Image Source: DiaMedica Therapeutics
 

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company developing treatments for preeclampsia and acute ischemic stroke, recently completed a $12.2 million financing through its at-the-market (ATM) offering program, providing additional capital to advance its clinical programs.
 

Strategic Capital Raise Bolsters Financial Position

On January 5, 2026, DiaMedica disclosed the sale of 1.5 million common shares to a healthcare institution fund at $8.10 per share through a block trade executed on December 19, 2025. The transaction generated $12.2 million in gross proceeds before fees and expenses.

This financing comes at a time when the company is making notable progress across its development programs, particularly in preeclampsia—a serious pregnancy complication affecting maternal and fetal health with no FDA-approved treatments currently available.
 

Solid Cash Position to Support Clinical Advancement

As of September 30, 2025, DiaMedica reported combined cash, cash equivalents, and marketable securities of $55.3 million. With the recent capital raise, the company's pro forma cash position is estimated at approximately $66-67 million (adding net proceeds and accounting for typical quarterly operating expenses). This positions DiaMedica to continue advancing both its preeclampsia and acute ischemic stroke programs through key clinical milestones.

The company previously stated that its existing cash resources would be sufficient to fund operations for at least 12 months from the Q3 2025 filing date, and this additional capital further extends that runway.
 

Meaningful Progress on Preeclampsia Program Following FDA Meeting

On December 18, 2025, DiaMedica announced completion of a productive in-person pre-IND meeting with the FDA regarding its DM199 program for preeclampsia. The meeting provided important regulatory clarity on the non-clinical requirements needed before submitting an Investigational New Drug (IND) application.

"We believe the meeting minutes provide important regulatory clarity on our non-clinical package as we prepare to submit an IND for the study of DM199 in patients with early-onset preeclampsia," said Rick Pauls, President and CEO of DiaMedica.

Key highlights from the FDA meeting and program update include:

Regulatory Path Forward: The FDA has requested one additional non-clinical study—a 10-day modified embryo-fetal development (EFD) and pre- and postnatal development (PPND) study in a rabbit model. Preparations for this study have already commenced, with results expected by the second quarter of 2026.

Encouraging Clinical Data from Leading Preeclampsia Experts: The ongoing Phase 2 investigator-sponsored trial continues to show promise. The study is being conducted at Tygerberg Hospital in Cape Town, South Africa, under the leadership of Professor Catherine Cluver, MD, Ph.D., Professor of Maternal-Fetal Medicine at Stellenbosch University, in collaboration with DiaMedica. This team is uniquely distinguished as the only group worldwide to have successfully conducted successive clinical trials evaluating novel therapeutics for the treatment of preeclampsia, positioning them as recognized leaders in the field.

The trial has now dosed over 30 women with late-stage preeclampsia, and interim data demonstrates:

•  Encouraging safety and efficacy signals

•  Statistically significant reductions in blood pressure

•  Dilation of intrauterine arteries

•  Importantly, no placental transfer of DM199, minimizing potential fetal exposure
 

Clinical Investigator Enthusiasm

During a Cantor Global Healthcare Conference Fireside Chat, Dr. Cluver expressed notable enthusiasm about her experience treating patients with DM199. She described witnessing blood pressure reduction within 5-10 minutes in patients with severe, refractory hypertension—calling the experience "it feels a bit like magic!"

Dr. Cluver also observed resolution of edema in patients, a hallmark feature of severe pre-eclampsia. Perhaps most significantly, she noted that patients treated with DM199 did not become as severely ill as she had anticipated, suggesting meaningful therapeutic benefit.

While the initial regulatory focus for DM199 is early-onset pre-eclampsia, Dr. Cluver believes the therapy may also prove beneficial for fetal growth restriction and potentially as a preventative treatment for women at high risk of developing pre-eclampsia—expanding the potential addressable patient population considerably.
 

Addressing a Critical Unmet Medical Need

Preeclampsia represents a significant market opportunity with substantial unmet medical need. The condition is one of the leading causes of maternal and neonatal morbidity and mortality worldwide, yet there are currently no FDA-approved therapeutics specifically for this indication.

Dr. Julie Krop, Chief Medical Officer of DiaMedica, noted: "The ongoing Phase 2 investigator-sponsored trial of DM199 in South Africa has now dosed over 30 women with late-stage PE. Interim data show encouraging safety and efficacy signals, including statistically significant reductions in blood pressure and dilation of intrauterine arteries, and importantly, with no placental transfer of DM199, thereby minimizing unforeseen fetal exposure."

The lack of placental transfer is particularly significant, as many traditional blood pressure medications can cross the placental barrier and potentially harm the developing fetus—a major limitation that has prevented their use in pregnancy.
 

Dual Program Strategy Creates Multiple Value Drivers

While the preeclampsia program is generating excitement, DiaMedica continues to advance its Phase 2/3 ReMEDy2 clinical trial for acute ischemic stroke (AIS). The company is expanding this trial globally, with regulatory approval recently obtained in the United Kingdom and preparations underway in additional European countries.

The dual program approach provides investors with multiple potential catalysts:

•  Preeclampsia program: IND submission expected after completion of the rabbit study (Q2 2026 results)

•  Acute ischemic stroke: Interim analysis of ReMEDy2 trial expected in second half of 2026
 

Looking Ahead

DiaMedica's recent capital raise, combined with its strengthened cash position and meaningful clinical and regulatory progress, positions the company to execute on key milestones over the coming quarters. The preeclampsia opportunity represents a potentially significant market with clear unmet need, while the acute ischemic stroke program continues to advance toward pivotal data readouts.

With an estimated cash position of approximately $66-67 million and a clear regulatory path forward following the FDA pre-IND meeting, DiaMedica appears well-positioned to advance its novel therapeutic candidate DM199 through important clinical and regulatory milestones in 2026.
 

About DiaMedica Therapeutics

DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel treatments for preeclampsia, fetal growth restriction, and acute ischemic stroke. The company's lead product candidate, DM199 (rinvecalinase alfa), is a recombinant form of human tissue kallikrein-1 protein with a novel mechanism of action.

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