Good morning, and welcome to the iTeos Therapeutics Business Update Conference Call. At this time, all participants are on a listen only mode. Following the formal remarks, we will open the call for your questions. Please be advised this call is being recorded at the company's request. At this time, I'd like to turn it over to Ryan Baker, Head of Investor Relations at iTeos. Thank you for joining us today. Joining me from iTeos are Michel Detheux, President and CEO, Matthew Gall, Chief Financial Officer, Matt Call, Chief Operating Officer, and Dr. Joanne Lager, Chief Medical Officer. This morning, iTeos issued a news release announcing that it has entered into a partnership with GlaxoSmithKline to co-develop and co-commercialize iTeos' anti-TIGIT antibody, EOS448, as a potential treatment for people with cancer. Before I turn the call over to Michel to discuss the details of the partnership, I would like to note that the team will be making forward-looking statements in the prepared remarks and during the Q&A session. Please take a moment to review slide number two on the webcast, which contains our forward-looking statements. These forward-looking statements involve risks and uncertainties, many of which are beyond iTeos's control. Actual results could materially differ from these forward-looking statements, and any such risks can materially and adversely affect its business, the results of operations and trading prices for iTeos' common stock. For a detailed description of applicable risks and uncertainties, we encourage you to review our most recent quarterly report on Form 10-Q filed with the SEC, as well as the company's other SEC filings. The company does not undertake any obligation to publicly update its forward-looking statements, including any financial projections provided today based on subsequent events or circumstances. I will now turn the call over to Michel. Michel, please proceed. Thank you, Ryan. Good morning or good afternoon, everyone. I'm thrilled to share with you a very exciting update. As many of you already know, earlier today, we announced a transformative collaboration with GlaxoSmithKline to co-develop and co-commercialize EOS448, our TIGIT antibody program. First, I'd like to remind everyone why we believe EOS448 is highly differentiated. Second, I will highlight the context, the value, the vision, and the key component of this collaboration. Third, I will explain why this partnership is transformative and supports our long-term vision for iTeos, its shareholders, and people living with cancer. Starting with slide three, when we think about EOS448, we need to consider the two domains of the antibody, which has been designed to enhance the antitumor response through a multifaceted immunomodulatory mechanism. On the top, we have selected an antibody with a unique binding domain to TIGIT, which provides high affinity and high potency. EOS448 blocks inhibitory interaction of TIGIT with its ligands to stimulate immune response and tumor cell killing. On the bottom, we have selected an IgG1 isotype, which are engaged with Fc gamma receptor on immune cells to trigger pro-inflammatory cytokine release, activation of antigen-presenting cells, and depletion of TIGIT positive Tregs and exhausted T cells. We believe that these characteristics of EOS448 provides a differentiated profile, which has the potential to lead to clinical benefit. On slide four, we have summarized the initial data from our phase I single agent dose escalation study presented at AACR in April. On the top left, out of 20 evaluable patients, we observed one patient with a confirmed partial response and nine with stable disease, which is the best clinical benefit rate reported in the phase I clinical trials for a single agent TIGIT antibody. On the top right, we observed a manageable tolerability profile consistent with other checkpoint inhibitors, with the most common adverse events being immune-related. Finally, below, EOS448 is the first TIGIT antibody in clinic, which has demonstrated a strong depletion of TIGIT+ Tregs at all doses tested in the dose escalation, confirming the multifaceted mechanism of EOS448 in cancer patients. In summary, this efficacy, safety, and biomarker data demonstrates differentiated profile of EOS448. Now, moving to the second part of the presentation, I'm going to highlight the context, the value, the vision, and the key components of this collaboration with GSK on slide five. I'd like to share a bit of background and why we believe this collaboration represents a great opportunity for improved treatments for people living with cancer, for both partners and for our shareholders. TIGIT was the first new generation IO drug with positive data in a randomized phase II study reported last year, almost nearly 10 years after the first approval of an immune checkpoint receptor antagonist. These data were a catalyst for the field. As we consider our options to accelerate and expand the clinical development of EOS448, we were approached by several large companies who recognized the differentiated profile of EOS448. We were under no pressure to partner, and it was important to us that any strategic partnership accomplish the following objectives, as summarized on the left of slide five. First, accelerate and expand the development of EOS448 by engaging with a committed and capable partner. Second, position EOS448 as a core part of the IO strategy of both collaboration partners. Third, retain co-commercialization rights in the U.S. In this agreement with GSK, we've accomplished all of these objectives as described on the right. We cannot be happier to be working with a partner which shares our commitment to moving quickly and aggressively to advance EOS448 in multiple indications. Indeed, GSK is the ideal partner for us because of their development. Operator, we may have lost Michel's line. Can you hear me now? Yeah, I can hear you, but it's showing that his line is still connected. Okay. I can take over. This is Matthew Gall, CFO. Okay. Okay. In this agreement with GSK, we've accomplished all of these objectives as described on the right. We cannot be happier to be working with a partner which shares our commitment to moving quickly and aggressively to advance EOS448 in multiple indications. Indeed, GSK is the ideal partner for us because of their development capabilities in immuno-oncology, their approved PD-1 program, their focus on the TIGIT pathway that will allow for multiple novel combinations, and their commitment to invest substantially to advance clear and differentiate path forward for EOS448, which we expect to become the cornerstone of GSK's immuno-oncology pipeline. Finally, the co-commercialization agreement in the U.S. that will allow iTeos to keep upside. Let's review the terms of the agreement on slide 6. GSK will make an upfront payment of $625 million in cash to iTeos. GSK and iTeos will share responsibility and also costs with a 60-40 ratio, respectively, for the global development of EOS448. Should the EOS448 program achieve certain development and commercial milestones, iTeos will be eligible to receive up to an additional $1.45 billion in potential milestone payments. The two partners will jointly commercialize and equally split profits in the U.S. Outside of the U.S., GSK will receive an exclusive license for commercialization, and iTeos will receive tiered double-digit royalty payments. Both GSK and iTeos have the opportunity to independently run additional trials, including combinations with iTeos' inupadenant A2AR antagonist program or GSK pipeline programs. Finally, on slide 7, we will explain why this partnership is transformative and supports our long-term vision for iTeos, its shareholders, and people living with cancer. The partnership for EOS448 TIGIT anti-program, the box is in green, allows us to expand and accelerate the development plan, and we expect to initiate a new trial evaluating the combinations with pembrolizumab and with inupadenant in the next few months. We plan to initiate a phase II combination study with GSK early next year. We plan to expand the clinical development of our potent and highly selective A2A receptor antagonist, inupadenant, the box is in blue, where we've already seen promising responses with monotherapy and have identified a potential predictive biomarker. As a reminder, we already have combination studies underway exploring inupadenant in combination with pembrolizumab and chemotherapy. We are also pursuing research programs with focus on targets that address additional mechanisms of immunosuppression and expect to nominate an additional product candidate for IND-enabling studies before the end of 2021, the box in orange. Recall that both inupadenant and EOS448 derive from internal discovery, and we will continue to invest in our people and science to grow the pipeline. In conclusion, the collaboration with GSK that we've announced today is just the beginning of what we believe will be a transformational period for iTeos. In the past year, since becoming a publicly traded company, we have continued to create value by developing therapies to improve the lives of people with cancer. With our differentiated clinical programs, robust internal expertise and capabilities, a very strong balance sheet, and of course, an ideal partner in GSK, iTeos is well-positioned to become a leader in the competitive immuno-oncology space. We are more confident than ever in our ability to succeed and see this partnership as a validation of our science and a catalyst for the future of the company. Thank you very much for your attention on today's call and your ongoing interest, and I'd like to now turn the call back over to the operator for questions. Our first question comes from Anupam Rama with JP Morgan. Hey, guys. Thanks so much for taking the question, and congrats on the deal. Maybe strategically, you could walk us through why it was important for you guys to keep U.S. co-commercialization rights versus partnering U.S. as well, or keeping U.S. to yourself within the partnership. Thanks so much. I'm not sure if Michel was able to get back on, but if not, I can hand that over to Matthew Gall, our COO. Thanks, Anupam. Appreciate the question. It was very important for us, as we discussed in past calls, to retain significant upside in the downstream economics as well as the ability to integrate the company more fully into the commercial space. Our view in a very competitive space, like TIGIT is that this was the appropriate mix. Being able to partner with GSK, retain rights in the U.S. to co-commercialize and have the profit split so that we could compete with everyone else that's in this space. Then ex-U.S., GSK has those rights. We view this as really the appropriate structure for us, given the competitive nature of this space, to be able to lean into the partnership with GSK and do this together in the U.S. Through that structure, be able to keep up and keep pace with others in the field. Great. Thanks so much for taking our question, congrats again. Thank you, Anupam. Our next question comes from Daina Graybosch with SVB Leerink. Hi. Thank you for the questions, and congratulations on the deal. I think I'll have two, one sort of practical one and one science one. The practical one, can you help us understand this 40/60 split for studies in the global development plan? Is this for any study that iTeos, let's say, with your new adenosine target you want to combine with TIGIT, will GSK pay 60% and vice versa for any of their combinations, let's say, with their CD96, you would pay 40%? Then the science side, GSK has two other assets in CD226 asset that we know of. They have the anti-PVRIG they licensed from Surface, and I think they have their own CD96 antagonist. I wonder if you could tell us if being able to combine amongst the assets is exciting to you scientifically, and if so, which combinations are you most excited about? Sure. I can start with the first part and then hand off to Jo to discuss the pipeline. Everything that's in the global development plan follows that 60/40 split. If there are combinations, and the one with inupadenant would be an example that are independent to the parties, then they cover those costs independently. The same would apply to territory-specific combinations, or other things potentially involving the GSK portfolio, with standard kind of buy-in rights after the independent research. I'll hand over to Jo to discuss the pipeline. Thanks, Matthew, and hi, Daina. We are excited about the other TIGIT CD226 pathway targets that GSK has in their portfolio. Yes, they have antibody targeting CD96, which is another co-inhibitory factor in that pathway, as well as they have antibody in preclinical development that's targeting CD112 receptor. I think both are quite interesting potential combinations. The CD96 we anticipate will be able to move into clinic sooner given that that one's currently in phase I. Can you give any context in the biology which one you think is more interesting or exciting? Well, we believe, Daina, that we have now the full panel and we have all the options to develop the specific combination based on indications. We don't believe that we will have one single combination that will be the most relevant, but we believe that we are now uniquely positioned with GSK to address specific combination based on the cancer type and our scientific approach. Great. Thank you. Our next question comes from Chris Raymond with Piper Sandler. Just two questions. By the way, congrats from us on this landmark deal. Just on the plans to combine with the GSK PD-1, Jemperli, just talk about maybe, Michel, the level of diligence you guys have done on that molecule, and the comfort. It's approved. It's one of the late-to-market PD-1s. Obviously, it's only approved in endometrial cancer. I get it's early, but just what kind of comfort did you get that it'll ultimately be as versatile as the other PD-1s? As you're tying your wagon, if you will, obviously to that molecule from a combo standpoint. Then maybe the second question, more of a strategic one? This capital infusion is pretty significant. I know you guys have talked about next generation adenosine pathway program as sort of a next focus for you guys from a pipeline standpoint. Does this change the near-term timing of that program? Are there other sort of discovery stage programs you might be able to accelerate now with these new resources? Thanks. Thanks, Chris. For the first question, indeed, we spend a lot of time to evaluate what would be the best option for combination with the PD-1, and we want to stress that we still have several options there to move forward. What we like with the data that we have seen for GSK is that they have a very strong package indeed. A recent approval is also an important one, and they are currently comparing the dostarlimab with pembrolizumab into a specific indication that will make us even more comfortable to move forward. Clearly the bigger this value with GSK is that they consider TIGIT as a significant, I would say, program to build their IO pipeline. That will give different options for combination. For the second part of the second question, indeed, this is a significant infusion of cash, which is going to help us to accelerate the development of iTeos. On top of the TIGIT co-development investment, we are going to continue to invest into our best-in-class A2A receptor antagonist, inupadenant. We have also a series of targets that we are interested in. There's the current preclinical program which continue to go forward toward the selection of the IND candidate later this year. We have several targets under consideration where we are going to have a mix of internal effort, academic collaboration, and also in licensing opportunities to expand our pipeline. Yeah. Thank you very much. Our next question comes from David Nierengarten with Wedbush Securities. Hey, thanks for taking the question, and congrats on a very nice deal. Maybe moving to inupadenant, you're going to initiate a combo study with pembro. Is there any desire or opportunity for you to take a look at dostarlimab in combination with your A2A, or is that not in the cards? Thanks. Jo? Yeah. Hi, David. We currently are conducting a study of inupadenant, our A2A receptor antagonist, with pembrolizumab. There may be options in the future to combine with dostarlimab, but that hasn't been discussed at this point. Yeah. That was the quick follow-up was, you didn't discuss options for potentially partnering or doing any other collaboration with GSK on A2A? No, the discussion purpose was all focused around EOS-448. Yep. Okay. Thank you. Our next question comes from [Zain Falrama with Acacia Research]. Yeah. Congratulations, Michel and team, for forging a really good relationship. A quick question from me, just trying to think about what sort of indications would the collaboration be looking at? Also, are there certain tumors that you would do independently of GSK? Jo? Yes. The clinical development plan with GSK will build on what we've already disclosed. We had said with EOS-448 that we'll be pursuing non-small cell lung cancer, head and neck cancer in combination with PD-1. We'll also be combining with inupadenant and looking at melanoma, and we are also planning a study in myeloma. Those activities will all continue. We've been having discussions with the colleagues at GSK about extension indications, but we'll be disclosing those at a later time. Thank you, folks. We have a follow-up question from Daina Graybosch. I mean, sorry, Daina Graybosch with SVB Leerink. Hi, thanks for the follow-up. I want to get some clarity around which PD-1 you would combine with necessarily. Will you be moving forward to registration always of GSK's PD-1? Could you, in some indications, keep combining with and plan to move forward in registration with pembrolizumab? Hi, Daina. For now, we will be planning our registration studies as part of the global development plan with GSK in combination with dostarlimab. We do have flexibility to continue to evaluate combinations with other anti-PD-1 antibodies in the future. I guess a follow-up on that, if you do decide to combine with other anti-PD-1s, that would be a joint decision, let's say, based on unique indication and positioning a different PD-1 has over where GSK could be, or would that be a decision you could make on your own, joint? It's a little complicated to go into, but generally it will be a joint decision.
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