Hello and thank you for standing by. My name is Regina, and I will be your conference operator today. At this time, I would like to welcome everyone to Innate Pharma’s Third Quarter 2024 Business Update and Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. {Operator Instructions} I would now like to turn the conference over to Henry Wheeler, Vice President, Investor Relations. Please go ahead.

Thank you. Good morning, good afternoon, and welcome everyone. This morning, Innate issued a press release for our Q3 2024 business updates and financial results. We look forward to highlighting the progress made during the year-to-date, as well as addressing future goals and milestones. The press release and today's presentation are both available on the IR section of our website. On Slide 2, before we start, I would like to remind you that we'll be making forward-looking statements regarding the financial outlook in addition to regulatory and product plan developments. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. Slide 3, on today's call, we are very pleased to be joined by Jonathan Dickinson, our new Chief Executive Officer. Jonathan is a seasoned healthcare professional and joins from Incyte. He has a strong background in oncology, and previous roles include ARIAD, BMS, Roche, and Novartis. On the next slide, today’s agenda, after an introduction from Jonathan, Sonia Quaratino, our Chief Medical Officer, will cover updates on lacutamab and IPH6501 and 4502. We will then hand to Yannis Morel, Chief Operating Officer, who will discuss the ANKET platform ADC SITC and monalizumab updates; Arvind Sood, EVP, US Operations will wrap up and close, and we’ll also have Frederic Lombard, our CFO on the line for questions. Jonathan, I now hand the call over to you.

Thank you, Henry. Good morning, and good afternoon to everybody on the call. I am very excited to join Innate, a company that is at the forefront of cutting-edge science in oncology. The unit of innovative work being done at Innate is truly inspiring and world-class, and I'm looking forward to using my extensive oncology experience to shape the Innate portfolio to maximize its future commercial potential and drive the next chapter of Innate's exciting journey. I look forward to meeting with as many of you as possible in the coming weeks. Turning to Slide 6, I would like to remind you of our strategy. As a company with proprietary assets in early critical stages and partnered assets in early to later stages, our strategy involves leveraging our world-class expertise to develop first and best-in-class antibody-based therapies for cancer. Our current business model centers around the three priorities highlighted in Slide 6, where we look to drive value from our proprietary R&D efforts through our well-established late-stage partnerships. Our ambition is to take our proprietary assets further along the clinical development pathway and thereby transform cancer care through a strong pipeline of novel differentiated antibodies. The first of these priorities is our lead proprietary asset, lacutamab, where we look to create near-term value. Lacutamab is in development for T-cell lymphoma, and the top-line Phase 2 CTCL data has already been presented. Based on this data, we've had recent interactions with the FDA. Sonia will cover this feedback later in today's presentation, and we're now assessing the best path forward to maximize the potential of lacutamab, including a potential partnership. Second, we continued to fill our pipeline and create longer-term value by leveraging our antibody engineering capabilities to develop innovative molecules, with a primary focus on our multi-specific NK cell engager proprietary platform called ANKET. We are pleased to see continued progress with Sanofi presenting various updates to the lead ANKET program IPH61/SAR’579. We're pleased to see our lead proprietary ANKET, IPH6501, continue to progress in Phase 1. As we develop antibody targets for our ANKET platform, we recognize that some of these targets may be better suited to an ADC approach. We will illustrate further details on our ADC pipeline today, where our lead asset, IPH4502, has now received IND clearance from the FDA and will start Phase 1 trials by Q1 next year. Finally, we're building strong and sustainable foundations for our business by developing value-creating partnerships across industry and academia. Monalizumab, which has been partnered with AZ, is a good example of the partnership, and the product as part of this collaboration is advancing well in Phase 3 trials in lung cancer. Turning to Slide 7, this shows a summary of our pipeline, which highlights how we continue to translate our savings into a robust portfolio of proprietary and partnered assets. When the IPH4502 Phase 1 study starts by Q1 next year, we will have eight clinical assets. This slide also illustrates how we are executing against our strategy with our lead proprietary assets, lacutamab, ANKET, and emerging ADC, supported by partnered products from late to early-stage with AstraZeneca and Sanofi. We anticipate a series of potential clinical data readouts and catalysts in the short to mid-term as we leverage our R&D engine and scientific know-how to create a sustainable business. Moving to Slide 8, which highlights our Q4 conference activity at SITC and ASH. At the SITC Meeting last week, we presented further clinical data on our next-generation CD20 targeting ANKET, IPH6501, as well as pre-clinical data on our Nectin-4 targeting ADC, IPH4502, which will be covered by Yannis later in today's presentation. At ASH, we were pleased to see that the lacutamab data was accepted for an oral presentation, highlighting follow-up on the TELLOMAK trial in relapsed recurrent cutaneous T-cell lymphoma, as well as a poster on translational analysis. I would like to now pass the call over to Sonia, who will review the progress made with our clinical portfolio.

Thank you, Jonathan. I will now cover the key proprietary clinical programs in the next slide: lacutamab, IPH6501, our CD20 targeting NK-engager, and now also IPH4502, the Nectin-4 ADC that is fast approaching the clinic. Can you move to the next slide, please? Thank you. On this slide, I will briefly recap where we are with lacutamab before moving to the feedback from our recent interaction with the FDA. We have already presented the primary results of the TELLOMAK trial, a Phase 2 single-arm study that includes both Sézary and mycosis fungoides patients. The data in Sézary syndrome were presented at ASH last year, and the results in mycosis fungoides at ASCO this year. Also, this year, we will have a relevant presence at ASH with an oral presentation on the health-related quality of life in Sézary and translational results from TELLOMAK. The TELLOMAK study is continuing, and we are collecting more follow-up data from these patients. Similarly, in peripheral T-cell lymphoma, we continue to enroll patients in the acute trial, a randomized Phase 2 where lacutamab is administered in combination with gemcitabine and oxaliplatin versus gemcitabine and oxaliplatin alone. We believe that this combination may offer additional benefit to patients with PTCL. As a reminder, lacutamab is a monoclonal antibody that targets KIR3DL2 and was shown to deplete the cells that express the receptor, which is expressed in more than 90% of Sézary syndrome patients and approximately in 50% of patients with mycosis fungoides or PTCL. The FDA granted orphan drug designation for lacutamab for the treatment of CTCL and fast-track designation for the treatment of adult patients with refractory relapsed Sézary syndrome who have received at least two prior lines of systemic therapies. We submitted the results from the TELLOMAK trial and the proposed regulatory pathway to market approval including the possibility for accelerated approval for Sézary syndrome to the FDA and received encouraging feedback. The company will continue to align with the FDA around the necessary confirmatory Phase 3 trial. We are currently evaluating the next steps for the program, including potential licensing with partners to deliver the confirmatory Phase 3 trial in CTCL. Now, where do we stand in terms of business case? On this slide, the data generated from the TELLOMAK trial confirmed clinical benefit not only in Sézary but also in mycosis fungoides, regardless of the expression of the target KIR3DL2, highlighting an opportunity for the CTCL space without a companion diagnostic. Therefore, the number of CTCL patients that could potentially benefit from lacutamab expands from 1,500 to 3,500 in the two-plus lines of therapy and to 5,000 patients should we move to an earlier line setting. With the strong Sézary syndrome and mycosis fungoides data we presented at ASH last year and ASCO this year, there is increased confidence in the potential of lacutamab. Our aim is to ensure that lacutamab reaches patients who need it as quickly as possible and to maximize the value via an accelerated approval. Now, switching gears to our most advanced proprietary ANKET asset, IPH6501, a tetraspecific antibody-based NK cell engager therapeutic. The IL-2 variant in this second-generation tetraspecific ANKET aims to induce activation and proliferation of endogenous NK cells in the tumor microenvironment. We were pleased to announce earlier this year that IPH6501 entered the clinic, and the first-in-human trial started with the first patient dosed in March. The trial is currently recruiting patients with relapsed refractory B-cell non-Hodgkin lymphoma. We presented preclinical data at the ASCO Meeting this year, showing that IPH65501 effectively, and preferentially stimulated NK cell proliferation from PBMC of NHL patients and depleted autologous CD20 positive B-cells from healthy donors with greater efficacy than a CD20 T-cell engager, using lower levels of pro-inflammatory cytokines, which are often a limiting factor in the use of T-cell engagers. The current Phase 1/2 study has been presented as a trial in progress at ASCO this year and the European Hematology Association Congress and more recently, at the SIDC Annual Meeting, which Yannis will cover shortly. In the next Slide, I’ll give you an overview of the timeline for IPH6501. Throughout this year and into next year, we plan to complete the dose escalation and look forward to initial safety data, pharmacokinetics, and pharmacodynamic readouts, as well as preliminary efficacy signals. Throughout 2025 and beyond, we will open the dose optimization part of the study to select the optimal dose for subsequent studies and then open expansion cohorts in non-Hodgkin lymphoma subtypes. On Slide 15, I will summarize the next step of our lead ADC IPH4502. Following the IND clearance at the end of September, we are working actively to progress towards Phase 1 and look forward to generating preliminary Phase 1 safety data in 2025 and then establishing anti-tumor activity in tumor types with both low and high expression of Nectin-4. IPH4502 is a novel ADC targeting Nectin-4, and the pre-clinical characterization was presented at ACR and CITC this year highlighting the key differential features of this product. Based on this data, we feel that we have a novel and differentiated ADC to target Nectin-4 in a broad panel of tumor indications beyond blood cancer, overcoming the challenges associated with Nectin-4 MMAE-based ADCs, including Enfortumab Vedotin. I will now hand over to Yannis to cover the earlier pipeline of ANKET and ADCs, as well as partnered asset Monalizumab.

Thank you, Sonia. I will now discuss two promising next-generation antibody therapeutics that are the focus of our research efforts: the NK cell engager, ANKET, and ADC. On Slide 17, I want to highlight our ANKET portfolio. ANKET is our unique first-in-class NK cell engager platform, a versatile plug-and-play technology designed to direct NK cells to cancer cells by activating the most stable NK cells, known as NKp46. This platform's notable feature is its ability to create multiple drug candidates by swapping out the tumor-binding part of the ANKET molecule, targeting various oncology challenges and potentially enabling NK cells to fight pathogenic cells in other diseases like autoimmune disorders. Earlier this year, Sanofi advanced our most developed ANKET, SAR’579, to Phase 2 following positive initial efficacy data demonstrating durable complete responses in relapsed refractory AML patients. They also initiated a new Phase 1/2 trial in frontline AML alongside venetoclax and azacitidine. As Sonia mentioned, our lead proprietary ANKET, IPH6501, is currently in clinical trials. This second-generation molecule utilizes a variant of IL-2 to stimulate the growth of patients’ own NK cells. The first patient was dosed in March, and we recently shared new supportive preclinical data at the SITC Conference. I will now summarize the key updates we presented at SITC for both IPH6501 ANKET and the Nectin-4 ADC IPH4502. The IPH6501 poster outlined the rationale for targeting different subtypes of relapsed or refractory B-NHL patients. As shown on the left, we believe a significant advantage of ANKET over existing CD20-targeting antibodies like rituximab is that while CD16, the receptor for mediating ADCC, is downregulated on NK cells in patient lymph nodes, NKp46 remains stable, providing a strong base for the ANKET. We have demonstrated that IPH6501 can effectively induce killing by diseased NK cells across various T-cell and NHL subtypes, including diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. Additionally, we observed that post-CAR-T patients exhibited an increased NK cell ratio and higher NKp46 expression, reinforcing the rationale for evaluating IPH6501 in these patients. On the next slide, the IPH4502 poster details the important scientific characteristics of our initial candidate. As we presented earlier this year at ACR, IPH4502 is a new exatecan-based Nectin-4 ADC capable of targeting Nectin-4 in low-expressing tumors where other treatments have not been effective. In the SITC poster, we further illustrated that IPH4502 can target tumors with varying levels of Nectin-4 expression. By mixing a Nectin-4 expressing cell line with a cell line negative for Nectin-4 in a 1 to 1 ratio, mimicking a heterogeneous tumor with 50% positivity, IPH4502 caused complete tumor regression in the mixture. This effect is entirely dependent on Nectin-4 and is not due to a non-specific effect, as IPH4502 showed no impact on Nectin-4 negative cells. We also demonstrated effectiveness in a PDX model of acquired resistance created through five injections resulting in a PDX model that relapses on its own and is entirely sensitive to IPH4502, showcasing its potential to benefit patients previously exposed to other treatments. Both posters are accessible on our website. On Slide 20, I want to remind you about Monalizumab, the anti-NKG2A therapy we have licensed to AstraZeneca for oncology. This slide provides another perspective on the late-stage development of Monalizumab in lung cancer. Following the Phase 2 COAST data, AstraZeneca commenced the Phase 3 trial called PACIFIC9 in May 2022, evaluating either Monalizumab or oleclumab combined with durvalumab in patients with unresectable Stage 3 non-small cell lung cancer who have not progressed after concurrent chemoradiotherapy. We were pleased to receive a recommendation from the Independent Data Monitoring Committee to continue the Phase 3 PACIFIC9 trial based on the pre-planned analysis. Along with the COAST and the latest COAST data shared at the World Lung Congress in September, we provided substantial evidence in the Phase 2 control study that Monalizumab enhances antitumor activity when added to durvalumab earlier in treatment. I will now turn it over to Arvind.

Thank you, Yannis. Good morning, good afternoon, everybody. We have several upcoming R&D catalysts that can be meaningful to our long-term growth. I would draw your attention particularly to the ones that are bolded on this slide. In the near term, we are looking forward to the next steps for lacutamab now that we have positive FDA feedback. Programs coming out of our ANKET platform continue to advance as IPH6101 targeting CD123 in hematologic malignancies partnered with Sanofi progressed to Phase 2 earlier this year. Our proprietary tetraspecific ANKET, IPH6501, is now in clinical development. Our ADC targeting Nectin-4 has cleared IND and is due to start Phase 1 soon. I would like to conclude our prepared comments with a few thoughts outlined on Slide 24. We have a differentiated pipeline with several first-in-class opportunities. We now have 7 products in clinical development with 3 that are proprietary and 4 that are partnered. Our cash position of around 96.4 million euros through the end of September will enable us to fund operations through the end of 2025. With that, I would like to open the call for Q&A. Regina, perhaps you can review the process for asking questions for our listeners.

{Operator Instructions} Our first question will come from the line of Lisa Baker with Evercore ISI. Please go ahead.

Hi, this is on for Lisa. Thanks for taking our questions. I'm wondering if you could provide some insights on the lacutamab data to be presented at ASH? Specifically, what does the translational data entail? It would also be helpful if you could share some information regarding the regulatory path for lacutamab. Is the FDA supportive of filing with the current data in Sézary syndrome for accelerated approval? Or is the filing dependent on securing a partnership? Thank you.

Thank you for the question. Sonia, could you take that one, please?

Absolutely. Just unmuted. Regarding the data that are going to be presented at ASH, I'm afraid I cannot add any color. There are some embargoes that need to be respected. So, I'm afraid you have to wait until December for that. I can provide a bit more, perhaps color on the FDA interaction that we had. We have received encouraging initial feedback. The FDA endorsed our proposed regulatory pathway in general terms. The FDA acknowledged that the currently available data from the Phase 1 and Phase 2 Tellomak studies may be sufficient to support the BLA submission, paving the path for an accelerated approval for Sézary syndrome. The company will then align with the FDA around the confirmatory Phase 3 trial to support such, let's say accelerated approval, and we are working towards this to make it happen.

Got it. If I may follow up really quickly? Could you provide some color on the timing for the next step? Or when should we expect to hear about details for alignment with the FDA for the Phase 3 confirmatory trial? Thank you.

The timing for the FDA will also depend on our business case in the sense that we are also looking for partners that can potentially carry out the Phase 3 trial. We will pave the way by producing the regulatory strategy, which eventually may also need to be discussed with the potential partner.

Got it. Thank you.

Our next question comes from the line of Daina Graybosch with Leerink Partners. Please go ahead.

Hi, thanks for the question. I think I understand from the previous one. I'll just follow up on that. You really need to find a partner to do a confirmation study, and that will gate reviewing that with the FDA and having a more concrete path to accelerated filing. Could you confirm that? And then talk to us about what you're doing to find that partner and how those conversations have been going?

Sonia, do you want to take the first part of that question? And then, we'll come back to Yannis and myself.

Certainly. As I just briefly mentioned, we are working towards this confirmatory Phase 3 study for the CTCL indication in more general terms. Of course, it would be nice to be aligned with a potential partner before going for another Type C meeting with the FDA to discuss the - let's say the Go Live of this study. We are looking for partners and many other options to make this happen.

Thank you, Sonia. I can add something to what Sonia just said. We're keeping our options open at this stage. We are actively seeking a partner. But we're also exploring other ways that we might be able to take forward a lacutamab study that would meet the FDA requirements. So, it's difficult to say any more on that. We're in discussions at this point in time, and I think when we have some information that we can provide, we will share that moving forward.

Can you provide maybe your guiding principles for why you would go with a partner versus these other ways? So we can better understand that process?

Yannis, do you want to take a stab at that?

Yeah hi, Daina. Like Jonathan said, we are on top of several options in parallel. I would say practical partnering is one option. And what will guide us is the way to maximize the return for Innate. We really want to - we think that we have a drug with real activity in CTCL. We want to execute the registrational part of the development, and anything that maximizes the return for the company and the shareholders will be prioritized.

Our next question will come from the line of Rajan Sharma with Goldman Sachs. Please go ahead.

Hi. Thank you for taking my question. Sorry, just another one on lacutamab and partnering strategy. I am just wondering if you kind of have an internal deadline in mind for finding a partner and executing on a potential deal versus what will be some point in time when you decide that that’s not going to happen and you’ll start to take this forward alone. And then, maybe related to that, just on cash. So your run rate to the end of 2025 is sort of into the last 12 months. I guess, is that something that you are comfortable with, and what are the options to extend the run rate here? And then I have a follow-up on Nectin-4 which I will come back to you.

Thanks, Rajan. Maybe Yannis, you can take the first part and then we can go to Frederic for the cash runway.

Yeah, hi, Rajan. It will be busy during the next few months. The FDA feedback was an important milestone to resume discussions with several partners, but also for the other types of options we are exploring. Clearly, this is something that we can achieve during the next several months.

Okay, thank you, Yannis. Frederic?

Yeah, on the cash runway, just one thing. First is that when we communicated on this cash runway, there are no options that are not fully guaranteed. We are comfortable with the cash runway that we are publishing. The second one is that we are, as usual, constantly monitoring financing needs, including dilutive and non-dilutive options that we are currently working on. We will provide an update when needed, when finalized.

Any other questions that are important?

Yeah, so just on that one, obviously clear on the slide that you see the potential for the asset in EV refractory patients. But just thinking about differentiation beyond that, do you think about differentiation beyond that? Do you think there is an opportunity to differentiate on tolerability or safety, and are there any key adverse events that you might call out as a differentiation?

Yannis, do you want to take that?

Yeah, we think that there are several lines of differentiation. As we have shown at SITC, IPH4502 is working in preclinical models that are EV resistant, both through primary resistance and acquired resistance, as I just shown today. We also have data in other tumor types, like breast cancer. This is really a differentiating factor compared to existing therapies. In terms of reliability, as we are using exatecan, we do not expect the same kind of toxicity as with MMAE. That's basically the differentiation possibilities that make the potential business case for these Nectin-4 candidates.

{Operator Instructions}

We’ll take a question received online from Eric Le Berrigaud with Stifel. On the lacutamab, is the understanding correct for your initial interactions with the FDA that the agency will not be against filing the drug for Sézary syndrome or maybe even CTCL with the potential for conditional approval based on a confirmatory Phase 3 trial? If this understanding is correct, is this what a partner is waiting for to move on and sign up for a collaboration with you on this asset? Or is it more of the PTCL data-dependent? Well, I'll stop there. Sonia, probably a question for you.

Henry, I'm not sure I understood the first part of the question. Would you mind repeating that?

Is the understanding correct from the initial interactions with the FDA that the agency would not be against filing the drug for Sézary syndrome and maybe even CTCL with the potential for conditional approval based on a confirmatory Phase 3 trial?

Correct, right. Yes, sorry, I was the negative that skipped my understanding before. Yes. Basically, the data in Sézary would be looking for the accelerated approval because, of course, accelerated approval can only be given to indications with a high unmet medical need, and Sézary would qualify for such an indication. It would be based on the Phase 2 and Phase 1 data. But of course, any accelerated approval can only be obtained when the confirmatory trial is up and running. Depending on the recruitment rate must be quite advanced on that. This approval is completely independent from the PTCL, which is a very different indication in that respect.

Yannis? Do you want to take the…

Yeah, and with the other, the question on the partnership, I would not say that the FDA feedback was awaited to sign a deal. It was more an important milestone to progress discussions, and that's where we are today.

And then the second part of that question, what would you consider as the most likely next step for the lacutamab, formal filing with the FDA or a partnership of the third-party, and what are reasonable timelines for this to happen?

Maybe Sonia.

The most likely timelines are really to go ahead and prepare a Phase 3 that can then be taken up by a partner and or to eventually find either option to fund the study and conduct it in a different way.

Okay. Thank you. Another offline question from Jingming at Evercore ISI. Could you please remind us what Sanofi decided to return like IPH67 ANKET? Is it due to activity signal, safety, or other reasons such as strategic prioritization?

Hi, Jingming. Sanofi did not provide any specific reason for the termination. I just remind you that IPH67 was a very early-stage research program. So not even at the candidate selection point. There are no specific technical or scientific reasons behind that decision. It's really up to Sanofi to comment on that. I also remind you that the rest of the agreement is intact. We are having the CD123 and the BCMA in Phase 2 and Phase 1. We have the B7H3 ANKET program progressing well in preclinical developments.

Okay. Operator. Next question, please.

We'll take our next question from the line of Arthur He with HCW. Please go ahead.

Hi, good morning. I am Arthur on for RK. Thanks for taking my question. I have two questions on the ANKET. The first is for the IPH6501. You said you are currently in a clinical trial. So, could you give us some guidance on the timing for the data update from this your own program?

Sonia. Can you take that one, please?

Of course. I think you are referring to IPH6501, which is the second-generation ANKET in B-cell non-Hodgkin lymphoma. We opened the Phase 1 dose escalation, which goes according to the usual kinds of a dose escalation with BLT windows, etc. We believe that we will complete that dose escalation by 2025 and then open a dose optimization. We expect to have data around safety, pharmacokinetics, pharmacodynamics, and early clinical anti-tumor efficacy by 2025, and in 2026, we expect more clinical efficacy data.

Thanks, Sonia. And so another question is just want to follow up on the IPH67. Are you able to disclose which target they are - this asset targeting or it’s still kind of discussions?

I can answer that one. That’s the target that we're not currently disclosing at this point in time.

Okay. That’s all. Thanks for taking my question.

{Operator Instructions} We have no further questions at this time. Ladies and gentlemen, that will conclude today's meeting. Thank you all for joining. You may now disconnect. We're all clear.

Great. Thank you, Regina.