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]

Summary of Nuvation Bio Conference Call Company Overview - **Company**: Nuvation Bio - **Focus**: Development of innovative therapies, particularly in oncology, with a strong emphasis on ROS1 inhibition for non-small cell lung cancer [1][2] Key Points and Arguments Drug Development and FDA Approval - Nuvation Bio is on the verge of receiving FDA approval for its first drug, **telotrectinib**, a ROS1 inhibitor targeting ROS1-driven non-small cell lung cancers [3][4] - The New Drug Application (NDA) was submitted last year and accepted with priority review, with a PDUFA date set for **June 23** [4][9] - Telotrectinib shows an **overall response rate of 89%** and a **progression-free survival (PFS) of 46 months**, significantly outperforming standard care options [5][10] Patient Outcomes - The drug has demonstrated long-term PFS, with some patients remaining progression-free for **up to nine years** [6][10] - The average age of patients with ROS1 lung cancer is around **50 years**, with a significant number developing brain metastases early in the disease [4][5] Competitive Landscape - Nuvation Bio is the only ROS1 agent in development with **breakthrough designation** in both first and second-line settings [8][36] - The company has a robust safety database with over **400 patients** and a follow-up time of up to **nine years** [37] Market Opportunity - The potential market for telotrectinib is estimated at nearly **$4 billion annually** based on current DNA testing, with expectations to exceed **$5 billion** once RNA testing becomes standard [24][25] - The company anticipates commanding a significant share of this market due to its favorable drug profile [25] Launch Preparations - The commercial team is fully prepared for an immediate launch upon FDA approval, leveraging prior experience from successful launches at Medivation [18][20] - The team is confident in the drug's value proposition and market opportunity, despite acknowledging that launches can be challenging [23] Regulatory Changes - Recent updates to NCCN guidelines now contraindicate the use of immunotherapy for patients with ROS1 mutations, which is expected to shift treatment dynamics significantly [14][15] Pipeline and Future Developments - Nuvation Bio is also developing **safacitinib**, a mutant IDH1 inhibitor, which has shown promising response rates in glioma [39][40] - The company is exploring the potential of safacitinib as a new generation oral immuno-oncology agent [42] - The drug-drug conjugate platform, including candidate **1511**, is currently in clinical trials for various difficult-to-treat cancers [45] Financial Position - Nuvation Bio has **$62 million** on its balance sheet and expects to access an additional **$250 million** in non-dilutive capital upon approval [47] - The company is actively seeking new opportunities to bolster its pipeline, with a focus on innovative deals [48] Additional Important Insights - The launch in China has been positively received, with endorsements from medical organizations, indicating strong potential for international markets [32][33] - The company is committed to increasing awareness and testing rates for ROS1 mutations, which could further enhance patient identification and treatment rates [28][29] This summary encapsulates the critical insights from the Nuvation Bio conference call, highlighting the company's strategic positioning, drug development progress, and market opportunities.

Nuvation Bio (NUVB) Q1 2025 Earnings Call May 07, 2025 04:30 PM ET Company Participants Robert DeVita - Executive Director, Corporate Development & IRDavid Hung - Founder, President & CEOColleen Sjogren - Chief Commercial OfficerPhilippe Sauvage - CFOMichael Yee - Managing Director Conference Call Participants Gregory Renza - Director & Senior Analyst of Biotechnology Equity ResearchKaveri Pohlman - Managing Director, Senior Equity Research AnalystSoumit Roy - Biotech Research AnalystYaron Werber - Managing ...

Nuvation Bio (NUVB) Q1 2025 Earnings Call May 07, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome to the Nuvation Bio First Quarter twenty twenty five Financial Results and Business Update Conference Call. Please be advised that today's conference call is being recorded. At this time, all participants are in a listen only mode. Following the formal remarks, we will open the call for questions. I would now like to turn the call over to J. R. DeVita, Executive Director of Corporate Development and Inves ...