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, 2024 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 ...

Exhibit 99.1 Applied Therapeutics Reports First Quarter 2024 Financial Results - Govorestat NDA for Classic Galactosemia under Priority Review, PDUFA target action date of November 28, 2024 - Govorestat MAA under review by EMA; Day 120 3-month clock-stop extension granted; decision expected in early Q1 2025 - Company discussing potential NDA submission under Accelerated Approval for govorestat for treatment of SORD Deficiency with Neurology I Division of FDA NEW YORK, May 9, 2024 – Applied Therapeutics, Inc ...

NEW YORK, April 15, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the appointment of Dale Hooks as Chief Commercial Officer, replacing Adam Hansard, effective immediately. Mr. Hooks joins Applied with over 30 years of biopharmaceutical experience in rare disease marketing and sales, holding various leader ...

ARISE-HF研究结果 - 应用治疗公司将在2024年美国心脏病学会（ACC）年会上展示ARISE-HF研究的全面结果[1] - AT-001治疗可有效稳定心脏功能能力，防止糖尿病心肌病（DbCM）患者进展至明显心力衰竭[2] - AT-001治疗在大规模患者中表现出安全性和良好耐受性，证明技术已克服“旧”醛固酮还原酶抑制剂的选择性和安全问题[3]

公司背景 - Applied Therapeutics, Inc. (APLT) 是一家专注于开发针对罕见神经、心脏和眼科疾病的新型疗法的临床阶段公司[1] - 公司的主力候选药物是 govorestat（也称为AT-007），目前正在开发用于三种罕见神经疾病的治疗，包括半乳糖症、山梨醇脱氢酶（SORD）缺乏症和磷酸甘露糖异构酶2缺乏症[2] - 除了govorestat外，Applied Therapeutics的管线还包括另外两个研究候选药物，分别是用于治疗糖尿病心肌病的AT-001和用于治疗糖尿病视网膜病变的AT-003[3] govorestat项目进展 - APLT股价在过去一个月飙升了124.3%，而行业增长仅为2.9%，这主要受到govorestat开发项目取得鼓舞人心的监管/发展更新的推动[4] - 在2月中旬，Applied Therapeutics宣布了govorestat正在进行的第III期INSPIRE注册研究的积极中期12个月结果，这一消息引发了股价上涨[5] - INSPIRE研究正在评估一种名为govorestat的每日一次口服药物在美国和欧盟的16-55岁患有SORD缺乏症的56名患者中的疗效[6] govorestat监管申请 - FDA已接受了APLT关于govorestat治疗经典半乳糖症的优先审查申请，这进一步推动了股价上涨[9] - 管理层计划与FDA会面，讨论基于INSPIRE研究12个月中期分析结果的govorestat治疗SORD缺乏症的潜在监管申请[8] - govorestat获批后将成为治疗半乳糖症的首个药物，也是Applied Therapeutics的首个商业产品[10] 未来展望 - 目前，欧盟正在审查govorestat治疗经典半乳糖症的监管申请，公司预计将在2024年第四季度做出决定[11]

公司财务状况 - 应用治疗公司报告2023年第四季度和年度财务业绩[1] - 公司通过私募融资强化资产负债表，预计将现金运营时间延长至2026年[4] - 公司现金及现金等价物和短期投资截至2023年12月31日总计为4990万美元[7] - 2023年净亏损为1.198亿美元，每股基本和摊薄普通股亏损为1.42美元[10] - 公司预计现金及现金等价物，加上2024年2月私募融资的收益和预期的Advanz欧洲许可合作伙伴关系里程碑，将资助业务至2026年[11] - 2023年12月末，公司现金及现金等价物为49,898千美元，较2022年同期增长了199.6%[16] - 2023年公司总收入为9,993千美元，主要来自许可收入和研发服务收入[17] 研发情况 - Govorestat NDA获得FDA优先审查，PDUFA目标行动日期为2024年8月28日[2] - Govorestat在SORD缺陷的INSPIRE第3期试验中取得积极结果[5] - 2023年研发支出为5390万美元，较2022年减少了约170万美元[8] - 2023年总体和行政支出为2060万美元，较2022年减少了约670万美元[9] - 公司2023年研发支出为53,905千美元，较上一年有所下降[17]

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, 2023 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 ...

Applied Therapeutics (NASDAQ:APLT) stock is on the rise Wednesday after the clinical-stage biopharmaceutical company got an update from the Food and Drug Administration (FDA).The FDA has accepted the company’s New Drug Application (NDA) for govorestat as a treatment for Classic Galactosemia. It was also granted Priority Review status with a target action date of Aug. 28, 2024.To go along with this, the FDA is planning an advisory committee meeting to review the NDA for govorestat. Investors will note that t ...

Financing includes significant participation from a number of large healthcare dedicated institutional and mutual fund investors Net proceeds, along with existing cash and cash equivalents, are expected to extend cash runway into 2026 NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that i ...

AndreyPopov/iStock via Getty ImagesApplied Therapeutics (NASDAQ:APLT) announced positive 12-month interim results from its phase 3 INSPIRE study using AT-007 for the treatment of patients with Sorbitol dehydrogenase deficiency [SORD deficiency]. The last time I spoke about this biotech, I noted that it had several value generating inflection points using AT-007 for the treatment of patients with rare diseases. I spoke about such possible inflection points in a prior Seeking Alpha article entitled "Appli ...