Ocugen (NasdaqCM:OCGN) 2025 Conference September 25, 2025 09:30 AM ET Company ParticipantsShankar Musunuri - CEO, Co-founder & Chairman of the BoardHuma Qamar - Chief Medical OfficerNoneWe're good to go. Okay. Good afternoon, and thanks for joining us to have a conversation with Shankar Moussunari, CEO, and Huma Kumar, CFO I mean, CMO of Ocugen. Ocugen is a biotech company focused on discovery, development, and commercializing novel gene and cell therapies. The company's proprietary gene therapy platform ha ...

Sean Daly writes on ETFs, biotech and FINTECH solutions in the banking space. He teaches international finance and financial risk management at Pace University and was a visiting lecturer at Princeton University from 2005 to 2009. He was educated at Columbia University. He has also written extensively on real estate and economic development, exploring issues as diverse as Chinese urbanization, CMI multilateral currency swap arrangements, energy geopolitics, and Asia's sovereign wealth funds. Global strategy ...

Sean Daly writes on ETFs, biotech and FINTECH solutions in the banking space. He teaches international finance and financial risk management at Pace University and was a visiting lecturer at Princeton University from 2005 to 2009. He was educated at Columbia University. He has also written extensively on real estate and economic development, exploring issues as diverse as Chinese urbanization, CMI multilateral currency swap arrangements, energy geopolitics, and Asia's sovereign wealth funds. Global strategy ...

My name is María Fernanda and I'm currently studying an MBA. My inspiration investors are Warren Buffett, Peter Lynch and Terry Smith, so I look for quality companies at a reasonable valuation. I believe that, in the long term, fundamentals are what drive the share price, so I look to predict what a business's earnings per share will do.Analyst’s Disclosure:I/we have a beneficial long position in the shares of MUEL either through stock ownership, options, or other derivatives. I wrote this article myself, a ...

Key Points The company signed a licensing agreement with South Korea's Kawngdong Pharmaceutical. This is one of the top pharma companies in the prosperous Asian country. 10 stocks we like better than Ocugen › On Monday, investors clearly saw excellent value in the stock of Ocugen (NASDAQ: OCGN), a biotech that concentrates on treatments for eye disorders. They traded the company's shares up by more than 12%, on the back of a fresh licensing agreement signed with a peer in Asia. That 12% absolutely ...

Ocugen, Inc. OCGN shares traded higher on Monday after the company announced a licensing agreement with Kwangdong Pharmaceutical for the exclusive Korean rights to OCU400.OCGN shares are powering higher on strong volume. Find out why here.What To Know: Ocugen said it executed a licensing agreement with Kwangdong for rights to OCU400, its modifier gene therapy for retinitis pigmentosa. The deal marks Ocugen's first regional partnership for the program.Under the agreement, Ocugen will receive upfront license ...

交易概览 - Ocugen与韩国Kwangdong制药就OCU400达成独家授权协议 授权范围涵盖韩国地区[1] - OCU400是用于治疗视网膜色素变性(RP)的修饰基因疗法 目前处于临床三期阶段[1][5] 财务条款 - Ocugen将获得最高750万美元的首付款及近期开发里程碑付款[2] - 在韩国市场每实现1500万美元销售额 Ocugen可获得150万美元销售里程碑付款 预计商业化前10年销售额达1.8亿美元或更高[2] - Ocugen将获得Kwangdong销售OCU400净销售额25%的特许权使用费[2] - Ocugen将负责OCU400的商业化生产供应[2] 市场机会 - 韩国约有7000名RP患者 相当于美国市场规模的7%[3] - OCU400有望成为一次性终身疗法 为韩国患者提供新治疗选择[4] - 通过此协议 Kwangdong有望成为韩国眼科基因治疗领域的领导者[3] 合作方背景 - Kwangdong是韩国前五大制药和健康企业 拥有处方药和OTC健康产品组合[4] - Kwangdong正在开发老花眼和儿童近视管线 此次合作将加强其眼科产品组合[5] - Kwangdong在韩国制药和健康公司中排名前十[9] 开发进展 - OCU400目前处于临床三期阶段 目标于2026年向美国FDA提交生物制剂许可申请(BLA)[5] - Kwangdong计划利用Ocugen的临床数据和BLA申请作为韩国监管提交的一部分[6] - 完成临床试验后 Kwangdong将尽快推动产品在韩国上市[5]

公司管理层活动安排 - 公司董事长兼首席执行官将于2025年9月8日参加H C Wainwright第27届全球投资会议的炉边谈话活动[1][3] - 公司高管将于2025年9月25日参加慕尼黑Biotech on Tap会议的专题小组讨论 主题为"FDA挑战 成功获批策略"[1][3] - 公司高管团队将进行一对一会议展示其独特修饰基因治疗平台的业务和临床开发策略[2] 公司业务定位 - 公司是专注于 blindness diseases 基因治疗领域的先驱型生物技术企业[4] - 公司突破性修饰基因治疗平台采用基因不可知论方法 有望解决大量患者群体未满足的医疗需求[4] - 公司当前开发项目涵盖影响全球数百万患者的 inherited retinal diseases 包括 retinitis pigmentosa Stargardt disease 和 geographic atrophy[4] 活动参与战略意义 - 会议活动为公司提供了与生物技术和医疗保健领域关键投资者会面的重要机会[2] - 公司计划通过Biotech on Tap会议扩大在欧洲投资圈的接触范围[2] - 炉边谈话活动将通过网络直播播出 录像保留90天供投资者回看[3]

评级升级与投资逻辑 - Ocugen被上调至Zacks Rank 2（买入）评级 反映其盈利预期向上修正趋势[1] - 评级变化的核心依据是公司盈利前景的改善 可能对股价产生积极影响[2] - Zacks评级系统基于盈利预期修订 被证明与短期股价变动存在强相关性[3][5] 盈利预期变化 - 机构投资者通过盈利预期计算公司公允价值 其大规模投资行为直接影响股价变动[3] - Ocugen的盈利预期持续上调 过去三个月Zacks共识预期增长2.9%[7] - 公司2025财年每股收益预期为-0.23美元 与去年同期持平[7] 评级系统特性 - Zacks评级系统将4000多只股票分为五档 仅前5%获"强力买入"评级 后续15%获"买入"评级[8] - 排名前20%的股票具有优异的盈利预期修订特征 可能产生超额回报[9] - Ocugen位列前20% 表明其盈利预期修订表现突出[9] 历史表现数据 - Zacks Rank 1股票自1988年以来实现年均25%的回报率[6] - 评级系统经过外部审计验证 具有可靠的历史跟踪记录[6] - 系统使用四个盈利预期相关因素进行股票分类[6]

核心观点 - 欧洲药品管理局人用药品委员会认可OCU410ST单次美国临床试验作为欧盟上市许可申请依据 显著加速基因疗法OCU410ST用于斯塔加特病的监管审批进程[1][3] 监管进展 - CHMP基于Phase 1试验安全性和耐受性数据认可单中心试验设计 包括病灶生长速度降低48%和BCVA显著改善2行/9个字母(p=0.031)[1][2] - 该意见将显著减少欧盟上市授权所需时间和成本 与近期获得的罕见儿科疾病认定(5月)、IND批准(6月)和首例患者给药(7月)形成里程碑组合[3] - 公司计划2026年第一季度完成患者招募 2027年上半年提交生物制剂许可申请 符合三年内提交三个BLA的目标[3] 临床试验设计 - Phase 2/3试验采用适应性设计 计划招募51名斯塔加特病患者 其中34名接受单次视网膜下注射OCU410ST(200μL浓度1.5×10¹¹ vg/mL) 17名作为未治疗对照组[2] - 试验包含对24名受试者(16名治疗组/8名对照组)的8个月盲态中期分析 主要终点为萎缩性病灶尺寸减少 关键次要终点包括BCVA和低亮度视敏度改善[2] - 一年随访数据将同时支持美国BLA和欧盟MAA申请[2] 产品机制与市场 - OCU410ST采用AAV载体递送RORA基因 通过核激素受体调节斯塔加特病相关病理生理通路 包括脂褐素形成、氧化应激和炎症反应[4] - 该疗法瞄准欧美约10万名斯塔加特病患者群体 目前该疾病尚无获批治疗方案 属于遗传性黄斑变性的最常见形式[3][5][6] 公司背景 - Ocugen专注于开发基因疗法治疗重大眼盲疾病 其修饰基因治疗平台采用基因不可知论方法 有望解决大规模患者群体的未满足医疗需求[7]