Great. Thank you, as always, to the folks who are operating this, making our lives very easy and, you know, just simple to kind of get it going. We're getting to the end of the second day of the Oppenheimer Healthcare Conference in 2024. On this track, it is really my pleasure to have Bob Duggan and Dr. Maky Zanganeh are presenting for Summit Therapeutics. This is a company that I actually covered a while ago. I've known Bob and his team when they were at Pharmacyclics, and so have had a real pleasure in working with some companies doing some pretty innovative stuff. Summit has been now really kind of doing, I would call it again, you know, just really fundamental work in the area of cancer, and gotten a really great partnership. We'll let them present, hopefully leave us about five or 10 minutes for Q&A right at the end. Thank you very much, Hartaj. I would like to thank Oppenheimer and Hartaj to give us the opportunity to talk about Summit and our product development. With me, as Hartaj said, Bob Duggan, our CEO and Chairman of the Board, is with us on the call. In the room with Manmeet Soni, our Chief Operating Officer, Dave G.—I call him Dave Gancarz—is our Chief Business and Strategic Officer, as well as Dr. Allen Yang, our Chief Medical Officer. As you can see, our looking-forward statement, which I believe all of you are very familiar with. Technical problem, as always. Thank you. So let me talk a little bit about our company, Summit Therapeutics. We are a mission-focused company led by Bob Duggan and myself as a co-CEO. Bob's first investment started in December 2019. I joined Bob in November 2020. As a reminder, the company at this moment of time was an anti-infective drug company. The past three years, our leadership team joined us. It's an unmatched high-speed execution team with a proven track record. In 2022, we decided to transform the company from an anti-infective company to an oncology company. Our BD team looked at more than 100 companies and more than 40 drug candidates. And finally, we decided to partner with Akeso and develop ivonescimab. We in-licensed ivonescimab from our partner at Akeso. Our lead compound, ivonescimab, is the only phase III PD-1/VEGF bispecific antibody in our licensed territory, which is the United States, Europe, Japan, and Canada. We have three offices in Florida, California, and U.K., which is at Oxford. In total, we have over 110 employees. Our market cap is around $3.1 billion, and our cash is around $186 million as of last year. Our focus of 2024 is to execute on our two phase III clinical trials and to expand our clinical development plan. Let me talk about our partner, Akeso. Akeso is a leading biopharmaceutical company in China, led by Dr. Michelle Xia, who is the co-founder, chairwoman, and the CEO and president of Akeso. It has over 2,800 employees. They have an end-to-end in-house capability. Their current value is around $5 billion. They are a source of incredible innovation, having discovered over 30 compounds in-house. Three of these compounds have been successfully developed from discovery through approval and commercialization in China, highlighted by the world's first marketed approved PD-1 bispecific, in which the name is cadonilimab in China. Their foundation, which is their Tetrabody platform, has produced six bispecific antibodies, including cadonilimab, as well as our phase III innovative candidate, ivonescimab. As mentioned, Akeso has 30 drug candidates, has 120 clinical trials completed or in progress, 19 clinical stage candidates, and they have six bispecific antibodies. More than 1,600 patients have been treated with ivonescimab across 19 clinical trials, and that foundation from Akeso has allowed us to immediately start two phase III trials in non-small cell lung cancer, HARMONi and HARMONi-3. Of note, Akeso has impressive manufacturing capability for its clinical and commercial antibody, and we are planning to have multiple supply chains in our territories for ivonescimab. We are thrilled to have Akeso as partner. Let me give you an update on what we have done last year. Our partnership agreement became effective in January 2023. We spent entire year 2023 accelerating the development of ivonescimab in our licensed territory. We held multiple FDA meetings for multiple phase III clinical trials for ivonescimab. In addition, we have interacted with the EMA in Europe, as well as PMDA in Japan. We raised $500 million, which included about 1,500 individuals participating in a capital raising with a cost of only $500,000. We launched our first phase III clinical trials, HARMONi, in a record time and treated our first patient just four months after we received the rights to ivonescimab. During the year, we presented the data, phase II data for ivonescimab, in different events at ASCO, SITC, ESMO, and we began enrolling patients in our second phase III trial, HARMONi, last quarter. In both of our clinical trials, we are working together with Akeso to enroll patients in our licensed territory, in addition to China, for collapsing time, increasing patient diversity, and setting up ivonescimab for global success. Besides these two phase, first two clinical trials in non-small cell lung cancer, we plan to develop ivonescimab in tumors outside of lung cancer. We have received and accepted several proposals from investigators seeking to sponsor a number of trials with ivonescimab across a number of different tumors. We are now working with those investigators and institutions to move those trials forward. Next slide. Let me discuss a little bit about ivonescimab's mechanism of action. As you know, ivonescimab, as I said, is a first-in-class PD-1 VEGF bispecific antibody that was intentionally designed to improve the safety and efficacy standards of two established and approved targets. The question is, why ivonescimab is different? Why can we not simply administer two established drugs sequentially? Ivonescimab is different because of its cooperative binding. Let me discuss a little bit about this cooperative binding. This cooperative binding increases the binding strength of each target in the presence of the other target in vitro. In other words, cooperative binding allows for strong simultaneous blocking of both PD-1 and VEGF, which are present at their highest concentration in and around the tumor. Because ivonescimab's binding strength or affinity to each target is highest in the presence of both targets and both PD-1 and VEGF are their highest concentration in and around the tumor, it is believed that ivonescimab is effectively activated in the tumor microenvironment, where ivonescimab is designed to be and can drive its anti-tumor activity. In addition, concentrating in the tumor microenvironment is believed to reduce certain adverse events, which may occur from binding to PD-1 or VEGF outside of the tumor microenvironment, including bleeding risk associated with some VEGF antibodies. Ivonescimab goes where it is intended to, optimizing its anti-tumor activity and safety profile. Again, I remind you that ivonescimab is the most advanced PD-1 VEGF bispecific antibody in clinic. It's the only phase III compound of its kind in any of the licensed territories, including the United States, Europe, Japan, and Canada. Let me explain what we mean by cooperative binding and the basis for the mechanism of action of ivonescimab. You can see from the image here, ivonescimab not only performs the function of both an anti-PD-1 agent and an anti-VEGF antibody, but it optimizes the activities of both in such a unique way. It is intended to be greater than the sum of its individual parts. The presence of VEGF increases ivonescimab's affinity to PD-1 by over 18-fold, and the same is true of PD-1 increasing ivonescimab's binding affinity to VEGF, in this case, by four-fold. With PD-1 and VEGF highly concentrated in many tumor types, ivonescimab's binding strength is then activated in the tumor microenvironment. This is a critical component to explain the promising data we've seen in phase II clinical trials to date. By concentrating in the tumor microenvironment, it enhances the activity of T cells. Both elements of ivonescimab work together to stimulate the immune system. Because VEGF is often found as a dimer and ivonescimab has the ability to bind to multiple VEGF proteins through its tetravalent structure, it can not only concentrate in the tumor microenvironment but also cluster or daisy-chain together, as illustrated here, further enhancing the PD-1 inhibition of the checkpoint on T cells and allowing the immune system to further destroy tumor cells. This is a critical component of the bispecific design. This is something that we believe cannot be replicated by co-administering an anti-PD-1 and anti-VEGF separately. This is a truly novel mechanism that differentiates ivonescimab from any existing compound or combination of different drugs. There are currently 19 trials being conducted or that have been conducted with ivonescimab, either as a monotherapy in combination with chemotherapy or in combination with another antibody or anti-tumor agents. Having explored more than a dozen tumor types, we have the opportunity to work with Akeso to chart the best path forward without having to start from scratch in the typical drug development where we would need to begin in phase I and slowly progress. As you can see in the presentation, ivonescimab is being developed in several types of non-small cell lung cancer, as well as gynecological cancer, breast cancer, colorectal cancer, several other GI cancers, head and neck squamous cell carcinoma, and various other solid tumors. So in total, we have 19 clinical trials, 4 phase III, 13 phase II, 2 phase I, right now in progression or completed with ivonescimab. With over 1,600 patients treated with ivonescimab, we are quickly generating the proper path to advance ivonescimab in late-stage trials through the help and collaboration with our partners at Akeso. As data continue to mature from these studies, we are planning to expand our current portfolio of clinical trials by initiating additional late-stage studies. I just want to remind you that ivonescimab was dosed its first patient in the second half of 2019. Substantial progress has been made at rapid speed without even accounting for the global pandemic that derailed many clinical development plans in 2020 and 2021. The combined operational and strategic speed at which both we at Summit and our partners at Akeso operate is a differentiator in terms of our combined ability to maximize the potential of ivonescimab. As you can see, ivonescimab is in four phase III trials in non-small cell lung cancer in China. I'm going to present Akeso's most recent updated phase II data in my next slide. The first phase III trial is in the second-line EGFR. Can you go back? Thank you. The first phase III trial is in the second-line EGFR TKI progressors, HARMONi, 400 patients in total, combination with chemo versus chemo. Akeso already completed their enrollment and submitted their data to the CDE, the Chinese Regulatory Authority. The second phase III trial is in frontline advanced and metastatic squamous non-small cell lung cancer, HARMONi-3 study, combination with chemo versus pembrolizumab plus chemo. We started to enroll the first patient last quarter. The third phase III is the sister study to HARMONi-3, which is Akeso's study in China, is tislelizumab plus chemo versus ivonescimab plus chemo. The fourth phase III study is a monotherapy study of pembrolizumab versus ivonescimab in frontline patients. Next slide. Let me discuss about ivonescimab clinical data that has been presented by Akeso at ASCO 2023, with some additional data having been released recently by ASCO, by Akeso. As mentioned, based on phase II data generated by our partners at Akeso, we initiated multiple phase III clinical trials in 2023. Here, I will go into more details on the data from the AK112-201 phase II clinical trial. We will present on two of the cohorts from this trial that support our phase III clinical trials, HARMONi and HARMONi-3. I want to present the data in frontline advanced metastatic squamous non-small cell lung cancer, an area with less development and competition in the lung cancer field, but with significant opportunity to improve the efficacy for patients needing further advancement. We are highly encouraged by what we have seen in a phase II setting. Looking at the waterfall plot on the left, only two patients saw a minimal increase in tumor burden. The remaining patients saw a reduction of the tumor burden, often significant. The overall response rate is 67%, and disease control rate of 95%. The progression-free survival in the 63-patient single-arm phase II trial exceeds the historical standard of care, with median progression-free survival being 11 months. Showing you both the global trial that led to the approval of a combination of pembrolizumab and doublet chemotherapy and the Chinese extension of the trial, their median PFS is around 8 months. You can see that the data generated by our partners at Akeso in China is very promising. This helped us move directly into phase III. Recently, Akeso announced the updated overall survival data for patients in this phase II, both 12 months and 24 months overall survival rates of patients looking very promising in this setting. Over 85% of patients in this study were alive after 1 year, which would exceed what has been seen by the standard of care historically. While median overall survival has not yet been reached after a median follow-up time of 21 months, you can start to see with a lower bound of the 95% confidence interval of 22.5 months that we believe that there is a significant opportunity here. We are evaluating ivonescimab in frontline metastatic squamous non-small cell lung cancer in order to demonstrate its efficacy and safety profile. I would like to remind you that overall survival is our primary endpoint in our HARMONi-3 phase III study. From a safety perspective, ivonescimab plus doublet chemotherapy was generally well tolerated, highlighted by the fact that there were no treatment-related adverse events leading to death in the phase II trial. What makes this so critical is that certain prior anti-angiogenic antibodies, such as Avastin, were not able to be developed in this squamous non-small cell lung cancer setting because of the risk of severe bleeding. The fact that ivonescimab, across 63 patients specifically in the squamous cell carcinoma setting, has not seen the same issues previously observed further amplifies the notion that ivonescimab mechanism is unique from previous compounds or combinations. Now, I would like to present the data on second-line EGFR TKI progressors. Taking a look at the phase II trial data supporting those patients who have progressed after an EGFR tyrosine kinase inhibitor, such as osimertinib, we find that there is promise in this space in which there is little effective therapy approved after the front-line TKI. This data supports, in part, our HARMONi phase III clinical trial. The overall response rate is 68.4%, with a median PFS of 8.5 months. Note that historical experience with the standard of care has seen an overall response rate of 27.1% and a median PFS of 5.5 months. We have included data related to ivonescimab in a phase II setting, as well as recently released data from trials that read out in 2023 in this setting. Note that the chemotherapy arm of one of these trials shown in the final column on the right is a representation of the current second-line standard of care after progression from osimertinib or a third-generation EGFR TKI. I remind you that this regimen, placebo plus platinum-doublet chemotherapy, is the same regimen as our control arm in our HARMONi study. The phase II data for ivonescimab plus chemotherapy is encouraging across this metric, considering currently established data in this space. Should the phase II data translate into a phase III trial in the way in which we believe it will, it will be another example of the differentiation of ivonescimab from a PD-1 inhibitor and immunotherapy agent, or a combination of the PD-1 and another agent. Ivonescimab is a unique mechanism with great potential. Finally, presented here is updated data recently released by Akeso with respect to overall survival from the phase II study in this setting. Our median overall survival is at 22.5 months versus control arm 14.7 months. Again, the control arm of our HARMONi study is placebo plus chemotherapy. We are highly encouraged by the potential for ivonescimab to help accomplish our mission, and we are testing ivonescimab plus chemotherapy in this setting to demonstrate the efficacy and safety of the combination for patients with a significant unmet medical need. From a safety perspective, ivonescimab plus chemotherapy was generally well tolerated in this setting. We are enthusiastic about the possibility of making a significant difference in patient outcomes with this regimen. I would like to present the safety data. Ivonescimab has been generally well tolerated with chemotherapy across the two phase II settings in which we spoke. If you look at the data, treatment-related adverse events leading to the discontinuation of ivonescimab was 11% and 0% in patients with first-line squamous cell carcinoma and EGFR-positive patients progressing after a TKI, respectively. Let me talk about ivonescimab opportunity. 50+ approved indications for PD-1 and PD-L1 checkpoint therapy, if you look at it. According to TD Cowen, estimated PD-1 sales worldwide will exceed $64 billion by 2027 with continued adoption across various tumor types and the combination of PD-1 and other therapies. This provides a great opportunity for ivonescimab going forward. As mentioned, there is no PD-1/VEGF-specific antibody approved or in phase III in Summit's licensed territory. Lung cancer represents a significant market opportunity, more than $20 billion for PD-1 and PD-L1 alone, according to Cowen, and a significant unmet medical need requiring more innovations for patients. Specific to lung cancer, there are so many individuals that are unfortunately affected by this terrible disease each year, 600,000 annual cases of lung cancer patients in the United States, Europe, and Japan alone. You can see within the major markets of our licensed territory, there remains a significant unmet medical need in the settings where we are conducting HARMONi and HARMONi-3. HARMONi addressable patient population in this market is around 40,000, and HARMONi-3 estimated patient population in this market is around 80,000. So now, let's take a look at short-term catalysts of growth around ivonescimab over the next six to 12 months. Next quarter, there are two key milestones expected from randomized phase III clinical trials from our partners at Akeso. AK112-301, a large majority of which represent the Chinese patient population of our HARMONi study, was submitted to the Chinese Regulatory Authority last year, signaling marketing approval in China. A decision is expected in the second quarter of this year from China's CDE. We also expect that Akeso will provide a data readout of the top-line result of their trial at this time. Additionally, Akeso has an interim analysis planned for next quarter for its study comparing ivonescimab to pembrolizumab in a monotherapy setting for lung cancer patients with tumors with positive PD-L1 expression. This direct comparison against pembrolizumab will be a differentiator for ivonescimab as a monotherapy, considering allowing for ivonescimab to showcase its trait directly. Given the direct implication of the AK112-301 result on our HARMONi study in the same patient population, as well as the ability to compare ivonescimab to Keytruda in one of Keytruda's most important settings in randomized phase III clinical trials, we believe that this event will be pivotal drivers in the development of ivonescimab globally. As we announced in our last earnings call, we also plan to complete enrollment in the HARMONi study in the second half of this year, providing momentum towards a submission for ivonescimab in our licensed territory. Finally, it's important to reiterate that physicians specializing in several different tumor types have reached out and submitted proposals to investigate ivonescimab in various potential settings outside of non-small cell lung cancer. Mechanistically, this novel agent carries a lot of interest in how it can shape the future standard of care in many solid tumors. With that, I would like to thank you for your attention during our presentation, and I open the Q&A for our team. Hartaj, back to you. Yeah, yeah, sorry, thank you. I was looking. I muted myself. Thank you, that was, Maky, that was fantastic. And, again, thank you for, you know, participating. This is, you know, this is the second day after many, many, many presentations. I should be exhausted, and you just had me, like, I was like, "Oh my God, this is really good stuff." You know, we cover Regeneron, and, you know, the Chief Scientific Officer was so confident of his PD-1 that they decided to go up against pembrolizumab, which, it seems, you know, you're doing with ivonescimab, you and your partner, Akeso. You know, maybe we just start off, there's so many questions, but, you know, one thing that stuck out to me, and I just wanted to kind of talk to you a little bit about the data that you diligenced, and, you know, what do you really like to point out, aside from what you've shown, you know, that gives you confidence on especially the metastatic non-small cell lung cancer chemo combo, essentially, right? And I'm looking at your slide 10 here, where you highlight the median PFS, 11.1 months, in that phase II study, right, of metastatic squamous non-small cell lung cancer, and the lower bound of your confidence interval is actually higher than the higher bound of pembrolizumab, from the studies that they had, or roughly speaking, right? That's fascinating to me. You know, can you talk to me about, you know, aside from just the data that you've shown, what is it about, you know, the data you saw in phase II, what were some of the other aspects of that data that give you a lot of confidence in your non-small cell lung cancer, you know, first-line trial? Hartaj, thank you very much. Allen, do you want to? Sure, Hartaj, I'll take that question. Let me back up here. I don't know if you can see me. Okay, here. Oh, yeah, so I think you're asking us, like, for the HARMONi-3 study, why we're confident. So, besides that, before I talk about ivonescimab, let me talk about the landscape. So, as you know, Avastin or VEGF targeted agents are active in lung cancer, but they weren't developed in squamous cell, non-small cell lung cancer because of this risk of bleeding. And so we know that there will be benefit from the VEGF. The phase II data shows a very interesting safety profile and efficacy profile. And as you pointed out, the efficacy was very striking in squamous, and we're continuing to follow that. We think that that's just a reflection of the product, but is there something unique about squamous cell cancers that specifically respond to this PD-1 VEGF combo or ivonescimab? We're not yet sure of. But the data are very strong, as you said, and so we're very confident around the HARMONi-3 study. And it's, you know, the big indication for us, it's the low-hanging fruit. We know VEGF will work there. We know PD-1 is working there. The standard of care is based on the KEYNOTE-407 study. This study is very similar in that design. We're just adding the VEGF with this cooperative binding PD-1. Yep. And, you know, just going to that, you know, the landscape in non-small cell lung cancer is changing, you know, very quickly. Merck is, you know, they're working very, very hard to make sure they don't run out of that, you know, pembrolizumab runway that they have towards the end of the decade, right? Gilead, for example, we covered them. They're going with PD-1 plus TIGIT, all the other approaches. How are you thinking, assuming you still have success, maybe your first phase III trial looks like your phase II, how do you think the landscape looks at that moment in terms of a competitive dynamic? Yeah, so from a competitive dynamic, they're going to have to work with us. So we're not tending to be the ninth or tenth approved PD-1, right? It's not another me too. You know, I think Regeneron was the sort of last PD-1 approved in this space, right? We're clearly trying to replace PD-1. We have four phase III studies ongoing. Three of them are against PD-1, right? So this will be a paradigm shift. So there are other checkpoint inhibitors being developed to add on to PD-1s. There's nothing that excludes us from doing that. If you want to talk about the landscape changing constantly with, you know, perioperative, adenosquamous, you know, squamous seems to be our strong point. A lot of companies are falling by the wayside there, so that's our first entry into that. We're looking at adeno very closely. You know, that's where there's a lot of activity with ADCs. There's nothing that precludes us from being combined with ADCs or some of these other agents as well. You know, we also think there's opportunities. If you look at the perioperative space, when we first looked at that space, we thought it was too fragmented. There was neoadjuvant, adjuvant, you know, neoadjuvant plus chemoradiation. I think the recent Merck data with the KEYNOTE-671 consolidates that and just sort of lines it up for us. We can do an easy study against pembrolizumab if we choose to, and there's phase II data that's ongoing that we're waiting for. So I think there's a lot of changes. I think our strategy is going to be minimally impacted by any changes. And, you know, I think we're very excited about the opportunities. Alan, this is really good stuff. I was actually, I've got, like, five questions I've written up, and we're at 3:10 P.M. Sure. You know, I know we met in San Francisco, had a great conversation. I look forward to keeping the conversation going. Manmeet, Dave, everybody out, thank you so much. You know, we look forward to, like I said, keeping the conversation going. Thank you for participating, and we look forward to more data, more presentations, and also meeting at medical conferences. Like I said, this is really eye-opening stuff. We're looking forward to more updates. Thanks, Hartaj. Thank you, Maky. See you. Thank you. Thank you, everyone. Take care.