Nuvation Bio Inc. (NUVB) Earnings

Management highlights

### Ibtrozi Commercial Launch Progress - Ibtrozi is now the market leading ROS1 TKI in first-line and overall new patient starts for advanced/metastatic ROS1-positive lung cancer, with 85% of Q2 new patient starts in the first-line setting (up from 30% at launch 12 months prior), and 30% quarter-over-quarter growth in first-line new patient starts. - Ibtrozi holds a unique differentiated profile: it is the only brain-penetrant ROS1 TKI with no CNS adverse reaction warnings on its label, with 90% objective response rate (ORR) and a 50-month median duration of response (DOR) and median progression-free survival (PFS) in first-line patients, a durability profile unmatched by any other approved therapy in this indication. - Growth is broad-based across academic, community and integrated delivery network (IDN) practice settings, with academic accounts contributing 50% of current business. The total first-line ROS1 TKI market has grown ~20% since Ibtrozi's launch, driven by increased provider adoption of targeted therapy over chemotherapy/immunotherapy per updated guidelines. ### Safucitinib (IDH1 Mutant Glioma) Pipeline Expansion - Updated Phase II J201 data for safucitinib in treatment-naive grade 2 IDH1 mutant gliomas showed a 52% ORR (up from 44% at earlier follow-up) and 79% 36-month PFS rate, with no new safety signals, results that compare favorably to competing agent voracitinib's 21% ORR and 52% 36-month PFS rate. - The company expanded the clinical development program to cover all four grades and risk segments of IDH1 mutant glioma, adding two new studies: G307, a Phase III trial for low-grade low-risk disease outside the US, and G209, a Phase II trial for patients progressing after voracitinib treatment in the US, which addresses a growing unmet need. - The program now evaluates tumor growth rate (TGR) as an earlier surrogate efficacy endpoint to potentially read out clinical benefit sooner than ORR. ### Corporate & Financial Updates - The company completed a 5x oversubscribed 0.75% convertible senior notes offering, generating ~$279.1 million in net proceeds. Proceeds were used to retire higher-cost existing term debt, lowering annual interest expense, with remaining capital strengthening the balance sheet for pipeline execution and strategic business development opportunities. - The drug-drug conjugate (DDC) platform remains on track to provide a clinical development plan update by the end of 2026.

Guidance

- Management reaffirmed that current cash and capital position is sufficient to fund Ibtrozi commercial growth, the expanded safucitinib development plan, and DDC platform advancement, and to reach profitability ahead of the expected launch of safucitinib. - No changes to planned 2026 spending levels; R&D investment will continue to support the expanded safucitinib program and DDC platform, while SG&A will support Ibtrozi commercialization. - Topline data from the two Phase III safucitinib studies (SIGMA and G307) is expected in 2029. - Ibtrozi approval in the EU is expected in the first half of 2027 (late Q1/early Q2), triggering a $30 million milestone payment from partner ATI. - Management maintained long-term expectations for a chronic disease-like revenue growth model for Ibtrozi, driven by long treatment durations for first-line patients and stacking of successive patient cohorts.

Segment performance

1. **Ibtrozi (US commercial product)**: Delivered $23.2 million in net product revenue for Q2 2026, growing 25% quarter-over-quarter, and represented 73% of total Q2 revenue. Cumulative net Ibtrozi revenue for the first half of 2026 was $41.7 million. 2. **Collaboration and license**: Generated $8.5 million in Q2 2026, representing 27% of total Q2 revenue, from royalty streams with partner companies. Total company Q2 2026 revenue was $31.7 million, with total first half 2026 revenue reaching $114.9 million.

Risks & headwinds

- Actual future results, including clinical trial outcomes, regulatory approvals, and revenue growth, may differ materially from forward-looking statements due to inherent risks and uncertainties in drug development and commercialization, detailed in the company's recently filed Form 10-Q. - Changing entrenched physician prescribing habits of using chemotherapy/immunotherapy instead of targeted therapy for first-line ROS1-positive lung cancer in community settings is gradual, which could slow near-term adoption growth. - Tumor growth rate (TGR) is not yet a validated regulatory endpoint for FDA approval, which may limit its utility for early regulatory interactions or submissions. - Market competition from newly approved ROS1 TKIs could impact Ibtrozi's market share growth, though management does not see current competing products as a material threat to Ibtrozi's leading position.

Analyst Q&A

• Q: How does GSK's newly approved ROS1 TKI G-dator's pricing and label differences impact Ibtrozi's commercial strategy? /

  A: Management was surprised to see G-dator carries CNS adverse reaction warnings, placing it in the same bucket as other competing ROS1 TKIs and leaving Ibtrozi as the only option without this labeling. G-dator's efficacy (49% ORR, 48% intracranial ORR) is inferior to Ibtrozi's (56% ORR, 66% intracranial ORR) even in the second-line setting, and G-dator's higher pricing aligns with its later-line indication. Management sees no material threat to Ibtrozi's first-line leadership, as G-dator has no published first-line data and is years behind Ibtrozi in clinical development.

• Q: How has the earlier-than-expected launch of GSK's new drug changed Ibtrozi's tactical plan, and how does one year of launch experience confirm the long-term patient stacking opportunity? /

  A: The earlier approval did not alter Ibtrozi's strategy, and seeing the full label early actually helped confirm Ibtrozi's differentiated safety advantage. The pre-treated late-line patient pool was depleted faster than expected, which confirms Ibtrozi's strong market adoption, and the business has already shifted to 85% first-line patients as planned. The patient stacking dynamic is already playing out: first-line patients stay on therapy for years, building a compounding base of active patients that drives 25% quarter-over-quarter revenue growth even as late-line volume declines, matching the expected chronic disease model.

• Q: What initiatives is Novation taking to increase ROS1 testing rates, especially in underpenetrated community settings, to drive further adoption? /

  A: Management works directly with large community oncology groups to highlight their own testing rates, which are often lower than internal leadership estimates, and many centers have already doubled testing rates after this awareness building. The company is also advocating for RNA-based testing, which is ~30% more sensitive than DNA testing for identifying ROS1 fusions, and running programs to flag positive mutation status before physicians default to chemotherapy/immunopathy. While entrenched habits persist, the strong efficacy and durability of Ibtrozi is itself driving market growth and increased testing adoption.

• Q: What is the opportunity and regulatory path for the new G209 study of safucitinib in patients that have progressed on voracitinib? /

  A: There are already over 5,500 patients on voracitinib, with ~25% expected to progress within 1.5 years, creating an immediate unmet need for ~1,250+ patients. Management expects the study will enroll 40-50 patients, and an ORR of ~20% with 6-month duration of response would be sufficient to warrant serious discussions for accelerated approval, matching the precedent of prior approved drugs in this space. The study will also evaluate TGR as an early efficacy signal to potentially read out activity sooner, and there are US and Western trial sites to support regulatory applicability, with no biological difference in IDH1 mutations across geographies.