5/5/2026

speaker
Operator
Conference Operator

Hello, everyone. Thank you for joining us and welcome to the Arcus Biosciences first quarter 2026 business updates and financial results. After today's prepared remarks, we will host a question and answer session. Please limit yourself to one question and one follow up. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. I will now hand the conference over to Holly Kolke. VP of Corporate Affairs. Holly, please go ahead.

speaker
Holly Kolke
VP of Corporate Affairs

Good afternoon, and thank you for joining us on today's conference call to discuss Arcasys' first quarter 2026 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 development strategies and our expectations regarding the advantages and opportunities afforded by our investigational products, our clinical development milestones and timelines, our projected cash runway, and our financial outlook. 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 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 will hear from our CEO, Terry Rosen, Chief Medical Officer, Richard Marcus, President, Juan Jaen, and CFO, Bob Guelph. With that, I'd like to turn the call over to Terry.

speaker
Terry Rosen
CEO

Thanks very much, Holly, and thanks, everyone, for joining us this afternoon. We're starting a new era for Arcus with full ownership of our lead program guest data fan, our phase three kidney cancer study peak one enrolling rapidly, a clear path to win in the front line, and a next generation of molecules for inflammation and immunology that can be advanced rapidly into and through development. And with that, the strategic optionality imparted by a rich portfolio of wholly owned molecules and programs. We are at an inflection in value creation for patients and shareholders that will continue to accelerate over the next 12 to 18 months. Arcus has proven to be a highly productive company, creating and advancing a steady stream of potential best-in-class molecules for patients with cancer and inflammatory and autoimmune diseases. We believe that discovery is not a commodity, and we've built exceptional small molecule medicinal chemistry and drug discovery capabilities. Our scientists utilize proven biology to create unmatched medicines designed to raise the standard of care. Since its inception, Arcus has advanced molecules from program initiation to IND filing in as short as 18 months and accelerated platform and signal-seeking studies to move from proof-of-concept phase one studies to randomized phase two and registrational phase three trials in just a few years. Today, the company is laser-focused on castatafan, which represents a market opportunity of more than $5 billion in kidney cancer alone. I want to stress that castatafan's efficacy advantages are underpinned by much better molecular properties and a superior pharmacodynamic profile. This profile reflects the key capabilities in ARCIS that I described earlier. The simple fact is that castatafan hits its target much harder in an amorphous, stained way than does belzutafan is illustrated on slide six. This is a point we've emphasized since the data first emerged. These data are clear and they're striking. We believe this fundamental differentiation between castatafan and belzutafan and the limitations of belzutafan's pharmacodynamic profile and durability of effect are undoubtedly contributors to, if not the principal driver of, the outcome of FlightSpark 012. And the pharmacodynamic advantages of castatafan will continue to result in improved clinical outcomes across lines of therapy. I want to emphasize this point. This dramatic difference in profile has been evident since late last year. It is not esoteric. Its manifestations on clinical outcomes are dramatic and are at the core of our differentiation. No results to date are surprising. Our top priorities for 2026 are clear. One, complete enrollment for peak one, our second line phase three study, and two, initiate a phase three study in the frontline patient population. With the recent outcome of LightSpark 012, castatafan has a clear path to consolidate a fragmented frontline setting as the first hip 2 alpha inhibitor in this setting. Let me spend a moment on why castatafan is at the center of everything we do. We believe castatafan can transform the treatment paradigm in clear cell renal cell carcinoma And our development strategy is designed to generate evidence to secure CAST as a backbone therapy so that every patient has the opportunity to benefit from CAST across each line of therapy. Peak one represents our fast to market strategy. This is designed to build on the clinician enthusiasm that we've seen for CAST as an experimental agent and to generate the data to support the approval of a foundational treatment for Clear Cell RCC as rapidly as possible. Enrollment in PEAK 1 is accelerating, and we're on track to complete enrollment by year-end 2026. We're confident that PEAK 1 will establish CAS plus CABO as the new standard of care in the IO experience setting. The peak sales opportunity for CAS in this setting alone is more than $2 billion. At the same time, we are aggressively building a holistic strategy to embed CAS across the treatment paradigm. We have been making tremendous progress in the frontline setting with multiple IO combinations now enrolling in ARC-20 and generating data in support of our first-line strategy. These approaches offer the greatest potential for long-term survival for patients. One of our key objectives today is to make very clear our integrated development strategy for Cas-Statafed. It's actually quite straightforward. And here's how we believe things will play out. In the first line, our bedrock therapy will be CAS, IPI, anti-PD-1. We believe that we can drive the 35% share of ipinevo to a regimen with greater than 50% of the important first-line market. While the IO regimen of ipinevo is the dominant therapy today, there's a segment of physicians that's always going to want to reach for TKI. particularly for patients with a fast-growing bulky tumor. Therefore, we will also be developing a CAS combination inclusive of a TKI. A TKI with a well-established track record of both efficacy and safety that will allow the patient to have CAS-CABO as a subsequent regimen. Our second-line treatment, now enrolling its registration on trial week one, will be CAS-CABO, building on the standard of care in this line, cabozatinib monotherapy. Finally, we will have a third-line plus regimen cast with another well-established TKI, and we will be investigating this regimen in both Belzunafan-naive and Belzunafan-experienced patients. We think this is a very important kind of cool study. We also plan to explore novel cast combinations in ATC liver cancers. I would like to emphasize that all of the clinical development plans discussed today are accounted for within our existing budget and have no impact on the guidance and runway that we have provided. We now control, in all respects, our early stage pipeline, including our CCR6, CD89, and CD40 ligand programs, all of which are expected to support IND candidates in the next 6 to 18 months. As we focus our resources, capital, human, and otherwise, on the late-stage development of CasDataFan, the follow-on programs in our pipeline are early, but also with clear, early, and capital-efficient clinical proof-of-concept opportunity and huge commercial potential. Therefore, we anticipate low spend and short timelines to get to proof-of-concept that will drive disproportionate value creation. Juan will discuss these programs in more detail later on in this call. If you want to walk away with just one thing from today, it's that Arcus has complete control of its destiny. The core asset of the company is Castatafan, and we have the strategy, data, and resources to transform the treatment of Clear Cell RCC and create a $5 billion plus drug. Bob will further elaborate on the enormous commercial opportunity here. We also continue to leverage our demonstrated competitive advantage in small molecule drug discovery and increasingly scarce capability to generate wholly owned and unique development candidates, the advancement of which further enhances our strategic optionality. With that, I'd like to turn the call over to Richard to discuss our clinical programs.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-