Nuvation Bio (NUVB) investor relations material

Strategic overview and product performance

• IBTROZI, a ROS1 inhibitor, has demonstrated a 90% response rate and 15-month duration of response in first-line oncology, unmatched by competitors.

• The drug's tolerability is high, with a 6.5% discontinuation rate and minimal adverse events.

• Revenue stacking from long duration of response could drive annual sales from $1B to $4B, potentially exceeding $5B as RNA testing becomes standard.

• IBTROZI has captured 20% of the ROS1 market within a year, with further growth expected as NCCN guidelines shift and testing rates improve.

• Market expansion is targeted through physician education, patient advocacy, digital marketing, and partnerships with healthcare organizations.

Competitive landscape and market dynamics

• IBTROZI is now the only ROS1 agent without CNS warnings, providing a significant safety advantage over new entrants.

• Competitors face higher CNS toxicity and other adverse events, making IBTROZI more attractive for long-term use.

• The main competition remains IO chemo and under-testing, not other ROS1 agents.

• Physician experience and positive outcomes are driving repeat prescriptions and deeper market entrenchment.

Pipeline and clinical development

• Safusidenib, an IDH1 inhibitor for glioma, shows a 79% non-progression rate and increasing response rates at three years, outperforming competitors.

• Four clinical trials target all glioma subtypes, with two response rate trials potentially reading out before 2029.

• Safusidenib may have immune-modulating effects, distinguishing it from other IDH1 inhibitors.

• The company aims to capture the entire glioma market, not just the segment addressed by VORANIGO.

• Enrollment for key trials is on track, with sufficient patient pools and strong clinical rationale for success.