Exelixis, Inc. Price & Performance (EXEL)

During the course of this presentation, we will be making forward looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial and strategic matters. After all events, our results could, of course, differ materially. We refer you to the documents we file from time to time with the SEC which under the heading Risk Factors identify important factors that could cause our actual results to differ materially from those expressed by the company verbally and in writing today including without limitation, risks and uncertainties related to product market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners and the level of costs associated with discovery, product development, business development and commercialization activities.

And with that, I will turn the call over to Mike. All right. Thank you, Susan, and thanks to everyone for joining us on the call today.

Exelixis had a breakout year in 2024 and we're already sprinting into 2025 after a busy January. Where we provided important updates across all components of our business.

Exelixis has built significant momentum to establish a multi compound, multi franchise oncology business as we advance our cabozantinib, zanzilantinib and early pipeline [indiscernible] And momentum of the Cabo franchise in The U. S. And globally both in terms of absolute revenue and relative growth compared to the competition, we expect to see additional upside with potential new indications. We outlined important news and priorities to Jumpstart twenty twenty five at our corporate update in January at the JPMorgan Healthcare Conference. I won't reiterate everything here today, but just focus on the top highlights, including first, saw a strong performance of the cabozantinib business in the fourth quarter full year twenty twenty four with approximate 11% growth in demand new starts and revenue. CaboMedix maintained its status as the leading TKI for RCC in both the frontline IO TKI market and the second line monotherapy segment. Fourth quarter twenty twenty four U. S. Cabo franchise net product revenues grew 20 over year to $515,000,000 compared to fourth quarter twenty twenty three. Full year 2024 U. S. Cabo franchise net product revenues grew 11% to $1.11810000000.00 dollars compared to full year 2023. Continuing its role as the worldwide leading TKI, global cabo franchise net product revenues, approximately $690,000,000 in and $2,500,000,000 in the fourth quarter and full year 2024, respectively.

Chris will review our 2025 financial guidance, for the base business in his prepared remarks. Will provide updated guidance including the net opportunity at a later date Second, our top priority is to advance the cabo net indication with ongoing regulatory activities for the sNDA based on the CABINET Phase III pivotal trial. As you'll recall, we announced that the FDA had accepted our sNDA seeking a with the PDUFA date of 04/03/2025. Details final results from Cabanet were presented at ESMO twenty twenty four and were concurrently published in the New England Journal of Medicine, which supported the addition of cabo to the recently updated NCC guidelines for net. We're collaborating closely with the FDA on the review and won't speak to any details of that process today. As we've highlighted at recent investor conferences and webcasts, we are launch ready and eager to engage as soon as approval is secured. [indiscernible] expect XANTSA to take center stage in 2025 as our next oncology franchise opportunity. Important anticipated ZANZA data milestones from pivotal trials include [indiscernible] from STELLAR-three zero three in colorectal cancer and STELLAR-three zero four in non clear cell kidney cancer and a decision to advance to the Phase three portion of STELLAR-three five in head and neck cancer.

All projected to occur in the second half of the year pending event rates for each trial. In addition, we expect to initiate STELLAR-three eleven trial of ZANZZA in NET in the first half of twenty twenty five anticipate Mork will initiate two RCC studies evaluating ZANZZA, plus balsutafan this year. I'll remind everybody again that Exelixis is running ZANZZA pivotal trials against a contemporary standard of care for each trial. Regorafenib for STELLAR-three zero three, sunitinib for STELLAR-three zero four and a pembro placebo combination for STELLAR-three zero five. Recent speculation during ASCO GI comparing ZANZZA to cabo is misguided and a distraction from the focus of our ZANZZA development activities. As highlighted on our third quarter call, our $5,000,000,000 projection for ZANZZA in 02/1933 is based on success and indications in we believe are independent from any overlap Fourth, as we highlighted recently, our Exelixis IND pipeline is full for the next several years. With potentially differentiating molecules based on extensive preclinical testing. 2025, we're looking to accelerate the Phase one development of XL [indiscernible] a potential therapy for tumors that have become refractory to PARP inhibitor therapy as well as in combination with PARP inhibitors to deepen and prolong responses.

Also, we're pleased with our progress of Phase one trials for XB010 and XL-four 95, see the opportunity to file up to three new INDs for XB628 XB-sixty four, XB-three 71. We expect a significant number of data presentations for these molecules at major scientific meetings throughout 2025. Business development activities continue to focus on late stage assets in the GUGI space. Back end loaded paper success transactions that tuck nicely into our existing and potential future oncology franchise remain a top priority. In terms of capital allocation, we're confident we have the balance sheet and the expected free cash flows to advance our pipeline priorities access new high conviction assets and continue to repurchase shares. So with that, please see our press release issued an hour ago for our fourth quarter and full year 2024 financial results an extensive list of key corporate milestones achieved in the quarter. I'll now turn the call over to Chris. Thanks, Mike. The fourth quarter twenty twenty four, the company reported total revenues of approximately $5.00 $67,000,000 which included cabozantinib franchise net product revenues of $515,200,000 HAVO Medix net product revenues were $512,800,000 and included approximately $3,000,000 in clinical trial sales. Is lower than our clinical trial sales in Q3 twenty twenty four.

As a continued reminder, clinical trial sales have historically been choppy between quarters and we expect this to continue into the future. Gross to net for the cabozantinib franchise in the fourth quarter twenty twenty four was 26.8% which is incrementally higher than the gross to net we experienced in the third quarter twenty twenty This increase in gross to net deductions in the fourth quarter twenty twenty four is primarily related to higher co pay assistance assistance for our commercial patients and Medicare Part D expenses. Additionally, we estimate that our gross net for the full year 2025 will be between 2930%. As previously disclosed, Exelixis has been designated as specified small manufacturer which requires Exalexis to pay a 1% discount in 2025 on all Medicare Part D sales and is included in our gross net estimate for the year. As we've mentioned in the past, gross to net tends to be higher in the first quarter over year We project that the first quarter twenty twenty five gross to net will be similar primarily due to higher co pay assistance expenses for our commercial patients. Our CABOMETYX treat inventory was flat at two point one weeks on hand at the end of the year when compared to the third quarter twenty twenty four.

Total revenues also included approximately $51,500,000 in collaboration revenues, which includes approximately $44,000,000 in royalties earned from our partners, it's an indicator on their sales of cabozantinib. Total operating expenses, excluding restructuring and impairment charges for the fourth quarter twenty twenty four were approximately $4.00 $3,000,000 compared to $352,000,000 in the third quarter twenty twenty four. The sequential increase in these operating expenses was for drug development candidates, higher clinical trial and licensing costs and by higher general and administrative costs in the fourth quarter twenty twenty four. For income taxes for the fourth quarter twenty twenty four was approximately $44,900,000 compared to a provision for [indiscernible] The company reported GAAP net income of approximately $139,900,000 or $0.49 per share basic and $48 per share diluted for the fourth quarter twenty twenty four. The company also reported Non GAAP net income of approximately $160,300,000 or $0.56 per share basic and $0.55 per share diluted. Non GAAP net income excludes the impact of approximately $20,000,000 of stock based compensation compensation expense net of the related income tax effect. Cash and marketable securities for the year ended 12/31/2024 was approximately $1,750,000,000 During fiscal year twenty twenty four, we repurchased approximately $656,000,000 of the company's shares.

Resulting in the retirement of approximately $26,400,000 of the company's shares at an average price per share of $24.82 As of the end of fiscal year twenty twenty four, we had approximately As of the end of fiscal year twenty twenty four, we had approximately $294,000,000 remaining under the $500,000,000 stock repurchase plan authorized by the company's Board in August 2024. And finally, turning to our financial guidance for the full year 2025. Announced our 2025 financial guidance during the JPMorgan Conference in January. Which is detailed on Slide 19 of our earnings presentation. As Mike mentioned, we will provide updated net product revenue guidance And with that, I'll turn the call back over to Mike.

All right. Thanks, Chris. I'll wrap up here by thanking the entire XOXX' team for their As I've said previously, success never comes in a straight line in this business and I want to commend everyone in for their individual and collective urgency and resilience as we navigated our past challenges continue to advance our discovery, development and commercial priorities. 2025 is already shaping up to be another inflection year for the business the patients we hope to serve now and in the future. I am so proud to be part of the team that makes every hour count as we excel on our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future Thank you for your continued support and interest in Exelixis. We're happy to now open the call for questions.

And our first question will come from the line of Astika Gunawarden with Truist.

Your line is open.

Hi, guys. Thanks for taking my question and congrats on all the progress made.

Mike, just to everyone who's worried about Zadzia looking like cabo the misguided notion that you talked about earlier today. Can you just just to dismiss that a little bit more, could you just talk to us a little bit about one, the lack of overlap in the approved indications to Cabo and where you're dispensed will be? And I think the important one here is if you've ever seen the payers I guess, force a a substitution with the generic of something that is not the actual generic product?

I don't think I've ever seen that happen, but would like to get your thoughts on that.

Yes. Thanks, Jessica. Look, I don't want to speculate that level of details. I think the main focus is we are comparing ZANZZA combinations to individual standards of care for STELR-three zero three STELA-three zero five, certainly plan to do that with STILRET-three zero four as well, as well as what we have planned for three eleven in the net area. So So the goal here is to obviously run large global randomized pivotal trials that will allow us to generate positive data if it's there, to be able to push those indications forward. So that's the only comparison that comes to us. All the hand waving between small data sets, single arm or very small randomized Phase two data sets is very, very challenging Everybody knows that. We certainly know that and we're focused on running executing and reading out these pivotal trials because ultimately that's what will drive the label enabling efforts that we need to get Stanza moving forward into more patients in the commercial setting and really helping those patients who need better therapies.

Thank you. One moment for our next question.

And that will come from the line of Michael Schmidt with Guggenheim Securities. Your line is open.

This is Paul on for Michael. Thanks for taking our question. One is on cabo for Fernet. Sort of pending the label discussions and the formalization how are you currently thinking about the launch trajectory and expectations for uptake Do you see any potential for an initial bolus here given that this is a sort of indolent disease? And then for SPIRZANZA, can you just comment on the emerging safety profile now that we have more data and indications beyond RCC? On balance, what are your current thoughts on the ability to maintain dose intensity with ZANZZA especially when combining with checkpoint inhibitors? Thank you.

DJ, do you want to take the first part? Yes. Thanks for the question, Paul. With regards to net, as Mike mentioned, we are completely launch ready. And the team is, I would say, very excited and just with neuroendocrine tumors pending an FDA approval. That said, as we've said previously, we believe that the opportunity is significant We've talked about the fact that in 2025, we look at the net market and the oral shares within that market, we believe the oral market in 2025 in contemporary pricing dollars is about $1,000,000,000 so substantial opportunity. And when we think about the cabinet study and the data set, it's a broad data set, really the only of its kind that addresses all sites of origin for NET. All the different grades of the tumor, different SSTR status etcetera. So it can really be a choice for any type of net patient pending approval. We've talked about before too the overlap of customers that we see in terms of customers both that we are calling on currently for our approved on label indications as well as prescribers who have already written CABOMETYX is about 80%. So that's significant. So that speaks to really the ability for us to really come out of the gates fast and accelerate the launch trajectory of this.

And we hear from market research that physicians are excited about the data They like the efficacy AAC. They understand the safety. And when they find out this is cabo that they're familiar with, it really makes them comfortable in terms of dose reduction and managing that toxicity profile. So I'm really excited And just can't wait to get out there and bring this to patients. The final thing I'd mention here too is that the oral therapies we're competing with effectively sunitinib everolimus and Captem are all generic. So this will also give us We believe a substantial advantage in terms of share of voice and other aspects of things. So we're excited for the launch.

Thank you. One moment for our next question. And that will come from the line of Sean Lamann with Morgan Stanley. Your line is open.

Hi, Mike, Chris and Susan. I hope you're all well. [indiscernible] My question relates to the balance sheet. There's really good liquidity there to despite that I think on the cash flow statement you bought back $650,000,000 worth of stock. I think the commentary has been that you're winding down Carbo, winding it up in Zanza, but you're probably looking at a net neutral outcome If I got our past discussions correct in terms of OpEx, Then you've talked about accelerated development of three zero nine. Potential three new INDs, I think you said, Mike.

But it kind of still suggests that you're going to still end up with highly liquid and lazy balance sheet. So how would how do you think about that in terms of further buybacks versus potentially bolstering the pipeline with M and A? Yes. Thanks for the question. So I'm not sure I'd characterize that much free cash flow. It's lazy.

If so, then most other companies would want to aspire to that. So yes, look, I think we've articulated a plan. Where we have built a business and run a business with a great degree of discipline. So we can move our pipeline priorities forward with Cabo, with ZANZZA, with the rest of the pipeline. We can do the appropriate capital allocation to buyback shares when we think the price is appropriate. And then to invest in new assets we have the conviction that they will help move the needle for patients. And for our revenue goals going forward.

So So we have the opportunity and I would argue the responsibility to manage that very carefully. Those three different [indiscernible] in terms of pipeline, in terms of returning cash to shareholders and then BD, a way that moves the business forward in the short term and the long term. So I like that optionality and I like flexibility. We're spending about $1,000,000,000 in R and D this year And we think we have the opportunity to prioritize and focus based upon how the data comes in. And what that tells us in terms of where to put money behind the winners. And when to stop the losers. So I think we've got that well handled and we're looking forward to continue to move the ball down field in a way that helps patients and builds value for our shareholders.

Thank you. One moment for our next question. And that will come from the line of David Lebowitz with Citi. Your line is open.

Thank you very much for taking my questions. On the recent net data presented at ASCO GI, could you tell us about how we should view the various subgroups relative to actually how the drug might be used in clinical practice and what the label might ultimately look like?

Hi, David. This is Amy. Thanks for the question. So we can't really speak to what the label might look like. We're in negotiations and discussions with the agency. But given the population that was evaluated in cabinet, it really reflects a very broad patient population. We have pancreatic neuroendocrine tumor, GI neuroendocrine tumor, lung neuroendocrine tumor, functional non functional neuroendocrine tumors and neuroendocrine tumors enrolled regardless of their somatostatin receptor expression of those And benefits we're seeing across all subgroups and what was shown at ASCO GI was that the benefit within those patients tumor originates from a GI origin. Their benefits were consistent with the benefits seen in the overall population. So [indiscernible] we think broadly applicable. Thank you. One moment for our next question. And that will come from the line of Akash Tewari with Jeff Your line is open.

Hi. This is Anastasia on for Kash. I just had a follow-up question on nets.

Specifically, for your 2025 guidance, just wondering how much of that comes from net versus other indications, if you could give us a sense of what near term versus long term growth might look like, that would be great.

Hey, Anastasia, it's Chris. So we haven't as we said at JPMorgan and we've said today, we haven't put net in our guidance. We'll do that at some point in the future when we understand what our final label is, but it also understand what the launch trajectory is post approval.

And that will come from the line of Gregory Renza with RBC Capital Markets. Your line is open.

Great. Good afternoon, my and team. Congrats on the progress. Thanks for taking my question. Mike, just in relation to that pursuit of expansion getting more out of out of cabo, just beyond Net, just wanted to ask that you comment a bit on the pushes and pulls for submission in in, of course, prostate cancer and contact two. So Could you just speak to your confidence in that regulatory process course, that absence of OS and and your plan on timing and getting the ducks in the road there? Yes. Thanks, Craig. As we talked about early in the year at PM, only singular focus right now from a regulatory point of view is getting net over the goal line, having that reviewed and approved. Once we get that done, we will circle back to the prostate opportunity with Kontact-two and at the appropriate time give you updates on where that's going.

And that will come from the line of Eva Forteo Verdejo. With Wells Fargo. Your line is open. Hi. This is Yvonne on for Derek. Thanks for taking our question. A quick one from us So on STELLAR-three zero three, the patient population included is both RAS wild type and mutant.

In the recent STELLAR-one readout, the patient population was just RAS wildtype. So How should we be thinking about how the differences in patient population could impact the overall survival for Zansa plus Atezo?

Hi, Eva. This is Amy. Thanks for the question. So I'm just going to step back a second to remind everybody what was the purpose of STELLAR-one, which was was really to establish or evaluate whether or not there was a contribution of components when you added atezolizumab to zanzolitinib in patients with colorectal cancer.

The rationale for choosing wild type RAS wild type patients was because we have observed higher responses in those patients. And of course, that's one metric of contribution of components Suffice it to say that in that study, we actually saw the contribution of atezotuzanza across all three efficacy components, namely ORR, PFS and OS. And so we're encouraged by those results as far as the read through to three zero three. I think we're anticipating the events as Mike alluded to the second half half of 2025, we are encouraged by the results that we saw in STELLAR-one. And that's really about all I can say with regard to how to pull that through.

Thank you. One moment for our next question. And that will come from the line of Jason Gerberry with Bank of America Securities. Your line is open.

Hey, guys. Thank you for taking my question. Mike, I just wanted to follow-up on the comments earlier about the non overlap and the $5,000,000,000 peak. I think the thing that I think investors struggle with is RCC is still a big percentage of the addressable patients in the kind of patient build And then the comment about the non overlap, I guess it suggests either that the novel agents added to an RCC combination are really what drives the incremental benefit or that you won't compare against Cabo is one of the RCC standards of care. And I imagine the answer is we can't tell you much until second half when you and Merck disclose your trial designs. But anything you can offer just to help maybe investors get around that, I guess, that issue or that lack of understanding?

Yes. Thanks, Jason. Look, I would just I'll just repeat in a more abbreviated fashion what I said to Astika. Right? I think the way to look at this is looking at how we're running the pivotal trials for three zero three, 305, three zero four, three zero five, 311 and the the two more trials that obviously we haven't talked about yet. So there's a little bit more information to come there. The main focus is the comparison into the standard of care that's being run-in those pivotal trials. We think and just to look forward in the RCC space, that RCC will look differently in 02/1930 and 02/1931 than it does in 2024 and 2025. You have to have to look at what's happening and the competitive nature of that indication and true for all of oncology to look forward to plan pivotal trials that you'll actually be able to then then frame what success looks like. So I understand the easy part of comparing cabo to ZYNZZA and we're certainly excited about how ZYNZA looks with all the caveats of having a number of small single arm in some cases small randomized studies bottom line is you generate good comparative data by running the right pivotal trials where you compare against standard of care and you compare efficacy and safety.

We're doing that. We have three going with ZANZA right now. We'll have three more going this year. And we expect a second wave coming after that. And that's how you define really the next wave of standard of care as we did with Cabo in the late teens, early 20s as we'll do with ANZSA going forward.

Thank you. One moment for our next question. And that will come from the line of Andy Hsieh with William Blair. Your line is open.

Thanks for taking my question. So the ADC modality is a core corporate focus. So just curious about the learnings that you can leverage from the XB002 program to XB371 to ensure it's best in class? And more specifically, do they share the same antibody [indiscernible] Thanks for the question, Andy. This is Dana. So XB002, was anti tissue factor targeting ADC with a microtubule targeting payload. XB371 uses the same antibody with a drug antibody ratio of eight and a topoisomerase inhibitor. Drug payload. We're excited about how That antibody differentiates from other tissue factor antibodies because of the epitope that it binds to, not causing problems with blood clotting. And we remain excited about that potential differentiation factor. Most importantly, with three seventy one, we're very excited about how it gives us the potential opportunity to move with a biologic, with an ADC into colorectal cancer. As you know, Mike's talked many times in the past about how we're really focused on building a franchise in GI with STELLAR-three zero three, LASONSSA and colorectal, even with cabo and NETZ. So this gives us another opportunity to move into this indication and create a bit of a franchise with that ADC.

Thank you. One moment for our next question. And that will come from the line of Yaron Werber with TD Cowen. Your line is open.

Great. I have an interrelated question, Mike, or whoever wants to take it. For RCC, mean, it sounds like the future is going to look different than now. So I know you don't want to say too much ahead of announcing the trial design. But should we assume there's going to be a ZENZZA BELF-two 50 BELCEUTIFAN triplet combo going to first line? Is that sort of how you're thinking about it maybe with IO And then secondly, just for STELLA-three zero five, what's the go no go based on the Phase two? What do you want to see then to progress into the Phase Thank you.

Yes. So I guess I would frame your follow-up question around RCC as I think the pharmaceutical biopharma community is everybody is working to improve standard of care. Going forward. I think that's how we help patients and that's obviously how we move new molecules into the system, right? That's the goal across the board. So there's certainly there's nothing different about what our strategy is here with ZANZZA. Right? We're using what we think is a best in class TKI the appropriate combination partners to be able to compare against contemporaneous standards of care molecules to be able to prove efficacy improved efficacy and safety. So it's a standard process. But looking ahead, if you if you assume these are going to be the same five years ahead, then to be frank, we're all dropping the ball, right? Come on, That's the goal. The goal is to improve outcomes for patients. That's why we're here. So again, I don't want to get into the weeds or into the roots about what's going to happen with RCC. We will announce those trials at the appropriate time with Merck. But again, we're focused on improving standard of care for patients with cancer.

We're doing it right now. The plan is with three zero three and CRC three zero four in non clear cell RCC, three zero five in head and neck cancer and many more to come after that. So stay tuned.

Thank you. One moment for our next question.

And that will come from the line of Peter Lawson with Barclays. Your line is open.

Great. Thanks so much. Thanks for the detail. That question. I guess maybe just around contacting to just if you could give us an update where that stands at didn't hear you mention today. I know you talked about it. The beginning of the year. Yes. Thanks, Peter. I think as I mentioned to Greg, a few minutes ago, our main focus, our singular focus right now a regulatory point of view is on cabinets in the net indication getting that approved and moving that forward. Once that's secured, then we'll focus back on contact to and CRPC, nothing more to add on that today.

Thank you. One moment for our next question.

And that will come from the line of Stephen Willey with Stifel. Your line is open.

Yes, thanks for taking the question. Maybe just a follow-up on the question of RAS mutational status in 03/2003. Can Can you just help us understand kind of what the expected distribution of wild type versus mutant is now expected to be in the upsized version of this trial. I know the [indiscernible] version, I believe, specified primary efficacy endpoint that was in RASWILD type only there was an enrollment cap that you had put in place for RAS mutant. So just wondering if you can comment on whether the The upsizing now changes the expected distribution here of RAS status.

All right. Thanks.

For the question, Steven. So you were right. We did modify the primary endpoint to focus more on patients with out liver metastases also we refer to as the non liver met patient population. The rationale for that was because of publications situation with those patients is much stronger than say for example RASP or gene mutation or wild type and as well the data that we understand from others and that we have been following that IO therapy seems to do well for especially in patients without Libermets, which doesn't mean that it doesn't work in patients with liver mets, it's just most of the patients have been studied without them. So we modified the study to really focus on the non liver mat versus the patient population. And right now, I can't really I can't give you what the breakdown is of the RAS mutational status to wild type in the study, but it will be when the data comes, you'll have that answer.

Yes. And Steve, I would refer you back to the Merck, LEAP 17, both presentation and paper. When they broke out the RAS mutational status, by at least by hazard ratio in the forest plot, The mutant RAS population actually did better than the wild type population, okay? Has a ratio and from that study, was 0.76 for the mutants and 0.9 for the wild type. So So again, I think if people are focused on 30 patients from Ocavo Phase Ib or from a 30 patients from a cabo IST mean that was interesting to us. It certainly was hypothesis generating, but I think when the as the non liver met kind of story started to evolve and then LEAP-seventeen came out where Liverman went the right way. In fact, the rest mutants went the other way. That was very, very important for us to take in into account. Again, that's a large randomized global run pivotal trial. So it's really the gold standard from our point of view about guiding us on how to then evolve STLR-three zero three.

Thank you.

And that will come from the line of Ash Verma with UBS. Your line is open. Hi, great. Thanks for taking my question here. So for ZYNZANS, CRC, with this ASCO GI data in hand, I'm not trying to compare it to to cabo, but if you look at the Zantac plus Atezo efficacy, versus what we've seen with the rigorafoneb, would this level of efficacy still allow you to get to your peak sales guidance more broadly speaking? Thanks.

Thanks, Ash for the question. So we're actually encouraged by the data that we saw. Again, the study design was really to demonstrate whether or not there was a contribution of components, which we clearly did demonstrate across all three efficacy endpoints. When you actually look at outcomes of OS, say for example in the IT of eleven point seven months for XANZATYZO, That actually bodes well against what one might expect or what has been published in the literature with rigorafenib where the median overall survival is anywhere from six point five to seven point five months.

How that pulls through to three zero three remains to be seen as Mike has said and as we have said it requires a very large randomized Phase three study that can generate a P value that gives you some sense of truth. And the other thing I'll point out as well in the non Libermat patient population, the median survivals ranging from eighteen to twenty one months also I think bodes well given that the our CAD Foundation published data from their data set that includes correct and recourse in a couple of Phase two studies with TAS and REGO. As the control arm and in the non Libermat patient population, the median overall survival And we know the median overall survival from VAL and IO combination in non liver meds was about twenty months. So we're benchmarking well.

Thank you. One moment for our next question. And that will come from the line of Sudan Loganathan with Stephens. Your line is open.

Hi, good afternoon. Thanks for taking my question.

I specifically want to ask about the Feller programs three zero three, three zero four and three zero five. What will be the driving force to prioritize one program over the others to bring to market [indiscernible] potential of taking all three indications simultaneously submitting for a regulatory approval the data looks good and it's undeniable that you have that strategy submit for approval. Thanks.

Yes. Thanks for the question. Yes, the only Gabe Sears value if the trials work, obviously, we would take those forward with great speed and focus. We're in the game of running pivotal trials and then moving them forward from a regulatory point of view. And that's our business. So we've done that numerous times with Cabo and certainly plan on doing that again here if successful. So we're just in the execution phase. There's no dates. Clearly no gates besides us having studies work. Thank you. And that will come from the line of Chris Shibutani with Goldman Sachs. Your line is open.

Hi, this is Kevin on for Chris. Thanks for taking our questions. I just wanted to touch on the earlier stage pipeline. You mentioned that there should be a number of presentations this year. Just wanted to ask on the amount of data that we might see and the cadence of these updates. And then as you think about three new INDs coming in. How are you making go no go decisions as it relates to these these programs? Thank you. Dana?

Okay. So as Mike said in his prepared remarks, we're planning for presentations at scientific meetings. We don't typically give more information than that until the abstract is published. So I would just say stay tuned on those programs. So we're excited about the data that we're planning to present to the community those programs. And then regarding the early stage pipeline, we follow what I would consider to be best practices in the industry, which is we follow a certain cadence of IND enabling activities, including GLP toxicology. The assets pass all of the the bars for that are required to convince us as well as investigators that there is a good high hypothesis to be tested, we then file the INDs and start the Phase one trials.

So we are progressing on that track with all three of those assets. And we'll continue to make announcements as those INDs are accepted by the FDA and we start executing those trials.

Thank you. At this time, there are no further questions. And so I will turn the call over today's host, Susan Hubbard. Ms. Hubbard? Thank you, Sheree, and thank you all for joining us today. We certainly welcome your follow-up calls with any additional Thank you.

This concludes today's program. Thank you all for participating. You may now disconnect.