分组1 - 公司新任命了Ambarish Shah为首席技术官,他拥有25年以上的生物制药从业经验,曾在多家知名制药公司担任重要职务 [7] - 公司修改了ReMEDy2临床试验的纳入/排除标准,将目标患者群体聚焦于中度缺血性卒中患者,这一变更有望提高临床试验的成功概率并加快试验进度 [9][10][11][12][13][14] - 公司还将排除发生在大脑后循环的缺血性卒中患者,因为这类患者在NIH卒中量表评分上存在偏差 [15][16] - 公司还取消了临时分析时的"显著疗效"评估,这将提高整体试验的成功概率 [17][18] 分组2 - 公司目前现金和现金等价物为5.62亿美元,预计可支持临床开发和运营至2026年 [25][27] - 研发费用同比增加,主要是为了解决临床试验临时停止的问题以及进行其他试验和生产工艺开发 [28][29] - 行政费用同比增加,主要是由于与PRA公司诉讼相关的法律费用以及人员成本增加 [30][31] 问答环节重要的提问和回答 问题1 **Thomas Flaten 提问** 排除机械取栓和静脉溶栓患者后,预计还有多少可纳入的患者? [35][36][37] **Rick Pauls 回答** 公司预计中度卒中患者占所有卒中患者的35%-40%,这是公司的目标患者群体。公司认为如果能在这一群体中获得更大的治疗效果,将有利于未来的商业化 [36][37] 问题2 **Alexander Nowak 提问** 公司是否仍计划排除既往接受机械取栓的患者? [47][48][49] **Scott Kellen 回答** 是的,公司仍计划排除既往接受机械取栓的患者,这占所有卒中患者的约20%。同时也会排除后循环卒中患者,因为NIH卒中量表不能很好地评估这类患者 [48][49][50][51] 问题3 **Francois Brisebois 提问** 聚焦中度卒中患者的机制依据是什么?如何确保这不会影响入组难度? [64][65][66][67] **Rick Pauls 回答** 公司分析了II期试验数据,发现基线NIHSS评分在6-10分的患者治疗效果最佳。这一评分范围属于中度卒中,预计能获得更好的治疗效果。同时,这一评分范围也与中国KAILIKANG试验的患者群体相符 [65][66][67]

新产品和新技术研发 - DM199是一种新型生物治疗药物，针对急性缺血性中风(AIS)患者，具有FDA快速通道指定[5] - DM199的主要作用是增加侧支循环，扩张缺血半影区的血管，无需穿越血脑屏障[5] - DM199治疗窗口为24小时，是tPA(4.5小时)的5倍，有望成为急性缺血性中风的新疗法[5] - DM199的市场潜力巨大，美国急性缺血性中风市场规模超过100亿美元[7] - DM199通过提高KLK1水平来治疗和预防中风，KLK1水平低与中风发病率和不良结果相关[10] 未来展望 - DM199的市场潜力巨大，美国急性缺血性中风市场规模超过100亿美元[7] - DM199 P2/3 AIS研究的设计基于P2结果，旨在观察不接受MT和/或tPA的患者中的最佳疗效信号[28] - DM199 AIS P2/3研究具有潜在的单一研究路径，可获得FDA批准[39] 市场扩张和并购 - DM199的市场潜力巨大，美国急性缺血性中风市场规模超过100亿美元[7] - DM199针对急性缺血性中风（AIS）市场机会达到100亿美元以上[39] 其他新策略和有价值的信息 - DM199具有多层次的知识产权地位和潜在的监管独家权[32] - DiaMedica的领导团队包括具有丰富经验的专业人士，涵盖了财务、技术、商业等领域[33][34][35][36][37][38] - DMAC在纳斯达克上市，网址为www.diamedica.com[40]

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, 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: 001-36291 ____________________ DIAMEDICA THERAPEUTICS INC. ...

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q2 2023 Earnings Call Transcript August 15, 2023 8:00 AM ET Company Participants Rick Pauls - President and CEO Scott Kellen - CFO Conference Call Participants Thomas Flaten - Lake Street Capital Alex Nowak - Craig-Hallum Capital Group Dan Hultberg - Oppenheimer Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Second Quarter 2023 Conference Call. An audio recording of the webcast will be available shortly after the call today on ...

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, 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: 001-36291 DIAMEDICA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) B ...

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q1 2023 Earnings Conference Call May 16, 2023 8:00 AM ET Company Participants Rick Pauls - President and Chief Executive Officer Scott Kellen - Chief Financial Officer Conference Call Participants Thomas Flaten - Lake Street Capital Alex Nowak - Craig-Hallum Daniel Hultberg - Oppenheimer Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter 2023 Conference Call. An audio recording of the webcast will be available shortl ...

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, 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: 001-36291 ____________________ DIAMEDICA THERAPEUTICS INC. (Exac ...

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q4 2022 Earnings Conference Call March 29, 2023 8:00 AM ET Company Participants Rick Pauls - President and Chief Executive Officer Scott Kellen - Chief Financial Officer Kirsten Gruis - Chief Medical Officer Conference Call Participants Thomas Flaten - Lake Street Capital Markets Alexander Nowak - Craig-Hallum Capital Group Daniel Hultberg - Oppenheimer Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics ReMEDy2 Update Conference C ...

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, 2022 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: 001-36291 DIAMEDICA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Britis ...

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q2 2022 Earnings Conference Call August 11, 2022 8:00 AM ET Company Participants Rick Pauls - President and Chief Executive Officer Kirsten Gruis - Chief Medical Officer Scott Kellen - Chief Financial Officer Conference Call Participants Thomas Flaten - Lake Street Capital Markets Alex Nowak - Craig-Hallum Capital Group Elemer Piros - ROTH Capital Partners Francois Brisebois - Oppenheimer Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Ther ...