文章核心观点 - 公司已获得欧盟和英国市场的湿性年龄相关性黄斑变性(wet AMD)治疗用贝伐珠单抗眼用制剂的首次授权批准 [1][3] - 公司计划于2025年第一季度在欧盟和英国启动LYTENAVA™(贝伐珠单抗伽马)的商业化推广 [3] - 在美国,ONS-5010/LYTENAVA™正在进行非劣效性研究,如果成功,可能足以让公司重新向FDA提交生物制品许可申请 [3] 财务和运营情况 - 公司将于2024年8月14日发布2024财年第三季度的财务业绩 [1][2] - 公司管理层将在当天上午8:30举行电话会议和网络直播,讨论运营和财务业绩 [2]

ISELIN, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced that it will report its financial results for third quarter fiscal year 2024 on Wednesday, August 14, 2024. Outlook Therapeutics management will host its quarterly conference call and live audio webcast to discuss the o ...

Company to participate in a fireside chat on Monday, August 5th at 8:00 AM ET ISELIN, N.J., July 30, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retina diseases, today announced that Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics will participate in a fireside chat at the BTIG Virtual Biotechnology Con ...

Outlook Therapeutics NASDAQ: OTLK has gained attention, with analysts forecasting an upside of over 500% based on the consensus price target. Outlook Therapeutics TodayOTLKOutlook Therapeutics$7.07 -0.49 (-6.48%) 52-Week Range$4.00▼$37.00Price Target$46.43Add to WatchlistIt's essential to remember that low-float biopharmaceutical companies often experience volatility due to frequent breaking news and technical factors such as float size and short interest. While the bullish price target is noteworthy, it's ...

Zorica Nastasic Outlook Therapeutics (NASDAQ:OTLK) is a late clinical-stage biopharmaceutical company focusing on ONS-5010/LYTENAVA (bevacizumab-vikg) indicated for retinal conditions such as wet age-related macular degeneration [wet AMD], diabetic macular edema [DME], and branch retinal vein occlusion [BRVO]. The company is resubmitting a BLA for ONS-5010 at the end of 2024 after executing an FDA-recommended non-inferiority study that will present top-line data in Q4, 2024. In May 2024, the ONS-5010 dr ...

Live video webcast on Tuesday, June 18th at 12:00 PM ET ISELIN, N.J., June 11, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the commercialization and development of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, today announced that it will present at the Virtual Investor Pitch Conference on June 18, 2024 at 12:00 PM ET. As part of the event, Russell Trenary, President and Chief Executive Officer o ...

文章核心观点 - 公司专注于ONS-5010/LYTENAVA™(bevacizumab-vikg; bevacizumab gamma)的商业化和开发,用于治疗视网膜疾病,包括湿性AMD、DME和BRVO [1][4] - LYTENAVA™(bevacizumab gamma)是首个获得欧盟市场授权用于治疗湿性AMD的贝伐珠单抗眼科制剂 [4] - 公司正在努力在欧盟启动LYTENAVA™(bevacizumab gamma)的商业化,并已在英国提交ONS-5010用于治疗湿性AMD的上市申请 [4] - 在美国,ONS-5010/LYTENAVA™正在进行非劣效性研究用于治疗湿性AMD,如果成功,可能足以让公司重新向FDA提交生物制品许可申请 [4] 公司概况 - 公司专注于ONS-5010/LYTENAVA™的商业化和开发 [1][4] - 公司正在努力在欧盟启动LYTENAVA™的商业化,并已在英国提交ONS-5010用于治疗湿性AMD的上市申请 [4] - 在美国,ONS-5010/LYTENAVA™正在进行非劣效性研究用于治疗湿性AMD [4] 行业信息 - LYTENAVA™(bevacizumab gamma)是首个获得欧盟市场授权用于治疗湿性AMD的贝伐珠单抗眼科制剂 [4] - 如果在美国获批,ONS-5010/LYTENAVA™将是首个用于视网膜适应症(包括湿性AMD、DME和BRVO)的贝伐珠单抗眼科制剂 [4]

LYTENAVA™ (bevacizumab gamma) becomes first ophthalmic formulation of bevacizumab to receive European Commission Marketing Authorization for the treatment of wet AMD European Commission decision applies automatically to all 27 EU Member States and, within 30 days, also to Iceland, Norway and Liechtenstein LYTENAVA™ (bevacizumab gamma) receives ten years of market exclusivity in EU Advancing toward commercial launch of LYTENAVA™ (bevacizumab gamma) in EU expected in calendar Q1 2025 Strategic partnership wit ...

财务数据和关键指标变化 - 公司最近完成了一轮高达1.72亿美元的私募融资,其中6500万美元已经到账,另外1.07亿美元将在认股权证全部行权后到账 [11][12] - 公司认为这笔融资可以为业务提供所需资金,支持公司在欧洲的潜在批准和商业化发布,以及完成NORSE EIGHT试验并获得美国FDA批准及随后的上市 [11][12] 各条业务线数据和关键指标变化 - 公司正在积极推进ONS-5010在欧洲和英国的上市工作,预计将于2024年第二季度获得欧盟批准,2024年第三季度获得英国批准,并于2025年第一季度在欧洲和英国启动首次商业化发布 [9][13] - 在美国,公司已与FDA达成特殊方案评估(SPA)协议,正在进行NORSE EIGHT 90天非劣效性研究,预计将于2024年第四季度获得试验数据,并在此后尽快提交生物制品许可申请(BLA) [10][16] 各个市场数据和关键指标变化 - 欧洲是仅次于美国的第二大湿性AMD市场,每年约有300万次贝伐珠单抗(Avastin)非适应症使用注射 [25] - 与美国相比,欧洲的价格水平略有压缩,但仍是一个非常有吸引力的市场机会 [25] 公司战略和发展方向及行业竞争 - 公司的目标是通过获得ONS-5010在美国和欧洲的首次批准,提升湿性AMD治疗的标准 [8] - 公司计划自主在欧洲开展商业化,并利用Cencora(原AmerisourceBergen)在欧洲的现有基础设施和专业知识提供支持 [26] - 在美国,公司将继续与FDA互动,解决CMC问题,并计划在2024年第四季度重新提交BLA申请 [16][59] - 公司未来还计划开展DME和BRVO适应症的临床试验,并将与FDA就试验设计等进行讨论 [49][51] 管理层对经营环境和未来前景的评论 - 管理层认为,随着一些新产品的上市,抗VEGF药物的平均价格有望上升,这将有利于公司的定价策略 [36][37] - 管理层表示,公司与FDA的关系已经发展到一个非常健康的水平,通过与FDA的互动,有望顺利解决CMC问题并推进BLA重新提交 [59][60][61] 问答环节重要的提问和回答 问题1 **Julian Harrison 提问** 询问NORSE EIGHT试验的前期数据支持情况以及欧洲市场的规模和商业化策略 [24][25][26] **Russell Trenary 回答** - NORSE TWO试验的前90天数据与NORSE EIGHT试验的设计相同,结果显示ONS-5010与鲁利珠单抗(Lucentis)在视力改善方面无显著差异,为NORSE EIGHT的成功提供了支持 [27][28] - 欧洲是仅次于美国的第二大湿性AMD市场,每年约有300万次贝伐珠单抗(Avastin)非适应症使用注射,公司计划自主开展商业化,并利用Cencora的基础设施和专业知识提供支持 [25][26] 问题2 **Eddie Hickman 提问** 询问NORSE EIGHT试验的临床站点数量及进度,以及公司在定价方面的考虑 [33][34][37] **Russell Trenary 回答** - 目前已有60多个临床试验站点参与NORSE EIGHT,4月份基本达到满负荷状态,5月份继续保持这一水平,预计将在第三季度完成患者入组 [34][35] - 公司认为,随着一些新产品的上市,抗VEGF药物的平均价格有望上升,这将有利于公司的定价策略,公司计划采取与医生和支付方期望一致的定价方式 [36][37][38][39] 问题3 **Douglas Tsao 提问** 询问公司是否考虑DME和BRVO适应症的开发计划 [48][49] **Russell Trenary 回答** - 公司未来计划开展DME和BRVO适应症的临床试验,并将与FDA就试验设计等进行讨论,以确保与FDA在这些适应症上的要求达成一致 [49][51] - 公司希望ONS-5010能覆盖湿性AMD、DME和BRVO等全部适应症,为销售团队提供更广泛的推广能力 [49]

Exhibit 99.1 Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2024 and Provides Corporate Update · Positive opinion received from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for ONS-5010/LYTENAVA (bevacizumab gamma) · United Kingdom (UK) Marketing Authorization Application (MAA) submitted · NORSE EIGHT fully underway in the US; Topline readout expected in Q4 CY2024 · Resubmission of the ONS-5010 Biologics License Application (BLA) ...