Oh, I would like to welcome you to the Arcus Biosciences corporate update call. My name is Brica, and I'll be today's event specialist. Following the presentation, we will have a question- and- answer session. If you would like to register a question, please press star, followed by the number one on your telephone keypads. I would now like to hand the whole call over to your host, Holli. Holli, please go ahead.
Good morning, everyone. Thank you, Brica. Thank you all for participating in today's call to discuss our announcement this morning regarding Gilead's early option exercises. Joining me from Arcus are Terry Rosen, Chief Executive Officer, Juan Jaen, President, Jennifer Jarrett, Chief Operating Officer, Bob Goeltz, Chief Financial Officer, and Kartik Krishnan, Chief Medical Officer. I'd like to remind you that on the call, management will make forward-looking statements within the meaning of securities laws safe harbor provisions. For example, statements about our future clinical development plans and data releases, as well as any anticipated benefits of the transaction. All statements other than historical facts involve risks and uncertainties that may cause the company's actual results to differ. Those risks and uncertainties are described in the annual report on Form 10-K and quarterly report on Form 10-Q, which have been filed with the SEC.
We strongly encourage you to review those filings. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 18, 2021. With that, I'll turn the call over to Terry.
Thank you, Holli, and thank you all for joining us. As Holli mentioned, we have an exciting update to share today. This morning, Gilead and Arcus announced that Gilead has exercised their option rights to three Arcus programs earlier than expected. The expanded partnership enables both parties to accelerate exploration of novel and innovative combination therapies with first-in-class potential. This represents an enormous opportunity for us to bring transformative treatments to patients with the most difficult to treat and prevalent cancers. I'll spend a few minutes reminding you of the structure of our original agreement with Gilead and our current programs and development activities. Then I'll go through the terms of the option exercises and the new component to our collaboration, a research agreement.
In May 2020, Arcus entered into an option and collaboration agreement with Gilead, under which Gilead made an upfront payment of $175 million and an equity investment of $200 million to acquire rights to zimberelimab, or zim, a PD-1 antibody, and an option to obtain rights to our other programs over the ten-year term of the collaboration. Under the agreement, Arcus and Gilead will co-develop these three option programs globally, and if approved, jointly co-commercialize these molecules in the U.S. Gilead will hold exclusive rights outside the U.S., subject to any rights of Arcus' existing collaboration partners, and Gilead will pay Arcus a tiered royalty on net sales for each optioned product. In January of this year, Gilead made an additional equity investment in Arcus, which increased their ownership to approximately 19.7%.
Since the agreement was executed, our teams have worked together closely, and through these interactions, Gilead has become very familiar with our R&D capabilities and our portfolio molecules. That brings us to our joint announcement today that Gilead has exercised its options for our anti-TIGIT program, which includes domvanalimab, or dom, AB308, etrumadenant, or etruma, our dual adenosine receptor antagonist, and quemliclustat, or quemli, our small molecule CD73 inhibitor. These option exercises were executed as part of an amendment to our original agreement with the overarching intent to accelerate and expand our clinical development efforts for dom, etruma, and quemli, while increasing the alignment and collaboration between our companies, including at the research level.
With these options, upon closing of the transaction, Gilead and Arcus will be collaborating on the development of five clinical-stage molecules, and our teams can now focus on executing a broad joint development plan that maximizes the potential of our combined clinical portfolio. I want to spend a minute on the status of these four molecules, starting with domvanalimab, our Fc-enabled anti-TIGIT antibody, which is currently being evaluated in ARC-7, a 150-patient phase II study in first-line PD-L1 positive metastatic non-small cell lung cancer. As a reminder, in this study, patients are being randomized to one of three arms, zim alone, dom plus zim, which we refer to as the doublet, or dom plus zim and etruma, which we refer to as the triplet.
In the second interim analysis, which we shared in our earnings release last week, both dom-containing arms showed differentiated clinical activity to that of zim alone. Arcus is excited about these results, which provided further conviction to accelerating the development plans for dom. We have advanced dom into its first registrational phase III study, ARC-10, which is targeting the same setting as ARC-7, with over 30 sites active to date. We have other phase III studies in planning with Gilead, which we'll talk about a little later on the call. We've shared the detailed results of the second interim analysis with AstraZeneca, who remains on track to initiate a second registrational study for dom, PACIFIC-8 which will evaluate dom plus durva, AstraZeneca's anti-PD-L1 antibody in unresectable stage III non-small cell lung cancer by year-end.
AB308, our Fc-enabled anti-TIGIT antibody, is currently in a phase I study in combination with zim in advanced malignancies. Five expansion cohorts are currently open for enrollment. These cohorts will be used to generate clinical signals that we can explore in future clinical studies for our TIGIT program. Now to etruma and quemli, both of which hit key targets in the CD73 adenosine pathway. Etruma is currently in four randomized clinical studies. As I mentioned earlier, etruma is being evaluated as part of our triplet arm in ARC-7, and to date, this arm has outperformed both the zim mono and doublet arms, respectively. In addition to ARC-7, etruma is being evaluated in ARC-4 in EGF receptor-positive non-small cell lung cancer, ARC-6 in castrate-resistant prostate cancer, and ARC-9 in metastatic colorectal cancer.
All of these studies, with the exception of ARC-9, are expected to generate important data over the next 12 months that could inform and lead to registrational trials. Next, quemli is currently being evaluated in the ARC-8 phase I/1b study in combination with zim and gemcitabine/ nab-paclitaxel, which we'll refer to as gem/Abraxane, in first-line metastatic pancreatic cancer, a really devastating cancer where there's been no treatment advancement beyond chemo in almost a decade. This month, we'll complete enrollment well ahead of schedule of the 90-patient randomized portion of the study, which is evaluating quemli plus gem/Abraxane plus zim versus quemli plus gem/Abraxane to provide an early look at contribution of components.
As the early opt-in discussions advanced, we and Gilead began discussing the best form for presentation of our ARC data, ARC-8 data, as well as other data sets, and we agreed to present the ARC-8 data at a medical conference in 2022. These data would include PFS from the randomized portion of the study. We continue to be really excited about the potential of quemli and are very pleased that with Gilead's early opt-in, we have an opportunity to expand the development plan for this exciting promising molecule. Now let's get back to the announcement today. Consistent with the terms of our original agreement, following closing of the transaction, which we expect to occur by year-end, Gilead will pay to Arcus option payments totaling $725 million for the three programs.
Following this payment, all in, Gilead will have invested approximately $1.4 billion into Arcus. In addition, costs and expenses related to the global co-development program and advancement of these molecules will be shared effective at closing. We'll also receive retroactive reimbursement for Gilead's share of the cost for ARC-10, the ongoing registrational phase III study for dom. Arcus will commit to operationalizing at least 50% of joint clinical development activities for each option program. This commitment reflects both companies' confidence in Arcus' clinical team. It also allows both parties to benefit from strategic resourcing and Arcus' speed while allowing Arcus to maintain an active role in the strategy, planning, and execution of its development programs. In addition, Arcus and Gilead added a research collaboration whereby Arcus will lead the discovery and research efforts for two novel research targets.
The new research collaboration will be overseen by an existing joint research committee with the intent to facilitate experiments to guide the selection of novel combinations for clinical studies and deepen the relationship between our research teams. Our two research teams have gotten to know each other well over the last year, and so we are very excited about the expansion of our current alliance, and we appreciate Gilead's confidence in our discovery capability. Finally, upon closing of Gilead's early opt-in to all three clinical programs, Gilead will not be obligated to make the $100 million option continuation payment in 2022. The parties also agreed to a slight reduction in Arcus' ex-U.S. royalties to mid-teens to low 20s. Our ex-U.S. royalties will continue to be tiered. The royalties for zimberelimab and future option programs under the original agreement are not affected by these changes.
What does this all mean for Arcus? First, the early opt-ins represent a major acceleration expansion of our collaboration activities with Gilead. Arcus has always referred to our partnership as an all-in collaboration, and today's announcement reinforces our mutual commitment to one another and our shared vision for creating one of the largest, most diversified, and premier oncology portfolios in the industry. Second, Gilead brings a significant operational expertise with global reach. The $725 million upfront payment and cost sharing for five clinical-stage molecules, together with the $743 million of cash we had at the end of the third quarter, puts Arcus in a strong position to invest aggressively in our clinical-stage molecules and research programs.
The early opt-ins by Gilead also enable us to access and benefit from the clinical, commercial, and global resources of a much larger partner. Third, Gilead exercising all three options now provides us with a tremendous amount of certainty and clarity, enabling us to go full steam ahead on our shared clinical development plans. It also simplifies the development of combination therapies, with Gilead now having shared rights to all of the components of Arcus' intra-portfolio combinations. Fourth, the amendment entered into today is anticipated to accelerate the exploration of new cross-portfolio combinations with first-in-class potential. Before we move to Q&A, I want to spend a minute on the clinical development plans for the molecules for which Gilead is exercising their option rights. As I mentioned earlier, our four ongoing randomized clinical studies for etruma will be used to inform and design potential later-stage studies.
This includes new clinical studies to evaluate our first-in-class triplet, dom plus zim plus etruma, based on the results seen thus far in ARC-7. We'll focus on settings where adenosine plays an important role in blocking checkpoint inhibitors from achieving optimal efficacy. For quemli, our ARC-8 pancreatic cancer study is really just the tip of the iceberg. AstraZeneca recently presented very exciting randomized data for their CD73 antibody in stage III non-small cell lung cancer, further validating the potential of this mechanism. The early opt-in for quemli upon closing of transaction will allow us to expand our development plans for this molecule into other settings. For dom, there's much more to do with this molecule and mechanism. Gilead and Arcus are actively evaluating the initiation of several potentially registrational trials in 2022 in settings of significant unmet need in large patient populations.
We believe anti-TIGIT will become an essential backbone and expect to share further combination studies leveraging the mechanisms within both the Arcus and Gilead portfolios. Lastly, we're exploring clinical collaborations with third parties, which would enable us to maximize the value of our portfolio by combining our proprietary molecules with current or emerging standard-of-care therapies. The PACIFIC-8 study with AstraZeneca is an example of this. AstraZeneca will operationalize the study, which will be funded by AstraZeneca and us. Every day, it's more apparent that the path to differentiation in cancer is through novel combinations. This is becoming true for every class of drugs for cancer, whether anti-PD-1s, KRAS inhibitors, TKIs, or even cell therapy. We believe that access to our molecules will allow for the creation of first and best-in-class combinations that offer meaningful clinical differentiation over other regimens.
Before we wrap up, I wanted to share an update on our HIF-2α inhibitor, AB521, our newest molecule to enter the clinic. Enrollment has just begun on our healthy volunteer phase I study, and information on this study is now available on clinicaltrials.gov. We started the year with a clear message that 2021 would be a transformational year for both Arcus and the field. It has been. As we approach 2022 with six outstanding molecules in the clinic, all with validated mechanisms, we expect that the year ahead will bring a number of important readouts and a corresponding portfolio of late-stage trials of innovative combination therapies that have the potential to change the treatment landscape for patients who need better options. In closing, we're thrilled to deepen our partnership with Gilead.
With our combined laser focus on the advancement of our molecules, we could not be more confident in our ability to accelerate programs and get new possible combination therapies to patients as quickly as possible. 2022 is going to be an incredible year. We'll now open up the line to questions.
Thank you. As a reminder, if you would like to ask any questions, please press star followed by one on your telephone keypads. We now have the first question on the line from Geoffrey Porges of SVB Leerink. So Geoffrey, please go ahead.
Thank you very much for taking the question, and congratulations, Terry and the whole team, on this great validation. Very nice to have this surprise coming late in the year before we expected. A couple of questions, if I may. One question that's come up is could you talk just about zim? I know it's not the focus of the call today, but just, what do you need to do to get zim registered, and is that essential to the registration of some of the combinations? Could you talk a little bit about that? Then Terry, tantalizingly, we were close to seeing more data for quemli. We were close to seeing the second interim disclosure on ARC-7, and now you're pushing that off till next year.
Could you just give us a sense of what you consider to be differentiated? Are we talking 10 percentage points of difference, or a couple of percentage points of difference? Because that's sort of what you've given us for the triplet over the doublet and the doublet over the monotherapy, and then also for what I'll call the quad over the doublet in pancreatic cancer. Just related to that, of course, Roche has a CITYSCAPE update coming in the next few weeks. I'm sure you're tracking ARC-7 to CITYSCAPE. Could you reassure us that your trajectory of responses is, as you've said before, following CITYSCAPE for both the monotherapy and the doublet arm? Thanks. Sorry for all the questions.
Well, that's great. Thank you, Geoff. I'm gonna let Kartik start by commenting on zim, and then I'll talk a little bit about ARC-7 and ARC-8.
Sure. Thanks, Geoff. As far as zim goes, couple of ways that we're taking that forward, first and foremost is in ARC-10, the phase III, it's looking at the path to registering zimberelimab as a monotherapy, and that study remains on track. The second is through the combinations, some of which we've worked with our partners at Gilead to get through into phase III studies and ultimately register as part of a combination. I think we have a couple of different ways to get zim across the registration finish line.
Thanks, Kartik.
Okay.
First off, on ARC-7, as you know, we're purposefully not being quantitative, this study is still enrolling. What I'll tell you about the triplet versus the doublet and the singlet obviously is that it's really firing on all cylinders, better than the doublet. ORR, depth of response, both look substantially better. It's a meaningful differentiation. The other thing I'll point out in that triplet, to just be clear, there's only been one patient to date that's gone on to progressive disease. The triplet is looking very exciting, clear differentiation. As far as ARC-8, yeah, you're right. We were teed up. We're actually gonna do a substantial presentation on that.
What I'll just point to is the data continued to look as we saw at the time of the ASCO GI presentation. Then we've seen things I'll just comment on a couple of qualitative aspects of that study that clearly are differentiating from gem/ Abraxane. One of those is simply what we've seen in a number of situations are very prolonged stable diseases, so even cases where we've gone out well over a year. The other thing that we've seen are responses that come, you know, three, four, even five or six scans into the treatment.
You have this very much immunotherapy-looking type of response profile that qualitatively is very different from what one normally sees with gem/Abraxane, where if you are gonna see a responder, it's usually on the first or second scan, and then you may often see a rapid progression. Aside from the numeric aspects of it that are keeping us excited about it, some of these qualitative differences that point to an immunotherapy mechanism give us confidence in the addition of 680 and what it's bringing to that chemo regimen.
Great. Thanks, Terry.
Thanks, Geoff.
Thank you, Geoff. We now have the next question from Umer Raffat of Evercore ISI. Umer, please go ahead.
Hi. Thanks so much. Congratulations, guys. I feel like Gilead opting in on TIGIT may not be a particular surprise given everything you guys discussed last week. I do find it interesting that they're opting into the CD73 and the adenosine program as well. I guess my first question is, did Gilead look into any interim randomized data of ARC-8 in pancreatic? Or was it only just single-arm data at the 100 and 125 dose? I have the same question also on the TKI-refractory lung study in EGFR-positive. Did they look at anything on early randomized data there as well? One question for Bob or Jen, if I may.
I know, you guys are tracking at $280 million run rate on R&D right now, and presumably there's a sort of whole host of trials that need to get started and run in a very efficient way. On the flip side, Gilead will be picking up half the cost. I guess I'm trying to understand where is R&D headed? Is there a scenario where Arcus alone could be reporting over $500 million in R&D, let's say in 2023 timeframe? I'm just trying to understand how we should model all this out.
Thanks, Umer. Appreciate the questions on. So insofar as the randomized data, too early to look at those data, so no, Gilead has not seen any randomized data there, but we have not either. What I would also comment though is clearly the opt-in to all of the assets, you know, recognizes the profiles, the quality of the molecules, the data that we've generated to date. Clearly from a strategic standpoint, you do have this biological and clinical nexus between the mechanisms and, you know, I think Gilead, like us, recognizes that the opportunity is to fully leverage and be as smart as possible, you know, across settings, across combinations, to be able to utilize all of the components of the puzzle.
Yeah. Umer, this is Bob. On the financial part of the question, you're right on in terms of kind of our current run rate. I think the way to think about it is if you were to look at the programs that are the subject of the options today together with zim, that represents slightly less than half of the spend rate of Arcus. You know, we've made and we'll continue to make a substantial investment in early stage research. That core run rate will continue and will grow modestly over time. As we mentioned on the portion that does relate to these molecules, obviously going forward, Gilead will be sharing those costs with us.
You know, we've got ambitious plans, and we're gonna be working with our colleagues at Gilead to fine tune those plans for each of the molecules for the next several years. It also takes a little bit of time to get those programs up to full steam in terms of a spend rate. You know, the type of magnitude of spend that you were alluding to is not something that we would anticipate seeing any time in the near future. Maybe just to comment and kind of frame it more broadly, you know, we had been guiding that we'll have cash runway at least through 2023. We would expect that today's news will significantly extend that cash runway.
As we have a chance to work with our colleagues at Gilead, we hope to provide a little bit more granular detail in terms of longer term guidance and guidance especially for 2022 in the early part of next year, because we know that'll be a bit challenging to model.
Thank you so much.
Thanks, Umer.
Thank you, Umer. We now have the next question on the phone lines from Robyn Karnauskas from Truist Securities. Robyn, your line is open.
Hey, guys. This is Kripa for Robyn. Congratulations. Very exciting to see this before the end of the year. So, you know, the triplet data, obviously, Gilead has had a chance to look at it. Can you talk a little bit about what they've seen with 354 and what the strategy is. Do you expect it to still be heme focused? One of the things you mentioned in the PR is potential Trodelvy combos, a chemo-free option. Do you guys have any internal data to support this? Finally, maybe you've mentioned this multiple times, but just can you remind us of the exclusivity of this option with all the three molecules in the U.S. in terms of potential collaborations with other partners? Like, how does it work with the AstraZeneca collaboration that you have? Thank you.
Sure. Thank you, Kripa. First off, on 308, which is what I thought you probably meant when you said what we're planning, how we're planning to use that. Our guidance on that continues to be the same that you know it's in expansion studies. We may learn something from those expansion studies that just informs our you know our entire strategy, including with 154. That molecule, at this point, we would maintain that optionality if we did go into hematological malignancies. Insofar as the strategy for the triplet, I would just say that's something that you should expect to see us really leverage.
This really the differentiating aspect of our program. If you think about the two companies that we look at as most competitive in this space, Merck and Genentech, they don't have either a CD73 inhibitor or an A2a receptor antagonist. We feel that differentiation across settings and in with various therapies, particularly you know, therapies that are immunogenic in nature really confer an advantage. I think as we go into 2022, you'll see a very robust development plan that takes advantage of an ability to not just run in a race that's you know, doublet versus doublet, but where we have something that has that intrinsic competitive advantage.
Kripa, on your last question regarding commercial exclusivity, us and Gilead will share commercial rights in the U.S. To that point, they do have exclusive commercial rights with us in the U.S. That said, we have plenty of flexibility to do clinical collaborations, much like we did with AZ. They were very much a part of those discussions, so they're very familiar with PACIFIC-8 and are very excited about PACIFIC-8. The advantage that something like PACIFIC-8 gives us is that we have a partner that can operationalize the study. It just allows us to expand our footprint beyond what we'd be able to do on our own. We also co-fund the study with them, so it also helps from a funding perspective.
These types of collaborations provide us with a lot of advantages with us and Gilead, and I think you'll see more of those types of deals out of us.
I think you asked one other question that related to combinations involving Trodelvy. That's something we'll talk about more. We don't have any specific guidance to give at this point. Even from the first day that Gilead had rights to Trodelvy, we recognized you can think about some of the settings where Trodelvy is already in play. We believe that is, you know, it kills cancer cells through an immunogenic mechanism. We can definitely contemplate multiple combinations with our portfolio. I think we'll be, you know, forming up a firmer plan with Gilead on that in that area.
Okay, great. Thank you so much, and congratulations.
Thank you, Kripa.
The next question we have comes from Alethia Young from Cantor Fitzgerald. Please go ahead. I've opened your line.
Hey, guys. Thanks for taking my question. That was a pretty good guess on my name. Congrats. Good stuff, guys. One is just like maybe a strategic question. You know, now, with all these opt-ins, can have a lot of programs and a lot of expansion you have to. Just can you talk a little bit about maybe some of the discovery work you might be looking to do and, like, in what ways might you expand? Obviously, you've spent a lot of time on the adenosine axis. Would you want to go somewhere else, or that's the first question.
The second question is with CD73, can you talk about maybe, just maybe, I mean, I know you're not tight on the clinical programs, but maybe like the science behind maybe other kinds of combinations, since you have many, many different things now kind of in the hopper as well. Thanks.
Sure. So thanks for the question. I think the essence of your question is, where do you go with adenosine modulation, and how do we think of that?
Where do you go in your pipeline next?
Okay, got it. First, let me talk about the adenosine piece of things. This is a very ubiquitous pathway in cancer. Virtually all cancers, you'll find those cancer cells are covered with CD73, and that's because it does confer a survival advantage. Tumors are loaded with adenosine, and it's a very well understood molecular mechanism that adenosine causes T cells to become essentially quiescent. That's something that wherever you have an immunogenic therapy, for example, in that stage III lung trial, you have a pretreatment with radiation. Radiation's known, for example, to really upregulate CD73 expression. A number of chemotherapies kill cells in an immunogenic mechanism that generates what we'll call an adenosine fog. You can expect to see us go fairly broadly.
We've you know already had and generated positive single-arm data in colorectal cancer. We've reported out early data in prostate cancer. We've shown the pancreatic cancer data, ASCO GI. You can think of things very broadly in terms of setting because this mechanism you know is highly prevalent. When you think about therapies that are particularly immunogenic in nature, almost inherently, they're gonna all be having somewhat of an inhibition by the presence of that adenosine. I would say more broadly, when you ask where's our portfolio going, you know, we've talked about HIF-2, very different mechanism. We're very excited about our molecules that enter phase I.
We feel we have a number of opportunities to differentiate there, both by combinations, but we think that we even have a molecule that might have better pharmacokinetic properties than the Merck Peloton molecule that might offer an advantage there. We, as you might have seen recently, disclosed a first target in inflammation. It's something that we'll be talking about later next year. We could have a molecule that we'd be taking into the clinic as early as next year. If you think about our biology, it's very immunology-focused. Even though the settings that we've gone into are oncology, we feel very comfortable within the immuno-oncology space. We feel very comfortable in a cell-intrinsic mechanism for cancer.
In fact, you can expect to see us even expand into more immunological targets per se.
Awesome. That's helpful. Thank you.
Thank you. Next question.
We now have a question from Peter Lawson of Barclays. So Peter, your line is open.
Great. Thank you. Thank you so much. Congratulations on the news. Just, I guess, firstly on the royalties, again, slightly reduced. What helped drive that? Was it better bargaining position and was there an offset that we should be thinking about?
Yeah. First of all, it's a very minimal reduction in royalties. They were high to begin with, and they'll stay high, we think, for a collaboration like this. They're tiered, as a reminder, and they'll range from mid-teens to the low 20s. That's a very, very good ex-U.S. royalty rate. As I said, the reduction is minimal. Really the offset was because they are opting in early, particularly in quemli and etruma. There's a huge savings on our part as far as the R&D associated with those two molecules. As soon as this closes, they will be responsible for 50% of the development costs as well as all the other costs involved in developing those two molecules. That's really what we were offsetting with the slight reduction in royalties.
Keep in mind that still in U.S., everything stays the same 50/50.
Gotcha. Okay. Thank you so much. On etruma, what trial data drove that opt-in, early opt-in there? Was it ARC-7 or-
Yeah, I would say that you should think about the drivers here is really much more holistic than any one data set. It goes back to what I was talking about. There's a clear if you look at all of our data, we believe, and I think the field believes CD73 inhibition and A2 receptor antagonism is gonna lead to drugs. These have very broad potential roles. To be opted into one or not the other, it really ties a bit of your hands behind your back to really pursue the opportunities that are inherent in the portfolio. I think you know, both Gilead and us wanna go in all in on you know, bringing what we think will be very transformational therapies to patients. You need access to all of the molecules.
Great. Thank you. Just, I guess, final question just on the ability to combine with other things in Gilead's pipeline. What do you find most intriguing? Is it kind of the CD47 side of things or the Trop-2 ADC? Just your thoughts there.
Both of those are, you know, appealing. You know, you may hear more from Gilead, but we see, you know, possibility for synergy with both of those mechanisms.
With, I'd say, cell therapy as well. We've generated some interesting data on combining adenosine inhibition with cell therapy. That's something else that we're also really interested in exploring with them.
Great. Thanks so much. Thanks for the call. Congrats.
Thank you.
Thank you. We now have our next question today from Salveen Richter from Goldman Sachs. Salveen, your line is open.
Good morning. Thanks for taking my questions, and congratulations here. Maybe just a question here on the adenosine programs. You know, you've shown us some early data over the years, but what do you think would be required to really give us proof of concept in terms of the upcoming trials?
Salveen, we actually think that proof of concept is out there from both, you know, our data to date. We believe when we share the data, particularly from ARC-7, that's extremely compelling, and it's a randomized data set. We think the COAST data, you know, are fairly unequivocal of the role of CD73 in that particular setting. We look at those COAST data also like our own, given that adenosine is pretty much everywhere, that it. That's why we talk about the tip of the iceberg, that it's really a mechanism that, you know, goes across settings and across therapies.
We'll obviously have more proof of concept, you know, over the next kinda six to nine months with ARC-4, ARC-6, and then, you know, when people see the data at a medical conference from ARC-7.
I think the proof of concept part of this is that genie's out of the bottle.
Great. Thank you.
Thank you, Salveen.
Thank you, Salveen. We now have Yigal Nochomovitz from Citigroup. Yigal, please go ahead.
Hi. Great. Thanks for taking the questions. Let me add my congrats on the Gilead deal. I just have two. First, regarding future clinical strategies, does Arcus reserve the right to combine dom 308, etruma, or quemli with any of Arcus' earlier stage molecules like the HIF-2α or even one still in the preclinical stage? Or does Gilead take full control of dom 308, etruma, and quemli now in terms of future combo strategies? Second, obviously the CD73 is a fairly crowded space. So can you talk a bit more about what Gilead sees in quemli that offers differentiation versus the competitive landscape, especially versus the AstraZeneca molecule? Thank you.
Sure. Thanks, Yigal . Insofar as combining, absolutely, we can combine with anything in our portfolio, and in fact you would expect to see us combine with our HIF-2α inhibitor. In terms of differentiation, and I think you picked the right molecule to compare to AstraZeneca with their CD73 antibody. I think it's a great antibody, but we do think that we have substantial differentiation both-