.
Candidate identification over 65 program, but against the experiments seller.
Starting by the excess with the excitement the Nic data and its buffers banged up in Asia.
Unknown Attendee: Kia ora. Thank you.
That we are doing and we are testing multiple binders with different FTE different epitopes.
Diana Graybosch: Our next question comes from Diana. Great, great boss from Lebrink Partners. Your line is now open.
Speaker 3: Uh, and we are supporting that with some, some of that.
And we are supporting that with some of that so we think that the.
Speaker 3: So we think that the candidate that we have selected to move into the clinic is having good properties.
Diana Graybosch: Hi, thank you for the question.
Yannis Morel: I have one on NCAT.
The Comdata that were selected were moving into the clinic is a I would say is.
Yannis Morel: I wonder if you could talk about what you've learned from the preclinical data for the CD123 NCAT on where the optimal dose may be, specifically, you know, how, if there is a bell shaped dose curve, how much room you have at the top of that bell, the flexibility or how much room could to know if you have, and then more broadly as you look across to other NCAT programs. How much have work have you done optimizing affinity with affinity to extend the plateau of a potential bell shaped dose curve, and how difficult is that or different is that for the NCAT 4 versus the NCAT 3.
Having a good product.
Speaker 3: uh and it also has the as eric has presented some of his uh presentation at ash and various scientific congress
And.
Also as of year as Eddie has presented several of these.
Presentation at Ash and values offensive combat.
Speaker 3: So, we are really increasing the potency of the drug.
This format is yet and that will work to shore visibility even at very low.
So we are a year and switching gears with MTF.
Sure.
Speaker 9: This question of the bell-shape might be a little bit different with the YRK4, because we may not need so high concentration of drugs as for the YRK3. But again, I mean, data will tell us. Clinical data. Clinical data, yeah. Yeah, that's very helpful.
This question of the basic might get it could be different this year.
Because we may not need so to a high concentration of Basel III.
Yannis Morel: Thank you. Hi, they are. Yannis, you're sitting. Yeah, actually, in the processing is something that we can observe, the bell shaped curve, and as you may know, it's not unique to an engage or something that you can see also with some piece of an engage or something that can be bothered and it's confirmed by experience. They are several parameters that are in the engine, these bell shaped dose of the bell, namely the density of the entry chain on one side, the density of the entry chain.
But again I mean, that's how we'd get us.
Clinical data clinical data, yes, yes, that's very helpful.
Thank you thank you Dan.
Operator.
Speaker 1: It seems like we don't have any questions from our end right now. I'd now like to hand back to Henry. Thank you.
Keith back we don't have any questions from our end right now I'd now like to hand back to Henri Thank you.
Speaker 2: Thank you very much. It appears we don't have any further questions on the web chat either. So I think this concludes the call.
Thanks very much.
And as we don't have any further questions on the web channel either.
So in this case.
Thank you very much.
Yannis Morel: Let's have a look at the other side and the affinity of the dose binder, so it's quite easy to build a model. It's, it's really confirmed by the experimental experience, and it's really part of the, I would say, the utilization part of the, of the candidate identification. So, I think that we, and now it's more in the end of time, with running the first one and also informing all these notice with the key data that they will correct, and we may hear more or so at the, at the smoke, as you know, they have an abstract on this topic for the city one to pick.
Thank you.
Thank you for attending today's session.
Speaker 1: Thank you for attending today's session. We hope you found it useful. You may now disconnect. Have a wonderful day.
You may now disconnect have a wonderful day.
Yannis Morel: The literature question. Yeah, I think so, so the city one, I just wonder how you thought about it for the ones that follow, particularly your CV 20 and how you're going to. Yeah, what you expect and what we should expect of that one. It's something also that that we have looked at in the, and the candidate identification for the 65 program, but again, it's very experimental. I mean, we are talking about the experiment, the 19 data, and it's part of the binder of the action that that we are doing, and we are taking multiple binders with different activities, different epitopes.
Yannis Morel: And we are also posting that with some, some models, so we think that the, the, the candidate that we are selected to move into the clinic is, which is having a good properties. And it also has the, as Eric has presented some of his presentation at, and the various scientific conglets, this, this format, and the identity also to show pretty good efficacy, but not very low. So we are really increasing the potential of the right, so the, the question of the very shape might be a little bit different with the architecture, because we may not need so, so high compression of rice and for the young. Preet. But again, I mean, that's how we've got us.
Unknown Attendee: Yes, that's very helpful. Thank you. Thank you, Jan. Okay, I come. Seems like we don't have any questions from our end right now.
Henry Wheeler: I'd like to hand back to Henry Wheeler. Thank you. Thanks very much.
Operator: It appears we don't have any further questions on the web chat either. So I think this concludes the report. Thank you very much. Thank you. Thank you for attending today's session. We hope you found it useful.
Operator: You may not always connect.