BeyondSpring(US:BYSI)2021-06-05 04:03Plinabulin Clinical Development & Regulatory Status - Plinabulin's U S NDA for Chemotherapy-Induced Neutropenia (CIN) has been accepted with Priority Review, and a China NDA has been submitted [13] - Phase 3 DUBLIN-3 trial for Non-Small Cell Lung Cancer (NSCLC) is fully enrolled, with topline Overall Survival (OS) data expected mid-2021 [13] - PROTECTIVE-2 (Phase 3) study met primary endpoint, showing a statistically significant reduction in Grade 4 neutropenia in Cycle 1: 31 5% vs 13 6% (p=0 0015) [36] Plinabulin Commercial Opportunity in CIN - The global market for G-CSF (used in CIN prevention) is approximately $7 billion annually, involving 4 million cycles [49] - Top 3 deciles of Pegfilgrastim Patient Distribution contribute 81% of patients (~360 accounts) [54] - The combination of Plinabulin and G-CSF addresses the "Neutropenia Vulnerability Gap" (NVG) in week 1 after chemotherapy [29, 33] Plinabulin in Immuno-Oncology (I/O) - A Phase 1 study of Plinabulin + Nivolumab + Ipilimumab in Small Cell Lung Cancer (SCLC) showed an Overall Response Rate (ORR) of 46% in 13 evaluable patients [102] - In the same study, 2nd line Platinum failed patients showed ORR of 50% (3/6) and 3rd line Platinum and CPI failed patients showed ORR of 43% (3/7) [102] - The triple I/O combo is initiating Phase 1 trials in 7 cancers at MD Anderson in Q2 2021 [14, 94] Financial Position & Pipeline Expansion - The company's cash position was $109 5 million as of December 31, 2020 [9] - SEED Therapeutics, a research subsidiary, has an $800 million partnership with Eli Lilly [9]