DiaMedica Therapeutics Inc. reported a net loss of $24.4 million for the fiscal year ending December 31, 2024, compared to a net loss of $19.4 million in the previous year. The company's total operating expenses increased to $26.7 million from $21.3 million, primarily driven by a rise in research and development (R&D) expenses, which reached $19.1 million, up from $13.1 million in 2023. This increase is attributed to ongoing costs associated with the ReMEDy2 clinical trial for DM199, the company's lead product candidate aimed at treating acute ischemic stroke (AIS) and preeclampsia (PE).
In terms of financial position, DiaMedica had cash, cash equivalents, and marketable securities totaling $44.1 million as of December 31, 2024, a decrease from $52.9 million in the prior year. The company’s working capital also fell to $39.2 million from $50.9 million, reflecting the net cash used in operating activities, which amounted to $22.1 million for the year. The company anticipates that its current cash resources will be sufficient to fund operations for at least the next 12 months, although it may require additional funding to support ongoing clinical trials and other operational needs.
Strategically, DiaMedica is focused on advancing its clinical programs for DM199, which has received Fast Track designation from the FDA for AIS. The ReMEDy2 trial is a Phase 2/3 adaptive design study intended to enroll approximately 300 participants at up to 100 sites globally. However, the company has faced challenges with slower-than-expected site activations and patient enrollment, attributed to staffing shortages in hospitals and competition for research staff. To address these issues, DiaMedica has expanded its internal clinical team and is exploring global trial site options, including in Canada, Australia, and several European countries.
In addition to its AIS program, DiaMedica is also developing DM199 for the treatment of PE, with a Phase 2 investigator-sponsored trial currently underway in South Africa. The first subject was enrolled in late 2024, and topline results are expected in the second quarter of 2025. The company believes DM199 has the potential to address significant unmet medical needs in both AIS and PE, particularly as there are currently no approved treatments for PE in the U.S. or Europe.
Looking ahead, DiaMedica's management remains optimistic about the potential of DM199, but acknowledges the inherent risks and uncertainties associated with clinical development and regulatory approval processes. The company plans to continue its focus on executing its clinical trials and may seek additional partnerships to support the commercialization of DM199, should it receive regulatory approval.
About DiaMedica Therapeutics Inc.
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