BeyondSpring (BYSI) Earnings Call Presentation

Plinabulin's Mechanism and Preclinical Evidence - Plinabulin is a unique tubulin binder with a distinct binding site compared to other tubulin-binding agents[16, 21] - Preclinical studies show that Plinabulin, combined with radiation and anti-PD-1, activates dendritic cells (DCs), stimulates T-cell proliferation, and achieves abscopal effects[17, 24] - Plinabulin induces DC maturation, especially when administered after irradiation (IR), and Plinabulin-treated DCs stimulate T cell proliferation, enhanced by combining with IR[25] Clinical Efficacy and Immune Activation - In a Phase 1 study, the Plinabulin triple combination (with radiation and PD-1/PD-L1 inhibitors) led to an 80% disease control rate (DCR) in 10 IO-refractory patients[18, 32] - Durable responses were observed in 2 Hodgkin lymphoma patients who progressed after 12 or 16 prior lines of therapy[33] - Responding patients exhibited early immune activation with DC maturation and proinflammatory monocytes in the peripheral blood across six different cancer types[19, 35] Summary and Future Directions - Plinabulin demonstrates induction of DC maturation and re-sensitization to anti-PD(L)1 in IO-refractory tumors[37] - The impressive overall results, showing a high 80% disease control rate in ICI-refractory and heavily pre-treated patients, warrant further clinical studies of Plinabulin/IO combinations in IO-refractory settings[37, 38]