Nuvation Bio Inc.

Hello and welcome to NovationBio's first quarter 2026 financial results and corporate update call. Today's call is being recorded and a replay will be available on the company's website. All participants are currently in a listen only mode. A brief question and answer session will follow the prepared remarks. 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.

Thank you, and good afternoon, everyone. Earlier today, we issued a press release summarizing our financial results for the quarter ending March 31st, 2026, and provided a business update. The press release is available on the investor 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 Safucitinib, our plans for Safucitinib development and future data presentations, 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.

Thanks, JR. Good afternoon, everyone, and thank you all for joining us. Today, I'm excited to discuss the progress we've made across our business in the first quarter. Following the line agnostic FDA approval of Ibtrozi in June 2025, ReHintered 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 Ibtrozi's differentiated profile. Overall, we are very pleased with our continued execution, highlighted by strong demand for Ibtrozi 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 Ibtrozi 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 Ibtrozi 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 the PTROSY 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 medicine, especially now given that based on a recent new analysis presented at AACR, Ibtrozi 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 the 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 Trosi's prescribing information, 6.5% of the 337 patients with an advanced RAS1-positive NSCLC are in our pivotal trust studies discontinued therapy due to any adverse reaction. And as we have previously presented, only one of these patients are 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 Ibtrozi's clinical profile, citing the durability and tolerability, and a real-world experience is giving physicians increased confidence to both keep patients on therapy longer and to choose Ibtrozi when considering a preferred first-line treatment option. This response further supports our belief in both consensus net revenue estimates for Ibtrozi in 2026 and its long-term potential. We are also encouraged by the addition of Iptrosi to the latest CNS-NCCN guidelines as a systemic therapy option for ROS1-positive NSCLC patients with brain metastases. We believe this is an important recognition of Iptrosi'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 TRUST1 and TRUST2 studies at the American Association of Clinical Research Congress, or AACR. These updated data continue to reinforce the strength of Ibtrozi's profile. In TKI Naive Patients in TRUST1, as recently published in the Journal of Clinical Oncology, Median duration of response and median progression pre-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 TRUST2, 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, Ibtrozi 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 pool of analysis and more than four years of follow-up in TRUST1, we believe this data further supports Ibtrozi as an effective, durable, and tolerable treatment option for patients living with advanced ROS1-positive NSCLC. At AECR, we also presented preclinical data, which continues to build on our broader scientific understanding of Iptrosi's differentiated profile. As I discussed on our last earnings call, Iptrosi is designed to achieve deep and durable inhibition of ROS1 while maintaining measured activity against TREC-B. Our presentation showed two important points. First, telotrectib has nearly complete coverage of ROS1 fusions at clinically relevant concentrations and is effective against ROS1 resistance mutations. Second, telotrectib has partial yet biologically meaningful inhibition of TREC-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 TREC-B sparing agent failed to control tumor migration and markers of invasion and metastases, which were well controlled by telotreptinib. These data support the concept that some degree of TREC-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 Ibtrozi'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 safucitinib, 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 safucitinib could address a broad segment of the glioma market and therefore represent a meaningful long-term value opportunity for the company. Safucitinib is currently being evaluated in the ongoing Phase III 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 III oligodendroglioma following surgery. In phase one and phase two single arm studies, saflusetinib 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, voracitinib, is approved in the low-grade, low-risk glioma setting, and prior data have shown limited activity in enhancing our high-risk, high-grade tumors. In contrast, safucitinib has shown significant activity in clinical studies across all four subgroups of IDH1 mutant glioma. The safucitinib 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 new glioma patients. We're also exploring potential studies to further develop safucitinib in the final piece of the pie, low-grade low-risk glioma, and we'll provide an update on our plans later this year. I'd also like to highlight that a November 2025 publication in Neuro-Oncology summarized the Phase II study of Saffucidinib patients with chemotherapy and radiotherapy-naive grade II IDH1 mingliomas as of a March 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 sapucitinib in patient populations with significant unmet need and limited or no FDA-approved targeted treatment options. Importantly, in April, we acquired exclusive rights to sapucitinib in Japan from our partner, Daiichi Sankyo. With that agreement now complete, we plan to expand the pivotal Phase III SIGMA study into Japan continue to advance the global development program, and pursue presentation and publication of longer-term Phase II 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 for our 2026 outlook. We are seeing solid new patient demand, improving mix toward first-line use, and continued confirmation of Iptrosi's encouraging efficacy and tolerability profile in the real world. We believe these trends position Iptrosi 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'll turn the call over to Colleen.