RCUS

Biogen Inc. (BIIB) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended September 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on October 28. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly earnings of $2.04 per share in its upcoming report, which represents a year-over-year change of -57.6%. Revenues are expected to be $2.59 billion, up 2% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 1.77% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Biogen, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +1.81%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Biogen will most likely beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Biogen would post earnings of $3.04 per share when it actually produced earnings of $3.60, delivering a surprise of +18.42%. Over the last four quarters, the company has beaten consensus EPS estimates four times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Biogen appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Arcus Biosciences, Inc. (RCUS), is soon expected to post loss of $0.92 per share for the quarter ended September 2026. This estimate indicates a year-over-year change of +27.6%. This quarter's revenue is expected to be $11.88 million, down 54.3% from the year-ago quarter. The consensus EPS estimate for Arcus Biosciences has been revised 2.4% higher over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +1.39%. This Earnings ESP, combined with its Zacks Rank #4 (Sell), makes it difficult to conclusively predict that Arcus Biosciences will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Biogen Inc. (BIIB) : Free Stock Analysis Report Arcus Biosciences, Inc. (RCUS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

The market expects Arcus Biosciences, Inc. (RCUS) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.92 per share in its upcoming report, which represents a year-over-year change of +27.6%. Revenues are expected to be $11.88 million, down 54.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 2.39% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Arcus Biosciences, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +1.39%. On the other hand, the stock currently carries a Zacks Rank of #4. So, this combination makes it difficult to conclusively predict that Arcus Biosciences will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Arcus Biosciences would post a loss of$0.98 per share when it actually produced a loss of -$0.72, delivering a surprise of +26.53%. Over the last four quarters, the company has beaten consensus EPS estimates three times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Arcus Biosciences doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Arcus Biosciences, Inc. (RCUS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Image source: The Motley Fool. Wed., Aug. 5, 2026 at 4:30 p.m. ET Vice President of Investor Relations - Pia Eaves Chief Executive Officer - Terry Rosen Chief Medical Officer - Richard Markus President - Juan Jaen Chief Financial Officer - Bob Goeltz Operator: Hello, everyone. Thank you for joining us and welcome to the Arcus' Second Quarter 2026 Earnings Call. After today's prepared remarks, we will host a question-and-answer session. [Operator Instructions] I will now hand the conference over to Pia Eaves, Vice President of Investor Relations. Pia, please go ahead. Pia Eaves: Good afternoon, and thank you for joining us on today's conference call to discuss Arcus' second 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 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 Investors section of our website. This afternoon, you'll hear from our CEO, Terry Rosen, CMO, Richard Markus, President Juan Jaen, and CFO, Bob Goeltz. With that, I'll turn the call over to Terry. Terry Rosen: Thank you very much, Pia, and thanks so much, everyone, for joining us this afternoon. We continue to make substantial progress in advancing our portfolio of oncology and immunology programs. Execution throughout the first half of the year has been tremendous, and this tangible productivity will be a focus of today's discussion. Our highest priority, no surprise, continues to be the advancement of casdatifan, which we believe has clear potential to be a $5 to $10 billion drug. The remainder of our pipeline has also been advancing quite well, and we're beginning to share the details and breadth of our other programs. These create a steady and sustainable stream of additional opportunities, as well as strategic optionality. So starting with casdatifan, our next-generation HIF-2-alpha inhibitor. The advancement of cas has driven reflection and value for Arcus, and we expect further data this year to accelerate this reflection. Our first Phase III trial, PEAK-1, evaluating cas plus cabozantinib, the gold standard of care in second-line clear cell RCC, has tremendous investigator enthusiasm, and we remain on track to complete enrollment by the end of this year. Last year, we presented a wealth of data that demonstrated clearly casdatifan's efficacy advantages over belzutifan. Over the next 6 months, we will share new data that will provide clear line of sight to casdatifan's full market potential. Based upon casdatifan's superior profile, as well as our development strategy, we expect cas to become the backbone therapy for all patients in all lines of treatment in clear cell RCC, and we're maximizing that opportunity by rapidly expanding our development program. With the recent failure of Merck's LITESPARK-012 study, cas now has no competition in the frontline space. And our development plan, already ongoing, creates a clear path for cas to consolidate what's currently a fragmented frontline market as the first and only HIF-2-alpha inhibitor in this setting. We're leveraging our platform study ARC-20 in addition to collaboration studies to support the key combination regimens we'll pursue for first-line treatments. We had our meeting with the FDA to discuss our first frontline Phase III study in the setting. We're calling that PEAK-20, and we remain on track to start this registrational trial by the end of 2026. Across the development program, casdatifan is being evaluated in several different combinations across all lines of therapy. We're doing this in both a capital and resource-efficient manner by securing partnerships, more specifically clinical collaborations, and these all allow us to retain the full rights to the casdatifan program. We believe that we are the partner of choice for collaborations involving a HIF-2-alpha inhibitor. This is enabling investigation of the smartest mechanistic combinations and settings. Keep in mind, belzutifan is readily available to anyone. We do not believe it's an accident that others want to combine with casdatifan. We've initiated multiple new clinical trial collaborations in the last 2 months. In June, we announced the collaboration with BMS to evaluate cas in combination with pumita, their bispecific anti-PD-L1/VEGF antibody in the first-line setting. In July, we announced the collaboration with Summit Therapeutics to evaluate cas in combination with ivo, their bispecific anti-PD-1/VEGF antibody. Arcus will be conducting this study in a first-line cohort as part of ARC-20. This is the second of three collaborations we've executed to evaluate cas with an anti-PD-1/VEGF bispecific in the first line. So just to emphasize, we have three collaborations with anti-PD-1/VEGF antibodies. In addition, in July, we also announced the collaboration with AVEO, in which we'll be combining cas with tivo in advanced belzutifan-experienced patients. This study will also enable our planned late-line registrational study that will evaluate cas-tivo in both HIF-2 inhibitor-experienced as well as HIF-2 inhibitor-naive patients. So now, let me spend a few minutes describing our holistic development strategy for casdatifan. Let me emphasize an important point in introducing this topic. While we believe that casdatifan will completely transform the clear cell RCC treatment paradigm, our strategy is totally consistent with the current treatment paradigm. We're simply creating a framework that will provide HIF-2-alpha inhibitor enhanced options that only casdatifan with its unique profile can offer, basically adding on top of the best current regimens that are favored by both physicians and patients. So in the first line, we plan to develop multiple options that will make cas the foundational medicine regardless of the selected combination partner. Our strategy is designed to provide flexibility to physicians with a HIF-2-alpha inhibitor enhanced regimen corresponding to their preferred treatment approach for all types of clear cell RCC patients. With belzutifan's recent frontline setback, casdatifan has clear paths to become the common denominator in what's currently a fragmented frontline setting as the first HIF-2-alpha inhibitor available to these patients. A casdatifan-based TKI-sparing IO/IO regimen is the bedrock of our first-line strategy. It's intended to address the key limitation of ipi plus nivo, which is an approximately 20% rate of primary progression. Currently, ipi-nivo represents the most commonly used frontline regimen, with a market share of about 30%. And we believe cas has the potential to increase that to 50% or more. We also plan to develop a cas-based TKI-inclusive first-line regimen for that segment of physicians who are always going to prefer to reach for a TKI, especially for patients with fast-growing bulky tumors. Our partner TKI in the setting will be axitinib, well established as an effective frontline TKI, and very importantly, aligning well with subsequent regimens, including cabo and tivo, over the long-term treatment strategy. You have to remember that when making prescribing decisions, physicians are considering how they will sequence multiple TKIs to potentially give patients 10 or more years of survival. So combination choices are not selected in a vacuum. Lastly, in the first line, as I mentioned earlier, we're leveraging our partnerships, including with BMS and Summit, to evaluate casdatifan in combination with three different novel anti-PD-1/VEGF antibodies. We believe anti-PD-1/VEGF bispecifics may play an increasingly important role in the treatment of kidney cancer going forward. Both the PD-1 and VEGF pathways are factors in disease progression, and there's strong biologic rationale for pairing them with a hard-hitting HIF-2-alpha inhibitor like casdatifan to deliver both an early treatment effect and sustained tumor suppression. The rationale for this class of bispecific utility in clear cell RCC is as strong as in any setting. And the combination could provide a TKI-sparing regimen that still incorporates the essential biology of the TKI, but without the baggage that's associated with the poor selectivity of the TKI class. In the second line, cas plus cabo is intended to build on the current second-line standard of care. This combination is now in registrational testing with our Phase III PEAK-1 trial. Cabo is the most commonly prescribed TKI monotherapy in the setting. It's the TKI that physicians prefer and have greatest experience in managing AEs with the recognition of a better toxicity profile relative to that of the belzutifan combination partner, also sold by Merck, lenvatinib. Lenva's toxicity profile is well documented with greater rates of cardiovascular toxicities. Notably, in LITESPARK-011, all-grade cardiac dysfunction was 7% for belz-lenva versus just 1% for cabo. Grade 3 or higher cardiac dysfunction was 5% for belz-lenva versus 0.5% for cabo. That's a big deal. That's a tenfold difference. Keep in mind, these data are a direct comparison from a randomized study. With cas's superior efficacy profile versus belz, and cabo's tolerability advantages versus lenva, we expect cas plus cabo to be the preferred HIF-2-alpha combination in the second line based on both efficacy and safety. Finally, with the announcement of our collaboration with AVEO, we're developing casdatifan plus tivo in second-line plus clear cell RCC, including in belzutifan-experienced patients. As I mentioned, this will precede a registrational trial in both HIF-2-alpha inhibitor-experienced and naive patients. In an upcoming investor event in October, we'll be sharing key ARC-20 data readouts for casdatifan. These will be in the first, in the second, and late-line settings. These data will provide a holistic picture that will demonstrate the potential for cas to benefit patients across the treatment paradigm. This will be a large and comprehensive data set, including data from over 200 patients. Richard will go into more detail on the specific readouts, but I'd like to take a moment to provide some scientific context and a framework for thinking about patient outcomes with casdatifan in the various settings. In this context, in parallel to executing on our holistic development strategy for cas, we've been committed to the advancement of the highest quality research in the HIF-2-alpha space, particularly on translational studies that have a direct impact on the development program. I want to emphasize that this work, a hallmark of the casdatifan program on all fronts, is not esoteric, but in fact provides the basis for the quality and profile of the molecule, as well as the foundation for our development strategy. Our initial work on casdatifan and HIF-2-alpha biology was published recently in Nature last month. The manuscript describes exceptional scientific research carried out across our drug discovery, bioinformatics, translational and clinical teams, and includes a number of our clinical collaborators from the academic community. This is the first study to comprehensively connect clinical outcomes from patients receiving a HIF-2-alpha inhibitor with peripheral biomarker changes in associated tumor biology. The research showed that HIF-2-alpha inhibition with casdatifan monotherapy in clear cell RCC patients resulted in deep and sustained suppression of erythropoietin, and that the depth of that suppression correlated with higher response rates and longer progression-free survival. Suppression of erythropoietin, or EPO, production is good. It correlates with positive outcomes. This is just one example of the strides our research team has made towards developing a thorough understanding of HIF-2-alpha biology and its linkage to patient outcomes in kidney cancer. Okay. Now, the important piece, thinking prospectively. We've also been investigating how exposure to prior therapies may impact clinical outcomes. For example -- let me tie this all together. For example, it's known that, not surprisingly, prior TKI exposure in RCC leads to poorer outcomes for patients who are treated with a TKI in subsequent lines of therapy. So therefore, patients who receive a TKI in the first line are currently underserved by the most commonly prescribed TKI monotherapies in the second line and beyond. At the same time, however, TKI exposure has been shown to result in an upregulation of HIF-2-alpha activity. We've illustrated this on Slide 31 of our corporate deck. So let me repeat that. Greater TKI exposure has been shown to result in upregulation of HIF-2-alpha activity. One point I'd like to link back to now. In our Nature paper, we elucidated that high HIF-2-alpha activity is correlated with improved PFS in patients treated with casdatifan. However, interestingly, subgroup patient analyses reported by Merck showed that patients treated with belzutifan in LITESPARK-005 or LITESPARK-013 had an inverse correlation of efficacy outcome with number of prior TKI therapies. That is, more prior TKI therapies led to worse outcomes with belzutifan. By contrast, what I can tell you is that in our analyses of our late-line casdatifan monotherapy cohort, that's 120 patients, we do not show this inverse correlation. We therefore believe that more robust and in fact more durable HIF-2-alpha inhibition with casdatifan may provide better outcomes for patients with prior TKI exposure. And this will be one of the parameters that we analyze across our datasets, and we'll be speaking more about our analysis on this topic at the investor event in the fall. A little bit of a transition now. Our commitment to research has been at the core of the company since our founding, and despite relatively minimal capital investment, our parallel work in immunology has enabled us to build a rich portfolio of programs. Perhaps one of the broadest and deepest earlier portfolios of high-quality molecules in the industry. These programs were all created in-house over the last several years and are now approaching clinical development. Our portfolio addresses a number of validated and emerging targets, including MRGPRX2, the TNF receptor 1, CCR6, CD89, STAT6, and CD40 ligand. We expect to initiate human dosing of AB102, an oral small molecule MRGPRX2 antagonist, this month. It will be followed shortly thereafter by our oral and selective TNF receptor 1 inhibitor in early 2027. Overall, the portfolio has the potential to generate a steady flow of INDs between now and the end of 2027. These programs afford us great strategic optionality in disease areas with high unmet need and also with extremely large markets. Finally, in addition to cas and our immunology programs, we also have an ongoing Phase III study in pancreatic cancer. So coming out of ASCO, there's been increasing focus and excitement in this space. We're preparing for initial data from our Phase III PRISM-1 study of quemliclustat and chemotherapy in the frontline setting. We expect this to read out in the first half of next year. We actually see a major opportunity for quemli as an all-comer, first-line, and importantly, a very well-tolerated option for treatment of this devastating disease. With that, I'll turn the call over to Richard to discuss the status of our clinical programs and upcoming data readouts. Richard Markus: Thanks, Terry. As Terry described, our strategy is to establish casdatifan as a foundational standard of care across every line of therapy in clear cell RCC. We're currently pursuing multiple different combination studies for casdatifan across the first, second, and late lines. In order to conduct this work in a capital and resource-efficient manner, we have been leveraging our ARC-20 platform study and generating data through partner platform studies to support and enable our ongoing and planned registrational studies. We will have multiple important data readouts from ARC-20 later this year, and there will be a lot of data. So I'll walk through each study, its rationale, and the nature of the near-term readouts. Starting with the first-line clear cell RCC, we are pursuing a TKI-free approach as the foundation of our strategy, while also developing a TKI-inclusive option. The current TKI-free standard of care is the IO doublet, ipi-nivo. And let me remind you exactly what this regimen is. It's a maximum of 4 cycles, or 12 weeks, of ipi plus nivo, followed by nivo for the duration of the treatment. This therapy is highly valued for the overall survival benefit it provides and would be used more if the rate of primary progression, which is roughly 20%, were lower. We believe a combination with casdatifan can improve upon that rate of primary progression in addition to improving progression-free survival and ultimately, overall survival. To support the TKI-free approach, there are two key cohorts in ARC-20. First, casdatifan plus zimberelimab, our anti-PD-1, plus ipi, an anti-CTLA-4. This cohort has enrolled well, and we expect enrollment to complete very soon. We're also evaluating a cas plus zim first-line cohort in ARC-20, which completed enrollment at the beginning of this year, for which we've already described a very low rate of primary progression of 7%. That's just 2 of 30 patients. Keep in mind that anti-PD-1 monotherapy was previously reported to show a 30% rate of primary progression in this frontline setting. Now, for the TKI-inclusive approach, we'll be developing casdatifan in combination with axitinib, a well established TKI in the frontline that will sequence well with cas plus cabo as a subsequent regimen. We expect a new cohort in ARC-20 evaluating this combination to initiate in the fourth quarter this year. In collaborations with BMS and Summit, we are also evaluating novel TKI-free VEGF targeting combinations with anti-PD-1/VEGF bispecific antibodies in the first-line setting. BMS will be evaluating two cas plus pumita-based combinations in its platform study, ROSETTA RCC-208. In collaboration with Summit, we'll be adding a new cohort to ARC-20 to evaluate cas plus ivo in first-line clear cell RCC. Both of these studies are expected to begin by the end of this year. Now in the second line, the current standard of care is cabozantinib monotherapy, representing roughly 40% of the second-line market. PEAK-1, which is evaluating cas plus cabo versus cabo, is our first registrational study for casdatifan. Site activation and enrollment have been going quite well, and we expect to complete enrollment by the end of this year. We also have an ongoing cohort in ARC-20, evaluating cas plus cabo in a second-line, IO-experienced setting. We shared initial efficacy data for this cohort last year at ASCO. And finally, in late-line clear cell RCC, where the current standard of care is belzutifan or TKI monotherapy, we're adding a new randomized cohort in ARC-20 to evaluate casdatifan plus tivo versus tivo alone in patients that have received prior belzutifan. This cohort will generate data to support a registrational strategy combining cas with tivo by clarifying casdatifan's benefit specifically in HIF-2-alpha inhibitor-experienced patients. We expect enrollment to begin later this year. Now, let me briefly summarize the readouts coming from ARC-20 this year. In the first line, initial safety data from the ARC-20 cohort evaluating cas plus zim plus ipi. We've already met with the FDA and EMA to discuss how these data will support the start of our registrational trial evaluating cas plus nivo plus ipi as the bedrock of our frontline strategy. We will also be able to share preliminary data on primary progression. Also in the first line, we'll have ORR data with approximately 11 months of follow-up from the cohort evaluating cas plus zim. We will share waterfall and spider plots for that cohort. And given that the median progression-free survival for ipi-nivo from CheckMate 214 in this first line is just 12.4 months, we expect the spider plots for this cohort to be informative since they may impart an early look at how PFS will unfold for this cohort. In the second line, we'll have more mature ORR and PFS data for cas plus cabo in approximately 45 patients with at least 18 months of follow-up, and we may have an early read on OS. And in our late-line monotherapy cohorts, we'll be able to share an early look at overall survival with approximately 28 months median follow-up from the approximately 120 late-line monotherapy patients. While OS is not required for approval and registration of trials for clear cell RCC, it could impact access in ex-U.S. regions and is recognized as another potential major differentiator relative to belzutifan, which has now failed to show statistically significant benefit in OS in 3 out of 3 registrational trials. So this first look at OS for casdatifan will provide important comparative data. Taken together, these data readouts will create a holistic picture of casdatifan's efficacy across all lines of therapy and should generate strong conviction in its potential as the new backbone of kidney cancer treatment. As Terry mentioned, we expect to share the totality of these data together in an investor forum in October prior to ESMO. And with that, I'll turn the call over to Juan to discuss our immunology portfolio. Juan Jaen: Thanks, Richard. Over the past few years, the same discovery team that created casdatifan has been working on creating a broad portfolio of programs that span the whole spectrum of autoimmune and allergic diseases. While we haven't said much about this effort until now, we are very proud of its quality and scope. The overarching strategy has been to design molecules that might provide safe treatments for important patient segments across the immunology landscape. We have also prioritized approaches that leverage our demonstrated expertise in designing potent and selective molecules that work in the real world under physiological stress rather than just in a culture dish. Further, we have looked for ways to minimize the inherent biological risk associated with novel mechanisms of action. You may notice a couple of recurring themes in the mechanisms of action that we have chosen to pursue in implementing our portfolio strategy, including the development of oral small molecule alternatives to established biologics and an emphasis on targeting immune cell populations that have generally been understudied. We expect a steady cadence of molecules advancing into the clinic, beginning with our MRGPRX2 antagonist and followed by our TNF receptor 1, CCR6, STAT6, CD89, and CD40 ligand programs, all of which are positioned to deliver IND-ready candidates between now and the end of 2027. Our first program, AB102, an oral MRGPRX2 antagonist being developed for chronic spontaneous urticaria or CSU and atopic dermatitis, is wholly owned by Arcus. Available biologics have meaningfully advanced the treatment of allergic conditions, but substantial clinical need remains. X2 is a key regulator of mast cell activation in these diseases, releasing inflammatory signals that drive swelling and itch, making this a promising target for conditions like CSU and atopic dermatitis. At the Society for Investigative Dermatology annual meeting earlier this year, we presented preclinical data on an oral X2 approach showing full blockade of X2-dependent mast cell degranulation and inhibition of all common human X2 variants. This data supports the potential for a potent selective once-daily oral X2 antagonist to impact key disease outcomes in conditions driven by aberrant mast cell activity. AB102 is entering the clinic imminently, with PK profile data expected in the fourth quarter from the first cohorts of our first-in-human healthy volunteer study. We expect to follow with a proof-of-concept study in CSU in mid-2027. Unlike other recent clinical failures in the X2 space, we believe that the excellent potency of AB102, optimized to be efficacious under physiological conditions, provides the best opportunity to run the definitive proof-of-concept study with an X2 antagonist in CSU. We also are developing an oral small molecule TNF inhibitor as a potential treatment for conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Our TNF inhibitor is designed to selectively block TNF receptor 1, which we believe could translate into better safety and efficacy relative to approved anti-TNF biologics, which block both TNF receptors 1 and 2. As you may know, blocking TNF receptor 2 can paradoxically lead to an inflammatory response in some patients. We expect this program to enter the clinic in early 2027. Behind AB102 and our TNF programs, we have a portfolio of earlier-stage immunology programs for which we will share more details as they approach entry into the clinic. I'll now hand it over to Bob to discuss the market opportunity for casdatifan as well as our financial results. Robert Goeltz: Thanks, Juan. Before I get into the quarter's financials, I want to spend a few minutes on the multi-billion-dollar market opportunity for casdatifan. Sales for RCC drugs in just the major markets are expected to grow to roughly $13 billion by 2030. Historically, this market has been fragmented, primarily split across the IO and TKI classes. With only two HIF-2-alpha inhibitors on the horizon and clear advantages for casdatifan, we believe Arcus has a path to become a common denominator across lines of kidney cancer treatment. Casdatifan is targeting lines of therapy with large patient populations and long treatment durations. PEAK-1 addresses approximately 20,000 IO-experienced patients in the major markets, representing an opportunity of more than $2 billion. And the first-line opportunity is even larger, exceeding $4 billion. All told, we see a total peak sales opportunity for casdatifan of $5 to $10 billion, driven in part by duration of therapy from a long-term tail effect. This is something we've seen consistently in our late-line monotherapy data, where approximately 25% of patients remain on treatment beyond 2 years. As a reminder, Arcus owns all commercial rights to casdatifan outside of Japan and certain other Asian territories where rights are held by our partner, Taiho. Turning to quemli, we continue preparations for the readout from PRISM-1. While there's been exciting progress made in the treatment of later-line pancreatic cancer, quemli has the opportunity to be the first meaningful advancement in the frontline in decades. We believe this is a multi-billion-dollar commercial opportunity. Further, we believe quemli's well-tolerated profile as well as its promise to substantially enhance the benefit of immunogenic chemotherapy would make it attractive as a combination partner if PRISM-1 is successful. I also want to touch on capital efficiency. Full ownership of casdatifan gives us significant strategic optionality and supports a capital-efficient collaboration strategy. Our new agreements with BMS, Summit, and AVEO are structured to advance casdatifan combinations without placing outside demands on our own resources. The same is true of our wholly owned immunology portfolio where the TNF program is the only one carrying an option held by Gilead. Turning to our financial results for the quarter, our cash and investments as of June 30th, 2026 were $775 million, as compared to $876 million at the end of the first quarter. We continue to expect to end 2026 with approximately $600 million in cash and investments and expect these resources to provide runway into at least the second half of 2028. We recognized GAAP revenue for the second quarter of $41 million and now expect full year 2026 GAAP revenue of $65 to $75 million. Revenue continues to be driven primarily by our collaboration agreements. Future operating results are expected to reflect lower collaboration revenue due to reduced activity under the Gilead collaboration, driven by the wind-down of the domvanalimab program. Our R&D expenses for the second quarter were $113 million net of reimbursements, and we continue to expect a meaningful decrease in overall R&D spend in 2026 and 2027 relative to 2025 as a result of the wind-down of the dom Phase III trials and reduced spend on quemli, together with broader spend management. By 2027, we expect more than 80% of our portfolio spend to be directed toward casdatifan development. G&A expenses were $24 million for the second quarter, and total non-cash stock-based compensation was $15 million. For more details regarding our financial results, please refer to our earnings press release from earlier today and our 10-Q filing. I'll now turn it back to Terry for closing remarks. Terry Rosen: Thanks very much, Bob. So let me close by summarizing our priorities for the remainder of 2026. No surprise, casdatifan remains our number one priority. We're working aggressively, both independently and with clinical collaborators, to expand the development program with the goal of positioning cas to be the [ CAG all-cas ] backbone of kidney cancer treatment across all lines of therapy. In the coming months, we'll share data for casdatifan as monotherapy and in combination in first, second, and late-line settings. We expect these to further reinforce casdatifan's best-in-class profile and drive conviction in its potential as a transformative therapy. These studies will support a broad registrational strategy, bringing both the qualitative and quantitative advances that HIF-2-alpha inhibition offers for the clear cell RCC treatment paradigm, starting with the ongoing PEAK-1 study, which is on track for full enrollment by year-end, as well as a Phase III trial, again that's called PEAK-20, that's evaluating cas plus ipi plus nivo in first line to be initiated by year-end. For clarity, I want to confirm that we will be using ipi-nivo as the combination partner for casdatifan in this registrational study. And for non-casdatifan, our PRISM-1 Phase III trial for quemliclustat in pancreatic cancer remains on track for a readout next year. And Juan walked you through the exciting progress across our immunology portfolio, with AB102 advancing into the clinic, followed by our TNF inhibitor shortly thereafter, and other immunology programs over the next 18 months. With $775 million in cash and investments, and runway into at least the second half of 2028, we're well positioned to execute on all of these priorities. We see a clear opportunity for value creation for patients and shareholders to accelerate, perhaps dramatically, over the coming months. Thank you for joining us today. We appreciate your interest and continued support of Arcus, and we'll now open the call for questions. Operator: We will now begin the question-and-answer session. [Operator Instructions] Your first question comes from the line of Salim Syed with Mizuho. Salim Syed: Just one kind of going into all the October data, obviously a lot of data that we'll be getting, is there a bogey or measure of success that you're looking at in each of these lines that you would care to elucidate here for folks? And also, while we're there, are there any particular parts of the dataset that you would like to place a little bit more prominence on where you want people to anchor to? Terry Rosen: Thanks, Salim. Great question, and I'll address all that. I'll start at a very high level, and then I'll get increasingly granular. So I think you can walk away with some very clear expectations as to how we're looking at things. So at the highest level, I think we want people to walk away and believe they will walk away knowing that casdatifan is going to become the backbone standard in RCC across all lines of therapy. So I think one of the ways to frame this is put it in the context of value and value creation and looking at it through an investor standpoint. I think it's very clear that last year we received an inflection in value that was due to recognition in the investor community, that there was really a very substantial differentiation between casdatifan and belzutifan. And what we've heard from a lot of investors is that led sort of to a recognition, a value that was reflected in our second-line strategy that we were given value for an expectation that cas plus cabo is going to beat cabo and that's going to look good. I think the other piece, though, was that with that differentiation, there still remain questions as to whether that differentiation, which is clearly there, how will that translate more broadly and particularly in the frontline. And I think a couple of things have happened. First, you had the failure of LITESPARK-012, but then we've also had another year's worth of follow-up clinical data. So I think what's going to happen as we come into this readout is that we'll be able to give very strong conviction across all lines of therapy, including the frontline. And the frontline is huge because that's the $5 billion-plus part of the market opportunity. So keep in mind, we have no competition in the frontline without belzutifan. There, the competition is the standard of care. So in that context, let me go down another layer and talk about the frontline and build on a couple of things that Richard pointed out. So our foundational registrational study there will be cas plus ipi plus nivo versus ipi-nivo. And what we're going to have, we'll have at least 20 patients' worth of data from that cas anti-PD-1 ipi cohort that we're running as part of ARC-20. Keep in mind, this is exactly what we've agreed upon with the FDA in terms of safety. So we'll have a safety profile with that 12 or more weeks. And we'll also have a look at the rate of primary progression. So I think the thing that might surprise people as they're thinking about this now, and we get more granular, is that the cas-zim dataset is actually going to be relatively mature despite being an early data set. Because if you contextualize a PFS for ipi-nivo that's just over 12 months, as well as a well-done study with pembro alone where you have a PFS on the 7 to 8 months, you'll be able to get a feel from our curve as to how our PFS is looking compared to those regimens. Also, with over 18 months of median follow-up, I think we'll have a good look potentially at OS, as we move into the second line, is playing out, and some of these things will start to go across studies. So let me now talk about the second line and build on what I just said there. So in the second line, our cas-cabo data will really support that we will have what will look like a better PFS than what was seen with belz-lenva. And I think given the safety, and we talked a little bit earlier about what's been associated with lenva and lenva-belz, that we think we'll have advantages that read on both the safety and efficacy. The other thing to look at is that given that maturity, as I was saying of over 18 months, I think the shape of our curve will give you a sense that we could have a very dramatically different hazard ratio when we compare it to cabo versus the hazard ratio of 0.7 that was seen for belz-lenva. I think the more important piece, though, is that given that the -- given what's known for the OS of cabo, which is just over 21 months, given that we'll have that 18 months of follow-up, we may see, in fact, what appears to be an OS advantage for the casdatifan regimen. Keep in mind, our OS is only going to be based upon how we look relative to direct comparison to cabo, and that'll be defined by its hazard ratio. As Richard mentioned, thus far, belzutifan has been [ 0.43 ]. So we're pretty excited about having those first data that read on OS. And that brings me to the late line. So the late line, we've clearly shown, as a single agent, a very dramatic difference compared to the data that have been generated with belzutifan, but we'll have 28 months of follow-up. And again, given that the OS for belzutifan is just over 20 months, I think it gives us an opportunity. You'll see the Kaplan-Meier curves. We don't know how it's going to play out, but I think with the very robust durable HIF-2 inhibitor, this will start to perhaps show us the -- how important HIF-2 really is as a target in clear cell RCC. And you'll clearly have some sense, we all will, of how OS will look in that setting. And I think the nice thing there, since it's single agent, that will give read-through. And you were asking about what things are important. I think that'll read through to the mechanism across lines of therapy. So just to summarize, I think overall success will be that you come away knowing that not only do we have a plan for casdatifan to win. I think we've laid that out pretty clearly, we're executing on it, but those data will have enough data now that you'll see we actually will win and that casdatifan really will look like it's going to become the common denominator for all clear cell RCC treatments. Operator: Your next question comes from the line of Daina Graybosch with Leerink Partners. Daina Graybosch: Looking forward to another fall event. I wonder if you can talk about LITESPARK-012, which we'll see at ESMO after that event, and your expectations for PFS and OS in that study. And is there a specific signal that would give you confidence or increase your confidence that cas can exceed there with axi and a PD-1 where belz, lenva, and pembro failed? Terry Rosen: Thanks, Daina. So this is going to be a theme we come back to. People ask a lot of times about read-through from trials and talk about there's read-through from things where we have the data, LITESPARK-012. We don't have the data, but I think the most important thing is go to Slide 5. You can say like elections have consequences, biomarker data have consequences. And when you look at the comparative durability of the ability to suppress erythropoietin, so the ability to inhibit HIF-2, I think that's the thing that tells 90-plus percent of the story. So people speculated about safety issues of the triplet, et cetera. I think everything comes down to a dramatic differentiation of the molecules. And I think what you're starting to see now is data where that'll play out. So I think the biggest problem that belzutifan probably had is the durability and the decrease with time and ability to inhibit HIF-2 where their own papers talk about effect on the biomarker looking very nominal at just 12 weeks. Keep in mind the PFS for the control arm there is 24 months. So the fact that you're not inhibiting strongly for that durability, I think that's the issue. And then the thing that gives us confidence is we know that casdatifan is inhibiting not only robustly on day 1, but out past the year, and in fact, as long as you're on treatment. So you do not run into those issues. Keep in mind, one last piece that, again, however that affects things. As we've talked about, treatment with TKI does induce the increased activity of HIF-2-alpha. So you get more HIF-2-alpha activity. So essentially, what you have in that study is the treatment with the TKI, this is not a discontinuous event that happens in a continuous way. So you've got increasing levels of HIF-2 activity and you've got a HIF-2 inhibitor that is measured by that biomarker work is clearly not inhibiting HIF-2 as strongly with time. So less activity of the molecule, more activity coming from the TKI-induced HIF-2 activity. So I think that's a recipe for difficulty. Whereas the Arcus molecule, you're talking about a paradigm of a tumor where 85 to 90-plus percent of the patients have HIF-2 as a driver. And you're going to put a HIF-2 inhibitor, which only brings anemia on top of a good regimen of a TKI and an anti-PD-1, and we feel super excited about it. And we can't even imagine something that would come out of LITESPARK-012 that will cause us to think differently. And I'll remind you, our number one focus there is on top of ipi-nivo, and you'll see a really strong dataset, I think, as we go into fall. So we'll feel really great about the frontline. Operator: Your next question comes from the line of Jonathan Miller with Evercore ISI. Jonathan Miller: A couple more about what we're expecting in October. In the second-line cohort, can you remind us how much prior LENVIMA those patients have gotten? Terry, to your point, not all TKIs are created equal and we know that sequencing has effects. I think we've seen prior TKI treatment numbers, but how many patients got LENVIMA prior? And secondly, in first line, I'm a little surprised that you're so hesitant about giving ORR or broader efficacy readouts for the triplet in first line. You'll have two scans or more for most patients. What do you expect to see for time to response in first line versus second line? Why are you so hesitant to give ORR and why do you think that there won't be enough to at least start directionally talking about that? Terry Rosen: Okay, so remind me the first question and then I'll get to the ORR. Jonathan Miller: That's prior LENVIMA. Terry Rosen: By the way, we're not hesitant. Prior lenva. So we'll give you specific numbers at the time. Let me remind everyone else as well. It's probably when people talk about differences between the ARC-20 cas-cabo as well as our registrational study versus the LITESPARK-011 study, because in that study, Merck had cabo in the control arm and a lenva in the study arm, really the only TKIs of probably substantial number that they saw were patients on axi, so it was probably a mix of axi and ipi-nivo. We'll give specific numbers at that time, but what I'd say is our lenva patients are very representative of what you would normally see in the first line. So we'll have a substantial number of lenva patients out of that 40-some-odd patients who looks relatively like the distribution. In terms of your other question, we will share those information. There's no hesitancy. I think just on expectations, given that, keep in mind that study's enrolled very quickly, that triplet. We think the most important part of those data will be, first, the safety and second, the rate of primary progression, because that's really what you're addressing. And we think even what you'll see from just our anti-PD-1 plus cas, that'll give you warm feelings about efficacy, given we'll have that 11 months of median follow-up, and that still may improve. But we'll see -- we'll share what the early responses looked like. I think the thing to think about is that the timing of an IO plus a casdatifan regimen may look a little bit more like IO alone or HIF-2 inhibitor alone where responses, that did you cross 30% or not, when that happens may be more prolonged. The thing is when you combine with the TKI, as you know, you're really affecting the vascular system, and it's a very -- or a very sort of response fast type of phenomena, but then obviously it doesn't give you the durability. So we'll share those data, but I think the more important things that you'll get out of it are the safety of the triplet, the rate of primary progression, the rate of primary progression from any of the studies we've done that don't include a TKI, particularly those in the earlier lines as well as a few other monotherapy datasets. And then the cas plus zim simply because you will have a longer period of treatment. And so not only will you see ORR there, but I think the shape of the curve, particularly knowing that if you look at actually ipi-nivo out at 12 months, you're getting in that 50-ish percent plus or minus place. It will just be a very clear comparison. But you shouldn't think we have any hesitancy sharing those data, it's just that time will probably affect more of the response rate. I think one other thing that is worth -- I'll just use this as an opportunity to highlight this. I think it's probably not fully appreciated because of the totality of the belzutifan data, how profound the ability to inhibit HIF-2 is on durability. But I'll just use actually belzutifan data. People ask for read-through, we get asked about read-through from LITESPARK-012 where we haven't seen the data, but the places where we've seen a lot of data, for example, LITESPARK-005, and we've seen a monotherapy data. Now, interestingly enough, if you go back and look at those data, median PFS for belzutifan in that late-line setting was about 5.6 months, which is about the same as the median PFS for everolimus. Similarly, the rate of primary progressions for the two were very much the same. We think those sort of relate to the ability to hit the target hard. However, they still won. The drug got approval and that's because so much of the manifestation of hitting HIF-2 is coming from what that does to the tumor and how it plays out on the other side of the median. So we think HIF-2 is going to turn out, and I think our data will certainly give the opportunity to assess that, that HIF-2 is going to turn out to be something that affects everything on those durability measures. And I think that the belzutifan data have foreshadowed that because despite what's probably a marginal ability to really hit HIF-2 hard and hit it long, they still had very good effects. So I think the first place where you saw the manifestation of that less than optimal durability of hitting HIF-2 hard for a long period of time came in their frontline study. And that's probably not surprising because it's comparing versus the longest PFS in the control arm. So the percentage of time that it's bringing value is smaller compared to whether it's the LITESPARK-005 or LITESPARK-011, where it's fighting a shorter battle compared to the standard of care. Operator: Your next question comes from the line of Li Watsek with Cantor. Li Wang Watsek: Congrats on the progress. I have two questions. Maybe first, follow up on the lenva question for the second-line, cas plus cabo cohort. How should we think about the impact of prior lenva exposure on the types of patients enrolled into the study relative to the LITESPARK-011 trial? Just trying to understand the right PFS benchmark, given there's some differences in the patient population. And then second, Terry, you mentioned prior TKI exposure increases the HIF-2 levels. Just trying to clarify if you're implying cas PFS has a positive relationship with prior lines of TKI. Terry Rosen: Okay. So thanks on both of those. So the first thing we would say is we actually feel quite good. And I mentioned what we saw in the late line, that we did not see a degradation in the monotherapy, 120 patients prior TKI and we'll share very specific data in the fall, but we did not see a falloff in efficacy associated with those patients that had seen more TKIs versus the trend that was seen in LITESPARK-005 and LITESPARK-013. So going in, we're feeling really confident that despite the fact that we'll have those TKI-experienced patients and lenva patients, we feel very optimistic about the benefit that those patients will receive. So sort of across the frontline strategies, we feel good that the benefit that HIF-2 will bring on top of cabo will be advantageous. In terms of comparisons, to your point, one of the things that gives me an opportunity to talk about how we'll present the data. So I'll even use the word that Jonathan used a second ago about hesitancy. We're going to be effusive with the data. And when we share our data, you can assume we've squeezed all the water out of the sponge of what we know at the time. And you'll have complete knowledge of what we have. And one of the things we're going to do is we're going to use every comparative data set that we can to illustrate what the advantages of casdatifan are. We feel like it's a great opportunity because casdatifan is going to bring a lot to the table. And one of the tools that we'll have is the study CaboPoint. And CaboPoint, if you go back and read what the intent was, it really was designed where it looked in two separate groups, randomized, where you had patients that were treated with TKIs and patients that were treated with IO/IO. And then how did those different groups look when they then received cabo. So it's a perfect comparison. Yes, we'll compare to belz-lenva. Yes, we'll compare to any other registrational data with cabo alone. But we also have those nice data sets that were really, if you look at the genesis of that study, the intent was that for future combinations, you'd be able to have a clean dataset to see how anything new -- what it was bringing to the table. So it's a perfect dataset. So we will do subpatient analyses since we'll be forced to go cross-trial comparison, as much as everybody doesn't like it, actually everybody loves it, and so we'll look at how we compare to both of the segments of the population from the CaboPoint study to see how the advantages we're bringing to cabo, whether it's from prior TKI treatment or prior IO/IO treatment. And keep in mind, we're going to have curves. So those curves will not only give you a sense of static differences, but I think they'll give you a sense of how the hazard ratios are going to play out because with that 18 months of follow-up and all the landmark data that comes with that, knowing that the tails are a big deal, you'll see how those tails are corresponding both to what you would see with cabo and what you saw with belz-lenva. Nicely, both of our programs are run against the same control. And so you'll get a sense of both our hazard ratio versus cabo as well as how you might think that'll compare to a hazard ratio of what you saw for belz-lenva. Operator: This brings us to the end of the Q&A session. I will now turn the call back to Terry Rosen, CEO, for closing remarks. Terry Rosen: So I want to thank everybody. We're looking forward to speaking more. A couple of you asked some really great questions, and I think not only will we have a lot of clinical data but we'll have a lot of science and translational work much like we had in the Nature paper. So I think we're going to have a lot of great discussions about the future of casdatifan-based therapy. So thanks for joining and we look forward to speaking to you over the coming months. Operator: This concludes today's call. Thank you for attending. You may now disconnect. 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Interested in Arcus Biosciences, Inc.? Here are five stocks we like better. Casdatifan is Arcus’ top priority: The company is expanding the HIF-2 alpha inhibitor’s development across first-, second- and later-line clear cell renal cell carcinoma, with data from more than 200 patients expected at an October investor event. The Phase III PEAK-1 trial remains on track to complete enrollment by the end of 2026. Arcus is advancing additional pipeline programs, including the Phase III PRISM-1 pancreatic cancer study, which is expected to produce initial data in the first half of 2027, and AB102, an oral immunology candidate slated to begin human dosing this month. Second-quarter cash totaled $775 million, while revenue reached $41 million, primarily from collaborations. Management expects to end 2026 with about $600 million in cash and investments, providing runway into at least the second half of 2028. From laggards to leaders: Small caps on the rise Arcus Biosciences (NYSE:RCUS) outlined plans to expand development of its casdatifan cancer program across multiple lines of clear cell renal cell carcinoma, or ccRCC, while reporting second-quarter financial results and updates on its pancreatic cancer and immunology pipelines. Chief Executive Officer Terry Rosen said casdatifan, an investigational HIF-2 alpha inhibitor, remains the company’s top priority. Arcus is pursuing combinations designed to position the drug as a treatment option in first-line, second-line and later-line ccRCC. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling MarketBeat Week in Review – 7/10 - 7/14 The company expects to present data from more than 200 patients across its casdatifan program at an investor event in October, ahead of the European Society for Medical Oncology meeting. The planned disclosures are expected to include results from first-line, second-line and late-line cohorts in Arcus’ ARC-20 platform study. Arcus’ first registrational casdatifan study, the Phase III PEAK-1 trial, is evaluating casdatifan plus cabozantinib against cabozantinib in patients with previously treated ccRCC. Rosen said enrollment remains on track to finish by the end of 2026. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Gilead Boosts Biotech Footprint With Stakes In AlloVir And Arcus Chief Medical Officer Richard Markus said Arcus expects to disclose more mature objective response rate and progression-free survival data from approximately 45 second-line patients receiving casdatifan plus cabozantinib, with at least 18 months of follow-up. The company may also have an early look at overall survival, he said. In the first-line setting, Arcus plans to initiate PEAK-20, a registrational Phase III trial of casdatifan combined with ipilimumab and nivolumab, by the end of 2026. Rosen said the company has discussed the study with the FDA. → No Hangover: Revisiting Microsoft One Week After Earnings ARC-20 also includes a cohort evaluating casdatifan with zimberelimab, Arcus’ anti-PD-1 antibody. Markus said enrollment in that cohort was completed early this year and that the company previously reported a 7% primary-progression rate, representing two of 30 patients. Arcus expects to report objective response rate data, waterfall plots and spider plots with approximately 11 months of follow-up. Another ARC-20 cohort is evaluating casdatifan, zimberelimab and ipilimumab. Arcus expects enrollment to complete soon and plans to share initial safety data and preliminary primary-progression data later this year. The company also plans a first-line cohort evaluating casdatifan plus axitinib, with initiation expected in the fourth quarter. In addition, Arcus has established collaborations with Bristol Myers Squibb and Summit Therapeutics to study casdatifan with anti-PD-1/VEGF bispecific antibodies in first-line ccRCC. BMS will study casdatifan-containing regimens in its ROSETTA RCC-208 platform trial, while Arcus plans to add a casdatifan-plus-ivo cohort to ARC-20 through its Summit collaboration. For later-line disease, Arcus is working with AVEO Oncology on casdatifan plus tivozanib. A randomized ARC-20 cohort will compare the combination with tivozanib alone in patients previously treated with belzutifan. Enrollment is expected to begin later this year and is intended to support a planned registrational strategy in HIF-2 inhibitor-experienced and HIF-2 inhibitor-naive patients. Rosen pointed to recently published research in Nature examining casdatifan’s effects on erythropoietin, or EPO, and HIF-2 alpha biology. According to Rosen, the research found that deeper and sustained EPO suppression in clear cell RCC patients receiving casdatifan monotherapy correlated with higher response rates and longer progression-free survival. Management also discussed the potential effect of previous tyrosine kinase inhibitor, or TKI, treatment. Rosen said Arcus’ analysis of approximately 120 patients in its late-line casdatifan monotherapy cohort did not show the inverse relationship between prior TKI exposure and efficacy that had been reported in certain belzutifan analyses. Chief Financial Officer Bob Goeltz said sales of renal cell carcinoma drugs in major markets are projected to reach roughly $13 billion by 2030. Arcus estimates the second-line opportunity addressed by PEAK-1 represents more than $2 billion, while the first-line opportunity exceeds $4 billion. The company estimates total peak sales potential for casdatifan at $5 billion to $10 billion. Arcus retains commercial rights to casdatifan outside Japan and certain other Asian territories, where Taiho holds rights. Beyond casdatifan, Arcus said its Phase III PRISM-1 study of quemliclustat plus chemotherapy in first-line pancreatic cancer remains on track for an initial readout in the first half of 2027. The company is also advancing an immunology portfolio. President Juan Jaen said Arcus expects to begin human dosing this month for AB102, an oral MRGPRX2 antagonist being developed for chronic spontaneous urticaria and atopic dermatitis. Pharmacokinetic data from the first healthy-volunteer cohorts are expected in the fourth quarter, followed by a planned proof-of-concept study in chronic spontaneous urticaria in mid-2027. Arcus expects its oral, selective TNF receptor 1 inhibitor to enter the clinic in early 2027. Additional programs targeting CCR6, STAT6, CD89 and CD40 ligand are positioned to deliver IND-ready candidates through the end of 2027, according to management. Cash and investments totaled $775 million as of June 30, down from $876 million at the end of the first quarter. GAAP revenue was $41 million in the second quarter, primarily driven by collaboration agreements. Arcus expects full-year 2026 GAAP revenue of $65 million to $75 million. Research and development expense was $113 million, net of reimbursements, while general and administrative expense was $24 million. Non-cash stock-based compensation totaled $15 million. Goeltz said Arcus expects to end 2026 with approximately $600 million in cash and investments, providing runway into at least the second half of 2028. The company expects research and development spending to decline meaningfully in 2026 and 2027 compared with 2025, reflecting the wind-down of domvanalimab Phase III trials, lower quemliclustat spending and broader expense management. By 2027, Arcus expects more than 80% of its portfolio spending to be directed toward casdatifan development. Arcus Biosciences is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel cancer immunotherapies. The company's research platform centers on modulating tumor microenvironments and immune checkpoints through both small-molecule and antibody-based candidates. Arcus aims to enhance antitumor immune responses by targeting pathways such as the adenosine axis and inhibitory receptors on immune cells. The company's lead clinical programs include etrumadenant, an orally administered A2A adenosine receptor antagonist being evaluated in combination with anti-PD-1 therapy, and domvanalimab, an anti-TIGIT monoclonal antibody. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Arcus Biosciences Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management believes casdatifan has potential to become the 'common denominator' across all lines of clear cell RCC treatment, targeting a $5 to $10 billion peak sales opportunity. The failure of Merck's LITESPARK-012 study is viewed as a strategic opening, leaving casdatifan with no direct HIF-2-alpha inhibitor competition in the frontline setting. Performance attribution for casdatifan's perceived superiority is linked to more robust and durable HIF-2-alpha inhibition, evidenced by deep and sustained erythropoietin suppression. Strategic differentiation in the second line focuses on combining casdatifan with cabozantinib, which management claims has a superior safety profile compared to the belzutifan-lenvatinib combination. Management highlighted that while prior TKI exposure typically degrades outcomes for subsequent TKI therapies, it upregulates HIF-2-alpha activity, potentially making these patients more responsive to casdatifan. The company is utilizing a capital-efficient collaboration model with BMS, Summit, and AVEO to evaluate casdatifan in novel combinations while retaining full program rights. Beyond oncology, Arcus is advancing a parallel portfolio of immunology programs that have been part of the company's core research since its founding., leveraging internal discovery expertise to target validated and emerging pathways like MRGPRX2 and TNF receptor 1. Arcus expects to initiate the Phase III PEAK-20 registrational trial evaluating a casdatifan-based triplet in the frontline setting by the end of 2026. Management anticipates completing enrollment for the Phase III PEAK-1 study in second-line RCC by year-end 2026, supported by high investigator enthusiasm. Financial guidance assumes a year-end cash balance of approximately $600 million, providing a projected operational runway into at least the second half of 2028. A major data event is scheduled for October 2026, which will include holistic readouts from over 200 patients across first, second, and late-line settings. The company expects a steady cadence of immunology INDs through 2027, with 80% of total portfolio spend directed toward casdatifan development by that year. Revenue is expected to decline in future periods due to reduced activity under the Gilead collaboration following the wind-down of the domvanalimab program. Management flagged the 20% primary progression rate of current frontline standard-of-care (ipi-nivo) as a key hurdle they aim to address with casdatifan combinations. The company noted that while overall survival (OS) is not required for U.S. registration, it remains a critical factor for ex-U.S. market access and a key point of differentiation against belzutifan. R&D expenses are projected to decrease in 2026 and 2027 relative to 2025 as legacy Phase III trials wind down and spend management initiatives take effect. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management aims to demonstrate that casdatifan's differentiation from belzutifan translates into superior clinical outcomes, particularly in the $5 billion frontline market. Key metrics will include safety data for the frontline triplet and a look at primary progression rates, which management expects to be lower than historical IO-monotherapy norms. For the second line, management expects the data to suggest a better hazard ratio and potentially a more favorable OS trend compared to the 0.7 HR seen with belzutifan-lenvatinib. Terry Rosen attributed competitor failures to a lack of durable target inhibition, noting that HIF-2-alpha activity increases with TKI treatment while competitor molecules show nominal biomarker effects by 12 weeks. Arcus claims casdatifan maintains robust inhibition beyond one year, which they believe is essential for success in frontline settings where control arm PFS is long (approx. 24 months). Management stated that their late-line monotherapy data did not show the inverse correlation between prior TKI lines and efficacy that was observed with belzutifan. They intend to use the 'CaboPoint' study as a benchmark to illustrate the additive benefit casdatifan provides to cabozantinib across different prior-treatment segments.

Arcus executes on strategy to establish casdatifan as a backbone therapy across each line of treatment for clear cell renal cell carcinoma (ccRCC), including three new clinical trial collaborations that advance distinct casdatifan-based combinations New research published in Nature, evaluating patients with advanced ccRCC who were treated with casdatifan, provided the first data that comprehensively connect clinical outcomes for patients receiving a HIF-2α inhibitor with peripheral biomarker changes and associated tumor biology Multiple ARC-20 data readouts for casdatifan across lines of therapy are expected in the second half of 2026, including initial efficacy data for casdatifan plus zimberelimab in first-line, progression-free survival (PFS) data for casdatifan plus cabozantinib in second-line and overall survival data for casdatifan monotherapy in late-line ccRCC With $775 million in cash, cash equivalents and marketable securities at quarter-end, Arcus is well positioned to advance casdatifan aggressively, with cash runway until at least the second half of 2028 HAYWARD, Calif., August 05, 2026--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a pipeline update on its clinical-stage investigational molecules and discovery programs. "Our recent publication in Nature demonstrated our commitment to being the scientific leader in HIF-2α biology and translational medicine. We are leveraging these insights and the differentiated profile of casdatifan compared to that of the competition to ensure that casdatifan becomes the backbone of treatment across every line of therapy in kidney cancer. In the front-line setting especially, we see a clear path to be first-to-market and to provide the best options for physicians and patients," said Terry Rosen, Ph.D., chief executive officer of Arcus. "The ARC-20 platform study and strategic clinical collaborations are enabling us to efficiently pursue an integrated approach across multiple lines of therapy, and we expect this year’s upcoming ARC-20 data readouts in first-, second- and late-line settings to clarify casdatifan’s potential to transform the treatment paradigm for kidney cancer." Casdatifan (HIF-2α inhibitor) Development Strategy: Arcus's development strategy is designed to generate evidence to secure casdatifan as a backbone therapy in ccRCC so that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care. Arcus is executing on this strategy, including embedding casdatifan into the treatment paradigm in combination with the most commonly used dual-immunotherapy regimen in the first-line setting, nivolumab (an anti-PD-1) plus ipilimumab (an anti-CTLA-4) and the standard of care in the second-line setting, cabozantinib. Arcus’s combinations were selected to complement these two core regimens. The holistic strategy, which has the opportunity to provide the first and only HIF-2α inhibitor-based TKI-sparing first-line therapy, provides consecutive casdatifan-containing regimens in the first-, second- and third-line-plus settings highly aligned with a new treatment paradigm offered by the robust HIF-2α inhibitory profile of casdatifan. In this context, Arcus will also begin to evaluate casdatifan plus TKI-containing regimens in first-line and late-line settings, the latter in belzutifan-experienced patients. Arcus’s newly announced clinical collaborations described below support these efforts, enabling the company to evaluate numerous casdatifan-based combinations in parallel. Casdatifan Partnership Updates: Arcus will receive a $15 million milestone payment from Taiho Pharmaceutical in the third quarter, triggered by PEAK-1 enrollment in Japan, under the parties’ option and license agreement. Taiho holds rights to casdatifan in Japan and certain territories in Asia. New Clinical Collaborations: Arcus announced three new clinical collaborations to evaluate casdatifan-based combinations in first-line and late-line ccRCC: Bristol Myers Squibb (BMS): Casdatifan combinations will be added as two new arms of the BMS-sponsored Phase 1/2 ROSETTA RCC-208 study in advanced RCC, evaluating casdatifan in combination with the anti-PD-L1/VEGF-A bispecific antibody pumitamig, which is being jointly developed by BioNTech and BMS. Summit Therapeutics: A new cohort in the ARC-20 platform study in ccRCC will evaluate casdatifan with the PD-1/VEGF bispecific antibody ivonescimab in the first-line setting. AVEO Oncology: A new ARC-20 cohort will evaluate casdatifan with the VEGFR TKI tivozanib in patients previously treated with belzutifan. Arcus has also executed one additional clinical collaboration agreement to evaluate a casdatifan combination with another anti-PD-x/VEGF bispecific antibody in first-line ccRCC, which is expected to initiate in the fourth quarter of 2026. Development Program: First-Line ccRCC: The first-line setting today is divided into immunotherapy (IO/IO) regimens, representing roughly one-third of the market, and IO/TKI regimens, representing roughly two-thirds of the market. Arcus’s casdatifan strategy encompasses both, plus another novel TKI-free combination approach: IO-Experienced (second-line) ccRCC: Enrollment in PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib alone in IO-experienced metastatic ccRCC, is accelerating, and Arcus remains on track to complete enrollment by year-end 2026. Arcus is confident PEAK-1 will establish casdatifan plus cabozantinib as the new standard of care in the IO-experienced setting. Late-Line ccRCC: A new randomized ARC-20 cohort will evaluate casdatifan plus tivozanib versus tivozanib alone in patients who received two or more lines of prior therapy, including a belzutifan-containing regimen, which will elucidate the impact of prior HIF-2α inhibitor treatment on casdatifan’s activity. Enrollment in this new ARC-20 cohort is expected to begin in the fourth quarter of 2026. Casdatifan Research Published in Nature: In July, Arcus announced that results from the ARC-20 study evaluating casdatifan monotherapy were published in Nature. This is the first study to comprehensively connect clinical outcomes in patients treated with a HIF-2α inhibitor with peripheral biomarker changes and associated tumor biology. HIF-2α inhibition with casdatifan resulted in deep and sustained suppression of the hormone erythropoietin in blood (serum EPO), which correlated with higher response rates and longer PFS. Planned Data Readouts: Arcus expects multiple data readouts for casdatifan in 2026: In first-line ccRCC, initial data from the ARC-20 cohorts evaluating casdatifan in early-line settings, including early efficacy data for the cohort evaluating casdatifan plus zimberelimab and early safety data for the cohort evaluating casdatifan plus zimberelimab plus ipilimumab in first-line ccRCC. In second-line IO-experienced ccRCC, more mature overall response rate data and initial PFS data, including Kaplan-Meier curve(s), for approximately 45 patients treated in the ARC-20 cohort evaluating casdatifan plus cabozantinib. All patients will have had at least 18 months of follow-up. In late-line ccRCC, updated data from the ARC-20 monotherapy cohorts, including overall survival data. Quemliclustat (small-molecule CD73 inhibitor) The European Medicines Agency granted orphan drug designation in May 2026 to quemliclustat for the treatment of pancreatic cancer, adding to the orphan drug designation received from the U.S. Food and Drug Administration in June 2025. Enrollment was completed in September 2025 for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma. Results from this study are expected in the first half of 2027. Immunology Portfolio Arcus is applying its proven expertise developing potent and selective small-molecule drugs to address large markets in immunology, pursuing mechanisms that regulate key cytokines validated by existing biologics and targeting immune cell types that are central to disease but historically understudied. A steady cadence of immunology molecules will be ready for advancement into the clinic, with multiple new clinical candidates expected between 2026 and 2028. AB102 (oral MRGPRX2 antagonist): This month, Arcus expects to initiate a first-in-human healthy volunteer study of AB102, a highly selective oral MRGPRX2 antagonist and potential treatment for atopic dermatitis and chronic spontaneous urticaria. TNF Inhibitor: Arcus has selected a development candidate as an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease, which is expected to enter the clinic in early 2027. Additional Targets: Arcus is advancing additional programs across its immunology portfolio. Arcus’s programs for a small-molecule CCR6 antagonist for psoriasis and inflammatory bowel disease, a STAT6 small molecule program for atopic dermatitis and asthma, a CD89 monoclonal antibody program for the treatment of rheumatoid arthritis, and a CD40L small molecule program for the treatment of multiple sclerosis and systemic lupus erythematosus, are each expected to deliver IND-ready candidates by the end of 2027. Anti-TIGIT Program and Related Partnerships Following the discontinuations of the Arcus and Gilead STAR-221 and STAR-121 studies in upper gastrointestinal cancer and non-small cell lung cancer (NSCLC), respectively, Arcus and AstraZeneca will discontinue the Phase 3 PACIFIC-8 study, evaluating domvanalimab in combination with durvalumab versus durvalumab alone in patients with PD-L1 positive, Stage III unresectable NSCLC. In connection with the wind-down of these Phase 3 trials and resulting streamlined operational relationship with Arcus, Gilead has relinquished its three seats on Arcus’s Board of Directors, effective as of August 5, 2026. Financial Results for Second Quarter 2026: Cash, Cash Equivalents and Marketable Securities were $775 million as of June 30, 2026, compared to $1.0 billion as of December 31, 2025. The decrease during the period is primarily due to the use of cash in our research and development activities. Arcus expects to end 2026 with approximately $600 million in cash. Based on the existing business plan, Arcus believes that its cash, cash equivalents and marketable securities will be sufficient to fund its planned level of operations until at least the second half of 2028. Revenues were $41 million for the second quarter 2026, compared to $160 million for the same period in 2025. The decrease in revenue was primarily driven by the cumulative catch-up from license and development services revenue of $143 million in 2025 relating to pausing future development of etrumadenant and Gilead's related return of its license to the program, partially offset by an increase in access rights revenues recognized in June 2026 related to the expiration of Gilead's option rights and increased revenues related to programs optioned under the Taiho Collaboration Agreement. Arcus expects to recognize GAAP revenue of between $65 million and $75 million for the full year 2026. Research and Development (R&D) Expenses were $113 million for the second quarter 2026, compared to $139 million for the same period in 2025. The decrease was due to (i) late-stage development activities decreasing primarily due to the wind down of the domvanalimab program and the completion of enrollment of PRISM-1, partially offset by increasing activities in our Phase 3 studies for casdatifan; (ii) early-stage development activities decreasing primarily due to the wind down of Phase 2 studies related to domvanalimab and lower Phase 2 study costs for casdatifan; partially offset by (iii) partnership reimbursements decreasing, primarily due to Gilead-led activities representing a larger share of total joint development costs and a shift towards programs fully funded by us. Non-cash stock-based compensation expense was $9 million for the second quarter 2026, compared to $8 million for the same period in 2025. For the second quarters 2026 and 2025, Arcus recognized gross reimbursements of $17 million and $33 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.Arcus expects R&D expenses to continue to decline in the near-term relative to what we have incurred as we wind down studies for domvanalimab. Streamlining initiatives Arcus has undertaken across its R&D operations in connection with this wind-down, together with efficiencies the company is pursuing across its programs outside the Gilead collaboration, are expected to further reduce costs. These decreases will be partially offset by increased investment in the development of casdatifan and advancement of our small-molecule immunology programs. General and Administrative (G&A) Expenses were $24 million for the second quarter 2026, compared to $29 million for the same period in 2025. The decrease was primarily due to streamlining initiatives Arcus has undertaken across its operations. Non-cash stock-based compensation expense was $6 million for the second quarter 2026, compared to $7 million for the same period in 2025. Net Income (Loss) was $91 million net loss for the second quarter 2026, compared to $— million for the same period in 2025. Conference Call Information Arcus will host a conference call and webcast today, August 5, 2026, at 1:30 PM PT/4:30 PM ET to discuss its second-quarter 2026 financial results and pipeline updates. To access the call, please dial +1 (585) 542-9983 (local) or +1 (833) 461-5787 (toll-free), using Meeting ID: 156828313. Participants may also register for the call online using the following link: https://events.q4inc.com/attendee/156828313. To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory and autoimmune diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2α inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com. Forward-Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Arcus’s development strategies and opportunities, including the potential for casdatifan to become the backbone of treatment across every line of therapy in kidney cancer; the timing and achievement of milestones, including the completion of enrollment in PEAK-1, the initiation of PEAK-20, and the progress and cadence of additional molecules from Arcus’s immunology programs to IND-readiness; the timing of future data readouts and presentations; and expectations regarding the decline in its operating expenses, year-end cash balance and its anticipated cash runway. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks associated with: Arcus’s ability to manage the breadth and pace of its development plans for casdatifan; the unexpected emergence of adverse events or other undesirable side effects with casdatifan, alone or in combination with other agents; difficulties or delays in initiating, enrolling and completing clinical trials, including due to regulatory review, site activation, patient identification or enrollment, or manufacturing and supply constraints of investigational or standard-of-care products for such clinical trials; interim data not being guarantees of future data or replicated in other studies evaluating casdatifan, including the Phase 3 PEAK-1 study; adverse data from toxicology studies that affect Arcus’s ability to advance development candidates from its immunology programs; the risk that the preclinical profiles of Arcus’s development candidates may not translate in clinical trials; changes in the competitive landscape for Arcus’s programs; the inherent uncertainty associated with pharmaceutical product development and clinical trials; and risks associated with Arcus’s ability to accurately forecast financial results and changes in Arcus’s operating plans. Risks and uncertainties facing Arcus are described more fully in the "Risk Factors" section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission (SEC) and in other filings that Arcus makes with the SEC from time to time, which are available at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release, except to the extent required by law. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners. View source version on businesswire.com: https://www.businesswire.com/news/home/20260805395862/en/ Contacts Investor Inquiries: Pia EavesVP of Investor Relations & Strategy(617) [email protected] Media Inquiries: Holli KolkeyVP of Corporate Affairs(650) [email protected] Maryam BassiriDirector of Corporate Affairs(510) [email protected]

This article first appeared on GuruFocus. Release Date: July 23, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Summit Therapeutics Inc (NASDAQ:SMMT) reported a strong cash position of approximately $690.7 million at the end of Q2 2026, an increase from the previous quarter. Ivanizumab, the company's lead investigational asset, has shown positive data in four Phase III clinical studies, leading to two approvals in China and a pending BLA with the U.S. FDA. The HARMONY trial demonstrated a consistent overall survival benefit across different geographic regions, indicating the potential for global applicability. Summit Therapeutics Inc (NASDAQ:SMMT) has established collaborations with major pharmaceutical companies like GSK and Arcus Biosciences to explore novel combinations with Ivanizumab. The company has initiated over 50 clinical trials for Ivanizumab, covering a wide range of solid tumors, indicating a robust and diverse pipeline. The company reported an increase in GAAP operating expenses to $220.5 million in Q2 2026, primarily due to higher R&D expenses. Despite positive trial results, Ivanizumab has not yet achieved statistically significant overall survival benefits in some settings, which is necessary for FDA approval. The enrollment for some trials, such as HARMONY 3, was back-end loaded, potentially affecting the follow-up time and interim analysis results. There is a risk of competition from other emerging therapies like amivantamab and Trope 2 ADCs, which could impact Ivanizumab's market positioning. The company has no debt, but it relies heavily on ATM facilities for financing, which could pose risks if market conditions change. Warning! GuruFocus has detected 2 Warning Signs with SMMT. Is SMMT fairly valued? Test your thesis with our free DCF calculator. Q: Could you speak to the translatability of the recent overall survival results from the second-line EGFR study to other larger markets, specifically frontline non-small cell lung cancer? A: Dave Yankars, Chief Business and Strategy Officer, explained that maturity in follow-up time is critical for ivanescimab, a next-generation immunotherapy. The consistent magnitude of benefit observed with meaningful follow-up time in the recent study suggests that similar clinically meaningful results could be achieved in other frontline studies with appropriate follow-up times. Q: Can you provide more granularity on the timing for the final PFS and early interim OS look for Harmony 3 in the second half of this year? A: Dave Yankars noted that event rates have slowed down, and while they still expect to reach the number of events needed for the PFS analysis in the second half of this year, it is likely towards the middle to back end of 2026. The disclosure plan is not yet determined, but they expect to see a meaningful overall survival trend. Q: With the Harmony 3 survival analysis, will we get an overall survival hazard ratio at the interim analysis in the first half of next year? A: Dave Yankars confirmed that the first half of 2027 will be the first analysis independent of any pre-planned PFS analysis. The median follow-up is expected to be consistent with previous studies, providing a meaningful look at overall survival. Q: How do you think about the level of follow-up in the context of the interim OS readout for Harmony 3, given the separate squamous and non-squamous cohorts? A: Dave Yankars explained that the interim OS analysis in the second half of this year will support the PFS analysis. The first half of 2027 will provide a powered interim look at OS, with median follow-up time consistent with previous studies, allowing for a clearer picture of overall survival. Q: Could the updated Harmony data result in a major amendment and potential delay of the PDUFA date? How do you view the competitive positioning of ivanescimab? A: Dave Yankars stated that while the updated data has been submitted to the FDA, any decision on the PDUFA date or an ODAC panel is up to the agency. Regarding competitive positioning, ivanescimab offers a manageable safety profile and provides a different mechanism of action compared to other agents, offering physicians and patients more treatment options. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

As you might know, Arcus Biosciences, Inc. (NYSE:RCUS) last week released its latest quarterly, and things did not turn out so great for shareholders. It was not a great result overall, as revenues of US$17m fell 42% short of analyst expectations. Unsurprisingly, statutory losses ended up being15% larger than the analysts expected, at US$1.02 per share. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. So we collected the latest post-earnings statutory consensus estimates to see what could be in store for next year. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Taking into account the latest results, the eleven analysts covering Arcus Biosciences provided consensus estimates of US$87.6m revenue in 2026, which would reflect a sizeable 63% decline over the past 12 months. Per-share losses are expected to explode, reaching US$3.54 per share. Yet prior to the latest earnings, the analysts had been forecasting revenues of US$91.2m and losses of US$3.84 per share in 2026. So there seems to have been a moderate uplift in analyst sentiment with the latest consensus release, given the upgrade to loss per share forecasts for this year. See our latest analysis for Arcus Biosciences The consensus price target was broadly unchanged at US$34.30, implying that the business is performing roughly in line with expectations, despite adjustments to both revenue and earnings estimates. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. There are some variant perceptions on Arcus Biosciences, with the most bullish analyst valuing it at US$47.00 and the most bearish at US$20.00 per share. Note the wide gap in analyst price targets? This implies to us that there is a fairly broad range of possible scenarios for the underlying business. Of course, another way to look at these forecasts is to place them into context against the industry itself. We would highlight that revenue is expected to reverse, with a forecast 73% annualised decline to the end of 2026. That is a notable change from historical growth of 3.3% over the last five years. Compare this with our data, which suggests that other companies in the same industry are, in aggregate, expected to see their revenue grow 21% per year. It's pretty clear that Arcus Biosciences' revenues are expected to perform substantially worse than the wider industry. The most important thing to take away is that the analysts reconfirmed their loss per share estimates for next year. Unfortunately, they also downgraded their revenue estimates, and our data indicates underperformance compared to the wider industry. Even so, earnings per share are more important to the intrinsic value of the business. Still, earnings are more important to the intrinsic value of the business. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. At Simply Wall St, we have a full range of analyst estimates for Arcus Biosciences going out to 2028, and you can see them free on our platform here.. We don't want to rain on the parade too much, but we did also find 3 warning signs for Arcus Biosciences (1 is concerning!) that you need to be mindful of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Management is transitioning Arcus into a 'new era' characterized by full ownership of the lead asset, cascadifan, and a strategic pivot toward wholly owned immunology and inflammation (I&I) programs. The company attributes cascadifan's superior clinical performance to better molecular properties and a more robust pharmacodynamic profile compared to the competitor belzutafan, specifically citing sustained target inhibition. Management believes the recent failure of Merck's LITESPARK-012 study validates their thesis that belzutafan's efficacy diminishes over time, creating a clear opening for cascadifan to become the first-line standard of care. Strategic positioning is focused on establishing cascadifan as a 'backbone therapy' across all lines of renal cell carcinoma (RCC) to maximize patient lifetime value and duration of treatment. The company is leveraging its small-molecule discovery engine to develop a pipeline of I&I candidates (CCR6, CD89, CD40L) that offer high strategic optionality and capital-efficient proof-of-concept opportunities. Operational efficiency has been prioritized through a 10% headcount reduction and a reduction in domvanalimab-related investment following the discontinuation of the STAR-121 study. The company expects to complete enrollment for the Phase 3 PEEK-1 study in second-line RCC by year-end 2026, targeting a $2 billion-plus market opportunity. Management plans to initiate a Phase 3 frontline RCC study by late 2026, assuming that a cascadifan plus IO/IO regimen can capture over 50% of the market share. Financial guidance assumes a cash runway into 2028, with R&D spend expected to decline in 2026 and 2027 as legacy oncology programs wind down and focus shifts to cascadifan. By 2027, management anticipates that more than 80% of portfolio spend will be dedicated to cascadifan development, reflecting a concentrated capital allocation strategy. The I&I portfolio is expected to reach clinical milestones rapidly, with AB-102 entering the clinic in 2026 and PK data anticipated shortly thereafter. The Phase 3 STAR-121 study for domvanalimab was discontinued due to futility, though management noted zimberelimab's performance was consistent with other anti-PD-1 therapies. Management highlighted a $5 billion to $10 billion peak sales opportunity for cascadifan, predicated on its potential to extend the duration of treatment beyond current standards. The company recorded nonrecurring workforce costs in Q1 2026 related to the 10% headcount reduction aimed at lowering the ongoing cost structure. Arcus retains full commercial rights to cascadifan in all major markets except Japan and certain Southeast Asian territories held by Taiho. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management argues that competitor failures resulted from a 'diminishing effect' of their HIF-2 inhibitor over time combined with high toxicity from specific TKI partners. Arcus intends to use a TKI with a more favorable safety profile and believes cascadifan's durable pharmacodynamic effect will maintain a positive hazard ratio. Management is deprioritizing the adjuvant setting because the market opportunity is smaller and the clinical bar to add therapy on top of standard care is perceived as too high. Resources are being diverted to first-, second-, and third-line settings where the duration of therapy and patient need are greater. Management believes they can overcome the preference for TKIs by proving that cascadifan plus IO/IO can match TKI primary progression rates (currently 7% in early data). The strategy relies on convincing clinicians that they can achieve rapid tumor control without the long-term toxicity associated with TKIs. The plan involves an accelerated healthy volunteer study to establish PK, followed by rapid mechanistic confirmation and a Phase 2 study in chronic spontaneous urticaria. Management is also exploring allergic asthma as a secondary indication to demonstrate the broad value of the MRGPRX2 mechanism. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.