公司产品及合作 - 公司专注于通过超脉冲注射开发眼部疾病治疗产品候选物[7] - 公司最先进的临床开发产品候选物是一种专有的阿昔替尼悬浮液，用于超脉冲注射[16] - 阿昔替尼目前已获批用于治疗肾细胞癌，公司认为其作为小分子药物具有较少的免疫反应和炎症的潜力[17] - XIPERE是一种用于SCS的三氯醋酸曲安奈德注射悬浮液，用于治疗葡萄膜炎相关的黄斑水肿[22] - XIPERE已获得治疗葡萄膜炎相关黄斑水肿的批准[22] - 公司与Bausch Health等公司合作，扩大SCS注射平台的全球覆盖范围[23] - 公司与Bausch签署许可协议，在美国和加拿大独家开发、生产、推广和销售XIPERE[24] - 公司将在2023年第二季度开展ODYSSEY阶段2b临床试验，预计2024年下半年获得数据[21] - 公司计划使用aflibercept作为ODYSSEY试验中的比较药物[21] - 公司与Arctic Vision签署了独家许可协议，授予Arctic Vision在中国、香港、澳门、台湾和韩国等地区开发、分销、推广、营销和商业化XIPERE的独家许可[27] - Arctic Vision已支付公司2020年3月的4百万美元的预付款，并在2021年12月收到了美国FDA批准XIPERE后的4百万美元里程碑付款[27] - 公司有权收取Arctic Vision在Arctic Territory实现一定年度净销售门槛时的10%至12%的分阶段特许权使用费，持续至特许权到期[27] - 公司与REGENXBIO签署了选择权和许可协议，授予REGENXBIO使用SCS Microinjector技术进行基于AAV的基因治疗的独家许可[28] - REGENXBIO已支付公司300万美元用于开发里程碑，并同意在销售里程碑达到时向公司支付高达1.02亿美元的费用[28] - REGENXBIO目前正在进行两项多中心、开放标签、随机、对照、剂量递增的第2期临床试验，评估使用SCS Microinjector技术进行RGX-314的超脉冲递送治疗湿性AMD和糖尿病视网膜病变的疗效、安全性和耐受性[29] - 公司通过Clearside Royalty LLC与HealthCare Royalty Management签署了购买和销售协议，将部分收入权出售给HCR，以换取高达6500万美元[30] - 公司与Aura Biosciences签署了全球许可协议，使用SCS Microinjector将Aura的专有药物候选物递送到SCS，用于潜在治疗某些眼部癌症，包括脉络膜黑色素瘤[29] - Aura利用公司的SCS Microinjector将其病毒样药物结合物bel-sar递送用于治疗脉络膜黑色素瘤，并展示了良好的疗效数据[29] - 公司与REGENXBIO签署了REGENXBIO选择权和许可协议，授予REGENXBIO使用SCS Microinjector技术进行湿性AMD、糖尿病视网膜病变等基于AAV的基因治疗的独家许可[30] 监管和法律 - 美国FDA根据《食品、药品和化妆品法案》对药品和器械产品进行监管，包括联合产品的监管[50] - 公司的产品候选药物在美国和其他国家受到政府机构的广泛监管，包括进行临床试验、制造、标签、存储、分销、广告、推广、进口、出口和营销等方面[51] - 临床试验和批准过程需要大量时间、精力和财务资源，FDA可能随时暂停临床试验，包括实验室评估、动物研究和人体临床试验[53] - FDA接受、审查和批准新药申请，可能包括咨询委员会审查和对生产设施进行检查以评估是否符合当前良好生产规范[52] - FDA可能要求进行后市场测试和监测以监测产品的安全性或有效性[55] - FDA可能要求实施风险评估和减轻策略以确保产品的安全使用[55] - 公司在寻求药物批准时，必须在FDA的《橙皮书》中列出涵盖公司产品的专利[61] - 临床试验、市场授权和产品销售的外国监管要求[64] - 联邦和州的欺诈和滥用法律、数据隐私和安全以及透明度法律[65] - 欧盟的一般数据保护条例（GDPR）和加利福尼亚消费者隐私法（CCPA）对公司数据处理和隐私权的影响[67] 公司信息 - 公司在美国拥有36名全职员工，没有劳工工会或集体谈判协议[75] - 公司总部位于乔治亚州阿尔法雷塔的900 North Point Parkway，电话号码为(678) 270-3631[76] - 公司的网站地址为www.clearsidebio.com，可以在网站上找到更多关于公司的信息[77]

Company Participants Conference Call Participants Operator I would now like to hand the conference over to your speaker today, Jenny Kobin, Investor Relations. Please go ahead. Good afternoon everyone and thank you for joining us on the call today. Before we begin, I would like to remind you that during today's call, we will be making certain forward-looking statements. Various remarks that we make during this call about the company's future expectations, plans and prospects constitute forwardlooking statem ...

LEARSID BIOMEDI Corporate Presentation November 2022 : | --- | --- | |-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Forward-Looking Statements | | | This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of | 1995, as amended. | Developing and Delivering Treatments that Restore and Preserve Vision for Serious Back of the Eye ...

LEARSID BIOMEDI Corporate Presentation November 2022 : | --- | --- | |-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Forward-Looking Statements | | | This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of | 1995, as amended. | Developing and Delivering Treatments that Restore and Preserve Vision for Serious Back of the Eye ...

Clearside Biomedical, Inc. (NASDAQ:CLSD) Q3 2022 Earnings Call Transcript November 9, 2022 8:30 AM ET Company Representatives George Lasezkay - Chief Executive Officer Tom Ciulla - Chief Medical Officer, Chief Development Officer Charles Deignan - Chief Financial Officer Dr. Arshad Khanani - Managing Partner at Sierra Eye Associates, Clinical Associate Professor at the University of Nevada Jenny Kobin - Investor Relations Conference Call Participants Andreas Argyrides - Wedbush Annabel Samimy - Stifel John ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 | --- | --- | --- | |----------------------------------------------------------------------------|--------------------------------------------------|---- ...

LEARSI BIOMEDI Corporate Presentation August 2022 . Forward-Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forwardlooking statements conta ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 | --- | --- | --- | |------------------------------------------------------------------------------------------------------------------|---------------------- ...

Clearside Biomedical Inc (NASDAQ:CLSD) Q2 2022 Earnings Conference Call August 9, 2022 8:30 AM ET Company Participants Jenny Kobin - Head of IR George Lasezkay - President, CEO and Director Tom Ciulla - Chief Medical Officer and Chief Development Officer Charles Deignan - CFO Conference Call Participants Stacy Lee - Stifel Rohit Bhasin - Needham & Company Yi Chen - H.C. Wainwright William Wood - B. Riley Operator Good day, and thank you for standing by. Welcome to the Clearside Biomedical Q2 2022 Financial ...

Clearside Biomedical, Inc. (NASDAQ:CLSD) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Jenny Kobin - Investor Relations George Lasezkay - President and Chief Executive Officer Thomas Ciulla - Chief Medical Officer and Chief Development Officer Charles Deignan - Chief Financial Officer Conference Call Participants Zegbeh Jallah - ROTH Capital Partners Jonathan Wolleben - JMP Securities Yi Chen - H.C. Wainwright Serge Belanger - Needham Julian Harrison - BTIG Operator Good day ...