DiaMedica Therapeutics Updates Business and Reports Q1 2024 Financials

DiaMedica Therapeutics, Inc., a biopharmaceutical firm listed on Nasdaq under the ticker DMAC, recently shared a business overview and financial summary for the quarter ending March 31, 2024. The company, which is focused on developing innovative treatments for neurological disorders and cardio-renal diseases, will discuss these updates further in a conference call on May 9, 2024.

The firm has made significant progress in its ReMEDy2 trial, aimed at treating acute ischemic stroke (AIS) with its product candidate DM199 (rinvecalinase alfa). The trial restarted patient enrollment recently and has opened eight clinical sites since December 2023, with expectations to activate most U.S. sites by the third quarter of 2024. Internationally, the company is also advancing, receiving support from the Canadian Stroke Consortium and identifying six top sites for the trial in Canada. Regulatory filings to Health Canada are anticipated this month, with site activations expected in the fourth quarter of 2024. The Australian Stroke Trials Network has also endorsed DiaMedica’s protocol, and site selections are underway, with activations set to begin before the end of 2024. The company anticipates completing enrollment for the 144-patient interim analysis by the first quarter of 2025.

Dr. Lorianne Masuoka, DiaMedica’s Chief Medical Officer, emphasized the company's efforts to engage leading stroke centers to ensure robust patient participation. She highlighted the enthusiasm from premier research sites and the company's commitment to developing DM199 for stroke patients.

Financially, DiaMedica reported $46.5 million in cash, cash equivalents, and investments as of March 31, 2024. This is a decrease from $52.9 million at the end of 2023, attributed to operational funding and deposits for the ReMEDy2 trial. The net cash used in operating activities for the first quarter of 2024 was $6.7 million, up from $5.1 million in the same period in 2023, mainly due to trial-related expenses.

Research and development expenses increased slightly to $3.7 million for the first quarter of 2024, from $3.6 million in the previous year. This rise was related to the ReMEDy2 trial but was partly offset by cost reductions from completed phases of other trials. Looking ahead, DiaMedica expects R&D expenses to grow moderately as the ReMEDy2 trial expands globally and more sites and participants are involved. General and administrative expenses rose to $2.1 million from $1.9 million, driven by increased personnel costs, although partially offset by lower insurance premiums. These expenses are expected to remain stable in the near term.

Other income for the first quarter of 2024 was $597,000, up from $256,000 in the same period in 2023, influenced by higher interest income from increased marketable securities.

The ReMEDy2 trial is designed as an adaptive, randomized, double-blind, placebo-controlled study to evaluate DM199 in approximately 350 AIS patients across up to 100 global sites. Patients will receive either DM199 or a placebo within 24 hours of AIS symptoms and will be monitored for 90 days. The trial aims to exclude those treated with other standard AIS treatments like tissue plasminogen activator (tPA) or mechanical thrombectomy. If successful, the trial could serve as a pivotal study for DM199 in AIS treatment.

DM199 is a synthetic form of human tissue kallikrein-1 (rKLK1), a serine protease that regulates various physiological processes by enhancing blood flow and neuronal survival. It aims to improve blood flow and promote neuronal survival in stroke patients. DiaMedica is the first to clinically study this recombinant protein, which has been used in non-recombinant forms in Asia for ischemic conditions.

In summary, DiaMedica Therapeutics is making notable progress in its clinical efforts to develop DM199 for AIS, supported by ongoing international expansions and robust financial management. The upcoming months and years will be crucial as they advance through regulatory processes and complete essential trial phases.