Nuvation Bio (NUVB) investor relations material

Commercial and clinical progress

• Achieved commercial stage status with the launch of Iptrozi (Taltrectinib) for ROS1+ non-small cell lung cancer, recording 204 new patient starts in the first full quarter, six times higher than the previous generation competitor.

• Iptrozi demonstrated a nearly 90% response rate and a progression-free survival (PFS) of 50 months, with a highly favorable tolerability profile and minimal discontinuations.

• Market opportunity for Iptrozi estimated at $1 billion annually, potentially rising to over $5 billion with improved RNA-based testing and broader patient screening.

• Early payer coverage for Iptrozi reached 80% to label, with expectations for further increases as adoption grows and NCCN guidelines now contraindicate IO chemo in ROS1 disease.

• An adjuvant study for Iptrozi in early-stage ROS1 lung cancer has begun, aiming to expand the market by approximately 30%.

Pipeline and innovation

• Safusidenib, an IDH1 mutant glioma inhibitor, showed a 44% response rate and only 12% progression at two years in low-grade glioma, outperforming the only approved competitor.

• In high-grade glioma, Safusidenib achieved a 17% response rate, including complete responses in aggressive tumors, with durable remissions observed.

• The pivotal study for Safusidenib targets both high-grade and high-risk low-grade glioma, with a primary endpoint of PFS and readout expected by 2029.

• Safusidenib’s tolerability profile is favorable, with mostly grade 1/2 immune-related adverse events, suggesting potential immune activation benefits.

• The glioma market is split evenly between high- and low-grade, with long durations of therapy supporting significant revenue stacking potential.

Financial position and strategic outlook

• Ended the third quarter with $550 million in cash, supported by a $150 million synthetic royalty and $50 million debt financing, providing ample runway to profitability.

• Current patient starts alone could generate $220 million in annual revenue, even without further growth, supporting a strong path to profitability.

• Additional capital is available for R&D and potential asset acquisitions.