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sec.gov/Archives/edgar/data/1677940/000114036121021106/brhc10025730_ex99-1.htm 2025-03-19 00:47 EX - 99.1 2 brhc10025730_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Beyond Spring Announces First Quarter 2021 Financial Results and Provides a Corporate Update -NDA Filed by U.S. Food and Drug Administration ( FDA ) and given Priority Review for plinabulin plus G - CSF for the prevention of CIN . A PDUFA date of November 30 , 2021 has been assigned by the FDA . - Highlighted PROTECTIVE - 2 Phase 3 data at two scientific conferences - ASCO and FOCIS - showing plinabulin in combination with G - CSF to have superior benefit in reducing the incidence and severity of febrile neutropenia and hospitalization rates and better QoL compared to pegfilgrastim alone - Advanced clinical development of combination plinabulin + checkpoint inhibitors in PD - 1 / PD - L1 - resistant tumors : presented promising Phase 1 anti - cancer data in PD - 1 / PD - L1 - resistant SCLC at ASCO 2021 ; dosed first patient in a triple IO combination Phase 1 study in seven advanced solid tumors NEW YORK , Jun . 16 , 2021 – BeyondSpring Inc. ( the “ Company ” or “ BeyondSpring " ) ( NASDAQ : BYSI ) , a global biopharmaceutical company focused on the development of innovative cancer therapies , today announced its financial results for the first quarter ended March 31 , 2021 and provided an update on recent corporate events . " This quarter was marked by meaningful progress on the road toward building our lead first - in - class asset , plinabulin , as a pipeline in a drug , from treating chemotherapy side effects to treating cancer directly , ” said Dr. Lan Huang , co - founder , chairwoman and chief executive officer of BeyondSpring . " We are grateful that our NDA for chemotherapy - induced neutropenia ( CIN ) prevention was filed by the U.S. FDA with priority review . Our plinabulin and G - CSF combination has the potential to elevate the standard of care in CIN for the first time in 30 years . In addition , in the coming months , we plan to announce topline anti - cancer overall survival data from the Phase 3 DUBLIN - 3 trial in NSCLC . We are building clinical evidence to demonstrate that plinabulin is a potent antigen presenting cell ( APC ) inducer with potential to be a ‘ game changer ' in cancer treatment for severely unmet medical needs . " Recent Corporate Highlights Lead Asset Plinabulin , a “ Pipeline in a Drug " Clinical Update • • June 2021 : Announced Food and Drug Administration ( FDA ) filing of New Drug Application with Priority Review for plinabulin and G - CSF combination for the prevention of CIN . The FDA set a Prescription Drug User Fee Act ( PDUFA ) target action date for November 30 , 2021 . June 2021 : Presented three poster presentations at the 2021 Annual Meeting of the American Society of Clinical Oncology ( ASCO ) highlighting the Company's PROTECTIVE - 2 Phase 3 data demonstrating combination plinabulin + pegfilgrastim offers superior benefit in reducing the incidence and severity of febrile neutropenia ( FN ) and hospitalization , with better quality - of - life ( QoL ) , compared to pegfilgrastim alone . https://www.sec.gov/Archives/edgar/data/1677940/000114036121021106/brhc10025730_ex99-1.htm 1/21