Nuvation Bio Inc. Q1 FY2025 earnings call

• Taletrectinib, a next-generation ROS1 inhibitor for non-small-cell lung cancer (NSCLC), has a PDUFA date of June 23, 2025. It demonstrated a confirmed ORR of 89% in treatment-naïve patients with a median PFS of 46 months and median DOR of 44 months. It has breakthrough therapy designation in first and second line settings and a new drug application under priority review with a strong data package. • Commercial team is ready with experienced members who have launched leading oncology therapies. They are preparing go-to-market initiatives like finalizing go-to-market plan, continuing medical education, optimizing patient experience, and patient support programs. • Sagard Healthcare Partners provided $250 million non-dilutive financing, strengthening cash position and flexibility. • Pipeline includes safusidenib (immune IDH1 inhibitor) with early clinical data showing deep responses in glioma, preparing for pivotal development; NUV-1511 (drug conjugate platform) in Phase 1; NUV-868 (BD2-selective BET inhibitor) with good tolerability and target selectivity.

No detailed financial performance by product segments provided in the transcript. Focus is on taletrectinib and pipeline programs like safusidenib, NUV-1511, NUV-868.

• Confident in taletrectinib approval on or before PDUFA date of June 23, 2025. • Post-approval, primary KPI will be number of patients on therapy as a leading indicator of adoption. • Cash position, including Sagard financing, is solid, providing flexibility for execution and strategic moves. • No revenue guidance provided, but focusing on patients helped and metrics like time to treatment initiation, coverage approval rates, and testing related metrics.

• Uncertainties in clinical trial outcomes and regulatory approvals. • Competition in the oncology space. • Challenges in patient identification and adoption of taletrectinib in the market. • Potential differences in market reception and adoption rates compared to historical oncology drugs.

Q: Greg Renza asked about prioritization of taletrectinib's features, NCCN guidelines tailwind, and pricing.

A: David Hung said progression-free survival and duration of response are key metrics, NCCN guidelines change is a tailwind, and pricing will be announced post-approval.

Q: Kaveri Pohlman asked about CNS disease and taletrectinib use.

A: David Hung said taletrectinib is intended for first line use due to strong PFS and DOR, and CNS activity supports upfront use.

Q: Soumit Roy asked about physician education and adoption rates.

A: David Hung said physician education is important, and adoption is not rapid but confident in compelling profile.

Q: Michael Yee asked about expanded access program and safusidenib data.

A: David Hung said EAP details not publicized yet, and safusidenib data is compelling with plans for pivotal study.

Q: Yaron Werber asked about taletrectinib patient breakdown and safusidenib data release.

A: David Hung said patient data is well balanced across demographics, and safusidenib data release depends on agency approval.

Q: Unidentified Analyst asked about learnings from China launch and market expansion.

A: Colleen Sjogren said team has different strategy and confident in execution, and team has experience in complex markets.