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 Q2 2025, the company reported total revenue of $4.8 million, which includes $1.2 million in net product revenue from Iptrozy during the first 13 business days post-FDA approval [25][26] - R&D expenses for the quarter were $27.4 million, while SG&A expenses were $38.5 million, primarily driven by commercial build-out efforts [28] Business Line Data and Key Metrics Changes - The company achieved a significant milestone with the FDA approval of Iptrozy, a ROS1 TKI, which is now indicated for adults with ROS1 positive non-small cell lung cancer [5][6] - As of July, 70 patients had started treatment with Iptrozy, reflecting a strong early adoption rate [10][28] Market Data and Key Metrics Changes - The NCCN added Iptrozy as a preferred agent for ROS1 positive non-small cell lung cancer, enhancing its competitive position [6][7] - Early engagement with payers has resulted in confirmed coverage for Iptrozy from payers representing 58% of covered lives [7] Company Strategy and Development Direction - The company aims to increase awareness of ROS1 testing and ensure appropriate targeted therapy is administered, with an estimated 3,000 advanced ROS1 positive NSCLC patients diagnosed annually in the U.S. [19][20] - The company is also developing sacrocitinib for IDH1 mutant glioma, which presents a potentially larger market opportunity than ROS1 positive NSCLC [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Iptrozy becoming the standard of care for ROS1 positive NSCLC, citing strong early uptake and positive feedback from physicians [32] - The company is focused on executing its commercial strategy while advancing its pipeline of therapies [32] Other Important Information - The company ended the quarter with $607.7 million in cash and equivalents, bolstered by a financing agreement providing up to $250 million in non-dilutive capital [29][30] - The company plans to provide updates on its pipeline, including sacrocitinib and NUV1511, later this year [24][31] Q&A Session Summary Question: Guidance on next quarter sales and patient enrollment - Management indicated that the current rate of patient enrollment appears to be increasing, with about three new patients per day in early August compared to two per day in July [36][37] Question: Expected data at the Lung Cancer Conference - The company will provide updates on TRUST one and TRUST two data, including efficacy and safety, but has not yet decided on a new data cutoff [39] Question: Impact of NCCN guidelines on physician prescribing - Management confirmed that the rapid inclusion of Iptrozy in NCCN guidelines has positively influenced discussions with physicians and payers [43][44] Question: Breakdown of patients on Iptrozy - Approximately 90% of the 70 patients on Iptrozy were new patient starts, with only six patients enrolled in the early access program [56] Question: Revenue recognition from Japanese approval - The company expects to recognize a $25 million milestone payment from its partner in Japan as revenue, pending assessment of performance obligations [63][64]

Nuvation Bio (NUVB) Conference Call Summary Company Overview - Nuvation Bio is focused on developing small molecules with a strong pipeline built through acquisitions [5][6] - Key assets include teletrektinib (ROS1 targeted inhibitor) with a PDUFA date of June 23, and sapucitanib (IDH1 for glioma) [5][6][8] Pipeline and Product Development - Teletrektinib has received breakthrough designation for first and second line treatments and is already approved in China [8][9] - Clinical data for teletrektinib shows 46 months of progression-free survival (PFS), 44 months of duration of response (DOR), and an 89% overall response rate [10] - The company is working on pivotal trials for sapucitanib and has shown promising Phase I results [6][55] Market Landscape and Treatment Guidelines - There are approximately 3,000 patients diagnosed annually in the U.S. with ROS1 mutations, but current treatment rates are low [12][14] - Recent changes to NCCN guidelines now recommend testing for ROS1 mutations and switching to targeted agents if found [19][20] - The company believes that the profile of teletrektinib will encourage physicians to change their prescribing behavior [17][18] Competitive Positioning - Teletrektinib is positioned as a superior option compared to existing ROS1 TKIs, which have lower response rates and shorter PFS [11][22] - The safety profile of teletrektinib is expected to be better than competitors, particularly regarding CNS side effects [23][27] Financial Position and Funding - Nuvation Bio has a strong cash position of approximately $460 million, bolstered by a recent non-dilutive financing of $250 million [36][37] - The company does not anticipate needing to raise additional cash, aiming for profitability with current resources [38] International Expansion - Nuvation Bio has licensed teletrektinib to Innovent in China and Nippon Kayaku in Japan, with ongoing discussions for partnerships in Europe [45][46] Future Outlook and Metrics - The company plans to disclose patient numbers and real-world testing rates as key metrics for measuring the success of the launch [47] - Upcoming data releases for sapucitanib are anticipated in the second half of the year, with a focus on both low and high-grade glioma [55][56] Regulatory Interactions - Nuvation Bio reports normal and professional interactions with the FDA, expressing confidence in approval by the PDUFA date [58][59] Drug Conjugate Programs - The company has completed dose escalation for its drug-drug conjugate program and expects to release results by the end of the year [60][61]