Arcus Biosciences, Inc.RCUS
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Arcus Biosciences, Inc. 12th Annual Cantor Fitzgerald Global Healthcare Conference

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Li WatsekBiotech Analyst

Okay, good morning. Welcome to our day 2 of the Cantor Healthcare Conference. My name is Lee Wazzak, a biotech analyst at Cantor. It is my great pleasure to be hosting our next company, Arcus. With me today is CFO Bob and Pia, head of IR. Bob, I would love to maybe hand it over to you to walk us through what the story is today.

Bob GoeltzCFO

Great. Thanks very much, Lee. Thanks very much for having us. Arcus is a company very focused on high-quality drug discovery, in particular with a focus on small molecules. What we really like to do is leverage that expertise where we see targets that have strong biologic validation, where we think a very high-quality molecule can make a big difference. Our lead program is casdatifan, which is being developed for the treatment of clear cell renal cell carcinoma and kidney cancer. We have a very broad development program there, and it has probably garnered by far the most investor interest. We do have a broad pipeline behind it. Notably, actually, we have a late-stage pancreatic cancer trial that will have an interim analysis. So this is frontline PDAC in the fourth quarter of this year. We are very excited about that. That is a CD73 inhibitor.

Bob GoeltzCFO

The value proposition there is in the context of immunogenic chemotherapy, essentially enabling the immune system to contribute to the response to the cancer. In addition to that, we have a fairly broad early-stage immunology portfolio exploring a number of different inflammatory conditions. But I am sure today we will talk mostly about casdatifan, which certainly has garnered most of the investor attention.

Li WatsekBiotech Analyst

Yeah, a lot to look forward to. Let us get into the October event update first. Just at a high level, what would be the key takeaways that you want investors to walk away with casdatifan?

Bob GoeltzCFO

Sure. The key takeaway that we'd like to see from the event is that we think that there's the potential for broad utilization of casdatifan in every line of treatment for metastatic clear cell RCC. That's what our development program is geared towards. At a very high level at the event, which will be October 20th here in New York, we'll be sharing data from late line monotherapy.

Bob GoeltzCFO

as well as second line, in combination with cabozantinib, and then also some frontline data. In the frontline, our strategy is going to be to combine casdatifan with ipi/nivo, which is a regimen that has roughly a 30% share in the frontline market today. We have a pretty holistic development strategy really for each line of therapy for patients, and the event I think will provide windows into each of those settings and allow investors to assess important attributes of the molecule, and efficacy across a range of settings and combinations.

Li WatsekBiotech Analyst

Maybe start with the second line cas plus cabo update. I think that's one focus for investors, just given the way through to your ongoing Phase III PEAK-1.

Li WatsekBiotech Analyst

You also mentioned that you hope that you would demonstrate just from a PFS hazard ratio perspective, casdatifan will be better than belzutifan. So we're talking about the LITESPARK-011.

Li WatsekBiotech Analyst

study. Yep. So in that study, we are looking at hazard ratio of 0.7.

Li WatsekBiotech Analyst

So question number one, what is a better hazard ratio? Should we assume maybe 0.6 or even lower? And the second question is, when we look at the benchmark studies out there, right?

Li WatsekBiotech Analyst

We perhaps have three. Are you implying the hazard ratio would be better when you compare to all three Yeah benchmark studies?

Bob GoeltzCFO

Yeah, I think it's hard to be quantitative in terms of it because the data that we'll be sharing will be single-arm data.

Bob GoeltzCFO

When we think about the concept of hazard ratio, and it's really the concept that we're talking about, when we think about the concept of hazard ratio, we're thinking about the obvious cross-trial comparisons that people will make relative to the patient populations. There are different prognostics for patients in the second-line therapy for kidney cancer depending on what treatment that they received previously. In LITESPARK-011, the prior treatments were quite a bit different than the patient population that we're going to be looking at. When we talk about developing confidence or engendering confidence for investors in our ability to have a better hazard ratio than LITESPARK-011.

Bob GoeltzCFO

I think what we're thinking about is a comparison to the relevant benchmarks for each of the patient populations and feeling strong that our performance is at or better than what belzutifan has demonstrated, so that in the aggregate it would be better. I think it's probably premature to start talking about quantifying the difference from a hazard ratio benefit perspective. I should say, too, the one thing that's important to underscore is that while we do think we will have a better hazard ratio than LITESPARK-011, one of the fundamental decisions we made early on in our trial structure was the combination agent. We're combining with cabozantinib, which is clearly the preferred agent and had a 40% market share before any adoption of a HIF-2α inhibitor in the second line. It was the lion's share of second-line markets.

Bob GoeltzCFO

Physicians are very comfortable with cabozantinib and prefer using that drug in that setting. We've combined with that. The Merck combination includes lenvatinib. I think that the first point of differentiation in our combo is the combination partner.

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