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December 10, 2019

BeyondSpring's Study 106 Phase 3 Superior Trial Design Combining Plinabulin with Pegfilgrastim Versus Pegfilgrastim Alone for Chemotherapy-Induced Neutropenia Presented at ASH 2019 Annual Meeting

Trial Aims to Optimize Chemotherapy by Minimizing Dose Modifications Due to Chemotherapy-Induced Neutropenia or Bone Pain

NEW YORK, Dec. 10, 2019 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company’s abstract for its Phase 3 Study 106 clinical trial design with lead asset, Plinabulin, for chemotherapy-induced neutropenia (CIN) prevention was accepted for poster presentation at this year’s American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The poster presentation took place during the evening of December 9, 2019.

The abstract titled, “A Randomized Phase 3 Clinical Trial of the Combination of Plinabulin (Plin) + Pegfilgrastim (Peg) versus (vs) Peg Alone for TAC (docetaxel, doxorubicin, cyclophosphamide) Induced Neutropenia (CIN),” provides rationale for combining Plinabulin with Pegfilgrastim (Neulasta) due to their differing mechanisms of action for preventing CIN. Previously, BeyondSpring reported positive Phase 2 data for Study 106, which demonstrated that Plinabulin combined with Neulasta offered superior protection against CIN and significantly less bone pain for patients compared to Neulasta alone, with statistical significance. The upcoming confirmatory Phase 3 portion of Study 106 will test the Plinabulin-Neulasta combination, which may offer superior protection against TAC-induced CIN without causing bone pain, compared to Neulasta, the current standard of care.

“To date, mortality rates caused by myelosuppressive chemotherapies are still significant despite the widespread use of G-CSF, including Neulasta, the current standard of care for CIN. Combining Plinabulin with Neulasta not only offers the potential for superior protection against CIN, but also has the potential to optimize chemotherapy for patients through minimizing dose modifications, which are typically imposed by the occurrence of severe CIN. In addition, the combination has demonstrated the potential to eliminate bone pain as well as to prevent the immunosuppressive effect of Neulasta alone. Plinabulin’s anticancer activity provides an important added benefit,” said Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s Study 106 and Professor of Medicine at the Stanford University School of Medicine.

“Despite the arrival of immunotherapy treatments, chemotherapy is here to stay,” says Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President of R&D. “Adding chemotherapy to immunotherapy further enhances the efficacy of immunotherapy, and combination therapies will increasingly dominate in first-line anti-cancer treatments. Multiple published studies have demonstrated that 15 percent less relative dose intensity in chemotherapy (which includes the 4 “D’s” – decreased dose, delayed dose, downgraded regimen and discontinued chemotherapy) could lead to 50 percent less overall survival. Therefore, the optimization of chemotherapy use is an important objective in achieving the best standard of care for patients, and BeyondSpring’s Study 106 is designed to meet this objective. Patient enrollment has already been initiated in Study 106, allowing BeyondSpring to stay on track for our intended New Drug Application (NDA) for CIN in 2020 in the U.S.”

Neutropenia is a common side effect of chemotherapy in cancer patients, which marks the destruction of a type of white blood cell (neutrophil) that is a key component of the immune system. Neutrophils are a patient’s first line of defense against infections, and patients with severe neutropenia are more susceptible to bacterial, viral and fungal infections in addition to sepsis, which requires hospitalization and has a high mortality risk. Approximately 650,000 cancer patients in the U.S. receive chemotherapy in an outpatient oncology clinic each year.

About BeyondSpring
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.

About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a marine-derived small molecule that sequesters tubulin heterodimers in a differentiated manner from other agents in this class. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The anticancer benefits of Plinabulin have been associated with positive effects on antigen presenting cells and T-cell activation, as well as to the direct killing of cancer cells. Plinabulin’s CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

About Chemotherapy-Induced Neutropenia (CIN)
CIN is a common, often severe side effect that cancer patients who are undergoing treatment experience involving the destruction of neutrophils, which are a type of white blood cell and a patient’s first line of defense against infections. The current standard of care for CIN prevention is G-CSF monotherapy, which has serious limitations as described in its product information summary.

As many as 90 percent of patients who receive high-risk chemotherapy and G-CSF monotherapy may still experience grade 3 or 4 neutropenia [Lee et al., Annals of Surgical treatment and research 94(5): 223-228 (2018)]. Patients with grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, making these patients more susceptible to bacterial / fungal infections and sepsis, which can require hospitalization and be fatal. Grade 4 CIN can have an adverse effect on chemotherapy administration and is usually considered a significant predictor of low relative dose intensity (RDI), dose delays and dose reductions [Lalami Y, Critical Reviews in Oncology / Hematology, 120: 163 – 179 (2017)]. Even a 15 percent chemotherapy dose reduction can reduce long-term survival by as much as 50 percent [Bonadonna, Med Oncol 29:1495–1501 (2012)].

Additionally, as many as 70 percent of patients using G-CSF monotherapy experience bone pain [Moore et al., Annals of Pharmacotherapy 51(9): 797-803 (2017)]. Twenty-five percent of patients also report that the pain is severe. The National Comprehensive Cancer Network (NCCN) guidelines require that patients with grade 3 or 4 neutropenia decrease chemotherapy dose intensity, delay chemotherapy cycle timing or discontinue chemotherapy, each of which can have a negative effect on the long-term outcomes of cancer care [Lalami et al., Critical Reviews in Oncology / Hematology 120: 163-179 (2017)].

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.

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