Arcus Biosciences, Inc.

Hello everyone, and thank you for joining the Arcus Biosciences full year and fourth quarter 2025 earnings and financial results call. My name is Claire and I'll be coordinating your call today. During the presentation, you can register a question by pressing star followed by one on your telephone keypad. If you change your mind, please press star followed by two on your telephone keypad. I will now hand over to Holly Colkey from Arcus Biosciences to begin. Please go ahead.

Good afternoon, and thank you for joining us on today's conference call to discuss ARCIS' fourth quarter and full year 2025 financial results and pipeline updates. I will be filling in for Pia Eads, our head of IR, who is out on maternity leave. I would like to remind you that on this call, management will make forward-looking statements, including statements about our cash runway, our projected 2026 revenue, 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 most recent annual report in Form 10-K that has been filed with the SEC. For today's call, please refer to our latest corporate presentation posted in the investor section of our website. This afternoon, you'll hear from several members of our management team. So now, I'll turn the call over to our CEO, Terry Rosen, to begin.

Thanks very much, Holly, and thank you, everyone, for joining us this afternoon. 2026 is going to be a transformative year for Arcus. As you know, we are, we've been focused on establishing Castatafan as the unequivocal best-in-class HIF-2-alpha inhibitor in the new standard of cure for clear cell renal cell carcinoma. And this year is going to be another substantial year for data presentations, as well as the advancement and expansion of our Phase III clinical program for Cas. I want to emphasize, particularly those who are new to Arcus or Cas DataVan, that the advantages of Cas DataVan are well understood. That's all connected. from the earliest days of its design and development. The advantages derive from dramatic differentiation of Castatophan's PK-PD profile. These are evident in the highly quantitative and reproducible differentiation on the primary biomarker for HIF-2-alpha inhibition, EPO production, and the manifestation is improvement on all key efficacy measures. Castatophan hits a target harder, hits it earlier. Just this week, we shared updated data from our 20 cohorts evaluating cast data fan monotherapy in late-line clear cell RCC. We're also thrilled that Dr. Tony Sherry will be presenting his data this weekend at ASCO-GU. We're going to discuss these data in more detail today, but suffice it to say the bottom line is that single-agent cast continues to achieve unprecedented ORR and PFS and late-line clear cell RCC. It's not only relative to data for Belzutifan, the only currently marketed HIF-2-L inhibitor, but also relative to data for standard of care TKIs. This can be seen very clearly on slide seven of our corporate deck. Importantly, Castatafan achieves these outcomes without the debilitating toxicities associated with TKIs. In addition to the clinical data, the ESCO-GU presentation will include biomarker data that further reinforce the confidence in the differentiation of castatafan versus belazudafan. Also at ASCO-GU, we're going to see the detailed results from the Phase III LightSpark-0011 study. This evaluated belazudafan plus lumvatinib versus cabozantinib in IO experience clear cell RCC. These data should be both validating and highly de-risking for our ongoing phase three peak one study, which is evaluating Cas plus Cabo in a similar setting and with the same control arm. With both our own data and the Belzunifan data being presented, this ASCO-GU will be an extremely important event for the HIF-2-alpha inhibitor class, firmly establishing it as a key standard of care in the treatment of RCC. We believe HIF-2-alpha inhibitors will have a place in every line of treatment for RCC, And CAST is extremely well positioned to be the HIF-2 alpha inhibitor of choice across all settings. In fact, as we will describe later, we believe the profile of CAST will enable a unique frontline regimen that will transform the patient journey in the setting and could translate into multi-billion dollar commercial opportunities. Our first phase three study for CAST peak one is designed to get CAST approved and to patients as quickly as possible. This represents our fast-to-market strategy. There's already a high level of excitement driving enrollment in peak one, and the strength of our new ARC-20 data, coupled with the further validation of the HIF-2-alpha inhibition in early-line settings by the LightSpark data, will amplify the enthusiasm for the study. So by combining our best-in-class HIF-2-alpha inhibitor with the most widely used TKI cabozantinib, we believe will capture a substantial share of the IO experience setting. Now I'd like to spend a few minutes on our frontline strategy, because this is going to be a huge focus for us throughout 2026. Our frontline strategy is enabled by the consistently low rate of primary progression that's been observed with CAST DataFan across settings. This is shown very clearly on slide 20 of our corporate presentation. Primary progression reflects portion of patients whose disease progresses at or before the first scan. It's important for this rate to be as low as possible, particularly in early-line treatment, because patients with primary progression do not get an opportunity to benefit from therapy. This is devastating for both patients and their doctors. In contrast to the low rates for CAS, Belzutifan is associated with a very high rate of primary progression. Thirty-five percent is monotherapy in its Phase III trials. The manifestation of this key differentiation is that in frontline RCC, Belzudifan will likely always require a combination with a TKI to keep primary progression low. In fact, Merck's phase three study in the frontline setting is evaluating exactly that, Lenva, Belz, Pembroke. That's a pretty nonpatient-friendly regimen in the context of quality of life. A TKI-free regimen, on the other hand, is much more desirable for both patients and clinicians. The most common feedback that we receive from investigators is that given Casdatafan's profile, the use of a TKI can likely be put off for years. This offers a far better option for patients that would greatly improve their quality of life. Therefore, our frontline strategy is to develop Casdatafan without a TKI and specifically with a backbone of Casdatafan plus Anti-PD-1 which we can build upon with a third non-TKI mechanism. We plan to execute on this strategy quickly and efficiently using our ARC-20 study. This is probably a good time to explain how we have and will continue to leverage ARC-20 to drive our development strategy for CAS. First, with four monotherapy cohorts and 121 patients of efficacy data in late-line Clear Cell RCC, ARC-20 enables us clearly demonstrate that Cas has the best-in-class HIF-2-alpha inhibitor profile. Second, with these four monotherapy cohorts, which were designed to satisfy Project Optimus, we've established that 100 milligrams once a day is the optimal going-forward dose of Cas Datafant. Finally, the design allows us to rapidly and efficiently add and enroll cohorts to evaluate Cas and Cas-based combinations in other settings. We now have around 30 sites across four countries active in this study, and this drives efficiency. We first utilized this with the Cas plus Cabo cohort, where we quickly generated data to support our first Phase III study, Peak 1. We then added three new cohorts, approximately 90 patients in total, to demonstrate the feasibility of using Cas without a TKI in early-line settings. One of these cohorts is the Casplazim cohort, which is fully enrolled and for which we've already shared a primary progression rate of 9% for the first 23 of 30 patients. With the low rate of primary progression across all settings, we and our investigator advisors are convinced that the ideal frontline therapy is a TKI sparing castatafan regimen. And we just started enrolling a new cohort to evaluate Cas plus anti-PD-1 and anti-CTLA-4 to support the rapid initiation and execution of our first Phase III study in the frontline setting. Finally, while RCC is our top priority, we've generated exciting preclinical data for Cas and HCC and are evaluating opportunities to pursue HCC in a cost and resource efficient manner. We spent a lot of time already on Cas-Statafam, but I want to transition now to our immunology portfolio where there's been a lot of and growing interest. We've leveraged the same small molecule capability that created castatafan to build an emerging portfolio of inflammation and immunology programs. Two of these are expected to enter the clinic over the next 12 months. We are focused on addressing validated targets against which it has historically been difficult to create small molecule drugs that have optimal pharmaceutical properties. For this reason, We expect limited competition for our I&I programs, similar to what we're seeing with CasdataFan. Our three most advanced molecules are an MRGPRX2 antagonist, a TNF inhibitor, and CCR6 antagonist. Later on this call, Juan will speak in more detail about the potential differentiation of our compound relative to others. But before we go there, I'd like to turn the call over to Richard to review the new and updated CasdataFan data that we'll be presenting at ASCO-GU this coming weekend.