NUVB

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8 a.m. ET Vice President of Corporate Development and Investor Relations - Robert DeVita Founder, President and Chief Executive Officer - David Hung Chief Commercial Officer - Colleen Sjogren Chief Financial Officer - Philippe Sauvage Operator: Hello, and welcome to Nuvation Bio's Second Quarter 2026 Financial Results and Business Update Call. Today's call is being recorded, and a replay will be available on the company's website. [Operator Instructions] Now I'd like to turn the call over to J R DeVita, Vice President of Corporate Development and Investor Relations at Nuvation Bio. Please go ahead. Robert DeVita: Thank you, and good morning, everyone. Earlier today, we issued a press release summarizing our financial results for the quarter ending June 30, 2026, and provided a business update. The press release is available on the Investors section of our website at nuvationbio.com. Today's call includes forward-looking statements, including statements about the therapeutic and commercial potential of IBTROZI and safusidenib, our development plans for safusidenib and our drug-drug conjugate platform, along with our plans for future updates from these programs, the components of our anticipated product revenue, expected milestone payments 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 quarterly report on Form 10-Q, which we filed with the U.S. Securities and Exchange Commission today. Joining me on today's call are our Founder, President and Chief Executive Officer, Dr. David Hung; our Chief Commercial Officer, Colleen Sjogren; and our Chief Financial Officer, Philippe Sauvage. Now I'll turn the call over to Dr. David Hung. David, please go ahead. David Hung: Thanks, J R. Good morning, everyone, and thank you all for joining us. I'm excited to discuss the continued progress we made across our business in the second quarter. IBTROZI delivered another strong quarter with net revenue growing 25% to $23.2 million, in line with the median estimate from our 10 covering analysts. Approximately 160 new patients started treatment with IBTROZI in the quarter, but importantly, about 85% of these starts were in the first-line setting, our highest percentage since launch only 12 months ago. While we believe that revenue is the metric that best reflects the health and trajectory of the business, we felt it was helpful to again provide new patient starts this quarter to give more color on positively shifting launch dynamics. I'd also like to provide you with 3 specific points of context to further frame our view of the launch today. First, we are executing on our commercial plan well, and we are now the ROS1 TKI market leader in both first-line and overall new patient starts. Second, we are expanding the ROS1 market beyond how it has been viewed historically with the majority of IBTROZI's growth coming from the first-line setting. And third, the promise of IBTROZI's clinical differentiation is being realized in the real world. Now I'll spend some time walking through these points in more detail. We are very encouraged that the number of first-line patients starting IBTROZI continues to robustly grow. In fact, we saw growth in first-line new patient starts of approximately 30% from the prior quarter. The remainder of our new patient starts were within the TKI pretreated population, which we believe is lower than previous quarters because we've now treated so many of these more advanced patients in the 12 months since our FDA approval. We expect the first-line patients to become the main driver of long-term growth due to the much longer duration of treatment in the first-line setting, and we see this dynamic happening in real time. As Colleen will discuss, we are thrilled that IBTROZI is now the #1 choice for newly diagnosed advanced or metastatic ROS1-positive lung cancer patients. The profile of IBTROZI is exceptional. In TKI-naive patients in TRUST-I, IBTROZI demonstrated an objective response rate or ORR of 90% and both a median duration of response or DOR and median progression-free survival or PFS of 50 months, a response and durability profile to our knowledge has not been shown by any approved therapies in and durability profile to our knowledge has not been shown by any approved therapies in any solid tumor oncology indication. When a drug combines this level of efficacy and durability with a generally favorable tolerability profile, there is a potential for patients to remain on treatment for years. As more patients start and stay on IBTROZI, the prevalent patient pool grows, while the population is simultaneously expanded by new incidence patients per year. As the dynamic shifts to more patients staying on drug longer rather than patients coming off of drug more rapidly, we believe IBTROZI's launch begins to look more and more like a chronic disease drug launch than a typical cancer drug launch. Short durations of response are common for many oncology agents measured in months rather than years. This short duration of response does not generally allow these agents to appreciably grow the number of patients treated year-over-year. Celgene's blockbuster Revlimid with a nearly 3-year DOR in multiple myeloma is an example of an oncology agent that was able to grow its treated population year-over-year due to its durability. The clinical data set our expectations high, and we are pleased that commercially, we are meeting them. Adverse event-driven discontinuations remain low, while discontinuations that we do observe continue to be concentrated in later-line patients with greater disease burden and exposure to multiple prior therapies. The increasing proportion of first-line patients gives us significant confidence in the long-term trajectory of IBTROZI. Feedback from both our field organization and leading thoracic oncologists has remained positive and highly consistent. At the American Society of Clinical Oncology or ASCO Annual Meeting, reception from the medical community exceeded our expectations. There is genuine conviction in IBTROZI's clinical profile, recognition of the impact we are having on patients and a growing appreciation that the durability data we are generating puts IBTROZI in a category of its own in ROS1. Many oncologists drew a parallel between IBTROZI's more than 4-year DOR to lorlatinib's recent and impressive long-term CROWN data and how it has changed the treatment paradigm in ALK-positive lung cancer. We believe the growing maturity of the IBTROZI data is having a similar effect on physician prescribing decisions in ROS1-positive disease. Also at ASCO, we presented new patient-reported outcomes from the TRUST-II study that further characterized what patients experience while receiving IBTROZI. At the first assessment, 88% of patients reported improved or stable global health and quality of life scores. And importantly, cognitive function improved or remained stable over the course of treatment. It is notable that IBTROZI is the only brain-penetrant ROS1 TKI today that carries no warning for CNS adverse reactions, a direct result of the outstanding clinical safety data set. This stands in contrast to the 3 other brain-penetrant ROS1 TKIs on the market, including last month's newly approved ROS1 TKI, where CNS warnings are part of all of their labels. Importantly, CNS adverse events, which may include cognitive impairment, directly affect how people living with the disease think, communicate and function in their daily lives. And for someone who would hope to be on therapy for years, that is not a small thing. The commercial trends, physician feedback, quality of life findings and longer-term efficacy data taken together continue to reinforce our belief that IBTROZI is becoming the standard of care in advanced ROS1-positive lung cancer. Turning to safusidenib. We are equally excited about the progress we are making toward developing a comprehensive treatment option across the broad spectrum of IDH1-mutant glioma. We recently announced updated long-term results from the Phase II J201 study in 27 patients with chemotherapy and radiotherapy naive Grade 2 IDH1-mutant glioma. With a median follow-up of 39 months, the centrally assessed ORR increased to 52% from 44% at 28 months of median follow-up. Median PFS had not yet been reached and the 36-month PFS rate was 79%. Responses in the study have continued to deepen and no new safety signals were observed with additional follow-up. While we realize the limitations of cross-trial comparisons due to differences in study designs, patient populations, endpoints and sample size, we believe these results can be viewed favorably against the latest update from the INDIGO study of vorasidenib, in which with median follow-up of 42 months, the ORR was 21% and the PFS rate at 36 months was 52%. These updated data continue to reinforce safusidenib's differentiated profile and compelled us to expand our clinical development plan. As we have previously discussed, we think about the IDH1-mutant glioma market in 4 broad segments: Group A, high-grade high-risk disease; Group B, high-grade low-risk disease; Group C, low-grade high-risk disease and Group D, low-grade low-risk disease. This is a helpful slide that shows which subgroups are being addressed by our 4 clinical studies. Our existing Phase III SIGMA study evaluates safusidenib in groups A and C as maintenance therapy for patients with high-risk IDH1-mutant astrocytoma following standard of care. A separate exploratory cohort is evaluating safusidenib in Group B, enrolling patients with Grade 3 oligodendroglioma following surgery and before chemotherapy and radiation. Together, those portions of the program address 3 of the 4 segments of the glioma opportunity. We recently announced 2 additional studies that extend the program into the remaining Group D, the low-grade low-risk disease segment, which will also present an important new treatment sequencing opportunity. The first new Group D study, G307, is a randomized Phase III trial that will evaluate safusidenib in 140 patients with newly diagnosed Grade 2 IDH1-mutant glioma who have not yet received chemotherapy or radiation. The study will be conducted outside the United States in regions where vorasidenib is not yet approved or accessible and its primary endpoint will be PFS. This study also gives us a direct opportunity to evaluate safusidenib in the low-grade, low-risk setting where vorasidenib is FDA approved. And upon completion and assuming the study is successful, we plan to engage with FDA to discuss the potential for an NDA submission on the basis of these results. The second new Group D study, G209, is a Phase II trial that will enroll up to 40 patients in the United States with Grade 2 or Grade 3 IDH1-mutant glioma whose disease has progressed following treatment with vorasidenib, but are not in need of immediate treatment with chemotherapy or radiation. The primary endpoint is ORR, and this study will also likely capture patients from Group C and B, given the broad population being treated commercially with vorasidenib. This is an increasingly relevant real-world treatment setting. As more patients receive vorasidenib, physicians and patients will need an effective option when the disease eventually progresses, particularly one that may allow patients to further delay chemotherapy and radiation, which can present significant long-term side effects for these younger patients in the prime of their lives. We believe demonstrating activity following vorasidenib could further strengthen safusidenib's potential across the low-grade glioma market and provide these patients with a critical option. While our 2 Phase III studies, SIGMA and G307 have PFS as their primary endpoint with data expected in 2029, we now also have 2 exploratory studies which use ORR as the primary endpoint, the Grade 3 oligodendroglioma cohort and the G209 study post-vorasidenib. In these studies, we are now also evaluating tumor growth rate or TGR, as a potentially even earlier signal of efficacy. In our safusidenib data, we've observed favorable TGR changes prior to formal RANO responses in all responders. While TGR is not yet a validated regulatory endpoint, it may be an earlier surrogate marker with the potential to identify those patients who are likely to go on to achieve measurable response or clinical benefit. We look forward to generating data that we may be able to share externally. Taken together, SIGMA and the Grade 3 oligodendroglioma exploratory cohort, G307 and G209 allow us to efficiently evaluate safusidenib across all grades and risk groups within the IDH1-mutant glioma landscape in both before and after treatment with vorasidenib. That is what we mean when we say we're pursuing the full glioma opportunity. We also remain on track to provide an update on our drug-drug conjugate or DDC platform by the end of the year. That update will include additional detail on our clinical development plan. Finally, in June, we completed an opportunistic approximately 5x oversubscribed convertible debt financing, which provided both an attractive opportunity to retire higher cost debt and add further strategic flexibility, including for business development. Philippe will discuss the transaction in greater detail. With that, I'll turn the call over to Colleen. Colleen Sjogren: Thank you, David, and hello, everyone. 4 quarters in, and our commercial team continues to raise the bar. Our cumulative new patient starts have significantly outpaced prior ROS1 launches, and we continue to pull ahead of both repotrectinib and entrectinib combined. That is a direct reflection of physician confidence in IBTROZI's clinical profile and the relentless focus of our commercial organization. What I want to highlight today, though, is that the growth we are seeing this quarter goes beyond the numbers. It is the composition of that growth and what it signals about the long-term opportunity that makes me most optimistic about where we are headed. IBTROZI is now the most prescribed ROS1 TKI across all lines of therapy in 2026 based on IQVIA claims data from January to May. And importantly, data show doctors are now choosing IBTROZI for new patients over 50% of the time in the first-line setting. This reflects the medical community's growing confidence in IBTROZI and conviction that its clinical profile, specifically long-term durability and manageable safety makes it the right choice in the first-line TKI-naive setting. That conviction is translating into something more meaningful than just market share, namely market sequencing. The treating community has increasingly designated IBTROZI as the standard of care in the first-line setting with other currently approved therapies viewed as options that follow IBTROZI in the treatment paradigm. And we expect that trend will only continue to build. We believe that IBTROZI's profile in the TKI-naive setting is unmatched, a confirmed 90% overall response rate and a median duration of response of 50 months. Equally important is IBTROZI's differentiated safety profile compared to other CNS-penetrant ROS1 inhibitors, both in adverse events as well as warnings and precautions. As previously mentioned, IBTROZI is today the only brain-penetrant ROS1 TKI to not have CNS warnings and precautions in its label. Durability over time, combined with tolerability is what defines the value of a therapy in oncology, and that is where IBTROZI's data stands out. For a physician making a first-line treatment decision for a newly diagnosed patient, that distinction is not a footnote, it is a defining factor. What makes this even more meaningful is the directional shift we are seeing within our own new patient starts, which totaled approximately 160 for the quarter. Importantly, approximately 85% of these 160 new patient starts were from the first-line setting compared with approximately 30% first-line use in patients starting IBTROZI at launch less than a year ago. In practical terms, the center of gravity of our business is moving toward patients who are beginning their ROS1 journey for the first time. And our first-line new patient starts are at their highest point ever, growing approximately 30% over the prior quarter. Our patient starts in the later line setting are slowing due to IBTROZI's successful capture over the past year of many of the TKI pretreated patients who on earlier generation ROS1 TKIs had either progressed or failed for tolerability. For first-line patients, starting on IBTROZI means the potential for 4-plus years of durable response. That is the long-term value of this clinical profile fully realized, and it is where our commercial team has been deliberately and systematically driving prescriber behavior since day 1. As David mentioned, net revenue grew 25% quarter-over-quarter, and that growth is not concentrated in any one provider segment. It is happening across every practice setting. This reflects the medical community's deep belief in IBTROZI's clinical profile, our ability to remove barriers in treatment decisions, favorable market access positioning and our commitment to getting patients on therapy quickly. Integrated delivery networks, or IDNs, large integrated health systems that span hospitals, outpatient clinics and physician practices have become a meaningful and accelerating contributor to demand. Community demand has notably grown since launch and academic accounts continue to demonstrate strong and expanding adoption of IBTROZI, contributing to 50% of our business. When growth is broad-based across academic, community and IDN settings simultaneously, it reflects institutional confidence in IBTROZI's profile, and that is exactly what we are seeing. One of the most encouraging trends this quarter is that the ROS1 lung cancer market itself is growing. And I want to put that in context for a moment. ROS1 inhibitors have been available for nearly a decade, and we came to market as the fourth option in this class. Based on IQVIA claims, the number of patients receiving any ROS1 TKI in the first-line setting grew almost 20% from our launch through May 2026 compared to the same period a year earlier. In other words, more newly diagnosed ROS1-positive patients are being treated with the TKI today than ever before. While this growth is encouraging, on top of that expanded pool of patients receiving a ROS1 TKI, there are still substantial numbers of ROS1-positive patients receiving chemotherapy and/or immunotherapy in the first-line setting, even though this regimen is no longer recommended by NCCN guidelines. We would expect these patients receiving IO and/or chemo to over time be treated with IBTROZI. Changing this entrenched market behavior takes time, but the trend is moving in the right direction, and we believe IBTROZI is a meaningful driver of this initial shift. That said, we continue to execute focused initiatives to disrupt the habitual tendency towards chemotherapy and IO in the community setting and ensure that every ROS1-positive patient and their physician have the information they need to make a treatment decision that is consistent with current treatment guidelines. We strongly believe every patient with a ROS1 fusion deserves the opportunity to benefit from the prolonged durability and high response rate IBTROZI has demonstrated in the first-line setting. And partnering with the community to make that happen remains one of our most important priorities. Ultimately, everything we do comes back to patients living with and impacted by this disease. When I think about what potentially 4-plus years of response actually means for somebody who has just been told they have ROS1-positive lung cancer, that is what motivates us the most here at Team Nuvation. Our purpose is reflected in every metric we track. This quarter demonstrates continued execution from a team that understands how to win in targeted oncology. First-line market share leadership in new patient starts, demand growing across every setting and a real-world tolerability profile and duration of use that mirrors our clinical data. The foundation we are building cohort by cohort, physician by physician is what we believe will drive the long-term revenue opportunity David described earlier. Now I'd like to turn it over to Philippe. Philippe Sauvage: Thanks, Colleen, and good morning, everyone. For detailed second quarter 2026 financial results, please refer to our earnings press release, which is available on our website. I will highlight a few key points from the quarter. In the second quarter, we generated $31.7 million in total revenue, which was greater than the median estimate of our 10 covering analysts. This included $23.2 million in IBTROZI net U.S. product revenue, which, as David mentioned, was in line with the median estimate of our 10 covering analysts and $8.5 million in collaboration and license revenue. For the first 6 months of 2026, total revenue was $114.9 million, including $41.7 million in IBTROZI net U.S. product revenue. As David and Colleen mentioned, our IBTROZI net revenue grew 25% from the first quarter. This was mainly driven by both growth in first-line new patient starts and an increasing percentage of first-line patients making up our active patients on therapy. We believe these trends will support the long-term potential of IBTROZI because we expect these patients will stay on therapy for years. From the outset, we understood that the pretreated ROS1 population represented a finite opportunity and that later-line patient accrual will naturally diminish over time as we successfully shifted our focus towards the first-line setting. It has happened a bit faster than we expected, which is a testament to the impressive pace of our launch and our successful capture of the TKI pretreated population. Our access strategy continues to be effective with broad coverage to label across Commercial, Medicare and Medicaid plans. Gross to net deductions were stable at around 30% in the second quarter. We expect this to continue to remain generally stable as our payer mix and contracting mature. The remainder of our revenue was generated through collaboration and license agreements. We continue to receive royalty revenue from Innovent Biologics in China and Nippon Kayaku in Japan, and we remain eligible to receive approximately $30 million from Eisai upon the potential approval of IBTROZI in Europe next year. We continue to invest in the business and our programs, resulting in total operating expenses of $73.3 million for the quarter. R&D expenses were $30.7 million for the quarter and $65.7 million for the first 6 months of 2026, primarily reflecting investment in the TRUST and safusidenib clinical development programs, including SIGMA and preparation for the 2 newly announced studies. SG&A expenses were $42.6 million for the quarter and $80.9 million for the first 6 months of 2026, primarily driven by support for the commercialization of IBTROZI. We do not expect changes to our general spending patterns for the remainder of the year. Turning to the balance sheet. We had cash, cash equivalents and marketable securities of $661 million as of June 30. As David mentioned, we recently completed an offering of 0.75% convertible senior notes due 2032, which resulted in total proceeds of approximately $279.1 million, net of fees and related reimbursements. Our cash balance at quarter end includes $242.6 million of these net proceeds as $36.5 million was secured from exercise of the overallotment option, which occurred after quarter close. We were thrilled that the transaction was approximately 5x oversubscribed, and we upsized the original offering amount. This deal was entirely opportunistic as we believed we had sufficient capital to reach profitability prior to the offering. As we approach the June 30 deadline under our term loan agreement with Sagard, we had the option to draw an additional $50 million at a minimum interest rate of 10%. We determined that it made more financial sense to access the convertible market at a 0.75% coupon, elect not to draw the additional $50 million and pay the approximately $58.7 million for the voluntary prepayment of the $50 million already outstanding under the term loan, along with accrued and unpaid interest, fees, costs and expenses. As a result, the transaction materially lowers our cash interest expense, and we expect to pay less interest under the new notes than we would have paid even without drawing the extra $50 million under the Sagard facility. We still retain the synthetic royalty interest financing we closed with Sagard last year. Of course, we are sensitive to the implied dilution for our shareholders, which is why we also entered into capped call transactions designed to reduce potential dilution upon conversion of the notes. The capped call has an initial cap price of $10.458 per share, representing an 80% premium to the closing share price at the time of the offering. After paying the cost associated with the capped call, repaying the term loan and covering transaction expenses, the remaining proceeds further strengthen our balance sheet and provide additional flexibility for general corporate purposes. This transaction does not change our approach to business development. We will remain disciplined and we will pursue only opportunities that we believe can generate compelling returns and meaningfully increase long-term shareholder value. The additional capital simply gives us greater flexibility and the ability to be more competitive if and when we identify the right opportunity. Overall, our capital position enables us to support the continued growth of IBTROZI, execute the expanded global development plan for safusidenib, advance our DDC platform and evaluate additional strategic opportunities from a position of strength. Based on our current operating plan and revenue trajectory, we continue to believe we have sufficient capital to reach profitability and fund the anticipated launch of safusidenib. I'll now turn it back to David for closing remarks. David Hung: Thanks, Philippe. This quarter reinforces what we are building at Nuvation Bio. We believe we have the commercial program with the potential to turn advanced ROS1-positive lung cancer into a disease that patients can live with for years, a second program positioned to address the broad spectrum of IDH1-mutant glioma and the financial strength to advance both opportunities with urgency and discipline. We also continue to work toward enhancing our pipeline further with our DDC platform. I'm proud of the progress our team continues to make and grateful to our employees, investigators, partners and shareholders and the patients and families who place their trust in us. I'll now ask the operator to open the line for questions. Operator: [Operator Instructions] Your first question comes from the line of Farzin Haque with Jefferies. Farzin Haque: Congrats on the progress. Maybe related to IBTROZI, like what is your read on the GSK's Jideytro pricing at roughly 8% higher than IBTROZI? They also have like the CNS AEs and pancreatic tox on the label. That was a bit surprising to us. But the label does not explicitly say that they excluded the concomitant driver mutations. So to what extent do these label differences influence your commercial message? David Hung: So I'll let Philippe answer the question on pricing, but I'll get to the other one. If we look at the label that we saw with zidesamtinib, I think probably the biggest surprise to us was the CNS warnings and precautions. Zidesamtinib since its inception has always been touted as a CNS sparing TKI for ROS1. And I think we were surprised to see that if you look at the label, a 25% incidence of CNS adverse reactions that include dizziness and ataxia, cognitive impairment, psychiatric disorders, seizure. These are things that I don't think we expected. We had not seen that previously. And as I said in the script, that now places zidesamtinib in the same bucket as repotrectinib and entrectinib as the brain-penetrant ROS1 TKIs that all have CNS warnings and precautions, and that makes entrectinib the only ROS1 TKI without CNS warnings and precaution. The other thing that we were, I think, a bit surprised by, if you look at the other adverse events like a 38% rate of edema, 25% rate of peripheral neuropathy, 22% amylase and 25% lipase elevations, which are indicative of pancreatic toxicity, 15% rate of shortness of breath. Not only were we surprised by the magnitude of these findings, but that's after only a very short follow-up period. We're talking about a follow-up period of 1/4 of what we had with IBTROZI. And we know that adverse events are linearly correlated with length of follow-up. So when we look at all these numbers with 1 quarter of our follow-up period, we would expect since they're linear that when these -- when the follow-up reaches the length of IBTROZI's follow-up, we would expect these AEs to potentially quadruple. So I think we were surprised by that. We don't see anything in the label that we find a threat to IBTROZI. If we just look at the efficacy numbers with the caveat of cross-trial comparison, of course. But in the second-line setting, the ORR for zidesamtinib was 49%. In our JCL pool data, it was 56% and maybe the most important, if you look at the intracranial response rate, this is the main way that these patients progress, and that's what limits their survival more than anything. zidesamtinib's intracranial ORR was 48%, ours was 66%. So we just don't see anything in the efficacy side or the safety side that we feel is a threat, and we will maintain -- we believe that we are the best-in-class ROS1. I think that our adoption is consistent with that. We've seen broad enthusiasm for IBTROZI across all segments. As you know, when we started our launch, 75% of our customers were academic, 25% community. Now it's 50-50. So when we have broad support across really all segments, and I think that really speaks to our label. We just don't see anyone on the horizon that we think is going to be a threat to our label and our profile. Philippe, I'll let you answer the pricing question. Philippe Sauvage: Yes, just like you, I guess, my reaction was very much about this is a pricing strategy for later line drug, which kind of makes sense considering we are a first-line drug and they are not. It's a later line approval. We made at the time of the launch, as you remember, a very different strategy of being slightly lower than repotrectinib because we really wanted to have broad access for a line-agnostic therapy. Clearly, GSK went through a different direction with a higher price, which is more aligned with the later line drug strategy. I don't have any more insight than that, but that was the first thing that came to my mind. David Hung: And the other thing, Farzin, which I didn't -- I was talking about second-line characteristics, our first-line data, we don't even know what zidesamtinib's first-line data are because we have a 90% response rate and a 15-month duration of response. There hasn't been any drug ever in oncology that has matched that. So we think the chance of that being matched or better by another drug is probably pretty remote. So we just don't -- and no matter how you look at it, if their follow-up in the second line is a quarter of ours, you can imagine that the amount of time they are behind us in the first line is even well beyond that, years behind where we are. So we don't see competition in the second-line setting. We know that their priority approval was for the third-line setting. We think these patients need a third-line drug. We'd be delighted to see another option for those patients. But in the second-line setting, we still believe that our safety and tolerability as well as efficacy are superior. And we do think in the first-line setting, there's nothing to even begin to compare with our data because there is not. So we feel very confident now that we -- the last card is on the table, I think we feel very confident of our position in ROS1. Operator: Your next question comes from the line of Gregory Renza with Truist Securities. Gregory Renza: Congrats on the quarter and progress. David, maybe just to follow up on the GSK approval and launch. You talked about some of the -- maybe the surprises and just the positioning with IBTROZI now against the latest entrant. I'm just curious with respect to the early approval earlier than the anticipated PDUFA, how has that sort of informed and maybe altered the tactical plan with Colleen and the team, just given it has come to market sooner than expected? And then just secondly, maybe as a follow-up and looking longer term, as you contextualize this market, in that theoretical fashion, the longer-term patient stacking opportunity into the launch. How has the 1 year under our belt really helped to maybe alter or provide some headwinds or tailwinds to some of the patient stacking theoretical data that you've provided to us about the multiyear stacking opportunity IBTROZI? David Hung: Thank you. Let me start, and then I'll turn it to Colleen. So with regard to an earlier approval than the September 18 PDUFA date, I don't think that has any significance for us at all. In fact, frankly, for us, it's always been a little bit of a mystery of what we were competing against, and it was actually helpful for us to see the label early. And as I said, that it surprised us. We did not expect to see a tolerability profile as challenging as we did see in their label. So for us to know that sooner was actually helpful to us. It didn't change at all our tactical strategy on commercial. I'll let Colleen address that. But the most important thing on this call is that we've said all along from day 1, even though we -- of course, the prevalence pool of pretreated patients is larger than the incidence pool. When we started a year ago, there were somewhere between 1,000 and 1,500 prevalence patients. We've now marched through most of those patients, which is why we've actually depleted that pool. And if you look at new patient starts diminishing somewhat because we actually went through that pool a lot faster than we ever thought we would, which is a testament to the strong profile, safety and efficacy of IBTROZI. But we've always said that this is a first-line market. And the fact that we are now 85% of first-line patients, that's we're pretty pleased about that. And I think that we would expect -- I think I said on the last quarter call that this was going to be a biphasic NPS number. You start with a pool, you start treating through it, that number is going to diminish and then you're going to grow the market. Colleen already said, we've already grown the market 20% in the total ROS1 TKI number since our launch, and we would expect a number of drivers to continue to grow that. Number one, when good drugs are available, more people use the markets grow, number one. Number two, we know that testing is going to increase. That's a general thing -- a trend in the entire industry, not just for us, but for all precision oncology. We know that's going to happen. Number three, within the testing, even if you have a positive test, we still know that IO chemo is still being used a lot more than it should be. But remember that the NCCN guidelines that contraindicate IO only came out on January 7 of last year. So that's about 1.5 years ago. So even though IO chemo has been used for years and years in ROS1, it's not the right therapy. NCCN finally came out with the right physician to contraindicated, but physician change in behavior is not immediate. That's happening. That will continue to switch. We will continue to see even with testing what we call effective testing so that we will switch from not just having a ROS1 patient that's diagnosed, but then goes on IO. Now those patients who are diagnosed will get on the appropriate ROS1 TKI, and we don't think there is a ROS1 drug better than IBTROZI in that regard. And then the last point is that as we shift from DNA to RNA testing, we will also see about hopefully a 30% or so increase in the number of diagnoses because RNA is about 30% more sensitive than DNA identifying ROS1 fusion. Colleen, I'll turn it back to you. Colleen Sjogren: Yes. I think that you just asked one of the most important questions in the launch right now and asking about sort of this first-line shift in revenue stacking. I'm actually glad you asked it. So when we look at the earlier line patients and looking at earlier line patients responded at higher rates, they obviously tolerate our therapy better. They're staying on treatment significantly longer. And when we look at IBTROZI specifically, when we talk about demonstrating a median duration of response of 50 months in the TKI-naive patients, and then we compare that to the later-line patients where disease progression, they've been on many prior different therapies and that's really their primary driver of discontinuation. So when we look at each sort of successive cohort of first-line patients and they begin their therapy and they remain on therapy, that's what creates for us this compounding base of active patients. So that's what's building our revenue over time. So when we look at the 25% of sequential growth for the revenue that we've delivered this quarter, while managing the natural transition away from these later-line patients, that's early evidence of the dynamic beginning to play out. So David mentioned this, too, but we really are starting to build a chronic disease model and the shift in patient mix is really the foundation of that. Philippe Sauvage: And Greg, maybe to add one thing to Colleen's point and your question about the timing of launch. What is really important to note, as you noted yourself, is that our late-line patient pool has already been depleted from our perspective. All those patients have been -- have had an opportunity to use IBTROZI prior to the launch of zidesamtinib, which is, again, a testament to the speed and the impact of Colleen's team to really make sure that all those patients could benefit from IBTROZI. As of now, when you look ahead, as we've always said, this is a first-line story. And really, just to remind you again, it doesn't have a first-line indication now. So all these later-line patients have already, from our perspective, had an opportunity to use IBTROZI prior to zidesamtinib launch, which I think is really, really important for us. Operator: Your next question comes from the line of Mayank Mamtani with B. Riley Securities. Mayank Mamtani: Congrats on a strong quarter. I was just curious against the roughly 750 newly diagnosed front-line patients, there's still a lot of capture rate you can grow here, Colleen, and David. I was just curious, any testing initiatives you're involved with directly? And how can we see this penetration kind of move up? I know you talked about some IO plus chemo trend, but just the underlying testing, how that can grow? That was question number one. And I do have a follow-up on the [ SIGMA ] program. David Hung: Mayank, let me start, and I'll turn to Colleen. So when we started off in our launch, we made the comment that if you look at the academic setting, testing rates are nearly 100%, and they are. But if you look at community centers, depending on the community center, while some can have pretty high testing rates in the 80% plus range, there are some that have testing rates of 50% or even lower. So we've actually met with many of the larger community oncology aggregators who have low testing rates and embarked upon projects to point out to them their testing rates. And interestingly, many of them were surprised at their own testing rates, they actually internally had thought they were higher, but they weren't. And by raising that awareness, we were able to, in several centers, more than double their testing rate just so far. And we think that, that's something we're going to continue to do. So we're trying to point that out. The other thing we're trying to point out to these same centers is that some of them have much higher IO chemo use than they would have actually thought. When we talk to the management, they think it's low. We actually look to the data and the electronic medical records, they're actually much higher. Again, a surprise to even their own institution, and we've been pointing that out to them as well, and that's also helped. Colleen? Colleen Sjogren: Yes. So Mayank, thank you for that question because it's really insightful. And it's a real dynamic across targeted therapies in lung cancer. And I want to be very clear, we're not dismissive of it. So despite NCCN and ASCO guidelines specifically recommending against chemo with or without the use of IO and recommending targeted therapies such as IBTROZI for our ROS1-positive patients, it's that habitual prescribing pattern in the community that persists. So you asked about what we're looking to do. So we have several targeted specific initiatives to disrupt this cycle specifically and have direct partnerships with community practices. We have patient identification programs and different tools that are making it easier for physicians to identify and flag these mutations and make sure that the mutational status is flagged before defaulting and making a treatment decision in that first line. So -- and as David mentioned, on the testing side, obviously pushing and advocating for the RNA-based testing. We know in the publications that it shows to have a significantly improved detection rate upwards of 30%. So we -- as I said, insightful question. We see it across lung cancer, but we are addressing it head on, and we believe that we are making extremely good positive progress for these patients. Philippe Sauvage: Mayank, we have one more thing, which Colleen alluded to, if you can hear me, Mayank, which Colleen alluded to, which I think is really important that the point you're making is so important for patients but it goes beyond ROS1, many targeted oncology. There is still a lot of efforts to do. And if you were at ASCO, like we were, you saw the big push from our colleagues at Pfizer for -- in [ ALK ] because those problems exist there as well. It's really something that we all have collectively to do for patients in the U.S., make sure everybody important -- understands the importance of testing, being properly tested and identifying those mutations. David Hung: And let me make one other point. I've said that good drugs grow markets. And if you look at IO chemo and the PFS for IO chemo, which is used -- has been used for a decade or forever. The PFS of IO chemo is about a year or less. So if you look at one of the first early ROS1 TKIs entrectinib, well, their PFS is 16 months. One could argue that 16 months is not that different than 12 months. So back then, when that was your option, how compelling it was to necessarily use a ROS1 TKI over IO chemo wasn't the same level. It was just not as compelling an argument. You can make the argument, but it was closer. Now when repotrectinib came out with a 36-month PFS, 34-month duration of response, that significantly changed the bar, and that was really when the NCCN changed their guidelines. It was really based on the repo data. But now with the IBTROZI'S data of 50-month DOR, it's virtually impossible to make that clinical argument. Now you're talking about years of life difference. So the necessity for testing just got greater because you can do more about it. And so this is what I meant when I said good drugs change markets, and that's what we're already seeing now. And we go into these centers, those who used to use repotrectinib, repotrectinib even get to the brain, entrectinib has a pretty short PFS, they get it. And now things are changing. It's not overnight, but this is why when I say good drugs grow markets, they do, and we're already seeing that. Mayank Mamtani: Just very quickly on the [ G209 in glioma ], obviously, a lot of investor interest there and expanded program. Just very curious to hear the post vora cohort you've added? And maybe just talk to a little bit about your expectation on the data there itself and how big the population you intend to have exposure there where maybe engaging with regulators would make sense? David Hung: So if you look at Servier's statements in the last quarter about how many patients were on vora, they said over 5,500 patients were on vora, not clearly, that number is even higher with the latest quarter. And if you look at the initial INDIGO study, 23% of those patients progressed at 1 year. So since vora has now been out for over 1.5 years, we would expect about 1/4 of those patients to be failing or already having failed. So that's -- we're talking about 1,250-plus patients who have probably already failed or failing vora. And so that speaks to 2 things. Number one, it speaks to how large the unmet need is. If you look at the duration of response of vora, even though it is the best thing in glioma currently, the duration of response is not 80% at 3 years like we've seen in our J201 study. So there is a need for a longer, more effective therapy, and that's what we're developing safusidenib. So we do think that it speaks to the importance of the unmet need of this market, but it also speaks to the feasibility of enrolling that study because there are so many patients now who are failing vora. We've said before, if you look at the precedent of other companies in the space, Chimerix got approved on a 22% response rate in 50 patients. So that would basically be 11 patients out of 50 to get a response. So I don't know if that's the number. Ojemda did it in 77 patients, but somewhere between, let's say, 50 and 80 patients. 20% of that is somewhere between maybe 10 to 15 patients. That's what we're looking for, for a response rate that we think could allow us to take a package to FDA to start discussing what the regulatory approval strategy could be. We think that's not only exciting, but not that far away. And on top of that, we made -- I made a comment in the script about this new endpoint, tumor growth rate. So before tumors can shrink, it's got to slow down. It doesn't just go from growing to shrinking. It plateaus and then -- so the slope is positive, then it becomes more neutral and then it goes -- becomes negative, right? So by definition, you have to go to a -- you have to change your tumor growth rate before you can get a response. And in all of our responders in the safu study, we saw a shift in the slope of TGR. So we can tell when patients are slowing down and when -- and we believe that depending on the rate of slowing and the magnitude slowing, we can predict [ because ] likely want to have a response. So that's potentially even earlier readout than ORR in seeing if safu has activity. So we think that's another important point. And in fact, even though it's not currently a regulatory endpoint, in many ways, I think it's legitimate. A tumor that's slowing down and then shrinking it's probably pretty important to a patient. So if it isn't a current regulatory endpoint, in our opinion, it should be considered, and that's a discussion we intend to have with FDA. Operator: Your next question comes from the line of Michael Yee with UBS. Matthew Hagood: This is Matt on for Mike. Congrats on a nice quarter. Maybe one more on the IDH1. I just wanted to ask kind of what gives you confidence that the FDA would be amenable to filing in low grade using the OUS data. Do you think you will need to supplement with some U.S. data? Or I guess I'm asking kind of how do you think that's going to play out in that low-grade setting around that placebo-controlled study? David Hung: Well, the most compelling argument is that once they fail vora, there's nothing. So there is no option. I think that there is no evidence that the biology of IDH1-mutant glioma is different across geographies or ethnicities. And once they fail vora, they're in a really, really tough position. So I just -- I find it hard to imagine why anyone wouldn't want to give patients that option. They have nothing left. If you're talking about trying to go for radiation or chemo, which is single-digit response rates. And by the way, that isn't benign. There's only so much radiation you give any brain. At some point, you're killing regular brain in addition to your tumors. You just can't keep doing that. So -- and on top of that, our studies actually do have sites in Western countries. We're not -- there will be areas where we can enroll these patients even in the U.S. or Western countries. And so we are looking at real-world evidence approaches here. So it's not going to just be only in remote countries that don't have applicability to Western patients. Operator: Your next question comes from the line of Yaron Werber with TD Cowen. Yaron Werber: Great. Maybe just a question as a follow-up, David. The study in the vora failures, how fast do you think you can enroll that? And then for FDA for an accelerated approval, should we sort of expect that you need to have a 12-month sort of DOR or is 6 months sort of the bogey? And are we still thinking about the sort of 40 to 50 patients is the right bogey that would be amenable to filing? David Hung: We think that, that 50 to 77 patient number is in the ballpark. We won't know until we've done it because we have to take the data to FDA and they said they want to see it. But if you look at the 2 precedents, they've actually approved 2 drugs based on one on a 50-patient study, one on a 77-patient study. So they've done it before. We think that's a reasonable ballpark. Could it be slightly bigger? I guess it could be. I'm not sure why it would be because there is nothing for these patients. In terms of response rate, as I said, Chimerix was 22%. We think that's -- given the fact there's nothing there in chemo is, what, 8% or less response rate. I think I just think that, that's -- we think it's going to be in that ballpark. So I can't say that we know that to be true. But from our preliminary discussions, I think that's probably clearly in the ballpark. On duration, we think 6-month DOR. So that's what we have so far. Of course, they've said they want to see the data. But from their discussions with the FDA so far, we think in the range of 40 to 50 patients, 6-month DOR, efficacy greater than 20%, we think that is -- that would warrant a really serious discussion on approval. Operator: The next question comes from the line of David Nierengarten with Wedbush Securities. David Nierengarten: Just one on the dynamics of the kind of dispersion amongst prescribers. Just when you are in the field, is there any pushback or accounts that prefer to use other ROS1 agents or have been using other ROS1 agents in the front line? And as a follow-up to that idea, are there -- are you more successful in getting the accounts who have been in second line to move to their front-line setting in new patients? Or are there some remainders who are using other approved agents? Colleen Sjogren: Yes. David, so what I can tell you, let's first look at just go to channels. You asked about traction in the different channels. So we're definitely seeing a broad-based simultaneous growth across all 3 of the settings. And why that matters is when growth is just concentrated, as you know, in one segment, that's where it's kind of fragile and you get concerned. So when it's happening everywhere at once, which is what we're seeing, it's really reflecting genuine real institutional confidence. So the academic accounts, they still represent about 50%, as David said, of our business, and they continue to demonstrate strong adoption across many of the leading cancer centers. So we're seeing that strength continue. And then what's really great is community demand has grown notably since launch. So we're really seeing traction picking up there. When we look at sort of the IDN accounts, they now are also a meaningful and accelerating contributor to our demand. So again, all 3 combined signal such a healthy growth and trajectory for our launch. So -- and we talk about this a lot, but that combination does reflect both the clinical belief in IBTROZI's profile and the work that my team is doing to ensure that these physicians have the access support and all the information they need to prescribe. So when we see sort of that base growing in the way that it is collectively across all 3 channels, it gives us incredible confidence. And to your other question, when you're asking about converting, when we look at that 160 of last quarter and talk about the importance of the composition, 85% of those 160 are now in that first-line TKI-naive setting. So we're seeing success there, too, and our team is doing a great job conveying our message there. Philippe Sauvage: David, just to keep that in mind because it's so important for the confidence in the drug. Quarter-on-quarter for first-line patients, you're talking about 30% growth. So the confidence is broad for the first-line patients, 30% growth quarter-on-quarter on first-line patients. So it's really important to keep in mind. Operator: Your next question comes from the line of Silvan Tuerkcan with Citizens Bank. Joshua Werman: This is Josh on for Silvan. Congrats on the progress here. Yes. I mean, I guess you already touched a little bit on the revenue stacking. But I guess as you look to build on these strong results, do you have any insights you can share on repeat prescriptions and how that sort of is tracking with the impressively low discontinuation rate that you saw in TRUST-I and TRUST-II? And can you also just reiterate the status of the EU application, which I think was validated in March maybe. So is the expectation for a standard review time in the EU and the milestone following thereafter? David Hung: What I can tell you is that we had -- we met with a ton of KOLs at ASCO and like any drug, you don't know until you know. And when KOLs have used IBTROZI, we have found that when they do get another ROS1 patient having used IBTROZI, they're very, very likely to re-prescribe it. In fact, we've seen that a ton. So we've seen such appreciation for the durability in particular as well as tolerability, but most physicians make their treatment decisions based on durability. It's hard to argue for anything else. So when patients have used IBTROZI and find it as tolerable as it is, given the DOR, we see a ton of re-prescriptions for new patients. And I think that's what we're most heartened by. Philippe, do you want to comment on the Eisai? Philippe Sauvage: Yes. We messaged to your point about that prior. We expect first -- an approval in the first half of next year. We said probably late Q1, early Q2 maybe, so first half of next year. And that will trigger, as we said, a $30 million milestone from Eisai. It's the standard review, but everything is progressing very well, and we have no concern for now. Colleen Sjogren: And Josh, just one more addition to that. You talked about discontinuation. So obviously, that obviously is also an indication of repeat prescriptions and refills. So when you look at our adverse event-driven discontinuations, they do remain low, and they remain in line with our clinical trial data. So the direction of this dynamic is exactly where we want it to be. And so I think that, that just speaks to, again, the persistence of the patients staying on therapy. Operator: Your next question comes from the line of Boris Peaker with Jones Research. Boris Peaker: Great. Let me add my congratulations on the progress. Just a question on ROS1 testing. So you've mentioned that community settings, some are not aggressive at testing. I'm just curious, is it just lack of awareness? Or are there maybe some other incentives is why they don't bother with testing? Are there any logistics hurdles or reimbursement pushbacks that they're dealing with? Curious what you observed there. David Hung: It's really hard to know. I would say I think a fair amount of it is still just lack of awareness. We don't have complete visibility to all the incentives that drive behavior within any practice. But I think that in 2026, it's hard to argue that any other behavior other than genetic testing for lung cancer is appropriate. This is the most treatable cancer on the planet. If you have a precision oncology mutation, I think that we just need to impress upon people that fact. I think there's still -- especially maybe among older practitioners, only 15 years ago, lung cancer was considered a smoker disease and incurable. And no matter what you did, it was poor prognosis. That's changed in the last 15 years, but not everybody knows that. Colleen Sjogren: Yes. And I would just add to that, Boris. We believe at heart, oncologists have good intent. They have good intent. We talk about this effective testing rate, and that's where we're trying to educate and improve. So it's not only having that test performed, it's advocating for the RNA, which is more sensitive to the ROS1 fusion pickup. But then the effective testing rate goes all the way through the treatment decision. So making sure that, that test is received, it's understood by the care team within that office, and it's acted upon appropriately when these patients have an active mutation. That's really what we're trying to influence the effective testing rate of these patients. Operator: There are no further questions at this time. I will now turn the call back to David Hung, CEO, for the closing remarks. David Hung: Well, thank you all for attending. We're super excited about the quarter. We think things are going extremely well. We are really enthusiastic about what we're seeing in first line, which is the main driver of our model of revenue stacking. And we think that the safu program is really flying now that we are in all these indications. So we're pretty excited about where we are. Our financing puts us in a very strong position. We're going to be talking about DDC shortly. So I think we're firing on all cylinders. I want to thank you all for your support, and we'll see you at the next call. Operator: This concludes today's call. Thank you for attending. You may now disconnect. Before you buy stock in Nuvation Bio, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Nuvation Bio wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Nuvation Bio (NUVB) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Interested in Nuvation Bio Inc.? Here are five stocks we like better. IBTROZI momentum strengthened: Second-quarter revenue reached $31.7 million, including $23.2 million in U.S. product revenue, up 25% sequentially. About 85% of new patient starts were first-line, supporting longer treatment durations and potential future growth. Safusidenib development is expanding: Updated Phase II data in IDH1-mutant glioma showed a 52% objective response rate and a 79% three-year progression-free survival rate. Nuvation is adding Phase III and Phase II studies targeting earlier-stage disease and patients who progress after vorasidenib. Balance sheet strengthened: Nuvation held $661 million in cash and marketable securities at June 30 and raised approximately $279.1 million in net proceeds through convertible notes. Management said its capital should support operations through profitability and the anticipated safusidenib launch. Nuvation Bio (NYSE:NUVB) reported second-quarter total revenue of $31.7 million, including $23.2 million in net U.S. product revenue from IBTROZI, as the company said use of the ROS1-targeted lung cancer therapy continued to shift toward first-line patients. IBTROZI revenue increased 25% from the first quarter, while approximately 160 patients began treatment during the period, Chief Executive Officer David Hung said. About 85% of those new starts were in the first-line setting, compared with roughly 30% at launch less than a year earlier. The company said first-line starts rose about 30% sequentially. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling Hung said Nuvation views revenue as the principal measure of IBTROZI’s commercial performance, but provided patient-start figures to illustrate changing launch dynamics. The company said it has treated many of the available later-line, TKI-pretreated patients since the drug’s approval, while first-line patients are expected to remain on therapy longer. “We expected first-line patients to become the main driver of long-term growth due to the much longer duration of treatment in the first-line setting, and we see this dynamic happening in real time,” Hung said. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Chief Commercial Officer Colleen Sjogren said IQVIA claims data from January through May showed IBTROZI was the most prescribed ROS1 tyrosine kinase inhibitor, or TKI, across all treatment lines in 2026. She added that physicians chose IBTROZI for more than half of newly treated first-line patients during that period. The company cited data from its TRUST-I study in TKI-naive patients, where IBTROZI demonstrated a 90% objective response rate and median duration of response and progression-free survival of 50 months. Hung also pointed to patient-reported outcomes from TRUST-II presented at the American Society of Clinical Oncology meeting, where 88% of patients reported improved or stable global health and quality-of-life scores at the first assessment. → No Hangover: Revisiting Microsoft One Week After Earnings Nuvation said adverse-event-driven discontinuations have remained low, with discontinuations concentrated among later-line patients with more extensive disease and prior treatment exposure. The company also said IBTROZI is the only brain-penetrant ROS1 TKI without central nervous system warnings in its label. During the question-and-answer session, management discussed a newly approved competing ROS1 therapy from GSK, referred to on the call as zidesamtinib. Hung said Nuvation was surprised by CNS warnings and other adverse events included in that therapy’s label, while Chief Financial Officer Philippe Sauvage characterized its pricing as consistent with a later-line treatment strategy. Nuvation said the earlier-than-expected approval of the competing drug did not alter its commercial plan. Sjogren said demand for IBTROZI has grown across academic centers, community practices and integrated delivery networks. Academic accounts represented about 50% of the company’s business, she said. Management said more ROS1-positive lung cancer patients are receiving targeted therapy in the first-line setting, though some patients continue to receive chemotherapy and immunotherapy despite current treatment guidelines. According to Sjogren, the number of patients receiving any ROS1 TKI in the first-line setting increased nearly 20% from IBTROZI’s launch through May 2026 compared with the prior-year period, based on IQVIA claims data. Hung said the company has worked with community oncology organizations to improve testing rates and awareness of treatment patterns. He said some centers were unaware that their genetic testing rates were lower than expected and that Nuvation had helped certain centers more than double their testing rates. The company is also advocating for RNA-based testing, which management said is more sensitive than DNA testing for identifying ROS1 fusions. Nuvation also outlined an expanded clinical development plan for safusidenib, its investigational therapy for IDH1-mutant glioma. The company recently reported updated Phase II J201 results in 27 patients with chemotherapy- and radiotherapy-naive Grade 2 IDH1-mutant glioma. With median follow-up of 39 months, centrally assessed objective response rate rose to 52% from 44% at 28 months of follow-up, while median progression-free survival had not been reached and the 36-month progression-free survival rate was 79%, Hung said. No new safety signals were observed with additional follow-up. The company announced two additional studies for lower-grade, lower-risk disease: G307: A randomized Phase III trial enrolling 140 patients with newly diagnosed Grade 2 IDH1-mutant glioma who have not received chemotherapy or radiation. The study will be conducted outside the U.S. in regions where vorasidenib is not approved or accessible, with progression-free survival as the primary endpoint. G209: A U.S. Phase II study enrolling up to 40 patients with Grade 2 or Grade 3 IDH1-mutant glioma whose disease progressed after vorasidenib treatment but who do not yet require chemotherapy or radiation. The primary endpoint is objective response rate. Hung said the company expects data from its Phase III SIGMA and G307 studies in 2029. Nuvation also plans to assess tumor growth rate as a possible earlier indicator of activity in exploratory studies, though management noted it is not a validated regulatory endpoint. Operating expenses totaled $73.3 million in the second quarter, including $30.7 million in research and development expense and $42.6 million in selling, general and administrative expense. For the first six months of 2026, Nuvation reported total revenue of $114.9 million, including $41.7 million of IBTROZI net U.S. product revenue. Cash, cash equivalents and marketable securities totaled $661 million as of June 30. During June, Nuvation completed an offering of 0.75% convertible senior notes due 2032, generating approximately $279.1 million in net proceeds before the subsequent overallotment exercise. The company used proceeds to repay its outstanding term loan with Sagard and said the transaction reduced expected cash interest expense. Sauvage said Nuvation continues to believe its capital is sufficient to reach profitability and support the anticipated launch of safusidenib. The company also said it remains on track to provide an update on its drug-drug conjugate platform by the end of 2026. Nuvation Bio is a clinical-stage biotechnology company dedicated to discovering and developing small-molecule therapies for patients with cancer. The company employs an integrated research and development platform that spans target identification, preclinical evaluation, process chemistry, and early-stage clinical trials. By centralizing these capabilities, Nuvation Bio aims to accelerate the translation of promising drug candidates from laboratory research to first-in-human studies. The company's pipeline comprises multiple oncology programs, with small-molecule kinase inhibitors and targeted agents in Phase 1 development for both hematologic malignancies and solid tumors. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Nuvation Bio Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved 25% sequential net revenue growth for IBTROZI, driven by a strategic shift where 85% of new patient starts are now in the first-line setting. Transitioning the business model from a typical oncology launch to a chronic disease framework, leveraging IBTROZI's 50-month median duration of response to build a compounding pool of prevalent patients. Established market leadership in the ROS1 TKI space, capturing over 50% of new first-line starts and successfully depleting the finite pool of pretreated patients faster than anticipated. Expanding the total addressable market by 20% through initiatives aimed at converting patients from suboptimal chemotherapy and immunotherapy regimens to targeted TKI therapy. Differentiating IBTROZI as the only brain-penetrant ROS1 TKI without CNS warnings, a critical factor for long-term treatment adherence and patient quality of life. Broadened commercial adoption across academic, community, and integrated delivery network (IDN) settings, with community demand showing notable growth since launch. Executing a comprehensive 'full glioma opportunity' strategy for safusidenib, targeting all four risk segments of IDH1-mutant disease across four clinical studies. Initiating the G209 Phase II study to evaluate safusidenib in up to 40 patients who have progressed on vorasidenib, targeting a potential accelerated approval path. Anticipating a strategic update on the drug-drug conjugate (DDC) platform by year-end 2026, including detailed clinical development plans. Projecting European approval for IBTROZI in the first half of 2027, which would trigger a $30 million milestone payment from partner Eisai. Maintaining a cash runway sufficient to reach profitability and fund the anticipated commercial launch of safusidenib, bolstered by a $279.1 million convertible debt financing. Completed an opportunistic 5x oversubscribed convertible debt offering at a 0.75% coupon to retire higher-cost debt and increase strategic flexibility for business development. Implemented capped call transactions to mitigate potential shareholder dilution, setting an initial cap price at an 80% premium to the share price at the time of offering. Identified 'tumor growth rate' (TGR) as a potential early surrogate marker for efficacy in glioma, which management plans to discuss with the FDA as a novel regulatory endpoint. Noted that recent competitor labels for ROS1 TKIs included unexpected CNS warnings and pancreatic toxicity, reinforcing IBTROZI's perceived best-in-class safety profile. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expressed surprise at the 25% incidence of CNS adverse reactions in the competitor's label, noting it places the drug in the same 'warning' category as older TKIs. Argued that IBTROZI's 50-month duration of response in the first-line setting remains unmatched and unlikely to be challenged by the competitor's current data set. Characterized the competitor's higher pricing as a strategy typical for later-line drugs, whereas IBTROZI is positioned for broad first-line access. Management believes a study of 50 to 77 patients with a 20% response rate and 6-month duration of response could support a serious discussion for accelerated approval. Highlighted that approximately 1,250 patients are already failing vorasidenib annually, creating a significant unmet need and a feasible enrollment environment. Confirmed plans to use real-world evidence and data from Western clinical sites to support potential NDA submissions to the FDA. Directly partnering with community oncology aggregators to raise awareness of low testing rates and the high use of contraindicated IO-chemo regimens. Advocating for a shift from DNA to RNA-based testing, which management states is 30% more sensitive in identifying ROS1 fusions. Implementing patient identification programs to ensure mutational status is flagged before physicians default to habitual chemotherapy prescriptions.

Achieved $31.7 million in second quarter 2026 total revenue, including $23.2 million in net product revenue for IBTROZI® (taletrectinib) IBTROZI is the most prescribed ROS1 TKI in in both first-line and overall new patient starts in 2026 based on IQVIA claims from first five months of the year ~85% of the approximately 160 new patients were TKI-naïve, representing QoQ growth of ~30% in this setting Announced positive updated long-term Phase 2 data for safusidenib and significant expansion of clinical program to address broad spectrum of IDH1-mutant glioma Robust balance sheet with cash, cash equivalents, and marketable securities of $661.0 million as of June 30, 2026; additional $36.5 million in net proceeds secured in July 2026 from exercise of the convertible senior notes overallotment option Company to host a conference call today at 8:00 am ET NEW YORK, Aug. 6, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. "IBTROZI is now the most prescribed ROS1 TKI in both first-line and overall new patient starts in 2026, based on IQVIA claims data from the first five months of the year, reflecting the medical community's growing conviction that IBTROZI's durability profile belongs at the front of the treatment sequence. Consistent with this, approximately 85% of new prescriptions this quarter were for TKI-naïve patients who have the potential to be on therapy for many years. The continued shift toward TKI-naïve use highlights the increasing recognition of our long-term follow-up data in TRUST-I, which show a confirmed 90% response rate and a median duration of response of 50 months," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "This efficacy profile, combined with a generally tolerable safety profile and as the only brain-penetrant ROS1 inhibitor today without a CNS warning and precaution in its label, reinforces our belief that IBTROZI is becoming the standard of care for patients with advanced ROS1-positive NSCLC." Dr. Hung continued, "We are equally excited about the progress of safusidenib, with our updated Phase 2 data showing further deepening and durable responses in IDH1-mutant gliomas. We now plan to evaluate the potential of this investigational medicine across the broad spectrum of patients in hopes of fulfilling our ultimate goal of providing an effective therapy for nearly every patient with this disease. During the second quarter, we also strengthened our balance sheet through our convertible notes offering, providing us with the financial flexibility to continue to invest in growing our portfolio." Second Quarter 2026 and Recent Highlights: IBTROZI® (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC In the second quarter of 2026, Nuvation Bio reported $23.2 million in net product revenues for IBTROZI, and a 25% quarter-over-quarter growth that reflects the continued adoption and durability of treatment. In June 2026, Nuvation Bio announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) validated the Marketing Authorisation Application (MAA) submitted by partner Eisai Co., Ltd. for taletrectinib for the treatment of advanced ROS1-positive non-small cell lung cancer (ROS1+ NSCLC). In May 2026, Nuvation Bio announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027. The submission includes an additional 10 months of data from the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff, demonstrating a median duration of response (mDOR) of 49.7 months and median progression-free survival (mPFS) of 49.6 months in TKI-naïve patients in TRUST-I and mDOR of 19.4 months in TKI-pretreated patients in TRUST-II. In the TRUST-II study, the mDOR had not yet been reached in TKI-naïve patients at the time of the data cutoff and is subject to change as the data mature. Importantly, the safety profile remained consistent with prior reports, and no new signals were identified. In May 2026, Nuvation Bio announced new patient-reported outcomes data from the pivotal TRUST-II study of IBTROZI in patients with advanced ROS1+ NSCLC, presented at the 2026 ASCO Annual Meeting. Findings showed that 88% of patients reported improved or stable global health quality-of-life scores at first assessment, cognitive function scores improved or remained stable throughout treatment, and patients experienced rapid relief from burdensome symptoms including cough and shortness of breath. In May 2026, Nuvation Bio announced the successful completion of process technology transfer and product introduction to Thermo Fisher Scientific for U.S.-based manufacturing of drug product for IBTROZI, further securing critical drug supply for ROS1+ NSCLC patients and providers. In April 2026, Nuvation Bio presented updated pooled results from the TRUST-I and TRUST-II studies of IBTROZI in both TKI-naïve and TKI-pretreated patients at the American Association for Cancer Research (AACR) Annual Meeting 2026. Notably, in the pooled TKI-naïve population, IBTROZI demonstrated robust confirmed overall response rates (cORR), mDOR and mPFS in TKI-naïve patients. Updated results from the TRUST-I study were also simultaneously published in the Journal of Clinical Oncology. In April 2026, Nuvation Bio announced that taletrectinib (IBTROZI) has been added to the latest National Comprehensive Cancer Network® Clinical Practice Guidelines (NCCN Guidelines®) in Oncology for Central Nervous System (CNS) Cancers. Specifically, the NCCN Guidelines® for CNS Cancers now recommend taletrectinib (IBTROZI) as a systemic therapy option for ROS1+ NSCLC patients with brain metastases. Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma In July 2026, Nuvation Bio announced updated positive long-term follow-up data from the Phase 2 (J201) study of safusidenib in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma. Highlights of the findings, at a median of 38.8 months of follow-up, include the following: In July 2026, Nuvation Bio also announced a significant expansion of the clinical development program for safusidenib supported by the updated long-term follow-up data from the Phase 2 (J201) study. The company initiated two new studies to evaluate safusidenib across the broader landscape of IDH1-mutant glioma: a pivotal Phase 3 study in patients with grade 2 IDH1-mutant glioma outside the U.S. (G307; NCT07712757) and a Phase 2 study in patients with IDH1-mutant glioma that has progressed after prior treatment with vorasidenib in the U.S. (G209; NCT07703436). In April 2026, Nuvation Bio announced that it has acquired the Japan rights to safusidenib from Daiichi Sankyo, giving Nuvation Bio full global development and commercialization rights. The agreement also transfers ownership of the global clinical development program to Nuvation Bio, inclusive of clinical trials, past and current data generation, and future publications. Drug-drug conjugate (DDC) platform: Solid tumors Nuvation Bio continues to explore new preclinical candidates for this novel modality and aims to provide further updates by year-end 2026. Corporate Update: In July 2026, Nuvation Bio successfully completed a public offering of 0.75% Convertible Senior Notes with estimated net proceeds of approximately $279.1 million, net of fees and related reimbursements. In order to reduce dilution, the Company concurrently entered into capped call transactions at a cap price of $10.4580 per share, representing an 80.0% premium over the last reported sale price of $5.81 per share. Second Quarter 2026 Financial ResultsAs of June 30, 2026, Nuvation Bio had cash, cash equivalents, and marketable securities of $661.0 million. This does not reflect net proceeds of $36.5 million from exercise of the overallotment option in the Company's recent convertible senior notes offering, which occurred in July 2026. Product Revenue, Net To date, Nuvation Bio's only source of product revenue remains from the U.S. sales of IBTROZI, which Nuvation Bio began distributing to its U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $23.2 million for the three months ended June 30, 2026. Collaboration and License Agreements RevenueFor the three months ended June 30, 2026, collaboration and license agreements revenue was $8.5 million, compared to $3.6 million for the three months ended June 30, 2025. The increase is primarily due to a $3.6 million increase in product supply, and a $1.8 million increase in royalty revenue, offset by a $0.5 million decrease in research and development service revenue. Taletrectinib was included in China's National Reimbursement Drug List effective January 1, 2026. Royalty revenue for the quarter from collaboration agreements for China and Japan was $2.1 million. Research and Development ExpensesFor the three months ended June 30, 2026, research and development expenses were $30.7 million, compared to $27.4 million for the three months ended June 30, 2025. The increase was primarily due to $4.6 million increase in third-party costs related to clinical trial expense offset by a $1.3 million decrease in personnel costs as the prior period included a one-time stock-based compensation charge for performance-based awards that vested upon U.S. FDA approval of taletrectinib. Selling, General and Administrative ExpensesFor the three months ended June 30, 2026, selling, general, and administrative expenses were $42.6 million, compared to $38.5 million for the three months ended June 30, 2025. The increase was due to a $0.7 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, $0.8 million increase in legal fees, $0.7 million increase in professional fees, $0.5 million increase in sales and marketing expenses, $0.3 million increase in foreign currency impact and a $1.1 million increase in miscellaneous expense. Net incomeFor the three months ended June 30, 2026, Nuvation Bio reported a net loss of $62.8 million, or $(0.18) per share on a basic and diluted basis. The net loss for the comparable period in 2025 was $59.0 million, or $(0.17) per share on a basic and diluted basis. Conference Call and WebcastNuvation Bio will host a conference call and webcast today, August 6, 2026, at 8:00 am ET to discuss its financial results for the second quarter of 2026 and provide business updates. Investors and the general public are invited to listen to the live webcast and may register on the Investor Relations section of the Nuvation Bio website. To access the live conference call, participants can dial +1 833-461-5787 (U.S. toll-free) and enter access code 762246460. An archived recording will be available on Nuvation Bio's website for 90 days following the event. About ROS1+ NSCLCEach year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases. About IBTROZIIBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com. About the TRUST Clinical ProgramThe TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs. IndicationIBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC). IMPORTANT SAFETY INFORMATION FOR IBTROZI® (taletrectinib) WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months). Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients. Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients. Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months). ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients. QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner. In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients. Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc. Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients. Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months). Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation. Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients. Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman. ADVERSE REACTIONSAmong patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%). DRUG INTERACTIONS Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use. Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI. OTHER CONSIDERATIONS Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity. Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose. Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible. Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established. Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation. Please see accompanying full Prescribing Information. About IDH1-mutant GliomaGliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high grade tumors. About SafusidenibSafusidenib is an investigational, oral, brain-penetrant, selective inhibitor of mutant IDH1. It is being studied in patient populations with significant unmet medical need, including settings where there are limited or no approved targeted treatment options. In Phase 1 and Phase 2 clinical studies, safusidenib demonstrated encouraging clinical activity, including delayed disease progression and durable responses across a range of tumor grades and risk groups, with a favorable risk-benefit profile. These early findings support further investigation of safusidenib in the currently enrolling Phase 3 SIGMA study, as well as in the Phase 3 G307 study outside the U.S. where vorasidenib is not yet approved or accessible and the Phase 2 G209 study in a post-vorasidenib setting. About the SIGMA (G203) StudySIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients. About Nuvation BioNuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc). Forward-Looking StatementsCertain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements about IBTROZI and safusidenib's therapeutic and commercial potential, Nuvation Bio's belief that IBTROZI is becoming the standard of care in advanced ROS1+ NSCLC, Nuvation Bio's plans to evaluate safusidenib across the broad spectrum of patients with IDH-1mutant glioma, and Nuvation Bio's evaluation of additional preclinical candidates and timelines for further updates. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to whether Nuvation Bio is successful in commercializing IBTROZI; the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; whether Nuvation Bio meets its post-marketing requirements and commitments for IBTROZI; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on August 6, 2026 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release. Media and Investor Contacts Nuvation Bio Investor ContactJR [email protected] Nuvation Bio Media ContactKaitlyn [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/nuvation-bio-reports-second-quarter-2026-financial-results-and-provides-business-update-302844260.html

The second-quarter 2026 earnings season is currently in full swing. The scorecard for the Medical sector is pretty good so far. The sector primarily comprises pharma/biotech and medical device companies. The earnings season for the pharma/biotech sector kicked off last month when pharma bellwether Johnson & Johnson posted better-than-expected results and upped its annual guidance. Swiss pharma giant Novartis also beat on earnings and sales in the second quarter. On the biotech front, Bristol-Myers (BMY) beat earnings and revenue estimates, driven by Growth Portfolio strength and Eliquis demand. Biogen also posted strong results, beating both earnings and sales estimates. The Earnings Trends report indicates that, as of July 29, 10.2% of the companies in the Medical sector, representing about 32.2% of the sector’s market capitalization, have reported quarterly earnings. While 100% of the companies topped on earnings, 94.7% beat on sales. While earnings increased 18.1% year over year, sales grew 6.8%. Overall, second-quarter earnings are expected to fall 15.2% year over year, while revenues are likely to rise 6.1%. Even though some of the bigwigs from the biotech sector have already announced results, there are many companies that are yet to report. Some of them seem poised to surpass estimates for the quarter. Here, we have highlighted four biotech companies, Arcutis Biotherapeutics ARQT, Nuvation Bio NUVB, Perspective Therapeutics, Inc. CATX and Tango Therapeutics TNGX — that are expected to deliver a beat in their upcoming quarterly results. Earnings ESP is our proprietary methodology for determining the stocks with the best chance of delivering an earnings surprise. It shows the percentage difference between the Most Accurate Estimate and the Zacks Consensus Estimate. According to the Zacks model, the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. The selection can be made with the help of the Zacks Stock Screener. Our research shows that the chance of an earnings surprise for stocks with this combination is as high as 70%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter. Arcutis Biotherapeutics, a commercial-stage medical dermatology, has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Continued robust demand for flagship product, Zoryve, is boosting top-line revenue growth. ARQT has an Earnings ESP of +52.94% and a Zacks rank 2. The Zacks Consensus Estimate for the to-be-reported quarter’s revenues is pegged at $121.85 million, while the same for earnings is pinned at 9 cents per share. Arcutis Biotherapeutics, Inc. price-consensus-eps-surprise-chart | Arcutis Biotherapeutics, Inc. Quote ARQT is scheduled to report second-quarter results on Aug. 5. Nuvation Bio is a global oncology company focused on developing innovative therapies for difficult-to-treat cancers. Its pipeline includes taletrectinib (IBTROZI), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and a novel drug-drug conjugate (DDC) program, all aimed at improving outcomes for patients with cancer. NUVB has an Earnings ESP of +10.35% and a Zacks Rank of 2. The Zacks Consensus Estimate for revenues is pegged at $27.12 million, while the same for earnings is pinned at a loss of 15 cents per share. Nuvation Bio Inc. price-consensus-eps-surprise-chart | Nuvation Bio Inc. Quote NUVB is scheduled to report second-quarter results on Aug. 6. Perspective Therapeutics is a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body. The company is advancing a portfolio of clinical-stage programs in the United States, including VMT-α-NET (neuroendocrine tumors), VMT01 (melanoma), and PSV359 (solid tumors). CATX has an Earnings ESP of +1.89% and a Zacks Rank of 2. The Zacks Consensus Estimate for revenues is pegged at $0.2 million, while the same for earnings is pinned at a loss of 27 cents per share. Perspective Therapeutics, Inc. price-consensus-eps-surprise-chart | Perspective Therapeutics, Inc. Quote CATX is scheduled to report second-quarter results on Aug. 10. Tango Therapeutics is a clinical-stage biotechnology company focused on discovering novel cancer drug targets and developing next-generation precision medicines. The company is advancing two selective PRMT5 inhibitors targeting MTAP-deleted cancers. TNGX’s lead candidate, vopimetostat (TNG462), is being evaluated for non-central nervous system (non-CNS) cancers as both a monotherapy and in combination with RAS inhibitors. The company's second candidate, TNG456, is a next-generation, brain-penetrant PRMT5 inhibitor being developed for central nervous system (CNS) cancers, including glioblastoma (GBM). The company has an Earnings ESP of +1.06% and a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here. Tango Therapeutics, Inc. price-consensus-eps-surprise-chart | Tango Therapeutics, Inc. Quote The Zacks Consensus Estimate for second-quarter earnings is pegged at a loss of 31 cents per share. Tango Therapeutics beat on earnings in two of the trailing four quarters and met in the remaining two, delivering an average surprise of 301.61%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Arcutis Biotherapeutics, Inc. (ARQT) : Free Stock Analysis Report Nuvation Bio Inc. (NUVB) : Free Stock Analysis Report Tango Therapeutics, Inc. (TNGX) : Free Stock Analysis Report Perspective Therapeutics, Inc. (CATX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

The market expects Nuvation Bio Inc. (NUVB) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 6. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.15 per share in its upcoming report, which represents a year-over-year change of +11.8%. Revenues are expected to be $27.12 million, up 461.5% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 2.5% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Nuvation Bio, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +10.35%. On the other hand, the stock currently carries a Zacks Rank of #2. So, this combination indicates that Nuvation Bio will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Nuvation Bio would post earnings of $0.12 per share when it actually produced earnings of $0.01, delivering a surprise of -91.67%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Nuvation Bio appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. EyePoint (EYPT), another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report loss per share of $0.92 for the quarter ended June 2026. This estimate points to a year-over-year change of -8.2%. Revenues for the quarter are expected to be $0.25 million, down 95.3% from the year-ago quarter. The consensus EPS estimate for EyePoint has been revised 8.9% lower over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -9.39%. This Earnings ESP, combined with its Zacks Rank #3 (Hold), makes it difficult to conclusively predict that EyePoint will beat the consensus EPS estimate. The company could not beat consensus EPS estimates in any of the last four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Nuvation Bio Inc. (NUVB) : Free Stock Analysis Report EyePoint, Inc. (EYPT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Performance in Q1 was characterized by a significant shift in patient mix, with TKI-naive (first-line) patients exceeding 50% of new starts for the first time since launch. Management attributes the 18% sequential product revenue growth to 'revenue stacking,' where durable first-line patients accumulate while later-line patients discontinue quickly due to disease progression. The company is pivoting its narrative from new patient starts to revenue-based metrics, arguing that the 50-month median duration of response in first-line patients makes durability the primary value driver. Operational focus is targeting the 'testing gap' in community centers, where ROS1 mutation identification rates remain below 50%, representing a major untapped addressable market. Strategic positioning was bolstered by the inclusion of Iptrozy in NCCN CNS guidelines, which management believes validates the drug's 66% intracranial response rate versus non-penetrant competitors. The acquisition of safusitinib rights in Japan from Daiichi Sankyo consolidates global control and allows for the expansion of the Phase 3 SIGMA study into the Japanese market. Management expects revenue growth to accelerate as the base of long-duration first-line patients builds, assuming the current 35% quarter-over-quarter growth in first-line mix continues. Gross-to-net discounts are projected to stabilize around 30% following typical first-quarter seasonal upticks related to 340B and Medicaid mix. The company anticipates a $30 million milestone payment from Eisai contingent upon Iptrozy's expected European approval in 2027. Strategic updates on the drug-drug conjugate (DDC) platform and development plans for low-grade, low-risk glioma are scheduled to be provided by the end of 2026. Cash runway of $533.7 million is stated to be sufficient to fund current operations and the Iptrozy launch without the need for additional external financing. Discontinuation rates remain concentrated in later-line patients (third-line and beyond), which management notes can cause near-term revenue variability despite steady new demand. The company recognized $64.7 million in collaboration revenue, primarily driven by a one-time $60 million upfront payment from the Eisai partnership. Management flagged the 'unacceptable' low testing rates in community oncology as a structural headwind to reaching the full addressable population of 3,000 to 4,000 annual patients. Adverse event-related discontinuations were highlighted as a key safety metric, remaining low at 6.5% in pivotal studies and consistent in real-world application. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management explained that the total number appears flat because rapid discontinuations of late-line patients are offsetting the steady growth of first-line incident cases. They emphasized that first-line patients are more valuable due to a 50-month progression-free survival, which will eventually lead to a larger 'active' patient base as the late-line pool is depleted. David Hung clarified that while competitors may show activity in the third-line setting after Iptrozy failure, Iptrozy's 90% response rate and superior durability solidify its position as the preferred first- and second-line therapy. He noted that the FDA's Breakthrough Therapy designations reflect this sequencing, with Iptrozy focused on earlier lines and competitors filling the third-line gap. Colleen Sjogren noted that while 100% of top accounts have prescribed Iptrozy, community testing remains a bottleneck due to a lack of comprehensive molecular testing standards. The company is implementing direct partnerships with testing platforms and educational initiatives to ensure oncologists wait for full driver results before initiating treatment. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Image source: The Motley Fool. Monday, May 4, 2026 at 4:30 p.m. ET Chief Executive Officer — David Hung Chief Commercial Officer — Colleen Sjogren Chief Financial Officer — Philippe Sauvage Need a quote from a Motley Fool analyst? Email [email protected] David Hung: Thanks, J.R. Good afternoon, everyone, and thank you all for joining us. Today, I am excited to discuss the progress we have made across our business in the first quarter. Following the line-agnostic FDA approval of Iptrozy in June 2025, we entered 2026 focused on continuing to build a successful commercial launch in ROS1-positive non-small cell lung cancer, with specific focus on educating physicians, supporting patients, and generating new clinical evidence that reinforces Iptrozy’s differentiated profile. Overall, we are very pleased with our continued execution, highlighted by strong demand for Iptrozy and our ability to significantly increase the percentage of new patients treated in the first-line setting. We successfully treated approximately 200 new patients with Iptrozy in the first quarter, which makes three consecutive quarters of about 200 new patient starts, bringing our total to over 600 since launch. We see a growing trend of more new patients coming from the first-line setting and, in turn, a lower percentage of patients coming from the third-line setting or later. In fact, for the first time since launch, more than half of the new patients who started Iptrozy in the quarter were TKI-naive. Given the changing dynamics of patient mix and moving from later-line to the first-line setting, and considering the significantly increased durability of Iptrozy in earlier versus later-line settings, we are just beginning to see revenue stack in this quarter, as Philippe will shortly discuss. This revenue dynamic is the most important metric for the launch going forward. Therefore, at some point in the future, we will focus on revenue and no longer report new patient starts. This has meaningful implications for the long-term opportunity for our brand, especially now given that based on a recent new analysis presented at AACR, Iptrozy has now extended its median duration of response to 50 months in TKI-naive patients in the pooled results from the pivotal TRUST studies. When patients are treated earlier in their disease course, they are often in a better position to realize increased benefit from a therapy with durable efficacy and generally favorable tolerability. Over time, we believe this can build a larger, longer-duration base of active patients on Iptrozy and support more substantial revenue growth. Since launch, our discontinuations have been driven primarily by disease progression in later-line patients. This is expected in any oncology launch as these patients have already progressed through other approved therapies. From the data that we see, discontinuations in earlier-line patients or for adverse events are consistent with clinical trial results and remain relatively low. As a reminder, and as detailed in Iptrozy’s prescribing information, 6.5% of 337 patients with advanced ROS1-positive NSCLC in our pivotal TRUST studies discontinued therapy due to any adverse reaction. And as we have previously presented, only one of these patients, or 0.3%, discontinued treatment due to any of the six most common adverse events, including liver enzyme elevations, diarrhea, nausea, vomiting, or dizziness. The feedback we continue to receive from both key opinion leaders and our sales organization has been highly consistent. Physicians are impressed with Iptrozy’s clinical profile, citing the durability and tolerability, and the real-world experience is giving physicians increased confidence to both keep patients on therapy longer and to choose Iptrozy when considering a preferred first-line treatment option. This response further supports our belief in both consensus net revenue estimates for Iptrozy in 2026 and its long-term potential. We are also encouraged by the addition of Iptrozy to the latest NCCN CNS guidelines as a systemic therapy option for ROS1-positive NSCLC patients with brain metastases. We believe this is an important recognition of Iptrozy’s demonstrated intracranial activity and further supports its differentiated position in the ROS1 treatment landscape. Turning to our recent abstracts and publications, we were thrilled to present updated pooled results from the August 2025 data cutoff of the TRUST-1 and TRUST-2 studies at the American Association of Cancer Research congress, or AACR. These updated data continue to reinforce the strength of Iptrozy’s profile. In TKI-naive patients in TRUST-1, as recently published in the Journal of Clinical Oncology, median duration of response and median progression-free survival have both now increased to approximately 50 months, or more than four years. As presented at AACR in TKI-pretreated patients, the median duration of response was nearly 20 months in TRUST-2, and the overall survival in the pooled TKI-pretreated population showed a median of nearly 30 months, which is unprecedented in this space. And with this longer follow-up, Iptrozy continued to demonstrate a manageable and consistent safety profile, including lower rates of neurologic adverse events and no new safety signals. We believe these durability data matter not only clinically but commercially. Drugs that combine deep and durable efficacy with a favorable tolerability profile are well positioned to become the therapy of choice for TKI-naive patients, and that is exactly the trend we are seeing in our launch. With approximately three years of follow-up in the pooled analysis, and more than four years of follow-up in TRUST-1, we believe these data further support Iptrozy as an effective, durable, and tolerable treatment option for patients living with advanced ROS1-positive NSCLC. At AACR, we also presented preclinical work which continues to build on our broader scientific understanding of Iptrozy’s differentiated profile. As I discussed on our last earnings call, Iptrozy is designed to achieve deep and durable inhibition of ROS1 while maintaining measured activity against TRK-B. Our presentation showed two important points. First, talotrectinib has nearly complete coverage of ROS1 fusions at clinically relevant concentrations and is effective against ROS1 resistance mutations. Second, talotrectinib has partial, yet biologically meaningful, inhibition of TRK-B, while being sufficiently balanced to avoid significant CNS-related adverse events as seen in our clinical trials and real-world experience. Of note, in the same experiment, a TRK-sparing agent failed to control tumor migration and markers of invasion and metastases, which were well controlled by talotrectinib. These data support the concept that some degree of TRK-B inhibition may be required to inhibit systemic progression, prevent the migration of lung cancer cells, and protect against metastases to the brain. This analysis showed that our medicine may have a mechanistic profile which we believe leads to a potential impact on tumor invasiveness and metastatic behavior in patients, while limiting neurologic adverse events. This balanced approach and ability to prevent resistance could ultimately play an important role in the long-term durable control of ROS1-positive lung cancer, as demonstrated in Iptrozy’s median progression-free survival of over four years. At ASCO in June, we will be presenting additional data from our TRUST program on patient-reported outcomes and our ongoing TRUST-4 study in the adjuvant setting. Turning to safusitinib, we remain very excited about the potential of this program and the opportunity it represents for patients with IDH1-mutant glioma. Beyond its potential clinical importance, we believe safusitinib could address a broad segment of the glioma market and therefore represent a meaningful long-term value opportunity for the company. Safusitinib is currently being evaluated in the ongoing Phase 3 SIGMA study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard of care, and in a non-pivotal cohort with grade 3 oligodendroglioma following surgery. In Phase 1 and Phase 2 single-arm studies, safusitinib has shown very encouraging efficacy signals, including durable responses and prolonged progression-free survival across both low- and high-grade IDH1-mutant gliomas. We think about the glioma market as a pie with four parts: low-grade low-risk, low-grade high-risk, high-grade low-risk, and high-grade high-risk tumors. Today, the only approved glioma drug, vorasidenib, is approved in the low-grade, low-risk glioma setting, and prior data have shown limited activity in enhancing or high-risk, high-grade tumors. In contrast, safusitinib has shown significant activity in clinical studies across all four subgroups of IDH1-mutant glioma. The safusitinib SIGMA pivotal trial will target three of the four pieces of the glioma pie, enrolling high-grade high-risk, high-grade low-risk, and low-grade high-risk IDH1-mutant glioma patients. We are also exploring potential studies to further develop safusitinib in the final piece of the pie, low-grade low-risk glioma, and we will provide an update on our plans later this year. I would also like to highlight that a November 2025 publication in Neuro-Oncology summarized the Phase 2 study of safusitinib in patients with chemotherapy- and radiotherapy-naive grade 2 IDH1-mutant gliomas as of a 03/10/2023 data cutoff. Strikingly, as of February 2026, 12 of the 27 patients evaluated in this study remained on treatment with a median follow-up of more than five years. We believe these data continue to support the potential of safusitinib in patient populations with significant unmet need and limited or no FDA-approved targeted treatment options. Importantly, in April, we acquired exclusive rights to safusitinib in Japan from our partner Daiichi Sankyo. With that agreement now complete, we plan to expand the pivotal Phase 3 SIGMA study into Japan, continue to advance the global development program, and pursue presentation and publication of longer-term Phase 2 data so the scientific community remains current on these findings. Finally, we remain on track to provide an update on our drug-drug conjugate platform by the end of the year. Overall, the first quarter confirmed important points in our 2026 outlook. We are seeing solid new patient demand, improving mix toward first-line use, and continued confirmation of Iptrozy’s encouraging efficacy and tolerability profile in the real world. We believe these trends position Iptrozy well for long-term success while we continue to advance a broader pipeline designed to address significant patient needs and create additional future value. With that, I will turn the call over to Colleen. Colleen Sjogren: Thank you, David, and hello, everyone. We continue to see strong momentum in the launch of Iptrozy, and we are particularly encouraged by what we have accomplished in just three quarters, especially when viewed against relevant targeted therapy launch analogs. Based on our internal data, we have generated more new patient starts than the prior ROS1 launches combined over the same time period. We believe this early success reflects the compelling clinical profile of Iptrozy and the focused execution of our commercial team. In addition, it represents a strong foundation for long-term value creation. As David mentioned, new patient starts remained robust at approximately 200 for the third quarter in a row, and this included a greater proportion of patients initiating treatment in the first-line setting. Importantly, our internal data sources indicate that for the first time, over half of new patient starts in the quarter were TKI-naive, compared to approximately 30% in the first full quarter following launch. This continued shift from later-line to frontline use is one of the clearest indicators of the strength of the launch and is in line with what we would expect based on typical uptake trends with new oncology agents. This gives us confidence in Iptrozy’s long term because these patients respond at a higher rate, have the potential to remain on therapy for years, and contribute to a more durable active patient base over time. This dynamic is also important in understanding the discontinuation patterns we have observed, as we are encouraged by how Iptrozy’s clinical profile has translated to the commercial setting. Discontinuations continue to be concentrated among later-line patients, which is expected given the more advanced disease in this population and exposure to multiple prior therapies. As we discussed last quarter, most discontinuations are driven by disease progression in later-line patients rather than tolerability, and this dynamic can introduce some variability in near-term revenue even when new patient demand is steady. Importantly, adverse event-related discontinuations remain low and in line with what we observed in clinical trials, reinforcing the strong overall clinical profile of Iptrozy, including its favorable tolerability. Taken together, these observations, along with feedback from both patients and physicians, reinforce our view that Iptrozy is well positioned to serve patients across the ROS1 lung cancer treatment landscape and has not changed our view of the potential for Iptrozy in this setting. This increasing strength in patient mix and positive real-world feedback on Iptrozy’s treatment profile is matched by expanding adoption across both academic and community settings. We are especially encouraged by the pace of uptake we are seeing, particularly given that ROS1 is a rare disease and the prescriber base is relatively broad. Our commercial efforts continue to translate into strong physician awareness, which we believe is a meaningful indicator of successful launch execution. Based on our most recent market research, aided awareness of Iptrozy among target physicians has reached 97%, underscoring the breadth of our commercial reach and the growing visibility of Iptrozy in the market. We understand that academic and community customers have different needs, and we have been deliberate in aligning our commercial strategy with the distinct value drivers for each setting. As a result, 100% of the top 50 historical TKI accounts in the country have prescribed Iptrozy. Our broad account adoption is another important indicator of launch strength, and when paired with favorable placement on pathways and formularies, it reinforces our belief that institutions recognize the differentiated clinical profile of Iptrozy. We believe the launch progress we have seen to date also reflects the strength of a team that knows how to win in targeted oncology. We are seeing our efforts translate into meaningful account and physician traction, the result is an appreciation for the durability that Iptrozy has to offer and the openness to partnering with Nuvation Bio Inc. Taken together, we believe this positions us well to continue building momentum in the full ROS1 market over time. Lastly, we believe there is meaningful opportunity to increase the number of ROS1-positive patients who are diagnosed and treated with a ROS1 TKI today. Publications and data from the field suggest there should be approximately 3 thousand patients with advanced ROS1-positive non-small cell lung cancer diagnosed annually in the U.S. based on DNA testing. As the field shifts to using RNA- and DNA-based testing together, which may detect an additional 30% of fusions, the annual addressable population could expand to approximately 4 thousand patients. Unfortunately, although effective testing is better in most academic centers, it is currently significantly lower in parts of the community, including below 50% in some centers. To combat this, we have implemented several initiatives to partner with and educate the community on the importance of testing for oncogenic drivers. We strongly believe all patients should have the opportunity to benefit from the prolonged durability and high response rates Iptrozy has shown in the first-line setting, consistent with the NCCN guidelines issued last year. Improving patient identification is the right thing to do for patients and will be a key driver of long-term value for Nuvation Bio Inc. Overall, we are encouraged by the level of demand we are seeing, the shift towards earlier-line use, and the strength of the launch execution to date. The medical community recognizes that Iptrozy’s long durability gives physicians an important tool and offers patients the potential for long-lasting benefit with a generally favorable safety profile so they can stay on therapy for years. With an experienced commercial team, a clear strategy, and disciplined execution across the launch, we believe we are well positioned to continue building momentum and the long-term success of Iptrozy. Now I will turn it over to Philippe. Philippe Sauvage: For detailed first quarter 2026 financials, please refer to our earnings press release which is available on our website. I will highlight a few key points from the quarter. In the first quarter, we generated $83.2 million in total revenue, including $18.5 million in Iptrozy net U.S. product revenue. This represents 18% growth in net product revenue from the prior quarter, which was not only driven by yet another quarter of about 200 new patient starts, but importantly, from a growing population of active patients remaining on Iptrozy due to increasing frontline use. As you can see on this slide, the number of patients starting Iptrozy in the last three quarters has been consistent; however, due to the percentage of first-line patients increasing from approximately 30% in the third quarter last year to approximately 40% in the fourth quarter last year to now more than 50%, net product revenue has grown from $7.7 million to $15.7 million to now $18.5 million, in spite of an expected uptick in gross-to-net. We expect this trend to continue and also expect the number of new patient starts to increase as more U.S. physicians become aware of Iptrozy and testing rates in the community continue to improve. As previously mentioned, our long-term success will be driven by the exceptional duration of response with Iptrozy in the first-line setting. We are pleased that the growing number of TKI-naive patients have started our medicine since the early months of our launch. This trend, combined with our ability to grow revenue despite later-line patients dropping off Iptrozy, demonstrates the potential impact of revenue stacking going forward. Lastly, as noted, we did see an expected uptick in gross-to-net discount at the start of the year; we still expect our gross-to-net expansion to gradually stabilize from here. In addition to product revenue, we recognized $64.7 million in collaboration and license revenue in the quarter, including an upfront payment of nearly $60 million from Eisai pursuant to our partnership, which was announced in January. We also received approximately $1.7 million in royalty payments from our partnerships in Japan and China, both of which are exceeding initial expectations on a new patient starts and net revenue basis. As a reminder, talotrectinib was listed in China’s National Reimbursement Drug List, or NRDL, in January and, since then, sales from Innovent’s launch have increased rapidly. We believe this significant commercial uptake is due to a greater appreciation for effective testing in China, and we also believe this rate of adoption will translate to the U.S. market as patient identification improves over time. We continue to invest in our business and in our programs, resulting in total operating expenses of $73.5 million for the quarter. R&D expenses were $35.0 million, driven by increased investment in the SIGMA and TRUST clinical studies, and SG&A expenses were $38.3 million, primarily driven by commercialization activities. Turning to the balance sheet, we ended the quarter with $533.7 million in cash, cash equivalents, and marketable securities. In addition, $50 million remains available under our existing term loan agreement with Sagard Healthcare Partners through June 30. We also expect to receive a milestone payment of approximately $30 million from Eisai upon the approval of Iptrozy in Europe in 2027. Lastly, on the business development front, we announced our partnership with LSI in January to commercialize Iptrozy in Europe and other territories outside of China and Japan, which we discussed on our previous earnings calls. In April, we also announced the agreement with Daiichi Sankyo to acquire rights to safusitinib in Japan. This transaction made sense to us from a strategic and financial perspective, as it allowed us to fully secure global rights to safusitinib, including ownership of all clinical data and rights to future publications and data generation, without changing our expected cash runway. Acquiring full global rights will reinforce our speed of execution and now allow us to expand our commercial reach to Japan. I would like to thank Daiichi Sankyo for their efforts in developing safusitinib and for their confidence in us to take the program forward to potential global regulatory approvals. Overall, our capital position continues to provide us with the flexibility to support the Iptrozy launch, advance our pipeline, evaluate additional strategic opportunities, all while maintaining a disciplined approach to spending. We continue to believe we are well positioned to execute on our priorities without the need for additional external financing, even on our current trajectory and operating plan. I will now turn it back to David for closing remarks. David Hung: Thanks, Philippe. As we move through 2026, we remain focused on disciplined execution, continuing to build on the momentum of the launch, advancing our clinical and scientific understanding of Iptrozy, and progressing our broader pipeline. I want to thank our team for their continued commitment, our investigators, partners, shareholders, and, most importantly, patients and their families for their ongoing support. We will now open the call for questions. I will now ask the operator to open the line. Operator: We will now begin the question-and-answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press 1 to raise your hand. To withdraw your question, press 1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please standby while we compile the Q&A roster. Your first question comes from the line of an analyst with Jefferies. Your line is now open. Please go ahead. Analyst: Thank you. Congrats on the progress, and thank you for taking my question. Can you comment on whether the growing first-line patients are coming from the academic or the community settings? And then what specific educational field force initiatives have been implemented to accelerate adoption in the high-volume community setting? Right, adoption and basically use over the chemo-IO agent. Colleen Sjogren: Hey, Farzin, it is Colleen. I will take that one. First, we are very encouraged. We have about 97% awareness right now, and this is uniform adoption of Iptrozy across both academic and community. Most importantly, when we look at historically the top ROS1 accounts—which we have a historical list of about 50 of those accounts—100% of them have prescribed Iptrozy. So we are seeing broad adoption across all channels: academic, IDN, and community. We believe that speaks directly to oncologists being driven by the clinical evidence and TRUST data. It is so compelling that, in each channel, we are seeing really good uptake and adoption. On your question about specific initiatives to accelerate adoption over chemo-IO, one of the things we are really focused on is testing rates. This is a real challenge, and we are not dismissive of it, but we are also not passive about it. The gap between academic and community testing is very well documented, and, frankly, in some community centers, we are seeing testing rates that still remain below 50%. In our opinion, that is unacceptable from a patient care standpoint and represents a really meaningful community opportunity. What gives us confidence is that we have a targeted strategy in place. We are partnering directly with community oncology practices, investing in educational initiatives, and directly working with testing platforms to make sure comprehensive molecular testing is the standard of care and not the exception. We believe in the size of this market, we acknowledge the testing issue, and we are addressing it directly. David Hung: Hi, Farzin. This is David. To add a little more precision, the ability to get first-line patients really depends on them being diagnosed. While we have great awareness in both community and academic centers, testing rates are currently higher in academic centers than community centers. Therefore, the diagnosis of new patients is right now higher in academic centers because that is where more testing is being done. But we have already seen significant improvement in multiple community centers, and we are very heartened by that improvement in testing rates and the awareness that there is a drug that is highly efficacious, durable, and well tolerated to use when those diagnoses are made. We are excited about the change we have seen in first-line percentage—from about 30% in the first quarter after launch to about 40% and now to over 50%. That is a pretty exciting growth trajectory for us because we think it will allow us to meet our consensus expectations for the year if that were to continue. Analyst: Thank you so much. Congrats. Operator: Your next question comes from the line of an analyst with RBC Capital Markets. Your line is now open. Please go ahead. Analyst: Thanks for taking my question. I wanted to follow up on that a little bit, trying to better understand the dynamics of the new patient starts. It seems like it has been 200 for the past three quarters, and you have laid out a lot of reasons why there should be growing awareness and better testing. I am trying to understand why that has not pulled through into more new patient starts yet. For example, why the proportion is changing towards first-line, but you are not necessarily also seeing more of the later-line patients coming on as well. Is there a bottleneck somewhere? If this is something that can be helped by expanding the salesforce and hitting more prescribers, please talk about that dynamic. Thank you. David Hung: It is a great question. The main reason is that, in our early quarters of launch, we were getting mainly late-line patients—third-, fourth-, and fifth-line. Those patients can discontinue therapy in literally a month or two. Very late-line patients drop out very quickly, unfortunately, to pursue other therapies or they pass away. The reason it appears to be a plateau is not that demand is plateauing; it is that the late-line patients are dropping out very quickly. We are getting first-line patients, but those are incident cases. The prevalence pool has already been diagnosed—those are easier to find because they have already had a ROS1 diagnosis and have been on therapy—but they do not stay on very long and drop off quickly. The first-line patients have to be newly diagnosed, and that incidence pool obviously takes longer time to build. The fact that we have gone from 30% to 40% to now over 50% first-line shows we are finding those first-line patients, while the third-, fourth-, and fifth-line patients are dropping off rapidly. That should stabilize because eventually we will deplete that pool. We think we have already captured a significant amount of the late-line patients. That is why we are really focused on first-line. That is what really matters given that we now have a PFS or DOR of more than four years—50 months—which no drug is even within a year of. We think that is going to lead to revenue stacking that will really start to kick in, and we are just seeing that this year. So even with roughly the same number of new patient starts, and in spite of an increase in gross-to-net, revenue still went up 18%. If we keep the same growth rate in first-line patients that we have seen from Q3 to Q4 and Q4 to Q1, we think we should make our consensus for the year comfortably. Operator: Your next question comes from the line of an analyst with Clear Street. Your line is now open. Please go ahead. Analyst: Good evening. Thanks for taking my questions. Maybe a question on repeat prescriptions and distribution. Previously you mentioned a 70% versus 30% academic versus community split, but today you also mentioned that 100% of top 50 accounts have prescribed Iptrozy, which I assume are mostly community-based. Any insight you can provide there? Also, how does the NCCN CNS guideline inclusion help you get more first-line adoption? And on the lower testing rates in the community, are these rates lower because of lack of awareness, or are there other hurdles that could take longer to change? Colleen Sjogren: A couple of things to keep in mind. Across the top historical accounts—100% of those 50 accounts have now written Iptrozy—we see much greater usage now across community, IDN, and academic. You are right: when we first launched, we saw very fast uptake in academics. Now we are seeing just as much strength in uptake across other channels, especially in the community. Academic oncologists are driven by clinical evidence, and the TRUST data speaks directly to that. Community oncologists need practical support—reimbursement pathways, patient support programs, and confidence that their patients can tolerate therapy over time. They are now seeing all of that: the surround sound of Nuvation Connect, reimbursement pathways in effect, and our patient support programs. We believe that is directly linked to increasing uptake in the community. On testing, our accounts are increasingly prioritizing flagging mutation status. As RNA-based testing gains ground alongside DNA, more ROS1-positive patients are starting to be identified each month and year. We are laying the groundwork in education, positioning Iptrozy to benefit as identification rates improve. We are also educating on effective testing—making sure oncologists wait until they get all oncogenic driver testing back before making a treatment decision. David Hung: On the NCCN CNS guidelines, that is important because one of the most widely used previous TKIs in ROS1 was crizotinib, and crizotinib does not get into the brain. The new NCCN CNS guidelines specifically call out the CNS profile of Iptrozy, which contrasts starkly against crizotinib’s complete absence of brain penetration. About 36% of ROS1 cases have brain metastases at first diagnosis, and another 50% will progress in the brain upon first progression. It would be inappropriate to give a drug that is not CNS-penetrant. Not only is Iptrozy highly CNS-penetrant, but even in the second-line setting—often the most difficult-to-treat patients—our intracranial response rate is 66%, the highest recorded so far of any TKI in the pretreated space. That is independent of our unmatched first-line durability. We think the new NCCN CNS guidelines make it even more imperative that doctors select the right therapy. Colleen Sjogren: And, Kaveri, to add to David’s point, we have already received early feedback from HCPs that this will enhance Iptrozy’s profile and impact treatment decisions. Analyst: Very helpful. This has a lot of exclamation points. Thank you so much. Operator: Your next question comes from the line of an analyst with Truist Securities. Your line is now open. Please go ahead. Analyst: Good afternoon, David and team. Congrats on the progress and results, and thanks for taking my question. A competitor recently presented data suggesting activity in patients previously treated with talotrectinib. How would you expect treating physicians to interpret such results? Would you see this influencing sequencing decisions or Iptrozy’s positioning compared to competing or potential agents in the market? David Hung: It does have implications. First, we are delighted that new treatment options are becoming available for patients as they fail therapy. But if you look at Iptrozy’s efficacy—with a response rate of 90% and now a PFS of about 50 months—there is nothing close to it in the first-line space. Repotrectinib’s PFS is about 36 months, so you are still talking about almost a year-and-a-half difference. In the second-line setting, with our DOR approaching 20 months and a response rate of 56% without excluding any oncogenic drivers—and an intracranial response rate of 66% without excluding any oncogenic drivers—there are no agents today that can claim numbers that match those. When a competitor has data in the third-line setting showing response after Iptrozy fails in the second-line setting, we are delighted that patients have another option in the third line. The competitor you are referring to received Breakthrough Therapy designation in the third-line setting, while Iptrozy received Breakthrough Therapy designation in the first- and second-line settings. We think things are playing out as the FDA initially saw them: Iptrozy will be used in the first- and second-line settings; other agents are needed in the third line, and we welcome that because that is what patients need. Operator: Your next question comes from the line of an analyst with B. Riley. Your line is now open. Please go ahead. Analyst: Good afternoon, team. Thanks for taking our questions. Building on the prior point of how Iptrozy is now considered relative to crizotinib and how entrenched positions could shift with additional market education—how relevant is the development of new CNS meds to the clinicians you talk to? And could you comment on dose interruptions or reductions tracking in frontline patients versus later lines? And on a go-forward basis, since new patient adds may not be a very relevant metric, what should we focus on—updates on first-line proportion, durability, gross-to-net—to think about modeling beyond 2026? David Hung: CNS is highly relevant. ROS1 NSCLC is aggressive not only in tumor growth but also in where tumors go. More than a third of patients have brain metastases at diagnosis, and in 50% of cases, upon progression, the brain is the first site of metastasis. That makes it imperative to have CNS coverage as early as possible with an agent that has proven long-term efficacy. Our intracranial response rate in the second-line setting is 66%, our duration of response in second line is about 20 months, and overall survival approaches three years—no other agents have published data close to that. In first line, the difference is even more pronounced: there is no agent remotely within Iptrozy’s 90% response rate and 50-month PFS. Regarding dose reductions and interruptions, the drug is well tolerated. We are not seeing anything new in the real world that we did not see in clinical trials. Dose reduction and interruption rates in practice are essentially what we saw in clinical trials. On efficacy, it is early to quantify real-world durability, but we expect similar performance to trials—about 50 months in first line and roughly 20 months in second line—based on what we see so far and physician feedback. Philippe Sauvage: On the forward-looking metrics, the key driver is the build-up of first-line patients and the resulting revenue stacking. We grew first-line patients by roughly 35% from Q3 to Q4 and again by about 35% from Q4 to Q1. If we keep increasing at that rate from Q1 to Q4, we will hit consensus; if we do better, we can beat consensus. The apparent stability in total new starts reflects two opposing dynamics: first-line patients increasing quarter after quarter, while the finite pool of late-line patients drops off faster. Looking ahead, we will keep talking about first-line build, given the incredible tolerability and durability that help patients stay on therapy a long time and help us progress quarter after quarter. On gross-to-net, Q1 typically sees an uptick due to price changes and mix effects such as 340B and Medicaid. Our gross-to-net increased a few percentage points this quarter as expected. We continue to expect stabilization around the high-20s to roughly 30% over time. There are no surprises here—no surprises on GTN, patients, or operating expenses—everything is tracking as we anticipated. Operator: Your next question comes from the line of an analyst with TD Cowen. Your line is now open. Please go ahead. Analyst: Thank you so much, and thanks for all the detail. As the proportion of first-line, treatment-naive patients rises from 30% to 40% to now over 50% of new starts, can you give us a sense of what percentage of total on-therapy patients are treatment naive at this point? And on gross-to-net, should we assume you will be in the high-20s and stabilize there this year, given it was around 25% last quarter? Philippe Sauvage: On your first question, yes, the proportion of first-line patients among new starts is increasing quarter after quarter, and we expect that to continue. We have limitations on exact real-time data for the full on-therapy base, but you can estimate based on first-line growth rates and the drug’s favorable tolerability profile, plus the late-line versus first-line discontinuation dynamics we described. On gross-to-net, it is fairly mechanical. Increased 340B and Medicaid exposure and the inflation-linked price dynamics drive gross-to-net higher by roughly the amount of the price increase for those segments. We expect to stabilize around ~30% as the mix normalizes and inflation dynamics flow through. This is aligned with what we said previously. Operator: Your next question comes from the line of an analyst with JonesTrading. Your line is now open. Please go ahead. Analyst: Thanks for taking my questions. How is the duration of therapy in first-line patients comparing to your expectations based on clinical trials? And with the recent NCCN additions, do you expect a noticeable inflection, or is that more of a background tailwind? David Hung: It is still early, but first-line patients are clearly staying on longer, which is reflected in revenue growth and the growing active patient base. We expect an average of over four years, consistent with trials, and so far discontinuations are predominantly in late-line patients, as expected. Philippe Sauvage: Side-effect profiles are aligned with clinical trials, so there is no reason for adverse events to drive early discontinuations. David Hung: On the NCCN updates, there is usually some lag. The first NCCN change a year ago—clarifying that IO is contraindicated—took time to shift practice. The CNS guideline may be appreciated sooner given high awareness that ROS1 is brain-tropic. In any case, it is a positive tailwind consistent with Iptrozy’s profile. On issuing annual sales guidance, now that we have hundreds of patients and a clearer growth trajectory, we would be willing to consider providing guidance at some point in the future. Operator: Your final question comes from the line of an analyst with Citizens Bank. Your line is now open. Please go ahead. Analyst: Thanks for taking the question, and congrats on the results. We have gotten a lot of color on CNS efficacy. Could we get the team’s perspective on comparing talotrectinib’s CNS profile to emerging clinical candidates rather than already approved ones? And does the NCCN CNS guideline reinforce the benefit here? David Hung: The nearest not-yet-approved competitor has reported an intracranial response rate of about 45% in the second-line setting, with exclusions. Our intracranial response rate is 66% without excluding oncogenic drivers. Against approved TKIs, Iptrozy’s intracranial activity is also higher. So, based on available data today, Iptrozy’s CNS activity compares favorably, and the NCCN CNS guideline does reinforce that benefit. Operator: Your next question comes from the line of an analyst with UBS. Your line is now open. Please go ahead. Analyst: Hey, thanks for squeezing us in. A quick one on the IDH1 program. Could you remind us of the standard of care in the high-grade glioma setting? And what PFS or ORR would be clinically meaningful in the broader population and in the subset that could read out next year? What would a good result look like, and what could the next steps be? David Hung: The SIGMA trial is a placebo-controlled study. There is absolutely nothing approved for the management of high-grade IDH1-mutant glioma. Management today is surgery for tumor debulking, radiation, and chemotherapy, with limited effectiveness. For response rate, anything north of 20% would be clinically meaningful in an indication with no approved therapies, and we would go to the FDA to discuss an approval pathway. For grade 3 oligodendroglioma—less aggressive than grade 4 astrocytoma/GBM—we would expect higher response rates, and again anything north of 20% we believe would be of strong interest to the FDA given the lack of options. We feel good about this based on data presented so far. Operator: There are no further questions at this time. I will now turn the call back to David for closing remarks. David Hung: Thank you all for your support. We are really excited about what we are seeing with the Iptrozy launch—it has gone pretty much as we had hoped—and we cannot wait to report our next quarter’s results. Thank you very much. Operator: This concludes today’s call. Thank you for attending. You may now disconnect. Before you buy stock in Nuvation Bio, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Nuvation Bio wasn’t one of them. 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Achieved $18.5 million in first quarter of 2026 net product revenues for IBTROZI® (taletrectinib); majority of the approximately 200 patients started on IBTROZI in the first quarter of 2026 were TKI-naïve, highlighting continued momentum in the first-line setting Presented newly updated clinical data demonstrating IBTROZI's impressive durability of response and progression-free survival in TKI-naïve and TKI-pretreated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) at AACR 2026 Announced acquisition of Japan rights to safusidenib from Daiichi Sankyo, enabling global development and commercialization of promising investigational medicine Strong balance sheet with cash, cash equivalents, and marketable securities of $533.7 million as of March 31, 2026 Company to host a conference call today at 4:30 pm ET NEW YORK, May 4, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. "We are pleased with IBTROZI's ongoing launch trends in the first quarter of 2026, as we continue to deepen its adoption across lines of therapy and make significant progress in becoming the standard of care for people living with advanced ROS1-positive NSCLC. The newly updated long-term follow-up data from our pivotal studies presented at AACR demonstrated an unprecedented durability for IBTROZI of now more than four years in TKI-naïve patients, further supporting healthcare providers and their patients' confidence in selecting IBTROZI. With our partners, we are well on our way to bringing this important medicine to patients in need around the world," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We are also thrilled to have secured exclusive global development and commercialization rights to safusidenib. We look forward to advancing the pivotal Phase 3 SIGMA study for patients with high-risk IDH1-mutant glioma, where targeted treatment options are incredibly limited. Additionally, we are well on track to provide updates on our drug-drug conjugate platform later this year as we further our mission to tackle some of the toughest challenges in cancer treatment." First Quarter 2026 and Recent Corporate Highlights: IBTROZI® (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC In the first quarter of 2026, Nuvation Bio reported $18.5 million in net product revenues for IBTROZI. In the first quarter of 2026, more than half of the approximately 200 new patients who started treatment with IBTROZI for advanced ROS1+ NSCLC were TKI-naïve, reflecting a sustained high rate of adoption and confidence in IBTROZI among healthcare professionals and patients. Since launch in late June 2025, over 600 patients have started IBTROZI. In April 2026, Nuvation Bio presented updated pooled results from the TRUST-I and TRUST-II studies of IBTROZI in both TKI-naïve and TKI-pretreated patients at the American Association for Cancer Research (AACR) Annual Meeting 2026. Notably, in the pooled TKI-naïve population, IBTROZI demonstrated robust confirmed overall response rates (cORR), median duration of response (mDOR) and median progression-free survival (mPFS) in TKI-naïve patients. Updated results from the TRUST-I study were also simultaneously published in the Journal of Clinical Oncology. For TKI-naïve patients (n=157): the analysis showed a cORR of 89.8%, a mDOR of 49.7 months, a mPFS of 46.1 months and an intracranial response rate of 76.5% in patients with brain metastases (n=17). Median overall survival (OS) was not yet reached. For TKI-pretreated patients (n=113): the analysis showed a cORR of 55.8%, a mDOR of 16.6 months, a mPFS of 9.7 months and an intracranial response rate of 65.6% in patients with brain metastases (n=32). Median OS was 29.8 months. Notably, 98% of TKI-pretreated patients (111/113) enrolled following progressive disease on entrectinib or crizotinib rather than intolerance, a higher bar for efficacy. The remaining two patients were enrolled following intolerance to a prior TKI. A pooled safety analysis demonstrated a favorable and generally manageable safety profile for IBTROZI, consistent with its prescribing information and no new safety signals were identified with longer follow-up. In April 2026, Nuvation Bio announced that taletrectinib (IBTROZI) has been added to the latest National Comprehensive Cancer Network® Clinical Practice Guidelines (NCCN Guidelines®) in Oncology for Central Nervous System (CNS) cancers. Specifically, the NCCN Guidelines® for CNS Cancers now recommend taletrectinib (IBTROZI) as a systemic therapy option for ROS1+ NSCLC patients with brain metastases. In March 2026, Nuvation Bio announced with Eisai Co., Ltd. that the European Medicines Agency (EMA) had validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1+ NSCLC. The filing is being considered for full approval and will follow a standard review timeline. On January 11, 2026, Nuvation Bio entered an exclusive license and collaboration agreement with Eisai Co., Ltd. to develop, register and commercialize taletrectinib for the treatment of ROS1+ NSCLC in Europe and certain other territories outside of the U.S., China and Japan. Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma In April 2026, Nuvation Bio announced that it has acquired the Japan rights to safusidenib from Daiichi Sankyo, giving Nuvation Bio full global development and commercialization rights. The agreement also transfers ownership of the global clinical development program to Nuvation Bio, inclusive of clinical trials, past and current data generation, and future publications. Nuvation Bio plans to present longer-term data from the Phase 2 study at a future medical meeting. As of February 2026, 12 of the 27 patients in the study remain on treatment with safusidenib with a median follow-up of over 5 years. In January 2026, Nuvation Bio announced the finalization of the protocol amendment for the ongoing global Phase 3 SIGMA study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard-of-care (G203). At that time, Nuvation Bio also announced that the trial would enroll a non-pivotal single-arm cohort to examine the efficacy and safety of safusidenib in chemotherapy- and radiotherapy-naïve patients with grade 3 IDH1-mutant oligodendroglioma with the primary endpoint of this arm being objective response rate. Drug-drug conjugate (DDC) platform: Solid tumors Nuvation Bio continues to explore new preclinical candidates for this novel modality and aims to provide further updates by year-end 2026. Corporate Update: In March 2026, Nuvation Bio appointed Stephen Dang, Ph.D., as Chief Legal Officer. Dr. Dang originally joined Nuvation Bio in 2021 and has over 18 years of experience in the biopharmaceutical industry across all stages of the drug product life cycle. First Quarter 2026 Financial Results As of March 31, 2026, Nuvation Bio had cash, cash equivalents, and marketable securities of $533.7 million. Product Revenue, Net To date, Nuvation Bio's only source of product revenue remains from the U.S. sales of IBTROZI, which Nuvation Bio began distributing to its U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $18.5 million for the three months ended March 31, 2026. Collaboration and License Agreements Revenue For the three months ended March 31, 2026, collaboration and license agreements revenue was $64.7 million, compared to $3.1 million for the three months ended March 31, 2025. The increase is primarily due to a $58.7 million increase in license revenue because of the upfront payment received under the Eisai agreement, a $2.4 million increase in product supply, a $1.5 million increase in royalty revenue, and was offset by a $1.0 million decrease in research and development service revenue. Taletrectinib was included in China's National Reimbursement Drug List effective January 1, 2026. Royalty revenue for the quarter from collaboration agreements for China and Japan was $1.7 million. Research and Development Expenses For the three months ended March 31, 2026, research and development expenses were $35.0 million, compared to $24.6 million for the three months ended March 31, 2025. The increase was primarily due to a $1.5 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, and $8.9 million increase in third-party costs related to clinical trials. Selling, General and Administrative Expenses For the three months ended March 31, 2026, selling, general, and administrative expenses were $38.3 million, compared to $35.4 million for the three months ended March 31, 2025. The increase was due to a $5.7 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, and $0.1 million increase in taxes, offset by a $1.7 million decrease in sales and marketing expenses and $1.2 million decrease in professional fees. Net income For the three months ended March 31, 2026, Nuvation Bio reported a net income of $5.4 million, or $0.02 per share on a basic basis and $0.01 per share on a diluted basis. The net loss for the comparable period in 2025 was $53.2 million, or $(0.16) per share on a basic and diluted basis. Conference Call and Webcast Nuvation Bio will host a conference call and webcast today, May 4, 2026, at 4:30 pm ET to discuss its financial results for the first quarter of 2026 and provide business updates. Investors and the general public are invited to listen to the live webcast and may register on the Investor Relations section of the Nuvation Bio website. To access the live conference call, participants can dial +1 833-461-5787 (U.S. toll-free) and enter access code 266802059. An archived recording will be available on Nuvation Bio's website for 90 days following the event. About ROS1+ NSCLC Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases. About IBTROZI IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com. About the TRUST Clinical Program The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs. Indication IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC). IMPORTANT SAFETY INFORMATION FOR IBTROZI® (taletrectinib) WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months). Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients. Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients. Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months). ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients. QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner. In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients. Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc. Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients. Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months). Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation. Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients. Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman. ADVERSE REACTIONS Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%). DRUG INTERACTIONS Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use. Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI. OTHER CONSIDERATIONS Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity. Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose. Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible. Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established. Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation. Please see accompanying full Prescribing Information. About IDH1-Mutant Glioma Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH1-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high grade tumors. About Safusidenib Safusidenib is an investigational, oral, brain-penetrant, selective inhibitor of mutant IDH1. It is being studied in patient populations with significant unmet medical need, including settings where there are limited or no approved targeted treatment options. In Phase 1 and Phase 2 clinical studies, safusidenib demonstrated encouraging clinical activity, including delayed disease progression and durable responses across a range of tumor grades and risk groups, with a favorable risk-benefit profile that supports the currently enrolling Phase 3 SIGMA study. About the SIGMA (G203) Study SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. Data is anticipated to be available in 2029. A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients. Data is anticipated to be available in 2027. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc). Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements about IBTROZI and safusidenib's therapeutic and commercial potential, IBTROZI becoming the new standard of care in advanced ROS1+ NSCLC, Nuvation Bio's expectations that the MAA filing for taletrectinib will follow a standard review timeline and be considered for full approval, the need for new therapeutic options in IDH1-mutant gliomas, Nuvation Bio's plans for safusidenib development and future data presentations, and Nuvation Bio's evaluation of additional preclinical candidates. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to whether Nuvation Bio is successful in commercializing IBTROZI; the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; whether Nuvation Bio meets its post-marketing requirements and commitments for IBTROZI; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 4, 2026 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release. Media and Investor Contacts Nuvation Bio Investor Contact JR DeVita [email protected] Nuvation Bio Media Contact Kaitlyn Nealy [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/nuvation-bio-reports-first-quarter-2026-financial-results-and-provides-business-update-302761664.html

Nuvation Bio Inc. (NUVB) came out with quarterly earnings of $0.01 per share, missing the Zacks Consensus Estimate of $0.12 per share. This compares to a loss of $0.16 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -91.30%. A quarter ago, it was expected that this company would post a loss of $0.11 per share when it actually produced a loss of $0.11, delivering no surprise. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Nuvation Bio, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $83.23 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 0.36%. This compares to year-ago revenues of $3.08 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Nuvation Bio shares have lost about 49.9% since the beginning of the year versus the S&P 500's gain of 5.6%. While Nuvation Bio has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Nuvation Bio was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.23 on $34.97 million in revenues for the coming quarter and -$0.47 on $215.06 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Precision BioSciences (DTIL), another stock in the same industry, has yet to report results for the quarter ended March 2026. The results are expected to be released on May 5. This genome editing company is expected to post quarterly loss of $0.27 per share in its upcoming report, which represents a year-over-year change of +87.8%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Precision BioSciences' revenues are expected to be $7.7 million, up 25566.7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Nuvation Bio Inc. (NUVB) : Free Stock Analysis Report Precision BioSciences, Inc. (DTIL) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research