Nuvation Bio (NUVB) Q2 FY26 earnings call: guidance and Q&A

What is Nuvation Bio's read on GSK's zidesamtinib, its pricing, CNS warnings, and how it impacts IBTROZI's commercial message?

Management expressed surprise at zidesamtinib's CNS warnings and other high adverse event rates, noting IBTROZI is now the only brain-penetrant ROS1 TKI without CNS warnings. They believe IBTROZI's efficacy and safety profile remains superior, especially in the first-line setting where zidesamtinib lacks comparable data. Zidesamtinib's higher pricing was seen as a strategy for a later-line drug, contrasting with IBTROZI's broad access approach.

“We just don't see anything in the efficacy side or the safety side that we feel as a threat, and we will maintain -- we believe that we are the best-in-class ROS1.”

asked by Farzin Haque · answered by David Hung

How has the early approval of zidesamtinib affected tactical plans, and how has a year of IBTROZI's launch informed the theoretical patient stacking opportunity?

The early approval of zidesamtinib was helpful for clarity and did not change strategy. The company emphasized that IBTROZI is a first-line market drug, with 85% of new patients now in the first-line setting. The initial pool of pretreated patients has been largely captured, leading to a temporary dip in overall new patient starts, but the focus is on growing the first-line market. The long duration of response for IBTROZI (50 months) is building a compounding base of active patients, shifting towards a chronic disease model.

“The most important thing on this call is that we've said all along from day 1, even though we've -- of course, the prevalence pool of pretreated patients is larger than the incidence tool. When we started a year ago, they 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 role.”

asked by Gregory Renza · answered by David Hung

What testing initiatives is Nuvation Bio involved with to increase ROS1 penetration, and what are the expectations for the safusidenib G209 post-vorasidenib cohort data and regulatory path?

Nuvation Bio is working with community oncology aggregators to raise awareness of low testing rates and high I/O chemo use. They advocate for RNA-based testing (30% more sensitive) and targeted initiatives to disrupt habitual prescribing patterns. For safusidenib G209, management highlighted the unmet need for patients failing vorasidenib (estimated >1,250 patients). They believe a study of 50-77 patients with a 6-month DOR and >20% ORR could warrant serious discussion for accelerated approval, citing precedents. They also mentioned tumor growth rate (TGR) as a potential earlier surrogate endpoint.

“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.”

asked by Mayank Mamtani · answered by David Hung

What gives confidence that the FDA would accept OUS data for a low-grade glioma filing, and would US data supplementation be needed?

Management believes the compelling argument is the lack of options for patients once vorasidenib fails. They see no evidence of biological differences across geographies. The studies include sites in Western countries, and they are exploring real-world evidence approaches. They argue that if a drug shows activity in a population with no alternatives, it should be considered, especially given the severe side effects of current options like radiation.

“Well, the most compelling argument is that once they feel more, there's nothing. So there is no option. I think that there's no evidence that the biology of IDH1 reasonably almost different across geographies or ethnicities.”

asked by Matthew Hagood · answered by David Hung

Are there prescribers who prefer other ROS1 agents, and is Nuvation Bio more successful in converting second-line prescribers to frontline for new patients?

The company sees broad-based growth across academic, community, and IDN settings, reflecting institutional confidence. When KOLs have used IBTROZI, they are very likely to re-prescribe it for new patients due to its durability and tolerability. The shift to 85% first-line new patient starts indicates success in converting prescribers to the frontline setting. Adverse event-driven discontinuations remain low, in line with clinical trial data, supporting patient persistence on therapy.

“When KOLs have used IBTROZI, we have found that when they do get another loss location, having used IBTROZI, they're very, very likely to re-prescribe it.”

asked by David Nierengarten · answered by David Hung