DiaMedica Therapeutics Inc. (DMAC)·Q4 2024 Earnings Summary

Executive Summary

• DMAC reported FY 2024 results with cash, cash equivalents, and short-term investments of $44.1M and guided runway into Q3 2026, while Q4 disclosure focused on clinical milestones rather than standalone quarterly P&L figures .
• ReMEDy2 stroke trial progressed to 30 activated sites and cleared a DSMB safety review to continue without modification; however, management pushed the interim analysis timing to 1H 2026 to reflect slower-than-expected site activation/enrollment and protocol version 5.0 transitions, despite seeing an early-2025 uptick in enrollments .
• Preeclampsia Phase 2 Part 1A has completed multiple dose cohorts with no SAEs or hypotension observed; preliminary topline safety/efficacy data are expected in Q2 2025, and DM199’s large-molecule profile is not expected to cross the placental barrier—a key safety advantage .
• Strategic catalysts include inclusion of thrombolytic nonresponders and refrigerated storage (to improve site logistics/enrollment), publication of DM199’s AIS mechanism of action in Stroke, and addition of Dan O’Connor (former Ambrx CEO) to the Board .

What Went Well and What Went Wrong

What Went Well

• DSMB safety review concluded ReMEDy2 should continue “without modification,” with no significant safety concerns identified in the first 20 participants .
• Preeclampsia Part 1A: multiple dose cohorts completed; DM199 appeared well tolerated with no serious adverse events or pathological hypotension, with Q2 2025 preliminary read expected .
• Liquidity: CFO reaffirmed runway into Q3 2026 and detailed drivers of cash usage (R&D expansion and manufacturing), positioning the company to reach key clinical milestones .

What Went Wrong

• Interim analysis timing for ReMEDy2 moved to 1H 2026 as site activation/enrollment took longer than anticipated post-COVID staffing shortages, requiring higher-touch engagement; management underestimated startup time .
• R&D expenses rose to $19.1M in FY 2024 (from $13.1M), reflecting continuation/expansion of ReMEDy2 and manufacturing, increasing operating cash burn .
• Guidance cadence changed: prior Q4 2025 interim analysis expectation (and earlier Q1 2025 interim enrollment for 144 patients) was updated to later timing and a larger interim sample (200) to improve precision, delaying the inflection but intended to reduce total trial size/time .

Financial Results

Note: DMAC did not provide standalone Q4 2024 quarterly P&L; FY 2024 financial statements and prior-quarter disclosures are shown for context .

KPIs (operational)

Estimates vs. Actuals (Q4 2024)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We are pleased to report that multiple dosing cohorts in Part 1A have been completed with DM199 appearing to be well tolerated and no serious adverse events or signs of pathological hypotension being reported.” — Lorianne Masuoka, CMO .
• “Most notably, DM199 is a protein of a sufficiently large molecular size that it is not expected to cross the placental barrier, offering a key safety advantage for the developing fetus.” — Lorianne Masuoka, CMO .
• “We anticipate that our current cash and investments provide us a runway into Q3 of 2026.” — Scott Kellen, CFO .
• “We made significant progress in 2024, advancing our AIS program and expanding into preeclampsia.” — Rick Pauls, CEO .
• “The DSMB concluded that the ReMEDy2 trial should continue without modification…no significant safety concerns were identified.” — Company release .

Q&A Highlights

• Site activation/enrollment: ~13 of top 15 U.S. priority sites activated; targeting doubling the number of sites and 1–2 patients/site/month; ~6–12 months to ramp a site .
• DSMB review depth: DSMB reviewed the entire database up to a cutoff date, not just acute-phase safety .
• Interim analysis rationale: Increasing interim sample from 144 to 200 improves Bayesian precision and could reduce total sample size and overall cost/time .
• Protocol impact: Inclusion of thrombolytic nonresponders expected to improve enrollment and treatment effect; recent MeVO thrombectomy trial failures may expand eligible pool and site bandwidth .
• Regulatory: Amended statistical plan finalized with FDA .

Estimates Context

• Wall Street consensus estimates (S&P Global) for Q4 2024 EPS and revenue were unavailable at the time of this report due to data access limitations. As the company did not disclose standalone quarterly Q4 results in its 8-K/press release, comparisons to consensus for Q4 cannot be made at this time .

Key Takeaways for Investors

• Safety/operational de-risking: DSMB “continue without modification” reduces near-term safety risk and supports sustained enrollment momentum .
• Timeline recalibration: Interim analysis moved to 1H 2026 and interim N raised to 200—short-term timeline negative but designed to reduce total sample size and cost, potentially accelerating final completion thereafter .
• Enrollment catalysts: Inclusion of thrombolytic nonresponders and refrigerated storage logistics should expand the eligible population and improve weekend/after-hours enrollment; early-2025 uptick cited by management .
• Preeclampsia readout in sight: Q2 2025 preliminary topline (safety/BP/uterine artery perfusion) offers a nearer-term catalyst independent of AIS recruitment, with favorable early tolerability statements and placental barrier safety rationale .
• Liquidity runway: $44.1M cash/investments (12/31/24) and runway into Q3 2026 supports trial execution across AIS and preeclampsia milestones without immediate financing risk .
• Narrative drivers: Publication in Stroke and Board addition (O’Connor) bolster external validation and strategic execution credibility—potential positives for partner interest .
• Trading lens: Near-term stock moves likely keyed to enrollment updates (site count, geography expansion), DSMB/safety/regulatory clarity, and preeclampsia Part 1A signals; delays to interim timing are an overhang but may be mitigated if enrollment accelerates as protocol v5.0 scales .