BeyondSpring Inc. Q4 FY2020 earnings call

• Key 2020 accomplishments: Filed NDA for lead asset plinabulin in U.S. and China, built pipeline, added scientific and business leadership, and bolstered balance sheet.
• Plinabulin progress: NDA filed for CIN prevention indication, received breakthrough designation for plinabulin and G-CSF combination, DUBLIN-3 study enrolling 559 patients for non-small cell lung cancer, Phase I data on plinabulin with nivolumab and ipilimumab in small cell lung cancer, and a triple I/O combo study with PD-1/PD-L1 inhibitors, plinabulin, and radiotherapy.
• Pipeline development: Subsidiary using targeted protein degradation platform, collaboration with Eli Lilly.
• Commercial strategy: Focus on driving awareness of neutropenia vulnerability gap, positioning with key decision makers, and activating key accounts for plinabulin commercialization.

In the fourth quarter of 2020, research and development expenses were $8.4 million compared to $12.6 million in the same period prior year. General and administrative expenses were $10.4 million in Q4 2020 vs. $2.7 million in Q4 2019. Net loss attributable to BeyondSpring Inc. in Q4 2020 was $17.6 million vs. $14.1 million in the prior year. For the full year 2020, R&D expenses were $41.8 million vs. $31.3 million in 2019. G&A expenses were $22.6 million vs. $9.0 million in 2019. Net loss for the full year 2020 was $61.0 million vs. $38.1 million in 2019. As of December 31, 2020, cash and cash equivalents were $109.5 million.

• 2021 will showcase plinabulin's anti-cancer efficacy data, including topline overall survival data from the DUBLIN-3 study midyear.
• Anticipates near-term potential anticancer efficacy data from Phase III DUBLIN-3 study and early trials in immune-oncology regimes.

• Uncertainty around regulatory approval timelines for plinabulin.
• Variability in clinical trial results, especially for DUBLIN-3 and other cancer trials.
• Dependence on successful commercialization and market acceptance of plinabulin.

Q: About DUBLIN data readout expected mid-2021 and ASCO abstracts A: DUBLIN-3 data will not be in the ASCO meeting; midyear is the guidance. ASCO presentation will show additional reduction in FN and hospitalization for PROTECTIVE-2 Q: Components of DUBLIN trial data and comparison to other approaches A: DUBLIN-3 data not yet available; will consider ORR and PFS for comparison but data needs to be clean first Q: Rationale for small cell lung cancer study with plinabulin, nivolumab, and ipilimumab A: Plinabulin's synergy with checkpoint inhibitors to add benefit to existing I/O regimens in small cell lung cancer Q: Reimbursement, launch timing, and market focus A: Focus on key accounts, timing of launch depends on approval, and reimbursement coverage is expected based on historic G-CSF utilization patterns