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Ocugen | 8-K: Ocugen Provides Business Update with Third Quarter 2024 Financial Results

Ocugen | 8-K: Ocugen Provides Business Update with Third Quarter 2024 Financial Results

Ocugen | 8-K:Ocugen提供2024年第三季度财务业绩的最新业务情况
美股SEC公告 ·  2024/11/09 02:45

牛牛AI助手已提取核心信息

Ocugen announced Q3 2024 financial results and secured $30 million in debt financing, extending its cash runway into Q1 2026. The company reported operating expenses of $14.4 million, including $8.1 million in R&D and $6.3 million in G&A expenses. Cash and restricted cash totaled $39.0 million as of September 30, 2024.The company's gene therapy programs showed significant progress, with OCU400 Phase 3 liMeliGhT trial for retinitis pigmentosa on track to complete enrollment in 1H2025. OCU410 has advanced to Phase 2 of the Phase 1/2 ArMaDa trial for geographic atrophy, while the DSMB approved enrollment for the second phase of OCU410ST's GARDian trial. The FDA also cleared the IND application for OCU200's Phase 1 trial.Health Canada approved OCU400 trial expansion to Canadian sites, potentially broadening commercialization opportunities. The FDA approved an Expanded Access Program for adult RP patients, targeting a combined market of 300,000 patients across the U.S., Canada, and Europe. New data from ongoing trials will be presented at an upcoming Clinical Showcase on November 12, 2024.
Ocugen announced Q3 2024 financial results and secured $30 million in debt financing, extending its cash runway into Q1 2026. The company reported operating expenses of $14.4 million, including $8.1 million in R&D and $6.3 million in G&A expenses. Cash and restricted cash totaled $39.0 million as of September 30, 2024.The company's gene therapy programs showed significant progress, with OCU400 Phase 3 liMeliGhT trial for retinitis pigmentosa on track to complete enrollment in 1H2025. OCU410 has advanced to Phase 2 of the Phase 1/2 ArMaDa trial for geographic atrophy, while the DSMB approved enrollment for the second phase of OCU410ST's GARDian trial. The FDA also cleared the IND application for OCU200's Phase 1 trial.Health Canada approved OCU400 trial expansion to Canadian sites, potentially broadening commercialization opportunities. The FDA approved an Expanded Access Program for adult RP patients, targeting a combined market of 300,000 patients across the U.S., Canada, and Europe. New data from ongoing trials will be presented at an upcoming Clinical Showcase on November 12, 2024.
Ocugen宣布其2024年第三季度财务结果,并获得3000万美元的债务融资,将其现金流延长至2026年第一季度。该公司报告的营业费用为1440万美元,其中包括810万美元的研发费用和630万美元的销售及行政费用。截至2024年9月30日,现金及限制性现金总额为3900万美元。该公司的基因治疗项目取得显著进展,OCU400针对视网膜色素变性(retinitis pigmentosa)的III期liMeliGht试验预计将在2025年上半年完成入组。OCU410已进入地理性萎缩的I/II期ArMaDa试验的II期,而DSMB批准了OCU410ST的GARDian试验的第二阶段入组。FDA还批准了...展开全部
Ocugen宣布其2024年第三季度财务结果,并获得3000万美元的债务融资,将其现金流延长至2026年第一季度。该公司报告的营业费用为1440万美元,其中包括810万美元的研发费用和630万美元的销售及行政费用。截至2024年9月30日,现金及限制性现金总额为3900万美元。该公司的基因治疗项目取得显著进展,OCU400针对视网膜色素变性(retinitis pigmentosa)的III期liMeliGht试验预计将在2025年上半年完成入组。OCU410已进入地理性萎缩的I/II期ArMaDa试验的II期,而DSMB批准了OCU410ST的GARDian试验的第二阶段入组。FDA还批准了OCU200的I期试验的IND申请。加拿大卫生部批准OCU400试验扩展到加拿大场所,可能拓宽商业化机会。FDA批准了一项针对成人RP患者的扩展获取计划,目标是在美国、加拿大和欧洲的患者总市场达到30万名。最新的正在进行的试验数据将于2024年11月12日在即将举行的临床展示会上公布。

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