Nuvation Bio Inc. 2026 Q2 Earnings Call

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. I'll turn the call over to Dr. David Hung. David, please go ahead. Thanks, J.R.

Good morning, everyone. 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. 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. 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 have now treated so many of these more advanced patients in the 12 months since our FDA approval. 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. As Colleen will discuss, we are thrilled that IBTROZI is now the number 1 choice for newly diagnosed advanced or metastatic ROS1-positive lung cancer patients. The profile of IBTROZI is exceptional. In TKI-naïve 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 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 prevalence 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 three-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, importantly, positive 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. 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 this 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. 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 three of the four segments of the glioma opportunity. We recently announced two 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 U.S. 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. 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 U.S. 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.