DiaMedica Therapeutics(DMAC) - 2025 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of June 30, 2025, the company's cash, cash equivalents, and short-term investments were $30 million, down from $44.1 million as of December 31, 2024. However, including net proceeds from a July private placement, the pro forma cash position is approximately $60 million, which is expected to fund planned clinical studies and operations into 2027 [14][15][17] - The net loss for the three and six months ending June 30, 2025, was $7.7 million and $15.4 million, respectively, compared to $5.1 million and $10.3 million for the same periods in 2024, indicating an increase in net loss year-over-year [17] Business Line Data and Key Metrics Changes - Research and Development (R&D) expenses increased to $5.8 million and $11.5 million for the three and six months ended June 30, 2025, compared to $3.9 million and $7.6 million for the same periods in 2024, primarily due to costs associated with the REMEDY two clinical trial and expansion of the clinical team [15] - General and administrative expenses also rose to $2.2 million and $4.7 million for the three and six months ended June 30, 2025, compared to $1.7 million and $3.8 million in the prior year, driven by increased personnel costs and non-cash share-based compensation [16] Market Data and Key Metrics Changes - DiaMedica was added to the US small cap Russell 2000 and Russell 3000 indexes, enhancing visibility among institutional investors and the broader investment community [12] Company Strategy and Development Direction - The company is advancing its DM199 program for preeclampsia, with plans to conduct a Phase 2B trial in the US and other countries, and is preparing an FDA IND application [8][9] - The company aims to finalize a dosing regimen for the ongoing clinical trials and expand its indications to include fetal growth restriction [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the current cash position and its ability to fund clinical studies into 2027, despite an increase in net losses [14][17] - The interim results from the preeclampsia program were described as highly promising, with DM199 showing significant efficacy in managing maternal hypertension [6][9] Other Important Information - The company completed a $30 million private placement of common shares, which extends its cash runway into 2027 [9] - The new Chief Medical Officer, Dr. Julie Krop, brings extensive experience in the biopharma industry, particularly in women's health and preeclampsia [12][13] Q&A Session Summary Question: Why did Dr. Krop join the company, and what are her thoughts on the stroke program? - Dr. Krop expressed a strong commitment to women's health and excitement about the company's programs, highlighting the unmet needs in preeclampsia and ischemic stroke [20][21] Question: Can the company provide a timeline for the upcoming cohorts in the preeclampsia study? - Management indicated that Cohort 10 of Part 1B would start soon, with plans to push dosing higher and move into Part 2 and the fetal growth restriction cohort concurrently [25][27] Question: What is the current status of enrollment in the stroke study? - The company is currently at approximately 40 sites and is seeing an encouraging uptick in enrollment, with expectations for interim analysis to be completed in Q2 2026 [33][34] Question: Will the Phase 2B study have a primary endpoint that reflects pivotal regulatory endpoints for Phase 3? - Management stated that they are finalizing the protocol and are confident about the primary endpoint based on recent FDA feedback, but details will be shared once finalized [40]