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- Preeclampsia Phase 2 IST Trial: Part 1a Dose Escalation Cohort Complete with Expansion Cohort Now Enrolling; Screening for Part 3, Fetal Growth Restriction Cohort, Expected to Start in Coming Weeks<\/i><\/b><\/li>\n
- Held in Person pre-IND meeting with U.S. FDA to Discuss Plans for the Initiation of a U.S. Phase 2 DM199 Study in Preeclampsia<\/i><\/b><\/li>\n
- AIS enrollment in ReMEDy2 Phase 2\/3 Trial Nearing 50% of Target of 200 Patients for the Interim Analysis Expected in 2H 2026<\/i><\/b><\/li>\n
- $55 million in Cash, Cash Equivalents and Investments, Anticipated Runway into 2H 2027<\/i><\/b><\/li>\n
- Conference Call and Webcast on November 13 at 8:00 AM ET \/ 7:00 AM CT<\/i><\/b><\/li>\n<\/ul>\n
MINNEAPOLIS–(BUSINESS WIRE<\/a>)–
\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia (PE), fetal growth restriction and acute ischemic stroke (AIS), today provided a business update and reported financial results for the third quarter ended September 30, 2025. Management will host a conference call on Thursday, November 13, 2025, at 8:00 AM Eastern Time \/ 7:00 AM Central Time to discuss its business update and third quarter 2025 financial results.<\/p>\n\n\u201cWe are pleased to see the completion of cohort 10 and the initiation of enrollments in the Part 1a expansion cohort in the ongoing Phase 2 investigators sponsored trial (IST) in preeclampsia,\u201d said Rick Pauls, President and CEO of DiaMedica. \u201cRegarding our development program for PE in the United States, we believe that we had a productive in-person pre-IND meeting with the FDA and are awaiting minutes from the meeting. We plan to provide an update after we receive the minutes. Enrollment in our ReMEDy2 Phase 2\/3 trial in acute ischemic stroke continues to progress as we are nearing 50% of our interim target of 200 patients.\u201d<\/p>\n
Recent Corporate Highlights<\/b><\/p>\n
Preeclampsia Phase 2 IST Clinical Development:<\/b><\/p>\n
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- \nPart 1a (PE, planned delivery within 72 hours): Completed cohort 10, showing results consistent with cohorts 6-9. Enrollment has advanced to an expansion cohort of up to 12 additional participants at the expected therapeutic dose level. Completion of this cohort is expected in 1H 2026.<\/p>\n<\/li>\n
- \nPart 1b (PE, planned delivery within 72 hours) and Part 2 (early onset PE with expectant management): based on clinical learnings from Part 1a, a protocol amendment for Parts 1b and 2 is being implemented to refine treatment regimens.<\/p>\n<\/li>\n
- \nPart 3 (fetal growth restriction): Screening for participants who do not have PE but have early onset fetal growth restriction is expected to begin in the coming weeks.<\/p>\n<\/li>\n<\/ul>\n
Preeclampsia in Person Pre-IND meeting with FDA:<\/b><\/p>\n
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- \nGiven the complexities inherent in conducting clinical studies involving pregnant women, a very vulnerable patient group, DiaMedica requested a pre-IND meeting with the FDA to obtain feedback prior to submitting an IND application for preeclampsia.<\/p>\n<\/li>\n
- \nThe FDA granted DiaMedica an in-person meeting, which has been recently held. DiaMedica plans to provide an update regarding the meeting once final meeting minutes are received.<\/p>\n<\/li>\n<\/ul>\n
Acute Ischemic Stroke ReMEDy2 Phase 2\/3 Clinical Developments:<\/b><\/p>\n
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- \nEnrollment in DiaMedica\u2019s Phase 2\/3 ReMEDy2 (the ReMEDy2 trial \u2013 NCT065216<\/a>) trial is nearing 50% of the target of 200 participants for the interim analysis.<\/p>\n<\/li>\n<\/ul>\n
Financial Results Highlights for the Third Quarter Ended September 30, 2025<\/b><\/p>\n
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- Cash Position and Runway <\/b>\u2013 Cash and short-term investments were $55.3 million as of September 30, 2025, compared to $44.1 million as of December 31, 2024. The increase in combined cash and short-term investments is due to the net proceeds received from July private placement. Based on its current plans, DiaMedica anticipates its current cash and short-term investments will enable the Company to fund its planned clinical studies and support corporate operations into the second half of 2027.\n<\/li>\n
- Cash Flows<\/b> \u2013 Net cash used in operating activities for nine months ended September 30, 2025 was $21.3 million compared to $15.6 million for the same period in 2024. The increase in cash used in operating activities resulted primarily from the increased net loss in the nine months ended September 30, 2025 as compared with the prior year period, partially offset by changes in operating assets and liabilities during the current year period.\n<\/li>\n
- Research and Development (R&D) \u2013 <\/b>R&D expenses were $6.4 million and $17.9 million for the three and nine months ended September 30, 2025, respectively, up from $5.0 million and $12.6 million for the same periods in the prior year. The increase in both periods was due primarily to cost increases driven by the continued progress of the ReMEDy2 clinical trial, including its global expansion, progress with the Phase 2 IST in PE and the expansion of the clinical team during the current and prior year periods. These increases were partially offset by cost reductions related to manufacturing process development work performed and completed in the prior year period.\n<\/li>\n
- General and Administrative (G&A) \u2013 <\/b>G&A expenses were $2.6 million and $7.3 million for the three and nine months ended September 30, 2025, respectively, up from $1.9 million and $5.7 million for the three and nine months ended September 30, 2024, respectively. The increases in both periods resulted primarily from increased non-cash share-based compensation and increased personnel costs incurred in conjunction with expanding our team. Increases in investor relations, patent and professional fees also contributed to the increases in both periods.\n<\/li>\n
- Net Loss \u2013 <\/b>Net losses were $8.6 million and $24.0 million for the three and nine months ended September 30, 2025, respectively, up from $6.3 million and $16.5 million for the three and nine months ended September 30, 2024, respectively.\n<\/li>\n<\/ul>\n
Conference Call and Webcast Information<\/b><\/p>\n
\nDiaMedica Management will host a conference call and webcast to discuss its business update and third quarter 2025 financial results on Thursday, November 13, 2025, at 8:00 AM Eastern Time \/ 7:00 AM Central Time:<\/p>\n
- Cash Flows<\/b> \u2013 Net cash used in operating activities for nine months ended September 30, 2025 was $21.3 million compared to $15.6 million for the same period in 2024. The increase in cash used in operating activities resulted primarily from the increased net loss in the nine months ended September 30, 2025 as compared with the prior year period, partially offset by changes in operating assets and liabilities during the current year period.\n<\/li>\n
- Cash Position and Runway <\/b>\u2013 Cash and short-term investments were $55.3 million as of September 30, 2025, compared to $44.1 million as of December 31, 2024. The increase in combined cash and short-term investments is due to the net proceeds received from July private placement. Based on its current plans, DiaMedica anticipates its current cash and short-term investments will enable the Company to fund its planned clinical studies and support corporate operations into the second half of 2027.\n<\/li>\n
- \nEnrollment in DiaMedica\u2019s Phase 2\/3 ReMEDy2 (the ReMEDy2 trial \u2013 NCT065216<\/a>) trial is nearing 50% of the target of 200 participants for the interim analysis.<\/p>\n<\/li>\n<\/ul>\n
- Held in Person pre-IND meeting with U.S. FDA to Discuss Plans for the Initiation of a U.S. Phase 2 DM199 Study in Preeclampsia<\/i><\/b><\/li>\n
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