koto_feja/E+ via Getty Images Geron Corporation (NASDAQ:GERN) could reach a turning point on June 16, 2024, after 34 years of its foundation. This date could represent the new company's commercial transformation. It could bring its unique product Imetelstat to new life on the real market and this drug could be able to bring real benefits to serious and highly disabling hematological diseases (MDS and MF). If we analyze the results of the IMerge Phase 3 clinical study we can see how there is statistical evid ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 000-20859 GERON CORPORATION (Exact name of registrant as specified in its charter) DELAWARE 75-2287752 (State or other jurisdictio ...

财务数据和关键指标变化 - 截至2024年3月31日,公司拥有约4.65亿美元的现金和可流动证券,包括3月份公开发行股票和预付认股权证的净收益约1.41亿美元 [63] - 2024年第一季度总运营费用为5,640万美元,较2023年同期的4,010万美元有所增加 [64] - 2024年第一季度研发费用为2,940万美元,较2023年同期的2,720万美元有所增加,主要反映了商业制造批次的CMC成本时间安排和人员相关费用的增加 [64] - 2024年第一季度一般及行政费用为2,710万美元,较2023年同期的1,290万美元有所增加,主要反映了商业准备活动的投资和人员相关费用的增加 [65] - 公司预计2024年全年运营费用将在2.7亿美元至2.8亿美元之间 [67] 各条业务线数据和关键指标变化 - 公司正在为美国Imetelstat的商业化做准备,包括在2024年4月建立销售团队 [13][23] - 公司正在欧洲就Imetelstat的商业化进行战略评估,预计如获欧盟批准将于2025年在欧洲上市 [16] 各个市场数据和关键指标变化 - 公司的市场研究显示,Imetelstat在治疗依赖输血的低危MDS患者方面具有高度差异化的产品特征,受到医疗和支付方利益相关方的高度关注 [25][26] - 公司预计Imetelstat在依赖输血的低危MDS患者中的使用将覆盖ESA无法使用、ESA失败、RS阴性和RS阳性高输血负担患者 [37][38][39] 公司战略和发展方向及行业竞争 - 公司正在为Imetelstat在美国的商业化做好充分准备,包括建立销售团队、完成商业供应和分销网络、制定患者准入和支付解决方案等 [13][23][24][40][41] - 公司计划在Imetelstat获批后尽快与NCCN合作,将其纳入指南 [35][80] - 公司正在评估在欧洲的商业化策略,包括自主商业化或寻求合作伙伴 [16] - 公司正在推进Imetelstat在难治复发骨髓纤维化(MF)适应症的III期临床试验,该试验以总生存期为主要终点 [17][55][59][60] 管理层对经营环境和未来前景的评论 - 管理层对Imetelstat在治疗依赖输血的低危MDS患者方面的潜力表示高度兴奋和信心 [11][20][70] - 管理层认为Imetelstat可以有效满足目前治疗依赖输血的低危MDS患者的未满足需求,特别是对于ESA无法使用、RS阴性和高输血负担患者 [31][33][39] - 管理层对Imetelstat在难治复发MF适应症的III期临床试验结果持乐观态度,认为如果成功将可能改变这些患者的治疗格局 [19][59][60] 问答环节重要的提问和回答 问题1 **Tara Bancroft 提问** 关于MF试验时间线延长,是由于入组速度较慢还是事件发生率低于预期?对照组OS预期是否有变化? [73] **Faye Feller 回答** 入组速度和事件发生率都低于预期,具体原因难以确定。公司将继续密切监控并适时更新指引 [75][94][97] 问题2 **Corinne Johnson 提问** 公司是否已经与FDA就Imetelstat在低危MDS适应症的标签展开讨论? [77] **John Scarlett 回答** 公司已收到FDA的标签反馈,但在PDUFA前不会公开讨论监管互动的细节 [78] 问题3 **Gil Blum 提问** MF试验入组缓慢是否与近年来MF治疗标准的变化有关?公司采取了哪些措施来提高入组速度? [83] **Faye Feller 回答** 新JAK抑制剂的批准可能影响了入组,公司正采取多种措施如与研究者和患者团体加强互动等来提高入组速度 [84][94][100]

Geron (GERN) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.10. This compares to loss of $0.07 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 10%. A quarter ago, it was expected that this drugmaker would post a loss of $0.10 per share when it actually produced a loss of $0.09, delivering a surprise of 10%. Over the last four quarters, the company has surpassed consensus ...

Exhibit 99.1 Geron Corporation Reports First Quarter 2024 Financial Results and Business Highlights June 16, 2024 PDUFA date for imetelstat NDA for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS FOSTER CITY, Calif., May 2, 2024 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results and business highl ...

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公司背景 - Geron是一家专注于开发细胞疗法治疗各种血液癌症的生物技术公司[1] 产品介绍 - FDA咨询委员会以12票对2票的结果支持批准Geron的主打产品Imetelstat，用于治疗骨髓增生异常综合征（MDS）患者的输血依赖性贫血[2] - Imetelstat是一种能够阻断酶类活性的端粒酶抑制剂，用于治疗成人低风险MDS患者的输血依赖性贫血[6]

公司融资 - Geron Corporation宣布定价41,999,998股普通股和8,002,668股预先融资认股权证[1] - 该交易预计募集约1.5亿美元，用于潜在的imetelstat在美国和欧盟的商业化以及在relapsed/refractory myelofibrosis的持续发展[2] - TD Cowen、Stifel和Barclays担任本次交易的联席主承销商，Wedbush PacGrow担任副主承销商[3]

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Geron公司股价表现 - Geron公司股票在FDA咨询委员会对其主力资产Imetelstat的强烈支持下，股价飙升至历史新高[2] - Geron公司自1996年上市以来，股价经历了起伏不定的过山车式波动，尤其在点com繁荣时期曾一度飙升至70美元，但随后暴跌[4] Imetelstat潜力 - Imetelstat被认为是治疗转染依赖性贫血的潜在突破，受到赞誉[3]