FLORHAM PARK, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, today presented interim phase 2 data on the 303 Study, a study in 2L/3L non-small cell lung cancer (NSCLC) after disease progression on 1L PD-1/L1 inhibitors with and without chemotherapy, with financial support from Merck & Co., Inc’s (NYSE: MRK, known as MSD outside of the United States and Canad ...

The SEED-Eisai Research Collaboration leverages Eisai's leading expertise in neurodegeneration and cancer. SEED is entitled to receive upfront and milestone payments of up to $1.5 billion plus tiered royalties upon Eisai's exercise of their exclusive rights under the strategic research collaboration Concurrently, SEED has launched Series A-3 financing with a first close of $24 million from investors led by Eisai. A second close is targeted for Q4 2024 The Series A-3 financing will advance clinical developme ...

FLORHAM PARK, N.J., May 03, 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 it will host a Research and Development (R&D) Day to discuss the current unmet medical needs and the potential of Plinabulin as a novel immunochemotherapeutic in drug combinations and updates for SEED Therapeutics on Wednesday, May 15th, 2024 at 10:00 a.m. ET. The conference ...

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, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...

FLORHAM PARK, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI) ("BeyondSpring" or the "Company"), a global clinical-stage biopharmaceutical company focused on using a groundbreaking technology platform for drug discovery and developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs, today announced that on February 20, 2024, the Company received a written notification on minimum bid price compliance (the "Notification Letter") from The Nas ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of February 2024 Commission File Number: 001-38024 BeyondSpring Inc. BeyondSpring Inc. 100 Campus Drive, West Side, 4th Floor, Suite 410 Florham Park, New Jersey 07932 (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form ...

公司信息 - 公司总部位于纽约，地址为28 Liberty Street, 39th Floor[1] - 公司的主席兼首席执行官为黄兰女士[4] - 公司于2022年5月13日被美国证券交易委员会确定为HFCAA的委员会确定的发行人[3]

公司风险 - 公司目前面临的风险主要包括：有限的运营历史，难以评估当前业务和预测未来表现[15] - 公司依赖于Plinabulin的成功，但临床试验可能不成功，未来业务可能受到重大损害[16] - FDA如果不批准Plinabulin与G-CSF联合预防CIN的NDA，或者审查或批准过程延迟，公司业务和运营结果可能受到重大不利影响[17] - 公司的未来成功取决于保留首席执行官和其他关键高管，并吸引、留住和激励合格人员[28] - 公司需要获得额外融资以支持未来运营，否则可能无法完成当前或未来产品候选品的开发和商业化[33] - 公司自成立以来一直在消耗大量现金，2022年年底的运营活动净现金流为2,750万美元[34] - 未来需要额外融资以支持公司的运营，包括进行额外的临床试验、完成未来产品的开发和商业化[34] - 未来的资金需求取决于多个因素，包括当前、计划和潜在未来临床试验的成本、FDA、NMPA、EMA等监管机构的批准情况和商业化成本、未来产品候选品的开发和商业化成本等[34] - 需要通过股权和债务融资、潜在的许可和合作安排以及获得监管批准后销售产品来满足未来的现金需求[34] - 额外融资可能导致股东权益被稀释，限制公司的运营或要求公司放弃技术或产品候选品的权利[35] - 公司目前尚未从产品销售中产生收入，未来盈利取决于产品候选品的成功开发、获得必要的监管批准和成功市场推广[36] - 公司依赖Plinabulin等产品候选品的成功，如果无法商业化这些产品候选品或遇到重大延迟，公司业务将受到重大影响[37] - FDA未批准Plinabulin与G-CSF联合用于预防CIN，或审批过程延迟，将对公司业务和财务状况产生重大不利影响[38] - 公司可能无法成功发现或开发其他产品候选品，有限的资源和资本访问可能影响公司业务[39] 资金需求与融资 - 公司需要获得额外融资以支持未来运营，否则可能无法完成当前或未来产品候选品的开发和商业化[33] - 公司自成立以来一直在消耗大量现金，2022年年底的运营活动净现金流为2,750万美元[34] - 未来需要额外融资以支持公司的运营，包括进行额外的临床试验、完成未来产品的开发和商业化[34] - 未来的资金需求取决于多个因素，包括当前、计划和潜在未来临床试验的成本、FDA、NMPA、EMA等监管机构的批准情况和商业化成本、未来产品候选品的开发和商业化成本等[34] - 需要通过股权和债务融资、潜在的许可和合作安排以及获得监管批准后销售产品来满足未来的现金需求[34] - 额外融资可能导致股东权益被稀释，限制公司的运营或要求公司放弃技术或产品候选品的权利[35] 临床试验风险 - 临床药物开发过程漫长且昂贵，公司在进行临床试验方面经验有限，早期研究和试验结果可能无法在未来的临床试验中复制[42] - 临床试验可能会出现不可预测的结果，导致进展受阻[43] - 临床试验失败可能会导致额外成本或延迟开发和商业化[44] - 临床试验可能面临多种意外事件，延迟或阻止获得监管批准[45] - 临床试验可能因各种原因而被中止，导致额外费用和延迟[46] - 需要进行额外的临床试验或测试，可能导致延迟或无法获得监管批准[47] - FDA、NMPA、EMA等监管机构可能要求提供更多信息以支持批准[49] - 临床试验政策可能发生变化，我们需要适应变化以避免影响开发计划[50] - 监管机构可能会延迟或无法批准产品候选药物，影响商业前景[50] - 监管机构可能要求额外时间或研究来评估产品候选药物的安全性或有效性[51] 中国市场机遇与挑战 - 中国市场对Plinabulin的商业化和共同开发达成了独家协议[75] - Plinabulin在中国获得了突破性疗法认定[75] - Plinabulin被列入了中国国家药品优先审评清单[75] - Plinabulin有望被纳入国家医保体系[75] - 美国和其他地区计划寻求商业化合作伙伴来最大化Plinabulin在多种癌症适应症中的潜力[75] - 公司需要通过与第三方达成协议来开发销售和分销能力[74] - 公司目前没有内部销售、营销和分销能力[74] - 公司可能无法与其他制药公司建立或维持合作关系[76] - 公司面临着与其他制药和生物技术公司的激烈竞争[77] - 公司必须获得足够的报销覆盖才能成功商业化产品候选药物[78]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of February 2023 Commission File Number: 001-38024 BeyondSpring Inc. BeyondSpring Inc. 28 Liberty Street, 39th Floor New York, New York 10005 (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20 ...