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- **Preeclampsia progress**: DM199 shows dose-dependent BP drops (systolic/diastolic) and placental perfusion improvements, positioning for U.S. trial.
- **Stroke challenges**: Enrollment halved due to AI referrals; 35+ sites activated, seeking global expansion.
- **Financial stability**: $55.3M cash, net loss up 37% YoY driven by clinical costs.
- **Key milestones**: Cohort 10 expansion, FDA pre-IND update, and ReMEDy2 interim analysis in H2 2026.


**【CEO Summary Section】**
- Presented progress in preeclampsia and stroke programs, highlighting DM199's mechanism via bradykinin pathway activation.
- Preeclampsia interim results: Dose-dependent blood pressure reductions (systolic/diastolic) and uterine artery pulsatility index improvement, supporting placental perfusion claims.
- Stroke program updates: Enrollment challenges due to AI-driven referral shifts, revised U.S. trial plans for early onset preeclampsia, and $55.3M cash as of Q3 2025.
- Q&A emphasized KOL engagement, FDA pre-IND meeting progress, and Cohort 10's 12-patient expansion for U.S. trial preparation.

**【CFO Financial Commentary】**
- Cash position: $55.3M (vs. $30M prior quarter), sufficient for operations into 2027.
- R&D expenses: $6.4M/Q3, up 28% YoY, driven by ReMEDy2 expansion and preeclampsia trial costs.
- G&A: $2.6M/Q3, +37% YoY due to team expansion and IR/patent costs.
- Net loss: $8.6M/Q3, +37% YoY from clinical and manufacturing expenses.

**【Q&A Key Highlights】**
- Preeclampsia: KOLs praise placental barrier safety and blood pressure consistency; Cohort 10 IV-only dosing for U.S. trial.
- Stroke: Enrollment rates halved due to tele-neurology; 35+ sites activated, seeking OUS approvals.
- Interim analysis: Modified Rankin Scale targeting 15% improvement in non-thrombectomy patients.


DiaMedica Therapeutics Inc. (DMAC) Q3 2025 Earnings Call Transcript

- **Preeclampsia Breakthrough**: DM199 shows statistically significant BP reduction and placental safety, advancing to Phase IIb in U.S. with IND filing imminent.
- **Stroke Trial Progress**: ReMEDy2 enrollment surpasses 25% milestone, with interim analysis in Q2 2026; safety profile confirmed.
- **Financial Strength**: $60M cash runway post-private placement, supporting global trials through 2027.
- **Strategic Expansion**: New CMO strengthens pipeline, with Phase IIb U.S. study targeting high-need preeclampsia subpopulation.

**【CEO Opening Remarks】**
- **Preeclampsia Program Progress**: Interim results from Part 1a of Phase II trial show statistically significant reductions in systolic and diastolic blood pressure, with no placental transfer observed. Cohort 10 dosing begins next week to refine dosing regimen for Part 1b (30 patients) and Part 2 (early onset preeclampsia). Phase IIb U.S. trial IND filing expected soon.
- **Stroke Program Update**: ReMEDy2 trial enrollment tracking above 25th percentile milestone, with interim analysis of first 200 patients planned for Q2 2026. Positive DSMB review confirms safety profile.
- **Financial Milestone**: $30M private placement extends cash runway to H2 2027, supporting U.S. Phase IIb and global trials.
- **New Leadership**: Dr. Julie Krop joins as CMO, bringing expertise in preeclampsia and orphan drug development.

**【CFO Financial Commentary】**
- **Cash Position**: Pro forma cash of $60M (including July private placement), supporting operations into H2 2027.
- **R&D Expenses**: $5.8M (Q2) and $11.5M (H1), up 49% YoY, driven by ReMEDy2 expansion and clinical team growth.
- **G&A Expenses**: $2.2M (Q2) and $4.7M (H1), up 29% YoY, due to share-based compensation and legal fee reductions.
- **Net Loss**: $15.4M (H1), up 50% YoY, reflecting increased clinical activity.

**【Q&A Highlights】**
- **Preeclampsia Enrollment**: South Africa site enrolls 4-5 patients/day; U.S. Phase IIb targeting expected management (early onset) with primary endpoint aligned for pivotal trial.
- **Stroke Trial Momentum**: 40 active sites, with 80% of patients coming from top 20% of sites; Q2 2026 interim analysis confidence growing.
- **FDA Feedback**: Positive on DM199's disease-modifying potential; protocol finalization underway for U.S. Phase IIb.


DiaMedica Therapeutics Inc. (DMAC) Q2 2025 Earnings Call Transcript

- **Preeclampsia Trial Momentum**: Target dose identification nears completion; preliminary results expected June-July 2025.
- **Stroke Enrollment Gains**: 20-25% of interim analysis target met, with U.S. sites exceeding 1 patient/month enrollment.
- **Financial Stability**: $37.3M cash runway to Q3 2026; R&D expenses up 54% to support global trial expansion.
- **Strategic Initiatives**: Preeclampsia KOL event on May 28; DM199 placental transfer assay completion drives timeline certainty.


**【CEO Opening Remarks】**
- Preeclampsia Program Update: Phase 2 trial's Part 1a nearing completion of target dose identification for Part 1b. Preliminary top-line results expected in late June to mid-July, focusing on safety, blood pressure reduction, and uterine blood flow metrics.
- Stroke Program Progress: ReMEDy2 trial enrollment at 20-25% of interim analysis target (200 patients). Global expansion efforts and site engagement improvements driving momentum. Experienced stroke neurologist added to support enrollment during leadership leave.
- Upcoming Events: Preeclampsia KOL Call on May 28 to educate on disease state and trial design.

**【CFO Financial Review】**
- Cash Position: $37.3M as of Q1 2025, providing runway into Q3 2026. Operating cash outflow of $7.1M (vs. $6.7M in Q1 2024) driven by increased R&D expenses.
- R&D Expenses: $5.7M (vs. $3.7M prior year), reflecting expanded clinical trials, manufacturing, and team growth.
- G&A Expenses: $2.5M (vs. $2.1M), driven by share-based compensation adjustments.

**【Q&A Key Highlights】**
- Preeclampsia Trial Design: Part 2/3 will remain under current protocol without U.S. IND filing for now; U.S. expansion plans to be announced later.
- DM199 Cross-Placental Testing: Assay completion timing is primary variable for June-July results release.
- Stroke Enrollment Metrics: 30+ active sites globally, with high-volume U.S. sites enrolling 1-2 patients/month. Enrollment rate accelerating beyond initial expectations.


DiaMedica Therapeutics Inc. (DMAC) Q1 2025 Earnings Call Transcript

- **Preeclampsia Trial Momentum**: DM199 achieves early safety and tolerability in Phase 1A; Q2 2025 data to identify optimal dose.
- **Stroke Trial Expansion**: 30 U.S. sites active, with international expansion underway; interim analysis expected H1 2026.
- **Financial Stability**: $44.1M cash balance supports operations into Q3 2026; R&D expenses up 46% to fund clinical growth.
- **Key Regulatory Milestones**: FDA approves statistical plan for TPA non-responder inclusion; DSMB confirms trial safety.


**【CEO Opening Remarks】**
- Highlighted progress in both preeclampsia and stroke programs, emphasizing DM199's potential as a novel therapeutic for unmet medical needs.
- Announced activation of 30 clinical sites for the ReMEDy2 stroke trial and expansion into international markets (Canada, Australia, Europe).
- Recognized the team's efforts and reaffirmed commitment to advancing clinical programs.

**【CMO Update on Preeclampsia Program】**
- Achieved key milestones: ethics approval, regulatory clearance, and initiation of dosing in preeclamptic mothers within 12 months.
- DM199 demonstrated promising safety profile with no placental transfer, unlike small molecule antihypertensives.
- Phase 1A trial shows tolerability with no serious adverse events; expects Q2 2025 results for optimal dose identification.

**【CMO Update on Stroke Program】**
- Activated 30 U.S. sites with 13 of top 15 high-enrollment sites operational.
- Protocol v5.0 expanded eligibility to include TPA non-responders and enabled refrigerated drug storage.
- DSMB review in January confirmed no safety concerns, allowing trial continuation.
- Anticipates interim analysis in H1 2026 with potential sample size reduction based on efficacy signals.

**【CFO Financial Overview】**
- FY24 ending cash balance: $44.1M (down from $52.9M in FY23) with runway to Q3 2026.
- R&D expenses increased 46% to $19.1M due to ReMEDy2 expansion and manufacturing costs.
- G&A expenses decreased 7% to $7.6M due to legal cost reductions.
- Net cash used in operations: $22.1M (up 18% YoY) driven by clinical trial expenses.

**【Q&A Highlights】**
- Enrollment rates: Sites expected to enroll 1-2 patients/month, with 6-12 months to achieve steady state.
- DSMB review included full patient data up to cutoff date, confirming safety profile.
- FDA has finalized statistical analysis plan for ReMEDy2 protocol amendments.
- Preeclampsia Phase 1A success metrics: 10-20mmHg systolic BP reduction, placental barrier integrity, and uterine artery perfusion improvement.


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