Release Date: May 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Arcus Biosciences Inc (RCUS, Financial) reported a strong cash position with over $1 billion on hand, providing a runway into 2027.
- The company highlighted upcoming data events for four later-stage clinical programs, which are expected to drive significant progress in their pipeline.
- Arcus Biosciences Inc (RCUS) has established strategic partnerships with major pharmaceutical companies like Gilead, AstraZeneca, and Taiho, enhancing their development capabilities and funding.
- The company is poised to capitalize on first-to-market opportunities in various cancer treatments, potentially addressing a market of over $3 billion.
- Arcus Biosciences Inc (RCUS) is actively advancing its HIF-2-alpha inhibitor program, with promising early results suggesting potential superiority over existing treatments.
Negative Points
- Despite the strong financial position, the company faces significant competition in the oncology market, which could impact the commercial success of their products.
- The complexity and costs associated with advancing multiple late-stage clinical trials simultaneously could strain resources and affect operational efficiency.
- Arcus Biosciences Inc (RCUS) is heavily reliant on the success of its clinical trials, any negative results could significantly impact the company's valuation and future prospects.
- The regulatory landscape for cancer treatments is highly challenging, with stringent requirements that could delay or prevent the approval of their therapies.
- Dependence on partnerships for development funding and operational support could pose risks if these collaborations do not yield the expected benefits or are terminated.
Q & A Highlights
Q: For HIF-2-alpha, some of the literature suggests that HIF-2-alpha is upstream of ledger and it leads to production. So they're basically in the same pathway. Do you think that could make [cas] response to patients more sensitive to 521? And because of the same biology, do you expect to see any overlapping toxicities with belzu which is all resolved to ledger?
A: Terry Rosen - Arcus Biosciences Inc - Chief Executive Officer: Yes, they are in the same pathway. We do believe that HIF-2-alpha on the other hand, though, since the control is probably 100 genes, there are other effects ongoing in cancer. We don't really expect, and in fact, we know what the side effect and AE profile profiles are. So we do not expect that you would see overlapping toxicities. And I would just say that with HIF-2-alpha on those toxicities and AEs have already been well defined belzutifan. What you primarily see is very manageable anemia. We've seen similar. And even though we believe and know in fact that we're hitting the target harder, and essentially nature is built in a break because only so much HIF-2-alpha mediated EPO expression is happening in the kidney and there's other sources of EPO. And we've seen a safety profile that continues to look very similar to what has been reported for belzutifan. As Jen noted, we've actually even completed a 150 milligram cohort that, again, have not seen any DLTs to date.
Q: That's helpful. And then maybe a quick one regarding STAR-121 trial for first-line non-small cell lung cancer. It has primary endpoint of PFS and OS. Do you have to win on both? And what are the expectations from the Arm C? How much radiation from the control arm and/or ticket arm is acceptable?
A: Dimitry Nuyten - Arcus Biosciences Inc - Chief Medical Officer: So statistically speaking, the way it's set up, it's a dual primary endpoint, meaning at either PFS or OS, if either one of those is statistically significant, it would be a positive trial. I think we've been very clear in previous calls as well and lots of interactions that are in the public domain that from a regulatory perspective, OS is really the registrational endpoint; PFS is supportive. And your second question, can you repeat it, please? I didn't get the entire question.
Q: Just around HIF-2-alpha, the second half data, kind of what define success for you for that dataset? And can you remind us what Gilead -- what are the trigger points are for Gilead to potentially update?
A: Terry Rosen - Arcus Biosciences Inc - Chief Executive Officer: Yes, sure. Thanks, Peter. So on what defines success, as we've articulated on, there's a number of variables and opportunities for differentiation from belzutifan. So starting with response rate, rate of primary progression, depth of response, even if we're -- if we have PFS by that point. So we want to do better than belzutifan. I will remind you and thinking about our overall program goal, based upon what we've already seen, the data looked good. And we're full speed ahead to registrational trial. And keep in mind that we feel we are not going to be developing this, at least in the near term, as a monotherapy. We also believe, as Jen was discussing, that we'll be combining with a better TKI than lenvatinib. And that will give us another opportunity for differentiation. So there's multiple places. You know, when we think that we have an opportunity to beat belz on more than one of those. In terms of the Gilead opt-in, that's something that we would expect. We've converged on what would define that opt-in, and we would expect a decision either towards the end of this year or early into next year.
Q: Hi guys, this is (inaudible) on for Yigal. Thanks for taking my questions. I have a few on the EDGE-Gastric update at ASCO. And obviously, based on the data you've already shared, it looks like the Kaplan-Meier curves on PFS obviously are trending well beyond the seven to eight months hurdle, I think you cited, but naturally with a small end. So I'm just curious how much greater do you think the PFS benefit really needs to be to derisk STAR-221? And a more theoretical question, I guess, how well do you think PFS correlates with OS benefit in this setting given that's the primary endpoint in STAR-221?
A: Terry Rosen - Arcus Biosciences Inc - Chief Executive Officer: So thanks for your question. You're right on the sample size, and I think you'll be able to make your own call on that. As you suggested, it's known. And actually the data seems pretty tight. So you know, in addition to CheckMate 649, there's been two other registrational studies with anti PD-1 and chemo. They both come in and that roughly just under seven to eight months PFS. So that's a pretty firm number. We think our data will be quite meaningful. I think one other thing to keep in mind when you compare our datasets, interestingly enough, CheckMate 649 had 60/40 high PD-L1, low PD-L1, and we're actually 40/60. So pretty substantial difference. And as you saw, even our numbers in the all-comer population were pretty good. So we're three weeks away. We're excited about the data; you'll make your own call and how much you think they've derisked. Interestingly enough, as we also mentioned, we're on the cusp of that registrational study being completed. So you'll still see those data in a couple of weeks. In terms of the correlation on, as you know, in general, PFS and OS, particularly in the context of immunotherapy, are certainly qualitatively correlative. But I wouldn't necessarily think that you can plot a line for them. But given our dataset, I think you'll clearly be able to form some speculation as to what might have been on the US, just like you formed some speculation on the six-month landmark numbers, what might happen. I think those thoughts are going to connect at least qualitatively in a direction that will be confident in enhancing.
Q: Thanks, guys. A couple. I have two from me. Obviously, we're very excited to see the 100 milligram cohort release and get a better sense for HIF-2-alpha efficacy here versus the competitor. But I'm wondering why specifically the 50 milligram cohort isn't going to be part of that same release? That was enrolled before
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
