Nuvation Bio (NUVB) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Clinical program highlights

• Four clinical programs: taletrectinib (late-stage), safusidenib (mid-stage), NUV-1511 and NUV-868 (early-stage).

• Taletrectinib, a next-gen ROS1 inhibitor, shows 89% response rate and nearly 4-year median PFS in ROS1+ NSCLC.

• Safusidenib, a mutant IDH1 inhibitor, demonstrates 33% response in low-grade glioma and 17% in high-grade glioma.

• NUV-1511, a drug-drug conjugate, targets five hard-to-treat cancers and is in phase I/II.

• NUV-868, a highly selective BD2 BET inhibitor, is in phase I/II with promising tolerability.

Competitive positioning and efficacy

• Taletrectinib outperforms approved ROS1 TKIs in efficacy and durability, with favorable safety and low discontinuation rates.

• Shows higher intracranial response and resistance mutation efficacy compared to competitors.

• Safety profile is superior, with lower CNS toxicity than repotrectinib.

• Safusidenib's efficacy in glioma surpasses recently approved vorasidenib, especially in high-grade cases.

• DDC platform offers oral/IV bioavailability and targets both intra- and extracellular cancer targets.

Commercial strategy and market opportunity

• NDA for taletrectinib to be filed in Q4, with US launch planned next year; breakthrough designations in US and China.

• ROS1+ NSCLC US market estimated at $1B annually, with potential for revenue stacking due to long PFS.

• Commercial team assembled from Medivation; launch to focus on academic centers.

• Royalties expected from Innovent (China) and Nippon Kayaku (Japan) for taletrectinib.

• IDH1 mutant glioma market is five times larger than ROS1, with long treatment durations.