Nuvation Bio Q2 2025 Earnings Report

Nuvation Bio EPS Results

• Actual EPS: -$0.17
• Consensus EPS: -$0.17
• Beat/Miss: Met Expectations
• One Year Ago EPS: N/A

Nuvation Bio Revenue Results

• Actual Revenue: $4.83 million
• Expected Revenue: $0.42 million
• Beat/Miss: Beat by +$4.42 million
• YoY Revenue Growth: N/A

Nuvation Bio Announcement Details

• Quarter: Q2 2025
• Date: 8/7/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, August 7, 2025
• Conference Call Time: 8:00AM ET

Nuvation Bio (NYSE:NUVB), a clinical-stage biopharmaceutical company, focuses on the development of therapeutic candidates for oncology. The company's lead product candidate is NUV-868, a BD2 selective oral small molecule BET inhibitor that epigenetically regulates proteins that control tumor growth and differentiation, including oncogenes comprising c-myc; NUV-1156, an AR binder Xtandi that address advanced stage prostate cancers with the potential to move into earlier lines typically treated with surgical prostatectomy; and drug-drug conjugate (DDC) platform which leverages a novel therapeutic approach within the drug-conjugate class of anti-cancer therapies to deliver anti-cancer therapeutics to cancer cells, as well as NUV-1176, a PARP inhibitor to address ER+ breast and ovarian cancer. The company was founded in 2018 and is headquartered in New York, New York.

Nuvation Bio Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Iptrozy received full FDA approval on June 11 for ROS1-positive NSCLC and was added as a preferred NCCN agent for both first-line and subsequent therapy, bolstering its competitive position.
• Positive Sentiment: Early commercial launch delivered 70 new patients started on Iptrozy within its first full month (34 business days), with over 90% of Tier 1 accounts engaged and coverage confirmed for 58% of covered lives.
• Positive Sentiment: The company reported $4.8 million in Q2 revenue—including $1.2 million in net product revenue from Iptrozy—and ended the quarter with $607.7 million in cash and marketable securities after securing $200 million in non-dilutive financing.
• Positive Sentiment: Sacrocitinib, its IDH1 inhibitor for mutant glioma, showed a 33% overall response rate in low-grade and 17% in high-grade tumors, including two complete responses lasting multiple years.
• Neutral Sentiment: Q2 R&D expenses of $27.4 million and SG&A of $38.5 million reflect continued investment in pipeline advancement and commercial infrastructure, with no planned expansion of the 47-member sales force.

Presentation

[Robert DeVita, Executive Director, Corporate Development & IR at Nuvation Bio]

Innovation Bio's Second Quarter twenty twenty five Earnings Conference Call. Earlier today, we released financial results for the quarter ending 06/30/2025, and provided a business update. The press release is available on the Investors section of our website at nuvationbio.com. A recording of this conference call can also be found on the Investors section of our website following its completion. I'd like to remind you that today's call includes forward looking statements about Atrozy's launch, our pipeline progress and our cash runway.

[Robert DeVita, Executive Director, Corporate Development & IR at Nuvation Bio]

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 ks 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, Doctor.

[Robert DeVita, Executive Director, Corporate Development & IR at Nuvation Bio]

David Hung and our Chief Financial Officer, Philippe Savage. David will provide an overview of the Uptrozi commercial launch and additional pipeline updates, and Philippe will discuss our financial and operating updates for the quarter.

[Robert DeVita, Executive Director, Corporate Development & IR at Nuvation Bio]

David will then conclude with closing remarks. Now I'll turn the call over to Doctor. David Hung. David?

[David Hung, Founder, President & CEO at Nuvation Bio]

Thanks, JR, and good morning, everyone.

[David Hung, Founder, President & CEO at Nuvation Bio]

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 a commercial stage entity. Less than two months ago on June 11, we achieved our most important company milestone to date, receiving full FDA approval for Iptrozy, our next generation highly selective ROS1 tyrosine kinase inhibitor or TKI. Per our label, Iptrozy 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 Nuvation Bio team has been executing on multiple fronts to bring this therapy to patients in need.

[David Hung, Founder, President & CEO at Nuvation Bio]

Our next key achievement occurred on June 20, just the week following FDA approval when the National Comprehensive Cancer Network or NCCN added iptrozi 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. The NCCN guidelines also included specific recommendations for Yotrozy 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 Entrozia was added as a preferred agent in the NCCN guidelines gives credibility to its differentiated efficacy and safety profile while also highlighting yptrozy 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 setting.

[David Hung, Founder, President & CEO at Nuvation Bio]

This NCCN endorsement strengthens Atrozy's competitive position We believe it has been and will continue to be important in spreading awareness of the PIPROZI 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 July, we already have confirmed coverage of Eptralia from payers representing 58% of covered lives. In addition, our patient support program NuVation Connect is fully operational answering questions and helping patients and caregivers navigate reimbursement and access programs.

[David Hung, Founder, President & CEO at Nuvation Bio]

It is still early days, but the launch is building promising momentum. By the July, we had engaged with over 90% of our Tier one accounts and over 85% of our Tier two accounts across both community and academic centers, which combined are where we expect the majority, though not all, of Introzy prescriptions to come from. This engagement is critical to our launch as it ensures prescribers understand Iptrozy'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 Victoza. 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.

[David Hung, Founder, President & CEO at Nuvation Bio]

In addition, 80% of our top 10 target accounts have prescribed As a result of this positive traction, we are excited to report that seventy patients have started iptrozi as of the 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 4 holidays, these first seven weeks of commercial launch constituted only thirty four full business days. So out of the gate, we are already achieving slightly over two new patients starting on atrozy per business day, and we expect that pace to accelerate. Furthermore, more than ninety percent of the patients on Eptrozy 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 to be the best metric for future success independent of their reimbursement status.

[David Hung, Founder, President & CEO at Nuvation Bio]

We put our 70 patients on IMPROZI by the end of its first full month of launch into some context. Oktyro was also approved mid month. By the end of Oktyro's first full month of launch, there was only one patient on drug as reported by IQVIA. By the end of Octiral's second full month of launch, there were still only 18 patients on drug as reported by IQVIA, which we are well aware does not capture patients on free drug or even all patients on commercial drug. While some of our 70 patients were enrolled in our free trial program, this program typically runs for only one month to allow immediate access to Uptrozi while access issues like fire authorizations are resolved.

[David Hung, Founder, President & CEO at Nuvation Bio]

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 Vipchozy adoption thus far in our launch. We believe that it is a clear reflection of Iptrozy's highly differentiated efficacy and safety profile. We have previously commented that based on pooled data as published in the Journal of Clinical Oncology, IpTROGI's confirmed overall response rate of eighty nine percent 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 Atrozy label, the median DOR metrics for the individual TRUST one and TRUST two studies are now no longer reached.

[David Hung, Founder, President & CEO at Nuvation Bio]

This durability is a key factor in giving doctors confidence to prescribe Atrozy not only in the first line setting but across all lines of therapy. And given that our pivotal clinical trials for atrozy were started over five years ago, it will take many years for a Rosslyn TKI in development to reach the length of follow-up time used to evaluate the dyptosine clinical study. Therefore, we believe that our head start and dyptosine's robust median DOR will give dyptosine an important competitive edge in influencing physicians use of ROS1 therapy. Iprzy'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.

[David Hung, Founder, President & CEO at Nuvation Bio]

First, the most common lab based adverse events associated with Atrozy 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. 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 three thirty seven patients with Roslin positive NSCLC discontinued iptrozine due to these events. The most common clinical adverse event associated with iptrozine use is diarrhea, the vast majority of which is grade one, occurs within about two days of starting therapy and resolves in about twenty four hours. We have previously stated that we believe efficacy and safety profile will result in wider adoption and longer use of eptrozy and therefore create a larger commercial opportunity than has been seen to date for other loss on TKIs.

[David Hung, Founder, President & CEO at Nuvation Bio]

So far our early loss results appear to be consistent with our belief that eptrozy 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 eptrozy, 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 being prescribed in the frontline setting as Iptrozy's nearly four year median DOR suggests that this indication will generate the longest and highest revenue stream. In the second line setting, some patients have started iptrozi following progression on a prior TKI as we expected.

[David Hung, Founder, President & CEO at Nuvation Bio]

However of note, a portion of TKI pretreated patients have switched to Iptrozy due to tolerability issues with other prior Ryalsartan therapy. This indicates to us that both prescribers and patients feel Iptrozy 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 crizotinib to Entrozi 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 Trozi has strong CNS activity. In our experience, it is remarkable for oncologists to switch therapies for patients who have not yet progressed.

[David Hung, Founder, President & CEO at Nuvation Bio]

The crizotinib switches that we have already seen are promising and we believe the right thing to do for patients given atrozy'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 atrozy in both the first and second line settings. And in the latter, we're seeing switches to Uptrozy 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 Rosslyn positive NSCLC 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.

[David Hung, Founder, President & CEO at Nuvation Bio]

When combined with balanced and differentiated efficacy and safety profile, these signals give us confidence Iptrozy can become the standard of care and market leader in 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 Iptrosy, 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 three thousand advanced Rossmann positive NSCLC patients who could be diagnosed in The U. S.

[David Hung, Founder, President & CEO at Nuvation Bio]

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 four thousand new patients per year as publications have shown that RNA based testing will detect roughly thirty percent more ROS1 fusions than DNA testing. Therefore given Iptrozy'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 iprzy over this period to equilibrate at roughly sixteen thousand patients in year four. The prolonged durability of iprzy creates a patient stacking phenomenon that turns a small incidence population into a large prevalence population, thus generating an expanded market opportunity. 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.

[David Hung, Founder, President & CEO at Nuvation Bio]

Our 47 account managers supported by regional medical access and commercial specialists remain focused on removing barriers and expanding reach, particularly in the community setting to maximize the commercial opportunity of Atrozy. While we are now a commercial stage company, let us not overlook the other exciting programs in development in our pipeline. Saclucidinide, 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. As a reminder, there are approximately two thousand four hundred 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 ten to fifteen and three to seven years respectively.

[David Hung, Founder, President & CEO at Nuvation Bio]

Therefore the opportunity in IDH mutant glioma is expected to potentially be significantly larger than in ROS1 positive NSCLC, already a size four commercial opportunity. The only treatment option available for patients with IDH1 mutant glioma is vorasitinib, which was approved by The US FDA in August 2024 and only for low grade glioma. In its pivotal INDIGO study, vorasitinib demonstrated a progression free survival of PFS of twenty seven point seven months and an overall response rate or ORR of eleven percent. Clasicitinib showed an ORR of thirty three percent in a clinical study of patients with recurrent low grade IDH1 mutant glioma. Furthermore, there are no agents approved in high grade IDH1 mutant glioma where sacrocitinib showed an ORR of seventeen percent including two complete responses lasting multiple years in a clinical study.

[David Hung, Founder, President & CEO at Nuvation Bio]

To our knowledge, no other IDH inhibitors have demonstrated responses of this kind in this indication. We believe this speaks to the impressive clinical profile of sacrocitinib. We plan to disclose more data evaluating sacrositinib 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 sacrosanctib in The United States to evaluate maintenance treatment with sacrosanctib against placebo in high grade IDH1 mesothelioma. Please refer to clinicaltrials.gov for additional details on the study design.

[David Hung, Founder, President & CEO at Nuvation Bio]

Finally, we are in active discussions with the FDA regarding the development of sacrocitinib in 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 sacrocitinib 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 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.

[David Hung, Founder, President & CEO at Nuvation Bio]

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?

[Philippe Sauvage, CFO at Nuvation Bio]

Thanks, David, and good morning, everyone. For detailed second quarter twenty twenty five 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've generated $4,800,000 in total revenue. This includes $1,200,000 in net product revenue from Iprosy during the first thirteen business days from FDA approval to the June.

[Philippe Sauvage, CFO at Nuvation Bio]

As anticipated, most of the ZYPROZIE net revenues come 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 starts. 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 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. We would expect most patients on this program to generate full commercial revenue in their second month on IpTROZI. The remaining revenue comes from our collaboration and license agreement including product supply, royalty revenue and research and development services.

[Philippe Sauvage, CFO at Nuvation Bio]

While our current royalty revenue come from our commercialization partner in China in open biologics, we expect to begin receiving additional royalty revenue from our partner in Japan, Notably, approval and reimbursement listing in Japan will result in a $25,000,000 milestone payment from Nippon Kayakut 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 consuming patients prescribed Ichorodi. 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 YITROZI in clinical studies.

[Philippe Sauvage, CFO at Nuvation Bio]

David already mentioned that we have 70 patients on YITROZI at the July, which we believe is a very strong commercial start. On the expense side, R and D expenses for the quarter were $27,400,000 as we continued investments in our lead asset Uptrosy in our clinical stage pipeline including sapucidinib and NUV1511. SG and A expenses were $38,500,000 primarily driven by our continued commercial build out. This includes personnel 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 rightsized our sales force with 47 oncology account managers.

[Philippe Sauvage, CFO at Nuvation Bio]

We do not expect to increase our sales force or materially increase other parts of our commercial team. Turning to the balance sheet. We ended the quarter with $607,700,000 in cash, cash equivalents and marketable securities. This figure includes the proceeds received today from our recently announced financing agreement with Sagar Healthcare Partners, which provides up to $250,000,000 in non dilutive capital. To be precise, shortly after the FDA approval of Iturdi, we received $200,000,000 from Sagard including $150,000,000 of royalty financing and $50,000,000 under a term loan.

[Philippe Sauvage, CFO at Nuvation Bio]

An additional $50,000,000 under the term loan is available at our option until 06/30/2026. As we have stated previously, this transaction solidified our capital position. We already believe our cash balance prior to these non dilutive financings with Sagard was sufficient to fund operations for profitability including The U. Launch of Ithrozi and advancement of our pipeline. Now our ability to reach profitability without additional funding is even more clear.

[Philippe Sauvage, CFO at Nuvation Bio]

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. That discipline combined with the early Botrosi performance and robust cash balance positions us extremely well to execute the remainder of our twenty twenty five 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.

[David Hung, Founder, President & CEO at Nuvation Bio]

Thanks, Filip. The early momentum we're seeing with Introzy, 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 IpTruzia can potentially become the standard of care for patients with ROS1 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 the PROZIE to market and together they position Innovation Bio to make a long term impact.

[David Hung, Founder, President & CEO at Nuvation Bio]

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.

[Operator]

Thank you. We have our first question comes from Cavalry Pohlman from Clear Street. Please go ahead.

[Kaveri Pohlman, Managing Director, Senior Equity Research Analyst at Clear Street]

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? And any additional insight into first line versus second line use, if you can provide any breakdown there?

[Kaveri Pohlman, Managing Director, Senior Equity Research Analyst at Clear Street]

And what percentage of patients had drug switching from crizotinib in first line?

[David Hung, Founder, President & CEO at Nuvation Bio]

Hi, Kevary. So in answer to your first part of your question, the 70 patients that we have on drug at the July reflected thirty four business days, so about two patients per day. 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. So we do think that it's very early. It's hard to really know if that will sustain, But it looks to us like there is a slight uptick.

[David Hung, Founder, President & CEO at Nuvation Bio]

And you 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 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 uptick from what we saw in July.

[David Hung, Founder, President & CEO at Nuvation Bio]

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. So we actually don't see the characteristics there. And so I for me to speculate on what they will end up being when the vast majority of that data is blind to us, I think would 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.

[Kaveri Pohlman, Managing Director, Senior Equity Research Analyst at Clear Street]

Got it. That's fair. And can you tell us about the expected data at the Lung Cancer Conference in ESMO? What can we expect to see? Will it include the updated data cutoff for PFS and duration of response from TRUST one and two studies?

[Kaveri Pohlman, Managing Director, Senior Equity Research Analyst at Clear Street]

And could this lead to any changes to the label and its use drug use?

[David Hung, Founder, President & CEO at Nuvation Bio]

At World Lung, we're going to provide an update on the TRUST one and TRUST two data that we use for our NDA submission both on the efficacy and safety side. But we have not yet decided that 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 Iptrozy following entrectinib, And that's important, as you know, because entrectinib is one of the first gen TKIs that does cross the blood brain barrier. And so we're going to show data on what ipratrozy does following patients treated what up to us in patients following entrectinib treatment. So I think that will be important.

[Kaveri Pohlman, Managing Director, Senior Equity Research Analyst at Clear Street]

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

[David Hung, Founder, President & CEO at Nuvation Bio]

Thank you so much.

[Operator]

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

[Soumit Roy, MD - Healthcare at Jones Trading]

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 iprulzib being the preferred NCCN agent? And the second is, Are you getting any sense 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?

[David Hung, Founder, President & CEO at Nuvation Bio]

Okay. So on the first question, yes, we've spent a fair amount of time on the road talking to KOLs and also the management at aggregators around the country. And I would say we said in our script that we believe that the rapid inclusion into the NCC and Gala is in literally a week is quite unusual. 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 virtually all the people we've spoken to on the road.

[David Hung, Founder, President & CEO at Nuvation Bio]

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, you know, 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 the last in a few decades, lung cancer, especially the ones that have genetic mutations like EGFR, ALK, RET, now ROS1, have suddenly become some of the most treatable cancers on earth.

[David Hung, Founder, President & CEO at Nuvation Bio]

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 and talk about that. I do anticipate a switch to RNA. I just can't predict the time frame.

[Soumit Roy, MD - Healthcare at Jones Trading]

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

[David Hung, Founder, President & CEO at Nuvation Bio]

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

[Soumit Roy, MD - Healthcare at Jones Trading]

Totally understandable. One last question on tafasitamab. 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?

[David Hung, Founder, President & CEO at Nuvation Bio]

So our drug, sacrocitinib, is an IDH1 inhibitor. And IDH1 is ninety five 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.

[Soumit Roy, MD - Healthcare at Jones Trading]

No. I was meaning like R132HC, is that expanding to the other subtypes, GLS?

[David Hung, Founder, President & CEO at Nuvation Bio]

Yeah. We're targeting all of them.

[Soumit Roy, MD - Healthcare at Jones Trading]

Thank you so much and congrats again.

[David Hung, Founder, President & CEO at Nuvation Bio]

Thank you.

[Operator]

Thank you. We have our next question comes from Leonard Timmashev from RBC Capital Markets. Please go ahead.

[Anish Nikhanj, Senior Associate - Biotechnology Equity Research at RBC Capital Markets]

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.

[David Hung, Founder, President & CEO at Nuvation Bio]

Yes.

[David Hung, Founder, President & CEO at Nuvation Bio]

So ninety percent 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. Number of patients on free drug is still a relatively small minority. We expect those patients on free drug to convert to full commercial drug by the next month.

[Operator]

Thank you. We have our next question comes from Yaron Werber from Cowen. Please go ahead.

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

Great. Congrats on a good start. And I guess you can hear there's a fire alarm in the background at this time. A couple I have three questions. Maybe the first one, what percentage of the 70% gain of converting from clinical studies?

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

And if you can remind us in the Edge Plus program, what how many patients were in The U. S? I thought you had sort of more than 130 patients in The U. S, but I could be wrong. And then in terms of the once your partner in Japan gets approval for Sufe, would you record the $25,000,000 as a revenue line?

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

Or is that below the line in your amortized up payment?

[David Hung, Founder, President & CEO at Nuvation Bio]

Yes.

[David Hung, Founder, President & CEO at Nuvation Bio]

Okay. I'm sorry. I could not hear the first part of your question. Could you repeat that?

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

Yes. Okay. The fire alarm stopped. So what percentage of the 70 patients were clinical study patients? And then how many patients in nTrust in the nTrust program came from The US?

[David Hung, Founder, President & CEO at Nuvation Bio]

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

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

Okay. Great. And then just why there's so many patients that you have in The US in Entrance, in the Entrance program?

[David Hung, Founder, President & CEO at Nuvation Bio]

A 135 from Europe the Europe, North America, and 50 from The US.

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

Alright. So one thirty five with US Europe work from The US. One would imagine those will convert the commercial product. Right? You don't guarantee them drug for life under clinical study. Is that correct?

[David Hung, Founder, President & CEO at Nuvation Bio]

Can you repeat that again? You're kinda garbled. Sorry.

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

Yeah. Sorry. It's a bad reception. The The 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?

[David Hung, Founder, President & CEO at Nuvation Bio]

Well, we we are tracking these you know, 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. They'll stay on trial for a long period. I mean, the longer, the better for us. And we have we have so many patients who still are undrung and haven't progressed, we just it's really in our interest to keep them on trial as long as we can.

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

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, but it'll be amortized? Thank you.

[Philippe Sauvage, CFO at Nuvation Bio]

Yes. Let me take that, Yaron. So we will assess if there are remaining performance obligations, but at that stage we expect it to recognize at once in revenue line.

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

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

[Philippe Sauvage, CFO at Nuvation Bio]

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

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

Okay. Thank you.

[Operator]

Thank you. We have our next question comes from David DeWongarton from Wedbush Securities. Please go ahead.

[David Nierengarten, Managing Director - Equity Research at Wedbush Securities]

Hey, thanks. Most of my commercial related questions have been asked. So one on cefacitinib. Did the FDA recommend the addition of the maintenance evaluation or look to arm, whatever you want to call it, in the study? And just wondering on registration designs, you're thinking of you know, a typical PFS study or, you know, some other metric to measure in that study? Thanks.

[David Hung, Founder, President & CEO at Nuvation Bio]

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. The FDA did not make that recommendation. That was our decision.

[David Hung, Founder, President & CEO at Nuvation Bio]

You know Okay. When we get more visibility and finish those discussions, we'll make that all public on clinicaltrials.gov.

[Operator]

We have our next question from Sylvain Turken from Citizens. Please go ahead.

[Silvan Türkcan, Managing Director at Citizens JMP]

Yes, 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 upon finding that mutation, and obviously, you have small patient numbers here, but have you switching from, for example, pembro or any other checkpoint inhibitor to frontline iptrozi in any of your patients?

[David Nierengarten, Managing Director - Equity Research at Wedbush Securities]

And then I have a follow-up.

[David Hung, Founder, President & CEO at Nuvation Bio]

I think that's really hard for us to know. I think that 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 twelve months. And if you look at our duration response, 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 Rosslyn agent for a Rosslyn Cancer. So I think the NCCN guidelines are consistent with that. Know, IO is now contraindicated in ROS1 lung cancer.

[David Hung, Founder, President & CEO at Nuvation Bio]

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 very difficult for anything other than a Ryalsin agent to be prescribed for those patients, which is simply the right thing to do clinically.

[Silvan Türkcan, Managing Director at Citizens JMP]

Great. Thank you. And then on SAFU here, obviously, FDA discussion is still ahead of you. But maybe big picture, what's your thinking about high grade and low grade pivotal plans? Is there any way you can maybe file with data on hand at the high grade or two pivotal trials?

[Silvan Türkcan, Managing Director at Citizens JMP]

Or would it be a joint pivotal trial? Thank you.

[David Hung, Founder, President & CEO at Nuvation Bio]

Yes. So we've made the point that if you look at low grade glioma, which is where vorasitamab is approved, their response rate's about eleven percent. In our first study with Daiichi, we showed a low grade response rate of about thirty three percent, 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 we'll actually see PFS. So we're excited about that.

[David Hung, Founder, President & CEO at Nuvation Bio]

So we think that there are potentially advantages of sacrocitinib over vorasiden in the low grade setting. In the high grade setting, there is the response rate of vorasidenib is zero. And the response rate of safucitinib, as we mentioned, is seventeen percent. 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. So with our FDA discussions, we're really focused on what we need to do to make these trials registrational.

[David Hung, Founder, President & CEO at Nuvation Bio]

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 endpoint should be, what our design 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.

[Silvan Türkcan, Managing Director at Citizens JMP]

Great. Thank you,

[Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company]

and congrats again.

[David Hung, Founder, President & CEO at Nuvation Bio]

Thank you.

[Operator]

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

[David Hung, Founder, President & CEO at Nuvation Bio]

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.

[David Hung, Founder, President & CEO at Nuvation Bio]

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.

[Operator]

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

Participants

Executives

• Robert DeVita, Executive Director, Corporate Development & IR
• David Hung, Founder, President & CEO
• Philippe Sauvage, CFO

Analysts

• Kaveri Pohlman, Managing Director, Senior Equity Research Analyst at Clear Street
• Soumit Roy, MD - Healthcare at Jones Trading
• Anish Nikhanj, Senior Associate - Biotechnology Equity Research at RBC Capital Markets
• Yaron Werber, MD & Senior Biotechnology Analyst at Cowen and Company
• David Nierengarten, Managing Director - Equity Research at Wedbush Securities
• Silvan Türkcan, Managing Director at Citizens JMP