Nuvation Bio Inc.

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

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

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