Nuvation Bio (NUVB) Corporate presentation summary

Commercial profile and launch

• IBTROZI (taletrectinib) is approved line-agnostically for advanced ROS1+ NSCLC in the U.S., Japan, and China; EMA MAA validated.

• U.S. net product revenue reached $27.5m in Q3'26; cumulative revenue was $94m and new patient starts ~920 through September 30, 2026.

• More than 60% share of new first-line patient starts; ~480 first-line starts since launch, with broad favorable U.S. coverage.

• Theoretical maximum U.S. market opportunity estimated at ~$3.8bn, based on ~3,000 annual patients, ~$350,000 annual gross price, and IBTROZI's median PFS; excludes discounts, uptake, access, and other factors.

IBTROZI clinical profile

• First-line pooled TRUST-I/II data: ORR 90%, median DOR 50 months, median PFS 46 months, and intracranial confirmed ORR 77%.

• Second-line pooled data: ORR 56%, median DOR 17 months, median PFS 10 months, and intracranial confirmed ORR 66%.

• No CNS warning appears in the IBTROZI label, unlike other approved brain-penetrant ROS1 TKIs; 6.5% of 337 pivotal-study patients discontinued for a TEAE.

• 2026 NCCN guidelines added taletrectinib as a preferred first-line ROS1 therapy.

Safusidenib and glioma pipeline

• Safusidenib is a brain-penetrant IDH1 inhibitor being studied across IDH1-mutant glioma grades and risk groups; global rights include Japan, acquired from Daiichi Sankyo in April 2026.

• Phase 2 low-grade data showed 36-month PFS of 79%; a separate Phase 1 high-grade study reported 17% confirmed ORR, including two complete responses.

• SIGMA pivotal study enrolls high-risk IDH1-mutant astrocytoma; potential data update in 2029. A grade 3 oligodendroglioma subgroup update is expected in 2027.

• A Phase 2 post-vorasidenib study and a Phase 3 grade 2 IDH1-mutant glioma study were also outlined, with potential updates in 2027 and 2029, respectively.