Q2 2025 Nuvation Bio Inc Earnings Call
Speaker #1: Hell o, and welcome to the Nuvation Bio second quarter 2025 financial results. I'm corporate update call. Today's call is being recorded, and I will play will be available.
Speaker #1: 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 JL DeVitter, executive director of corporate development and investor relations of Nuvation Bio.
Speaker #1: Please go head.
Speaker #2: Thank you. And good ning, everyone. Welcome to the Nuvation Bio second quarter 2025 earnings conference call. Earlier today, we released financial results for the quarter ending June 30th, 2025, and provided a business update.
Speaker #2: The press release is available on 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.
Speaker #2: I'd like to remind you that today's call includes forward-looking statements about Atrozi's launch, our pipeline progress, and our cash runway. Because such statements do a future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: David will provide an overview of the Atrozi commercial launch and additional pipeline updates, and Philippe will discuss our financial and operating updates for the quarter.
Speaker #2: David will then conclude with closing remarks. Now, I'll turn the call over to Dr. David Hung. David, thanks.
Speaker #3: JR, 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 Nuvation Bio, namely as the commercial stage entity.
Speaker #3: Less than two months ago, on June 11th, we achieved our most important company milestone to date, receiving full FDA approval for Atrozi, our xt-generation highly selective ROS1 tyrosine kinase inhibitor, or TKI.
Speaker #3: Per our label, Atrozi is indicated for adults with locally advanced or metastatic ROS1 positive non-small cell lung cancer, or NSCLC, in the line agnostic setting.
Speaker #3: Since then, the Nuvation Bio team has been executing on multiple fronts to ing this therapy to patients in need. Our next key achievement occurred on June 20th, just the week following FDA approval, when the National Comprehensive Cancer Network, or NCCN, added Atrozi as a preferred agent for both first-line and subsequent lines of therapy for ROS1 positive non-small cell lung cancer patients consistent with our line agnostic label.
Speaker #3: The NCCN guidelines also included specific recommendations for Atrozi for patients with brain metastases and resistance mutations. The NCCN guidelines are highly regarded resource, in clinical decision-making, especially in community setting.
Speaker #3: In play a critical role in the development of formulary and treatment pathway decisions. We believe the rapidity with which Atrozi was added as a preferred agent in the NCCN guidelines gives credibility to its differentiated efficacy and safety profile while also highlighting Atrozi as the new and important treatment option for patients with ROS1 positive NSCLC.
Speaker #3: 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 conversations in both the academic and community setting.
Speaker #3: This NCCN endorsement strengthens Atrozi's competitive position, and we believe it has been and will continue to be important in spreading awareness of Atrozi among prescribers and payers.
Speaker #3: 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.
Speaker #3: As of the end of July, we already have confirmed coverage of Atrozi from payers representing 58% of covered lines. In addition, our patient support program, Nuvation Connect, is fully operational, answering questions and helping patients and caregivers navigate reimbursement and access programs.
Speaker #3: It is still early days, but the launch is building promising momentum. By the end of July, we had 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 our growing expected majority though not all Atrozi prescriptions to come from.
Speaker #3: This engagement is critical to our launch as it ensures prescribers understand Atrozi'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.
Speaker #3: Our engagements with key customers are already translating into early adoption of Atrozi. 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.
Speaker #3: In addition, 80% of our top 10 target accounts have prescribed Atrozi. As a result of this positive traction, we are excited to report that 70 patients have started Atrozi 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.
Speaker #3: 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 gate, we are already achieving slightly over two new patients starting on Atrozi per business day.
Speaker #3: And we expect that pace to accelerate. Furthermore, more than 90% of the patients on Atrozi were new patient starts after FDA approval, as only six patients were enrolled in our early access program.
Speaker #3: As we have previously indicated, we consider the number of patients on Atrozi to be the best metric for future success independent of their reimbursement status.
Speaker #3: To put our 70 patients on Atrozi by the end of its first full month of launch into some context, Octaro was also approved mid-month.
Speaker #3: By the end of Octaro's first full month of launch, it was only one patient on drug as reported by Acuvia. By the end of Octaro'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 drug.
Speaker #3: While some of our 70 Atrozi patients were enrolled in our free trial program, this program typically runs for only one month to allow immediate access to Atrozi while access issues like prior authorizations are resolved.
Speaker #3: 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 Atrozi adoption thus far in our launch and we believe that it is a clear reflection of Atrozi's highly differentiated efficacy and safety profile.
Speaker #3: We have previously commented that based on pooled data as published in the Journal of Clinical Oncology, Atrozi'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.
Speaker #3: And with almost five months of additional maturity for the efficacy data set that comprised the Atrozi label, the median DOR metrics for the individual trust one and trust two studies are now no longer reached.
Speaker #3: This durability is a key factor in giving doctors confidence to prescribe Atrozi not only in the first-line setting but across all lines of therapy.
Speaker #3: And given that our pivotal clinical trials for Atrozi were started over five years ago, it will take many years for a ROS1 TKI in development to reach the length of follow-up time used to evaluate Atrozi in linical studies.
Speaker #3: Therefore, we believe that our head start and Atrozi's robust median DOR will give Atrozi an important competitive edge in influencing physicians' use of ROS1 therapy.
Speaker #3: Atrozi'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.
Speaker #3: 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.
Speaker #3: First, the most common lab-based adverse events associated with Atrozi use are increased aspartate amino transferase or AST and increased alanine amino transferase or ALT.
Speaker #3: These laboratory abnormalities are not clinically apparent to patients, as they generally cause no symptoms, even though they do require appropriate monitoring. 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 300 patients with ROS1 positive NSCLC discontinued Atrozi due to these events.
Speaker #3: The most common clinical adverse event associated with Atrozi use is diarrhea. The vast majority of which is grade 1, occurs within about two days of starting therapy, and resolves in about 24 hours.
Speaker #3: We have previously stated that we believe Atrozi's efficacy and safety profile will result in wider adoption and longer use of Atrozi, and therefore create a larger commercial opportunity than has been seen to date for other ROS1 TKIs.
Speaker #3: So far, our early launch results appear to be consistent with our belief that Atrozi will become the treatment of choice for physicians and patients.
Speaker #3: Now, I'd like to provide a bit more detail on the types of patients that have been prescribed Atrozi. It shows the broad potential of our therapy.
Speaker #3: 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.
Speaker #3: We are delighted to see Atrozi being prescribed in the front-line setting. As Atrozi is nearly four-year median DOR, it suggests that it's indication will generate the longest and highest revenue stream.
Speaker #3: In the second-line setting, some patients have started Atrozi following progression on a prior TKI, as we expected. However, of note, a portion of TKI-pretreated patients have switched to Atrozi due to tolerability issues with other prior therapies.
Speaker #3: This indicates to us that both prescribers and patients feel Atrozi can provide not only an efficacious but a more tolerable treatment option as well.
Speaker #3: Additionally, and somewhat unexpectedly, we have also seen some switches from crizotinib to Atrozi that were not due to disease progression or tolerability issues. We believe this may reflect the appreciation by oncologists that crizotinib does not penetrate ROS1 the blood-brain barrier to prevent or treat brain metastases.
Speaker #3: While Atrozi 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 Atrozi's strong CNS activity and the fact that the brain is the primary site for disease progression.
Speaker #3: In summary, we are seeing broad adoption of Atrozi, in both the first and second-line settings, and in the latter, we're seeing switches to Atrozi for disease progression and tolerability issues with other TKIs, and even switches for neither disease progression nor tolerability issues with other TKIs.
Speaker #3: We're gratified that Atrozi has the potential to positively impact the lives of so many different types of patients with ROS1-positive NSCLC this early in our launch.
Speaker #3: We view these positive updates regarding NCCN inclusion, constructive engagement with payers and providers, and, most importantly, various types of new patient starts as encouraging indicators of our progress.
Speaker #3: When combined with Atrozi's balanced and differentiated efficacy and safety profile, these signals give confidence Atrozi can become the standard of care and market leader in ROS1 positive NSCLC.
Speaker #3: Looking ahead, we see considerable opportunities to increase the size of the ROS1 positive NSCLC market. While our team is focused on adoption of Atrozi, 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.
Speaker #3: 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.
Speaker #3: Therefore, given Atrozi's last published median DOR and median progression-free survival or PFS of nearly four years, we would expect the theoretical maximum number of first-line patients treated with Atrozi over this period to equilibrate at roughly 16,000 patients in year four.
Speaker #3: The prolonged durability of Atrozi creates a patient stacking phenomenon that turns a small instance population into a large prevalence population. Thus, generating an expanded market opportunity.
Speaker #3: Again, this example is based on first-line patients only, and does not account for the pretreated population that further increases the addressable population over this illustrative timeframe.
Speaker #3: 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.
Speaker #3: While we are now a commercial stage company, let us not overlook the other exciting programs in development in our pipeline. Staff who sit in this, our mutant IDH1 inhibitor, is being developed for diffuse IDH1 mutant glioma, a devastating brain cancer for which there are very few treatment options available today.
Speaker #3: 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 three to seven years respectively.
Speaker #3: Therefore, the opportunity in IDH mutant glioma is expected to potentially be significantly larger than in ROS1 positive NSCLC. Already a sizable commercial opportunity. The only treatment option available for patients with IDH1 mutant glioma is voricitinib, which was approved by the US FDA in August 2024, and only for low-grade glioma.
Speaker #3: In its pivotal indigo study, voricitinib demonstrated a progression-free survival of PFS of 27.7 months and an overall response rate of ORR of 11%. Docusitinib showed an ORR of 33% in the clinical study of patients with recurrent low-grade IDH1 mutant glioma.
Speaker #3: Furthermore, there are no agents approved in high-grade IDH1 mutant glioma, where docusitinib showed an ORR of 17%, including two complete responses lasting multiple years in a clinical study.
Speaker #3: To our knowledge, no other IDH inhibitors have demonstrated a response of this kind in this indication, and we believe this speaks to the impressive clinical profile of docusitinib.
Speaker #3: We plan to disclose more data evaluating docusitinib in the low-grade population post-surgical resection by year-end. Based on data generated to date, we have modified the ongoing phase two study of docusitinib in the United States to evaluate maintenance treatment with docusitinib against placebo in high-grade IDH1 mutant glioma.
Speaker #3: Please refer to clinicaltrials.gov for additional details on the study design. Finally, we are an active discussion with the FDA regarding the development of docusitinib in IDH1 mutant glioma.
Speaker #3: 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 docusitinib in low-grade IDH1 mutant glioma.
Speaker #3: We look forward to providing updates on our development plan later this year. NUV 1511 is the first clinical candidate of our drug-drug conjugate or DDC platform, and represents a new modality in targeted cancer therapy.
Speaker #3: We plan to provide an update 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 programs successfully to build lasting value and, most importantly, serve patients in need.
Speaker #3: With that, I'll turn it over to Philippe to provide an update on our operations and financials for the quarter. Philippe?
Speaker #4: Thanks, David. And good morning, everyone. For details on quarter 2025 financials, please refer to the press release we issued this morning, which is available on our website.
Speaker #4: 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've generated $4.8 million in total revenue.
Speaker #4: This includes $1.2 million in net product revenue from Atrozi, during the first 13 business days from FDA approval to the end of June. As anticipated, most of these Atrozi net revenues come from channel stocking.
Speaker #4: So we do not expect this to be a ant component of our sales in the future, and currently have more than enough demand to convert supply to new patient starts.
Speaker #4: As a inder, our limited distribution model will limit initial stock buildup and drug in channel, but will also provide better long-term efficiency and access.
Speaker #4: The remaining product revenue comes from new patient starts 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.
Speaker #4: We would expect most patients on these programs to generate full commercial revenue in their second month on Atrozi. The remaining revenue comes from our collaboration and license agreement.
Speaker #4: Including product supply, royalty revenue, and research and development services. While our current royalty revenue comes from our commercialization partner in China, Innovant 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.
Speaker #4: Notably, approval and reimbursement listing in Japan will result in a $25 million milestone payment from Nippon Kayaku to Nuvation 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.
Speaker #4: Given this, we will focus providing quarterly updates on the number of new and continuing patients prescribed Atrozi. 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 rate demonstrated by Atrozi in clinical studies.
Speaker #4: David already mentioned that we have 70 patients on Atrozi 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 investment in our lead asset Atrozi and in our clinical stage pipeline, including docusitinib and NUV 1511.
Speaker #4: As G&A expenses were $38.5 million, primarily driven by our continued commercial buildout. This includes personal-related expenses tied to commercial operations, as well as strategic investments in medical education, payer engagement, patient support programs, and marketing.
Speaker #4: As a reminder, we have right-sized our sales force with 47 oncology accounts managers. We do not expect to increase our sales force or materially increase other parts of our cial team.
Speaker #4: Turning to the balance sheet, we ended the quarter with $67.7 million in cash, cash equivalents, and marketable securities. This figure includes a perceived receipt to date from our cently announced financing agreement with Saga Healthcare Partners, which provides up to $250 million in non-dilutive capital.
Speaker #4: To be precise, shortly after the FDA approval of Atrozi, we received $200 million from Sagard, including $150 million of royalty financing and $50 million under a term loan.
Speaker #4: An additional $50 million under the term loan is available at our tion until June 30th, 2026, and we have stated previously this transaction solidified our capital position.
Speaker #4: We already believe our cash balance prior to this non-dilutive financing with Sagard was sufficient to fund operations for profitability including the US launch of Atrozi and advancement of our pipeline.
Speaker #4: 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 our pipeline, and evaluation of other exciting external opportunities.
Speaker #4: That discipline combined with early Atrozi 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.
Speaker #4: With that, I'll hand it back to David.
Speaker #3: Thanks, Philippe. The early momentum we're seeing with Atrozi including strong uptake constructive payer and provider discussions and enthusiastic physician feedback makes us confident we're on the right trajectory.
Speaker #3: It's still early days, and biotechnologists are always complex, but these first signs reinforce our conviction that Atrozi can potentially become the standard of care for patients with ROS1 positive NSCLC and more broadly, demonstrate how effectively our team can execute.
Speaker #3: 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 Atrozi to market.
Speaker #3: And together, they position Nuvation Bio 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.
Speaker #3: With that, operator, please open the lines for questions.
Speaker #1: Thank ou. If you would like to ask a question, please press star followed by one on your telephone keypad. To remove your question, press star followed by two.
Speaker #1: Again, to ask a question, please press star one. As a reminder, if you are using a speakerphone, please remember to pick up your handset before asking a question.
Speaker #1: And we pause here briefly as questions are registered. We have our first question comes from Calvary Pullman from Clear Street. Please go head.
Speaker #5: Yes. Good morning and congrats on the progress and thanks for ing 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?
Speaker #5: Do you expect the rate of enrollment to remain the same or perhaps increase? And any additional insight into first-line versus second-line use if you can provide any breakdown there?
Speaker #5: And you know what percentage patients had drug switching from Crizotinib in first-line?
Speaker #1: Hi, Calvary. So in answer to
Speaker #6: 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.
Speaker #6: And it's only 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 drug.
Speaker #6: So we we do think that you know that it's a y early and it's hard to really know that all sustained but it it looks to us like there is a slight uptick and we would expect this to accelerate as most launches do.
Speaker #6: So a successful drug. So I think that you know we feel pretty od about where we are. And you ow 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 for what we saw in July.
Speaker #6: On the second side, on the breakdown of the patients, it's still early in our launch that I think it's ing to be difficult for us to comment on that.
Speaker #6: We don't get to see a lot of that information because the vast majority of our patients are actually in special distributors which is blind to us.
Speaker #6: So we actually don't see the characteristics there. And so I for me, the speculate on what they will end up being when the vast majority of that data is blind to us, I think would you know I don't I just don't want to say something that doesn't end up being correct.
Speaker #6: And so I don't think we have enough visibility to make a comment on that.
Speaker #5: Got it. That's fair. And can you tell us about the expected data at the lung cancer conference? And more specifically, what can we expect to see?
Speaker #5: Will it include the updated data cutoff for PFS and duration of response from trust one and two studies? And could this lead to any changes to the label and its use?
Speaker #5: Drug use?
Speaker #6: So at World Lung, we're going to provide an update on the trust one and trust two data that we use for our MDA submission both on the efficacy and safety side.
Speaker #6: But we have not yet decided whether '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 Atrozi following and tracking them.
Speaker #6: And that's important as you know because in tracking this, one of the first gen TKIs that does cross the blood-brain barrier. And so we're going to data on what Atrozi does following patients treated what Atrozi does on in patients following it in tracking the treatment.
Speaker #6: So I think that'll be important.
Speaker #5: Got it. Appreciate . Thank you and congrats again.
Speaker #6: Thank you so much.
Speaker #1: Thank you. We have our next question comes from Sumit Roy from Jones Research. Please go head.
Speaker #7: 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 Atrozi being the preferred NCCN agent?
Speaker #7: And the second is.
Speaker #6: Yes.
Speaker #7: 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?
Speaker #6: 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 and around the country.
Speaker #6: And I would say you know we you know we said in our script that we believe that the rapid inclusion into the NCCN gamma gene literally a week is you know quite unusual.
Speaker #6: And we think it speaks to what an important option this drug is for patients and and how we believe our profile is differentiated. And we've had that echoed by most virtually all the people we spoke to on the road.
Speaker #6: So we've oken 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 etty consistent message where we're eing and it makes us you know feel good because we we believe this drug is differentiated and really important for patients.
Speaker #6: With regard to RNA testing, we do see a lot more people talking moving moving there. I think that there's a recognition that genetic testing is really important because you ow lung cancer only a few decades ago especially when the association with smoking was first discovered was really thought to be a death sentence.
Speaker #6: And suddenly, really in the last in a few decades, lung cancer especially the ones that have genetic mutations like EGFRL retinal ROS1 have suddenly become some of the most treatable cancers on Earth.
Speaker #6: 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 ink it's really becoming a rapidly more appreciated how important that is to find.
Speaker #6: So we are seeing people talking about a switch to RNA you never can predict how fast that'll happen. But we are hearing people recognize that and talk about that.
Speaker #6: And I do anticipate a switch to RNA I just can't predict the time frame.
Speaker #1: Is that something that kind of information you would provide us in like a couple of arters from now as you start seeing RNA versus DNA testing?
Speaker #1: Just curious. You know.
Speaker #6: If we see some more data that you ow that we can speak , I would be delighted to talk about that. I don't know how visible that will be to us because you know we're not we're not the makers of the test and we don't really control that data.
Speaker #6: So you ow if we can we can point out any data that comes that's brought to our attention, we'd be happy to do that.
Speaker #6: I don't know how much control we'll have over that data.
Speaker #1: Totally understandable. One last question on docusitinib. 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?
Speaker #6: So our drug docusitinib is an IDH1 inhibitor. And in IDH1 is 95, plus percent of you know glioma IDH1 mutated glioma. So you ow we're not an IDH2 drug, but as I said, you know very, very vast majority of these tumors are IDH1 mutated.
Speaker #6: So that's what we're going be focused on. You know.
Speaker #1: I was I was meaning like R132HC, is that expanding to the other subtypes, GLS?
Speaker #6: Yeah. We're we're we're targeting all of them.
Speaker #1: Thank you so much and congrats again.
Speaker #6: Thank you.
Speaker #1: Thank you. We have our next question comes from Leonard Timoshiff from LBC Capital Markets. Please go head.
Speaker #8: Hey, guys. It's Anishan 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?
Speaker #8: Just if you could give us the breakdown there. Thanks so much.
Speaker #6: Yeah. So 90% of those were were not EAP patients. As I said, we only had six patients on the EAP program. And I would say the the majority of patients are are paying patients.
Speaker #6: They're the the number of patients on free drug is still relatively small minority. And we and and we've kept those patients on free drug to convert to full commercial drug by the next month.
Speaker #1: Thank you. We have our next question comes from Yoan Werber from Colwin. Please go head.
Speaker #9: Great. Congrats on the and I just started and I don't know if you can ar this fire alarm in the background of this chat.
Speaker #9: A couple I have three questions. Maybe the first one, what percentage of the 70 came or converting from clinical studies and if you can remind us in the end trust program, what how many patients were in the US?
Speaker #9: I I thought you had sort of more than 130 patients in the US, but but it could be wrong. And then in terms of the once your your partner in Japan gets approval for a SUFA, would you record the 25 million as a revenue line or is that below the line in your amortized out payment?
Speaker #9: Thank you.
Speaker #6: Yeah. Okay. You're I'm sorry. I I could not hear the first part of your estion because you repeat that?
Speaker #9: Yeah. Oh, ay. Yeah. The fire alarm stopped. So what what percentage of the 70 patients were clinical study patients? And then how many patients in end trust of in the end trust program came from the US?
Speaker #6: So the number of patients there were zero patients from clinical trials. They were not clinical study patients. None of them.
Speaker #9: Okay. Great. And then and just remind us how many patients did you have in the US in end trust in end trust program?
Speaker #6: 135 from your the Europe North America and 50 from the US.
Speaker #9: All right. So 135 in the US, Europe, were from the US. One would have mentioned those who convert to commercial product, right? You don't guarantee them drug for life under clinical study.
Speaker #9: Is that correct?
Speaker #6: Could you repeat that again? kind of garbled. Sorry.
Speaker #9: Yeah. Sorry. 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?
Speaker #6: Well, we are tracking these you ow DOR of this drug is so long that that it is our to our benefit to continue to track them and and record the duration of response.
Speaker #6: So they'll stay on trial for a long period. I an, the longer the better for us. And we have we have so many patients who still are on drug and haven't progressed.
Speaker #6: So we just it's really in our interest to keep them on trial as long as we can.
Speaker #9: Got it. And just the question in terms of the milestones from the Japanese approval, would you record that as revenues or that's going to obviously hit your boost of cash position that you'll be amortized?
Speaker #9: Thank you.
Speaker #8: Yep. Let me 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 that once in revenue line.
Speaker #9: And that's the second half this year, would you say?
Speaker #8: That would be, yeah, later part of the year like we said in call.
Speaker #9: Okay. Thank you.
Speaker #1: Thank ou. We have our next estion comes from David Lewingardsen from Weber Securities. Please go head.
Speaker #10: Hey, thanks most of my commercial-related questions have been asked. So one on docusitinib. Did you know what did the FDA recommend the the addition of the maintenance evaluation or look to ARM, whatever you want to it, in the study?
Speaker #10: You know and and just wondering on registration designs if you're thinking of you ow typical PFS study or you know some some other metric to measure in that study.
Speaker #10: Thanks.
Speaker #6: Yeah. So we're still in discussions with the FDA. So once we've concluded that, we'll put all of that out on clinical trials.gov. So the FDA did not make that recommendation.
Speaker #6: That was our decision. But you ow.
Speaker #9: Okay.
Speaker #6: When we get more visibility and and and finish those discussions, we'll make that all public on clinicaltrials.gov.
Speaker #9: Okay. Thank you.
Speaker #1: Thank ou. We have our next question from Susan Turkin from Citizens. Please go head.
Speaker #11: Hey, good ning and congrats on the first quarter with the launch here. I'm just a question since the changes to the NCCN guidelines that require switching to a ROS1 agent from you ow upon finding that mutation, and you ow obviously you have small patient numbers here, but have you seen any switching from, for example, pembrol or any other checkpoint inhibitor to frontline Atrozi in any of your patients?
Speaker #11: And then I have a follow-up.
Speaker #6: No. 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 if you look at PFS of IL chemo, we're still talking about a PFS of 6 to 12 months.
Speaker #6: And if you look at you know our duration of response, and you ow 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 ROS1 agent for a ROS1 cancer.
Speaker #6: So you know I think the NCCN guidelines are consistent that. You know IO is now contraindicated in ROS1 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.
Speaker #6: So that's going to make it you know very difficult for anything other than a ROS1 agent to be prescribed for those patients, which is certainly the right thing to do clinically.
Speaker #9: Great. Thank you. And then on SAFO here, you ow obviously FDA discussion is still ahead of you, but maybe big picture, what's your thinking high-grade and low-grade pivotal plans?
Speaker #9: Is there any way you can maybe file with data on hand in the high-grade or a two-pivotal trials or would it be a joint pivotal trial?
Speaker #9: Thank you.
Speaker #6: Yeah. So you ow we've made the point that if you look at low-grade glioma, which is where we're certain of this approved you know their response rate is about 11%.
Speaker #6: 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 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 ally see PFS.
Speaker #6: So we're excited about that. So we think that there are you know potentially advantages of docusitinib over voricitinib in the low-grade setting. In the high-grade setting, there is the response rate of voricitinib is zero.
Speaker #6: And the response rate of docusitinib, as we mentioned, is 17%, but more interestingly, we're seeing in some cases very durable deep response, you know CRs that give out two and three and a half years.
Speaker #6: So with our FDA discussions, we're 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.
Speaker #6: 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 endpoint should be, what our is, and you can also probably have a better estimate of what time frame it would take to get this drug across approval finish line.
Speaker #9: Great. Thank you. And congrats again.
Speaker #6: Thank ou.
Speaker #1: Thank ou. We there are no questions waiting. At this time, and I'll pass the conference back over to David for any further remarks.
Speaker #6: Oh, you know 're very excited about our launch so far. We think it's going extremely well. We are very optimistic about the future feedback we've gotten just been really very encouraging.
Speaker #6: So we'll ep you updated as we get more data in the next quarter. And we're also equally cited about the rest of our pipeline.
Speaker #6: So stay tuned and we'll talk to you in another quarter. Thanks so much for joining.