Arcus Biosciences, Inc.

Thank you and welcome to the call. Following prepared remarks from the company, we will open the call for questions. To ask a question, please press star 1 on your telephone keypad. To withdraw your question, press star 2. This call is being recorded and will be available on the Investors section of the ARCUS website. I will now turn the meeting over to Pia Eves, Head of Investor Relations and Strategy.

Hello, everyone, and thank you for joining us on today's conference call to discuss ARGUS's third quarter 2023 financial results and pipeline updates, including today's presentation of data from our EDGE gastric trial at the ASCO monthly plenary. Today, you will hear from Terry Rosen, Chief Executive Officer, Dimitri Nautin, Chief Medical Officer, Jennifer Jarrett, Chief Operating Officer, and Bob Geltz, Chief Financial Officer. For Q&A, we will also be joined by Juan Jaen, President and Head of Research. I'd like to remind you that on this call, management will be making forward-looking statements, including statements about our cash runway, our investigational products, our expected clinical development milestones and timelines, and the potential market opportunity and drug treatable population of any indications being pursued by our program. All statements, other than historical facts, involve risks and uncertainties that may cause our actual results to differ. Those risks and uncertainties are described in our most recent quarterly report on Form 10-Q that has been filed with the SEC. We strongly encourage you to review the filing. For today's call, please refer to our latest corporate deck, which can be found on the investor section of our website. With that, I'll turn the call over to Terry.

Thank you very much, Pia, and thank you all for those who are on the line. This is the first quarterly earnings call we've had in some time. So, in addition to the DomVanilMab data that was just presented at Ascal Plenary, we're also going to discuss our other upcoming data readouts. Specifically, for AB521, our potentially best-in-class HIF2-alpha inhibitor, and Quemmin-Klustat, our first-in-class small molecule CD73 inhibitor, both of which we'll be sharing data with you just in the next few months. So, just a few hours ago, many of you likely watched Dr. Jan Jigian, present initial data from our Phase II study, Edge Gastric, for Dom Vanillamab and first-line metastatic upper GI adenocarcinomas. As a reminder, Dom is the only FC silent anti-tigit antibody in late-stage development, and we and our partner, Gilead, are pursuing a very broad development program that includes four Phase III studies in non-small cell lung and upper GI cancers. Today's data are extremely encouraging on all fronts. ORR for the PD-L1 high population clearly exceeded historical benchmarks in this setting. Data in the overall patient population appears differentiated, particularly relative to the most contemporary Phase III studies in this patient population, ORC's Keynote 859 and DateGene's Rationale 305. Most importantly, Six-month landmark PFS data for both the PD-L1 high and overall patient population appear to be quite differentiated from the benchmarks. These data are very supportive of our ongoing phase three study, STAR-221, which is evaluating DOM in the same combination, same setting underlying today's data set. STAR-221 is enrolling extraordinarily well and we expect that today's data will further enhance interest and actually accelerate recruitment in the study. In addition to DOM, we continue to execute on the remainder of our pipeline, including our HIF-2-alpha and adenosine pathway programs. Regarding our HIF-2-alpha inhibitor, AB521, early next year, we will be sharing detailed safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy data from the dose escalation portion of ARC20, which is a phase one 1B trial for AB521. We're close to completing enrollment, in fact, of the dose expansion cohort that's evaluating 100 milligram daily of AB521, the dose that we believe will hit the target substantially harder than the approved 120 milligram dose of Merck's Belzudafan. Merck's most recent data sets for Belzudafan presented at ESMO, continue to enhance our conviction around the opportunity for AB521. Those data were just what we've been expecting for months, if not the past year. Later in this call, we'll describe this program in much more detail. With respect to our adenosine programs, we'll discuss our ARC-8 trial evaluating our CD73 inhibitor, QEMLI. This is in combination with gemcitabine and abpaclitaxel, with or without our anti-PD-1 zimborellumab in first-line pancreatic cancer. As you may recall, ARC-8 completed enrollment way back in November of 2021. So the median follow-up, the most recent data cutoff, exceeded 21 months, and we just now achieved a sufficient number of events for mature median OS estimates. These data show clear differentiation from contemporary benchmarks for gemabraxane in this setting, one with huge medical need. Furthermore, we've generated a rigorous synthetic controlled data set for gemabraxane, which also shows very meaningful differentiation from our combination therapy. We also continue to work tirelessly to advance new molecules into the clinic. We just initiated our phase one study for AB801, our highly selective exon inhibitor And we expect to select a development candidate with potential best-in-class properties for our kit program for allergic diseases by year-end. So I'll now turn the call over to Dimitri to describe in more detail the edge gastric data that were presented earlier today.