other material
confidence high
sentiment neutral
materiality 0.60
DiaMedica files clinical hold response; Q1 cash $28.7M; Phase 1C confirms DM199 dose safety
DiaMedica Therapeutics Inc.
- Company will file complete clinical hold response to FDA this week for ReMEDy2 AIS trial; in-use study supports dose revision to 0.5 µg/kg IV.
- Phase 1C SAD study in healthy volunteers affirms revised DM199 IV dose is well-tolerated and achieves therapeutic blood levels.
- Cash, cash equivalents and investments $28.7M as of March 31, 2023; working capital $26.9M; cash runway into Q4 2024.
- R&D expenses $3.6M in Q1 2023, up 80% YoY, driven by clinical hold studies and team expansion; G&A $1.9M, up 19%.
- Post-quarter $0.75M private investment from newly appointed Chief Business Officer; net cash used in ops $5.1M in Q1.