Table of Contents 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, 2020 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: 001-38898 Applied Therapeutics, Inc. (Exact Name of Registrant as Specified in it ...

Table of Contents 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, 2020 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: 001-38898 Applied Therapeutics, Inc. (Exact Name of Registrant as Specified in its Cha ...

Table of Contents 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, 2020 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: 001-38898 Applied Therapeutics, Inc. (Exact Name of Registrant as Specified in its Ch ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 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 001‑38898 Applied Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 81‑3405262 (State ...

业绩总结 - 公司在2020年1月宣布了积极的顶线数据，预计在2020年下半年提交新药申请(NDA)[6] - AT-001在1/2期临床试验中，未观察到任何药物相关的不良事件，且耐受性良好[60] - AT-001治疗组患者的NTproBNP水平在28天内显著降低，基线平均为65 pg/ml[73] - 约50%的AT-001治疗患者在28天内NTproBNP水平下降超过25 pg/ml，显示出临床意义[74] 用户数据 - 美国约有2800名半乳糖血症患者，欧洲约有3500名，每年在美国新生儿中约有80例[21] - 糖尿病心肌病（DbCM）影响全球约7700万患者，占糖尿病患者的17-24%[52] - 在美国，DbCM患者约有1000万，市场潜力巨大[56] 新产品和新技术研发 - 针对糖尿病心肌病的AT-001，预计在2019年第三季度启动三期临床试验，数据将在2021年公布[16] - AT-007针对半乳糖血症的临床试验显示，20 mg/kg剂量可使血浆半乳糖醇水平降低45-54%（p<0.01 vs placebo）[40] - AT-007的口服给药方案具有12-18小时的半衰期，且在健康志愿者研究中未出现药物相关的安全性问题[43] - AT-001的开发路径清晰，仅需进行一项3期临床试验即可申请注册[56] - AT-001的剂量选择基于心脏炎症生物标志物的观察，支持其在关键研究中的应用[60] 市场扩张和并购 - 公司在糖尿病心肌病和半乳糖血症领域的临床机会被认为是潜在的重磅药物[7] - 公司计划在2019年第四季度完成针对经典半乳糖血症的生物标志物研究[49] 未来展望 - 公司在2020年将启动针对儿童的研究，以进一步评估AT-007的安全性[50] - AT-007的开发受益于FDA的新指导方针，降低了开发成本和时间[12] 负面信息 - 24%的DbCM患者在1.5年内进展为明显心力衰竭或死亡，5年内为37%[68]