Plinabulin

FLORHAM PARK, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that it has filed its annual report on Form 20-F for the fiscal year ended December 31, 2023 with the U.S. Securities and Exchange Commission (“SEC”) on April 29, 2024. The annual report on Form 20-F, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at www.sec.gov and on the Company’s website at www.beyondspringpharma.com under “Financials & Filings” in the Investors section. The Company will provide a hard copy of its annual report containing its audited consolidated financial statements, free of charge, to its shareholders upon request. Requests should be directed to Investor Relations, BeyondSpring Inc., 100 Campus Drive, Suite 410, Florham Park, NJ 07932 USA. About BeyondSpringBeyondSpring is a global clinical-stage biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, Plinabulin, as a direct anti-cancer agent in various cancer indications and to prevent chemotherapy-induced neutropenia. BeyondSpring’s pipeline also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring’s subsidiary, SEED Therapeutics, leverages a proprietary targeted protein degradation (TPD) drug discovery platform and has an initial R&D collaboration with Eli Lilly. Learn more by visiting https://beyondspringpharma.com. 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, our ability to continue as a going concern, 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 the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq's continued listing requirements, 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:IR@beyondspringpharma.com Media Contact:PR@beyondspringpharma.com

- BeyondSpring Dosed First Patient of Two Phase 2 Investigator-Initiated Trials (IIT) in Plinabulin and Keytruda Combination Studies - SITC 2023 Presentation of the Phase 1 Topline Clinical and Mechanism Data of BeyondSpring’s Lead Asset Plinabulin in Combination with PD-1 Inhibitor and Radiation in a Number of Immune Checkpoint Inhibitor Failed Cancers (Disease Control Rate >50%), Collaboration with MD Anderson - SEED Therapeutics (“SEED”), a BeyondSpring Subsidiary, Achieves Second and Third Molecular Glue Discovery Milestones in the Eli Lilly R&D Collaboration; Selected Investigational New Drug (IND) Candidate for Lead Oncology Internal Program - SEED was Featured in “Nature Biotechnology” March 2024 Review Article “The Glue Degraders” FLORHAM PARK, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today provided a business update and reported results for the year ended December 31, 2023. “2023 has been a year of building fundamental values for BeyondSpring. It is such an honor for our majority-owned subsidiary SEED Therapeutics to be featured among leading companies using target protein degradation molecular glue for innovative drug discovery. With our proprietary RITE3 platform, SEED continues to attract increased partnering interest. I am also pleased to report that SEED has made significant headway in advancing internal programs, with one oncology asset (expected to enter clinics in 1H 2025), Tau degrader(s), and external collaboration projects with Eli Lilly,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring. Dr. Huang continued, “BeyondSpring remains strategically positioned to advance our programs to near-term important inflection points. The Company continues to make progress in advancing our lead drug candidate, Plinabulin, a potent dendritic cell maturation agent, on the regulatory front in the U.S. and in China, and through a number of Plinabulin’s IIT studies at MD Anderson, Memorial Sloan Kettering and other institutions in the U.S. and China.” “PD-1/PD-L1 inhibitors had changed the treatment landscape in cancer, with annual sales well over $40 billion. However, around 60% of patients fail these therapies, and currently very limited therapies have been able to halt or reverse cancer progression in PD-1 failure patients across numerous patient settings, which presents a severe unmet medical need. Using a cost-efficient IIT study model and by working with leading institutions globally, we aim to demonstrate the important role that plinabulin can play in combination with radiation or chemotherapy and immune checkpoint inhibitors (ICI) for these cancer patients who failed ICI. These IIT studies are advancing well, and we aim to report results later in 2024.” Dr. Huang concluded. Recent Business and Clinical Updates Plinabulin Clinical Updates Conference Presentation at ASCO and SITC for Plinabulin In May 2023, the Company and Memorial Sloan Kettering Cancer Center (MSKCC) presented a poster on new data from a Phase 1 IIT study, highlighting Plinabulin’s ability to reduce infectious neutropenic fever for multiple myeloma patients undergoing Autologous Hematopoietic Stem Cell Transplantation (AHCT), at the American Society of Clinical Oncology (ASCO) Annual Meeting. In November 2023, the Company and The University of Texas MD Anderson Cancer Center presented new clinical data from a Phase 1 IIT study, highlighting preclinical and clinical POC immunomodulating activity of Plinabulin inducing dendritic cell maturation and re-sensitization in immunotherapy refractory tumors when combined with radiation and PD-1 inhibitors, at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting. First Patient Enrollment in Two Phase 2 IIT Studies for Plinabulin Combined with Keytruda In March 2023, the first patient was enrolled in a Phase 2 IIT study for Plinabulin in combination with Merck’s anti-PD-1 therapy, Keytruda, and docetaxel for patients with second and third line (2/3L) advanced and metastatic NSCLC who had failed immunotherapy alone or in combination with platinum-doublet chemotherapy. In March 2024, the first patient was enrolled in a Phase 2 IIT study with Keytruda, Plinabulin, plus Etoposide/Platinum (EP) for first-line (1L) Extensive-Stage Small-Cell Lung Cancer (ES-SCLC). Business Updates SEED Therapeutics Milestone Achievements In February 2023 and March 2024, SEED achieved two milestones for pre-clinical developments with Eli Lilly. Appointments of Directors In June 2023, SEED appointed Mr. Jackson Tai, a former director at Eli Lilly, HSBC and Mastercard, to the board of directors. Mr. Tai brings almost five decades of experience in finance, strategy, and risk governance. In October 2023, SEED appointed Mr. Ko-Yung Tung, a former board member at Eisai, former general counsel at World Bank, and a lecturer at Harvard Law School and Yale Law School to the board of directors. Mr. Tung brings five decades of experience in global health, law, governance, and international business. Announcement of IND Candidate for Oncology at “Targeted Protein Degradation (TPD) Think Tank” Symposium In October 2023, SEED held its first “TPD Think Tank” Symposium, in which SEED co-founders invited TPD thought leaders to present. Domestic and foreign attendees engaged in a collaborative and interactive session to advance the TPD field research. During the “TPD Think Tank” Symposium, it was announced that SEED had successfully discovered a new chemical entity (NCE) molecular glue. SEED has declared an IND Candidate status, targeting first human dose in 1H 2025. Advancement in Tau Degrader Molecular Glue Discovery SEED is targeting the protein Tau for degradation with a molecular glue, for the treatment of neurodegeneration. Within 6 months of starting the project, SEED has discovered multiple compound scaffolds with predicted brain permeability that glue tau to a novel E3 ligase selected by SEED’s RITE3 platform. Compounds are now being optimized for relevant activities and properties, including reduced Tau levels in cultured human neurons. SEED is targeting IND Candidate status for the Tau Project in 2H 2025. Expected Milestones in 2024 Plinabulin: Generate preliminary data in 2H 2024 for the Phase 2 IIT Study in combination with Keytruda and docetaxel in 2/3L NSCLC patients who failed PD-1/PD-L1 inhibitors. SEED: Significantly advance lead oncology asset in IND-enabling studies to enable its IND filing. Full Year 2023 Financial Results Research and development (“R&D”) expenses were $14.6 million for the year ended December 31, 2023, compared to $25.6 million for the year ended December 31, 2022. The $11.0 million decrease was primarily due to lower clinical development expense, lower professional service expense to support NDA submission and lower personnel costs. General and administrative (“G&A”) expenses were $10.2 million for the year ended December 31, 2023, compared to $13.0 million for the year ended December 31, 2022. The $2.8 million decrease was primarily due to lower personnel costs, and lower professional service expenses. Net loss attributable to the Company was $21.0 million for the year ended December 31, 2023, compared to $33.3 million for the year ended December 31, 2022. As of December 31, 2023, the Company had cash, cash equivalents, restricted cash, and short-term investments of $17.9 million. About BeyondSpring BeyondSpring is a global clinical-stage biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, Plinabulin, as a direct anti-cancer agent in various cancer indications and to prevent chemotherapy-induced neutropenia. BeyondSpring’s pipeline also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring’s subsidiary, SEED Therapeutics, leverages a proprietary TPD drug discovery platform and has an initial R&D collaboration with Eli Lilly. Learn more by visiting . 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, our ability to continue as a going concern, 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 the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq's continued listing requirements, and other risks described in BeyondSpring’s most recent Form 20-F on 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: IR@beyondspringpharma.com Media Contact: PR@beyondspringpharma.com Financial Tables to Follow BEYONDSPRING INC. CONSOLIDATED BALANCE SHEETS (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) As of December 31, 2022 2023 $ $ Assets Current assets: Cash and cash equivalents 34,396 7,809 Restricted Cash - 9,941 Short-term investments 2,872 193 Advances to suppliers 492 306 Prepaid expenses and other current assets 763 170 Total current assets 38,523 18,419 Noncurrent assets: Property and equipment, net 1,868 1,628 Operating right-of-use assets 5,484 4,397 Other noncurrent assets 347 364 Total noncurrent assets 7,699 6,389 Total assets 46,222 24,808 Liabilities and equity Current liabilities: Accounts payable 1,081 1,407 Accrued expenses 2,470 2,581 Current portion of operating lease liabilities 966 631 Deferred revenue 1,351 1,751 Other current liabilities 1,484 1,588 Total current liabilities 7,352 7,958 Noncurrent liabilities: Operating lease liabilities 3,995 3,364 Deferred revenue 34,221 33,242 Other noncurrent liabilities 3,661 3,705 Total noncurrent liabilities 41,877 40,311 Total liabilities 49,229 48,269 Commitments and contingencies Mezzanine equity Contingently redeemable noncontrolling interests 11,074 11,874 Shareholders’ deficit Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 38,999,597 and 39,029,163 shares issued and outstanding as of December 31, 2022 and 2023, respectively) 4 4 Additional paid-in capital 368,857 368,599 Accumulated deficit (375,276 ) (396,302 ) Accumulated other comprehensive income 436 894 Total BeyondSpring Inc.’s shareholders’ deficit (5,979 ) (26,805 ) Noncontrolling interests (8,102 ) (8,530 ) Total shareholders’ deficit (14,081 ) (35,335 ) Total liabilities, mezzanine equity and shareholders’ deficit 46,222 24,808 BEYONDSPRING INC. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) Year ended December 31, 2021 2022 2023 $ $ $ Revenue 1,351 1,351 1,751 Operating expenses Research and development (36,888 ) (25,582 ) (14,635 ) General and administrative (30,703 ) (13,008 ) (10,230 ) Loss from operations (66,240 ) (37,239 ) (23,114 ) Foreign exchange gain (loss), net 231 (429 ) (123 ) Interest income 98 195 421 Interest expenses (87 ) (17 ) - Other income, net 1,360 1,373 974 Loss before income tax (64,638 ) (36,117 ) (21,842 ) Income tax expenses (3,570 ) (163 ) (106 ) Net loss (68,208 ) (36,280 ) (21,948 ) Less: Net loss attributable to noncontrolling interests (4,029 ) (3,001 ) (922 ) Net loss attributable to BeyondSpring Inc. (64,179 ) (33,279 ) (21,026 ) Net loss per share Basic and diluted (1.64 ) (0.85 ) (0.54 ) Weighted-average shares outstanding Basic and diluted 39,023,643 39,093,246 38,996,463 Other comprehensive loss, net of tax of nil: Foreign currency translation adjustment (loss) gain (296 ) 1,483 725 Unrealized holding gain (loss) 5 (5 ) - Comprehensive loss (68,499 ) (34,802 ) (21,223 ) Less: Comprehensive loss attributable to noncontrolling interests (4,094 ) (2,482 ) (655 ) Comprehensive loss attributable to BeyondSpring Inc. (64,405 ) (32,320 ) (20,568 )