Innate Pharma S.A.

Continue to stand by, your conference will start very shortly. Please continue to stand by, your conference will start very shortly. good day and thank you for standing by and welcome to the innate farmer 2021 first quarter business update conference call At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. I must advise you that this call is being recorded today, Tuesday, the 11th of May, 2021. If you require any further assistance, please press star 0. I would now like to hand the call over to your first speaker today, Dr. Mondaire Majubi. Please go ahead, sir.

Thank you. Good morning, good afternoon, and welcome, everyone. This morning, ENAIT issued a press release providing a business update for the first quarter of 2021. I look forward to explaining the progress made during the quarter 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. Please move to slide number two. And before we start, I would like to remind you that we will make forward-looking statements regarding the financial outlook in addition to regulatory and product plan development. These statements are subject to risk and uncertainties that may cause actual results to differ from those forecasted. Please move to slide number three. On today's call, I'm delighted to be joined by Dr. Joyson Caraconell, EVP and Chief Medical Officer. I would also like to take this opportunity to welcome our new CFO, Frederic Lombard, who officially started at the company in April and will join the Q&A section of this webcast, which will follow the prepared remarks by myself and Joyce. As you may have noticed, in the past we have only held conference calls marking our half-year and annual results. However, in order to provide more regular updates on our business progress, we have decided to hold conference calls on a quarterly basis it's important to note though that as we do not publish full quarterly financials there will be no formal remarks about our financials during this call or the third quarter call on slide number four you have the uh classic intro slide of innate pharma uh We are a pioneer in the field of innate immunity, as you know, and NK cells, and we follow the science to develop innovative therapeutics for patients, leveraging our know-how and antibody generation platform. We are using this expertise and know-how to develop a robust pipeline of novel medicines for cancers, but also for other life-threatening diseases with high and met medical needs. Slide number five actually depicts our research strategy. And I'm very pleased to see the growing momentum in understanding the important role NK cells play in developing therapeutics to treat cancer. We are the leader in the field of using natural killer cells to activate innate immunity, and this scientific foundation is at our core. As you know, early approaches to immunotherapy were T-cell centric. and have mainly focused on enhancing T cell responses by targeting inhibitory pathways with immune checkpoint inhibitors, for example. These therapies have led to unprecedented successes and transformed the natural history of many cancers. However, the medical need is still high, as only a small fraction of patients respond to T cell therapy, and there remains significant relapse among those who do. Broadly speaking, T cells are not autonomous in their effector function and need help from cells of innate immunity, which we believe represents the second wave or the next generation of immunotherapy. And to us, choosing the right targets to direct the body's immune response is of paramount. We do this by utilizing our fundamental understanding of NK cell biology, tumor microenvironment, and tumor antigens. Please move to slide number six. Our pipeline shows how we have translated this into a robust portfolio of proprietary and partnered assets. It also illustrates how we are executing against our strategy with our lead asset, LACUTA Map, supported by a partnered and earlier stage product. we have a rich pool of preclinical projects which we will carefully select and bring forward to fuel our clinical pipeline. Let me remind you our strategy on slide number seven. Our strategy is centered around three core priorities. First, create a near-term value driven by our lead proprietary product candidate, Lacutamab, which is in development for T-cell lymphoma. Second, fueling our pipeline and creating longer-term value by leveraging our antibody engineering capabilities to develop innovative molecules with a primary focus on our multi-specific NKCL engager delivered from our proprietary platform. And third, we are building a strong and sustainable foundation for our business leveraging the various partnerships across industry and academia, which further validate our science and offer capital that we reinvest to advance our portfolio. And during the first quarter of 2021, we have worked diligently to execute against these three core priorities. Number one, we have continued to advance L'Aquitama as we pursue a broad development strategy across T-cell lymphoma. Earlier this year, in February, we had a virtual IR meeting where we highlighted the advancement of the mycosis fungoridis arm of our Phase II telomex study into Stage II, which occurred earlier than anticipated. In addition, we announced our stepwise approach in developing lecithinib in peripheral T cell lymphoma with two clinical studies for K3DL2 expression patients with relapsed PTCL, including randomized controlled trial in collaboration with our partner at the Lymphoma Study Association, or LISA. We have also worked hard to advance our R&D efforts with our early stage program moving forward. At the start of the year, we were pleased to announce that Sanofi made the decision to progress APS 6101, our lead NKCL engager, into R&D enabling studies. APS 6101 now is This is the first candidate to emerge from our multi-specific NKCL engagement platform, and we are excited by the prospect of this technology, which we believe will fuel our pipeline well into the future. And we look forward to telling you more about our progress here later in this call and in the near future. I would like now to pass the call over to Joyce, who will review the progress made with our portfolio. Jason?

Thank you, Bondar. On slide eight, let me start with Lakotema, our first-in-class humanized monoclonal antibody that targets the immune receptor KER3-DL2. As you may remember, KER3-DL2 is an inhibitory receptor found in approximately 65% of patients across all cutaneous T-cell lymphoma. and even more in certain aggressive subtypes, but with limited expression in healthy tissue. To date, data from Likudimab have shown promise, demonstrating compelling single-agent activity and offering immense potential in lymphomas historically associated with a poor prognosis for which there are few therapeutic options at advanced stages. On slide nine, as Mondaire mentioned, this past quarter, we hosted a virtual investor event featuring key opinion leaders in cutaneous and peripheral T cell lymphomas. During this event, we highlighted both the unmet need in these populations, as well as the therapeutic rationale for our telemedic study, evaluating lacudamab in subsets of CTCL. Additionally, we introduced a broad development strategy to advance this program initially for Cesare syndrome, a niche CTCL indication with high unmet need into other forms of T cell lymphomas, notably mycosis fungoides and the broader PTCL population. On slide 10, let me first highlight the progress in our ongoing phase two TELEMEC study for cesarean syndrome and mycosis fungoides. We were pleased to share that we had moved the cure 3DL2 expressing mycoses fungoides cohort from stage one to stage two, clearing a predetermined threshold before 50% of the cohort was enrolled. This was very encouraging, and I'm pleased to announce that the preliminary data from the stage one of this cohort will be presented by Dr. Martine Bagot in an oral session on the 22nd of June at the 16th International Conference on Malignant Lymphoma, ICML, Lugano. And this year it is being held virtually. For the sensory syndrome cohort, enrollment is on track. And we expect to be able to report top line data in 2022. Sensory syndrome offers us a potential fast to market opportunity as we received fast track designation in the US and prime designation in the EU last year. On slide 11, Simultaneously, we are working to advance our recently announced clinical development plan for peripheral T cell lymphoma, which will focus initially on the relapse setting, where the unmet medical need is most significant in patients expressing the target, Kir3DL2. We expect to initiate our phase 1B trial evaluating lacudimab as monotherapy by midyear. The study will enroll. approximately 20 patients, and it will evaluate safety and characterize clinical outcomes. First data are expected in 2022. Separately, our partner, Lisa, will initiate an investigator-sponsored Phase II study to evaluate lacudimab in combination with chemotherapy, GemOx, versus GemOx alone. This study will be multicenter, randomized study with approximately 60 relapsed refractory patients outside the US and is expected to be initiated in the second half of 2021. We believe that this stepwise approach will prove efficient in identifying the optimal regimen for lacunamide in the relapsed PTCL setting. Depending upon the data generated in these initial studies, we will consider initiating a separate trial in combination with other standard of care treatments, and eventually, we would look to move lacudimab into earlier lines of treatment, including as potential combination in the CHOP regimen in frontline PTCL, or as a consolidation therapy following standard first-line treatment. On slide 12, turning now to our R&D efforts, we continue to advance multiple programs forward based on our proprietary, multi-specific NK Cell Engager platform, which we believe will be the key to unlocking next-generation clinical molecules in immunotherapy. At the start of the year, we announced that Sanofi had taken the decision to progress IPH6101 or SAR443579 into IND-enabling studies. As you may remember, IPH6101 is an NKP46-based NK cell engager using our proprietary multispecific antibody format. IPH6101 is a part of our ongoing research collaboration with Sanofi to evaluate up to two NK cell engagers and is advancement into the IND-enabling studies milestone pavement 2 and 8. Sanofi is now responsible for all future development, manufacturing, and commercialization of IPH 6101, and we remain eligible for future development and commercial milestones. On slide 13, as you know, our NK Cell Engager platform is at the heart of our research and is a major component of our long-term development strategies. To date, we have developed a robust portfolio of product candidates using our tri-functional NK cell engenders, or NKCE3, which has demonstrated potent NK cell activation, cytotoxicity, and efficient control of tumor growth. Our innovative approach means that we are continually working with our NKCE platform to further develop and expand its capabilities, including the develop development of a next generation tetrafunctional NKCE or NKCE4. Our chief science officer, Eric Vivier, will speak more about these latest innovations in our platform during his plenary talk at the annual meeting of the Federation of Clinical Immunology Societies, also known as FOSIS, on the 10th of June. Additionally, we will hold an investor and analyst event mid-year where we will cover both the next generation NKCE platform and present the lacudimab and mycosis fungoides data that are being presented next month at the ICML Lugano Conference. In addition to our progress with lacudimab and our next generation NKCE antibody, we have also made progress with IPH5301, our CD73 blocking antibody, and a phase one trial is expected to begin later this year. IPH5301 targets the adenosine immunosuppressive pathway and has the potential to promote anti-tumor immune responses across a wide range of tumors. Now I would like to turn the call back over to Mondaire for concluding remarks.