Q3 2025 Innate Pharma SA Earnings Call & Business Update

<unk> prepared remarks, we will host a question and answer session. If you would like to ask a question. Please raise your hand, if you have dialed into todays call. Please press star nine to raise your hand and star six to amuse.

Operator: Financial results. After today's prepared remarks, we will host a question-and-answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. I will now hand the conference over to Stéphanie Cornen, Vice President, Investor Relations, Communication, and Commercial Strategy at Innate Pharma. Please go ahead.

I'll now hand, the conference over to Stephanie Cohen, Vice President Investor Relations Communications and commercial strategy at an H pharma. Please go ahead.

Good morning, and good afternoon, everyone. Thank you for joining us for <unk> 2025 business update and financial results Conference call.

Speaker #3: a differentiated, applying our deep value proposition for this

Speaker #3: high-value clinical pipeline

Stéphanie Cornen: Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma Q3 2025 Business Update and Financial Results Conference Call. The press release and today's presentation are both available on the IR section of our website. Before we begin, I'd like to remind everyone that today's presentation includes forward-looking statements based on current expectations. These statements involve risks and uncertainties that could cause actual results to differ materially. To begin, I briefly cover today's agenda. Our CEO, Jonathan Dickinson, will discuss our strategic priorities and path forward. Our CMO, Sonia Quaratino, will present clinical pipeline updates on IPH4502, monalizumab, and lacutamab. Afterward, I will present the commercial opportunity for lacutamab before turning back to Jonathan with closing remarks, and we'll open the call for Q&A. With that, I'll now hand it over to Jonathan.

Speaker #1: meeting. over to Stephanie Cornyn,

Speaker #3: truly transformative

Yes, we need in today's presentation are both available on the IR section of our website.

Speaker #2: Ladies and gentlemen, thank you for joining us and welcome to the Innate Pharma third quarter

Before we begin I'd like to remind everyone that today's presentation includes forward looking statements based on current expectations.

Speaker #3: seven, as we look announced the strategic decision to all our we announced the strategic decision

These statements involve risks and uncertainties that could cause actual results to differ materially.

Speaker #3: Investment on what we believe are assets.

To begin I believe he covert today's agenda, our CEO, Jonathan Dickinson will discuss our strategic priorities in place for a while.

Speaker #2: Communication and Commercial

And then our CMO soon Jaco Latino way to present clinical pipeline updates on I guess, 40, 502 modalities mob and lucky to have them up.

Speaker #3: foundation for future

The award I will present, the commercial opportunity for a lack of demand before turning back to Jonathan with closing remarks, and we would hope and solve the corner for Q&A.

With that I'll now hand, it over to Jonathan.

Thank you Stephanie and good morning to those joining from the U S and good afternoon to our European audience turning to slide five.

Speaker #3: Sonia. differentiated ADC IPH4502, our

Jonathan Dickinson: Thank you, Stéphanie. Good morning to those joining from the US, and good afternoon to our European audience. Turning to slide five, I would like to start with the strong momentum around lacutamab, supported by meaningful regulatory progress and new commercial opportunity insights. A few days ago, we received FDA clearance to initiate the TELLOMAK III phase 3 trial in cutaneous T-cell lymphoma. This is a major milestone for the program, positioning lacutamab to advance towards potential accelerated approval in Sézary syndrome, supported by robust phase 2 data. We expect the study to initiate in the first half of 2026, with filing anticipated following achievement of key enrollment milestones. Our CMO, Sonia Quaratino, will provide additional color on the phase 3 trial and the regulatory path. In parallel, we hosted a well-attended lacutamab KOL event in October, featuring leading experts in CTCL.

Speaker #4: Thank

Speaker #4: the three clinical Thank you,

I would like to start with the strong momentum around <unk> tomorrow supported by meaningful regulatory progress and new commercial opportunity insights.

A few days ago, we received FDA clearance to initiate the telematics III phase III trial in cutaneous T cell lymphoma.

This is a major milestone for the program.

<unk> tomorrow to advance towards potential accelerated approval in surgery syndrome supported by robust phase two data.

Speaker #4: IPH-4502 has negative four, as a

Speaker #4: demonstrated two major The first one features of

Speaker #4: differentiation to an approved drug such unfortunately, Vedotan. The first one is related to the is ecstatykan, a potent

We expect the study to initiate in the first half of 2026 with finding anticipated following achievement of key enrollment milestones.

Speaker #4: a potent opisomerase one

Speaker #4: inhibitor. cells. beneficial for

Our CMO Sonya quarantine will provide additional color on the phase III trial and the regulatory path.

Speaker #4: can induce a bystander

In parallel we hosted a well attended Likuta Mountain Kols event in October featuring leading experts in CTC L. The.

The discussions highlighted the continued unmet medical need for new effective well tolerated therapies in this space.

Jonathan Dickinson: The discussions highlighted the continued unmet medical need for new, effective, and well-tolerated therapies in this space, and reinforced lacutamab's unique positioning. During the event, we also presented new real-world claims data, underscoring the commercial opportunity in both CTCL, which we believe further strengthens the value proposition for this program. Stéphanie Cornen, our Vice President of Investor Relations, Communication, and Commercial Strategy, will review the real-world evidence-based commercial opportunities for lacutamab towards the end of our call today. Moving to slide six, as you know, Innate Pharma's core strength lies in applying our deep scientific expertise to advance life-enhancing cancer therapies. Through our years of pioneering work in antibody engineering, we have built a differentiated, high-value clinical pipeline supported by compelling data, positioning us to deliver treatments with truly transformative potential for patients and for all our stakeholders.

And reinforced macoutes maps unique positioning.

During the event, we also presented new real World claims data underscoring the commercial opportunity in both CTC L, which we believe further strengthens the value proposition for this program.

Speaker #4: preclinical models we have

Speaker #4: IPH-4502 can induce

Speaker #4: potent tumor regression findings. opportunity.

Speaker #4: Allowing us to target tumors that are

Stephanie Conan our vice President of Investor Relations and commercial strategy, we reviewed the real world evidence based commercial opportunities for <unk> towards the end of our call today.

Speaker #4: or have become resistant

Speaker #4: to parts the first in human trial on built the study design of the basis of this preclinical

Moving to slide six as you know in a farmer's core strength lies in applying our deep scientific expertise to advance life enhancing cancer therapies.

Speaker #4: in tumor types where negative for

Speaker #4: CTCL. The discussions path. In parallel, we

Speaker #4: Second, we enrich the study setting where of urothelial cancer

Through our years of pioneering work in antibody engineering, we have built a differentiated high value clinical pipeline supported by compelling data.

Speaker #4: space. And reinforced

Speaker #4: patient in the post-EV

Speaker #4: IPH-4502 may

Speaker #4: new real-world claims

Positioning us to deliver treatments with truly transformative potential for patients and for all our stakeholders.

Speaker #4: EV. This

Speaker #4: represents an area of high unmet the indication where need with no approved

Speaker #4: drugs and the potential to

Speaker #4: move rapidly into later

Moving to slide seven as.

As we look ahead.

Jonathan Dickinson: Moving to slide seven, as we look ahead, our path forward is clear and focused. As you remember, at our half-year results, we announced the strategic decision to focus our investment on what we believe are our highest-value clinical assets, including IPH4502, lacutamab, and monalizumab, to maximize impact and value creation. In parallel, we are advancing our next generation of ADC programs through research, building the foundation for future innovation. Finally, we are streamlining the organization to ensure we remain fit for purpose and aligned with our strategic objectives. I'll now hand over to Sonia, who will take us through the clinical pipeline progress. Sonia.

Our path forward is clear and focused.

Speaker #4: emerging clinical data will With this hypothesis, the

Speaker #4: indicate the indication

You remember at our half year results, we announced the strategic decision to focus our investments on what we believe are our highest value clinical assets, including IPX 40, 502, Likuta mob and Mona Lisa Meyer to maximize impact and value creation.

Speaker #4: impact. The first in human where IPH-4502 can make the greatest

Speaker #4: trial is guided by an adaptive design and the main objective of this

Speaker #4: trial is guided by an adaptive design and the main objective of this

Speaker #4: IPH-4502 in patients with advanced solid

Speaker #4: IPH-4502 in

In parallel we are advancing our next generation of ADC programs through research building the foundation for future innovation.

Speaker #4: Enrollment in the dose escalation part very well. We've

Speaker #4: clinical pipeline supported as you know, Innate

Finally, we are streamlining the organization to ensure we remain fit for purpose and aligned with our strategic objectives I'll now hand over to Sonya, who will take us through the clinical pipeline progress Sonya.

Speaker #4: Signs of clinical activity. We remain on track to.

Speaker #4: first quarter of

Speaker #4: 2026. And after that,

Thank you Jonathan and this update I would like to highlight the three clinical programs. We believe holds the strongest potential to create significant value for ignite.

Speaker #4: the dose optimization part of the

Stéphanie Cornen: Thank you, Jonathan. In this update, I would like to highlight the three clinical programs we believe hold the strongest potential to create significant value for Innate: IPH4502, monalizumab, and lacutamab. Starting with IPH4502, our differentiated ADC directed against Nectin-4. As a reminder, I would like to pinpoint the preclinical model where IPH4502 has demonstrated two major features of differentiation to an approved drug, such as enfortumab vedotin. The first one is related to the payload of IPH4502, which is exatecan, a potent topoisomerase I inhibitor. Exatecan can induce a bystander effect, a phenomenon where it kills neighboring cancer cells in addition to the targeted cells. The exatecan is released from the antibody-drug conjugate in the tumor and diffuses into nearby cells. This is beneficial for treating heterogeneous tumors where cancer cells may not all express the target antigens.

Speaker #4: slide 10 to provide an

Speaker #4: update on Monalizumab, which continues to advance in

The age 45 auto Monoline, XOMA and put them up.

Speaker #4: collaboration with combination with either

Speaker #4: Monalizumab, to maximize impact and aligned with our strategic IPH-4502, Lacutamab, and are our highest value clinical objectives. I'll now hand over fit for purpose and

Speaker #4: AstraZeneca. The Monalizumab as compared to

Starting with IP age $45 to our differentiated ADC directed against connecting for.

Speaker #4: double-blind pacific nine phase

Speaker #4: survival of oleclumab or

As a reminder, I would like to pinpoint in the preclinical model.

Speaker #4: Monalizumab as compared to

Speaker #4: Finally, we are streamlining the value creation. In

Well I P. H 45, or two has demonstrated the two major feature of differentiation.

When approved drugs, such as <unk> for Tomorrow.

Speaker #4: have not progressed after unresectable stage three platinum-based

Speaker #4: through the clinical pipeline

The first one is related to the payload of IV <unk> hundred 45, or two which is exciting and important topics or <unk> one inhibitor.

Speaker #4: very strong scientific

Speaker #4: rationale supported by

Speaker #4: earlier studies such as randomized one to one to one

Speaker #3: clinical programs we and aligned with our strategic objectives. I'll Jonathan. progress. In this update, I would believe hold the strongest innovation. Finally, we are streamlining value for now hand over to Sonia, who will take pipeline progress.

Except he can kind of use a bystander effect.

Speaker #4: NeoCOAST2 trials. This is a large global study that has fully

Nominal when it kills neighboring cancer cells. In addition to the target themselves. The extra taken is released from the antibody drug conjugate in the tumor and diffuses into nearby salads.

Speaker #4: patients randomized one to one to

Speaker #4: one across the three treatment monotherapy.

Speaker #4: The primary endpoint is

Speaker #3: directed against negative

This is beneficial for treating heterogeneous tumors, where cancer cells may not all express the target antigens.

Speaker #4: progression-free survival with

Speaker #3: would like to to an approved drug such differentiation

The second point of differentiation is that in preclinical models, we have demonstrated that <unk> 45, or two can induce potent tumor regression.

Speaker #3: demonstrated two major features of model where strongest potential to create Starting with Innate.

Speaker #4: study is fully recruited and combination arms versus durvalumab the independent data monitoring monotherapy. The committee recently recommended committee recently

Stéphanie Cornen: The second point of differentiation is that in preclinical models, we have demonstrated that IPH4502 can induce potent tumor regression in Padcev MME-resistant models, allowing us to target tumors that are or have become resistant to Padcev. We have therefore built the study design of the first in-human trial on the basis of these preclinical findings. First, we look for signals in tumor types where Nectin-4 expression may be low or heterogeneous, opening to a very broad opportunity. Second, we enrich the study of urothelial cancer patients in the post-EV setting, where IPH4502 may overcome resistance to EV. This represents an area of high unmet need with no approved drugs, and the potential to move rapidly into later stage development. With this hypothesis, the emerging clinical data will indicate the indication where IPH4502 can make the greatest impact.

In Paas, SaaS, and lemme resistant models, allowing us to target tumors that are all have become resistant to passive.

Speaker #4: And we look forward to the

Speaker #3: inhibitor. Ecstatykan can induce addition to the targeted

We have therefore built the study design of the first in human trial on the basis of this preclinical findings.

Speaker #3: Neighboring cancer cells in the payload of IPH4502 have been released from the antibody drug.

Speaker #4: our KOL event last month, our

First we will look for signals in tumor types, where <unk> four expression may be low or at a genius opening to a very broad opportunity.

Speaker #3: and diffuses into nearby

Speaker #4: development strategy is designed fungoides, and

Speaker #3: This is Allowing us to target tumors tumors where cancer cells that are or have

Speaker #4: to enable a stepwise with cesarean syndrome and indication

Speaker #3: treating heterogeneous

Speaker #4: approach beginning

Second we enrich the study of oral PDL cancer patient in the past EV setting well.

Speaker #4: with the highest unmet medical after mogamolizumab,

Speaker #4: patients who have progressed

Ipi $145 two may overcome resistance to EV.

Speaker #4: then progressing with a larger

Speaker #3: models we have demonstrated target IPH4502 can induce potent

Speaker #4: opportunity in mucosus the biologics license fungoides, and finally expanding

This represents an area of high unmet need with no approved drugs and the potential to move rapidly into later stage development.

Speaker #4: to peripheral T cell mogamolizumab, based on the preparing a confirmatory phase

Speaker #4: lymphoma. We are

Speaker #4: three study in

Speaker #4: MF and SS,

Speaker #3: become resistant

With this hypothesis that emerging clinical data will indicate the indication where IPA 45, or two can make the greatest impact.

Speaker #4: which, once underway, presents a potential path to

Speaker #3: We have therefore built the study design of the first in.

Speaker #4: opens the door for our

Speaker #4: filing of the biologics license application for cesarean syndrome post

Speaker #3: of this preclinical

The first in human trial is guided by an adaptive design and the main objective of the study.

Speaker #3: findings. First, models.

Stéphanie Cornen: The first in-human trial is guided by an adaptive design, and the main objective of the study is to assess the safety, tolerability, and preliminary efficacy of IPH4502 in patients with advanced solid tumors known to express Nectin-4. Enrollment in the dose escalation part of the study is progressing very well. We started the trial in January, and we have now reached already a pharmacologically active dose, and we have started to see early signs of clinical activity. We remain on track to complete the dose escalation by the first quarter of 2026. After that, the dose optimization part of the study should commence. Now, let's turn to slide 10 to provide an update on monalizumab, which continues to advance in collaboration with AstraZeneca.

Speaker #3: we look for signals in

Assess the safety Tolerability and preliminary efficacy of <unk> 45, or <unk> in patients with advanced solid tumors known to express let them fall.

Speaker #4: This represents a potential path

Speaker #3: expression may be low or tumor types where negative for heterogeneous, opening to

Speaker #4: key milestone expected

Speaker #3: a very broad

Speaker #4: in three will also include results of the

Speaker #4: 2027. The confirmatory phase

Enrollment in the dose escalation part of the study is progressing very well we started the trial in January and we have now reached already assigned biologically active dose and we have started to see early signs of clinical activity. We remain on track to complete the dose escalation.

Speaker #4: patients with mucosus fungoides,

Speaker #4: disease-modifying changer in the therapeutic confirmatory phase three

Speaker #4: therapies. These

Speaker #3: drugs and the potential to move

Speaker #3: rapidly into later stage

Speaker #3: development. setting where With with no approved

<unk> by the first quarter of 2026.

Speaker #4: MF and then full

Speaker #3: this hypothesis, the emerging clinical data will indicate

Speaker #4: approval for cesarean and

And after that the dose optimization part of the study should commence.

Speaker #4: a game changer in the

Speaker #4: therapeutic landscape across help establish Lacutamab as CTCL. and mucosis fungoides,

Speaker #3: greatest IPH4502 can make the

Speaker #3: The first-in-human trial is guided by an adaptive design, and the main.

Now, let's turn to slide 10 to provide an update on Mona Lisa mob, which continue to advance in collaboration with Astrazeneca.

Speaker #4: Our goal is to position preferred systemic

Speaker #3: objective of this study stage

Speaker #4: Lacutamab within the beyond CTCL, we are also

Speaker #3: is to assess the safety, development.

Speaker #3: tolerability, and preliminary efficacy of

The double blind the Pacific nine phase III trial aims to demonstrate improved progression free survival of durable allomap in combination with either <unk> or <unk> as compared to do follow up with placebo in <unk>.

Speaker #4: stage cesarean and mucosus

Speaker #4: fungoides but ultimately for earlier stage CTCL

Stéphanie Cornen: The double-blind PACIFIC-9 phase 3 trial aims to demonstrate improved progression-free survival of durvalumab in combination with either oleclumab or monalizumab, as compared to durvalumab with placebo in patients with unresectable stage 3 non-small cell lung cancer who have not progressed after platinum-based chemoradiotherapy. The PACIFIC-9 study builds on very strong scientific rationale supported by earlier studies such as COAST, NeoCOAST, and NeoCOAST II trials. This is a large global study that has fully completed enrollment with 999 patients randomized one-to-one-to-one across the three treatment arms. The primary endpoint is progression-free survival, with efficacy comparisons for both combination arms versus durvalumab monotherapy. The study is fully recruited, and the independent data monitoring committee recently recommended continuation of the trial following a pre-planned analysis, an important validation of the program progress. We look forward to the data expected in the second half of 2026.

Speaker #3: advanced solid tumors

Speaker #3: known to express negative

Speaker #3: four. Enrollment in

Speaker #4: patients who continue to

Speaker #4: options. Now,

Speaker #4: also advancing development of Lacutamab in

Patients with Unresectable stage III non small cell lung cancer was not progress after platinum based chemo radiotherapy.

Speaker #4: peripheral T cell lymphoma, beyond CTCL, we are

Speaker #3: started to see early signs of

Speaker #4: a particularly aggressive

Speaker #4: with few effective treatment

The Pacific nine study builds on very strong scientific rationale supported by earlier studies, such as coast nail coast and nil cost two trials.

Speaker #4: ongoing phase two study

Speaker #4: ongoing phase two study the accelerated approval mogamolizumab.

Speaker #4: will help define

Speaker #4: Lacutamab's role in this

Speaker #3: should quarter of commence. Now let's

Speaker #4: patient follow-up data from the telomarks

Speaker #4: population. Turning to slide 12, I would

This is a large global study that is fully completed enrollment with 999 patients from the minus one to one to one across the three treatment arms.

Speaker #4: for the accelerated

Speaker #4: approval in

Speaker #3: with trial aims to demonstrate

Speaker #4: cesarean post

Speaker #3: AstraZeneca. The double-blind improved progression-free survival. Now let's turn to...

Speaker #4: mogamolizumab. They are the long-term follow-up data from the

The primary endpoint is progression free survival with a secrecy comparison for both combination arms versus <unk> monotherapy.

Speaker #3: of durvalumab in

Speaker #4: presented at ASCO

Speaker #3: oleclumab or

Speaker #3: durvalumab with placebo

The study is fully recruited and the independent data monitoring Committee recently recommended continuation of the trial. Following a preplanned analysis, an important validation of the program progress and.

Speaker #3: in patients with

Speaker #3: unresectable stage three non-small

Speaker #3: cell lung cancer who have not three trial aims to demonstrate improved progression-free progressed after

Speaker #3: chemoradiotherapy. The pacific nine

Speaker #3: study builds on very strong scientific

We look forward to the data expected in the second half of 'twenty 'twenty six.

Now moving to slide 11 and to La Quinta mob.

Speaker #3: study that has fully

Speaker #3: This is a large global completed enrollment with the PACIFIC-9 study, which builds on...

Stéphanie Cornen: Now, moving to slide 11 and to lacutamab. As we highlighted during our KOL event last month, our development strategy is designed to enable a stepwise approach, beginning with Sézary syndrome, an indication with the highest unmet medical need, especially in patients who have progressed after mogamulizumab, then progressing with a larger opportunity in mycosis fungoides, and finally expanding to peripheral T-cell lymphoma. We are preparing a confirmatory phase three study in MF and SS, which, once underway, opens the door for our filing of the Biologics License Application for Sézary syndrome post-mogamulizumab, based on the existing phase two TELLOMAK data. This represents a potential path to accelerated approval, with a key milestone expected in 2027. The confirmatory phase three will also include patients with mycosis fungoides, the largest CTCL subtype, where there remains a clear need for disease-modifying therapies.

As we highlighted during our kols than last months. Our development strategy is designed to enable a step wise approach beginning with Saturday syndrome, an indication with the highest unmet medical need, especially in patients who have progressed.

Speaker #3: 999 patients

Speaker #3: across the three treatment

Speaker #3: arms. The

Speaker #3: primary endpoint is progression-free COAST, NeoCOAST, and

Speaker #3: comparisons for both combination

Speaker #3: arms versus survival with efficacy durvalumab completed enrollment

After vulgamore lease them up then progressing with a larger opportunity in mycosis, <unk> and finally, expanding to petty fellow T cell lymphoma.

Speaker #3: The study is fully recruited and the

Speaker #3: independent data monitoring arms.

Speaker #3: analysis and important validation of the program progress.

We are preparing a confirmatory phase III study in a mess and assess which once underway opens the door for our filing of the biologics license application for Saturday syndrome pulse smoke embolism up based on the existing.

Speaker #3: look forward to the data trial following a pre-planned Now moving to slide

Speaker #3: expected in the second half continuation of the trial 2026.

Speaker #3: 11 and to progress. analysis and important

Speaker #3: Lacutamab, as we And we

Speaker #3: highlighted during our data expected in the second

Speaker #3: KOL event last

Phase two <unk> data.

This represents a potential paths to accelerated approval with a key milestone expected in 2027.

Speaker #3: strategy is designed to half of month, our development enable a stepwise

Speaker #3: approach beginning with cezary 2026.

Speaker #3: syndrome and indication with the Now moving to highest unmet medical need especially in patients who

The confirmatory phase III will also include patients with mycosis <unk>, the largest safety Seattle subtype, where there remains a clear need for disease modifying therapies.

Speaker #3: have progressed after we highlighted during progressing with a larger opportunity in mucosis

Speaker #3: mogamolizumab, then Lacutamab, as

Speaker #3: finally expanding to

These results.

Speaker #3: peripheral T cell a confirmatory phase three

Of the confirmatory phase III trial will support a full approval in 2029 in MF and then full approval for Saturday and help establish <unk> as a game changer in the therapeutic landscape across C. D C L.

Stéphanie Cornen: These results of the confirmatory phase 3 trial will support a full approval in 2029 in mycosis fungoides and then full approval for Sézary and help establish lacutamab as a game changer in the therapeutic landscape across CTCL. Our goal is to position lacutamab within the NCCN guidelines as a preferred systemic therapy, not only for late-stage Sézary and mycosis fungoides, but ultimately for earlier stage CTCL patients who continue to face limited treatment options. Now, beyond CTCL, we are also advancing development of lacutamab in peripheral T-cell lymphoma, a particularly aggressive lymphoma subtype with few effective treatment options, and an ongoing phase 2 study will help define lacutamab's role in this patient population. Turning to slide 12, I would like to remind the data that will form the basis for the accelerated approval in Sézary post-mogamulizumab.

Speaker #3: and SS, which

Speaker #3: once underway opens the door for our filing of

Speaker #3: application for cezary syndrome post

Our goal is to position our crude them up within the NCC and guidelines as a preferred systemic therapy not only for late stage surgery and mycosis from lawyers, but ultimately for earlier stage <unk> patients will continue to face limited treatment.

Speaker #3: existing Phase Two Telomarks data. This represents

Speaker #3: accelerate the approval with a key

Speaker #3: milestone expected in

Speaker #3: 2027. The confirmatory phase three will the existing phase two

Speaker #3: mucosis fungoides, the

The option.

Speaker #3: largest CTCL telomere data.

Now beyond <unk>. We are also advancing development of local them up in peripheral T cell lymphoma at plastique without really aggressive lymphoma subtype with few effective treatment option and then ongoing phase two study will help.

Speaker #3: subtype where there remains

Speaker #3: disease-modifying therapies. These

Speaker #3: confirmatory phase three trial will

Speaker #3: support a full approval in

Speaker #3: MF and then full approval

Speaker #3: MF and then full approval the largest CTCL remains a clear need for for cezary and help establish Lacutamab as a game

Defining let's put them up a role in this patient population.

Turning to slide 12, I would like to reminder, the data that will form the basis for the accelerated approval inside study pulse.

Speaker #3: CTCL. Our

Speaker #3: goal is to position trial will support a full

Speaker #3: Lacutamab is expected to receive approval in 2029.

Speaker #3: NCCN guidelines as a

Speaker #3: preferred systemic therapy, not only for late stage cezary

Post Vulgamore leaves them up they are the longer term follow up data from the Telemark phase two trial that was presented that our scope 2025.

Stéphanie Cornen: They are the long-term follow-up data from the TELLOMAK phase two trial that was presented at ASCO 2025. Sézary syndrome is an aggressive subtype of CTCL, and post-mogamulizumab, there are no approved drugs that have demonstrated clinical efficacy. In heavily pretreated patients, all pretreated with mogamulizumab, lacutamab demonstrated an impressive global overall response rate of 42.9%, with a median duration of response of 25.6 months. The median progression-free survival for the whole population was 8.3 months. Of note, lacutamab was very well tolerated, with a very favorable safety profile, underscoring lacutamab's potential to deliver a meaningful clinical benefit in this aggressive and difficult-to-treat population. Turning now to mycosis fungoides, long-term follow-up data from the TELLOMAK phase two trial showed that lacutamab achieved a global overall response rate of 19.6%, with consistent activity observed regardless of KIR3DL2 expression level.

Speaker #3: earlier stage CTCL patients who continue to face

Speaker #3: limited treatment

So it is an aggressive subtype of city, Seattle, and Boston Logan lithium up there are no approved drugs that have demonstrated clinical efficacy.

Speaker #3: of Lacutamab in peripheral T cell lymphoma, a particularly aggressive lymphoma subtype with few

In heavily pre treated patients all proceeded with multiple Islam loquitur lump demonstrated an impressive global overall response rate of 42, 9% with a medium duration of response of 25 six months.

Speaker #3: effective treatment

Speaker #3: options, and an ongoing phase

Speaker #3: two study will face limited treatment help define Lacutamab's

Speaker #3: role in this patient

Speaker #3: population. Turning to slide 12, I would like to

The medium progression free survival for the whole population was eight three months.

Speaker #3: remind the data that

Speaker #3: will form the basis for lymphoma subtype

Of note last quarter remember was very well tolerated.

Speaker #3: They

Very favorable safety profile underscoring the potential to deliver a meaningful clinical benefit in these aggressive and difficult to treat population.

Speaker #3: are the long-term

Speaker #3: phase two trial that was

Speaker #3: presented at ASCO

Speaker #3: 2025. Cezary like to remind the data

Speaker #3: is an aggressive subtype of that will form the basis

Speaker #3: CTCL. And post

Speaker #3: mogamolizumab, there are no

Turning now to meet causes Fungoid us.

Speaker #3: approved drugs that have

Long term follow up data from the Telemark phase two trial showed that <unk> achieved a global overall response rate of 19, 6% with consistent activity observed regardless of <unk> two expression level.

In heavily pre treated patients all proceeded with multiple XOMA loquitur lump demonstrated an impressive global overall response rate of 42, 9% with a median duration of response of 25 six months.

Speaker #3: patients, all pretreated demonstrated clinical

<unk> is an aggressive subtype of city, Seattle and pulse mogul Liza map. There are no approved drugs that have demonstrated clinical efficacy.

In heavily pretreated patients all pretreated with multiple Islam loquitur lump demonstrated an impressive global overall response rate of 42, 9% with a median duration of response of 25 six months.

The medium duration of response was 13.8 months and median progression free survival was 10.2 months again with no difference between the two subgroup.

The medium progression free survival for the whole population was eight three months.

Stéphanie Cornen: The median duration of response was 13.8 months, and median progression-free survival was 10.2 months, again with no difference between the two subgroups. Also, in MF, lacutamab was very well tolerated, with an excellent safety profile that supports its potential use for long-term systemic therapy at an early stage disease. Turning to the clinical development plan for the confirmatory trial, this is an open-label, multicenter, randomized comparative phase 3 trial evaluating lacutamab in patients with cutaneous T-cell lymphoma who have failed at least one prior line of systemic therapy. In alignment with the FDA, the study includes two independent cohorts with distinct statistical analysis plans, one for Sézary syndrome, and the other for mycosis fungoides.

Of note last quarter remember was very well tolerated.

Very favorable safety profile, underscoring lockwood them up potential to deliver a meaningful clinical benefit in these aggressive and difficult to treat population.

Also in a less <unk>.

<unk> was very well tolerated with an excellent safety profile that supports its potential use for long term systemic therapy up in the early stage of disease.

The median progression free survival for the whole population was eight three months.

Of note Loquitur Mamba was very well tolerated, we can very favorable safety profile underscoring lockwood them up potential to deliver a meaningful clinical benefit in these aggressive and difficult to treat population.

Turning now to me causes phone guided us.

Turning to the clinical development plan for the confirmatory trial.

Long term follow up data from the Telemark phase two trial showed that <unk> achieved a global overall response rate of 19, 6% with consistent activity observed regardless of can't pre deal two expression level.

This is an open label multi center randomized comparative phase III trial evaluating <unk> in patients with cutaneous T cell lymphoma, what failed at least one prior line of systemic therapy.

Turning now to me causes Fungoid us.

Long term follow up data from the Telemark phase two trial showed that <unk> achieved a global overall response rate of 19, 6% with consistent activity observed regardless of Kim <unk> two expression level.

The medium duration of response was 13.8 months and median progression free survival was 10.2 months again with no difference between the two subgroup.

In alignment with the FDA. The study includes two independent cohort with distinct statistical analysis plans, one plus hazardous syndrome and the other four mycosis <unk>.

Also in MF.

In the sense that a syndrome cohort patients who have failed at least one prior systemic treatment, including multiple lease them up we'd be randomized one to one to receive either put them up or ROMI vaccine, which is currently the only FDA approved option for patients.

It was very well tolerated with an excellent safety profile that supports its potential use for long term systemic therapy. After the early stage of disease.

The medium duration of response was 13.8 months and medium progression free survival was 10.2 months again with no difference between the two subgroup.

Stéphanie Cornen: In the Sézary syndrome cohort, patients who have failed at least one prior systemic treatment, including mogamulizumab, will be randomized one-to-one to receive either lacutamab or romidepsin, which is currently the only FDA-approved option for patients who progressed after mogamulizumab. The primary endpoint is progression-free survival assessed by blinded independent central review, and the key secondary endpoint is overall survival. In the mycosis fungoides cohort, patients with stage IB to stage IV disease will also be randomized one-to-one between lacutamab and mogamulizumab, which represent the current standard of care for this population. Here again, the primary endpoint is PFS, with pruritus and quality of life as a secondary endpoint. As the Sézary syndrome and MF study subpopulations are considered as independent cohorts answering to distinct objectives, two sample sizes are estimated to meet the primary endpoint in both SS and MF cohorts independently.

Turning to the clinical development plan for the confirmatory trial. This is an open label multi center randomized comparative phase III trial evaluating <unk> in patients with cutaneous T cell lymphoma, what failed at least one prior.

Also in MF Lockwood, Amanda was very well tolerated with an excellent safety profile that supports its potential use for long term systemic therapy at an early stage of disease.

The progress of some of the more Lisa Loeb.

The primary endpoint is progression free survival assessed by blinded independent Central review and the key secondary endpoint is overall survival.

Turning to the clinical development plan for the confirmatory trial.

Line of systemic therapy.

In the mean causes from going this cohort of patients with stage one to stage four disease will also be randomized one to one between <unk> and Moca Muneeza lump, which represent the current standards of care for this population here.

In alignment with the FDA. The study includes two independent cohort with distinct statistical analysis plans, one for Saturday syndrome, and the other four mycosis <unk>.

This is an open label multi center randomized comparative phase III trial evaluating <unk> in patients with cutaneous T cell lymphoma, who have failed at least one prior line of systemic therapy.

<unk> syndrome cohort patients who have failed at least one prior systemic treatment, including multiple lease them up we'd be randomized one to one to receive either put them up or ROMI vaccine, which is currently the only FDA approved option for patients with <unk>.

Here again, the primary endpoint is PFS week, pruritus and quality of life as a secondary endpoint.

In alignment with the FDA. The study includes two independent cohort with distinct statistical analysis plans, one for Saturday syndrome, and the other four mycosis from Reuters.

As the sensory syndrome, and MF study subpopulation or consider as independent cohort.

In the sense that he syndrome cohort patients who have failed at least one prior systemic treatment, including mudguard, Melissa mob will be randomized one to one to receive either leucoderma or ROMI vaccine, which is currently the only FDA approved option for patients.

Setting two distinct objectives.

Some of them will ease up.

Sample size are estimated to meet the primary endpoint in both SMS and MMS cohort independently.

The primary endpoint is progression free survival assessed by blinded independent Central review and the key secondary endpoint is overall survival.

From a regulatory standpoint, we have received clearance from the SBA about this clinical trial protocol and therefore, we are well placed to initiate the phase III trial in the first half of 2026.

Stéphanie Cornen: From a regulatory standpoint, we have received clearance from the FDA about this clinical trial protocol, and therefore we are well placed to initiate the phase 3 trial in the first half of 2026. With that, I will now hand over to Stéphanie Cornen, who will walk us through the commercial opportunity for lacutamab and how we plan to unlock its full value across CTCL and beyond. Thank you, Sonia. Now, looking at the commercial opportunity, an important parameter is about the eligible population. CTCL is a rare and heterogeneous disease, and the assessment of incidence and prevalence remains a challenge, potentially underestimating its true burden. During our Q4 event, ZS Associates presented the most up-to-date source based on US claims data for the CTCL patient population, which highlights a higher incidence and prevalence than previously described.

In the mean causes from Gardez cohort patients with stage one to stage four disease will also be randomized one to one between <unk> and Moca Muneeza lumber, which represent the current standards of care for this population.

<unk> progress after mother Muneeza lump.

The primary endpoint is progression free survival assessed by blinded independent Central review and the key secondary endpoint is overall survival.

And we know that I will now hand over to Stefan the core NIM.

In the mean causes from Guy this cohort patients with stage one b to stage four disease will also be randomized one to one between Lakota mob and mogul Muneeza lamp, which represent the current standard of care for this population here again the primary endpoint.

Here again, the primary end point is PFS week, pruritus and quality of life as a secondary endpoint.

Will walk us through the commercial opportunity for luck with them up and our plan to unlock its full value across city, Seattle and beyond.

As the sensory syndrome, and adolescent studies subpopulation or consider as independent cohort.

Thank you Sonya.

Now looking at the commercial opportunity and then put on that is about the eligible population CTC and he's aware and <unk> disease.

Setting two distinct objective to sample size are estimated to meet the primary endpoint in both SMS and MMS cohort independently.

S PFS week, pruritus and quality of life as a secondary endpoint.

As the sensory syndrome, and a massive studies subpopulation or consider as independent cohort.

And the assessment of incidence and prevalence remained a challenge potentially endo estimates ingots to welded.

From a regulatory standpoint, we have received clearance from the FDA about this clinical trial protocol and therefore, we are well placed to initiate the phase III trial in the first half of 2026.

I'm setting two distinct objectives to sample size are estimated to meet the primary endpoint in both SaaS and MF cohort independently.

During a car while event Zss with gates presented the most up to date, so based on U S claims that that pharmacy Tcl patient population.

Which highlights the hydro incidence and prevalence as I previously described.

From a regulatory standpoint, we have received clearance from the FDA about this clinical trial protocol and therefore, we are well placed to initiate the phase III trial in the first half of 2026.

And with that I will now hand over to Stefan Nicole men.

So if we look into each of these opportunities staffing we see that extend harm as discussed he's really is in the near term I'm, calling the U S based on the phase II data.

Will walk us through the commercial opportunity for luck with them up and I would plan to unlock its full value across city, Seattle and beyond.

Stéphanie Cornen: If we look into each of these opportunities, starting with Sézary syndrome, as discussed, this is really the near-term encore in the US based on the phase two TELLOMAK data. Sézary syndrome may affect around three times more patients than previously believed, with an annual incidence around 300 patients, a prevalence around 1,000 overall diagnosed patients, and according to US claims data, approximately 300 patients treated with mogamulizumab annually. Importantly, this opportunity is a clearly defined and actionable opportunity concentrated in specialized and referral centers, which make it highly accessible with a focused commercial footprint. Our launch strategy will therefore target specialized centers already managing these patients, allowing for a near-term and de-risked opportunity in the US. Now, moving to mycosis fungoides, which represents a larger opportunity.

See that he sent the Honda may affect me effect of one three times more patients than previously believed with an annual incidence of one 300 patients pre balance or an one time event, although hard to diagnose patients and according to U S. <unk>, that's up approximately 300 patients treated with <unk>.

And with that I will now handover to stuff acne Carmen.

Thank you Sonya.

Will walk us through the commercial opportunity for luck with them up and our plan to unlock its full value across city, Seattle and beyond.

Now looking at the commercial opportunity and then put in Telecom Italia.

He is about the eligible population CTC and he's aware and if you have any new disease.

The assessment of incidence and prevalence remained a challenge potentially and maintained its true world. It during.

Thank you Sonya.

Any ideas.

Importantly, these opportunities are clearly defined and actionable opportunity concentrated in specialized and rectified Santos, which make it ideally exited a bedroom a waste of focused commercial footprint.

Now looking at the commercial opportunity and an important parameter is about the eligible population CTC and is aware and if you have any new disease and the assessment of antidotes and preeminence and remain a challenge potentially endo estimates ingots to London.

During a car while events Z in fiscal skate presented the more extra dates based on U S claims that that saw the C T cell patient population.

Like the hydro incidence and prevalence as I previously described.

Our launch strategy, which therefore target speaker like center all of edema and enjoying these patients early.

So if we look into each of these opportunities staffing, we see that extend harm as discussed he's really the near term I'm, calling the U S based on the phase II data.

During a car while event ZFS with gates presented the most ex debates hopes based on U S claim that that pharmacy, Tcl patient population, which highlights the hydro incidence and prevalence as I've previously described.

For any of them and de risk opportunity in the U S.

Now moving to micro <unk>, which represents a long term opportunity here again here what that actual idle incidents than previously reported with approximately 3000, new MF patients diagnosed each year in the U S.

She has already sent the Honda may affect me effects or one three times more patients than previously believed with an annual incidence of one 300 patients play balance are on one time events or are those patients and according to U S. Canada, that's up approximately 300 patients treated with Mohammed.

Stéphanie Cornen: Here again, real-world data show a higher incidence than previously reported, with approximately 3,000 new MF patients diagnosed each year in the US, and about one in four of these patients receive systemic therapy. The goal of our phase three, TELEMAK3, is to establish lacutamab as the new second-line standard of care, and our primary market research supports the view that physicians would adopt lacutamab as a second-line treatment base. Importantly, the commercial infrastructure built for Sézary syndrome would enable a seamless expansion into mycosis fungoides, since both indications are managed by the same network of prescribers. In summary, we see Sézary syndrome as our first focused entry point into the CTCL market in the US, a manageable and concentrated launch opportunity that will also serve as the foundation for a broader commercial rollout in MF.

So if we look into each of these opportunities staffing we see that extend harm as discussed he really is a near term I'm, calling the U S based on the phase II data market data.

And about one in four of these patients receive systemic therapy.

Sydney send Honda May affect me effect of one three times more patients than previously believed with an annual incidence of one 300 patients.

The Guardian of our phase III in IMAX three is to establish electrical and the new second line standard of care and our primary market research ship held the view that physician would adopt electric demand as a second line treatment base.

It's a bad idea.

And you had.

Importantly, these stop I can't see that clearly despite an extra enable opportunity concentrated in specialized and as I said hard to find out which make it ideally exited the bedroom with a focused commercial footprint.

And two on one time events are diagnosed patients and according to U S. Canzonetta approximately 300 patients treated with Mohammed needs a map and you Eddie.

And again importantly, the commercial Patrick Jobin profit at Sangamo would enable a seamless expansion into Mike will destroy this.

Our launch partner he would therefore target Speaker life center all of it in managing these patients.

Importantly, these opportunities are clearly defined and actionable opportunity concentrating in specialized and Zika hard sent out which make it ideally exit a bedroom with a focused commercial footprint.

The windfall of Neostem and Derisk opportunity in the U S.

Since both syndication I'm, an 80 basis send network of prescribers.

Now moving to micro <unk>, which represents a larger opportunity here again, we don't want that dash or idling students than previously reported with approximately 3000, new MF patients diagnosed each year in the U S and.

So in summary, we see says that returned home as our first focused entry points into the TTC and marketing in the U S. Magic button concentrated natural bottleneck is that we'd also serve as the foundation for a broader commercial rollout in Emmet.

Our launch strategy will therefore target a specialized center already managing these patients, allowing for any of them and de risk opportunity in the U S.

And about one in four of these patients receive systemic therapy.

Now moving to my colleagues from <unk>, which represents a larger opportunity here again, the Ottawa that dash of either incidence and previously reported with approximately 3000, new MF patients diagnosed each year in the U S.

Turning to slide 17, this slide illustrates the market potential from an African mobile <unk> and how we plan to expand over time through a stepwise strategy is absolutely I previously described.

The goal of our phase III than IMAX three.

Stéphanie Cornen: Turning to slide 17, this slide illustrates the market potential for lacutamab in CTCL and how we plan to expand over time through a stepwise strategy that Sonia previously described. We expect an initial opportunity of up to $150 million in the US with accelerated approval in Sézary syndrome, where the patient population is small but highly concentrated and addressable through a focused commercial footprint. As lacutamab moves into mycosis fungoides and secures full approval, the opportunity could expand to around $500 million across the US and Europe. Beyond that, we see additional upsides as part of our lifecycle management strategy. Lacutamab offers the potential to become the standard of care for early-stage patients, a segment where systemic treatments are less used today.

He is to establish <unk> as the news of Atlanta's standoff care and our primary market research. So probably view that physician would adopt electric I mab as a second line treatment baked.

And about one in four of these patients receive systemic therapy.

We expect an initial opportunity of up to 150 million into the U S with accelerated putting seemed that extend one where the patient population is small, but highly concentrated and address the birch with focused commercial footprint.

The garden of our phase III than IMAX III is to establish lexicon lab as the news of Atlanta's standoff care and our primary market research supervisor view that physician would adopt like with I Mab as a second line treatment base.

And again importantly, the Congo shallow Patrick Jobin profit at Sangamo would enable a seamless expansion into micro destroyed it seems.

Since both Densification mandated by the same network of prescribe.

As <unk> moves into make what he's forgoing desk and securely full are provided the opportunity could expand to.

So in summary, we see since I returned from our first focused entry points into the TTC end market in the U S magic button concentrates eventual bottleneck.

And again importantly, as a combo Shannon Patrick Jobin profit at Sangamo would enable a seamless expansion into Mike will destroy this since both densification among 80 basis Sem network of prescribers.

To around 500 million of course, the U S and Johan.

And beyond that we see additional upside as part of our ninth month, My lifecycle management strategy.

Does that mean also serve as the foundation for a broader commercial rollout in Emmet.

<unk> sells the potential to become the standard of care for early stage patient segments, where systemic treatments or less used to date.

So in summary, we see seasonally centcom as our first focused and viewpoint into the DTC AD market in the U S are manageable and concentrated natural bottleneck that will also serve as the foundation for a broader commercial rollout in MH.

Turning to slide 17, this slide illustrates the market potential for <unk> and how we plan to expand over time through a stepwise strategy is absolutely I previously described.

The unique profile of Mexico that combine tumor targeting activity improved quality of life and a favorable safety profile make you to competing candidates to unlock.

Stéphanie Cornen: The unique profile of lacutamab that combines tumor targeting activity, improved quality of life, and a favorable safety profile make it a compelling candidate to unlock earlier use of systemic therapy. While the phase 3 trial is designed to support registration across all stages of MF in the second-line setting, we see a broader opportunity in addressing the unmet medical needs of patients who are currently managed only with skin-directed therapy and may benefit from lacutamab. In short, lacutamab offers a clear de-risk path to commercialization, starting with Sézary syndrome, expanded into larger CTCL segments over time, and then an even larger opportunity in PTCL. Now I'll hand the mic to Jonathan for closing remarks. Thank you, Stéphanie. As part of our focus strategy, we're advancing three high-value clinical assets that form the core of Innate's portfolio.

We expect an initial opportunity of up to 150 million into the U S with accelerated of putting things out he sent home where the patient population is small, but highly concentrated and that's why I say birch focused commercial footprint.

Turning to slide 17, this slide illustrates the market potential from an academic lab in situ CN and how we plan to expand over time through a stepwise strategy is absolutely I previously described.

Use of <unk>.

Why does the phase III trial yard is designed to support registration across all stages of <unk> in the second line setting.

I would like to have moved into Mike when he spoke go index and secure full approval no parking equaled expense, Ohio to around 500 million of course, the U S and Johan.

We expect an initial opportunity of up to 150 million is the U S with accelerated applauding seem that extend one where the patient population is small, but highly concentrated and adverse events were focused commercial footprint.

We see a broader opportunity in addressing the unmet medical need of patient where Q1 came in H.

With the skin directed therapy and may benefit from an academic.

And beyond that we see additional upside as part of our ninth month, My lifecycle management strategy.

In short now Kitimat books are clear there is a path to commercialization and staffing we said that he sent home.

As luck would have moved into Mike what he's forgoing desk and securely full approval lopatin equaled expands Ohio to around 500 million across the U S and your work.

Lucky time, Apple sells a potential to become the standard of gas for early stage patient segments, where else systemic treatments or less used to date and the unique profile of Mexico that combine tumor targeting activity improved quality of life and a favorable safety profile.

Lending into lower <unk> segment over time, and then an even larger opportunity in PTC yet.

And beyond that we see additional upside as part of our ninth meant my lifecycle management strategy.

And now I'll hand, the mic to Jonathan for closing remarks.

<unk> sells a potential to become the standard of gas for early stage patient segments, where systemic treatment are less used to date.

Thank you Stephanie.

As part of our focus strategy, we are advancing three high value clinical assets that form the core of Eni's portfolio, starting with IP, aged 45 to our novel and differentiated Nexium for AGC, we see significant opportunity in bladder cancer.

Mickey to competing candidates to unlock our use of Sydney.

Why does the phase III trial yard is designed to support registration across all stages of MBS in the second line setting.

And the unique profile of Meloxicam that combine tumor targeting activity improved quality of life and a favorable safety profile Mackie to competing candidates to unlock our near our use of T cell interaction.

Stéphanie Cornen: Starting with IPH4502, our novel and differentiated Nectin-4 ADC, we see significant opportunity in bladder cancer, particularly in the post-Enfortumab vedotin setting, as well as across other solid tumors with low to medium Nectin-4 expression. Enrollment in the ongoing phase one trial is progressing well, with completion expected by late 2025 or early 2026. We've now reached a pharmacologically active dose level where we're beginning to see encouraging early signs of clinical activity. Monalizumab, partnered with AstraZeneca, continues to advance in phase three for unresectable non-small cell lung cancer, where enrollment in the PACIFIC-9 trial is now complete. Top-line data are expected in the second half of 2026, and this collaboration remains a key value driver with up to $825 million in total milestones and $450 million already received to date.

We see a broader opportunity in either way.

As soon as the unmet medical need of patient well country mandates.

<unk> in the post <unk> setting as well as across other solid tumors with low to medium <unk> four expression.

Why does the phase III trial yarn, India and is designed to support registration across all stages of MF in the second line setting.

With our skin brachytherapy and may benefit from <unk>.

Enrollment in the ongoing phase one trial is progressing well with completion expected by late 2025 or early 2026, we've now reached a pharmacologically active dose level.

In short no kitimat, both felt a clear their response to commercialization, starting we said that he sent home.

We see a broader opportunity in addressing the unmet medical need of patient where Q1 came in H on me with the skin Jackie therapy and may benefit from an academic.

Funded into low Jesse Tcl segment over time, and then an even larger opportunity in Pts yet.

Where we are beginning to see encouraging early signs of clinical activity.

And now I'll hand, the mic to jernigan for closing remarks.

In short Nike demand profile are clear there is a path to commercialization, starting we said that he sent home expanding into low Jesse Tcl segment over time, and then an even larger opportunity in Pts yet.

These are not partnered with Astrazeneca continues to advance in phase III, we'll unresectable non small cell lung cancer, whereas enrollment in the Pacific nine trial is now complete <unk>.

Thank you Stephanie.

As part of our focused strategy, we are advancing three high value clinical assets that form the core of a nice pool.

Portfolio.

Starting with <unk> 40, 502, our novel and differentiated Nexium for AGC we.

And now I'll hand, the mic to Jonathan for closing remarks.

Top line data are expected in the second half of 2026 and this collaboration remains a key value driver with up to $825 million in total milestones on $450 million already received to date.

Thank you Stephanie.

As part of our focus strategy, we are advancing three high value clinical assets that form the core of Eni's portfolio, starting with IP edge 40, 502, our novel and differentiated Nexium for AGC, we see significant opportunity in bladder cancer.

We see significant opportunity in bladder cancer, particularly in the post <unk> setting as well as across other solid tumors with low to medium <unk> four expression.

And with <unk>, our anti <unk> two antibody for cutaneous T cell lymphoma long term follow up from the Telemark Phase III study has demonstrated meaningful and durable clinical benefit in both mycosis, <unk> and surgery syndrome, leading to breakthrough therapy designation.

Roland in the ongoing phase one trial is progressing well with completion expected by late 2025 or early 2026, we've now reached a pharmacologically active dose level.

Stéphanie Cornen: With lacutamab, our anti-KIR3DL2 antibody for cutaneous T-cell lymphoma, long-term follow-up from the TELLOMAK phase 2 study has demonstrated meaningful and durable clinical benefit in both mycosis fungoides and Sézary syndrome, leading to Breakthrough Therapy Designation in Sézary syndrome. As you know, we've now received FDA clearance to proceed with the confirmatory phase 3 TELLOMAK 3 trial, and we're on track to initiate in the first half of 2026, supporting the potential for accelerated approval in Sézary syndrome. To wrap up today's call, I remind you that we have several value-driving catalysts ahead across Innate's portfolio. In the first half of 2026, we expect phase 1 data from IPH4502, our Nectin-4 ADC program. This will be followed in the second half of 2026 by data from the PACIFIC-9 phase 3 trial of mogamulizumab in collaboration with AstraZeneca.

Victory in the post <unk> setting as well as across other solid tumors with low to medium <unk> four expression.

Where we are beginning to see encouraging early signs of clinical activity.

Enrollment in the ongoing phase one trial is progressing well with completion expected by late 2025 or early 2026, we've now reached a pharmacologically active dose level.

In surgery syndrome.

<unk> partnered with Astrazeneca continues to advance in phase III, we'll unresectable non small cell lung cancer, whereas enrollment in the Pacific nine trial is now complete.

As you know we've now received FDA clearance to proceed with the confirmatory phase III Telematics III trial, and we're on track to initiate in the first half of 2026 supporting the potential for accelerated approval in February syndrome.

Where we're beginning to see encouraging early signs of clinical activity.

Top line data are expected in the second half of 2026 and this collaboration remains a key value driver with up to $825 million in total milestones on $450 million already received to date.

<unk> partnered with Astrazeneca continues to advance in phase III for Unresectable, non small cell lung cancer, whereas enrollment in the Pacific nine trial is now complete topline data are expected in the second half of 2026 and this collaboration remains a key.

To wrap up today's call I'll remind you that we have several value driving catalysts ahead across the <unk> portfolio in the first half of 2026, we expect phase one data from <unk> 45 of them to our netting for ADC program.

And with <unk>, our anti <unk> two antibody for cutaneous T cell lymphoma long term follow up from the Telemark Phase II study demonstrates a meaningful and durable clinical benefit in both my Cozy sung <unk>.

Value driver with up to $825 million in total milestones on $450 million already received to date.

This will be followed in the second half of 2026 by data from the Pacific Nine Phase III trial of <unk> in collaboration with Astrazeneca.

And with the Q tomorrow or anti cursory D O two antibody for cutaneous T cell lymphoma long term follow up from the Telemark Phase II study has demonstrated meaningful and durable clinical benefit in both my cozy spun gordy's in February syndrome, leading to breakthrough therapy designation.

Surgery syndrome, leading to breakthrough therapy designation in surgery syndrome.

Looking beyond 2027, and onward, we anticipate multiple milestones, including a potential accelerated approval for <unk> in surgery syndrome. The Mona Lisa My BLA filing and IP age 40, 502 expansion phase data <unk>.

Stéphanie Cornen: Looking beyond to 2027 and onward, we anticipate multiple milestones, including a potential accelerated approval for lacutamab in Sézary syndrome, the mogamulizumab Biologics License Application filing, and IPH4502 expansion phase data. Finally, we ended the third quarter of 2025 with a cash position of EUR 56.4 million, providing runway through the end of Q3 2026 to deliver on these key milestones. Operator, we can now open the Q&A session. Thank you. We will now begin the question and answer session. If you'd like to ask a question, please raise your hand now. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. Please stand by while we compile the Q&A roster. Your first question comes from the line of Christopher Liu with Lucid Capital Markets. Your line is now open. Please go ahead. Hey, guys.

As you know we've now received FDA clearance to proceed with the confirmatory phase III Telematics III trial, and we're on track to initiate in the first half of 2026 supporting the potential for accelerated approval in February syndrome.

Nation in surgery syndrome.

Finally, we ended the third quarter of 2025 with a cash position of.

As you know we've now received FDA clearance to proceed with the confirmatory phase III Telematics III trial, and we're on track to initiate in the first half of 2026 supporting the potential for accelerated approval in February singer.

To wrap up today's call I'll remind you that we have several value driving catalysts ahead across the <unk> portfolio in the first half of 2026, we expect phase one data from IP, aged 40, 502 are netting for ADC program.

$56 4 million euros, providing runway through the end of Q3 2026 to deliver on these key milestones operator, we can now open the Q&A session. Thank you.

To wrap up today's call I'll remind you that we have several value driving catalysts ahead across the <unk> portfolio in the first half of 2026, we expect phase one data for my ph 45 hours to our netting for ADC program.

We will now begin the question and answer session, if you'd like to ask a question. Please raise your hands now if you have dialed into todays call. Please press star nine to raise your hands and stars six to abuse. Please stand by while we compile the Q&A roster.

This will be followed in the second half of 2026 by data from the Pacific Nine Phase III trial of <unk> in collaboration with Astrazeneca.

Looking beyond 2027, and onward, we anticipate multiple milestones, including a potential accelerated approval for <unk> in surgery syndrome. The Mona Lisa My BLA filing and IP, aged 40, 502 expansion phase data.

This will be followed in the second half of 'twenty to 'twenty six by data from the Pacific nine Phase III trial of <unk> in collaboration with Astrazeneca.

Your first question comes from the line of Christopher Liu with Lucid capital markets. Your line is now open. Please go ahead.

Looking beyond 2027, and onward, we anticipate multiple milestones, including a potential accelerated approval for <unk> in surgery syndrome, the mono asthma, BLA filing and IP age 40, 502 expansion phase data. Finally, we ended the third quarter of <unk>.

Hey, guys. Thanks for the earnings call. This morning and for the question.

Finally, we ended the third quarter of 2025 with a cash position of.

Stéphanie Cornen: Thanks for the earnings call this morning and for the question. I have two. For the first one, what would you need to get done in the near term for the potential lacutamab commercial launch in Sézary syndrome? For the second question, for IPH4502 and the upcoming data set, could you give us a little bit more color on what we could see at that readout? Okay, Christopher, I can take that. From a commercial perspective, I think one of the key things that we would need to get done prior to Sézary launch is the work to ensure that lacutamab will be included in the NCCN guidelines.

So I have two for the first one what would you need to get done in the near term for the potential the crude map commercial launch and so is there a syndrome and for the second question.

$56 4 million euros, providing runway through the end of Q3 2026 to deliver on these key milestones operator, we can now open the Q&A session. Thank you.

For <unk> for $5 two in the upcoming data could you give us a little bit more color on what we can see at that readout.

<unk> 25, with a cash position of $56 4 million euros, providing runway through the end of Q3 2026 to deliver on these key milestones operator, we can now open the Q&A session. Thank you.

We will now begin the question and answer session, if you'd like to ask a question. Please raise your hands now if you have dialed into todays call. Please press star nine to raise your hands and starts 612 years. Please stand by while we compile the Q&A roster.

Okay Christopher I'll.

I can I can take that so.

So from a commercial perspective, I think one of the key things that we would need to get done prior to surgery launch is.

We will now begin the question and answer session, if you'd like to ask a question. Please raise your hands now if you have dialed into todays call. Please press star nine to raise your hands and star six to abuse. Please stand by while we compile the Q&A roster.

The work to ensure that the the macoute tomorrow will be included in the <unk> guidelines.

Your first question comes from the line of Christopher Liu with Lucid capital markets Your line.

What we're aiming to be able to do and we've already started the discussions on this with that with Kols.

<unk> is now open. Please go ahead.

Stéphanie Cornen: What we're aiming to be able to do, and we've already started the discussions on this with KOLs, is to ensure that when the BLA is approved for Sézary, we basically already have lacutamab included in those NCCN guidelines for Sézary syndrome, but also for mycosis fungoides. That will be one of the key pieces of work that we believe we will need to have in place prior to the BLA. IPH4502, in terms of what we hope to have next year, I think we've communicated this on a number of occasions, but what we're aiming to have is a cohort of patients in the Padcev resistance setting, probably 10-plus patients, where we will hopefully see an interesting response rate and be able to show clinical activity as well as safety data.

Hey, guys. Thanks for the earnings call. This morning and for the question.

Is to ensure that when the BLA is approved for surgery.

So I have two for the first one what would you need to get done in the near term for the potential of the crude map commercial launch and sensory syndrome and for the second question.

Your first question comes from the line of Christopher Liu with Lucid capital markets. Your line is now open. Please go ahead.

We basically already have likuta might be included in those end CCN guidelines for surgery syndrome, but also from Mike <unk> from <unk>. So that will be one of the key pieces of work that we believe we will need to have in place prior to the BLA.

Hey, guys. Thanks for the earnings call. This morning and for the question.

For <unk> 4502 in the upcoming data could you give us a little bit more color on what we could see at that readout.

So I have two for the first one what would you need to get done in the near term for the potential of the crude map commercial launch and so is there a syndrome and for the second question.

<unk>.

Then IP age 40 502 in terms of what we hope to have next year I think we've communicated this on a number of occasions, but what we're aiming to have is a cohort of patients in the <unk> resistant setting.

Okay, Christopher I'll I can I can take that.

So from a commercial perspective, I think one of the key things that we would need to get done prior to surgery launch is.

For IPL for fiber to the upcoming data side could you give us a little bit more color on what we can see at that readout.

The work to ensure that the the macoute tomorrow will be included in the <unk> guidelines.

Probably 10, plus patients, where we will hopefully see an interesting response rate.

Okay, Christopher I'll I can I can take that so from a commercial perspective, I think one of the key things that we would need to get done prior to surgery launch is.

What we're aiming to be able to do and we've already started the discussions on this with that with Kols.

Uh huh.

And be able to show clinical activity as well as safety data we also.

Is to ensure that when the BLA is approved for surgery that we.

The work to ensure that the the Mckew tomorrow will be included in the MCC on guidelines.

Hope to have data in one or two other tumor types.

Stéphanie Cornen: We also hope to have data in one or two other tumor types in a similar perspective, 10-plus patients in one or two tumor types. What we're doing with the study, and I think Sonia mentioned this earlier, is we've set up the study in a way where we can basically chase signals. We can backfill cohorts. When we see a signal in a particular tumor type, our objective is to backfill and to substantiate that signal. Hopefully then in one or two other tumor types, you would have 10-plus patients, and again, hopefully an interesting response rate that allows us to then move forward into the next stages for the development of the product. Thank you for the question, Christopher. Thanks. Your next question comes from the line of Justin Delling with BTIG. Your line is now open. Please go ahead. Thanks for taking our question.

We basically already have likuta might be included in those end CCN guidelines for surgery syndrome, but also for microchip from <unk>. So that will be one of the key pieces of work that we believe we will need to have in place prior to the BLA.

So what we're aiming to be able to do and we've already started the discussions on this with that with Kols is to ensure that when the BLA is approved for surgery that we basically already have likuta mabee included in those end CCN guidelines for surgery syndrome, but also from Mike <unk> from <unk>.

In a similar perspective so.

10, plus patients.

102 tumor types, what we're doing with the study and I think it's on Europe. I mentioned. This earlier is we've set up the study in a way where we can basically chase signals, we can backfill cohorts. So when we see a signal in a particular tumor type our objective is to backfill.

And then IP age 40 502 in terms of what we hope to have next year I think we've communicated this on a number of occasions.

So that will be one of the key pieces of work that we believe we will need to have in place prior to the BLA.

We're aiming to have is a cohort of patients in the concept resistant setting.

Im to substantiate that signals a hopefully then in one or two other tumor types. You would have 10, plus patients and again hopefully an interesting response rate that allows us to then move forward into the next stages for for the development of the product.

Probably 10, plus patients, where we will hopefully see an interesting response rate.

And then IP age 45 O too in terms of what we hoped to have next year I think we've communicated this on a number of occasions, but what we're aiming to have is a cohort of patients in the past SAP resistant setting.

Uh huh.

And be able to show clinical activity as well as safety data we also.

Thank you for the question Christopher Thanks.

Hope to have data in one or two other tumor types.

Probably 10, plus patients, where we will hopefully see an interesting response rate.

Your next question comes from the line of Justin selling BT.

In a similar perspective so.

Your line is now open. Please go ahead.

And be.

10, plus patients.

To be able to show clinical activity as well as safety data we also.

Thanks for taking our questions.

102 tumor types, what we're doing with the study and I think it's on Europe. I mentioned. This earlier is we've set up the study in a way where we can basically chase signals, we can backfill cohorts. So when we see a signal in a particular tumor type our objective is to backfill.

You've indicated that FDA views, an accelerated approval pathway here for accrued amount of buzz as viable once the phase III studies underway could you just expand whether FDA is looking for any additional supplementary analyses beyond the existing phase two dataset as part of that.

Hope to have data in a one or two other tumor types.

Stéphanie Cornen: You've indicated that FDA views an accelerated approval pathway here for lacutamab as viable once the phase three study is underway. Could you just expand whether FDA is looking for any additional supplementary analyses beyond the existing phase two data set as part of that accelerated approval package? Just second, off of the feedback from the October KOL event, do you have a sense of growing momentum from the KOLs for lacutamab to become the preferred second-line option here? Should we expect mogamulizumab to naturally move later in the treatment paradigm? Okay. Addressing the first part of your question, Justin, from an FDA perspective, they have not given us an indication that we would require any further substantial analyses.

In a seamless perspective so.

10, plus patients.

In one or two tumor types, what we're doing with the study and I think us on Euro I mentioned. This earlier is we've set up the study in a way where we can basically chase signals, we can backfill cohorts. So when we see a signal in a particular tumor type our objective is to backfill.

To substantiate that signals a hopefully then in one or two other tumor types you would have 10, plus patients and again hopefully an interesting response rate that allows us to then move forward into the next stages for for the development of the product.

Accelerated approval package.

And then just second staff.

The feedback from the October Kols event.

You have a sense of growing momentum from the Kols for tomorrow.

To substantiate that signals a hopefully then in one or two other tumor types you would have 10, plus patients and again hopefully an interesting response rate that allows us to then move forward into the next stages for our for the development of the product.

Thank you for the question Christopher Thanks.

Mab to become the first and second line option here and.

Your next question comes from the line of Justin Patterson with BT.

Should we expect more lean them out.

Naturally move later in the treatment paradigm.

Your line is open. Please go ahead.

Yeah.

Okay.

Thanks for taking our questions.

Addressing the first part of your question Justin So.

Thank you for the question Christopher Thanks.

[noise] indicated that FDA views, an accelerated approval pathway here for us.

From an FDA perspective, they have not given us an indication that we would require any any further substantial analyses. So basically the BLA approval will be based off the data we have in hand today from the Telemark study.

Your next question comes from the line of Justin Patterson with BT <unk>. Your line is open. Please go ahead.

But once the phase III studies underway could you just expand whether FDA is looking for any additional supplementary analyses beyond the existing phase II data set as part of that accelerated approval package.

Stéphanie Cornen: Basically, the BLA approval will be based off the data we have in hand today from the Telemak study and the results that we've already presented that led to the breakthrough therapy designation. We see that as reasonably straightforward. The key thing to unlocking the BLA submission here is having the confirmatory study up and running and to have established an enrollment trajectory into that study that would satisfy FDA that this study will complete and will deliver the confirmation of the accelerated approval. That's something that we're obviously working very hard to be ready to do that ASAP because that counts down, it's the countdown to the submission of the BLA. We hope to be able to initiate the confirmatory phase 3 study sometime around the middle of 2026. We would anticipate potentially a six-month enrollment period to get the right trajectory to satisfy FDA requirements.

Thanks for taking our questions.

You've indicated that FDA views, an accelerated approval pathway here for accrued amount of buzz as viable once the phase III studies underway.

And the results that we've already presented that led to the breakthrough therapy designation. So.

And then just second staff of the feedback from the October Kols event.

We see that as is reasonably straightforward.

Can you just expand whether FDA is looking for any additional supplementary analyses beyond the existing phase two dataset as part of that accelerated approval package.

You have ascend growing momentum from the Kols for La <unk>.

The key.

The key thing to unlocking the BLA submission here is having the confirmatory study up and running.

The per second line option here.

Should we expect.

And two are established.

And then just second staff of the feedback from the October Kols Avanti.

Naturally move later in the in the treatment paradigm.

And enrollment are true.

<unk> into that study that would satisfy FDA that this study will complete and we will deliver the confirmation of the accelerated approval. So that's.

Yeah.

You have a sense of growing momentum from the Kols furlough to mab to be to come.

Okay.

Dressing the first part of your question Justin So from an FDA perspective, they have not given us an indication that we would require any any further substantial analyses. So basically the BLA approval will be based off the data we have in hand today from the Telemark study and.

First back in my an option here.

That's something that we're obviously working very hard to be ready to do that Asap.

Shall we expect more.

Naturally move later in the in the treatment paradigm.

Because that counts down the Easter countdown to the submission of the BLA.

Okay.

Okay. So addressing the first part of your question Justin So from.

We hope to be able to initiate the confirmatory phase III study sometime around the middle of 2026.

From an FDA perspective, they have not given us an indication that we would require any any further substantial analyses. So basically agree that the BLA approval will be based off the data we have in hand today from the Telemark study and on.

And the results that we've already presented that led to the breakthrough therapy designation. So.

We would anticipate potentially a six month enrollment period to get the right trajectory to satisfy FDA requirements.

We see that as is reasonably straightforward.

And then that would allow us to submit the BLA sometime in early 2027, leading to FDA approval of the BLA hopefully sometime in the second half of 2027.

The key.

The key thing to unlocking the BLA submission here is having the confirmatory study up and running.

Stéphanie Cornen: That would allow us to submit the BLA sometime in early 2027, leading to FDA approval of the BLA, hopefully sometime in the second half of 2027. Yeah, that hopefully answers the first part of your question. In terms of KOL feedback, we do see very good KOL feedback on lacutamab, and we do sense a building momentum around that. I think if you were attending the KOL event, I think the KOL used the word game changer, which was, I think, something that summarizes what lacutamab can potentially bring not only to Sézary syndrome, but also to mycosis fungoides. I think there's particular excitement around basically what can happen in MF. If we look at the five-year survival of patients with MF, we do see a dramatic decrease in five-year survival when patients progress from stage 2A to stage 2B.

The results that we've already presented that led to the breakthrough therapy designation. So.

And two are established.

And enrollment.

We see that as is reasonably straightforward.

<unk> into that study that would satisfy FDA that this study will complete and we will deliver the confirmation of the accelerated approval. So.

So yeah, so thats hopefully answered the first part of your question then in terms of Colo Kols feedback.

The key.

The key thing to unlocking the BLA submission here is having the confirmatory study up and running.

We do see very good kols feedback on <unk>, and we do sense.

That's something that we're obviously working very hard to be ready to do that a S O P.

And two are established.

Our building momentum around that I think if.

Enrollment.

Because that counts down the Easter countdown to the submission of the BLA.

Trajectory into that study that would satisfy FDA that this study will complete and will deliver the confirmation of the accelerated approval. So.

If you were attending the Kols event and I think the Cairo used the word game changer.

We hope to be able to initiate the confirmatory phase III study sometime around the middle of 2026.

Which was I think something that summarizes what luca to map can potentially bring.

That's something that we're obviously working very hard to be ready to do that ISO P.

We would anticipate potentially a six month enrollment period to get the right trajectory to satisfy FDA requirements.

Only to surgery syndrome, but also to Mike Kozak from <unk> I think this particular excitement.

Because that counts down the Easter countdown to the submission of the BLA, we hope to be able to initiate the confirmatory phase III study sometime around the middle of 2026.

And then that would allow us to submit the BLA sometime in early 2027, leading to FDA approval of the BLA hopefully sometime in the second half of 2027.

Around <unk>.

Basically what can happen in MF.

We would anticipate potentially a six month enrollment period to get the right trajectory to satisfy FDA requirements.

If we look at the five year survival of patients with MF, we do see a dramatic decrease in five year survival when patients progress from stage two eight to stage two be it drops from 78% to 47% and we know that physicians want to be able to prevent that progression.

Yeah, So thats hopefully answered the first part of your question then in terms of Colo Kols feedback.

And then that would allow us to submit the BLA sometime in early 2027, leading to FDA approval of the BLA hopefully sometime in the second half of 2027. So yeah. So that hopefully answers. The first part of your question that in terms of.

We do see very good kols feedback on <unk>, and we do sense.

Stéphanie Cornen: It drops from 78% to 47%. We know that physicians want to be able to prevent that progression. Lacutamab, based on its tolerability profile and the excellent quality of life data for patients, is incredibly well placed to be able to slot into that area and be able to treat those patients at stage 1B, stage 2A, and hopefully prevent that progression of the patients to stage 2B when you see the reduction in five-year survival. That's clearly, I think, factoring into the thinking of KOLs and how they will use this drug. I think particularly in MF, we anticipate that lacutamab will be used ahead of Moga. In Sézary, we're studying post-Moga. Our expectation is that the product will be used post-Moga. Based on the excellent safety profile, I think some physicians may choose to use it in the first-line setting off-label as well.

Our building momentum around that I think.

And Lacuna Tomorrow based on its tolerability profile and the excellent quality of life data for patients is incredibly well placed to be able to slot into that area and be able to treat those patients at that stage won't be stage, two eh and hopefully prevent that progress.

If you were attending the Kols event, and I think that the Kols you used the word game changer.

<unk> Kols feedback.

We do see very good kols feedback on Likuta map, and we do sense a building momentum around that I think if.

Which was I think something that summarizes what luca to map can potentially bring.

Not only to surgery syndrome, but also to Mike Kozak from <unk> I think this particular excitement.

If you were attending the Carryall event, and I think the K O L used the word game changer.

<unk> of the patients to stage to be when you see the reduction in five year survival. So.

Around <unk>.

Which was I think something that summarizes what likuta map can potentially bring to <unk>.

Basically what can happen in MF.

That's clear.

Clearly I think factoring into the thinking of Kols and how they will use this drug so I think particularly in MF.

If we look at the five year survival of patients with <unk>, we do see a drastic decrease in five year survival when patients progress from stage two a two stage two be it drops from 78% to 47% and we know that physicians want to be able to prevent that progression.

Only to surgery syndrome, but also to Mike houses from <unk> I think this particular excitement around basic.

Anticipate that.

<unk> will be used ahead of moga.

Basically what can happen in MFS if.

In February we are studying post moga.

So our expectation is that the product will be used post moga.

If we look at the five year survival.

Patients with <unk>, we do see a drastic decrease in five year survival when patients progress from stage two a two stage two be it drops from 78% to 47% and we know that physicians want to be able to prevent that progression and lacuna tomorrow based on its tolerability.

And Lacuna Tomorrow based on its tolerability profile and the excellent quality of life data for patients is incredibly well placed to be able to slot into that area and be able to treat those patients that are at stage won't be stage, two eh and hopefully prevent that progress.

Based on the excellent safety profile I think some physicians may choose to use it in the first line setting off label as well.

But.

Our main assessments, where and where we're targeting for positioning the product is post moga and initially in the surgery syndrome indication.

Stéphanie Cornen: Our main assessment and where we're targeting for positioning the product is post-mogamulizumab and initially in the Sézary syndrome indication. Hopefully, I've answered your question. Great. That was great. If I could just fit in a quick question with a potential near-term approval here, could you just comment on your CMC readiness as far as commercial-scale manufacturing, PPQ runs, stability work for lacutamab? Yeah, I can. I can comment on that. I think the answer is we're in a good place. We're basically ready to go. That won't be on the critical path to submission of the BLA. We've ticked that box, and we're ready to go from that perspective. Thanks for taking our questions. Your next question comes from the line of Swarnpakula Ramakant with HC Wainwright. Your line is now open. Please go ahead. Hello. Good morning, Jonathan, and thanks for taking my question.

The profile and the excellent quality of life data for patients is incredibly well placed to be able to slot into that.

Hopefully I've answered your question.

<unk> of the patients to stage to be when you see the reduction in five year survival. So.

Great that was great if I could just spending on a quick question.

That's clearly I think factoring into the thinking of Kols and how they will use this drug so I think particularly in MF.

With a potential near term approval here could you just comment on your CMC readiness as far as commercial scale manufacturing PDQ, Ron stability work for Latuda Mab.

Area and be able to treat those patients that are at stage won't be stage, two eh and hopefully prevent that progression of the patients to stage to be when you see the reduction in five year survival. So.

We anticipate that.

Yes, I can I can comment on that and I think the answer is we're in a good place where we're basically ready to go and that won't be on the critical path to submission of the BLA.

<unk> will be used ahead of moga in surgery, we're studying post moga.

That's clearly I think factoring into the thinking of Kols and how they will use this drug so I think particularly in MF.

So our expectation is that the product will be used post moga based on the excellent safety profile.

So we've ticked that box and.

We anticipate that.

Some physicians may choose to use it in the first line setting off label as well.

And we're ready to go from a from that perspective.

Likuta Mab will be used ahead of moga Incisory, we're studying post moga and so our expectation is that the product will be used post moga based on the excellent safety profile I think some physicians may choose to use it in the first line setting off label as well.

Thanks for taking my questions.

Our main assessments were and where we're targeting for positioning the product is post moga.

Your next question comes from the line of swarm per cooler Rama come with H C. Wainwright. Your line is now open. Please go ahead.

Initially in the sensory syndrome indication.

Hopefully I've answered your question.

Great that was great if I could just spending on a quick question.

But.

Our main assessments were and where we're targeting the positioning the product is post moga and initially in the Treasury's syndrome indication.

With a potential near term approval here could you just comment on your CMC readiness as far as commercial scale manufacturing PDQ, Ron stability work for Latuda maps.

Hello.

Good morning, Jonathan and thanks for taking my question.

So.

Hopefully I've answered your question.

Appreciate your comments on how you plan to to file the accelerated approval application by the end of the country trying to fix.

Stéphanie Cornen: I appreciate your comments on how you plan to file the accelerated approval application by the end of 2026. Does this mean you're still hoping to get a partner on board? In your previous conversations with potential partners, how much stress was there in terms of getting a clear signal from the FDA and a protocol blessed by the FDA? Thank you for the question, Arcay. In terms of partner discussions, having FDA acceptance of the protocol was an important consideration. It was potentially one of those boxes that we needed to tick for a number of them for us to be able to progress with those discussions. Yes, it was an important clearing event to be able to move forward with some of those partnering discussions.

Great that was great if I could just spending on a quick question.

Yes, I can I can comment on that and I think the answer is we're in a good place where we're basically ready to go and that won't be on the critical path to submission of the BLA.

You know with a potential near term approval here could you just comment on your CMC readiness as far as commercial scale manufacturing PV kiran stability work relative to map.

So what.

So we take that box and.

Does that does this mean you are still hoping to get a partner on board and in your previous conversations with.

We're ready to go from a from that perspective.

Yeah, I can I can comment on that and I think the answer is where we are in a good place where we're basically ready to go on that won't be on the critical path to submission of the BLA.

Thanks for taking my questions.

Potential partners, how much stress for us there in terms of getting.

Your next question comes from the line of swarm per quarter, Brahma Com with H C. Wainwright. Your line is now open. Please go ahead.

So we take that box and and we're ready to go from a from that perspective.

Getting.

A clear signal from the FDA and.

And in our protocol.

Thanks for taking my questions.

Left by the FDA.

Okay.

Your next question comes from the line of swarm Pakula Rama Com with H C. Wainwright. Your line is now open. Please go ahead.

Thank you for the question RK so.

Good morning, Jonathan.

Thanks for taking my question.

In terms of partner discussions.

So.

Appreciate your comments on how.

Having FDA acceptance of the protocol was.

How do you plan to file.

File the accelerated approval application and upfront they're trying to fix.

An important consideration it was potentially one of those boxes that we needed to take.

Okay.

Good good morning, Jonathan.

So.

Thanks for taking my question.

So what does that does this mean you are still hoping to get a partner on board.

For a number of them for us to be able to progress with those discussions. So so so yes. It was an important clearing event to be able to move forward with with some of those partnering discussions are in terms of partnering commentary on partnering.

So appreciate your comments on and Ah Ha how are you.

In your previous conversations with.

To to file the accelerated approval application by the end of trying to trying to fix.

Potential partners.

Stress for us there in terms of getting.

So.

So what it.

Getting them.

Does that does this mean you are still hoping.

Stéphanie Cornen: In terms of partnering, commenting on partnering, I think what the company is looking to do is basically to keep our options open. We basically are continuously evaluating a variety of financial options to ensure we're appropriately positioned to support our growth initiatives and create long-term shareholder value. We remain disciplined and opportunistic in our approach to capital management, and we'll pursue the opportunities that basically support where we're going here. I think it's important that we keep the options open at this particular stage, particularly with the exciting news that we've seen more recently with lacutamab and the great path that we have forward. Thank you. Can I ask two quick follow-ups? One on IPH4502, what specific safety signals would you be looking out for, especially when you would like to see this differentiated against other topo-1 inhibitor ADCs?

Here.

I think what the company is looking to do is basically to keep all our options open.

No from the FDA and.

Get a partner on board on in your previous conversations with.

The protocol blessed by the FDA.

Basically we're continuously evaluating a variety of financial options to ensure we are.

Potential partners, how much stress for us there in terms of getting.

Okay.

Yeah.

Thank you for the question RK so.

Appropriately positioned to support our growth initiatives and create long term shareholder value and.

In terms of a partner discussions.

Getting a clear signal from the FDA and.

Uh huh.

Having FDA acceptance of the protocol was.

And a protocol.

We remain disciplined and opportunistic.

Left by the FDA.

Our approach to capital management.

An important consideration it was potentially one of those boxes that we needed to tick.

Okay.

We will pursue the opportunities that basically support where we're going here. So.

Thank you for the question RK so.

In terms of a partner discussions.

I think it's important that we keep the options open at this particular stage, particularly with the exciting news that we see more recently with Likuta Mab and the great path that we have forward.

For a number of them for us to be able to progress with those discussions. So so so yes. It was an important clearing event to be able to move forward with with some of those partnering discussions.

Having FDA acceptance of the protocol was.

An important consideration it was potentially one of those boxes that we needed to take.

Thank you can I ask two quick follow ups, one on fortify or to watch a specific safety signals.

In terms of partnering commentary on partnering.

For a number of them for us to be able to progress with those discussions. So so so yes. It was an important clearing event to be able to move forward with with some of those partnering discussions are in terms of partnering commentary on partnering I I think what the company is looking to do.

I think what the company is looking to do is basically to keep all our options open.

Looking out far, especially when you would like to see this differentiated against other topo one inhibitor disease.

We basically were continuously evaluating a variety of financial options to ensure we are.

And the second question is so what's the thought process now for the ankle platform.

<unk> position to support our growth initiatives and create long term shareholder value and.

Stéphanie Cornen: The second question is, what's the thought process now for the ANKET platform, especially them taking a little bit of a backseat? What's the long-term plan for that platform? Maybe I can take the first question, and then I will ask Sonia to take the question on the safety signals that we're looking out for. On the ANKET platform, we basically were actually finalizing the study for IPH6501. I think we mentioned previously that we'd completed the dose escalation phase of the study, and we were basically exploring the MTD at this stage. We're still in the process of doing that. We'll basically make any future decisions for IPH6501 based off clinical data. That clinical data should come sometime in the first half of next year, and then we will be able to make the evaluations and the next steps.

<unk> basically to keep our options open.

Especially now.

We remain disciplined and opportunistic in our approach to capital management.

I'm, taking a little bit of a back seat.

We basically were continuously evaluating a variety of financial options to ensure we are appropriately positioned to support our growth initiatives and create long term shareholder value and.

What's the long term plan for that for that platform.

We will pursue the opportunities that basically support where we're going here. So.

So maybe I can take the first question then I will ask Sonya to take the question on the safety signals that we're looking out for so.

I think it's important that we keep the options open at this particular stage, particularly with the exciting news that we see more recently with <unk> and the great path that we have forward.

We remain disciplined and opportunistic in our approach to capital management.

On the <unk> platform.

We basically waiting we're actually finalizing the study for IPO 60 fiber one.

We will pursue the opportunities that basically support where we're going here. So.

Thank you can I ask two quick follow ups, one on 45 or two what's specific safety signals.

I think it's important that we keep the options open at this particular stage, particularly with the exciting news that we see more recently with Likuta Mab and that the great path that we have forward.

I think we mentioned previously that we've completed the dose escalation phase of the study and we were.

Looking out far, especially Ben.

Basically exploring the MTGE at this stage, we're still in the process of doing that.

We'd like to see this differentiated against other topo one.

Thank you can I ask two quick follow ups, one on fortify or to watch a specific safety signals.

Peter Adcs.

And we will basically make any future decisions based on our four <unk> 65, a one based off our clinical data.

And the second question is.

So what's the thought process now for the anchor platform.

Looking out looking out far, especially when you would like to see this differentiated against other topo one.

Especially.

And that clinical data should come sometime in the first half of next year and then we will be able to make the evaluations and the next steps.

I'm, taking a little bit of a back seat.

What's the long term plan for that for that platform.

<unk> disease.

Yeah. So maybe I can take the first question then I will ask Sonya to take the question on the safety signals that we're looking out for so.

And the second question is.

So what's the thought process now for the anchored platform.

In relation to IPX 60, 101, we have now.

Stéphanie Cornen: In relation to IPH6101, we have now basically had most of the clinical data for the phase one and phase two return to us from Sanofi. We are now in the process of evaluating that data and trying to understand what next steps could be for the ANKET platform. What I would really like to clearly emphasize, though, is from a prioritization perspective, we are putting most of our time and effort behind IPH4502, behind lacutamab, and behind mogamulizumab, and making sure that we advance those three assets as quickly as possible, because we believe we have the highest chance to win for those three assets. Sonia, if you can take the question on the safety signals we are potentially looking out for. Well, in terms of signal for IPH4502, we try to establish a very well-tolerated and relatively safe drug.

Especially now that I'm, taking a little bit of a back seat.

Basically have most of the clinical data for the phase one and phase two.

On the <unk> platform.

What's the long term plan for that for that platform.

We basically waiting we're actually finalizing the study for IPO 60 fiber one.

Returned to us from Sanofi. So we're now in the process of evaluating that data.

So maybe I can take the first question and I will ask Sonya to take the question on the safety signals that we're looking out for so.

And trying to understand what next steps could be.

We mentioned previously that we've completed the dose escalation phase of the study.

For the <unk> platform, what I would really like to clearly emphasize though is our product from a prioritization perspective, we are putting most of our time and effort behind <unk> 40, 502 behind <unk> and behind <unk>, and making sure that we advance though.

On the <unk> platform.

Basically exploring the MTGE at this stage, we're still in the process of doing that.

We are basically you are waiting we were actually we are finalizing the study for IPO 60 fiber one.

And we will basically make any future decisions based on our on our for our IPO 65 are willing based off our clinical data.

I think we mentioned previously that we've completed the dose escalation phase.

The study and we were basically exploring the MTGE at this stage, we're still in the process of doing that.

And that clinical data should come sometime in the first half of next year and then we will be able to make the evaluations and the next steps.

Those three assets as quickly as possible because we believe we have the highest chance to win for those three assets.

And we will basically make any future decisions based on our on our for our IPO 60, 501 based off our clinical data.

So in Europe. If you can take the question on the safety signals were potentially looking out for.

In relation to IPX 60, 101, we have now.

And that clinical data should come sometime in the first half of next year and then we will be able to make the evaluations and the next steps.

Basically have most of the clinical data for the phase one and phase two a return.

But in terms of signal for IP age of 45, we try to establish a very well tolerated and.

<unk> returned to us from Sanofi. So we're now in the process of evaluating that data.

In relation to IPX 60, 101, we have now.

And trying to understand what next steps could be for the <unk> platform, what I would really like to clearly emphasize though is from a prioritization perspective, we're putting most of our time and effort behind <unk> 40, 502 behind <unk> and behind.

And relatively safe drivers and in particular are we trying to of course avoid all of the MMA specific adverse event like put if at all neuropathy that is that he often are not reversible.

Basically have most of the clinical data for the phase one and phase two.

Stéphanie Cornen: In particular, we try to, of course, avoid all the MMA-specific adverse events like peripheral neuropathy that is very often not reversible and ocular toxicity. So far, we did not see many adverse events or a specific trend in that respect. The plan is to provide clinical efficacy in, let's say, unusual indication or indication where the nectin-4 expression is not as high as urothelial cancer, with a very good benefit-risk ratio matched by a favorable safety profile. Thank you. Thank you. It's difficult to say a priori what you want to see. Yeah. Thanks. Thank you very much for taking my questions. You have any questions, Arcay? Your next question comes from the line of Diana Graybosh with Leerink Partners. Your line is now open. Please go ahead. Thanks for the question. You got Bill on for Dana.

Returned to us from Sanofi. So we're now in the process of evaluating that data.

And trying to understand what next steps could be for the anchor platform, what I would really like to clearly emphasize though is our product from a prioritization perspective, we're putting most of our time and effort behind <unk> 40, 502 behind Mckew to map and behind.

<unk> <unk>, making sure that we advance those three assets as quickly as possible because we believe we have the highest chance to win for those three assets.

And ocular toxicity and so far we did not see many adverse event or a specific trend.

In that in that respect.

Sonya if you can take the question on the safety signals were potentially looking out for.

And <unk> and making sure that we advance those three assets as quickly as possible because we believe we have the highest chance to win for those three assets.

So the plan is to provide clinical efficacy.

But in terms of signal for IP age of 45, we try to establish a very well tolerated and.

In.

Let's say unusual indication or indications, where the next thing for expression is not as high as order PDL cancer.

Sonya if you can take the question on the safety signals were potentially looking out for.

And relatively safe drag and in particular, we're trying to of course avoid all the MMA specific adverse event like put if at all neuropathy that is that he often not reversible.

We are very good benefit risk ratio matched by far.

Well in terms of signal for IP age of 45, when we try to establish a very well tolerated and.

<unk> safety profile.

And I think.

Closer to say a priori [laughter], what you want to see.

And relatively safe drag and in particular are we trying to of course avoid all of the MMA specific.

And ocular toxicity and so far we.

[laughter]. Thanks, Thank you very much for taking my questions.

Give me the question RK.

We did not see many adverse event or a specific trend.

Adverse event like peripheral neuropathy that is that he often not reversible.

Your next question comes from the line of Diana Great Bosch with Leerink Partners. Your line is now open. Please go ahead.

In that in that respect.

And ocular toxicity and so far we did not see many adverse event or a specific trend.

I saw that the plan is to provide clinical efficacy in let's say unusual indication or indications, where the lectin, Florida expression is not as high as order PDL cancer, we are very good.

Yeah.

Okay.

Okay.

Thanks for the question, Yes, Bill on for Dana.

That's a little bit.

Asking about model isn't map.

Stéphanie Cornen: I just want to change it up a little bit. Just asking about Mogamulizumab. I guess I'm just curious, can you just give us some, I guess, expectations for the readout in the second half of 2026? Sort of what gives you the confidence that Mogamulizumab, I guess, and Derva can actually win out against Derva? Thank you. Yeah. Maybe I can take that question. Basically, we have good expectations for the Pacific Nine study. What that is based on really is the co-study, which was the phase two study, a randomized phase two study that was replicating the Pacific Nine setting. If you look at the results and the Kaplan-Meier curves from that study, they're very interesting. When you added Mogamulizumab to Derva, you basically added 12-month median PFS on top of Derva.

So yes, I'm just curious can you just give us some I guess expectations for.

In that in that respect.

And so the plan is to provide clinical efficacy in.

The readout in the second half of 'twenty six sort of what gives you the confidence that the model isn't.

Good benefit to risk ratio matched by a favorable safety profile.

Let's say unusual indication or indications, where the next thing for expression is not as high as ordeal cancer. We are.

I guess <unk> can actually went out I guess turbo. Thank you.

And I say I don't think it's closer to say are pretty old.

Yes, so maybe maybe I can take that question.

What you want to see.

So.

[laughter]. Thanks, Thank you very much for taking my questions.

Basically we have good expectations for the Pacific Nine study and whatnot is based on really the coast study, which was the phase III study around a randomized phase II study, but was replicating the Pacific <unk>.

A very good benefit to risk ratio matched by S favorable safety profile.

Give me the question Sakai.

Your next question comes from the line of Diana Great Bosch with Leerink Partners. Your line is now open. Please go ahead.

And I, it's fair thank you.

Also to say a priori.

Or what you're willing to see.

If you look at the results in the Kaplan Meier curves from that study very interesting. When you added more movies mapped to deliver you basically added 12 months median PFS on top of that.

[laughter]. Thanks.

Yeah.

Thank you very much for taking my questions.

Okay.

Thanks for the question you got Bill on for Dana.

Give me the questions RK.

Your next question comes from the line of Diana Great Bosch with Leerink Partners. Your line is now open. Please go ahead.

I'll change it up a little bit.

So asking about mono isn't.

So yes. So I'm just curious can you just give us some I guess expectations for.

So if we retain a proportion of that effect size going into the Pacific Nine study is a very high chance that we will have a positive study so that gives us a I would say a relative sense.

Stéphanie Cornen: If we retain a proportion of that effect size going into the Pacific Nine study, there's a very high chance that we will have a positive study. That gives us, I would say, a relative sense of confidence that this will be a positive study. Hopefully, that addresses your question. Yes. Very helpful. Thank you. There are no further questions at this time. I will now turn the call back to Jonathan Dickinson, CEO, for closing remarks. I'd like to thank everybody for attending our quarterly earnings call. Thank you for your time and attention, and I wish you a great rest of the day. Thank you very much. This concludes today's call. Thank you for attending. You may now disconnect.

Yeah.

Okay.

The readout in the second half of 'twenty six sort of what gives you the confidence that <unk> can actually went out against Teva. Thank you.

Okay.

Thanks for the question yet bill on for Dana.

I'll change it up a little bit.

SaaS and about my knowledge of Mab.

<unk>.

This will be a positive study.

Yes. So I'm just curious can you just give us some I guess expectations for.

Yes, so maybe maybe I can take that question so.

Hopefully that addresses your question yes.

Basically we have good expectations for the Pacific Nine study and whatnot is based on really is the coast study, which was the phase III study run a randomized phase II study, but was replicating the Pacific nine Saturday.

Yes very helpful. Thank you.

The readout in the second half of 'twenty six sort of what gives you the confidence that <unk> can actually win out against driver. Thank you.

There are no further questions at this time I will now turn the call back to Jonathan to Kingston CEO for closing remarks.

Yes, so maybe it maybe I can take that question.

Okay I'd like to thank everybody for attending our quarterly earnings call and thank you for your time and attention and I wish you a great rest of the day. Thank you very much.

So basically.

If you look at the results in the Kaplan Meier curves from that study very interesting. When you added a moment leaves map to Debra you basically added 12 months median PFS on top of that.

Basically where we have good expectations for the Pacific Nine study and whatnot is based on really is the coast study, which was the phase III study around our randomized phase two study that was replicating the Pacific <unk> setting.

This concludes today's call. Thank you for attending you may now disconnect.

So if we retain a proportion of that effect size going into the Pacific Nine study is a very high chance that we will have a positive study so that gives us a I would say a relative sense comps.

If you look at the results in the Kaplan Meier curves from that study very interesting. When you added a moment leaves map to Dover you basically added 12 months median PFS on top of the.

Confidence.

This will be a positive study.

So if we retain a proportion of that effect size going into the Pacific Nine study is a very high chance that we will have a positive study. So that gives us a I would say a relative sense of confidence.

Hopefully that addresses your question.

That's very helpful. Thank you.

There are no further questions at this time I will now turn the call back to Jonathan to Kingston CEO for closing remarks.

This will be a positive study.

Okay I'd like to thank everybody for attending our quarterly earnings call and thank you for your time and attention and I wish you.

Hopefully that addresses your question yes.

Yes very helpful. Thank you.

There are no further questions at this time I will now turn the call back to Jonathan to Kingston CEO for closing remarks.

A great rest of the day, thank you very much.

This concludes today's call. Thank you for attending you may now disconnect.

Speaker #7: for attending. You may now disconnect.