Nuvation Bio (NUVB) Jefferies 2024 Global Healthcare Conference summary

Strategic developments and acquisitions

• Recent acquisition of AnHeart transformed the company into a late clinical stage, global oncology player, adding taletrectinib and safusidenib to the pipeline.

• Robust cash balance of nearly $600 million supports transition to a commercial organization by 2025.

• Acquisition of AnHeart was facilitated by unique circumstances during the China lockdown and a stock-based deal, positioning the company favorably.

Pipeline and clinical progress

• Taletrectinib, a ROS1 inhibitor, is completing two pivotal studies (TRUST-I in China, TRUST-II globally) with NDA filings and commercial launch targeted for next year.

• Safusidenib, a brain-penetrant mutant IDH1 inhibitor, is in phase II for IDH1 mutant glioma, showing higher response rates than the only approved competitor.

• NUV-868, a BD2 selective BET inhibitor, is in phase I combination studies, showing promising preclinical synergy with enzalutamide and PARP inhibitors.

• NUV-1511, a novel drug-drug conjugate, entered the clinic in March and is being tested in five hard-to-treat tumor types.

Taletrectinib clinical data and competitive positioning

• TRUST-I and TRUST-II studies together represent one of the largest datasets for ROS1-positive lung cancer, with consistent efficacy across Chinese and Western populations.

• Taletrectinib demonstrated a 91% overall response rate in TKI-naïve patients and 52% in TKI-experienced patients, with strong intracranial efficacy.

• Safety profile is favorable, with a 5% discontinuation rate and lower neurological toxicity compared to competitors.

• Priority review and breakthrough therapy designations have been granted in China and the U.S., with launch anticipated next year.