BeyondSpring (BYSI) investor relations material

Introduction and purpose

• FDA granted Fast Track designation to Plinabulin plus docetaxel for advanced or metastatic non-squamous NSCLC patients who progressed after immune checkpoint inhibitor and platinum-based chemotherapy, targeting those without actionable genomic alterations.

• Fast Track status aims to expedite development and review for therapies addressing serious conditions with unmet medical needs, enabling more frequent FDA interactions and potential rolling review.

Details of approval or decision

• Fast Track designation allows for more frequent FDA interactions, potential rolling review, and possible Priority Review eligibility if criteria are met.

Impact on industry and stakeholders

• Addresses a significant unmet need, as 12 prior phase III studies failed to show OS benefit over docetaxel in this population.

• The target population in the US and major EU markets could reach 135,000 patients by 2037, representing a substantial commercial opportunity.

• Strategic transaction with Biolin Investment Limited and sale of majority equity in the Chinese subsidiary funds the China portion of DUBLIN-4, covering about half of the planned 442 global patients and reducing cash requirements.

• BeyondSpring retains global rights to Plinabulin outside Greater China.