DiaMedica Therapeutics(US:DMAC)2025-05-14 13:02Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported total combined cash and investments of $37.3 million, down from $44.1 million as of December 31, 2024, indicating a decrease due to net cash used to fund operations [11] - Current liabilities were reported at $4.7 million, compared to $5.4 million in the previous quarter, while working capital decreased to $32.8 million from $39.2 million [11] - Net cash used in operating activities for Q1 2025 was $7.1 million, an increase from $6.7 million in Q1 2024, primarily due to an increased net loss [12] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5.7 million for Q1 2025, up from $3.7 million in Q1 2024, driven by costs associated with the REMEDY two clinical trial and global expansion [12][13] - General and administrative expenses rose to $2.5 million from $2.1 million, mainly due to additional non-cash share-based compensation [13] Market Data and Key Metrics Changes - The company is currently engaged in two clinical development programs: preeclampsia and stroke, with significant progress reported in both areas [4][8] - Enrollment for the stroke program is progressing steadily, with participant enrollment now between the 20th and 25th percentile mark for the interim analysis [9] Company Strategy and Development Direction - The company aims to advance its clinical development programs, particularly focusing on the preeclampsia program, which is currently the only novel agent being studied in pregnant women with this condition [8] - The management is also working on expanding the stroke program's enrollment and maintaining momentum through site engagement [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in both clinical programs and highlighted the importance of upcoming milestones, including preliminary results from the preeclampsia trial and interim analysis from the stroke program [43] - The company anticipates that its current cash and investments will provide a runway into Q3 2026, indicating a focus on sustaining operations while advancing clinical trials [12] Other Important Information - A key opinion leader call regarding preeclampsia is scheduled for May 28, 2025, to educate stakeholders about the disease and the company's clinical trial design [6][8] - The company is actively engaging with high-volume sites to drive enrollment in the stroke program, with a focus on maintaining relationships and expanding geographic reach [33] Q&A Session Summary Question: Clarification on laboratory test results for DM199 - Management confirmed that the main variable affecting the timeline for results is the placental transfer assay, which is being finalized [17] Question: Triggers for Parts 2 and 3 of the preeclampsia study - Management indicated that dilation of intrauterine arteries would trigger the fetal growth restriction cohort, with more details to be shared after upcoming results [19][20] Question: Anticipated read-through from preeclampsia data to AIS development - Management noted that while the indications are unique, positive results in preeclampsia would confirm the activity of the protein being studied [25] Question: Update on stroke program enrollment - Management reported that high-enrolling sites are seeing one to two patients per month, and overall enrollment is above plan, with encouraging momentum [31][32] Question: Expansion of the preeclampsia study to the U.S. - Management confirmed plans to expand the study to the U.S. in the future, but the current focus remains on completing Part 1a and moving into Part 1b [39]