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- Preeclampsia Phase 2 Trial Preliminary Topline Safety and Efficacy Data from Part 1A of the Study Expected in the Second Quarter of 2025<\/b><\/li>\n
- Acute Ischemic Stroke Phase 2\/3 Program Enrollment Ongoing<\/b><\/li>\n
- Appointed Experienced Biotech Executive Daniel J. O\u2019Connor to the Board<\/b><\/li>\n
- Cash Runway into Q3 2026<\/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 acute ischemic stroke and preeclampsia, today provided a business update and financial results for the year ended December 31, 2024. Management will host a conference call Tuesday, March 18, 2025, at 8:00 AM Eastern Time \/ 7:00 AM Central Time to discuss its business update and full year 2024 financial results.\n<\/p>\n\n\u201cWe made significant progress in 2024, advancing our AIS program and expanding into preeclampsia,\u201d said Rick Pauls, President and CEO of DiaMedica. \u201cBoth of these populations are critically underserved, representing substantial unmet medical needs and large commercial opportunities.\u201d\n<\/p>\n
Preeclampsia Phase 2 Clinical Developments<\/b><\/p>\n
\nDosing in the Phase 2 investigator-sponsored trial of DM199 for preeclampsia (DM199 For Pregnancy Complications trial \u2013 NCT06875141<\/a>) began in November 2024 in South Africa and is ongoing. Multiple dosing cohorts have now been completed. Topline preliminary safety and efficacy data from Part 1A of the study is anticipated in the second quarter of 2025.\n<\/p>\n
Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2\/3 Clinical Developments<\/b><\/p>\n
\nThe total number of activated study sites has reached 30 hospitals during the first quarter of 2025 for the Company\u2019s Phase 2\/3 AIS trial (the ReMEDy2 trial \u2013 NCT065216<\/a>). The majority of these sites are operating under version 5.0 of the study protocol, the latest version, which expanded the pool of eligible AIS participants. While the Company has noted an increase in enrollment in the first part of 2025, with delays in site activation during 2024, the transition to version 5.0 of the protocol and slower than expected enrollment, the Company anticipates the interim analysis for sample size re-estimation on the first 200 participants in the first half of 2026; the Company notes this timing is based upon anticipated increased enrollment.\n<\/p>\n
\nDiaMedica further reports that its data safety monitoring board (DSMB) completed its scheduled safety review of the new intravenous dosing rates implemented upon resumption of the ReMEDy2 trial. Based upon that review, the DSMB concluded that the ReMEDy2 trial should continue without modification. This pre-specified assessment was based on a comprehensive review of safety data from the first twenty (N=20) enrolled participants and no significant safety concerns were identified.\n<\/p>\n
Daniel J. O\u2019Connor Appointed to the Board<\/b><\/p>\n
\nMr. O\u2019Connor was appointed to DiaMedica\u2019s Board of Directors in February 2025. Most recently Mr. O\u2019Connor served as CEO of Ambrx, where he engineered a turnaround of the company resulting in a $2 billion acquisition by Johnson & Johnson in 14 months.\n<\/p>\n
Financial Results Highlights for the Year Ended December 31, 2024<\/b><\/p>\n
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- Cash Position and Runway <\/b>\u2013 Cash, cash equivalents, and short-term investments were $44.1 million as of December 31, 2024, compared to $52.9 million as of December 31, 2023. Based on its current plans, the Company anticipates its current cash, cash equivalents, and short-term investments will enable the Company to fund its planned clinical studies and support corporate operations into the third quarter of 2026.\n<\/li>\n
- Cash Flows<\/b> – Net cash used in operating activities for the year ended December 31, 2024 was $22.1 million compared to $18.7 million for the year ended December 31, 2023. The increase in cash used in operating activities resulted primarily from the combination of increased net loss and the advance of deposit funds to vendors supporting the Company\u2019s ReMEDy2 clinical trial during 2024.\n<\/li>\n
- Research and Development (R&D) \u2013 <\/b>R&D expenses were $19.1 million for the year ended December 31, 2024, compared to $13.1 million for the year ended December 31, 2023. The increase was due primarily to cost increases resulting from the continuation of the ReMEDy2 clinical trial, the expansion of the clinical team, and increased manufacturing development activity. Partially offsetting this increase were cost reductions related to completion of prior clinical and non-clinical work in 2023. DiaMedica expects its R&D expenses to increase moderately relative to recent prior periods as the Company expands its ReMEDy2 trial globally and continues site activation and enrollment and expands its DM199 clinical development program into preeclampsia.\n<\/li>\n
- General and Administrative (G&A) \u2013 <\/b>G&A expenses were $7.6 million for the year ended December 31, 2024, down from $8.2 million for the year ended December 31, 2023. The decrease resulted primarily from the combination of decreased legal fees and reductions in directors\u2019 and officers\u2019 liability insurance premiums.\n<\/li>\n
- Net Loss – <\/b>Net loss was $24.4 million, or $0.60 loss per share, for the year ended December 31, 2024, compared to $19.4 million, or $0.60 loss per share, for the year ended December 31, 2023.\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 full year 2024 financial results on Tuesday, March 18, 2025, at 8:00 AM Eastern Time \/ 7:00 AM Central Time:\n<\/p>\n
- Cash Flows<\/b> – Net cash used in operating activities for the year ended December 31, 2024 was $22.1 million compared to $18.7 million for the year ended December 31, 2023. The increase in cash used in operating activities resulted primarily from the combination of increased net loss and the advance of deposit funds to vendors supporting the Company\u2019s ReMEDy2 clinical trial during 2024.\n<\/li>\n
- Acute Ischemic Stroke Phase 2\/3 Program Enrollment Ongoing<\/b><\/li>\n
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