BeyondSpring E-Poster Presented at 2020 ASCO Virtual Scientific Program

June 02, 2020 NEW YORK, June 02, 2020 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that two Company abstracts were accepted at this year’s American Society of Clinical Oncology (ASCO) Virtual Scientific Program. Both abstracts evaluate BeyondSpring’s lead late-stage asset, Plinabulin, alongside Neulasta (pegfilgrastim), a long-lasting G-CSF, which is a predominant therapy to treat chemotherapy-induced neutropenia (CIN). Dr. Douglas Blayney, Professor of Medicine at Stanford Medical School and global Principal Investigator of Plinabulin’s CIN studies, e-presented the data. BeyondSpring’s e-poster presentation, titled, “Head-to-head comparison of the non-G-CSF small molecule single agent (SA) plinabulin with SA pegfilgrastim for the prevention of docetaxel chemotherapy (chemo)-induced neutropenia (CIN) in the protective-1 trial,” compares Plinabulin versus Neulasta as a monotherapy for CIN prevention. Additionally, BeyondSpring’s e-publication, titled, “Comparison of CD34+ mobilization effects of standard dose pegfilgrastim (Peg) versus low-dose peg combined with plinabulin (Plin),” demonstrates the efficacy of BeyondSpring’s Plinabulin-Neulasta combination in increasing CD34+ counts for patients. E-Poster: Plinabulin’s strength further solidified in head-to-head PROTECTIVE-1 trial with Plinabulin versus Neulasta. In BeyondSpring’s PROTECTIVE-1 (Study 105) Phase 3 trial, non-small cell lung, hormone-refractory prostate and breast cancer patients were randomized to receive either 40mg of Plinabulin (on Day 1; n=53) or 6mg of Neulasta (on Day 2; n=52), with Duration of Severe Neutropenia (DSN) as the primary endpoint. The trial aims to demonstrate non-inferiority of Plinabulin versus Neulasta. “The National Comprehensive Cancer Network (NCCN) recently updated its guidelines considering COVID-19 as a risk factor,” said Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President, Research and Development. “It recommends that intermediate-risk patients be considered for prophylactic CIN therapy, in addition to the high-risk population, to minimize hospital and ER visits from cancer patients experiencing neutropenia due to myelosuppressive chemotherapies. This guideline change represents a potential increase of more than 100 percent in the addressable U.S. patient population, according to our recent market research. BeyondSpring previously reported that the non-inferiority primary endpoint of the PROTECTIVE-1 Phase 3 trial was met at a pre-specified interim analysis. In addition, Plinabulin has a superior profile compared to long- or short-acting G-CSF therapies with its dosing on the same day as chemotherapy and its avoidance of bone pain and thrombocytopenia, which meets the NCCN’s objective of minimizing healthcare touches and the risk of contracting COVID-19 by these cancer patients.” E-Publication: When combined with Plinabulin, low-dose Neulasta increased CD34+ counts and resulted in fewer adverse events for patients. In clinical practice for CD34+ progenitor stem cell mobilization, the standard-dose of Neulasta at 6mg is often reduced to a low-dose at 3mg due to intolerable and unwanted side effects1. The low-dose of Neulasta is, however, less effective than the standard dose for CD34+ cell mobilization. In BeyondSpring’s PROTECTIVE-2 (Study 106) Phase 2 trial for CIN prevention for breast cancer patients receiving TAC (taxotere, doxorubicin and cyclophosphamide) chemotherapy, BeyondSpring analyzed whether adding Plinabulin to low-dose Neulasta at 3mg or 1.5mg would maintain CD34+ cell mobilization efficacy at the level of the standard dose of Neulasta, while still avoiding unwanted side effects from this standard dose. Patients (n=9) had received the low dose of Neulasta (seven patients received 3mg, and two patients received 1.5mg), combined with Plinabulin (20 mg/m2). Patients (n=7) received a standard dose of Neulasta at 6mg. The data shows that the low dose of Neulasta + Plinabulin had comparable efficacy in terms of blood CD34+ counts but reported fewer cases of bone pain, myalgia (muscle pain) and leukocytosis (high white blood cell count) side effects, compared with the standard dose of Neulasta alone at 6mg. 1 Pardee, T. S et al. Journal of Applied Research, 6(3), 196-200 (2006) 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, 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. 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. BEYONDSPRING INC. AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2019 AND UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF MARCH 31, 2020 (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) December 31,   March 31, 2019 2020 $   $ (Unaudited) Assets Current assets: Cash and cash equivalents 35,933   24,917 Advances to suppliers 4,519   4,384 Prepaid expenses and other current assets 410   452 Total current assets 40,862   29,753 Noncurrent assets: Property and equipment, net 209   203 Operating lease right-of-use assets 2,538   2,607 Other noncurrent assets 946   941 Total noncurrent assets 3,693   3,751 Total assets 44,555   33,504 Liabilities and equity Current liabilities: Accounts payable 2,537   5,140 Accrued expenses 5,861   4,697 Due to related parties 29   42 Current portion of operating lease liabilities 537   643 Other current liabilities 1,089   1,685 Total current liabilities 10,053   12,207 Noncurrent liabilities: Long-term loans 1,436   1,413 Operating lease liabilities 1,935   1,892 Total noncurrent liabilities 3,371   3,305 Total liabilities 13,424   15,512 Equity: Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 27,885,613 shares and 27,888,906 shares issued and outstanding as of December 31, 2019 and March 31, 2020, respectively) 3   3 Additional paid-in capital 246,979   250,417 Accumulated deficit (216,845) (232,929) Accumulated other comprehensive income 140   197 Total BeyondSpring Inc.’s shareholder’s equity 30,277   17,688 Noncontrolling interests 854   304 Total equity 31,131   17,992 Total liabilities and equity 44,555   33,504 BEYONDSPRING INC. UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2019 AND 2020 (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) (Unaudited) Three months ended March 31, 2019   2020 $   $ Revenue –   – Operating expenses: Research and development (6,330) (13,704) Selling, general and administrative (1,639) (2,928) Loss from operations (7,969) (16,632) Foreign exchange gain (loss), net 173   (74) Interest income 6   64 Interest expense (37)) (21) Other income –   1 Loss before income tax (7,827) (16,662) Income tax benefit –   – Net loss (7,827) (16,662) Less: Net loss attributable to noncontrolling interests (534) (578) Net loss attributable to BeyondSpring Inc. (7,293) (16,084) Net loss per share Basic and diluted (0.32)) (0.58) Weighted-average shares outstanding Basic and diluted 23,029,362   27,732,449 Other comprehensive loss Foreign currency translation adjustment (loss) gain (194) 53 Comprehensive loss (8,021) (16,609) Less: Comprehensive loss attributable to noncontrolling interests (575) (582) Comprehensive loss attributable to BeyondSpring Inc. (7,446) (16,027)