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 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 001-41614 MINERALYS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 84-1966887 (Sta ...

Exhibit 99.1 Mineralys Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update – Advance-HTN trial of lorundrostat for the treatment of uHTN or rHTN is anticipated to deliver topline data in Q4 2024 – – Ongoing Phase 3 pivotal Launch-HTN trial of lorundrostat for the treatment of uHTN or rHTN is anticipated to deliver topline data in 2H 2025 – – Ongoing Explore-CKD Phase 2 trial is anticipated to deliver topline data in Q4 2024 to Q1 2025 – – Conference call today at 8:30 a.m ...

Ta rget i ng Al dos t er one i n t he Tr ea t ment of Ca r di or ena l Di s ea s es Mar ch 2024 ...

Mineralys Therapeutics, Inc. (OTCQX:HCHDF) Q4 2023 Earnings Conference Call March 21, 2024 8:30 AM ET Company Participants Daniel Ferry - IR, LifeSci Advisors Jon Congleton - Chief Executive Officer Adam Levy - Chief Financial Officer and Chief Business Officer David Rodman - Chief Medical Officer Conference Call Participants Michael DiFiore - Evercore ISI Mary Kate - Bank of America Seamus Fernandez - Guggenheim Securities Operator Welcome to the Mineralys Therapeutics Fourth Quarter and Full Year 2023 Con ...

Exhibit 99.1 Mineralys Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update – Enrollment in the two pivotal trials of lorundrostat for the treatment of uHTN or rHTN is on track, with topline data expected for Advance-HTN trial in Q4 2024 and Launch-HTN trial in 2H 2025 – – Explore-CKD Phase 2 trial, a study for lorundrostat in hypertensive patients with stage 2-3b CKD on track for Q4 2024 to Q1 2025 topline data – – Conference call today at 8:30 a.m. ET – RA ...

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 fiscal year ended December 31, 2023 OR 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 001-41614 MINERALYS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 2834 84-1966887 ...

财务数据和关键指标变化 - 公司于2023年9月30日的现金、现金等价物和投资总额为2.659亿美元,较2022年12月31日的1.101亿美元大幅增加 [31] - 2023年第三季度研发费用为2250万美元,较2022年同期的610万美元大幅增加,主要是由于临床试验和前期研究成本的增加 [32] - 2023年第三季度一般及行政费用为380万美元,较2022年同期的140万美元大幅增加,主要是由于公司上市后的专业服务费用、人员薪酬和保险费用的增加 [33] - 2023年第三季度净亏损为2280万美元,较2022年同期的670万美元大幅增加,主要是由于研发和一般行政费用的增加 [35] 各条业务线数据和关键指标变化 - 公司目前正在进行的主要临床项目包括Advanced-HTN、Launch-HTN和Explore-CKD,均取得了积极进展 [10][12][24] - Advanced-HTN试验旨在证明lorundrostat在难治性高血压患者中的疗效,预计2024年下半年公布顶线数据 [11] - Launch-HTN试验旨在模拟lorundrostat在原发护理环境中用于不受控或难治性高血压的真实世界应用,预计2025年下半年公布顶线数据 [12] - Explore-CKD试验旨在评估lorundrostat治疗2-3B期慢性肾病合并高血压的疗效,预计2024年第四季度至2025年第一季度公布顶线数据 [13][24][25][26][27][28] 各个市场数据和关键指标变化 - 公司认为,lorundrostat针对高血压、慢性肾病等心肾代谢综合征的全面疗效优势,将是其与其他药物如GLP-1的差异化因素 [58][59] - 公司观察到医疗界对醛固酮在心血管和肾脏疾病中的作用越来越重视,lorundrostat的临床数据有助于提高这一认知 [56][57] - 公司认为,lorundrostat针对肥胖患者的特定治疗优势,将是其在高血压和慢性肾病治疗中的关键定位 [49][50][51][52][53] 公司战略和发展方向及行业竞争 - 公司正在优化Advanced-HTN试验的设计和执行,以提高入组和随机化速度,为后续试验提供经验 [63][64][65][66][67] - 公司计划将Launch-HTN试验的设计尽可能与之前的Target-HTN试验保持一致,以确认之前的结果 [68] - 公司密切关注行业内其他药物如Boehringer Ingelheim的醛固酮合成酶抑制剂的临床数据,并据此调整了Explore-CKD试验的设计 [43][44][45][46][47] 管理层对经营环境和未来前景的评论 - 公司认为,lorundrostat针对高血压、慢性肾病等心肾代谢疾病的全面疗效优势,将是其未来发展的关键 [58][59] - 公司观察到医疗界对醛固酮在心血管和肾脏疾病中的作用越来越重视,这有利于lorundrostat的市场推广 [56][57] - 公司认为,lorundrostat针对肥胖患者的特定治疗优势,将是其在高血压和慢性肾病治疗中的关键定位 [49][50][51][52][53] 问答环节重要的提问和回答 问题1 **Michael DiFiore 提问** 询问Advanced-HTN试验中已经过12周时间点但未进行治疗撤出的患者数量 [39] **Jon Congleton 回答** 公司尚未披露具体的患者入组数据 [40] 问题2 **Michael DiFiore 提问** 询问Explore-CKD试验中,联合用药的预期疗效目标和与竞争对手数据的比较 [41][42] **Jon Congleton 回答** 公司预期联合用药可以达到50%以上的尿白蛋白降低,这与竞争对手的数据相当,公司认为lorundrostat的独特优势在于可以同时改善高血压和肾脏保护 [43][44][45][46][47] 问题3 **Jack Padovano 提问** 询问lorundrostat临床数据的发表是否有助于提高医生对醛固酮抑制剂类药物的认知 [56][57] **Jon Congleton 回答** 公司确实观察到医生对醛固酮在心血管和肾脏疾病中的作用越来越重视,lorundrostat的临床数据有助于推动这一认知的提升 [56][57]

November 7, 2023 Mineralys Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update – On track to initiate planned Phase 3 pivotal Launch-HTN trial of lorundrostat to treat patients with uncontrolled or resistant hypertension in 2H 2023 – – Expect to initiate planned Phase 2 Explore-CKD trial of lorundrostat alone and in combination with SGLT2 inhibitor to treat hypertensive patients with chronic kidney disease (CKD) in 2H 2023 – – Conference call today at 4:30 p.m. ET – RADNO ...

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, 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 001-41614 MINERALYS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 84-1966887 ...

Mineralys Therapeutics, Inc. (NASDAQ:MLYS) Q2 2023 Results Conference Call August 7, 2023 4:30 PM ET Company Participants Dan Ferry - LifeSci Advisors Jon Congleton - Chief Executive Officer Adam Levy - Chief Financial Officer and Chief Business Officer David Rodman - Chief Medical Officer Conference Call Participants Michael DiFiore - Evercore Greg Harrison - Bank of America Mohit Bansal - Wells Fargo Rich Law - Credit Suisse Operator Greetings, and welcome to the Mineralys Second Quarter 2023 Earnings Cal ...