other material
confidence high
sentiment negative
materiality 0.80
DiaMedica identifies cause of DM199 clinical hold; plans FDA resubmission in Sep
DiaMedica Therapeutics Inc.
- Clinical hold cause: DM199 protein bound to prior IV bag, reducing dose; new bag delivered higher dose, causing hypotension.
- Will submit revised protocol to FDA in September requesting removal of clinical hold; FDA has 30 days to respond.
- Cash and investments $38.4M as of June 30, 2022; cash runway into 2024.
- R&D expenses $2.0M in Q2 2022 vs $2.2M Q2 2021; net cash used in ops $6.4M for six months.
- REDUX CKD trial close-out ongoing; company maintains focus on acute ischemic stroke program.