Diamedica Therapeutics Inc. · NASDAQ:DMAC
Diamedica Therapeutics — Corporate Update (May 2023)
6 slides from Diamedica Therapeutics's corporate update, May 22, 2023
Slide 1: ReMEDy2 Update
ReMEDy2 Update May 22, 2023
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements ‘This presentation contains forward-looking statements within the meaning ofthe US. Private Securities Litigation Reform Actof 1995 and forward-looking information that are based on the beliefs of management and reflect management's curtent expect
Slide 3: Background
Background + Human urinary-derived kallikrein (HUK)is approved to treat acute ischemic stroke (AIS) in China; ~600,000 patients treated in 2022 HUKis administered daily by intravenous (IV) infusion over three weeks ‘+ =1.5-hour drug half-life with IV dosing results in substantia daily pharmacokineti
Slide 4: Overview of Testing and Analytical Procedures
Overview of Testing and Analytical Procedures Phase 1C Trial Corroborates Safety & Tolerability - No Hypotensive Events at 0.5 g/kg Dose Level + Based upon a variety of interactions with the FDA, the following testing and analytical procedures were performed to support our hypothesis that the cause
Slide 5: DM199 Phase 1C Trial
DM199 Phase 1C Trial 0.5 g/kg PVC Bag Well Tolerated With Similar Drug Exposure Levels to 1.0 g/kg non-PVC Bag IV Dose well tolerated in Recent Phase 1C study IV Dose well tolerated with efficacy signal in REMEDy1 PVC Materials @ 0.5 ng/kg (N=3) Non-PVC Materials Polyolefin) @ 1.0 us/kg(N=3) AUC 94,
Slide 6: ReMedy2 Status
ReMedy2 Status * On May 19, 2023, DiaMedica submitted its complete response to the FDA, including: > Description/analysis of the cause of the hypotensive events + Unintentional overdose caused by change from non-PVC to PVC IV bag such that downward dose adjustment should mitigate against severe hypo