Nuvation Bio (NUVB) FY Conference Transcript

Summary of Nuvation Bio (NUVB) FY Conference Call - May 28, 2025 Company Overview - Company: Nuvation Bio (NUVB) - Focus: Oncology, specifically targeting ROS1 positive lung cancer with the drug telotrectinib Key Industry Insights - Upcoming Events: Important PDUFA date for telotrectinib on June 23, 2025, and presentation at ASCO meeting regarding TRUST datasets [5][6] - Market Dynamics: Changes in NCCN guidelines have shifted treatment recommendations, potentially increasing the use of ROS1 agents [19][20] Core Data and Findings - TRUST Studies: TRUST one (China) and TRUST two (global) datasets show consistent efficacy and safety across different ethnic groups, with response rates of 89% in TKI naive patients and 52% in pretreated Asian patients [6][7][10] - Comparative Efficacy: Telotrectinib demonstrated a 58% reduction in risk of disease progression and a 52% reduction in risk of death compared to Roslitech, and a 52% reduction in PFS and 66% reduction in risk of death compared to crizotinib [11][12] - Intracranial Response Rates: 77% in naive patients and 66% in pretreated patients, highlighting the drug's effectiveness in addressing CNS metastases [16][17] Market Opportunities and Challenges - Sales Growth: TKI sales have increased by 20% since the new NCCN guidelines, indicating a growing market for ROS1 agents [20][21] - Tolerability Issues: Oktyra has faced challenges due to tolerability, with a 30% dropout rate per quarter, emphasizing the importance of good tolerability for long-term use [21][22] - Patient Switching Dynamics: Patients on first-generation TKIs may switch to telotrectinib if they experience intolerable side effects or disease progression [34][36] Regulatory and Approval Insights - FDA Interactions: Positive and responsive interactions with the FDA under breakthrough designation, with expectations for approval by the PDUFA date [37][38] - Labeling Discussions: Ongoing discussions regarding labeling, with no advisory committee required for approval [39][40] Future Plans and Partnerships - European Market: Actively seeking partnerships in Europe, with existing partnerships in Japan and China for telotrectinib [50][51] - Pricing Strategy: Anticipated pricing to be similar to existing competitors, with a monthly cost around $30,000 [53] Additional Research and Development - IDH1 Mutant Product: Ongoing phase two study for glioma, with plans for a pivotal study based on upcoming data [57][62] - Response Rates in Glioma: Previous ORR in low-grade glioma was 33%, significantly higher than the INDIGO study's 11% [59][60] Conclusion - Commercial Focus: Nuvation Bio is committed to launching telotrectinib effectively, leveraging experienced teams and focusing on patient therapy metrics as key indicators of success [47][48]