- Four presentations to focus on the clinically meaningful endpoint improvement, including the reduction of febrile neutropenia and hospitalization, shown by plinabulin in the prevention of chemotherapy-induced neutropenia (CIN)

- An additional presentation to focus on plinabulin as an anti-cancer agent in combination with checkpoint inhibitors in patients with recurrent small cell lung cancer (SCLC) who have not received, or have failed checkpoint inhibitor therapy

NEW YORK, April 28, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced five presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held virtually June 4-8, 2021. The presentations will focus on their lead asset plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), as a “pipeline in a drug.”  

The presentations will focus on the clinically meaningful endpoint improvement, including the reduction of febrile neutropenia (FN) and hospitalization, shown by plinabulin in the prevention of chemotherapy-induced neutropenia (CIN). An additional presentation will focus on plinabulin in combination with nivolumab and ipilimumab as a potential treatment in recurrent small cell lung cancer (SCLC) patients who have not received checkpoint inhibitor therapy, or who have failed checkpoint inhibitor therapy.

“We are pleased to be sharing data at ASCO this year on plinabulin and its potential benefit in both the prevention of CIN and as an anti-cancer therapy. This data further supports the immense potential of plinabulin in the oncology space, and we are grateful to our collaborators for doing this important work with us,” said Ramon Mohanlal M.D., Ph.D., Chief Medical Officer and Executive Vice President of Research and Development at BeyondSpring. “Our company has had a tremendous few months of milestone achievement with a Breakthrough Therapy Designation for the use of plinabulin and G-CSF in CIN prevention last fall and NDA filings in both the U.S. and China in March 2021. In 2021, we look forward to showing plinabulin’s immune anti-cancer efficacy to round out its unique profile and bringing it to market next year in the hopes of improving the lives of oncology patients worldwide.”

Additional presentation details can be found below:

Title: Head-to-Head Comparison of Single Agent (SA) Plinabulin (Plin) versus Pegfilgrastim (Peg) for the Prevention of Chemotherapy-Induced Neutropenia (CIN) in the Phase 3 Trial PROTECTIVE-1
Session: Breast Cancer—Local/Regional/Adjuvant Poster Session
Date/Time: June 4, 2021 at 9 AM EDT
Presenter: Douglas W. Blayney, M.D.

Title: Clinical Trial Testing Superiority of Combination Plinabulin (Plin) and Pegfilgrastim (Peg) vs Peg Alone in Patients (pts) with Breast Cancer treated with High Febrile Neutropenia Risk chemotherapy (chemo): Final results of the Phase 3 Chemo-Induced Neutropenia (CIN) Prevention Trial (PROTECTIVE-2)
Session: Breast Cancer—Local/Regional/Adjuvant Poster Session
Date/Time: June 4, 2021 at 9 AM EDT
Presenter: Douglas W. Blayney, M.D.

Title: Chemotherapy Induced Profound Neutropenia (PN) in Patients (pts) with Breast Cancer (BC) after chemotherapy and Plinabulin (Plin) plus Pegfilgrastim (Peg) Combination versus (vs) Peg Alone. Final Phase 3 Results from PROTECTIVE-2 (BPI-2358-106)
Session: Breast Cancer—Local/Regional/Adjuvant Poster Session
Date/Time: June 4, 2021 at 9 AM EDT
Presenter: Yuankai Shi, M.D.

Title: Impact of Adding Plinabulin to Pegfilgrastim for the Prevention of TAC Chemotherapy (Chemo) Induced Neutropenia (CIN), on Patient Quality of Life (QoL)
Session: Health Services Research and Quality Improvement
Date/Time: June 4, 2021 at 9 AM EDT
Presenter: Ramon Mohanlal, M.D., Ph.D.

Title: A Phase I Trial of Plinabulin in Combination with Nivolumab and Ipilimumab in Patients with Recurrent Small Cell Lung Cancer (SCLC)
Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Poster Session
Date/Time: June 4, 2021 at 9 AM EDT
Presenter: Jyoti Malhotra, M.D., M.P.H

About BeyondSpring
Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSpring’s first-in-class lead asset plinabulin, a selective Immunomodulating Microtubule-Binding Agent (SIMBA), is being developed as a “pipeline in a drug.” It is filed for approval in the US and China for the prevention of chemotherapy-induced neutropenia (CIN) and has a fully enrolled pivotal study to test an anti-cancer benefit with an overall survival primary endpoint in non-small cell lung cancer (NSCLC). Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the effects of PD-1 / PD-L1 antibodies. In addition to plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.

Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Investor Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
+1 617-430-7577
arr@lifesciadvisors.com 

Media Contact:
Darren Opland, Ph.D.
LifeSci Communications
+1 646-627-8387
darren@lifescicomms.com

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