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DiaMedica Therapeutics Inc. (DMAC)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally solid with clinical execution the focus: DM199 preeclampsia Part 1A topline moved to a tighter late-June/early-July window; Part 1B is expected to start in Q3 2025, and ReMEDy2 interim analysis (first 200 patients) remains targeted for 1H 2026 .
  • Liquidity remains adequate: cash, cash equivalents and short-term investments of $37.3M at 3/31/25 with runway into Q3 2026, while R&D stepped up as ReMEDy2 expands globally and PE progresses; G&A held steady as guided .
  • EPS was in line with S&P Global consensus in Q1 (−$0.18 actual vs −$0.18 est), following a slight miss in Q4 2024 and a slight beat in Q3 2024; revenue remains $0 as a pre-commercial company (S&P Global) [GetEstimates].
  • Stock catalysts over the near term are clinical: preeclampsia Part 1A topline (late June/early July), KOL event on May 28, and continued enrollment momentum updates (mid-30s sites active; high-enrolling centers at 1–2/month) .

What Went Well and What Went Wrong

  • What Went Well

    • Clear near-term clinical catalysts: “preliminary topline safety and efficacy results from Part 1A… anticipated between the second half of June and the first half of July,” with Part 1B targeted for Q3 2025 .
    • Stroke trial momentum: management noted “participant enrollment now is between the 20th and 25th percentile mark of patients enrolled for the interim analysis,” and reiterated interim analysis on the first 200 in 1H 2026 .
    • Strategic positioning in PE: “to our knowledge, DM199 is the only novel agent currently being studied in pregnant women with preeclampsia,” underscoring first-mover potential in a large unmet need .

  • What Went Wrong

    • Modest schedule slippage in PE topline: guidance narrowed to late June/early July from prior Q2 language, driven by lab turnaround (placental transfer assay) .
    • Elevated operating cash burn as trials scale: net cash used in ops rose to $7.1M in Q1 2025 vs $6.7M in Q1 2024, largely from higher net loss tied to R&D scaling .
    • Ongoing ReMEDy2 operational complexity: while momentum is building, management still emphasizes the need to concentrate on high-enrolling sites and shutter underperformers to keep pace .

Financial Results

  • Income statement and operating metrics
MetricQ1 2024Q1 2025
Research & Development ($M)$3.68 $5.66
General & Administrative ($M)$2.07 $2.49
Other income, net ($M)$0.60 $0.44
Net Loss ($M)$(5.15) $(7.71)
EPS (Basic & Diluted)$(0.14) $(0.18)
  • Liquidity and working capital
MetricDec 31, 2024Mar 31, 2025
Cash & Cash Equivalents ($M)$3.03 $2.59
Marketable Securities ($M)$41.12 $34.73
Total Cash, Cash Equivalents & Short-term Investments ($M)$44.1 $37.3
Current Liabilities ($M)$5.39 $4.67
Working Capital ($M)$39.22 $32.76
Cash Runway GuidanceInto Q3 2026 Into Q3 2026 (reiterated)
  • EPS vs estimates and trend
MetricQ3 2024Q4 2024Q1 2025
EPS Actual ($)−0.15*−0.18*−0.18*
EPS Consensus ($)−0.155*−0.1725*−0.18*
Beat/(Miss) ($)+0.005*−0.0075*0.000*

Values retrieved from S&P Global*

  • KPIs (clinical execution)
KPIQ4 2024 (context)Q1 2025
ReMEDy2 sites activated30 (U.S.; plan to double globally) Mid-30s active; focus on high-enrolling sites; Georgia performing well
Enrollment progress (to interim)—20–25% of first 200 patients
High-enrolling site cadence—Some at 1–2 patients/site/month (building momentum)
PE Part 1A topline timing2Q 2025 (prior) Late June–early July 2025
PE Part 1B start—Expected Q3 2025
KOL Event—May 28, 2025 (preeclampsia)

Note: Company operates as a single segment; no revenue or margin breakdown is applicable at this stage .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Preeclampsia Part 1A topline window20252Q 2025 Late June–early July 2025 Slight delay/narrowed window
Preeclampsia Part 1B initiation2025—Q3 2025 New
ReMEDy2 interim analysis (first 200)20261H 2026 1H 2026 reiterated Maintained
R&D expense trajectoryOngoingModerate increase vs recent periods Moderate increase (as trials expand) Maintained
G&A trajectoryOngoingRemain steady vs recent periods Remain steady Maintained
Cash runwayThroughInto Q3 2026 Into Q3 2026 reiterated Maintained
Site activation/enrollment202530 sites active (U.S.) Mid-30s active; concentrate on high-enrollers; global push Improved execution focus

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3’24 and Q4’24)Current Period (Q1’25)Trend
PE program progressFirst patient dosed (Q4’24); Part 1A topline expected 1H25 Topline narrowed to late Jun/early Jul; Part 1B slated Q3’25 Slight schedule refinement; visibility improving
Stroke enrollment momentumProtocol v5.0 (tPA nonresponders included); 30 sites active; interim shifted to 1H’26 20–25% to interim; mid-30s sites; some high-enrollers at 1–2/mo; interim reiterated 1H’26 Improving momentum with focus on high-yield sites
Protocol updates (AIS)Inclusion of tPA nonresponders; interim sample size increased to 200 to improve precision/cost Sites affirm utility of v5.0; inclusion expected to aid enrollment and outcomes Positive site reception; expected operational benefit
Global expansion (AIS)Canada + EU expansion planned; KOL engagement Performing sites in Georgia; preparing filings for EU expansion Steady advancement
SafetyDSMB safety review cleared continued ReMEDy2 without modification (Jan 2025) No new safety issues noted; continued Stable
Regulatory/legal—PRA Netherlands appeals hearing held Mar 20, 2025; ruling expected ~Jun 20, 2025 Pending decision

Management Commentary

  • “With the upcoming release of preliminary topline safety and efficacy results from Part 1A of the Phase 2 preeclampsia study, DiaMedica is entering what we believe will be an exciting phase in the history of our company.” — Rick Pauls, CEO .
  • “To our knowledge, DM199 is the only novel agent currently being studied in pregnant women with preeclampsia.” — Management remarks on the call .
  • “We anticipate that our current cash and investments provides us a runway into Q3 of 2026.” — Scott Kellen, CFO .
  • “Some of these high-enrolling sites are seeing the 1 to 2 patients per site per month… currently, we are above our plan… momentum is being built.” — Management on ReMEDy2 enrollment .

Q&A Highlights

  • Preeclampsia topline timing and lab dependency: The critical gating item is the placental transfer assay; final timing depends on lab turnarounds, hence the late June/early July window .
  • Preeclampsia program sequencing: Part 1B expected to start in Q3; fetal growth restriction cohort contingent on uterine artery dilation signals; U.S. expansion contemplated later .
  • Read-through to AIS: While indications are distinct, positive PE data would further validate DM199’s biological activity; supportive precedent from KLK1 use in Asia .
  • Enrollment dynamics: Focus on high-volume centers; some sites now achieving 1–2 patients/month; site count mid-30s with international contribution (e.g., Georgia) .
  • Interim analysis path: Trajectory to 1H 2026 assumes continued pickup; management affirmed recent uptick vs last call .

Estimates Context

  • EPS: Q1 2025 actual −$0.18 vs −$0.18 consensus (in line); Q4 2024 actual −$0.18 vs −$0.1725 consensus (slight miss); Q3 2024 actual −$0.15 vs −$0.155 consensus (slight beat) (S&P Global).
  • Revenue: Pre-revenue; consensus $0 for all periods (S&P Global).

Values retrieved from S&P Global*

Key Takeaways for Investors

  • Near-term clinical catalyst: PE Part 1A topline (late June/early July) is the key binary/trend event; look for safety (no placental transfer), BP reductions (~10–20 mmHg toward ~140 systolic), and uterine artery pulsatility index improvements as directional readouts .
  • Stroke enrollment is improving; monitoring site-level productivity is crucial. Management is concentrating resources on high-enrolling centers; next milestone is 50% enrollment update and maintaining path to 1H 2026 interim .
  • Liquidity covers planned milestones into Q3 2026; watch R&D spend as global expansion and PE program drive modest opex increases, with G&A steady as guided .
  • Narrative bull case: First-mover potential in PE with no approved therapies and differentiated MOA, plus expanded AIS addressable population via inclusion of thrombolytic nonresponders (v5.0), which sites view positively .
  • Risk monitor: Any delay beyond early July for PE topline (lab dependencies), enrollment variability in AIS, and outcome of the PRA Netherlands legal matter (decision expected around Jun 20, 2025) .
  • Trading setup: The PE readout window and KOL event (May 28) are immediate sentiment drivers; strength/weakness likely tied to clarity and magnitude of PE signals and enrollment momentum commentary from management .

Citations:

  • Q1 2025 press release and financials
  • Q1 2025 Form 8-K (Item 2.02; Exhibit PR)
  • Q1 2025 earnings call transcript
  • Q1 2025 10-Q (program detail, liquidity, risks)
  • Q4 2024 update (context, prior guidance)
  • Additional Q2 2025 press releases (KOL, conferences)

Values retrieved from S&P Global* (EPS and revenue consensus/actuals via GetEstimates)