DiaMedica Therapeutics (DMAC) Q2 2024 earnings summary

Executive summary

• Significant progress in the ReMEDy2 Phase 2/3 stroke trial, with global expansion and high site interest to address slow activation and enrollment.

• DM199 is being advanced as a potential first-in-class therapy for preeclampsia, with a Phase 2 trial in South Africa expected to start in Q4 2024 and a highly experienced global research team engaged.

• Interim analysis enrollment for ReMEDy2 (144 patients) is targeted by end of Q1 2025, with top 15 U.S. centers prioritized.

• No product revenue to date; all operating losses attributed to R&D and G&A activities supporting DM199 development.

• Net proceeds of $11.7–$12 million were raised in a June 2024 private placement, extending the cash runway into Q3 2026.

Financial highlights

• Cash, cash equivalents, and investments totaled $54.1 million as of June 30, 2024, up from $52.9 million at year-end 2023.

• Net loss for Q2 2024 was $5.1 million, and $10.3 million for the first half of 2024, compared to $4.5 million and $9.7 million in the prior year.

• R&D expenses rose to $3.9 million for Q2 2024 (from $2.5 million in Q2 2023) and $7.6 million for the first half (from $6.2 million year-over-year), driven by clinical trial expansion and staffing.

• G&A expenses decreased to $1.7 million for Q2 2024 (from $2.2 million in Q2 2023) and $3.8 million for the first half (from $4.1 million year-over-year), mainly due to lower insurance and legal costs.

• Other income, net, was $526,000 for Q2 2024, up from $271,000 in Q2 2023, reflecting higher interest income.

Outlook and guidance

• Full enrollment for ReMEDy2 interim analysis (144 patients) targeted by end of Q1 2025; preeclampsia study enrollment expected to begin in Q4 2024, with top-line results anticipated in H1 2025.

• Cash runway projected to extend into Q3 2026 following recent financing.

• R&D expenses expected to increase moderately as Remedy 2 expands globally; G&A expenses projected to remain steady.

• Current cash resources expected to fund clinical trials and operations for at least the next 12 months; additional capital likely needed for full development and commercialization.