Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's Corporate Update Conference Call. At this time, all participants are in a listen-only mode. As a reminder, today's call is being recorded. An audio webcast of this call will be made available on Compugen's investor website, www.cgen.com. Please note that if the sirens go off during this call, we will need to end the call to take shelter. I would now like to introduce Yvonne Naughton, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.
Thank you, Yvonne, and thank you all for joining today's call on short notice. Today, we will be discussing this morning's announcements regarding Compugen's exclusive license agreement with Gilead for COM503. Joining me from Compugen are Dr. Anat Cohen-Dayag, President and Chief Executive Officer; Alberto Sessa, Chief Financial Officer; Dr. Henry Adewoye, Chief Medical Officer; Dr. Eran Ophir, Chief Scientific Officer; and Dr. Pierre Ferré, Vice President of Preclinical Development. Before we begin, we would like to remind you that during this call, we will make projections or forward-looking statements regarding future events, regulatory milestones, and financial performance of the company. We wish to caution you that such statements reflect only the company's current beliefs, expectations, and assumptions, and that actual results, performance, or achievements of the company may differ materially.
These statements are subject to known and unknown risks and uncertainties, which would cause the company's actual results to differ materially from those projected in such forward-looking statements. We refer you to the SEC filing for more details on these risks, including the company's most recent annual report on Form 20-F, filed with the SEC on February 28, 2023, as later amended. The company undertakes no obligation to update projections or forward-looking statements in the future. And with that, I'll turn the call over to Anat.
Thank you, Yvonne. Good morning and good afternoon, everyone, and thank you for joining this call. This morning, we announced the signing of an exclusive license agreement with Gilead for COM503, our novel and differentiated immuno-oncology preclinical antibody program, targeting IL-18 binding protein, which harness IL-18 biology to potentially treat cancer patients. We were delighted to be providing you with this exciting update. I would like to start by highlighting the value and importance of this collaboration to Compugen, its potential value for patients, and the opportunity to unlock shareholder value by supporting Compugen's long-term vision. I will then go through the details of the agreement and finally conclude with what we intend to focus on in 2024. Starting with the importance of the collaboration.
First, we believe this collaboration with Gilead is a testament to the leading edge of our antibody program against IL-18 binding protein. It represents a new way to harness IL-18 pathway biology for the treatment of cancer by using an antibody, and therefore potentially avoiding the challenges presented by administration of therapeutic cytokines. As you know, cytokines are powerful therapeutic tools. However, there is a challenge of giving them systemically at levels high enough to reach and modulate the tumor microenvironment without causing systemic side effects. Combining the cutting-edge capabilities and expertise of both Compugen and Gilead, our goal is to expedite the development of COM503, our novel potential first-in-class, high-affinity anti-IL-18 binding protein antibody, to maintain our leadership position in targeting the IL-18 pathway as a means to treat cancer patients.
Second, we believe this collaboration further validates Compugen's computational discovery capabilities, focusing on the discovery of new drug targets and new biological pathways, and our ability to act on these novel discoveries and translate them into investigational drugs. Leveraging these capabilities and the deep expertise in the IL-18 pathway biology, Compugen will lead the ongoing preclinical activities and is expected to lead the future phase I study. Third, this strategic partnership strengthens our balance sheet and extends our anticipated cash runway, allowing us to drive the development of our fully owned potential first-in-class anti-PVRIG COM701 antibody and potential best-in-class anti-TIGIT antibody, COM902, to potentially meaningful milestones, and invest in our early-stage pipeline to generate the next, the next computationally discovered novel assets that we hope can be advanced into the clinic.
We're finalizing our plans for 2024 and plan to provide updated guidance on our expected cash runway during our company's 2023 year-end earnings call. And fourth, with Gilead's impressive track record in therapeutic development and in delivering innovative medicines to patients around the world. Together with our shared immuno-oncology expertise and Compugen's deep knowledge of this program, we believe this collaboration brings us closer to realizing our goal to extend the reach of potential first-in-class cancer immunotherapies to new patient populations where the unmet need is significant. Moving next to the terms of the agreement, as outlined in the joint press release we issued this morning. Under the terms of the collaboration, Compugen is expected to conduct and fund the first-in-human phase I study, evaluating safety and tolerability of COM503. Gilead will assume clinical development and commercialization responsibilities thereafter.
Gilead will provide Compugen with an upfront payment of $60 million and $30 million in a near-term milestone payment, subject to COM503 IND clearance, expected in 2024. Compugen is eligible to receive up to an additional $758 million in future clinical, regulatory, and commercial milestone payments, bringing it to a total deal value of up to $848 million. Compugen is also eligible to receive single to low double-digit tier royalties on global net sales. Finally, advancing into 2024, our focus is expected to be on the execution of the following activities. One, the presentation of data from our ongoing MSS CRC proof of concept study, planned for the first half of 2024.
Two, in the Platinum-resistant ovarian cancer, we intend to focus on completing enrollment of up to 20 patients in our ongoing proof of concept study. This study is designed to add more data to the results we already presented, showing durable responses with good tolerability in this patient population and allow us to further assess, in this cohort, our initial findings relating to the role of PVRL2 as a predictive biomarker. As a reminder, we recently presented initial data showing an association between the expression of the PVRIG ligand, PVRL2, and clinical benefit that is consistent with our computational predictions. Strengthening this data may allow us to proceed with a biomarker strategy for patient enrichment and build a unique development path for our triplet regimen. In parallel, we plan to continue to optimize our PVRL2 assay to fit such a potential patient selection strategy.
Three, we plan to advance the COM503 program to IND clearance and plan to initiate the phase I program, evaluating safety and tolerability of COM503, subject to successful IND clearance. Four, we plan to continue to invest in our new early-stage pipeline programs to serve as future drug candidates for our next programs to potentially be advanced into the clinic. And finally, we look forward to following the continued progress of AstraZeneca's rilvegostomig, a PD-1/TIGIT bispecific, where the TIGIT component is derived from our clinical-stage anti-TIGIT COM902, which has advanced into phase III study as adjuvant therapy for biliary tract cancer after resection in combination with chemotherapy. We're entitled to receive a milestone payment of $10 million from AstraZeneca upon dosing of the first patient in this trial.
We believe that the progress of rilvegostomig clinical program in this phase III trial, along with the phase I and II trials in additional indications, demonstrate AstraZeneca's commitment to explore the potential of this bispecific antibody. I would like to thank the ongoing dedication and commitment of our teams, who are serving as an engine behind Compugen's innovative drug candidates, and in particular, to their resilience and teamwork, reflecting the strong culture we have built at Compugen, despite these challenging days we face here in Israel. With that, I will turn the call back to the operator to initiate the Q&A session.
Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. If you have a question, please press star one. If you wish to decline from the polling process, please press star two. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Please stand by while we poll for your questions. The first question is from Daina Graybosch of Leerink Partners. Please go ahead.
Hi. Congratulations on the deal, guys. I wonder if you could talk to questions on IL-18. One, if you could talk at all to how you believe, or your discussions with Gilead, and how the program will be developed? Single agent, combination, any more details you can give there? And two, and I think you said that you guys will be running the phase I, is that correct? Can you just talk operationally how the collaboration and joint venture will work together?
Sure. Thank you, Daina. So yes, we will be in charge of the preclinical and for the phase I study. We did not share too much information on this, but I think that you know that we were presenting data on this program, preclinical data, obviously, that related to monotherapy effect and to combination effect with PD-1. And we were also discussing the potential of this program to work in additional combination options. So I think that the fact that Gilead they entered into this license agreement was in line with how we Compugen see the potential of this program and how they see the potential of this program. So I can't state anything more than that about the path forward.
But it is in line with how we think about the program in general for quite some time, and that we shared it with the public. With respect to, you know, Compugen is going to conduct and fund this study. We appreciate Gilead a lot as a partner. We're so happy that we entered into this collaboration with them because of their commitment to oncology, because of their team expertise in immuno-oncology, which we believe is also complementary to what we bring to the table, and our expertise in the IL-18 pathway and the systems and the tools that we've developed in order to take it to the clinic.
I think that the fact that Gilead agreed under a license agreement to still leave, this is not an option agreement, to still leave this asset at the hands of Compugen, to take it forward, to phase I, including, states a lot about, what they think, about Compugen's capabilities to translate the biology that we discovered into drugs, investigational drugs. And we will be happy and looking forward to work under transparent, collaborative arrangements with Gilead. We have this experience in the company. This is not the first collaboration for us with pharma. I think this was contributing to the equation as well.
Great. Thank you.
The next question is from Stephen Willey of Stifel. Please go ahead.
Yeah, good morning. Thanks for taking the questions, and congratulations on the collaboration. Maybe just an accounting question first, and then just to follow up. So is the $60 million, do you know at this point, is that gonna be recognized as a single upfront, or is that gonna be amortized over some fixed duration of the collaboration period? And then, I guess just per details of the K that was filed earlier, I know that you're obligated to make, I think, certain upstream payments, and it sounds like Gilead's gonna be withholding taxes payable. So can you speak to what those upstream payments are and I guess what a net upfront looks like once these things are backed out?
Yes. So maybe I'll start with the upstream, and let Alberto relate to the recognition of the upfront and the withholding tax. During the process of the development of this program, we're working with providers that are supporting us on fronts that we don't have internally in the company, and we still believe that we shouldn't incorporate these capabilities into the company. Different type of services that we use. And as part of this agreement, there are some upstream payments that we need to take, and these are included in all the payments that we are taking into consideration when we relate to the cost of this program.
Obviously, obviously, the economics of the deal takes into account all this as a whole. Alberto, you can relate-
Yeah.
To the recognition of the upfront and withholding tax.
Yes. So first of all, regarding the recognition of the upfront, we're working, we're currently working with, studying exactly the, the contract and, and, working with, with our auditors in order to figure out what is the, right way to recognize. So at this point in time, I cannot refer exactly to your question. That will be certainly done during the year-end call, while we will present our financial reports for the year 2023. Regarding the withholding, Gilead will withhold the source, all taxes required from all payments under the license agreement. Now, there is a treaty between U.S. and Israel, according to which all royalty payments are subject to 15% withholding tax at source.
Okay, that's, that's helpful. And then, I guess maybe just lastly, kind of bigger picture, right? So I guess the totality of all these payments from Gilead, the milestone from Astra, would seem to provide you now with somewhere around, I guess, three years of additional cash runway, just per your recent burn rate. So does this now change about how you think about investing in the pipeline going forward? Just in terms of the-
That's a very good-
types of investments that you make and the magnitude of those investments.
So that's a very good question. As you know, we are committed to the COM701 and COM902 studies that we're pursuing. And we have the biomarker, initial biomarker data that generate more opportunities for us and potential opportunities. And we have the early-stage pipeline, and we're now formulating our plans. Actually, it's not now, we started it already, but we're formulating our 2024 plans, and we will be sharing some updated guidance taking into consideration these plans in the year-end call. We're committed to our pipeline and this will be reflected.
But, but I will also say that, we would like, under these capital market conditions, we would like to make sure that, that, we're generating a horizon of cash runway that is sufficient for this company. So it will be a balance between the plans and generating meaningful, milestones for our programs, the ability to generate meaningful milestones for our programs, but also making sure that we're, conservative with the cash investment.
All right. Thanks for taking the questions.
The next question is from Asthika Goonewardene of Truist Securities. Please go ahead.
Hey, guys. Thanks for taking my questions and congrats on the deal. I just have a quick one here. In terms of biomarker development for COM503, what were your thoughts on that? Is that? Is this something that's emerging right now, as something that's a potential biomarker that you wanna potentially focus on in the clinic? And how will that be handled in terms of the agreement with Gilead? Who runs point on the biomarker development? Thanks.
So obviously, we did not specifically relate to the plan. As you know, as Compugen, maybe I'll take the example of COM701. We were coming up with a hypothesis of the biomarker from the get-go, at the computational stage of the program. And we were making sure that we were acting on it. That led us to the point that we could come up with initial data. Compugen, that's the way we work on programs. We will be in charge of the phase I study. I cannot say more than that on any biomarker plans, but at the phase one study, we will be, we will be conducting the activities. So Gilead will obviously be a partner to the program, but we're conducting the activities in general.
Got it. Thanks, Anat. And then, just real quickly, on 701 , given that you have now two very interesting deals with, with some very good partners out there, can you tell us just a little bit about your, your strategy behind 701 , and 902 ? And, and, and if those are still, you know, how do you see a path forward with those and, and what you would like in a partner, a potential partner for those two assets?
So, you know, I'll start by connecting your question to Steve's question. Look, we have more money now, so we will make sure that we act on the opportunities that we have with COM701, COM902, triplet combinations, et cetera. But having said that, we are still committed, and as I said, we see our path forward with COM701 to bring it to exercise the potential to get to the market. We see our path forward with a partner, and different type of arrangements would be reasonable for us. What would be the exact path in order to get to the partnership? It still, you know, it still remains to be seen, but we're committed to this.
We don't have the access to the PD-1, and at a minimum, it's gaining some access to PD-1 in order to get to registration, right? So that's at a minimum. But different type of collaborations could be relevant, and we will push this program to get to meaningful data that will allow us to maximize the potential to take it forward with a partner to the market.
Awesome. Thanks for taking my questions, guys, and congrats again.
Thank you.
This concludes the Q&A session and Compugen's corporate update conference call. Thank you for your participation. You may go ahead and disconnect.