BeyondSpring Presents New Clinical Data in the Chemotherapy-Induced Neutropenia and NSCLC Programs at the 2022 ASCO Annual Meeting

NEW YORK, May 27, 2022 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have a high unmet medical need, today announced three poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3-7, 2022, in Chicago, Illinois. Presentation highlights: Chemotherapy-induced neutropenia (CIN): Real-world CMS data showed that week 1 after chemotherapy still presents unmet medical needs with febrile neutropenia (FN) risk, even with prophylactic G-CSF, among patients with breast cancer after high FN–risk chemoDUBLIN-3 (non-small cell lung cancer, NSCLC): Improved quality of life (QoL) in plinabulin/docetaxel combination vs. docetaxel alone in 2nd/3rd line EGFR-wild type NSCLC patients using the validated EORTC QLQ C30 and QLQ LC13 questionnairesDUBLIN-3 (NSCLC): Subgroup analysis in patients with non-squamous, EGFR-wild type, 2nd/3rd line NSCLC from the global Phase 3 trial showed a superior survival benefit of 2.6 months in median overall survival (OS) in the plinabulin/docetaxel combination (11.4 months) vs. docetaxel alone (8.8 months), HR=0.75, p=0.023 “We continue to develop plinabulin as a potential ‘pipeline in a drug,’ in both CIN prevention and in NSCLC. We now present ‘real-world’ data demonstrating an unmet medical need with standard of care (SoC) G-CSF for CIN, primarily due to G-CSF’s slow-onset mechanism of action (MoA) that leaves patients unprotected in Week 1 of the chemotherapy cycle. Plinabulin has a fast-onset MoA acting within 24 hours of administration and when combined with G-CSF provided superior CIN protection throughout the entire cycle,” said Dr. Ramon Mohanlal, executive vice president, research and development, and chief medical officer, at BeyondSpring. “In terms of the DUBLIN-3 Phase 3 data, patient QoL is an important factor for treatment decisions in 2nd/3rd line NSCLC. The improvement in QoL seen when plinabulin is added to SoC docetaxel vs docetaxel alone could be an important point of product differentiation. Whereas the mOS data in the overall intention to treat (ITT) population was positive, but somewhat modest, we now demonstrate a more robust mOS benefit (of 2.6 months) in a large subgroup of non-squamous 2nd/3rd line NSCLC patients. We continue to work with health authorities on a path to approval in the U.S. and in China.” Dr. Lan Huang, co-founder, chairman and chief executive officer at BeyondSpring, added, “Since we’ve started studying plinabulin, it has continued to show a strong potential to make a difference in a number of oncology indications. We’ve been able to demonstrate repeatedly how it has a two-pronged ability to help prevent CIN and treat cancer directly. We are pleased with the ongoing discussions with China NMPA on the NDA review of the plinabulin and G-CSF combination for the prevention of CIN and plan to file an NDA application to the NMPA for the use of plinabulin in NSCLC by year-end. I’m grateful to our team and partners over the years who have continued to do all the hard work at the bench and in clinical trials to fully understand what plinabulin has to offer for cancer patients. We continue to stay strongly committed to this work in the hopes of bringing plinabulin to patients around the globe.” Title: Real-world effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) early (week 1) and late (weeks 2-3) in the cycle for the prevention of febrile neutropenia (FN) among patients (pts) with breast cancer (BC) after high FN–risk chemotherapy (chemo)Abstract #: 599Poster Session: Breast Cancer—Local/Regional/AdjuvantDate/Time: June 6, 2022, 9 AM EDTPresenter: Douglas W. Blayney, M.D., FASCO, Stanford University The relative FN risk in Week 1 vs. Weeks 2-3 of the cycle with G-CSF is unknown. It was analyzed compared with no G-CSF in the real-world setting with high FN risk chemotherapy.Using a CMS database of administrative claims representing 100% of fee-for-service Medicare, an analysis of breast cancer patients who initiated docetaxel (T), doxorubicin (A) or cyclophosphamide (C) monotherapy or combination therapy between 01/01/2015 – 12/31/2019 was performed.Prophylactic G-CSF was highly effective for the prevention of FN in weeks 2-3 (only 0.8% of patients had FN) but relatively ineffective in Week 1 of cycle 1 (3.2% of patients had FN, which was not different from patients without G-CSF (3.6%)) in the real-world setting. This represents an unmet medical need in Week 1 of the cycle with SoC G-CSF.  Pts receiving G-CSF(N=13,544)Pts not receiving G-CSF (N=5,244)p-valueRate of FN events starting in week 1 of cycle 13.2% (n=440)3.6% (n=190)0.20Rate of FN events starting in weeks 2-3 of cycle 10.8% (n=106)5.2% (n=272)<0.0001 Title: DUBLIN-3 results on quality of life (QoL) in second/third-line EGFR-wild type NSCLC patients (pts) receiving docetaxel (Doc) with or without plinabulin (Plin) using the validated EORTC QLQ C30 and QLQ LC13 questionnairesAbstract #: 9091Session: Lung Cancer—Non-Small Cell MetastaticDate/Time: June 6, 2022, 9 AM EDTPresenter: Trevor Feinstein, M.D., Piedmont Cancer Institute In the ITT population of the DUBLIN-3 Phase 3 trial, the plinabulin/docetaxel combination had better quality of life versus docetaxel alone in second/third-line EGFR-wild type NSCLC patients (QTWiST, p=0.026).EORTC QLQ C30 and QLQ LC13 scores were collected at baseline, Day 1 and Day 8 of each cycle.Mean (SEM) change from baseline in cumulative C30 and LC13 were overall in favor of plinabulin/docetaxel. LC13 items in favor of plinabulin/docetaxel vs docetaxel alone were items 31 (coughing; p<0.05), 36 (sore mouth; p<0.01) and 37 (dysphagia; p<0.01).  C10C20C30Plin/Doc C30(n=278)440 (15.6)499 (23.7)515 (27.0)Doc C30(n=281)423 (13.2)457 (18.6)467 (21.6)Plin/Doc LC13(n=278)93 (4.2)106 (6.1)*110 (6.9)*Doc LC13(n=281)87 (4.3)93 (5.1)94 (5.3)*p<0.05    Title: Subgroup analysis in patients (pts) with non-squamous (N-Sq), EGFR-wild type (wt), second/third-line NSCLC from the global phase (Ph) 3 trial DUBLIN-3 with the plinabulin/docetaxel (Plin/Doc) combination versus Doc aloneAbstract #: 9090Session: Lung Cancer—Non-Small Cell MetastaticDate/Time: June 6, 2022, 9 AM EDTPresenter: Baohui Han, M.D., Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University With PD-1/PD-L1 inhibitors moving to first line in NSCLC, 2nd/3rd line NSCLC represents a severe unmet medical need, dominated by docetaxel-based therapies with >40% severe neutropenia and limited survival.In the ITT population of the DUBLIN-3 Phase 3 trial, the plinabulin/docetaxel combination had superior efficacy, safety and quality of life versus docetaxel alone in EGFR-wild type, second/third-line NSCLC patients.In this subgroup analysis of the non-squamous (N-Sq) subgroup, the addition of plinabulin to docetaxel was superior to docetaxel alone for efficacy (mOS 11.4 vs. 8.8 months, HR=0.75, p=0.023) and safety (Grade 4 neutropenia rate 13.9% vs 37.9%, p<0.001). N-Sq subsetmOS Mo [95% CI] RMST Mo [SE] 24 Mo OS-Rate (%)36 Mo OS-Rate (%)48 Mo OS-Rate (%)Gr4N Rate (%)Plin/Doc(n=153)11.4[9.37;12.4]16.1[1.188]24.9%14.2%11.85%13.9Doc(n=178)8.8[8.05;10.9]12.8[0.845]14.1%4.68%0%37.9HR0.75NANANANA P-value0.0230.0250.0250.03NA<0.001 About DUBLIN-3The DUBLIN-3 Phase 3 trial is a randomized, single blinded, active-controlled global trial that enrolled 559 patients with 2nd/3rd line NSCLC, EGFR wild type, with a measurable lung lesion. Patients were treated on a 21-day cycle with an infusion of docetaxel (75 mg/m2 on day 1) and plinabulin (30 mg/m2 on days 1 and 8) vs. docetaxel alone (75 mg/m2, day 1). The primary endpoint was overall survival. Secondary endpoints include ORR, PFS, grade 4 neutropenia, 2 year and 3 year OS rate and quality of life analysis. Plinabulin in combination with docetaxel (DP) showed statistically significant overall survival improvements compared to docetaxel alone (D) for the ITT population (DP: n=278; D: n=281). About BeyondSpring Headquartered in New York City, BeyondSpring is a clinical stage 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, is being developed as a potential “pipeline in a drug” in various cancer indications as a direct anti-cancer agent and to prevent chemotherapy-induced neutropenia (CIN). The plinabulin and G-CSF combination for the prevention of CIN has demonstrated positive Phase 3 data. In the DUBLIN-3 study, a global, randomized, active controlled Phase 3 study, the plinabulin and docetaxel combination met the primary endpoint of extending overall survival compared to docetaxel alone in 2nd/3rd line non-small cell lung cancer (NSCLC) (EGFR wild type). Additionally, plinabulin is being broadly studied in combination with various immuno-oncology regimens that could boost the efficacy of PD-1/PD-L1 antibodies in seven different cancers. Lastly, BeyondSpring’s pipeline includes three preclinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform. Cautionary Note Regarding Forward-Looking StatementsThis 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 the Company’s 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. RobinsonLifeSci Advisors, LLC+1 [email protected] Media Contact:Darren Opland, Ph.D.LifeSci Communications+1 [email protected]