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MINNEAPOLIS - DiaMedica Therapeutics Inc. (NASDAQ: DMAC), a clinical-stage biopharmaceutical company, has announced the regulatory go-ahead from the South African Health Products Regulatory Authority (SAHPRA) to begin a Phase 2 clinical trial of DM199, its proprietary recombinant serine protease for preeclampsia treatment. The trial, which is an investigator-sponsored study, received prior approval from the Health Research Ethics Committee at Stellenbosch University on June 26, 2024.
The study will be carried out at Tygerberg Hospital in Cape Town, South Africa, with Prof. Catherine Cluver, MD, PhD, leading as the principal investigator. DiaMedica anticipates the commencement of dosing within the fourth quarter of 2024. The company expects to release top-line results for Part 1a of the study in the first half of 2025.
Preeclampsia is a serious pregnancy complication, affecting up to 8% of pregnancies globally, with symptoms such as high blood pressure and organ system damage, often affecting the kidneys and liver. Currently, there are no approved therapeutics for preeclampsia in the United States or Europe.
The upcoming Phase 2 trial aims to enroll up to 90 women with preeclampsia and potentially 30 subjects with fetal growth restriction. The study's primary objectives are to evaluate the safety of DM199, its ability to lower maternal blood pressure, and its effectiveness in dilating intrauterine arteries to enhance placental blood flow.
DM199, also known as rinvecalinase alfa, is a recombinant form of human tissue kallikrein-1 (rhKLK1) and is being developed not only for preeclampsia but also for acute ischemic stroke. The enzyme is believed to play a key role in regulating various physiological processes, including the production of nitric oxide and prostacyclin, which are crucial for vascular health.
DiaMedica Therapeutics is committed to addressing the unmet medical needs in serious ischemic diseases, including acute ischemic stroke and preeclampsia, with its lead candidate DM199. This announcement is based on a press release statement and reflects the company's expectations for the upcoming clinical trial.
In other recent news, DiaMedica Therapeutics has demonstrated significant progress in its ReMEDy2 trial, with full enrollment anticipated by the first quarter of 2025. The clinical-stage biopharmaceutical company's lead candidate, DM199, is currently under investigation for its potential in treating acute ischemic stroke and preeclampsia. The company also plans to explore DM199 as a potential treatment for preeclampsia, with patient enrollment beginning in the fourth quarter of this year.
H.C. Wainwright initiated coverage of DiaMedica Therapeutics with a Buy rating, setting a price target at $7. The rating is based on the potential of DM199 to meet the substantial unmet need for stroke treatments.
Financially, DiaMedica is in a robust state with $54.1 million in cash and investments as of June 30, 2024. Despite a projected moderate increase in research and development expenses, general and administrative expenses have decreased compared to the previous year. Other income has seen a rise due to higher interest from marketable securities. These recent developments underscore DiaMedica Therapeutics' commitment to advancing in clinical trials and maintaining a solid financial standing.
InvestingPro Insights
DiaMedica Therapeutics Inc. (NASDAQ: DMAC) is making significant strides in its clinical development program, as evidenced by the recent regulatory approval for its Phase 2 trial in South Africa. This progress is reflected in the company's market performance, with InvestingPro data showing a remarkable 107.59% price total return over the past year.
The company's focus on addressing unmet medical needs in serious ischemic diseases aligns with its current financial position. According to InvestingPro Tips, DiaMedica holds more cash than debt on its balance sheet, which could provide the necessary financial flexibility to support its ongoing clinical trials and research efforts.
Despite the positive momentum in its stock price, with DMAC trading near its 52-week high, it's important to note that the company is not yet profitable. An InvestingPro Tip indicates that analysts do not anticipate the company will be profitable this year. This is not uncommon for clinical-stage biopharmaceutical companies, which often prioritize research and development over short-term profitability.
The market seems to be pricing in potential future success, as reflected in the company's Price to Book ratio of 3.72. Investors should be aware that while DiaMedica's stock has shown strong returns, the company's operating income stands at -$22.38 million for the last twelve months as of Q2 2024, underscoring the ongoing investment in its pipeline.
For those interested in a deeper analysis, InvestingPro offers 11 additional tips for DMAC, providing a more comprehensive view of the company's financial health and market position.
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