Arcus Biosciences, Inc.

Hello and welcome to the Arcus Biosciences full year slash Q4 2023 earnings call. My name is Elliot and I'll be coordinating your call today. If you would like to register a question during today's event, please press star followed by one on your telephone keypad. I'd now like to hand over to Pia Eves, Vice President of Investor Relations. The floor is yours. Please go ahead.

Hello, everyone, and thank you for joining us on today's conference call to discuss ARCIS' fourth quarter 2023 financial results and pipeline updates. I'd like to remind you that on this call, management will make forward-looking statements, including statements about our cash runway and our expected clinical development milestones and timelines. All statements, other than historical facts, reflect the current beliefs and expectations of management and involve risks and uncertainties that may cause our actual results to differ from those expressed. Those risks and uncertainties are described in our annual report on Form 10-K, which has been filed with the SEC. We strongly encourage you to review our filings. Today, you'll hear from our CEO, Terry Rosen, COO, Jennifer Jarrett, CMO, Dimitri Naughton, and CFO, Bob Gels. We'll also be joined by our President, Juan Jaen, for questions after the prepared remarks. During today's call, we'll refer to slides in our corporate deck, which can be found on the investor section of our website. With that, I'll now turn it over to Terry.

Thanks very much, Pia, and thank you all for joining us today. We've really come a long way since our founding nine years ago, and I think it's fair to say we have evolved into an integrated biopharmaceutical company. We've got seven molecules in clinical development, a broad late-stage portfolio, multiple mid-stage clinical trials, a robust discovery engine, and now something I think new line of sight to commercialization. With $1.2 billion in cash and equivalents in runway into 2027, we're well positioned to deliver on the promise of the late stage pipeline that we've built. We'll start three new registrational trials. We're going to continue to invest in our early stage programs. We also have a partnership with Gilead, as well as collaborations with Tyho, Exalexis, and AstraZeneca And I think it's very fair to say without these partnerships and the resources that these companies provide, we would not be able to execute on everything that we're doing. All of our programs target markets that are massive and, you know, really are the sweet spots of large pharmaceutical companies. All comer patient populations and lung cancer, gastric cancer, pancreatic cancer, and renal cell carcinoma, RCC. Our funding and partnerships enable us to not only pursue these settings, but to compete and compete effectively and aggressively. We're really doing what we're saying we're doing. We also continue to build for the long term with a broad pipeline of potential best-in-class and first-in-class product candidates that will continue to replenish organically with our drug discovery engine. Today we have three advanced clinical stage programs. Dom plus Zym, our FC silent anti-tigit, it's very differentiated in molecule, and our anti-PD1 antibody. our small molecule CD73 inhibitor, and 8521, our HIF-2-alpha inhibitor, which is, as of today, known by its generic name, Casdataban, or Cas. DomZim is in phase three, and we expect to initiate phase three studies for both Cas and Quimley by early next year. So we'll have four molecules, all with distinct mechanisms in phase three in 2025. We also have some exciting datasets coming in the first half of this year, for another molecule, and these really are exciting, eTRUMA. That's our A2 receptor antagonist, and it's Gilead believes support further investment in the molecule. We made a lot of progress across all these programs in 2023, presenting two large data sets for DomZim and two different cancers, and another large data set just last month for Quimley and pancreatic cancer. I want to start today by reviewing these programs and data sets, then spend a few minutes on the recent Gilead partnership updates, and finish with some new data for Cas, our HIF-2-alpha inhibitor. So starting with our anti-tigit program, DomZim. Our primary competitors in space are Merck and Roche. We have the only FC silent anti-tigit antibody in late-stage clinical development. So with Dom's potentially best-in-class profile, its optimized dosing regimen, as well as a broad development program focused on lung and gastric cancers, we're really in a very strong competitive position. Our conviction in DomZim supported by two data sets that we've presented in the last 12 months and are summarized on slide nine of our corporate deck. First, at ASCO last year, we presented data from our randomized phase two ARC7 study showing a PFS hazard ratio of 0.67 for DomZim relative to Zim monotherapy in first line PD-L1 high non-small cell lung cancer. We also presented data from our Phase II edge gastric study, where we evaluated DomZen plus chemo in first-line upper GI cancers at the escapulinary session in November. These data demonstrated impressive six-month landmark PFS rates of 93% in PD-L1 high patients and 77% overall. This really compares quite favorably to the historical benchmarks for anti-PD-1 plus chemo that are in the 50% to 60% range. Our development program for DomZim is focused on settings where we have the best chance to be a market leader. Today we have three phase three trials enrolling and we expect both STAR-121 and STAR-221, our chemo combo trials and PD-L1 all comers for first line non-small cell lung cancer and upper GI cancers respectively to complete enrollment this year. In fact, we can share now today that we anticipate STAR-221 will be fully enrolled by the middle of this year. Due to the extremely rapid enrollment of STAR-221 and relatively short OS for the standard of care, we expect STAR-221 to be the first of our Phase III trials to read out. And importantly, with no other Phase III trials ongoing with the antitiget antibodies in this setting, we expect to have a significant first-to-market advantage. Meanwhile, we continue to invest in the expansion of our DOMSIM program. We in Gilead will initiate STAR-131, which will evaluate DOMZIM plus chemo and perioperative lung cancer. This is an exciting early stage and potentially curative setting. We also expect to initiate a fourth phase two study in a setting outside of lung and GI cancers. Beyond our DOMZIM program, today we'll be sharing data from the dose escalation phase of our ARC-20 phase 1b trial of Casdatafan or AB521. The 100-milligram expansion cohort of ARC-20 enrolled quickly and then completed enrollment ahead of schedule, November of last year. Later today, we'll touch on what we're seeing so far in these data. The competitor here is Merck with their HIF-2-alpha inhibitor, Belzudifan, which was just approved for advanced clear cell RCC, but we believe that CAS has a best-in-class profile, and that's addressing a very well-recognized limitation of Belzudifan. What we've seen thus far in ARC-20 has given us confidence that our molecule has a superior profile to that of Belzodifan. We're advancing CAS rapidly and are on track to initiate a Phase III study early next year. And last for QEMLI, our CD73 inhibitor, we presented overall survival data in pancreatic cancer from our ARC-8 study at ASCO-GI last month. With a large pooled data set, 122 patients, we showed 15.7 months median overall survival for CoMLE plus chemo, both with and without ZIM. This compares to the median OS from historical GEM-NAP-paclitaxel studies, nine to 11 months in first-line pancreatic cancer. We also conducted a MAPS synthetic control analysis that showed a statistically significant improvement in OS with a hazard ratio of 0.63. Based on the strength of these data, we're on track to initiate a phase three pancreatic cancer trial by early next year. With Gilead's equity investment in January, we had approximately $1.2 billion of cash on hand, and we're really well capitalized to support the breadth of programs that we are pursuing. At a high level, Gilead's investment accomplishes two things. First, it provides us with runway into 2027 while enabling us to fund phase three programs for four different molecules. Second, it enables us to fund our pre-commercial activities and on the other end of the spectrum to continue supporting our robust discovery engine. I'd like to turn things over to Jen right now to spend a few minutes on the details.