Nuvation Bio (NUVB) investor relations material

Commercial performance and market trends

• IBTROZI's first-line patient numbers are growing at about 35% quarter-over-quarter, with over 50% of patients now in the frontline setting as of Q1, and this trend is expected to continue due to under-penetration and high demand.

• Crizotinib and entrectinib use are declining, while IBTROZI is gaining significant first-line share, outperforming competitors in efficacy and tolerability, especially in CNS control.

• Consensus for IBTROZI first-line patients is 130–140 for the year, and current growth rates are expected to meet or exceed this target.

• Increased physician familiarity and genetic testing are expected to further drive IBTROZI adoption.

• European approval is anticipated in Q1 or Q2 next year, with a €25 million milestone upon approval and potential for an additional €50 million drawdown.

Pipeline development and clinical studies

• Safusidenib is being advanced in multiple glioma subtypes, targeting areas not covered by current approvals, with studies designed for both high- and low-grade tumors and post-vorasidenib failures.

• The SIGMA study and a separate Grade 3 oligodendroglioma study are enrolling, with the latter aiming for a response rate above 20% in 40–80 patients, potentially supporting accelerated approval.

• Data from these studies are expected next year, with rapid site expansion underway.

• Post-vorasidenib failure study is being designed, targeting a population with significant unmet need and precedent for approval based on small patient numbers.

Competitive landscape and strategic outlook

• IBTROZI holds a strong position with a 90% first-line response rate and 50-month duration of response, considered unprecedented in oncology.

• Zidesamtinib is expected to launch in the second-line setting, but IBTROZI is projected to maintain a lead due to earlier market entry and more mature data.

• Business development focus is on late-stage, synergistic assets, with disciplined evaluation of global opportunities, including China.

• SG&A expenses are stabilizing post-launch, with no major fluctuations expected in the near term.