Nuvation Bio Inc.

Hello and welcome to the New Vision Bios second quarter 2025 financial results and corporate update call. Today's call is being recorded and a replay will be available. All participants are currently in a listen-only mode. A brief question and answer session will follow the prepared remarks. Now, I would like to turn the call over to Gerald DeVito, Executive Director of Corporate Development and Investor Relations at NuvationBio. Please go ahead.

Thank you, and good morning, everyone. Welcome to the NuvationBio second quarter 2025 earnings conference call. Earlier today, we released financial results for the quarter ending June 30, 2025, and provided a business update. The press release is available on the investor section of our website at nuvationbio.com. A recording of this conference call can also be found on the investor section of our website following its completion. I'd like to remind you that today's call includes forward-looking statements about Iptrosi's launch, our pipeline progress, and our cash runway. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the U.S. Securities and Exchange Commission. Joining me on today's call to discuss our quarterly results are our founder, president, and chief executive officer, Dr. David Hung, and our chief financial officer, Philippe Sauvage. David will provide an overview of the Obtruse commercial launch and additional pipeline updates, and Philippe will discuss our financial and operating updates for the quarter. David will then conclude with closing remarks. Now, I'll turn the call over to Dr. David Hung. David?

Thanks, J.R., and good morning, everyone. Thank you for joining us today. I'm excited to share a series of updates that mark an important new era for innovation bio, namely as a commercial stage entity. Less than two months ago, on June 11th, we achieved our most important company milestone to date, receiving full FDA approval for Iptrosi, our next-generation highly selective ROS1 tyrosine kinase inhibitor, or TKI. Per our label, Entrosi is indicated for adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer, or NSCLC, in the line agnostic setting. Since then, the Novation Bio team has been executing on multiple fronts to bring this therapy to patients in need. Our next key achievement occurred on June 20th, just a week following FDA approval, when the National Comprehensive Cancer Network, or NCCN, added in Trosi as a preferred agent for both first-line and subsequent lines of therapy for RAS1-positive non-small cell lung cancer patients, consistent with our line agnostic label. The NCCN guidelines also included specific recommendations where we have chosen for patients with brain metastases and resistance mutations. The NCCN guidelines are a highly regarded resource in clinical decision making, especially in the community setting, and play a critical role in the development of formulary and treatment pathway decisions. We believe the rapidity with which Iptrosi was added as a preferred agent in the NCCN guidelines gives credibility to its differentiated efficacy and safety profile, while also highlighting Iptrosi as the new and important treatment option for patients with ROS1-positive NSCLC. This viewpoint along with an associated urgency to utilize ROS1-targeted agents for these patients instead of immunotherapy and chemotherapy, has been echoed by oncologists in our post-approval marketing conversation in both the academic and community settings. This NCCN endorsement strengthens Iptrosi's competitive position, and we believe it has been and will continue to be important in spreading awareness of Iptrosi among prescribers and payers. On the access front, early dialogue with national and regional plans has been favorable. Major payers were engaged immediately following approval, and the initial coverage landscape is looking strong. As of the end of July, we already have confirmed coverage of Iptrosi from payers representing 58% of covered lives. In addition, our patient support program, Novation Connect, is fully operational, answering questions and helping patients and caregivers navigate reimbursement and access programs. It is still early days, but the launch is building promising momentum. By the end of July, we have engaged with over 90% of our Tier 1 accounts, in over 85% of our Tier 2 accounts across both community and academic centers, which combined are where we expect the majority, though not all, if TROSY prescriptions to come from. This engagement is critical to our launch as it ensures prescribers understand if TROSY's compelling efficacy and safety, convenient once daily dosing, and simple path to patient access through our specialty pharmacy and distribution partners, in addition to our previously mentioned Nuvation Connect patient support program. Our engagements with key customers are already translating into early adoption of Mitrosi. Doctors have written prescriptions in 100% of our six sales regions and 75% of our 47 sales territories, including over 50 different prescribers across community centers, academic centers, and integrated delivery networks. In addition, 80% of our top 10 target accounts have prescribed Iptrosi. As a result of this positive traction, we are excited to report that 70 patients have started Iptrosi as of the end of July, which constitutes roughly seven weeks of commercial effort given our mid-June FDA approval and July being our first full month of commercialization. And given the Juneteenth and July 4th holidays, these first seven weeks of commercial launch constituted only 34 full business days. So out of the gates, we are already achieving slightly over two new patients starting on Eptrosy per business day. And we expect that pace to accelerate. Furthermore, more than 90% of the patients on Eptrosy were new patient starts after FDA approval. as only six patients were enrolled in our early access program. As we have previously indicated, we consider the number of patients on Iptrosi to be the best metric for future success, independent of their reimbursement status. We put our 70 patients on Iptrosi by the end of its first full month of launch into some context. Octiro was also approved mid-month. By the end of Octiro's first full month of launch, there was only one patient on drug as reported by Acuvia. By the end of Octiro's second full month of launch, there were still only 18 patients on drug as reported by Acuvia, which we are well aware does not capture patients on free drug or even all patients on commercial drugs. While some of our 70 Iptrosi patients were enrolled in our free trial program, This program typically runs for only one month to allow immediate access to Iptrosi, or access issues like prior authorizations are resolved. Therefore, most patients on this program would be expected to generate full commercial sales starting in the second month. We are thrilled with the robust rate of Iptrosi adoption thus far in our launch, and we believe that it is a clear reflection of Iptrosi's highly differentiated efficacy and safety profile. We have previously commented that based on pooled data as published in the Journal of Clinical Oncology, Iptrosi's confirmed overall response rate of 89% and median duration of response, or DOR, of nearly four years in the first-line setting have not, to our knowledge, previously been shown by any approved cancer drug in any solid tumor indication. And with almost five months of additional maturity for the efficacy data set that comprise the ATROSI label, the median DOR metrics for the individual TRUST1 and TRUST2 studies are now no longer reached. This durability is a key factor in giving doctors confidence to prescribe ATROSI, not only in the first-line setting, but across all lines of therapy. And given that our pivotal clinical trials for Iptrosi were started over five years ago, it will take many years for a ROS1 TTI in development to reach the length of follow-up time used to evaluate Iptrosi in clinical studies. Therefore, we believe that our Head Start and Iptrosi's robust median DOR will give Iptrosi an important competitive edge in influencing physicians' use of ROS1 therapies. If Trosi's robust efficacy comes with a safety profile that shows it is generally well tolerated, including adverse events that are generally low-grade, transient, and manageable. While we will not walk through all adverse events detailed in our prescribing information today, I'd like to address the two most common safety events. First, The most common lab-based adverse events associated with Iptrosi use are increased aspartate aminotransferase, or AST, and increased alanine aminotransferase, or ALT. These laboratory abnormalities are not clinically apparent to patients, as they generally cause no symptoms, even though they do require appropriate monitoring. And when we look at how often the adverse events of AST and ALT increases, led to treatment discontinuation in our safety database. Only one out of 337 patients with ROS1-positive NSCLC discontinued Ibtrozi due to these events. The most common clinical adverse event associated with Ibtrozi use is diarrhea, the vast majority of which is grade one, occurs within about two days of starting therapy. and resolves in about 24 hours. We have previously stated that we believe Iptrosi's efficacy and safety profile will result in wider adoption and longer use of Iptrosi, and therefore create a larger commercial opportunity than has been seen to date for other ROS1 TKIs. So far, our early launch results appear to be consistent with our belief that Iptrosi will become the treatment of choice for physicians and patients. Now I'd like to provide a bit more detail on the types of patients that have been prescribed Entrosi, which shows the broad potential of our therapy. The makeup of these patients has been quite diverse and includes both TKI-naive and TKI pretreated populations, and patients from both academic and community settings across the country. We are delighted to see Entrosi being prescribed in the frontline setting, as Iptrosi's nearly four-year median VOR suggests that this indication will generate the longest and highest revenue stream. In the second line setting, some patients have started Iptrosi following progression on a prior TKI, as we expected. However, of note, a portion of TKI pretreated patients have switched to Iptrosi due to tolerability issues with other prior Roslin therapies. This indicates to us that both prescribers and patients feel Leptrosy can provide not only an efficacious but a more tolerable treatment option as well. Additionally, and somewhat unexpectedly, we have also seen some switches from Krizotinib to Leptrosy that were not due to disease progression or tolerability issues. We believe this may reflect the appreciation by oncologists that crizotinib does not penetrate the blood-brain barrier to prevent or treat brain metastases, while Trozy has strong CNS activity. In our experience, it is remarkable for oncologists to switch therapies for patients who have not yet progressed. The crizotinib switches that we have already seen are promising, and we believe the right thing to do for patients given that Trozy's strong CNS activity and the fact that the brain is the primary site for disease progression. In summary, we are seeing broad adoption of Abtrose in both the first and second line settings. And in the latter, we're seeing switches to Abtrose for disease progression and tolerability issues with other TKIs, and even switches for neither disease progression nor tolerability issues with other TKIs. We're gratified that it truly has the potential to positively impact the lives of so many different types of patients with ROS1-positive NSTLC this early in our launch. We view these positive updates, NCCN inclusion, constructive engagement with payers and providers, and most importantly, various types of new patient starts as encouraging indicators of how our launch will progress. When combined with Ibtrozi's balanced and differentiated efficacy and safety profile, these signals give us confidence Ibtrozi can become the standard of care and market leader in ROS1-positive NSCLC. Looking ahead, we see considerable opportunities to increase the size of the ROS1-positive NSCLC market. While our team is focused on adoption of Ibtrozi, We are also focused on increasing the awareness of the importance of testing for oncogenic drivers, like ROS1, and ensuring patients are treated with the appropriate targeted therapy. There are approximately 3,000 advanced ROS1-positive NSCLC patients who could be diagnosed in the U.S. every year by DNA-based testing. Looking further ahead, we would expect an eventual shift to RNA-based testing to increase the total addressable patient population to approximately 4,000 new patients per year, as publications have shown that RNA-based testing will detect roughly 30% more ROS1 fusions than DNA testing. Therefore, given Iptrosi's last published median VOR and median progression-free survival or PFS of nearly four years, We would expect the theoretical maximum number of first-line patients treated with Ibtrozi over this period to equilibrate at roughly 16,000 patients in year four. The prolonged durability of Ibtrozi creates a patient stacking phenomenon that turns a small incidence population into a large prevalence population, thus generating an expanded market opportunity. This example is based on first-line patients only and does not account for the pre-treated population that further increases the addressable population over this illustrative timeframe. Our 47 account managers supported by regional medical, access, and commercial specialists remain focused on removing barriers and expanding ATROZI's reach, particularly in the community setting, to maximize the commercial opportunity of ATROZI. While we are now a commercial stage company, let us not overlook the other exciting programs in development in our pipeline. Sacchicidinib, our mutant IDH1 inhibitor, is being developed for diffuse IDH1 mutant glioma. of devastating brain cancer for which there are very few treatment options available today. As a reminder, there are approximately 2,400 new cases of IDH mutant glioma per year, split almost evenly between low-grade and high-grade. While the incidence is smaller than ROS1-positive NSCLC, the market opportunity is materially larger because patients with low-grade and high-grade IDH mutant glioma live approximately 10 to 15 and 3 to 7 years respectively. Therefore, the opportunity in IDH mutant gliomas is expected to potentially be significantly larger than in ROS1-positive NSDLC, already a sizable commercial opportunity. The only treatment option available for patients with IDH1 mutant glioma is voracitinib, which was approved by the US FDA in August 2024. and only for low-grade glioma. In its pivotal indigo study, boracitinib demonstrated a progression-free survival of PFS of 27.7 months and an overall response rate of ORR of 11%. Bacucitinib showed an ORR of 33% in a clinical study of patients with recurrent low-grade IDH1 mutant glioma. Furthermore, There are no agents approved in high-grade IDH1 mucoglioma where sacrosanitinib showed an ORR of 17%, including two complete responses lasting multiple years in a clinical study. To our knowledge, no other IDH inhibitors have demonstrated responses of this kind in this indication, and we believe this speaks to the impressive clinical profile of sacrosanitinib. We plan to disclose more data evaluating sacrosanctinib in the low-grade population post-surgical reception by year-end. Based on data generated to date, we have modified the ongoing Phase II study of sacrosanctinib in the United States to evaluate maintenance treatment with sacrosanctinib against placebo in high-grade IDH1 mutaglioma. Please refer to clinicaltrials.gov for additional details on the study design. Finally, we are in active discussions with the FDA regarding the development of sapucitinib and IDH1 mutant glioma. These discussions cover the expansion of the ongoing study in high-grade glioma with registrational intent and the potential design of a pivotal study of sapucitinib in low-grade IDH1 mutant glioma. We look forward to providing updates on our development plan later this year. NUV1511 is the first clinical candidate of our drug-drug conjugate, or DDC platform, and represents a new modality in targeted cancer therapy. We plan to provide an update from our phase one dose escalation study in difficult-to-treat solid tumors later this year. We remain confident that we have the team, strategy, and mindset to execute our program successfully, build lasting value, and most importantly, serve patients in need. With that, I'll turn it over to Philippe to provide an update on our operations and financials for the quarter.

Philippe? Thanks, David, and good morning, everyone. For detailed second quarter 2025 financials, please refer to the press release we issued this morning, which is available on our website. Now let me bring your attention to a few highlights from the quarter. This is our first quarter reporting as a commercial company, and I'm pleased to inform you that we generated $4.8 million in total revenue. This includes $1.2 million in net product revenue from Iptrosi during the first 13 business days from FDA approval to the end of June. As anticipated, most of this Iptrosi net revenue comes from channel stocking, so we do not expect this to be a significant component of our sales in the future, and currently have more than enough demand to convert supply to new patient stocks. As a reminder, our limited distribution model will limit initial stock buildup and drug in-channel, but will also provide better long-term efficiency and access. The remaining product revenue comes from new patient stocks over this short period, some of which were enrolled in our free trial program, which typically runs for only one month to allow patients to receive needed treatment immediately without waiting for reimbursement approval. We would expect most patients on this program to generate full commercial revenue in their second month on IPTROSY. The remaining revenue comes from our collaboration and license agreements, including product supply, royalty revenue, and research and development services. While our current royalty revenue comes from our own commercialization partner in China, Innoven Biologics, we expect to begin receiving additional royalty revenue from our partner in Japan, Nippon Kayaku, following the anticipated approval of teletractinib in Japan later this year. Notably, approval and reimbursement listing in Japan will result in a $25 million milestone payment from Nippon Kayaku to Innovation Bio. As we mentioned on our last quarterly call, The real metric of success is the number of patients we help with our differentiated therapy. Given this, we will focus on providing quarterly updates on the number of new and continuing patients prescribed Iptrosin. This will offer key insights into how our launch is evolving and show how we can build a sustained revenue stream given the prolonged durability and high response rates demonstrated by Iptrosin clinical studies. David already mentioned that we have 70 patients on Iptrosi at the end of July, which we believe is a very strong commercial start. On the expense side, R&D expenses for the quarter were $27.4 million, as we continued investments in our lead asset Iptrosi in our clinical stage pipeline, including sapucidinib and NUV1511. SG&A expenses were $38.5 million, primarily driven by our continued commercial build-out. This includes personal related expenses tied to commercial operations, as well as strategic investments in medical education, payer engagement, patient support programs, and marketing. As a reminder, we have right sides of Salesforce with 47 oncology accounts managers. We do not expect to increase our Salesforce or materially increase other parts of our commercial team. Turning to the balance sheet, we ended the quarter with $607.7 million in cash, cash equivalents, and marketable securities. This figure includes the proceeds received to date from our recently announced financing agreement with Sagaar Healthcare Partners, which provides up to $250 million in non-dilutive capital. To be precise, shortly after the FDA approval of its RSI, we received $200 million from Sagaar including $150 million of royalty financing and $50 million under a term loan. An additional $50 million under the term loan is available at our auction until June 30th, 2026. As we have stated previously, these transactions solidified our capital position. We already believe our cash balance prior to these non-dilutive financings with Tagarde was sufficient to fund operations for profitability, including the US launch of ETHRO-D and advancement of our pipeline. Now, our ability to reach profitability without additional funding is even more clear. Operationally, we remain an agile organization with the flexibility to redirect resources as insights emerge into commercial launch, development of a pipeline, and evaluation of other exciting external opportunities. That discipline, combined with early, prosy performance and a robust cash balance, positions us extremely well to execute the remainder of our 2025 objectives. We have the right team, structure, resources, and preserved flexibility to continue to grow responsibly. With that, I'll hand it back to David.

Thanks, Philippe. The early momentum we're seeing within Trozy, including strong uptake, constructive payer and provider discussions, and enthusiastic physician feedback, makes us confident we're on the right trajectory. It's still early days, and biotechnologies are always complex, but these first signs reinforce our conviction that if TROSY can potentially become the standard of care for patients with BRAS1-positive NSCLC, and more broadly, demonstrate how effectively our team can execute. At the same time, we're advancing a pipeline designed to tackle some of the toughest challenges in cancer treatment. Each program reflects the same urgency and scientific rigor that brought Iptrosi to market, and together they positioned the vision valve to make a long-term impact. We're energized by the work ahead, and most importantly, by the opportunity to improve the lives of patients in need. With that, operator, please open the lines for questions.

Thank you. If you would like to ask a question, please press star float by 1 on your telephone keypad. To remove your question, press star float by 2. Again, to ask a question, please press star 1. As a reminder, if you are using a speakerphone, please remember to pick up your handset before asking a question. And we will pause here briefly as questions are registered. We have our first question comes from Kaveri Pullman from Clear Street. Please go ahead.

Yes, good morning and congrats on the progress and thanks for taking my question. I was wondering if you can provide any guidance on the next quarter sales or the number of patients on treatment you expect to see. Do you expect the rate of enrollment to remain the same or perhaps increase? Any additional insight into first-line versus second-line use, if you can provide any breakdown there? And, you know, what percentage of patients had drug switching from crizodinib and first-line?

Hi, Kaveri. So, in answer to your first part of your question, the 70 patients that we have on drug at the end of July reflected 34 business days, so about two patients per day. And there's only four business days in August, but so far in those four business days, we've now put about another three patients per day on drugs. So we do think that, you know, it's very early and it's hard to really know that all sustained but it looks to us like there is a slight uptick, and we would expect this to accelerate as most launches do for a successful drug. So I think that we feel pretty good about where we are, and as you know, it still takes a while to get the drug on the formularies of all the aggregators that you want, and so we think that there are a number of events coming up that will further accelerate that curve, but I would say so far, just from the early days of August, we're already seeing an uptake from what we saw in July. On the second side, on the breakdown of the patients, it's so early in our launch that I think it's going to be difficult for us to comment on that. We don't get to see a lot of that information because the vast majority of our patients are actually in specialty distributors, which is blind to us. We actually don't see the characteristics there. And so for me to speculate on what they will end up being when the vast majority of that data is flying to us, I think would, you know, I just don't want to say something that doesn't end up being correct. And so I don't think we have enough visibility to make a comment on that.

Got it. That's fair. And can you tell us about the expected data at the lung cancer conference and ESMO? What can we expect to see? Will it include the updated data cutoff for PFS and duration of response from Trust 1 and 2 studies? And could this lead to any changes to the label and its use, drug use?

At World Lung, we're going to provide an update on the TRUST1 and TRUST2 data that we use for our MDA submission, both on the efficacy and safety side. But we have not yet decided when we're going to do another cut of the data, so I don't know when that will be. At ESMO, we're going to provide additional data on patients treated with Iptrosi following Intractinib, and that's important, as you know, because Intractinib is one of the first-gen TKIs that does cross the blood-brain barrier. And so we're going to show data on what Ibtrozi does following patients treated, what Ibtrozi does in patients following intracranial treatment. So I think that'll be important.

Got it. Appreciate it. Thank you, and congrats again.

Thank you so much.

Thank you. We have our next question comes from Sumit Roy from Jones Research. Please go ahead.

Good morning, everyone, and congratulations on a solid start. Curious, when you're talking to the community center physicians, are you seeing any direct effect by it being the preferred NCCN agent? And the second is, yeah, are you getting any sense on the from the ground, like RNA testing if the academic or community centers are thinking about it? When do you think this could start picking up?

Okay. So on the first question, yes, we've spent a fair amount of time on the road talking to KOLs and also, you know, the management at aggregators around the country. And I would say, you know, we said in our script that we believe that the rapid inclusion into the NCCN guidelines in literally a week is quite unusual, and we think it speaks to what an important option this drug is for patients and how we believe our profile is differentiated. And we've had that echoed by most, virtually all the people we've spoken to on the road. So we've spoken to quite a few thought leaders, quite a few practices, quite a few aggregators, and we're hearing the same thing. So I think that it's a pretty consistent message we're receiving and it makes us feel good because we believe this drug is differentiated and really important for patients. With regard to RNA testing, we do see a lot more people talking about moving there. I think that there's a recognition that genetic testing is really important because lung cancer only a few decades ago, especially when the association with smoking was first discovered, was really thought to be a death sentence. And suddenly, really in a few decades, lung cancer, especially the ones that have genetic mutations like EGFR, ALK, RET, and now ROS1, have suddenly become some of the most treatable cancers on earth. And so it's really important to identify those mutations And if you can identify it with a more sensitive technique like RNA testing versus DNA testing, I think it's really becoming rapidly more appreciated how important that is to find. So we are seeing people talking about a switch to RNA. You never can predict how fast that will happen, but we are hearing people recognize that and talk about that. I do anticipate a switch to RNA. I just can't predict the time frame.

Is that something, that kind of information you would provide us in, like, a couple quarters from now as you start seeing RNA versus DNA testing? Just curious.

You know, if we see some more data that, you know, that we can speak to, I'm delighted to talk about that. I don't know how visible that will be to us because, you know, we're not the makers of the test and we don't really control that data. So, you know, if we can... We can point out any data that's brought to our attention. We'd be happy to do that, but I don't know how much control we'll have over that data.

Totally understandable. One last question on saposidinib. If you can talk us through the decision-making to switch to the maintenance setting, and is the enrollment criteria expanding to all mutations, all types of IDH1 mutations?

So our drug, sacrosanctinib, is an IDH1 inhibitor, and IDH1 is 95-plus percent of, you know, glioma, IDH1-mutated glioma. So we're not an IDH2 drug, but as I said, you know, the very, very vast majority of these tumors are IDH1-mutated. So that's what we're going to be focused on.

No, I was meaning like R132HC, is that expanding to the other subtypes, G, L, S? Yeah, we're targeting all of them. Thank you so much, and congrats again.

Thank you. Thank you. We have our next question, comes from from LBC Capital Markets. Please go ahead.

Hey, guys, it's Anish on for Leo. Congrats on the progress this quarter and for taking our question. Just a quick one from us. Would you tell us how many of the 70 patients are from clinical trials on a free drug program on EAP versus paid drug commercial patients? Just if you could give us the breakdown there. Thanks so much.

Yeah, so 90% of those were not EAP patients. As I said, we only had six patients on the EAP program. And I would say the majority of patients are paying patients. The number of patients on free drug is still a relatively small minority. And we have kept those patients on free drug to convert to full commercial drug by the next month.

Thank you. We have our next question comes from Yaron Wobo from Cohen. Please go ahead.

Great. Congrats from the other side. And I don't know if you can hear the fire alarm in the background. I have three questions. Maybe the first one, what percentage of the 70s became or converting from clinical studies? And if you can remind us in the entrance program, how many patients were in the U.S.? I thought you had sort of more than 130 patients in the US, but it could be wrong. And then in terms of once your partner in Japan gets approval for Sufi, would you record the $25 million as a revenue line, or is that below the line in your amortized dot payment? Thank you.

OK, Yoram, sorry. I could not hear the first part of your question. Could you repeat that?

Yeah, sorry, okay, I didn't follow and stop. So what percentage of the 70 patients were clinical study patients? And then how many patients in the interest of them came from the U.S.?

So the number of patients, there were zero patients from clinical trials. They were not clinical study patients, none of them.

Okay, great. And then just remind us, how many patients did you have in the U.S.

in the insurance program? 135 from Europe, North America, and 50 from the U.S.

All right, so 135 for U.S., Europe, work from the U.S. One would imagine those will convert to commercial product, right? You don't guarantee them drugs for life under clinical study. Is that correct?

Can you repeat that again? You kind of garbled. Sorry.

Yeah, sorry. It's a bad reception. The patients who are in clinical studies, one would imagine they will convert to commercial product, right? Or do they have sort of unrestricted clinical study drug until they get reimbursed?

Well, we are tracking these. The DOR of this drug is so long that it is to our benefit to continue to track them and record the duration of response. So they'll stay on trial for a long period. I mean, the longer, the better for us. And we have so many patients who still are on drug and haven't progressed, so it's really in our interest to keep them on trial as long as we can.

Got it. The question in terms of the milestone for the Japanese approval, would you record that as revenues, or that's going to obviously hit your booster cash position, but it will be amortized?

Thank you. Yep. Let me take that here on. So we will assess if there are remaining performance obligations, but at that stage, we expect it to recognize it once in revenue line.

And that's the second half this year, would you say?

That would be, yeah, later part of the year, like we said in the call.

Okay.

Thank you.

Thank you. We have our next question comes from David Galton from Weber Securities. Please go ahead.

Hey, thanks. Most of my commercial related questions have been asked, so why don't I just have to send them. Did the FDA recommend the addition of the maintenance evaluation or look to arm, whatever you want to call it, in the study? you know, and just wondering on registration designs, if you're thinking of, you know, a typical PFS study or, you know, some other metric to measure in that study. Thanks.

Yeah, so we're still in discussions with the FDA, so once we've concluded that, we'll put all of that out on clinicaltrials.gov and so on. The FDA did not make that recommendation. That was our decision, but When we get more visibility and finish those discussions, we'll make this all public on clinicaltrials.gov.

Okay. Thank you. Thank you. We have our next question from from Citizens. Please go ahead.

Yeah, good morning, and congrats on the first quarter with the launch here. Just a question. Since the changes to the NCCN guidelines that require switching to a ROS1 agent from, you know, upon finding that mutation, and, you know, obviously you have small patient numbers here, but have you seen any switching from, for example, PEMBRO or any other checkpoint inhibitor to frontline if Trosi in any of your patients? And then I will follow up.

I think that's really hard for us to know. I think that, you know, we've spoken previously about the pretty wide recognition that you look at the PFS of biochemo, we're still talking about a PFS of six to 12 months. And if you look at, you know, our duration response and, you know, we're just now approaching four years and still counting, I think it's going to become increasingly more difficult to justify anything other than a Roswin agent for a Roswin cancer. So Yeah, I think the NCCM guidelines are consistent with that. You know, IO is now contraindicated in Roslin lung cancer. And I think that we've already seen in a number of large aggregators, we've seen that contraindication now incorporated into their own internal guidelines. So that's going to make it, you know, very difficult for anything other than Roslin to be prescribed for those patients, which is certainly the right thing to do clinically.

Great, thank you. And then on FAFO here, you know, obviously FDA discussion is still ahead of you, but maybe big picture, what's your thinking about high-grade and low-grade PIVOT plans? Is there any way you can maybe file with data on hand in high-grade or two PIVOT trials, or would it be a joint PIVOT trial? Thank you.

Yeah, so, you know, we've made the point that if you look at low-grade glioma, which is square boros, certain numbers approved, you know, their response rate's about 11%. In our first study with Daiichi, we showed a low-grade response rate of about 33%, but we have a new trial with Daiichi that's going to be presented sometime later this year, and you'll see for the first time not only a response rate, but for the first time you'll actually see PFS. SO WE'RE EXCITED ABOUT THAT. SO WE THINK THAT THERE ARE, YOU KNOW, POTENTIALLY ADVANTAGES OF VOROCITINIB OVER VOROCITINIB IN THE LOW-GRADE SETTING. IN THE HIGH-GRADE SETTING, THERE IS THE RESPONSE RATE OF VOROCITINIB IS ZERO. AND THE RESPONSE RATE OF VOROCITINIB, AS WE MENTIONED, IS 17%. BUT MORE INTERESTINGLY, WE'RE SEEING IN SOME CASES VERY DURABLE DEEP RESPONSE, YOU KNOW, CRS THAT GO OUT TWO AND THREE, THREE AND A HALF YEARS. With our FDA discussions, we're really focused on what we need to do to make these trials registrational. And so that's what our discussions are focused on. And when we conclude those discussions, we're going to put those trial designs you know, make those public on clinicaltrials.gov, and then you'll get an idea of what the end point should be, what our design is, and you can also probably have a better estimate of what timeframe it would take to get this drug across approval finish line. Thank you, and congrats again. Thank you.

Thank you. There are no questions waiting at this time, and I will pass the conference back over to David for any further remarks.

Well, we're very excited about our launch so far. We think it's going extremely well. We are very optimistic about the future. The feedback we've gotten has been really very encouraging. So we'll keep you updated as we get more data in the next quarter. And we're also equally excited about the rest of our pipeline. So stay tuned, and we'll talk to you in another quarter. Thanks so much for joining.

Thank you. That concludes today's call. Thank you for your participation. You may now disconnect your line.