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Nuvation Bio (NUVB) investor relations material

Nuvation Bio Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary3 Nov, 2025

Executive summary

  • Achieved first full commercial quarter post-FDA approval of atrozine/IBTROZI in June 2025, with 204 new patient starts and rapid adoption in ROS1-positive NSCLC; regulatory approvals also obtained in Japan and China.

  • Expanded global reach with ongoing commercialization in China and advanced discussions for European partnerships.

  • Significant pipeline progress with initiation of pivotal phase III study for saflosotinib/safusidenib in high-grade IDH1-mutant glioma and continued development of NUV1511.

  • Net loss for Q3 was $55.8 million, reflecting increased R&D and SG&A investments.

Financial highlights

  • Q3 2025 total revenue was $13.1 million, including $7.7 million in U.S. atrozine/IBTROZI sales and $5.4 million in collaboration/license revenue.

  • Gross profit for Q3 2025 was $9.8 million; gross margin was approximately 74%.

  • R&D expenses were $28.8 million; SG&A expenses were $37.4 million, reflecting commercialization investments.

  • Cash, cash equivalents, and marketable securities totaled $549 million as of September 30, 2025.

  • Net loss per share was $0.16 for Q3 2025.

Outlook and guidance

  • Not providing formal net revenue guidance, but annualized net revenue from Q3 patient starts would exceed $55 million if patients remain on therapy for 12 months.

  • Confident in consensus estimates for 2026 of $115 million in revenue, with significant growth potential as first-line adoption increases.

  • $25 million milestone payment expected from Japan upon reimbursement price establishment by year-end.

  • Anticipates taletrectinib listing on China’s National Reimbursement Drug List in 2026.

  • Update from NUV-1511 Phase 1/2 study expected by year-end 2025.

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Frequently asked questions

Nuvation Bio Inc. is a clinical-stage biopharmaceutical company dedicated to addressing some of the most significant unmet needs in oncology. The company is focused on the development of differentiated and novel therapeutic candidates, aiming to significantly change the practice of oncology through medicines that offer meaningful improvements in quality of life and survival for cancer patients. Nuvation Bio's approach includes a wholly-owned deep pipeline of six differentiated and novel investigational oncology therapeutic candidates targeting critical pathways that cancer cells use for growth. The company is headquartered in New York, New York, and its shares are listed on the NYSE.

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