Nuvation Bio (NUVB) Jefferies London Healthcare Conference 2024 summary

Pipeline overview and clinical progress

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

• Taletrectinib, a next-gen ROS1 inhibitor, submitted for NDA in October; commercial launch expected mid-2025.

• Safusidenib, a mutant IDH1 inhibitor, shows promising phase II results in glioma; pivotal study planning underway.

• NUV-1511, a drug-drug conjugate, is in phase I targeting five high-need cancer indications.

• NUV-868, a highly selective BD2 BET inhibitor, completed phase I/II; future development depends on external approvals.

Taletrectinib efficacy, safety, and market potential

• Demonstrated 89% response rate and 46-month median PFS in ROS1-positive NSCLC, outperforming competitors.

• Breakthrough designation granted in both first- and second-line settings by FDA and Chinese NMPA.

• Superior intracranial response rate (66%) and lower CNS toxicity compared to repotrectinib.

• Discontinuation rate of 7%, among the lowest for ROS1 TKIs; favorable safety profile.

• U.S. market opportunity estimated at nearly $4 billion annually by year four due to long PFS and patient prevalence.

Regulatory and competitive landscape

• NDA for taletrectinib submitted in October; acceptance expected by year-end, approval anticipated mid-2025.

• TRUST-II pivotal study was global, with majority non-Chinese patients; extensive FDA engagement.

• Repotrectinib sales remain low due to CNS toxicity, positioning taletrectinib for better adoption.

• Plans to launch in the U.S. and partner in Europe; royalty agreements in China and Japan.