Nuvation Bio — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the three months ended September 30, 2026, was $45.0 million, compared to $13.1 million in the same period of 2025.
• Net product revenue from U.S. sales of IBTROZI was $27.5 million, representing an 18% quarter-over-quarter growth.
• Collaboration and license agreements revenue was $17.5 million, an increase from $5.4 million in the prior year period, driven by a $7.6 million increase in product supply revenue, a $5.0 million sales milestone from Innovent, and a $2.4 million increase in royalty revenue.
• Research and development expenses were $32.7 million, up from $28.8 million in the prior year period.
• Selling, general and administrative expenses were $42.6 million, up from $37.4 million in the prior year period.
• Net loss for the quarter was $41.9 million, or $(0.12) per share, compared to a net loss of $55.8 million, or $(0.16) per share, in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $663.4 million as of September 30, 2026.
• Total assets were $778.4 million as of September 30, 2026, compared to $594.8 million as of December 31, 2025.
• Total liabilities were $550.4 million as of September 30, 2026, compared to $289.1 million as of December 31, 2025.
• Convertible debt, net of deferred financing costs, was $279.5 million as of September 30, 2026.

Guidance and Future Outlook:

• The company aims to provide further updates on its drug-drug conjugate (DDC) platform by year-end 2026.
• The TRUST-IV Phase 3 study for IBTROZI in adjuvant treatment of early-stage ROS1+ NSCLC has a primary completion date estimated to be in 2030.
• The company plans to advance its comprehensive development program for safusidenib across multiple IDH1-mutant glioma subpopulations.

Business Segments and Product Lines:

• IBTROZI (taletrectinib):
  • Established as the market leader in advanced ROS1+ NSCLC for new patient starts and total active patients in both first-line and all lines of therapy combined, based on IQVIA claims data.
  • New patient starts in Q3 2026 remained consistent at approximately 160 patients, despite a 15% quarter-over-quarter decline in the overall ROS1+ NSCLC TKI market.
  • 65% of new patient starts were TKI-naïve, indicating adoption as standard of care in the first-line setting.
  • FDA approved a supplemental New Drug Application (sNDA) in September 2026, updating the label to reflect a median duration of response of 49.7 months in TKI-naïve patients.
  • Taletrectinib was included in China's National Reimbursement Drug List effective January 1, 2026.
• Safusidenib:
  • Received FDA Fast Track Designation in August 2026 for the treatment of IDH1-mutant glioma.
  • Updated Phase 2 J201 data showed a centrally assessed objective response rate (ORR) of 51.9% and a 36-month progression-free survival (PFS) rate of 79.1% in chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma patients.
  • Initiated pivotal Phase 3 study (G307) in patients with grade 2 IDH1-mutant glioma outside the U.S.
  • Initiated Phase 2 study (G209) in patients with IDH1-mutant glioma that has progressed after prior treatment with vorasidenib in the U.S.
  • Expanded the pivotal Phase 3 SIGMA study to include sites in the United Kingdom, France, Sweden, Germany, Italy, and Spain.
• Drug-Drug Conjugate (DDC) Platform:
  • Continuing to explore new preclinical candidates with updates expected by year-end 2026.

Market and Competitive Landscape:

• IBTROZI demonstrated growth in new patient starts while the broader ROS1+ NSCLC TKI market saw a 15% decline in new starts quarter-over-quarter.
• The company highlights the significant unmet need in IDH1-mutant glioma and the potential for safusidenib to address it.

Risks and Challenges:

• Forward-looking statements include risks related to commercializing IBTROZI, challenges in drug discovery and clinical studies, regulatory delays, subject enrollment difficulties, manufacturing issues, and adverse events.
• Specific safety warnings for IBTROZI include hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with CPK elevation, skeletal fractures, and embryo-fetal toxicity.

Management Commentary and Tone:

• CEO David Hung, M.D., stated that IBTROZI's rapid rise to market leadership reflects growing provider confidence in its durability and favorable safety profile.
• Management noted that the FDA's Fast Track Designation for safusidenib underscores the significant unmet need in IDH1-mutant glioma.
• The tone regarding IBTROZI is confident, citing its establishment as standard of care and clear data to guide treatment decisions.

Other Key Points:

• In July 2026, the company fully exercised the greenshoe option on its offering of 0.75% Convertible Senior Notes due 2032, increasing the aggregate principal amount sold to $287.5 million with net proceeds of approximately $279.1 million.
• Royalty revenue from collaboration agreements for China and Japan was $2.7 million for the quarter.
• The company hosted a conference call on November 4, 2026, to discuss results.
• The TRUST clinical program includes TRUST-I and TRUST-II (Phase 2), TRUST-III (Phase 3 confirmatory in China), and TRUST-IV (Phase 3 adjuvant).