Nuvation Bio

• Nuvation Bio has successfully raised $250 million in financing to support the commercial launch of taletrectinib, a novel ROS1 inhibitor for advanced non-small cell lung cancer. • The financing package includes both equity and debt components, strengthening Nuvation Bio's position to advance taletrectinib through final development stages and commercial preparations. • This strategic funding will enable Nuvation Bio to establish its commercial infrastructure and prepare for the anticipated US market entry of taletrectinib as a targeted therapy option.

• Nuvation Bio has secured a $250 million non-dilutive financing deal with Sagard Healthcare Partners, including $150 million in royalty financing and up to $100 million in term loans. • The financing package is contingent on FDA approval of taletrectinib, a targeted therapy for ROS1-positive non-small cell lung cancer, expected in mid-2025. • The funding will fully support taletrectinib's U.S. commercial launch and ongoing clinical pipeline development without requiring additional capital raises.

The FDA granted priority review to Nuvation Bio's NDA for taletrectinib, a next-generation ROS1 inhibitor, for advanced ROS1+ non-small cell lung cancer, setting a PDUFA date of June 23, 2025.

China's NMPA has approved Innovent's taletrectinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

• China's NMPA has approved taletrectinib for treating adults with locally advanced or metastatic ROS1-positive NSCLC previously treated with ROS1 TKIs. • The approval was based on the phase 2 TRUST-I trial, which demonstrated a 51.5% ORR in patients pretreated with crizotinib, with a median DOR of 10.6 months. • Taletrectinib has also received priority review for first-line treatment of ROS1-positive NSCLC, supported by data showing a 90.6% ORR in TKI-naive patients. • Clinical trials show taletrectinib's efficacy in CNS penetration and activity against resistance mutations, offering a potential best-in-class safety profile.

• Taletrectinib demonstrated an 89% tumor shrinkage rate in TKI-naïve patients with ROS1-positive NSCLC, showcasing its high efficacy. • The drug achieved a median duration of response of 44 months and progression-free survival of 46 months in TKI-naïve patients. • Taletrectinib exhibited a favorable safety profile with a low incidence of neurologic treatment-emergent adverse events. • Nuvation Bio plans to submit an NDA to the FDA in Q4 2024, aiming for a U.S. launch in 2025.