secwatch.observer — SEC 8-K summary ====================================== Issuer: DiaMedica Therapeutics Inc. (DMAC) CIK: 0001401040 Form: 8-K Filed at: 2022-11-09T23:59:59+00:00 Accession: 0001437749-22-026608 Event type: regulatory Sentiment: negative Materiality: 0.75 Item codes: 2.02, 9.01 LLM model: deepseek-v4-flash:cloud@v2 FDA maintains clinical hold on DM199 stroke trial; company to conduct additional IV stability study -------------------------------------------------------------------------------- - 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. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1401040/000143774922026608/0001437749-22-026608-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1401040/000143774922026608/dmtp20221108_8k.htm HTML page: https://secwatch.observer/filing/0001437749-22-026608 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer