Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the Exilexis Second Quarter 3026 Financial Results Conference Call. My name is Kathleen, and I will be your operator for today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today, Mr. Andrew Peters, Senior Vice President of Strategy and Investor Relations. Please proceed.

Thank you, Kathleen, and thank you all for joining us for the XLX's second quarter 2026 financial results conference call. Joining me on today's call are Mike Morrissey, our president and CEO, Chris Senner, our chief financial officer, Dana Aftab, our executive vice president of research and development, and PJ Haley, our executive vice president of commercial, who will review our progress for the second quarter 2026 and in June 30th, 2026. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release which is posted on our website for an explanation of our reasons for using such non-GAAP measures as well as tables deriving these measures from our GAAP results. 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, potential growth opportunities, and government drug pricing policies and initiatives. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the Securities and Exchange Commission, which, under the heading Risk Factors, identify important factors that can cause 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 commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners, and the level of cost associated with the discovery, Product Development, Business Development, and Commercialization Activities. With that, I'll turn the call over to Mike.

All right. Thank you, Andrew, and thanks to everyone for joining us on the call today. That's Alexis continues to execute across the key elements of our business, positioning the company to deliver on our strategic objectives for 2026 and beyond. We are in the early innings of our next phase of growth as we deliver on our strategy to evolve from a single compound company to one with a pipeline of potential oncology franchise opportunities. Zanzilintanib is poised to transform ExoLexis as our next franchise molecule, potentially first with the third-line plus CRC filing that's currently under review, followed by accelerating progress on the next six pivotal trials that we've highlighted recently. Importantly, a second wave of trials is lining up nicely to initiate potentially as early as 2027. Our confidence in Combo's long-term revenue growth trajectory remains unchanged. The updated financial guidance reflects modestly slower growth in 2026 due to a more gradual ramp for the net indication. which reflects the unique characteristics of the net patient population and histology. We remain confident in the long-term potential of the CABO net indication and view the net franchise as an important growth driver for CABO, ZANSA, and other molecules in our pipeline. We continue to see meaningful opportunities to expand our impact for patients, strengthen our commercial position, and create value for shareholders. Our strategy to build a multi-franchise oncology business contains five key elements, including first, execution. ANDA is leading the pack as our next potential franchise opportunity and our highest R&D priority. The Excel team continues to execute on key objectives across the program, including the stellar 303 regulatory review, pivotal trial data readouts, expediting clinical trial enrollments, and new study initiations. The second is expansion. We are building the foundation for the next wave of growth opportunities for Zanza. Beyond our current pivotal trials, we are actively evaluating new development opportunities that could further expand the scope, reach, and long-term value of Zanza in GU, GI, and other indications. Our goal is to build a durable franchise with stacking capabilities that could drive growth for years to come. Third key element is commercial performance. We continue to see substantial growth from the Cabo Xanthin franchise. Cabo remains the leading TKI for RCC, the market leader for the oral second line slash net segment, and a key player in the treatment of patients with liver and thyroid cancers. Second quarter of 2026, U.S. Cabo franchise net product revenues grew approximately 10% year-over-year to $573 million. Continuing its role as a worldwide leading TKI, global combo franchise, net product revenues generated by Exalexis and its partners grew approximately 13% year-over-year to $806 million in the second quarter of 2026. Fourth is preparation. We continue to prioritize our commercial readiness for the potential launch of Zanza and Thirdline Plus CRC, pending a positive regulatory review later this year. We believe the CRC opportunity represents an important first step towards establishing Zanza as our second oncology franchise and a significant driver of future growth. We see this element of our strategy as especially timely as we pursue new GU and GI indications, specifically in tandem, early and late stage opportunities in CRC with Stellar 303 and Stellar 316. Fifth and finally, discipline. We remain committed to rigorous expense management and capital allocation. This can be seen by trimming expense guidance while we invest in our mission-critical R&D priorities and keeping our projected free cash flow essentially unchanged. We believe this balanced approach remains an important differentiator and positions us to create long-term value while maintaining strategic flexibility. Taken together, these five strategic elements, working in tandem, underscore the strength of our strategy and the progress we are making across the business. We believe we are well-positioned to advance Zanza towards becoming a major oncology franchise, expand our development portfolio, drive continued growth to the Cabo Zantana franchise, and deploy capital in a disciplined manner to maximize shareholder value. So with that, we see our press release issued an hour ago for our quarterly financial results and a comprehensive summary of key corporate milestones achieved during the period. And with that, I'll turn the call over to Chris.

Thanks, Mike. For the second quarter of 2026, the company reported total revenues of approximately $629 million, which included Cowles Antenna franchise net product revenues of $573 million. KalbaMedics net product revenues were $571 million and included approximately $2.7 million in clinical trial sales. 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 KalbaZantina franchise in the second quarter of 2026 was 29.5%, which is lower than the gross to net we experienced in the first quarter of 2026. This decrease in gross to net deductions in the second quarter of 2026 is primarily due to lower copay assistance for commercial patients, which is partially offset by a modest increase in 340B utilization when compared to the first quarter of 2026. Additionally, we're updating our estimate for full year 2026 gross to net deductions, and we are now projecting that it will be between 30% and 31%. Our Cabo Medics trade inventory was flat at 2.1 weeks on hand, Thank you for joining us. Marketing expenses and stock-based compensation. Provision for income taxes for the second quarter of 2026 was approximately $50.6 million, compared to a provision for income taxes of approximately $57.2 million for the first quarter of 2026. Company reported GAAP net income of approximately $212 million or $0.85 per share basic and $0.82 per share diluted for the second quarter of 2026. The company also reported GAAP net income of approximately $237 million or $0.95 per share basic and $0.91 per share fully diluted. Non-GAAP net income excludes the impact of approximately $25 million to stock-based compensation and other related income tax effects. Cash and Marketable Securities for the quarter ended June 30, 2026 for approximately $1.4 billion. During the second quarter of 2026, we repurchased approximately $312 million of the company's outstanding common stock, resulting in the retirement of approximately 6.5 million shares of the company's outstanding common stock at an average price per share of $47.85. During the second quarter, we completed the October 2025 stock repurchase program. As of the end of the second quarter of 2026, We had approximately $598 million remaining under the $750 million stock repurchase plan authorized by the company's board in May of 2026. And finally, we're updating our full-year 2026 financial guidance. We are lowering and narrowing our total revenues and net product revenue guidance, which lowers the midpoint by $50 million when compared to our previous guidance. This updated financial guidance reflects modestly slower growth in 2026 due to a more gradual ramp for the net indication than the original projections. Additionally, we are reducing R&D expense guidance, lowering the midpoint of our R&D expense guidance range by $50 million when compared to the previous guidance. Details of our full-year guidance can be found on slide 14 of our earnings presentation. And with that, I'll turn the call over to PJ.

Thank you, Chris. Habomedics net product revenue grew 10% year-over-year for Q2 2026 relative to Q2 2025. The revenue growth for the first half of 2026 was modestly slower than we We are pleased that Cabo has achieved second-line plus oral class new patient market share greater than 45%, and we believe this is a leading indicator for future growth of the net business. The RCC business continues to grow as we have a strong promotional focus on our first-line 90-hour data, where we maintain a high market share as the number one TKI plus IO combination in addition to being the number one prescribed TKI in renal cell carcinoma. Prescription data in the oral TKI market basket of CABO, lunvatinib, exitinib, sunitinib, and pazopinib convey the strength of CABO relative to the competition. Looking at the TRX comparison, Q2 2025, to Q2 2026, Calvomatics grew two share points from 45% to 47%. Additionally, Calvomatics TRX volume grew 12% in Q2 2026 compared to Q2 2025, outpacing the growth rate of the market basket, which was 6% for the same period. Calvomatics was approved for NET about a year ago, and we have many learnings regarding this unique tumor type. Net is heterogeneous and generally more indolent than many more aggressive solid tumor malignancies. As we have been in the market speaking with physicians and conducting advisory boards, we have learned that this may lead to differences in management of these patients. Sometimes net patients are scanned less frequently than a standard three-month interval, and often a patient's disease may be relatively slow to grow. Furthermore, the initiation of subsequent therapies of a current treatment or sometimes a treatment break. Hence, the patient kinetics of NET in the Second Line Plus setting can be more gradual than other solid tumors. That said, we continue to be pleased with the market dynamics as the Cobb-O-Medic Second Line Plus oral new patient market share grew substantially in the second quarter to over 45%, extending the brand's leadership position in the space. We have begun to see the benefit of more patients on therapy as refills are driving more demand, and given the increased new patient market share, we expect refills to continue to increase going forward. Market research indicates that there is opportunity to continue to grow market share, particularly in the community setting. Our expanded GI sales team was in the field, providing greater reach into the community in Q2. and we believe this contributed to an increase in our Second Line Plus net market share. We've also acquired and implemented more granular utilization data that gives us greater resolution on the net business at the prescriber level for certain segments of the market. These data are giving us the ability to optimize our promotional efforts through refined targeting. The data highlight the potential for Cabo growth in net and we remain confident Our new representatives joined us with significant oncology sales experience, particularly in colorectal cancer and GI oncology. The expanded sales team will gain valuable experience selling CAVO before we turn our focus to the potential As we're thinking about building on and expanding our GI franchise, we're thrilled with the results of Stellar 303 and of a DUFA date set for later this year. Pending regulatory approval, we believe that these data would provide Exelixis with a compelling commercial opportunity in one of the big four tumors. Third line plus CRC setting consists of approximately 23,000 patients In the U.S. and represents an overall opportunity of $1.5 billion in terms of contemporary pricing. Our market research and advisory boards demonstrate positive feedback and excitement for the stellar 303 data. Physicians reiterate the significant unmet need for patients in the third-line CRC setting and are excited for the potential to have a regimen that includes an immune checkpoint inhibitor for the broader population of CRC patients. CaboMedic's business remains strong, with growth being driven by both RCC and NET, as our team's sole focus is maximizing the impact of our promotional efforts across all customers and tactics. Cabo remains well-positioned as the number one TKI and TKI plus IO combination in RCC, as well as the number one oral therapy in second line plus net. Looking forward to ZANZA, our internal team is in full launch preparation and the excitement around these efforts is palpable. We look forward to the opportunity to launch the next ExoLixis franchise later in the year to be able to help appropriate patients with colorectal cancer. Beyond Cellular 303, we are enthusiastic about the significant development plan for ZANZA Thanks, PJ.

My update today will be focused mostly on the seven ongoing or imminent pivotal trials for ZANZA, as well as some updates on additional exploratory studies and plans to continue driving the breadth of development of ZANZA, all of which is aligned with our strategy in R&D, which prioritizes developing ZANSA as a multidimensional solid tumor oncology franchise molecule. Starting with our NDA for ZANSA plus the TEZO and colorectal cancer, which is based on the results from the STELLAR-303 trial, this continues to be our top priority as we work toward the PDUFA date in early December. Our team continues to focus on the ongoing review and is fully engaged in launch preparations. and many more. Alongside those activities, we've also been steadily moving forward on our strategy to realize ZANZA's franchise potential by continuing to drive the breadth of development of ZANZA in key tumor landscapes and indications. In the early colorectal space, our team has been highly focused on launching the Stellar 316 trial, which will investigate ZANZA with and without subcutaneous pembro in patients with who, following definitive therapy, have tested positive for molecular residual disease, or MRD, and have no radiographic evidence of disease. The unmet need is high for these patients, and we've gotten a lot of positive feedback on the study from KOLs in the GI oncology community. Activation of the first site in this trial is imminent, with many more lined up behind it, and we anticipate patient screening to begin this month. With Natera as our collaborator, we've been able to select sites based on actual test metrics, prioritizing those with the highest numbers of MRD-positive patients, so we're confident this approach will translate to a steep enrollment curve, especially since there are no other ongoing Phase III trials competing for these patients. In the neuroendocrine situation, Stellar 311 is our global Phase III trial evaluating ZANVA compared to Everolimus. Thank you for joining us. Evaluating the combination of zanzibar plus nivolumab versus sunitinib in patients with locally advanced or metastatic non-clear cell renal cell carcinoma. I'd like to emphasize that the non-clear cell RCC space is underserved, with no positive readouts from a Phase III study specifically focused on these patients, despite them representing approximately 20% of all RCC cases. A handful of Phase II studies, the majority of which are single-arm, non-randomized trials, have shown activity with a range of treatments in the setting, with wide variations in response rates and durations of PFS for sunitinib and other agents that are currently used for these patients. Such variations are to be expected when comparing data across trials, especially when those trials are small and geographically restricted. Given the fact that STELR-304 is the first large randomized controlled Phase III trial for these patients and is also enrolling globally, We expect that, if positive, the trial could establish the first-ever Level 1 evidence for benefit and a new standard of care for these patients. We completed enrollment in Stellar 304 last year, and given current event rates, we continue to expect top-line results from the study in the second half of 2026. If positive, those results could lead to our second NDA filing for ZANSA. Pivoting now to Clear Cell RCC, progress continues with regard to the two pivotal Phase III studies that Merck is running to evaluate zanzalitinib in combination with speldutaban. The LightSpark 033 trial is comparing ZANZA plus BELS versus CABO in the frontline setting for patients who received adjuvant treatment with anti-PD-1 or anti-PD-L1 therapy. And LightSpark 034 is comparing ZANZA plus BELS versus BELS plus placebo in the second-line plus setting after both anti-PD1 or L1 and VEGFR TKI therapies. We're excited to see these phase three studies in Clear Cell RCC moving forward, and we believe there are other important opportunities to explore in this space, pairing ZANSA with other modalities and orthogonal mechanisms in first-line RCC, especially immunotherapies, given the demonstrated clinical differentiation we've observed with ZANSA and its potential to be the TKI of choice for combinations with immunotherapies as well as other mechanisms of action. Our discussions with potential collaborators have been advancing well, and we plan to give further updates on these activities as we get closer to launching the trials. Moving on now to other indications in the GU space, we're excited to advance an expansion cohort in the ongoing stellar 002 study to evaluate ZANSA in patients with metastatic bladder cancer. who have progressed on the combination of n-fortunavidotin, or EV, plus PEMBRO. The rationale for this cohort is based on a significant body of data generated with CAVO showing encouraging activity in bladder cancer. Bladder was not prioritized for pivotal development with CAVO due to the rapidly changing landscape at that time. What's changed since then is the approval of the combination of EV plus PEMBRO in multiple settings including in the front line for patients with metastatic disease. This resulted in an important new standard of care for these patients but very quickly a new unmet need emerged with essentially no established standard of care for patients after they progress on the combination. We're enrolling a cohort in Stellar 002 evaluating Zanza as a single agent in patients who progressed on EV plus Pembroke and we're already seeing encouraging signs of clinical activity. It's early days. But if the data continue to develop in this way, we plan to move quickly toward launching a pivotal study in this indication. Another expansion cohort for ZANZA in the stellar OO2 study is in combination with docetaxel in patients with metastatic castration-resistant prostate cancer, or CRPC, who have measurable disease. The rationale for this cohort is based on data with CAVO, where a small Phase II study showed favorable outcomes when CAVO was combined with docetaxel in patients with metastatic CRPC. We're particularly excited about this cohort because if ZANSA in combination with docetaxel is shown to be safe and active, that could open up a number of opportunities across a range of solid tumors where docetaxel, other chemotherapies, or ABCs carrying cytotoxic payloads remain the standard of care, such as in second-line non-small-cell lung cancer. Sites for this expansion cohort in Stellar 02 are now activated and open for enrollment. Moving on now to Stellar 201. This is our Phase 2 trial evaluating ZANZA in patients with recurrent meningioma who are no longer responsive to or eligible for local therapies. The primary endpoint of this trial is objective response rate with secondary efficacy endpoints including duration of response, progression-free survival, and overall survival. The trial will enroll up to 100 patients, and our enrollment in this trial so far is exceeding our initial projections, which we believe reflects the high level of interest and enthusiasm for the trial among neuro-oncologists. One factor driving excitement for this study is the fact that there are no approved systemic therapies for an infinite geoma that's refractory to local therapies. So this indication represents a very high unmet need in neuro-oncology. Pending favorable results and given the absence of any approved systemic therapies in this setting, the CELLAR-201 trial could be an important opportunity for ZANZA to become the first systemic therapy that could improve outcomes for these patients. Lastly, we've been making steady progress toward initiation of STELLAR-202, our planned Phase II trial in squamous non-small cell lung cancer that will explore the addition of STELLAR-202 in the maintenance phase after induction with PEMBRO plus chemotherapy. The rationale for this trial is partly based on data from the CONTACT-01 trial, where the subgroup of non-small cell lung cancer patients with squamous histology appear to derive substantial benefit from the combination of CABO plus Atenzo compared to chemo. This is an important opportunity given the relatively short PFS in the maintenance setting and the lack of any new approvals in frontline squamous non-small cell lung cancer since Keynote 4 has established the current standard of care with PEMBRO plus chemo. We expect to initiate stellar 202 in the second half of this year. Now shifting to our early clinical pipeline, our four molecules currently in clinical development, namely XL309, XB010, XB628, and XB371 continue to progress. And we are also continuing to move new small molecule NADC programs toward IND filings and development candidate nominations. And I look forward to sharing more details as these programs advance. So with that, I'll turn the call back over to Mike.

All right. Thanks, Dana. To close today's call, I'll start by thanking the entire XOXS team for their great efforts during the first half of the year. 2026 continues to be a potentially transformational year for the company, and everyone at ExoLexis is working together as one team with a single focus to improve outcomes for cancer patients and build value for all our shareholders. Advancing Zanza as our second potential franchise opportunity remains our top priority while we use the revenues from Cabo's growing business to invest in the pipeline while returning value to shareholders through our share repurchase program. I want to thank everyone at ExoLexis for their individual and collective efforts, incredible focus, as we work day in and day out 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 ExoLexis, and we're happy to now open the call for questions.

Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. And if you would like to withdraw your question, simply press the star 1 again. If you are called upon to ask a question and listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your questions. Also, please note to limit yourself with one question to accommodate others. Again, please press star 1 to join the queue. And our first question comes from the line of Paul Choi of Goldman Sachs. Please go ahead.

Hi. Thanks. Good afternoon, and thank you for taking the question. I want to ask on Stellar 304 and timing. Do you think this is something that might be able to make a major medical meeting this year? And just any sort of updated precision on data timing that you could offer would be great. Thank you.

Dana, go ahead, please.

Thanks for the question, Paul. So, you know, as I said in my prior remarks, we are expecting to achieve the And your next question comes from the line of Akash Thuri of Jefferies. Please go ahead.

Hi, this is Anastasia on for Akash. Thanks for taking the question.

So I wanted to ask about your first-line post-adjuvant study.

Specifically, I think you guys have made a comment about maybe like a 15K patient population. I'm wondering if that changes at all based on a wide-spark O2-2 study, the one that had improved DFS. Do you anticipate patients will start switching to an already existing like the Pembroke plus PIC2 alpha and If you do, does that reduce your patient population? How are you doing that data? Thanks.

Yeah, thanks for the question, Anastasia. This is PJ.

You know, I think obviously very early days for the LightSpark 22 combination just getting approved with Bells in the adjuvant setting. You know, I think what we see in the first-line setting in terms of patients overall coming off of previously treated adjuvant therapies in that kind of a 20% to 25% range of pursed-line patients. You know, I wouldn't want to speculate with regards to how much utilization the combination will be used in the adjuvant setting, but I will say historically, you know, that setting is one that's very sensitive to toxicity. This is, you know, I think a reason that Agents with positive studies such as sunitinib really didn't get uptake in that in the past. And I think with the overall survival bar that pembrol monotherapy has set there, it's a very high bar to beat. So I think physicians will think very carefully as to whether or not they want to add toxicity in terms of another agent in the setting.

And your next question comes from the line of and the Chair of William Blair. Please go ahead. Great.

Thanks for taking my question. Sorry about the background noise. I'm just curious about your take on the ongoing Stellar 311 study against the backdrop of the guidance lowering, whether there's a chance that it's cannibalizing Cabo sales and resulting in a more gradual ramp. Thank you.

Yeah.

TJ, please. Yeah, hi, Andy. Thanks for the question. You know, as Dana said, we're really excited, first and foremost, about the stellar 311 study. You know, I've had the opportunity to speak to a lot of KOLs, obviously, in the net space. And I'll just say, you know, they're very excited about that study. As Dana says, it's progressing well. So I think, you know, to your point, anytime you do have a study that is recruiting it, it does draw potential patients from the commercial patient pool, so to speak. It can be a bit exacerbated in a smaller tumor type, for example. You know, so we think that could be having a small impact, but I'd say, you know, certainly what I mentioned in terms of patient kinetics is In terms of just patients, you know, taking a bit more time to go from therapy in subsequent settings is really the driving factor as it is a more indolent tumor type. And fortunately, these patients, many of them may have the luxury of a little more time before going on to that therapy. You know, that said, I think it's really important just to reiterate that I remain really excited about the opportunity in that we're not really changing the outlook at all. As you mentioned, it's just kind of a The ramp is a little more gradual, but we're excited that we achieved A new patient market share over 45% this quarter. And, you know, I think I'm sure you'll recall that we always talked about the TAM in this setting as being about a billion dollars for the oral therapy market in the second line plus setting. So, you know, we're excited about that market share. Eventually those patients, you know, we believe when they do have a therapy selection, it will be CABO in most of those cases. So we're excited about that going forward.

and your next question comes from the line of A'shan Laman of Morgan Stanley. Your line is now open.

Hi Mike and team. Hope everyone's well and thanks for taking my question. Just with the CRC pedophilate coming up later this year, what level language would be the most commercially meaningful and what level limitations, if any, around liver mets, prior therapy or subgroup interpretation do you think could could be real that may constrain uptake. Thanks, Mike.

Yeah, thanks, Sean. Dana, do you want to take that one?

Yeah, sure. So as I mentioned, Sean, earlier, this is an ongoing review. Our team is highly focused and extremely excited, in fact, about what this can mean for the company, especially given the fact that if approved, this would be the first immunotherapy-containing regimen for the vast majority of patients. with this disease, and also it would be the first launch of our next franchise molecule. So it means a lot for patients and for the company. So there's a lot of excitement around this. Beyond that, we really can't comment on an ongoing review, and especially on a label that is really up to discussions with the agency.

Okay.

and your next question comes from the line of Silvan Turcun of Cephasun Bank. Please go ahead.

Hey, this is Josh on for Silvan. Congrats on the update and thanks for taking my question. At the beginning of maybe it was 2025, Exelixis shared their vision for $5 billion in revenue for ZANDA by 2033. Now, I guess a year and a half from that point, can you highlight the progress made towards that goal and if how the makeup of that projection has evolved since then?

Yeah, Josh, thanks for the question.

Yeah, that number was given, I would say, late 24 around our view on what success, aspirational view on what success could look like relative to our second franchise molecule. The fact that we have launched or are about to launch or one is imminent of the seven pivotal trials with the next wave on the way I think speaks to the depth and breadth of the opportunity going forward. Super excited about what's already happening. in the oven, if you will, and then the next wave, as you heard Dana talk about today, potentially involving other GU and GI indications we think is potentially super valuable for patients as well as driving value for shareholders. So, obviously, we have a lot of work to do. We're in the execution business, but we're committed to making this second franchise as valuable for patients and for shareholders as possible.

Great, thank you.

And your next question comes from the line of Kalpit Patel of Wolf Research. Please go ahead.

Yeah, hey, good afternoon, and thanks for taking the question. Just one on the HANDA's tentative approval. You know, we've been feeling questions on that, and my question is if they do get the conversion or they get the full approval, Does that in any sense accelerate the timing of the generic developers, the agreements that you have in place before the 2031 timelines? Thank you.

Yeah. Andrew? Yeah. Hey, Kalpit. Thanks for the question. You know, can't really get into the specifics of the agreements that we've had with the other true ANDA generic filers, but I would note that The sort of scenario that you're describing isn't particularly common in these sorts of agreements, and so I wouldn't think it's something to expect.

And your next question comes from the line of Yaron Werber of TD Cowen. Please go ahead.

Great. Thanks so much. I have maybe kind of a dual-part question. The first one, meningioma, Stella 201. So it's really encouraging to see how fast it enrolled. And we've seen in these areas that a single arm phase two can lead to approval. How fast do you think you can generate data? Kind of what's the standard of care historically shown? And then secondly, maybe just on HANDA, can you maybe walk us through some of the precedences on whether a new sort of Salt can actually get NCCN guideline placement without generating clinical data. Thank you.

Yeah, Dana, why don't you start, and then we'll do a quick turnover then. Sure. Yeah.

Sure. So, thanks for the question, Jeroen. This is a single-arm, phase 2 study designed to enroll 100 patients with meningioma who have progressed on or are no longer candidates for local therapies. As I mentioned, it's a very high-invent need. There's no standard of care for these patients. And the excitement on the trial is really being driven in part by the emerging data from a small group Thank you very much. designing a confirmatory phase three trial. So, you know, as you're kind of hinting at, this could be a very fast process. But, you know, the details of that really need to evolve over time. So we really can't comment on that at this time.

Good. Thank you. Andrew? Yeah, you were on say, so on the 505B2 dynamics, you know, a couple of things to mention here is, you know, there are pretty big differences between the kind of and a pathway in the 505B2. Things like labeling, therapeutic equivalence, interchangeability, those are all very different for 505B2 products. You correctly pointed out the new 505B2 is a different salt with very different properties around PK and some other things that we outlined in our citizen's petition. And so as NCCN considers all of those dynamics and the real lack of clinical data, it kind of contrasts with other 505 examples like Abraxane that have been successful in their adoption, but that has largely been based on large phase three trials, large randomized phase three trials, established efficacy. I guess kind of the key thing from XLX's perspective is we're focused on two things, patient safety and prioritizing our intellectual property rights, and we're going to continue to focus on those two things. But I think if you think about guideline recommendations, that patient safety dynamic is really important.

And your next question comes from the line of Michael Ashmead of Guggenheim Securities. Please go ahead.

Hi, guys. This is Michelle on for Michael. Thanks for taking my question. I just wanted to ask about Stellar 304. It seems like enrollment ran for about nine to ten months longer than the original protocol suggested, so I was just wondering if you could speak a little to what drove that enrollment delay, and if you think that this extra time and follow-up means that the OS will be more mature at top line than you had originally expected. Thank you.

Sure. Thanks for the question, Michelle. This is Dana. So, you know, you're commenting on and many more. We don't have a perfect crystal ball to understand how these dynamics are really going to play out. We put our best foot forward, but there's always some shift in these timelines, not just in enrollment timelines, but also in how the event rates come in. So as I mentioned in my prepared remarks, we're And actually, I think we mentioned for the first time last quarter at the earnings call that we're expecting the trial to read out in the second half of the year. It's still that now, right? We're still planning for the second half of this year. And again, that's our best estimate based on our event rates that are coming in currently.

Your next question comes from the line of Leonid E. Themeshev of RBC. Please go ahead.

Hey, guys. Josh on for Leo. Thanks for taking my question. So I was wondering how you might be thinking about Zanza playing alongside novel agents in nets like ADCs or some radio pharma programs that are out there.

Thanks. Thanks. PJ, want to take that one?

Yeah. So, I mean, I think as far as... Zanza and NETS, you know, the study is designed, and as Dana mentioned and I kind of reiterated earlier, a lot of excitement around this study is designed to really position Zanza to be potentially the first oral agent in neuroendocrine tumors. and other modalities are there. Obviously, you have the SSAs, you have the radioligand therapies and then kind of the orals. I'd say overall, as you think about the space, those are the three high-level modalities. So given the fact that this is the first study, you know, Phase III randomized study to go – to have the potential to read out positive relative to an approved oral agent. Success in this study with Physician Zanza, you know, I think very well in the neuroendocrine tumor marketplace.

Okay. Once again, if you wish to ask a question, please press star 1 on your telephone keypad. And our next question comes from the line of Jason Gerperi of Bank of America. Please go ahead.

Hey, guys. This is Chi. I'm for Jason. Thanks for taking our question. Question is on NETS. Given your observation on CABO RAM in the NET indication, do you expect to see similar patient inflow kinetic dynamics for SENSOR in NETS, or will you expect a different trajectory for SENSOR if you can secure or have to have data over error alignment in Stella 311? and just quickly, could you provide how much NET contributed to cargo sales this quarter? Thanks so much.

Yeah, thanks for the question, Xi. You know, again, I think when you think about ZANZA and that, some of the things I've already spoken to here that position it really potentially well, obviously given, you know, a positive study, regulatory approval projecting here in the future, the fact that it is head-to-head, as you point out, with Everolimus. So a few things. Patient eligibility in the study, it'll be positioned – really is potentially a first or second line agent. So I think when you think about that, that will change the potential for the kinetics of the patient flow in that setting. So we would expect it to potentially be different. Obviously very hard to project given so many variables before we see the data out in the future. But I think suffice it to say, as I mentioned, the KOLs are very excited about the study. You know, when our top physicians are excited about it, that always gives us excitement. So, you know, really looking forward to the readout of that study.

and your next question comes from the line of Edzer Daroud of Barcliffs. Please go ahead.

Hi, this is Edzer Daroud. Thanks for taking your question. You previously talked about potentially partnering Zanza in the same way that you did Cabo. Are you still looking to pursue that or are you going to try and keep Zanza internal globally?

Yes, Mike, thanks for the question. I think what we said previously is that we're looking at all options there very carefully and very thoughtfully, taking into account all the different Levers, and, if you will, polls and puts that are involved in potentially partnering something, you know, ex-U.S. So, still under evaluation. We have lots of options, lots of interest. Certainly, we expect that to continue to grow as we turn over more cards, hopefully positive in terms of pivotal trials. So, stay tuned.

Your next question comes from the line of Ash Verna of UBS. Please go ahead.

Okay, yeah, thanks for taking my question. Just going back to the SETA 303 study in CRC, what is your best guess in terms of what might have driven this recent update that the non-leverment subgroup did not achieve static OS benefit? Is it possible some subgroup analysis was, like, underpowered, or is it anything to do with that ISO that might see some diminishing efficacy? And have you discussed this with the agency as a part of your ongoing review?

Sure. Thanks for the question, Ash. So, yeah, regarding the non-liver meds primary endpoint, as we announced, I think, in June, that that endpoint essentially did not meet statistical significance, although I'd say that the The treatment effect was very similar to when we announced the interim results of that endpoint last year when we released the data on the ITT population. So basically, over time, we really didn't see the data evolve to a point where it became significant. And as you mentioned, you pointed to one potential factor there, that this is a very small subpopulation of the study. The most important thing to us is that the IDT population is the overall population. The entire population in the study includes both liver mets patients and non-liver mets patients. And those are the data that were the subject of the NDA that we submitted to the regulatory agency.

And your next question comes from the line of Diffel, and William Diffel. Please go ahead.

Yeah, good afternoon. Thanks for taking the questions. So I guess persistency with oral TKIs as maintenance therapy has historically been somewhat challenging across a number of different tuber types for various agents, I think mostly related to reasons that PJ cited when he was talking about adjuvant RCC. So Just curious, what can you do in these stellar 316 and 202 trials just to make sure that persistency doesn't end up confounding data interpretation?

Thank you.

Yeah, so let me start, and Dana or PJ can opine if needed. So I think the key there, and thanks for the question, Steve, is really around picking the right dose. and taking into account the patient population, you know, their kind of general performance status and, you know, what they're progressing from or after their last treatment to be able to maximize, you know, any potential clinical benefit and therapeutic ratio. So we feel like we've got a really good handle on that. Obviously, we have a lot of experience there with CAVO from the standpoint of, you know, picking a lower dose of 90R and really kind of looking at the temporal aspect of clinical benefit as opposed to an early response rate, which then you pay for later with potentially more time. So it's really balancing, you know, activity, short-term activity with long-term duration to be able to give benefit. Obviously, some of the earlier studies, maybe first generation or two of TKIs have some challenges there. You know, we feel really good about that with ZANs relative to the target inhibition profile, the pharmacodynamics, the short half-life. So, with whether it be 316 or 202 or even 201, we feel like we've got pretty good insight to be able to maximize that opportunity.

Thank you. And at this time, There are no further questions, so I will turn the call back over to today's host, Mr. Andrew Peters. Mr. Peters?

Thank you, Kathleen, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were unable to address during today's call. Have a good rest of your day.

Ladies and gentlemen, that concludes today's call. Thank you, everyone, for joining. You may now disconnect.