Arcus Biosciences, Inc.

Hello everyone and welcome to ARCA's Biosciences first quarter 2025 earnings and financial results call. My name's Lydia and I'll be your operator today. After the prepared remarks, there'll be an opportunity to ask questions. If you'd like to participate in the Q&A, you can do so by pressing star followed by one on your telephone keypad. I'll now hand you over to Pia Eates, Vice President of Investor Relations to begin. Please go ahead.

Good afternoon, and thank you for joining us on today's conference call to discuss ARGUS's first quarter 2025 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, our projected 2025 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 quarterly report on Form 10-Q that is filed with the SEC. Today you'll hear from our CEO, Terry Rosen, CMO, Richard Marcus, COO, Jennifer Jarrett, and CFO, Bob Gels. We'll also be joined by our President, Juan Jaen, for questions after the prepared remarks. With that, I'll turn it over to Terry.

Thanks very much, Pia, and thanks to all of you for listening in today. While the world around us has been somewhat or maybe definitely tumultuous. At Arcus, we've really remained focused on execution, and that execution goes with speed, efficiency, and most importantly, rigor. And so before we get into the details, I want to emphasize three points that will be apparent in our discussion today. So first off, our late-stage portfolio is rich, but our number one priority is unequivocally cast data fans. So far, the more data that we generate, the better it looks. So our goal is simple. We bring CAS to market and to patients as quickly as possible and create maximal value for this program. Second, we are well capitalized, and our long-term strategy has positioned us well to advance DOM, QEMLI, and CAS through their respective initial phase three readouts. Nonetheless, we're always cognizant of the macro environment We're committed to ensuring our resource deployment reflects our ongoing assessment of priorities so that our CASH runway extends as long as possible. Third, we expect to have a steady flow of data for CASH StataFan over the next couple of years that will reinforce the advantages relative to both Belzodifan and TKI monotherapy. In that vein, we're thrilled that our abstract describing initial data from the Cas plus Cabo cohort of ARC-20 was accepted for an oral presentation at ASCO. This is the same combination we're evaluating in our first and quarter. And these data should provide further support for the study. This will also be the third oral presentation of Cas-Statafan data at a major medical conference in just seven months, and there are a lot more to come. Okay, now some important granularity around the Cas-DataFan program. In our Phase 1b ARC-20 study, we now have eight cohorts evaluating different dosing regimens, combinations, and settings for Cas and Clear Cell RCC. This is why ARC-20 will generate meaningful data over the next two years that will serve several important purposes. First, continued elucidation of Cas-DataFan's differentiated efficacy profile relative to that of Belzuzudafan and de-risking of our first Phase III study, Peak 1. Second, continuing to drive the already extraordinary investigator enthusiasm for Peak 1 to support its rapid enrollment. And third, demonstrating the opportunity for Casdatafin in earlier line settings where Cas has the potential to ultimately displace TKIs. Before I turn the call over to Richard, I'd like to touch on a few additional topics starting with our development plan and our long-term vision for CasDataFan. Our Phase III trial, Peak 1, will evaluate Cas plus Cabo versus Cabo in clear cell RCC patients who have received prior immunotherapy. For our first registrational trial, we chose to combine Cas with Cabo because Cabo is the gold standard and most widely used TKI in the setting. In fact, in our ARC-20 monotherapy cohorts, 78% of patients received prior CAVO. That's greater than three times more than any other TKI. Clinicians are extremely comfortable administering and managing the toxicities of CAVO, and because of this, there's an extraordinary amount of interest in PEEK1. Also, because Hiv to Alpha inhibition affords a relatively benign safety profile, with the primary AEs being on-target anemia and hypoxia, we do not believe cats will have meaningful overlapping toxicities with cobble. As such, the key objectives of our upcoming ASCO presentation are to clearly demonstrate that these two molecules can be safely combined and that we can add efficacy to that of cobble monotherapy. We expect the data shared at ASCO will demonstrate exactly this. Longer term, Given the strength of CAS's efficacy and safety profile, a vision is to develop CAS in TKI-free regimens and even to displace TKIs in earlier lines of RCC treatment. TKIs have been very effective in treating RCC. Almost every RCC patient receives a TKI during the course of their treatment, but TKIs come with debilitating side effects that meaningfully impact quality of life. This cannot be overstated. So we believe there's a huge opportunity to develop CAS in earlier lines, driving a long-sought paradigm shift, enabling patients to avoid TKI therapy for as long as possible. This, in fact, reflects a core element of ARCIS's high-level strategy in oncology, driven by the advances in the understanding of tumor biology in the last decade. Being the leader in the development of innovative cancer therapeutics with improved efficacy that preserve quality of life during treatment. Specifically, we're collaborating with AstraZeneca to combine Cas with their anti-PD-1, anti-CTLA-4 bispecific antibody, furustamate, to create the first TKI-free HIF-2-alpha combination option for first-line RCC. I want to repeat that this will be the first TKI-free HIF-2-alpha combination option looked at in first-line RCC. Anti-PD-1, anti-CTLA-4 is one of the most commonly and widely used first-line regimens, particularly in academic centers, because it is TKI-free and conveniently prolongs survival. AstraZeneca will operationalize the study as part of their evolved portfolio, so this collaboration enables us to develop CAS in the first-line setting in an extremely cost- and resource-efficient manner, and with a world-class drug developer in oncology. The study is designed to demonstrate the safety of the combination to support late-stage development. This provides another opportunity to generate confidence-enhancing data for castatopan-based regimens over the next 18 to 24 months. Beyond EVOLVE, we've added three cohorts to ARC-20 that evaluate Cas and other early-line TKI-free settings. These are Cas plus Zim, our NIPD1 antibody, and first-line all-comer clear cell RCC, Cas monotherapy in first-line favorable risk patients, and Cas monotherapy in patients that have received prior IO but have not yet received a TKI. All three cohorts recently opened for enrollment and have generated significant interest in the investigator community, demonstrating and building on the robust interest in Cas, and in TKI-free regimens. As a result, these cohorts should enroll quickly and generate efficacy data over the next couple of years, informing future development opportunities. While cancer has moved front and center in our portfolio, our two other registrational programs, which are targeting massive patient populations with substantial unmet need, continue to advance towards data. For our Fc-saline anti-tidium antibody domedomelamide, first phase three study to read out will be START221, for which we have guided to 2026. This study is evaluating DOMZEM plus chemo versus NEVO plus chemo, the standard of care, and first-line gastric cancer. Later this year, we'll be sharing overall survival data, OS data, from the corresponding phase two study at gastric. This is evaluating the same regimen in the same setting as START221. We expect these data to reinforce confidence in STAR221, which has an overall survival primary endpoint. The competitive landscape in this field has seen a dramatic shift over the last six months, with the FC silent anti-tigit antibodies, specifically ours and AstraZeneca's anti-tigit, anti-PD1 bispecific antibody, now dominating the phase three landscape. These two molecules, have generated similar positive data in Phase II studies in both lung and GI cancers. AstraZeneca is now enrolling 10 different Phase III studies for its Eftesal and antitigin antibody. In addition, PRISM-1, our Phase III trial of QEMLI, our small molecule CD73 inhibitor, in combination with chemotherapy in first-line pancreatic cancer, is enrolling rapidly. There's been a tremendous enthusiasm for PRISM-1, and as a result, we anticipate the study will now be fully enrolled by the end of 2025, less than 12 months after initiation. This is our second global phase three study that will complete enrollment well ahead of initial expectations, and our goal is to replicate the success with the enrollment of peak one. This brings me to my final key point. Today, we have a strong balance sheet billion in cash and investments. This is not an accident. While there has been a dramatic shift in the macroeconomic environment, we are always scrutinizing our capital allocation, prioritizing our molecules and programs, and leveraging strategic collaborations. For example, those of Gilead, Tyho, and AstraZeneca to maintain a strong balance sheet. This will be particularly true going forward. to ensure that our capital stretches as long as possible and to enable us to continue funding our small molecule research programs. The discovery of castanophan, an exceptionally high-quality molecule against an extremely intractable target, is a reflection of the secret sauce of ARCIS, which is our research organization and small molecule drug discovery capability. Our next IMDs are likely to come from our inflammation and immunology programs which have been quietly but rapidly advancing in our focus on the creation of potential first and best in class small molecule drug candidates against validated targets. We're going to share more about these programs later in this year. With that, I'd like to turn the call over to Richard to speak about Cas-Statafan in greater detail.