Contradictions Uncovered: Analyzing DM199's Clinical Trial Progress and Key Challenges
Earnings DecryptTuesday, May 20, 2025 7:44 pm ET
2min read
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Clinical Development Progress:
- DiaMedica Therapeutics reported substantial progress in both preeclampsia and stroke programs.
- In the preeclampsia program, Part 1a of the Phase 2 trial is nearing the completion of identifying a target dose for Part 1b, expected between June and July.
- The stroke program enrollment is between the 20th and 25th percentile, with an interim analysis planned for the first half of 2026.
- The momentum in both programs is driven by improvements in study logistics and site engagement.
Financial Results and Cash Runway:
- The company reported $37.3 million in total combined cash and investments as of March 31, 2025 compared to $44.1 million in 2024.
- Research and development expenses increased to $5.7 million for Q1 2025, up from $3.7 million in Q1 2024.
- The decrease in cash and investments and the increase in R&D expenses are primarily due to funding operations and ongoing clinical trials.
- The current cash is projected to provide a runway into Q3 2026.
Preeclampsia Program and Market Awareness:
- Part 1a of the preeclampsia Phase 2 trial is nearing completion, with preliminary results expected between June and July.
- Key opinion leader (KOL) event on May 28 aims to educate investors and physicians about preeclampsia and the current state of treatments.
- The focus on preeclampsia is due to a lack of FDA-approved treatments despite its growing burden, and DM199 being the only novel agent studied in pregnant women with preeclampsia.
Stroke Program Enrollment and Site Engagement:
- Participant enrollment in the stroke program is between the 20th and 25th percentile, indicating steady progress.
- An experienced stroke neurologist has been engaged to support site engagement, contributing to recent enrollment momentum.
- The overall enrollment is expected to accelerate due to simplified study logistics and enhanced site communications.
Clinical Development Progress:
- DiaMedica Therapeutics reported substantial progress in both preeclampsia and stroke programs.
- In the preeclampsia program, Part 1a of the Phase 2 trial is nearing the completion of identifying a target dose for Part 1b, expected between June and July.
- The stroke program enrollment is between the 20th and 25th percentile, with an interim analysis planned for the first half of 2026.
- The momentum in both programs is driven by improvements in study logistics and site engagement.
Financial Results and Cash Runway:
- The company reported $37.3 million in total combined cash and investments as of March 31, 2025 compared to $44.1 million in 2024.
- Research and development expenses increased to $5.7 million for Q1 2025, up from $3.7 million in Q1 2024.
- The decrease in cash and investments and the increase in R&D expenses are primarily due to funding operations and ongoing clinical trials.
- The current cash is projected to provide a runway into Q3 2026.
Preeclampsia Program and Market Awareness:
- Part 1a of the preeclampsia Phase 2 trial is nearing completion, with preliminary results expected between June and July.
- Key opinion leader (KOL) event on May 28 aims to educate investors and physicians about preeclampsia and the current state of treatments.
- The focus on preeclampsia is due to a lack of FDA-approved treatments despite its growing burden, and DM199 being the only novel agent studied in pregnant women with preeclampsia.
Stroke Program Enrollment and Site Engagement:
- Participant enrollment in the stroke program is between the 20th and 25th percentile, indicating steady progress.
- An experienced stroke neurologist has been engaged to support site engagement, contributing to recent enrollment momentum.
- The overall enrollment is expected to accelerate due to simplified study logistics and enhanced site communications.
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