临床数据与疗效 - KSI-301在湿性年龄相关性黄斑变性（wet AMD）、糖尿病性黄斑水肿（DME）、糖尿病视网膜病变（DR）和视网膜静脉阻塞（RVO）方面具有最佳的疗效、耐久性和安全性[4] - KSI-301在湿性年龄相关性黄斑变性(wAMD)的耐久性评估中，83%的患者在首次再治疗前达到4个月或更长时间[32] - KSI-301在第20周的临床试验中，平均最佳矫正视力(BCVA)提高了4.3个ETDRS字母，中央视网膜厚度(OCT CST)减少了67微米[35] - KSI-301在第12周的临床试验中，平均BCVA提高了6.6个ETDRS字母，OCT CST减少了93微米[39] - KSI-301在糖尿病黄斑水肿(DME)的研究中，72%（8/11）患者在未进行再治疗的情况下，达到4个月或更长时间的持续疾病控制[43] - KSI-301在视网膜静脉阻塞(RVO)的研究中，32名患者在第12周的BCVA平均提高了19.8个ETDRS字母，OCT CST平均减少了401微米[55] - KSI-301在DME的研究中，81%（13/16）患者在最后一次加载剂量后，超过3个月未进行再治疗[43] - KSI-301在DR的研究中，所有患者在第12周时均改善或维持其DRSS评分[47] 研发与临床试验 - 2020年计划启动四项关键的KSI-301研究，此外还在进行DAZZLE湿性AMD研究[4] - KSI-301的临床试验设计包括对约550名患者进行的CRVO和DAZZLE研究，计划在2022年提交生物制品许可申请(BLA)[26] - KSI-301在糖尿病性黄斑水肿(DME)的三期临床试验中，计划招募约450名患者，比较KSI-301与Eylea的疗效[26] - KSI-301在糖尿病视网膜病变(DR)的三期临床试验中，计划招募约400名患者，比较KSI-301与安慰剂的疗效[26] - KSI-301的加速开发计划获得了2.25亿美元的融资，包括2.25亿美元的特许权使用费和3.17亿美元的公开股票发行[27] 给药方案与优势 - KSI-301的给药方案为仅需3次加载剂量，之后每12至24周给药一次，具体取决于预先设定的疾病活动评估[68] - KSI-301的设计旨在提高耐久性和生物相容性，具有更好的稳定性和快速的系统清除能力[8] - KSI-301的给药优势在于其较大的分子尺寸，能够延长耐久性和灵活的再治疗窗口[17] - KSI-301的临床剂量为5 mg（按抗体重量计算），相较于其他药物具有更高的等效摩尔剂量[16] 市场前景与战略 - KSI-301的目标是成为每种视网膜血管疾病的有意义的差异化一线治疗，以更好地满足全球关键利益相关者的需求[21] - 所有研究均预计将包括额外的KSI-301给药组，以1:2:2的比例随机分配[68][69][70] - 研究将在美国和欧盟的多个研究中心进行，确保样本的多样性和代表性[69] 安全性与不良事件 - KSI-301在临床试验中，未报告任何眼内炎症或药物相关的严重不良事件(SAE)[59]

Kodiak Sciences, Inc. (NASDAQ:KOD) Q3 2019 Results Conference Call November 12, 2019 5:00 PM ET Company Participants John Borgeson - Chief Financial Officer Victor Perlroth - Chief Executive Officer Jason Ehrlich - Chief Medical Officer and Chief Development Officer Conference Call Participants Max Skor - Morgan Stanley Gbola Amusa - Chardan Capital Markets Operator Good day, ladies and gentlemen, and welcome to the Kodiak Sciences Third Quarter 2019 Business Highlights Conference Call. [Operator Instructio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2019 Registrant's telephone number, including area code: (650) 281-0850 Securities registered pursuant to Section 12(b) of the Act: OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to _________ Com ...

NASDAQ: KOD KODIAK.COM | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|---------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | THE OPHTHALMOLOGY MEDICINES COMPANY | | | | | | | | | Corporate Presentation September 2019 | | | | | 2 | --- | |---------------------------------------------------------------------------------------------------------------------------------------------------- ...

NASDAQ: KOD KODIAK.COM | --- | --- | --- | --- | --- | --- | --- | |-------|-------|------------------------------------|-------|-------------------------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | THE OPHTHALMOLOGY MEDICINES COMPANY | | | | | | Corporate Presentation August 2019 | | | | | 2 | --- | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to _________ Commission File Number: 001-38682 KODIAK SCIENCES INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdict ...

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 March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to _________ Commission File Number: 001-38682 KODIAK SCIENCES INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdicti ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to _________ Commission File Number: 001-38682 KODIAK SCIENCES INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of ...