DiaMedica Therapeutics Updates on Business and Q2 2024 Financials

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, reported key business updates and financial results for the quarter ending June 30, 2024. The company continues to focus on developing innovative treatments for severe ischemic diseases.

Clinical Developments - Acute Ischemic Stroke (AIS)

The ReMEDy2 Phase 2/3 clinical trial for AIS is progressing well, with an increase in site activation activities. DiaMedica has prioritized fifteen research centers in the United States, anticipating these locations will recruit a large portion of study participants. Nine of these centers are expected to be activated in the current quarter. The company remains confident that the enrollment of 144 patients for the interim analysis will be completed by the first quarter of 2025.

Chief Medical Officer Dr. Lorianne Masuoka expressed enthusiasm over the progress, emphasizing that there have been no cases of hypotension among newly enrolled participants.

Preeclampsia Program

In June 2024, DiaMedica announced the expansion of its DM199 clinical development program to include preeclampsia (PE). PE is a serious pregnancy complication characterized by high blood pressure and damage to organ systems like the kidneys and liver, affecting about 8% of pregnancies globally. The condition poses significant risks, including stroke, placental abruption, and even death.

DM199 has shown potential to lower blood pressure, enhance endothelial health, and improve blood flow to maternal organs and the placenta. Preclinical studies in animal models have supported the safety of DM199 for use in pregnant humans. A placental transfer study revealed that DM199 did not cross the placental barrier, further supporting its safety.

A Phase 2 trial for PE is set to begin in the fourth quarter of 2024 at Tygerberg Hospital in Cape Town, South Africa. This trial will evaluate up to 90 women with PE and potentially an additional 30 subjects with fetal growth restriction. Initial results are expected in the first half of 2025.

Financial Performance and Funding

On June 25, 2024, DiaMedica announced a private placement of 4,720,000 common shares at $2.50 per share, raising $11.8 million in gross proceeds. The net proceeds of approximately $11.7 million will be used to support the ReMEDy2 trial and the expansion into the preeclampsia program, along with other corporate purposes. This financing is expected to extend the company's cash runway into the third quarter of 2026.

As of June 30, 2024, DiaMedica reported cash, cash equivalents, and investments totaling $54.1 million, an increase from $52.9 million as of December 31, 2023. The increase is attributed to the net proceeds from the private placement. The company used $11.2 million in operating activities in the first half of 2024, compared to $10.1 million during the same period in 2023.

Research and development (R&D) expenses rose to $3.9 million for the quarter ending June 30, 2024, compared to $2.5 million for the same period in 2023. This increase is primarily due to the continuation of the ReMEDy2 trial and staffing costs. General and administrative (G&A) expenses decreased to $1.7 million, down from $2.2 million for the same quarter in 2023, due to lower insurance premiums and legal fees.

Clinical Trials and Future Directions

The ReMEDy2 trial is a double-blind, placebo-controlled study designed to evaluate DM199 in treating AIS patients. The trial plans to enroll approximately 350 patients across up to 100 sites in the United States, with global expansion anticipated. The patients will be treated with either DM199 or placebo within 24 hours of AIS symptom onset, with follow-up at 90 days. The trial aims to serve as a pivotal registration study for DM199.

The Phase 2 trial for preeclampsia will also be a significant milestone, aiming to demonstrate the safety and efficacy of DM199 in lowering blood pressure and improving placental blood flow in affected women.

Conclusion

DiaMedica Therapeutics Inc. continues to make significant strides in its clinical programs for acute ischemic stroke and preeclampsia. With substantial financial backing and promising clinical data, the company is well-positioned to advance its innovative therapies and improve patient outcomes in these areas.

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