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DiaMedica Therapeutics Inc. (DMAC)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 EPS of $(0.18) modestly beat Wall Street consensus of $(0.19); net loss was $7.70M driven by higher R&D as ReMEDy2 expanded globally and preeclampsia programs advanced *. Values retrieved from S&P Global.
  • Positive interim Phase 2 Part 1a preeclampsia data showed statistically significant SBP/DBP reductions, no placental transfer, and meaningful uterine artery PI improvement; management moved to enroll additional cohorts and prepare a U.S. Phase 2b IND .
  • Cash runway extended into H2 2027 following a $30.1M private placement (8.6M shares at $3.50); pro forma cash ~$60M supports preeclampsia and AIS milestones .
  • ReMEDy2 stroke trial enrollment improved; interim analysis timing tightened to Q2 2026, with ~40 active sites and DSMB safety review positive after first 50 participants .

What Went Well and What Went Wrong

What Went Well

  • Strong preeclampsia signal: pooled cohorts 6–9 showed SBP reductions up to −25 mmHg at 5 minutes (p=0.0003) and DBP reductions up to −13 mmHg (p=0.0007); cohort 9 reached −35/−15 mmHg SBP/DBP at 5 minutes (p<0.05) . “These interim results exceeded our expectations…potential to be a first-in-class, disease modifying therapy” — Rick Pauls .
  • Safety profile supportive for pregnancy: no evidence of placental transfer and no serious TEAEs; PI improvement of −13.2% at 2 hours (p=0.0003) suggests improved placental perfusion .
  • Strengthened balance sheet/visibility: $30.1M private placement extended runway into 2027 and Russell 2000/3000 inclusion broadened investor reach .

What Went Wrong

  • OpEx stepped up: R&D rose to $5.82M (+49% y/y) and G&A to $2.19M (+28% y/y) on global trial expansion and team growth; operating loss widened to $8.01M .
  • Continued losses: net loss increased to $7.70M vs $5.12M in Q2 2024 as program investment escalated .
  • Stroke enrollment uneven across sites: management noted “80/20” contribution and actively discontinued non-performing sites; Europe/UK onboarding ongoing, implying execution risk until consistent rates sustain .

Financial Results

MetricQ2 2024Q1 2025Q2 2025
EPS ($USD)$(0.13) $(0.18) $(0.18)
EPS Consensus ($USD)$(0.1567)*$(0.18)*$(0.19)*
R&D Expense ($USD Millions)$3.93 $5.66 $5.82
G&A Expense ($USD Millions)$1.71 $2.49 $2.19
Operating Loss ($USD Millions)$5.64 $8.14 $8.01
Other Income, net ($USD Millions)$0.53 $0.44 $0.31
Net Loss ($USD Millions)$5.12 $7.71 $7.70
Weighted Avg Shares (Millions)38.07 42.84 42.96
Cash, Cash Equivalents + ST Investments ($USD Millions)—$37.3 $30.0; pro forma ~$60.0
  • Revenue: no product revenue line reported in the quarter’s statements .

Segment breakdown: Not applicable (clinical-stage, no commercial revenue) .

KPIs

KPIQ4 2024Q1 2025Q2 2025
Active ReMEDy2 Sites (#)30 (activated early 2025) —~40
DSMB Safety ReviewContinue without modification after first 20 participants —Positive DSMB review after first 50 participants; continue enrollment
Interim Analysis Timing (first 200 AIS patients)H1 2026 H1 2026 Q2 2026
Cash RunwayInto Q3 2026 Into Q3 2026 Into H2 2027
Financing——$30.1M private placement closed
Index Inclusion——Added to Russell 2000/3000

Note: *Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-yearInto Q3 2026 Into H2 2027 Raised
ReMEDy2 Interim AnalysisFirst 200 patientsH1 2026 Q2 2026 Tightened earlier
Preeclampsia ProgramPhase 2 (SA)Part 1a topline expected late Jun–mid Jul 2025 Part 1a positive; proceed to Cohort 10 and expand Part 1b/Part 2/Part 3 concurrently Advanced scope
U.S. IND for Phase 2bPreeclampsia/FGR—Plan to submit U.S. IND; Phase 2b study targeting expectant management New

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Preeclampsia efficacy/safetyDosing underway; Part 1a topline expected Q2 2025 Statistically significant BP/PI reductions; no placental transfer; expand cohorts and prep U.S. Phase 2b IND Accelerating
Stroke enrollment/sitesProtocol v5.0 adopted; enrollment expected to increase; 30 sites activated ~40 active sites; pruning non-performers; UK/EU onboarding; DSMB after 50 positive Improving execution
Capital position$44.1M cash/STI YE24; runway into Q3 2026 $30.1M private placement; pro forma ~$60M; runway into H2 2027 Strengthened
Index visibility—Added to Russell 2000/3000 Expanded investor reach
Management depth—Julie Krop, MD appointed CMO with preeclampsia experience Enhanced leadership
Regulatory planningPlanning for data-driven regulatory dialogue Pre-IND then IND submission for U.S. Phase 2b preeclampsia Clearer pathway

Management Commentary

  • “We believe that DM199 has the potential to be the first in class disease modifying treatment for preeclampsia…cohorts 6–9 demonstrated highly statistically significant and clinically meaningful reductions in blood pressure” — Rick Pauls, CEO .
  • “Including net proceeds from the July private placement, our pro forma cash position is approximately $60,000,000…anticipated to fund planned clinical studies and corporate operations into 2027” — Scott Kellen, CFO .
  • “Really having worked in women’s health before…there’s derisked biology with KLK1 as vasodilator and vascular repair…already shown promising clinical data” — Julie Krop, CMO .

Q&A Highlights

  • Preeclampsia trial roadmap: Management advancing to Cohort 10 (Part 1a), then expanding Part 1b and initiating Part 2 (expectant management) and Part 3 (FGR) concurrently; U.S. Phase 2b will target expectant management with pre-IND/IND filings in process .
  • Stroke enrollment dynamics: ~40 sites active; pruning non-performers; recent investigators’ meeting improved awareness; UK/EU sites onboarding; guidance for interim analysis in Q2 2026 reaffirmed .
  • Phase 2b endpoints: Company seeking expert input and recent FDA feedback to align primary endpoint with pivotal intentions; details to be finalized before disclosure .

Estimates Context

  • EPS vs consensus: Q2 2025 $(0.18) vs $(0.19) consensus (beat); Q1 2025 inline at $(0.18) vs $(0.18); Q2 2024 $(0.13) vs $(0.1567) (beat)*.
  • Revenue: Consensus $0; company continues without reported product revenue line in statements* .
  • Where estimates may adjust: Strengthened cash runway and accelerated preeclampsia development could lead to modest adjustments to OpEx trajectory and timing of preeclampsia Phase 2b readouts in models .

Note: *Values retrieved from S&P Global.

Key Takeaways for Investors

  • Preeclampsia program is now derisked with clear on-target hemodynamic and perfusion signals plus favorable fetal safety profile, increasing probability of technical success and regulatory engagement momentum .
  • Capital raise plus index inclusion broaden the investor base and remove near-term financing overhang; runway into H2 2027 allows multi-cohort execution and U.S. Phase 2b initiation .
  • Stroke program execution improved with ~40 sites and positive DSMB review after 50 participants; interim analysis in Q2 2026 can be a major binary catalyst .
  • Near-term catalysts: cohort 10 dosing results, Part 1b/Part 2/Part 3 enrollment updates, IND submission newsflow; monitor dosing optimization and endpoint selection for Phase 2b .
  • Expense profile will remain elevated given broader clinical activity; watch R&D cadence and any manufacturing scale-up costs; other income variability can modestly impact quarterly EPS .
  • Strategic leadership bolstered by new CMO with prior preeclampsia experience, supporting trial design and regulatory alignment for Phase 2b and beyond .
  • Trading implications: positive clinical signals and extended runway skew near-term risk/reward favorably; headline risk tied to enrollment pace and regulatory interactions warrants position sizing and catalyst calendar discipline .