Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________ FORM 10-Q For the Quarterly Period Ended June 30, 2021 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 001-36856 HEPION PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 46-2783806 (I.R. ...

Table of Contents 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 March 31, 2021 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 001-36856 HEPION PHARMACEUTICALS, INC. (Exact name of registrant as specified in ...

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 year ended December 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 001-36856 | | HEPION PHARMACEUTICALS, INC. | | (Exact Name of Registrant as Specified in Its Charter) | | Delaware ...

Table of Contents 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, 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 001-36856 HEPION PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware (State ...

业绩总结 - 公司在2020年6月30日的现金余额为1760万美元[7] - 截至2020年6月30日，公司的流通股数为900万股[7] 用户数据 - CRV431在健康受试者的单次剂量研究中，剂量范围为75 mg至525 mg，未出现严重不良事件[28] - 在多次剂量研究中，75 mg的剂量显示出与预临床模型中有效性相符的药物暴露水平[28] 新产品和新技术研发 - 公司在NASH治疗领域的CRV431已合成并筛选出约200种分子[19] - CRV431在小鼠肝纤维化模型中显示出82%的纤维化减少[27] - CRV431在高脂饮食和链脲佐菌素诱导的肝纤维化小鼠中，纤维化减少幅度为37%至57%[27] - CRV431在NASH/NAFLD相关基因中显示出TM6SF2基因的表达增加4.2倍，p值为0.0007[30] - ApoB基因的表达增加10.9倍，p值为0.0001，表明与脂质代谢异常和NASH相关[30] - 公司开发的AI-POWR™平台旨在通过多组学数据分析提高临床试验的成功率和效率[10] 未来展望 - CRV431作为NASH的治疗药物，预计将在2025年提交新药申请(NDA)[19] - Phase 2a研究中，CRV431的目标是评估75 mg和225 mg剂量在F2/F3 NASH患者中的安全性和耐受性[31] - 该研究为期28天，比较CRV431与安慰剂的抗纤维化活性[31] - Phase 2a研究的多中心设计包括10个地点，采用单盲、安慰剂对照的方式进行[32] - CRV431计划在2021年中期启动Phase 2B研究，利用AI-POWR™技术进行患者选择和生物标志物分析[35] 市场扩张和知识产权 - 公司在主要市场（包括美国、欧洲、澳大利亚等）拥有强大的知识产权保护，专利有效期至2039年，可能延长至2044年[7] - 传统临床试验的患者招募成本约占32%[17] - 通过AI技术，Novartis在试验中实现了10-15%的患者招募时间减少[16]

Table of Contents 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, 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 001-36856 HEPION PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware (State or ot ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☐ 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 001-36856 HEPION PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the 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 001-36856 HEPION PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of (I.R.S. Employer I ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended: September 30, 2019 o 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: 001-36856 HEPION PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 46-27838 ...

研发进展 - CRV431在NASH小鼠模型中显示出44%的肿瘤数量减少和52%的肿瘤评分减少[30] - CRV431在CCl4小鼠模型中显示出43%的肝纤维化减少，相较于对照组[22] - CRV431在11周的治疗中，能够显著降低肝脏炎症和纤维化，且在5µM浓度下完全阻止了纤维化的增加[31] - CRV431的抗纤维化机制涉及降低胶原蛋白生成，且对LOX基因表达的抑制是剂量依赖性的[25] - CRV431的抗病毒活性针对HBV、HCV、HDV和HIV-1，显示出多重治疗潜力[13] - CRV431在HBV的多次上升剂量研究中正在进行中，预计在2019年第三季度完成[11] - CRV431通过阻断cyclophilin A与NS5A的结合，抑制HCV复制[44] 安全性与给药方式 - CRV431的开发团队拥有超过30年的相关领域经验，曾开发出其他成功的药物[9] - CRV431的口服给药方式为每日一次，便于患者使用[9] - 在单次给药研究中，未报告严重不良事件（SAE），不良事件（AE）大多为轻度至中度，且与研究药物无关[38] - CRV431的安全性在临床和前临床研究中表现良好，支持其临床开发计划[38] 临床研究与市场需求 - 公司计划在2020年第一季度启动约100名受试者的二期NASH研究，CRV431将以每日一次口服方式给药，持续24周[48] - FDA鼓励药物开发聚焦于非肝硬化NASH伴肝纤维化的领域，以满足健康需求[41] - 预计慢性肝病的治疗需求将会非常庞大，因其在发达国家中占据了近45%的死亡原因[7] 药物动力学 - CRV431在单次给药研究中，525 mg剂量的药物暴露线性关系良好，R²为0.914[35] - CRV431在75 mg、225 mg、375 mg和525 mg剂量下的Cmax分别为334±106 ng/mL、1,368±221 ng/mL、1,488±176 ng/mL和1,655±250 ng/mL[35] - CRV431在375 mg剂量下的AUC0-inf为103,833±30,916 ng*h/mL，支持每日一次给药的方案[35] - CRV431在肝脏中的浓度是血液中的5倍，显示出其在治疗肝病方面的潜力[40] - CRV431对HBV的多项标志物（如HBV DNA、HBsAg等）均有显著降低[43]