Nuvation Bio (NUVB) investor relations material

Executive summary

• Q3 revenue was $45.0M, up from $13.1M YoY, led by $27.5M in IBTROZI U.S. product revenue and $17.5M in collaboration and license revenue.

• IBTROZI led advanced ROS1+ NSCLC in new patient starts and active patients across treatment lines; Q3 U.S. product revenue rose 18% QoQ.

• Safusidenib advanced across Phase 2 and pivotal Phase 3 programs; FDA granted Fast Track designation in August 2026.

• Net loss narrowed to $41.9M from $55.8M YoY, while cash, cash equivalents and marketable securities totaled $663.4M at quarter-end.

Financial highlights

• Q3 revenue was $45.0M vs. $13.1M YoY: $27.5M product revenue vs. $7.7M and $17.5M collaboration and license revenue vs. $5.4M.

• 9M revenue was $159.9M vs. $21.0M YoY, including $69.2M product revenue and $90.7M collaboration and license revenue.

• Q3 operating loss was $42.2M vs. $56.4M; net loss was $41.9M vs. $55.8M, or $(0.12) vs. $(0.16) per share.

• 9M operating loss was $89.4M vs. $179.0M; net loss was $99.3M vs. $168.0M, including a $9.5M debt-extinguishment loss in 2026.

• Q3 total costs and expenses were $87.2M, including R&D of $32.7M and SG&A of $42.6M.

Outlook and guidance

• Existing cash, cash equivalents and marketable securities were expected to fund operating expenses and capital needs for at least 12 months after issuance of the financial statements.

• Management said current revenue projections and the operating plan provide sufficient capital to reach profitability; additional funding may still be needed for development and commercialization.

• Safusidenib response-rate data from grade 3 oligodendroglioma and post-vorasidenib studies may begin in 2027; randomized PFS readouts are expected in 2029 or later.

• Further updates on preclinical drug-drug conjugate candidates, including plans to advance the program toward the clinic, were targeted by year-end 2026.