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June 9, 2020

BeyondSpring's PROTECTIVE-2 (Study 106) Phase 2 Trial for Chemotherapy-Induced Neutropenia Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes

- Plinabulin in Combination with Neulasta Improves Dose and Regimen Compliance of TAC Chemotherapy Compared to Neulasta Alone -

- Chemotherapy Dose Reduction and Regimen Downgrade Significantly Impacts Long-term Survival -

NEW YORK, June 09, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that its PROTECTIVE-2 (Study 106) Phase 2 superiority trial for chemotherapy-induced neutropenia (CIN) shows that the Company’s lead asset, Plinabulin, in combination with Neulasta, enables more cancer patients to receive the optimal chemotherapy dose and regimen, which potentially leads to better clinical outcomes.

“Clinical research demonstrates that patients who receive over 85 percent of the optimal chemotherapy dose on time have significantly better overall survival1,” said Dr. Lan Huang, BeyondSpring’s CEO and Co-Founder. "Additionally, monotherapy G-CSF has been shown to help some patients maintain chemotherapy regimens. However, in an analysis of over 16,000 patients with monotherapy G-CSF, very few patients are able to maintain their targeted regimen2. It is clear that oncologists and patients need more tools to stay the course for improved survival3.”

PROTECTIVE-2 evaluated superiority potential in the prevention of CIN in breast cancer patients treated with docetaxel, doxorubicin and cyclophosphamide (TAC, a high-risk chemotherapy) with 20mg/m2 of Plinabulin combined with 6mg of Neulasta (a long-lasting G-CSF and the standard of care for CIN) (n=16) compared with 6mg of Neulasta alone (n=22).

Plinabulin + G-CSF improves compliance with targeted chemotherapy:

  • Dose reduction (over 15 percent):
    • Only 6.3 percent of patients in the Plinabulin-Neulasta combination arm versus 22.7 percent in Neulasta arm – a 72 percent improvement
    • A chemotherapy dose reduction of over 15 percent leads to a 50 percent survival reduction4
  • Downgraded regimen (from TAC to TC):
    • No (0 percent) patients in the Plinabulin + G-CSF arm downgraded chemotherapy from the TAC regimen to the TC regimen versus 18.2 percent in the Neulasta arm – p < 0.05
    • TAC with an objective response rate (ORR) at 83 percent5 is a more effective chemotherapy regimen than TC with an ORR at 42 percent6

Grade 4 neutropenia occurs in as many as 52 percent of patients who are undergoing high-risk chemotherapy3, even with G-CSF treatment, and is the primary reason for changes in chemotherapy regimens (i.e., decreasing, delaying, downgrading or discontinuing chemotherapy treatment, or the 4D’s1).

“Having the ability to greatly reduce Grade 4 neutropenia means that oncologists can optimize cancer patients’ chemotherapy regimens, turning the 4Ds into the 4Ss: stable doses, sustained cycles and the strongest regimens, allowing patients to stay the course,” added Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President, Research and Development. “This approach provides potential benefits for both clinicians and patients: clinicians may gain greater control over cancer care, and patients may experience better clinical outcomes and an improved quality of life. The improvement in the prevention of Grade 4 neutropenia that is seen with the Plinabulin-Neulasta combination is even more important in today’s healthcare environment due to the devastating impact of COVID-19 on immune-suppressed patients. We look forward to the upcoming Phase 3 interim topline data readout for PROTECTIVE-2, which represents an important milestone to potentially serve as a new standard of care in CIN treatment.”

1Lalami et al. Critical Reviews in Oncology / Hematology 120: 163-179 (2017)
2 Lyman et al. JNCCN 13(11): 1382-1393 (2015)
3 https://jnccn.org/view/journals/jnccn/15/9/article-p1122.xml#T3
4 Bonadonna G et al. N Engl J Med 332:901-906 (1995)
5 O’Regan et al. Clinical Breast Cancer 6(2): 163-168 (2005)
6 Vasey et al. British J Cancer 87: 1072-1078 (2002)

About BeyondSpring
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first-in-class agent Plinabulin as an immune and stem cell modulator, 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. BeyondSpring is headquartered in New York City.

About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a differentiated immune and stem cell modulator. 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 durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). 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 with a rapid onset, but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

About Plinabulin in PROTECTIVE-2 (Study 106) CIN Study
Study 106 was designed to evaluate the safety and efficacy in breast cancer, treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with Plinabulin (40mg, Day 1 dose) + Neulasta (6mg, Day 2 dose) versus a single dose of Neulasta (6mg, Day 2). TAC is one example of high-risk chemotherapy. Plinabulin and G-CSF have complementary mechanisms in preventing CIN.  This is a superiority study in CIN efficacy in prevention of Grade 4 neutropenia, comparing the combination head-to-head against Neulasta and is currently enrolling. Literature shows that the Grade 4 neutropenia rate for TAC and Neulasta at 6mg is 83 to 93 percent, which presents severe unmet medical needs.

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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