DiaMedica Therapeutics Inc. (DMAC)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 delivered continued clinical progress in preeclampsia and fetal growth restriction while acute ischemic stroke (AIS) timelines were pushed out; net loss widened to $8.6M and diluted EPS was ($0.17), modestly missing consensus by $0.01. The company ended Q3 with $55.3M in cash and investments and reiterated runway into 2H 2027 .
• Preeclampsia: Part 1a Cohort 10 completed; expansion cohort (up to 12 patients) initiated; in-person pre-IND meeting with FDA held; U.S. Phase 2 expected to focus on early-onset patients under expectant management .
• AIS ReMEDy2: Enrollment nearing 50% of the interim target (200 patients), but management updated interim analysis timing to 2H 2026 due to lower-than-expected enrollment rates stemming from changes in stroke referral patterns (Viz.ai, teleneurology) — a key narrative risk for timelines .
• Capital: July private placement ($30.1M gross) strengthened balance sheet; cash and short-term investments rose from $30.0M at Q2 to $55.3M at Q3, supporting clinical execution into 2H 2027 .
• Near-term stock reaction catalyst: Additional details from FDA pre-IND minutes and pace of AIS site activation/enrollment; medium-term catalysts include U.S. Phase 2 PE trial initiation and progressing the South Africa IST expansion cohort .

What Went Well and What Went Wrong

What Went Well

• Cohort 10 completion and initiation of a 12-patient expansion at the expected therapeutic dose level in PE IST; management emphasized consistent, immediate BP reductions and mechanistic signals (uterine artery PI) supportive of disease modification .
• U.S. pre-IND meeting held; management characterized it as productive and expects to update after minutes; U.S. Phase 2 to target early-onset PE under expectant management, the highest unmet-need segment .
• Strengthened liquidity: Q3 cash and short-term investments reached $55.3M, up from $30.0M in Q2, aided by July financing; runway guided into second half of 2027 .

Management quote: “We believe that these interim results demonstrate that DM199 has the potential to be a first in class disease modifying treatment option for preeclampsia,” with confirmation DM199 did not cross the placental barrier .

What Went Wrong

• AIS ReMEDy2 interim analysis timing revised to 2H 2026 from Q2 2026 guidance due to slower enrollment tied to referral pattern changes (Viz.ai, teleneurology), reducing eligible patients at comprehensive centers .
• Operating loss widened to $9.0M and net loss to $8.6M; R&D and G&A increased on clinical progress, global expansion and team build, partially offset by prior-year manufacturing development completion .
• Modest EPS miss vs consensus by $0.01 highlights continuing opex intensity without revenue contribution; increases in non-cash share-based comp and professional fees contributed to G&A growth .

Financial Results

Quarterly P&L and Balance Metrics

Notes:

• Cash & ST investments increased sequentially on July financing; management reiterates runway into 2H 2027 .

Results vs Wall Street Consensus

Values with asterisk retrieved from S&P Global. The company does not report product revenue at this stage; statements of operations present operating expenses without revenue line items .

Year-over-Year Highlights (Q3)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We believe that these interim results demonstrate that DM199 has the potential to be a first in class disease modifying treatment option for preeclampsia,” emphasizing confirmed lack of placental transfer .
• “During the third quarter, [we] completed Cohort 10… and initiated dosing in expansion cohorts of up to 12 additional patients at the expected therapeutic dose level” .
• “We completed an in person pre-IND meeting with the FDA… we anticipate the upcoming U.S. phase II trial will be conducted in early onset preeclampsia patients” .
• AIS: “Current enrollment rates are lower than what we initially projected… primarily due to changes in stroke referral patterns driven by Viz.ai and teleneurology… we now expect the interim analysis… to be completed in the second half of 2026” .
• CFO: “Cash, cash equivalents, and short-term investments were $55.3 million… we feel confident [it] will fund… into the second half of 2027” .

Q&A Highlights

• PE KOL engagement and protocol design: Broad KOL outreach; safety profile underscored by no placental transfer; Part 1B moving to IV-only dosing until delivery to “dial in” BP control; Part 2 likely to leverage Cohort 10 dose level .
• Purpose of 12-patient expansion: Supplements prior plan for Part 1B; highest dose cohort (10) showing consistent BP reductions; expansion substitutes for prior dose-expansion concept .
• U.S. Phase 2 trigger: Company believes it has sufficient safety/efficacy and PK to proceed with ~30 participants, refining if additional data suggest adjustments .
• AIS site activation/enrollment: >35 sites; UK clearance; Europe expected; using actual site enrollment rates vs historical in updated forecast; not disclosing specific per-site assumptions .
• AIS powering: A 15% absolute improvement in mRS 0–1 (non-MT subgroup in prior Phase 2) would imply final sample size of ~300–350 patients; protocol excludes severe strokes to align with prior signal .

Estimates Context

• EPS modestly missed consensus by $0.01 (actual $(0.17) vs $(0.16) consensus); revenue consensus was $0.0 with no reported product revenues at this stage .
• Three covering estimates for EPS and revenue suggest a thinly covered name; near-term estimate revisions likely stable given opex-driven P&L and clinical timelines. Values with asterisk retrieved from S&P Global.

Key Takeaways for Investors

• The core bull narrative in PE remains intact and strengthening: immediate BP reductions and improved uterine artery PI, plus no placental transfer, support disease-modifying potential and de-risk fetal safety - .
• A U.S. Phase 2 in early-onset PE (expectant management) is a meaningful catalyst; formal alignment post pre-IND minutes could lift confidence and expand the addressable market signals .
• AIS program remains a strategic call option; the revised interim timeline to 2H 2026 is a watch item — monitor site activation pace, Europe onboarding, and enrollment mix to gauge schedule risk .
• Liquidity strengthened by July raise; $55.3M at Q3 and runway into 2H 2027 provide operational resilience through key PE and AIS milestones .
• Near-term expectations: More detail on FDA minutes and U.S. PE Phase 2 protocol; South Africa IST expansion progress; potential incremental updates on AIS sites and enrollment cadence .
• EPS and net loss will remain opex-driven; any estimate changes should key off R&D and G&A trajectories tied to trial execution, rather than revenue onset .
• Risk monitor: AIS referral dynamics (Viz.ai, teleneurology) impacting enrollment; regulatory feedback shaping PE trial endpoints and inclusion criteria .

KPIs

Additional Q3-Relevant Press Releases

• Positive PE Part 1a interim results: statistically significant BP and PI reductions; no placental transfer -.
• $30.1M private placement closed (net proceeds ~$29.9M), strengthening liquidity .
• Appointment of Dr. Julie Krop as CMO, bringing relevant PE development experience .

Values with asterisk retrieved from S&P Global.