DiaMedica Therapeutics Inc. (DMAC) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call reveals a mixed sentiment. While there is progress in clinical trials and a strong cash position due to private placement, increased expenses and net losses are concerning. The Q&A section highlights positive drug safety feedback and trial progression but lacks specifics on enrollment rates, indicating potential uncertainties. The absence of new partnerships or shareholder return plans further tempers enthusiasm. Given these factors, the stock price is likely to remain stable, suggesting a neutral sentiment.
Key Financial Performance
Cash, cash equivalents, and short-term investments $55.3 million as of September 30, 2025, compared to $30 million as of June 30, 2025, and $44.1 million as of the prior year-end. The increase is attributed to net proceeds from the July private placement.
Net cash used in operating activities $21.3 million for the 9 months ended September 30, 2025, compared to $15.6 million for the same period in 2024. The increase is primarily due to a higher net loss in 2025, partially offset by changes in operating assets and liabilities.
R&D expenses $6.4 million for Q3 2025 and $17.9 million for the 9 months ended September 30, 2025, compared to $5 million and $12.6 million for the same periods in 2024. The increase is due to progress in the ReMEDy2 clinical trial, global expansion, and the Phase 2 preeclampsia trial, as well as team expansion. Partially offset by reduced manufacturing process development costs.
General and administrative expenses $2.6 million for Q3 2025 and $7.3 million for the 9 months ended September 30, 2025, compared to $1.9 million and $5.7 million for the same periods in 2024. The increase is due to higher noncash share-based compensation, personnel costs, and increased investor relations, patents, and professional fees.
Net losses $8.6 million for Q3 2025 and $24.0 million for the 9 months ended September 30, 2025, compared to $6.3 million and $16.5 million for the same periods in 2024. The increase is due to higher R&D and administrative expenses.
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Operating Highlights
DM199: Lead product candidate, a recombinant form of the human tissue KLK1 protein, showing potential as a first-in-class disease-modifying treatment for preeclampsia, fetal growth restriction, and acute ischemic stroke. Positive interim results from Phase 2 trial in South Africa validate its biological activity and safety, with no placental barrier crossing. Demonstrated dose-dependent reductions in blood pressure, improved placental perfusion, and endothelial function.
Global Expansion of ReMEDy2 Trial: Progress in the global expansion of the ReMEDy2 clinical trial for stroke treatment. However, enrollment rates are lower than expected due to changes in stroke referral patterns and increased use of tele neurology. Strategies are being developed to address these challenges.
Financial Position: Cash, cash equivalents, and short-term investments increased to $55.3 million as of September 30, 2025, from $30 million in June 2025. Current cash position expected to fund operations into the second half of 2027.
R&D Expenses: Increased to $6.4 million for Q3 2025, up from $5 million in Q3 2024, due to progress in clinical trials and team expansion.
General and Administrative Expenses: Increased to $2.6 million for Q3 2025, up from $1.9 million in Q3 2024, driven by higher personnel costs, share-based compensation, and professional fees.
U.S. Phase 2 Preeclampsia Trial: Preparation underway for a U.S. Phase 2 trial in early onset preeclampsia patients, following a productive pre-IND meeting with the FDA.
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Risk or Challenges
Enrollment Challenges in Stroke Trial: Enrollment rates for the ReMEDy2 stroke trial are lower than initially projected due to changes in stroke referral patterns, such as increased use of AI and tele-neurology, which reduce patient transfers to larger research centers. This could delay trial timelines and impact the development of DM199 for stroke treatment.
Financial Losses and Increased Expenses: The company reported higher net losses of $8.6 million for Q3 2025 and $24 million for the first nine months of 2025, compared to the same periods in 2024. Increased R&D and administrative expenses, including costs for clinical trials and team expansion, are contributing to these losses, which could strain financial resources.
Regulatory and Clinical Trial Risks: The company is preparing for a U.S. Phase 2 trial for preeclampsia and implementing protocol amendments for ongoing trials. Any delays or issues in regulatory approvals or trial execution could impact the development timeline and market entry of DM199.
Operational Risks in Global Expansion: The global expansion of the ReMEDy2 trial and other clinical programs increases operational complexity and costs, which could lead to inefficiencies or delays.
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Guidance & Outlook
Preeclampsia Program: The company plans to expand its clinical study into early onset preeclampsia and fetal growth restriction cohorts. Completion of the expansion cohort is anticipated in the first half of 2026. Parts 1b and 2 protocol amendments are being implemented to refine the treatment regimen. A U.S. Phase 2 trial for early onset preeclampsia patients is being prepared, with updates expected after receiving final meeting minutes from the FDA.
Stroke Program: Enrollment rates for the Phase 2b/3 ReMEDy2 stroke trial have been updated due to changes in stroke referral patterns. The interim analysis based on the first 200 patients is now expected in the second half of 2026. The independent Data Safety Monitoring Board has reported no safety concerns and recommended continued enrollment.
Financial Outlook: The company’s current cash position of $55.3 million is expected to fund planned clinical studies and corporate operations into the second half of 2027.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you talk about the work you are doing with the preeclampsia KOL community and clinical trialists to increase awareness of what you've seen so far with the DM199 proof of concept?
A:The company has been extensively reaching out to KOLs across the U.S. and globally. Feedback has been encouraging, particularly regarding the drug's safety profile, as it does not cross the placental barrier. Immediate drops in blood pressure and signals of dilation of intrauterine arteries have been observed, which could indicate disease-modifying potential.
Q:What are the key factors you are considering for U.S. clinical trial sites?
A:The company is focusing on protocol changes, including IV-only administration into delivery with adjustable dosing to manage blood pressure. For Part 2, adjustments are being made based on data from Cohort 10 of Part 1a, which showed consistent and clear drops in blood pressure.
Q:What is the purpose of the 12-patient expansion cohort in Part 1a?
A:The 12-patient expansion cohort at Cohort 10 was intended to replace the previously planned dose expansion cohort for Part 1b. This cohort represents the highest dose tested and provides additional data for the IV-only approach in Part 1b.
Q:What data are you waiting for before initiating the Phase 2 study in the U.S.?
A:The company has analyzed efficacy, safety, and PK data and feels ready to proceed. Additional data, if available, could help refine the protocol. The Phase 2 study is planned for approximately 30 participants.
Q:What specifics can you share about Cohort 10 that led to the additional 12 patients?
A:Cohort 10 showed very clear and immediate drops in blood pressure, even in patients with resistant hypertension who were unresponsive to other treatments. This consistent response encouraged the company to expand the cohort.
Q:What are your expectations for stroke enrollment rates and site activation?
A:Historical stroke enrollment rates were around 0.25, but current rates are slightly lower. Over 35 sites are activated, with more coming online, including in the U.K. and Europe. The company is now using specific rates from current sites for revised forecasts.
Q:What is the enrollment rate assumption to meet the second-half target?
A:The company did not provide specific enrollment rate assumptions at this time.
Q:What would reflect a meaningful change in the Modified Rankin Scale (MRS) score at the AIS interim analysis?
A:The study is powered based on a 15% absolute improvement in MRS score of 0 to 1, as observed in Phase 2. Excluding severe stroke patients, the improvement was 19%. The final sample size is estimated at 300 to 350 patients.
Q:Review of Unclear Management Responses
A:The company avoided providing specific enrollment rate assumptions to meet the second-half target.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AI use
Africa result
Cluver Cohort
KLK
Phase trial
Professor Cluver
ReMEDy trial
assessment
center
class disease
control
delivery
dysfunction
endothelium
expansion cohort
function
hospital
hour
increase period
loss month
meeting
microgram kg
month period
need
onset preeclampsia
perfusion
period increase
population
position
potential class
potential hypertension
preeclampsia restriction
preeclampsia trial
pregnancy
progress Phase
restriction cohort
therapy
treatment option
DMAC Transcript
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The earnings call lacked key financial metrics, strategic initiatives, and operational updates, leaving investors without guidance. The emphasis on regulatory risks and uncertainties without any positive counterbalancing information is concerning. The absence of revenue, margin, and cash flow data further contributes to a negative outlook. This lack of transparency and clarity is likely to lead to a strong negative market reaction.
DiaMedica Therapeutics Inc. (DMAC) Q3 2025 Earnings Call Transcript
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The earnings call reveals a mixed sentiment. While there is progress in clinical trials and a strong cash position due to private placement, increased expenses and net losses are concerning. The Q&A section highlights positive drug safety feedback and trial progression but lacks specifics on enrollment rates, indicating potential uncertainties. The absence of new partnerships or shareholder return plans further tempers enthusiasm. Given these factors, the stock price is likely to remain stable, suggesting a neutral sentiment.
DiaMedica Therapeutics Inc. (DMAC) Q2 2025 Earnings Call Transcript
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The earnings call reveals mixed elements: increased R&D and G&A expenses leading to higher net losses, but also a promising outlook on clinical trials and a strong cash position post-private placement. The Q&A highlights positive sentiment towards leadership and program potential, yet some concerns over enrollment and lack of specific guidance. These factors balance out to a neutral sentiment, with no strong catalysts for significant stock movement in either direction over the next two weeks.
DMAC Report
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