---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-22-026608"
form_type: "8-K"
ticker: "DMAC"
cik: "0001401040"
company_name: "DiaMedica Therapeutics Inc."
filed_at: "2022-11-09T23:59:59+00:00"
generated_at: "2026-06-22T01:00:24.514295+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA maintains clinical hold on DM199 stroke trial; company to conduct additional IV stability study

## Summary
- FDA requires additional in-use in vitro stability study of IV administration of DM199 to resolve clinical hold on ReMEDy2 trial.
- Company to request Type A meeting with FDA in coming weeks for guidance on lifting hold.
- Cash and investments $36.1M as of Sep 30, 2022, down from $45.1M at Dec 31, 2021; runway into Q4 2024.
- R&D expense Q3 2022 $1.6M (down from $2.3M Q3 2021); G&A $1.5M (up from $1.1M).
- Net cash used in operating activities $8.7M for 9mo 2022, compared to $9.4M in 9mo 2021.

## SEC filing metadata
- accession: 0001437749-22-026608
- form_type: 8-K
- ticker: DMAC
- cik: 0001401040
- company_name: DiaMedica Therapeutics Inc.
- filed_at: 2022-11-09T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1401040/000143774922026608/0001437749-22-026608-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1401040/000143774922026608/dmtp20221108_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-22-026608
- JSON: https://secwatch.observer/filing/0001437749-22-026608.json
- Plain text: https://secwatch.observer/filing/0001437749-22-026608.txt

## Key facts
- Earnings Releases
  DiaMedica Therapeutics Inc. reported financial results for the three and nine months ended September 30, 2022.
  - Period: the three and nine months ended September 30, 2022
  - Result: reported results
  source text: On November 9, 2022, DiaMedica Therapeutics Inc. (the “Company”) announced its consolidated financial results for the three and nine months ended September 30, 2022.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1401040/000143774922026608/0001437749-22-026608-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.