Nuvation Bio (NYSE:NUVB) Q3 2025 Earnings Call November 03, 2025 04:30 PM ET Speaker1Hello and welcome to Nuvation Bio's third quarter 2025 financial result and corporate update call. Today's call is being recorded, and a replay will be available. All participants are currently in a listen-only mode. A brief question-and-answer session will follow the prepared remarks. Now I'd like to turn the call over to J.R. DeVita, Executive Director of Corporate Development and Investor Relations at Nuvation Bio. Pleas ...

Financial Data and Key Metrics Changes - For Q1 2025, the company reported R&D expenses of $24.6 million, reflecting continued investments in lead assets and clinical stage pipeline [31] - SG&A expenses were $35.4 million, primarily driven by pre-commercial build-out, including personnel-related expenses tied to commercial hiring [31] - The net loss for the quarter increased compared to the prior year, with a cash position of $461.7 million at the end of the quarter, not including proceeds from a recent financing agreement [32][34] Business Line Data and Key Metrics Changes - The company is preparing for the potential approval of telotrectinib, a next-generation ROS1 inhibitor for non-small cell lung cancer, with a PDUFA date set for June 23, 2025 [6][18] - Telotrectinib has demonstrated a confirmed overall response rate (ORR) of 89% in treatment-naive patients and a median progression-free survival (PFS) of 46 months [10][12] - The drug's safety profile is favorable, with a low discontinuation rate of 6.5% due to treatment-emergent adverse events [16] Market Data and Key Metrics Changes - ROS1 positive non-small cell lung cancer is estimated to affect approximately 2% of newly diagnosed non-small cell lung cancer patients, translating to about 3,000 new patients each year in the U.S. [24] - First-generation ROS1 TKIs like crizotinib and entrectinib generate less than $150 million in annual U.S. net sales, indicating significant unmet needs in the market [25] Company Strategy and Development Direction - The company aims to challenge the status quo in cancer treatment by providing better drugs that impact efficacy, safety, and convenience [7] - The commercial strategy focuses on ensuring quick access to telotrectinib for patients and maximizing long-term value through its impressive clinical profile [24][30] - The company has secured a $250 million non-dilutive financing agreement to support the launch of telotrectinib and advance its broader pipeline [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data supporting telotrectinib and the readiness of the team for the upcoming launch [39] - The new NCCN guidelines are expected to serve as a tailwind for the drug, emphasizing the need for ROS1 therapies over traditional IO chemotherapy [49] - The company believes that the market is ready for new alternatives, with telotrectinib positioned to reshape the ROS1 landscape if approved [19] Other Important Information - The company is also developing saclucitanib for diffuse IDH1 mutant glioma, with early clinical data suggesting deeper responses than other agents in this class [20][21] - The company is preparing to move saclucitanib into pivotal development this year, indicating a strong pipeline beyond telotrectinib [21] Q&A Session Summary Question: Can you discuss the tailwinds for the launch and how you prioritize them? - Management highlighted that duration of response and progression-free survival are key metrics for patients and physicians, positioning telotrectinib favorably against historical oncology agents [44] Question: What is the pricing strategy for telotrectinib? - Management indicated that pricing discussions are ongoing, with plans to announce the price shortly after the anticipated approval [50] Question: What is the targeted account strategy for ROS1 patients? - Management refrained from disclosing specific strategies but expressed confidence in their approach and the team's experience [58] Question: How does the company plan to address physician education regarding telotrectinib? - Management acknowledged the importance of physician education and emphasized that the drug's compelling data will incentivize prescriptions [70] Question: What are the expectations for the expanded access program (EAP)? - Management does not expect a large bolus from the EAP but remains confident in the overall launch strategy [85]