BeyondSpring Provides Second-Quarter 2020 Financial Results and Business Updates

- Reported Positive Topline Pre-Specified Interim Results from PROTECTIVE-2 (Study 106) Phase 3, Demonstrating Plinabulin’s Superiority in Combination with Neulasta for CIN Prevention vs. Neulasta Alone-

- Completed PROTECTIVE-2 Phase 3 Enrollment and On Track to Report Final Results in Q4 2020 / Expect to Submit NDA for CIN to the FDA by End of 2020 -

- Triple Plinabulin I/O Combination Achieved 100 Percent Complete Response in PD-1 Non-responsive Animal Model; To Initiate Clinical Studies at MD Anderson in H2 2020 -

NEW YORK, Sept. 03, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, announced today its financial results and provided an operational update for the three months ended June 30, 2020.

“BeyondSpring’s mission has been to develop innovative, transformative medicines that improve clinical outcomes in high unmet medical needs,” said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer of BeyondSpring. “With our lead asset, first-in-class agent Plinabulin in late stage developments in two large oncology market opportunities, CIN and NSCLC, we believe that we are at a significant inflection point that will potentially result in helping many patients in need.”

Dr. Huang continued, “We expect to file NDA for CIN, Plinabulin’s first indication, to the U.S. FDA by the end of the year. Plinabulin would potentially reduce infection and hospitalization after chemotherapy, and enable doctors to provide chemotherapy to their patients without compromise – this means stable doses, sustained cycles and the strongest regimens possible so that patients can stay the course with their treatment – for potential survival benefit.  As a potent antigen presenting cell inducer, we believe that Plinabulin is a ‘pipeline in a drug’ for multiple cancer indications.”

Select Second-Quarter 2020 and Recent Business Highlights

Recent Clinical Highlights

• Plinabulin in CIN indication

Positive Superior Topline Pre-Specified Interim Results from PROTECTIVE-2 Phase 3

In June 2020, BeyondSpring reported positive topline results of the pre-specified interim analysis of its PROTECTIVE-2 Phase 3 trial, evaluating Plinabulin in combination with Neulasta, compared to Neulasta alone. The interim results showed that the combination significantly enhanced the efficacy of Neulasta in the “rate of Grade 4 neutropenia prevention” (p