财务结果 - 公司报告2024年第二季度财务结果，包括业务更新[3] - 公司获得3260万美元的净现金从公开发行普通股[2] - 截至2024年6月30日，公司现金、现金等价物和限制现金总计1600万美元，而2023年12月31日为3950万美元[16] - 2024年第二季度总运营费用为1660万美元，包括研发费用890万美元和一般及行政费用770万美元[17] - 2024年第二季度净亏损为0.04美元每普通股，而2023年同期为0.10美元每普通股[18] - 公司报告了净亏损为15,280单位，与上一期的27,204单位相比有所减少[25] - 普通股股东可获得的净亏损为10,292单位，与上一期的22,216单位相比有所减少[25] - 用于计算每股净亏损的股份数为257,353,857股，与上一期的257,293,247股相比基本持平[25] - 普通股股东可获得的每股净亏损为0.04单位，与上一期的0.09单位相比有所减少[25] 临床试验进展 - 正在进行OCU400 Phase 3 liMeliGhT临床试验，样本大小为150名参与者[5] - OCU400 Phase 3试验的主要终点是Luminance Dependent Navigation Assessment (LDNA)，超过60%的意向治疗患者达到响应标准[5] - 公司计划在2026年为OCU400申请BLA和MAA批准[13] - OCU410 Phase 1/2 ArMaDa临床试验已完成第三组给药，九名GA患者已接受低、中、高剂量治疗[14] - OCU410ST获得FDA的孤儿药指定，用于治疗Stargardt病，目前正在进行高剂量给药[9] 股票和资本结构 - 公司赎回了4,988单位的B系列可转换优先股[25]

Ocugen, Inc. (NASDAQ:OCGN) Q2 2024 Earnings Conference Call August 8, 2024 8:30 AM ET Company Participants Tiffany Hamilton - Head of Corporate Communications Shankar Musunuri - Chairman of the Board, CEO & Co-founder Michael Breininger - Corporate Controller Huma Qamar - Chief Medical Officer Conference Call Participants Sean Lee - H.C. Wainwright Robert LeBoyer - Noble Capital Markets Janani Sundararajan - Chardan Capital Markets Operator Good morning, and welcome to Ocugen's Second Quarter 2024 Financial ...

研发管线和临床进展 - 公司正在开发基于核激素受体的修饰基因治疗平台，用于治疗视网膜疾病，包括遗传性视网膜疾病和多因素性疾病[115][116] - OCU400已获得FDA孤儿药物认定和RMAT认定，并在欧洲获得孤儿药物认定，显示其广泛的治疗潜力[116] - OCU400 I/II期临床试验结果显示，89%的受试者在最佳矫正视力、低照度视力或多光度移动测试评分方面有所保持或改善[118] - 公司已获FDA批准启动OCU400 III期临床试验用于视网膜色素变性的治疗，这是首个进入III期的广泛视网膜色素变性适应症的基因治疗项目[119][121] - OCU410和OCU410ST正处于I/II期临床开发阶段，分别用于干性年龄相关性黄斑变性和Stargardt病的治疗[123][125][126] - 公司正在与NIAID合作开展OCU500 COVID-19疫苗的I期临床试验[129] 财务表现 - 2024年第二季度合作安排收入为11.41亿美元，较2023年同期增加6.56亿美元[134] - 2024年第二季度研发费用下降5.67亿美元，主要由于COVAXIN项目终止导致费用减少[135] - 2024年第二季度一般及行政费用下降1.76亿美元，主要由于专业服务费用减少10%和人员成本下降8%[136] - 2024年第二季度其他收益(费用)净额下降0.31亿美元，主要由于利息收入减少[137] - 2024年上半年合作安排收入增加1.23亿美元，主要由于公司对合作伙伴提供的共同开发服务进行季度重新评估[142] - 2024年上半年研发费用下降9.02亿美元，主要由于COVAXIN项目终止和人员成本下降[143] - 2024年上半年一般及行政费用下降3.67亿美元，主要由于专业服务费用、人员成本和保险费用的减少[144] 现金流和持续经营能力 - 2024年6月30日公司现金、现金等价物和受限现金余额为16亿美元[146] - 2024年上半年经营活动产生的现金流出为20.51亿美元[151] - 2024年上半年投资活动产生的现金流出为2.87亿美元，主要用于购置固定资产[153] - 截至2024年6月30日，公司拥有约1600万美元的现金、现金等价物和受限现金[158] - 公司认为截至2024年6月30日的现金及现金等价物以及2024年6月30日之后筹集的资金预计将使公司的运营持续到2025年第三季度[158] - 公司需要筹集大量额外资金以为未来运营提供资金，管理层正在评估不同的融资策略[158] - 公司融资能力受地缘政治动荡、宏观经济条件以及通胀影响的制约，因此无法保证融资努力会成功[158] - 如果公司无法获得必要的资金，将需要推迟、缩减或取消部分或全部研发和商业化工作，并考虑其他战略选择[158] - 由于上述因素以及预计将持续的支出，公司持续经营能力存在重大不确定性[159] 其他披露 - 公司在报告期内没有任何资产负债表外安排[160] - 公司的关键会计政策和重大判断及估计在2023年年报中有详细披露，本报告期内未发生重大变化[161] - 公司已采纳的新会计准则在财务报表附注中有详细说明[162] - 公司未披露任何市场风险相关的定量和定性信息[162]

MALVERN, Pa., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. ("Ocugen" or the "Company") (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it has received notification from FDA to begin its expanded access program (EAP) for the treatment of adult patients, aged 18 and older, with retinitis pigmentosa (RP) with OCU400—a modifier gene therapy product candidate. "Each clinical milestone achieved by OC ...

MALVERN, Pa., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. ("Ocugen" or the "Company") (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it has received notification from FDA to begin its expanded access program (EAP) for the treatment of adult patients, aged 18 and older, with retinitis pigmentosa (RP) with OCU400—a modifier gene therapy product candidate. "Each clinical milestone achieved by OC ...

MALVERN, Pa., Aug. 02, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ:OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the closing of its previously announced underwritten public offering of 30,434,783 shares of its common stock. Each share of common stock was sold at a price to the public of $1.15 per share. The gross proceeds to the Company from the offering were approximately $35 million, before deducting und ...

MALVERN, Pa., July 31, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Nasdaq: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the pricing of its underwritten public offering of 30,434,783 shares of its common stock at an offering price of $1.15 per share of common stock for gross proceeds of $35 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Ocugen ...

MALVERN, Pa., July 31, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Nasdaq: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the pricing of its underwritten public offering of 30,434,783 shares of its common stock at an offering price of $1.15 per share of common stock for gross proceeds of $35 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Ocugen ...

MALVERN, Pa., July 31, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Nasdaq: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it has commenced an underwritten public offering (the "offering") of its common stock. In addition, Ocugen expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the aggregate number of shares of its common stock to be sold in the public offering at the pub ...

MALVERN, Pa., July 29, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ:OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it will host a conference call and live webcast to discuss the Company's second quarter 2024 financial results and provide a business update at 8:30 a.m. ET on Thursday, August 8, 2024. Ocugen will issue a pre-market earnings announcement on the same day. Attendees a ...