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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年第三季度財務業績的最新業務情況
美股SEC公告 ·  2024/11/09 02:45

Moomoo AI 已提取核心訊息

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宣佈其2024年第三季度財務結果,並獲得3000萬美元的債務融資,將其現金流延長至2026年第一季度。該公司報告的營業費用爲1440萬美元,其中包括810萬美元的研發費用和630萬美元的銷售及行政費用。截至2024年9月30日,現金及限制性現金總額爲3900萬美元。該公司的基因治療項目取得顯著進展,OCU400針對視網膜色素變性(retinitis pigmentosa)的III期liMeliGht試驗預計將在2025年上半年完成入組。OCU410已進入地理性萎縮的I/II期ArMaDa試驗的II期,而DSMB批准了OCU410ST的GARDian試驗的第二階段入組。FDA還批准了...展開全部
Ocugen宣佈其2024年第三季度財務結果,並獲得3000萬美元的債務融資,將其現金流延長至2026年第一季度。該公司報告的營業費用爲1440萬美元,其中包括810萬美元的研發費用和630萬美元的銷售及行政費用。截至2024年9月30日,現金及限制性現金總額爲3900萬美元。該公司的基因治療項目取得顯著進展,OCU400針對視網膜色素變性(retinitis pigmentosa)的III期liMeliGht試驗預計將在2025年上半年完成入組。OCU410已進入地理性萎縮的I/II期ArMaDa試驗的II期,而DSMB批准了OCU410ST的GARDian試驗的第二階段入組。FDA還批准了OCU200的I期試驗的IND申請。加拿大衛生部批准OCU400試驗擴展到加拿大場所,可能拓寬商業化機會。FDA批准了一項針對成人RP患者的擴展獲取計劃,目標是在美國、加拿大和歐洲的患者總市場達到30萬名。最新的正在進行的試驗數據將於2024年11月12日在即將舉行的臨牀展示會上公佈。
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