STOCK TITAN

DiaMedica Q3 2026 net loss widens to $11.3M

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Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
8-K

Rhea-AI Filing Summary

DiaMedica Therapeutics Inc. (DMAC) reported a third-quarter 2026 net loss of $11.310 million, compared with $8.620 million a year earlier; diluted net loss per share was $0.21 versus $0.17. Research and development expense was $9.243 million versus $6.437 million, and operating loss was $11.621 million versus $9.033 million. For the nine months ended September 30, 2026, net cash used in operating activities was $26.028 million, compared with $21.297 million. At September 30, 2026, cash and cash equivalents were $6.800 million and marketable securities were $28.105 million.

DiaMedica completed enrollment of the first two cohorts in its Phase 2 early-onset fetal growth restriction trial, with 12 participants in total; preliminary results are scheduled for a November 24, 2026 key opinion leader event. Its ReMEDy2 Phase 2/3 acute ischemic stroke trial surpassed the 200-participant enrollment threshold. A prespecified interim analysis is expected in the first quarter of 2027, after the 200th participant completes 90-day follow-up. Initial enrollment in the Phase 2 late-onset and early-onset preeclampsia studies is expected by the end of 2026.

0 points · 0 major

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 2 points

How the balance works

Positive

  • None.

Negative

  • Moderate pointQ3 net loss reached $11.310 million, versus $8.620 million a year earlier.
  • Moderate pointNine-month net cash used in operating activities was $26.028 million, versus $21.297 million.

Filing Explained

The filing says the pending ReMEDy2 interim review may recommend stopping the trial for futility or increasing its sample size; increasing it could add costs and delay completion.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Net loss $11.310 million Three months ended September 30, 2026; $8.620 million in 2025.
Diluted net loss per share $0.21 Three months ended September 30, 2026; $0.17 in 2025.
Operating loss $11.621 million Three months ended September 30, 2026; $9.033 million in 2025.
Net cash used in operating activities $26.028 million Nine months ended September 30, 2026; $21.297 million in 2025.
Cash and cash equivalents $6.800 million As of September 30, 2026.
Marketable securities $28.105 million As of September 30, 2026.
FGR first two cohorts 12 participants Enrolled in the Phase 2 early-onset fetal growth restriction trial.
ReMEDy2 enrollment threshold 200 participants The Phase 2/3 acute ischemic stroke trial surpassed this threshold.
pharmacodynamic medical
"safety and pharmacodynamic, proof-of-concept"
Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.
proof-of-concept medical
"safety and pharmacodynamic, proof-of-concept trial"
A proof-of-concept is a demonstration that shows a new idea or method can work as intended, serving as a small-scale test before full development. For investors, it signals that a concept has been successfully tested in principle, reducing uncertainty about whether it can be practically implemented. This helps determine if further investment or effort is justified to develop the idea further.
dose-escalation medical
"Part 1a late-onset PE: dose-escalation study"
Dose-escalation is the part of an early-stage clinical trial where researchers gradually increase a drug’s dose in small groups of participants to find the safest and most effective amount. Think of it like turning up the volume slowly to find the sweet spot: investors watch these results closely because they reveal safety risks, potential effectiveness, and how quickly a drug can move to later trials or approval, all of which affect the development timeline and commercial prospects.
dose-expansion medical
"Part 1b late-onset PE: dose-expansion study"
A dose-expansion stage is a part of an early clinical trial that follows initial dose-escalation: once one or more doses have been identified as tolerable, the trial enrolls larger groups (expansion cohorts) at those dose levels to gather more data on safety, side effects, and preliminary effectiveness. It is used to characterize how patients respond at the chosen dose(s) and to help select a recommended dose for later trials; dose-expansion cohorts are typically non-randomized and not intended to provide definitive proof of benefit.
expectant management medical
"until delivery (expectant management)"
ischemic penumbra medical
"surrounding area (the “ischemic penumbra”)"
A region of brain tissue surrounding the core area damaged by an acute ischemic stroke that is still alive but at risk of dying without timely restoration of blood flow. Like a neighborhood that has lost power but whose houses and wiring are intact enough to be repaired, the ischemic penumbra can potentially be saved by treatments; its size and recoverability are key clinical endpoints and affect the commercial and regulatory value of therapies and devices aimed at reducing permanent disability.
Net loss $11.310 million Compared with $8.620 million in the third quarter of 2025.
Diluted net loss per share $0.21 Compared with $0.17 in the third quarter of 2025.
Research and development expense $9.243 million Compared with $6.437 million in the third quarter of 2025.
Operating loss $11.621 million Compared with $9.033 million in the third quarter of 2025.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What was DMAC's net loss in the third quarter of 2026?

DMAC's third-quarter net loss was $11.310 million for the quarter ended September 30, 2026, compared with $8.620 million a year earlier; diluted net loss per share was $0.21, versus $0.17.

What is the status of DMAC's ReMEDy2 interim analysis?

ReMEDy2 surpassed the 200-participant enrollment threshold. The prespecified interim analysis is expected in the first quarter of 2027, after the 200th participant completes 90-day follow-up.

How many participants enrolled in the first two DMAC FGR cohorts?

The first two cohorts of DiaMedica's Phase 2 early-onset fetal growth restriction trial enrolled 12 participants in total. Preliminary results are scheduled for a key opinion leader event on November 24, 2026.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001401040 0001401040 2026-11-12 2026-11-12


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 

 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
 

Date of Report (Date of earliest event reported): November 12, 2026
 

DIAMEDICA THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)
 
British Columbia, Canada
001-36291
Not Applicable
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
 
301 Carlson Parkway, Suite 210
Minneapolis, Minnesota
55305
(Address of principal executive offices)
(Zip Code)
(763) 496-5454
(Registrant’s telephone number, including area code)
 
Not Applicable
(Former name or former address, if changed since last report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Voting common shares, no par value per share
DMAC
The Nasdaq Stock Market LLC
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐                               
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 



 
Item 2.02.         Results of Operations and Financial Condition.
 
On November 12, 2026, DiaMedica Therapeutics Inc. (the “Company”) announced its condensed consolidated financial results for the quarter ended September 30, 2026. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and the information set forth therein is incorporated herein by reference and constitutes a part of Item 2.02 of this report.
 
The information contained in Item 2.02 of this report and Exhibit 99.1 to this report shall not be deemed to be “filed” with the United States Securities and Exchange Commission for purposes of Section 18 of the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be incorporated by reference into any filings made by the Company under the United States Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in such filing.
 
Item 9.01.         Financial Statements and Exhibits.
 
(d)  Exhibits.
 
Exhibit No.
 
Description
99.1
 
Press Release dated November 12, 2026 providing a business update and announcing third quarter 2026 financial results (furnished herewith)
104
 
The cover page from this Current Report on Form 8-K, formatted in Inline XBRL
 

 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
DIAMEDICA THERAPEUTICS INC.
 
 
 
 
 
 
 
 
 
 
 
 
By:
/s/ Scott Kellen
 
 
 
Scott Kellen
 
 
 
Chief Financial Officer and Secretary
 
 
Dated: November 12, 2026
 

Exhibit 99.1

 

dia.jpg

 

DiaMedica Therapeutics Reports Third Quarter 2026

Financial Results and Provides Business Highlights

 

 

●

Enrollment Complete in First Two Cohorts of Phase 2 Early-Onset Fetal Growth Restriction Trial; KOL Event Featuring Preliminary Results Scheduled for November 24

 

●

ReMEDy2 Phase 2/3 Acute Ischemic Stroke Trial Surpasses 200-Participant Enrollment Threshold; Interim Analysis Expected Q1 2027

 

●

Conference Call and Webcast November 13 at 8:00 AM Eastern Time / 7:00 AM Central Time

 

Minneapolis, Minnesota – November 12, 2026 (Business Wire) – DiaMedica Therapeutics Inc. (“DiaMedica” or the “Company”) (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS), today provided a business update and reported financial results for the third quarter ended September 30, 2026. Management will host a conference call Friday, November 13, 2026, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and third quarter 2026 financial results.

 

"During the third quarter and recent weeks, we continued to advance DM199 across each of our clinical programs, including completing enrollment in the first two cohorts of our Phase 2 early-onset fetal growth restriction study and reaching the 200-participant enrollment threshold for the planned interim analysis of ReMEDy2," said Rick Pauls, President and Chief Executive Officer of DiaMedica Therapeutics. "We believe these programs address serious diseases in which impaired blood flow and vascular dysfunction play a meaningful role and where new treatment options are needed. We look forward to presenting preliminary results from the first two FGR cohorts at our November 24 key opinion leader (KOL) event and to the ReMEDy2 interim analysis expected in the first quarter of 2027."

 

"Our clinical programs are providing important opportunities to evaluate the pharmacologic effects of DM199 across pregnancy-related vascular disorders and acute ischemic stroke," said Julie Krop, MD, Chief Medical Officer of DiaMedica Therapeutics. "In preeclampsia, the Part 1a results demonstrated rapid and sustained reductions in maternal blood pressure and supported advancement into studies of early-onset disease. In FGR, enrollment of the first two dose cohorts has now been completed, and we look forward to reviewing the preliminary safety and clinical findings with leading maternal-fetal medicine experts later this month. In ReMEDy2, reaching the 200-participant threshold enables the prespecified interim analysis in AIS once the 200th participant completes their 90-day follow-up."

 

Recent Corporate Highlights

 

 

●

Fetal Growth Restriction Phase 2 Update: Enrollment has been completed in the first two of three planned cohorts of the investigator-sponsored Phase 2 early-onset FGR trial, consisting of 12 participants treated at the 5 µg/kg and 10 µg/kg dose levels. This is the first clinical study of DM199 in patients with early-onset FGR. DiaMedica will host a virtual KOL event on November 24, 2026, featuring leading maternal-fetal medicine experts Professor Catherine Cluver, MD, PhD; Professor Stephen Tong, MBBS, PhD; Professor Susan Walker, AO, MBBS, MD; and Professor Andrew Shennan, OBE, MBBS, MD. The event will include preliminary, interim topline results from the first two FGR cohorts and a discussion of FGR, the current treatment landscape and the clinical rationale for evaluating DM199 as a potential treatment in the management of FGR.

 


 

 

●

Health Canada Authorizes Global Phase 2 Early-Onset Preeclampsia Study: Following the September 2026 authorization from Health Canada, DiaMedica is preparing to initiate its open-label, Phase 2 dose-finding study in early-onset preeclampsia. The study is designed to enroll approximately 30 participants across three dose levels informed by results from both the initial dose-escalation cohort (Part 1a) and preliminary FGR results from the investigator sponsored trial. DiaMedica is working with clinical sites in Canada and is also preparing to expand this PE study to the United Kingdom, subject to regulatory authorization.

 

 

●

European Authorization for Early-Onset Preeclampsia Phase 2 Trial: In October 2026, DiaMedica received conditional authorization from the European Medicines Agency (EMA) for its open-label, Phase 2 dose-finding study in early-onset preeclampsia with consideration for full approval after submission of country-specific ethical and site requirements. This creates the opportunity for future global expansion.

 

 

●

U.S. Regulatory Update for Preeclampsia: DiaMedica continues its work to address U.S. Food and Drug Administration (FDA) feedback regarding the nonclinical reproductive toxicity information needed to support a U.S. Investigational New Drug (IND) application for DM199 in preeclampsia. In June 2026, DiaMedica received written feedback from FDA on this topic. Based on this feedback, the Company believes that the previously completed rat reproductive toxicity study may be adequate to support IND clearance, provided DiaMedica can demonstrate adequate DM199 exposure, enzymatic activity, and pharmacologic effect in rats. The in-life portion of this study has been completed and pharmacokinetic and pharmacologic results are due in the coming weeks. Once these results are completed, DiaMedica plans to submit the data package to FDA for review.

 

 

●

Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2/3 Clinical Developments: Enrollment in the pivotal Phase 2/3 ReMEDy2 trial (NCT05065216) has reached the prespecified threshold of 200 participants for the trial's planned interim analysis. The independent Data Safety Monitoring Board (DSMB) will conduct the interim analysis after the 200th participant completes their 90-day follow-up. The DSMB will assess the need for a sample-size re-estimation or stopping for futility based upon a primary efficacy endpoint analysis of the proportion of participants with a modified Rankin Scale (mRS) score of 0 or 1, indicating an excellent outcome. If the trial continues, the final sample size will range between 300 and 728 participants according to a predetermined statistical plan. DiaMedica will remain blinded to the data at the interim analysis. Patient recruitment will continue at clinical sites while the 200th participant completes 90-day follow-up and the interim analysis is conducted. The Company expects the interim analysis to be completed in the first quarter of 2027.

 

Financial Results Highlights for the Quarter Ended September 30, 2026

 

 

●

Cash Position and Runway – Cash, cash equivalents and short-term investments were $34.9 million as of September 30, 2026, compared to $59.9 million as of December 31, 2025. Current liabilities were $7.5 million as of September 30, 2026, resulting in working capital of $28.0 million, compared to current liabilities of $5.1 million and working capital of $55.5 million as of December 31, 2025. Based on its current plans, the Company anticipates its current cash, cash equivalents and short-term investments will enable the Company to fund its planned clinical studies and support corporate operations into Q4, 2027.

 


 

 

●

Cash Flows – Net cash used in operating activities for the nine months ended September 30, 2026 was $26.0 million compared to $21.3 million for the same period in 2025. The increase resulted primarily from the increased net loss, partially offset by changes in operating assets and liabilities during the current year period.

 

 

●

Research and Development (R&D) – R&D expenses were $9.2 million and $25.4 million for the three and nine months ended September 30, 2026, respectively, up from $6.4 million and $17.9 million for the three and nine months ended September 30, 2025, respectively. The increases are primarily due to cost increases driven by the expansion of the Company’s clinical team; the ongoing ReMEDy2 clinical trial, including its global expansion; the start-up of the Phase 2 PE trial in Canada and the UK; additional reproductive toxicity testing being performed in support of the PE program in the United States; increased manufacturing development activity and increased non-cash share-based compensation. The Company expects that R&D expenses will moderately increase in future periods relative to recent prior periods as enrollment continues in the ReMEDy2 trial and start-up progresses in the Phase 2 PE trial.

 

 

●

General and Administrative (G&A) – G&A expenses were $2.4 million and $7.2 million for the three and nine months ended September 30, 2026, respectively, down slightly from $2.6 million and $7.3 million for the three and nine months ended September 30, 2025, respectively. The decrease for the three-month period was driven primarily by decreased professional fees, partially offset by increased non-cash share-based compensation expense. The decrease for the nine-month period resulted primarily from a reduction in current-year legal and other professional fees, partially offset by increased personnel costs incurred in conjunction with staff expansion. The Company expects G&A expenses to remain steady in future periods as compared to recent prior periods.

 

 

●

Net Loss – Net losses were $11.3 million and $31.5 million for the three and nine months ended September 30, 2026, respectively, up from $8.6 million and $24.0 million for the three and nine months ended September 30, 2025, respectively.

 

Conference Call and Webcast Information

 

DiaMedica management will host a conference call and webcast to discuss its business update and third quarter 2026 financial results on Friday, November 13, 2026, at 8:00 AM Eastern Time / 7:00 AM Central Time:

 

Date:

Friday, November 13, 2026

Time:

8:00 AM EST / 7:00 AM CST

Web access:

https://app.webinar.net/E7o3nqXDVeq

Dial In:

+1 (646) 357-8766

Conference ID:

7582187

 

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on the Company’s website, under investor relations - events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until November 19, 2026, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 7582187#.

 


 

About the Phase 2 Investigator-Sponsored Trial of DM199 in Preeclampsia and Fetal Growth Restriction

 

The Phase 2 study is an open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept, investigator-sponsored trial of DM199 for the treatment of PE and FGR that is currently being conducted at Tygerberg Hospital in Cape Town, South Africa. This Phase 2 study consists of three studies (Part 1a, Part 1b and Part 2) in PE and a single study in FGR (Part 3). Part 1a has been completed; the FGR study has initiated enrollment, and its first two cohorts of 12 participants in total have been enrolled; and Parts 1b and 2 are expected to initiate in by the end of 2026, as follows:"

 

Preeclampsia (PE)

 

 

●

Part 1a late-onset PE: dose-escalation study evaluating single intravenous (IV) / single subcutaneous (SC) DM199 doses in late-onset PE subjects enrolled within 72 hours of delivery , including a confirmatory extension cohort of up to 12 participants at the cohort 10 dose level, which was completed in June 2026.

 

●

Part 1b late-onset PE: dose-expansion study evaluating continuous IV infusion in up to 30 late-onset PE subjects enrolled within 72 hours of delivery, using a dosing level identified in Part 1a; initial enrollment expected by the end of 2026.

 

●

Part 2 early-onset PE: evaluation of repeated SC dosing of DM199 in up to 30 early-onset PE subjects until delivery (expectant management), using three dose levels at 5, 10 and up to 15 µg/kg. The dose for the third cohort will be between 1 and 15 µg/kg based on results from the first two cohorts; initial enrollment expected by the end of 2026.

 

Fetal Growth Restriction (FGR)

 

 

●

Part 3 early-onset FGR: evaluating repeated SC dosing in up to 30 early-onset FGR subjects until delivery, using up to three dose levels initially based on Part 1a data; enrollment commenced in June 2026 and the first two cohorts of 5 and 10 µg/kg have completed enrollment of six subjects per cohort. The dose for the third cohort will be between 1 and 15 µg/kg based on results from the first two cohorts.

 

About Fetal Growth Restriction

 

Fetal growth restriction (FGR) occurs when a fetus fails to reach its genetically determined growth potential in the womb, most commonly due to placental insufficiency. FGR affects an estimated 10% of pregnancies worldwide and is associated with significantly increased risks of stillbirth, preterm birth, and neonatal morbidity, as well as long-term neurodevelopmental, cardiovascular, and metabolic complications. In severe, early-onset cases, FGR often necessitates delivery before 32 weeks of gestation, when the risks of prematurity must be weighed against the dangers of continued growth restriction in utero. See the recently released white paper, “Preeclampsia & Fetal Growth Restriction : DiaMedica Therapeutics, Inc. (DMAC.)”

 

About Preeclampsia

 

Preeclampsia is a serious pregnancy disorder that typically develops after the 20th week of gestation, characterized by high blood pressure and damage to organ systems, often the kidneys and liver. Affecting up to 8% of pregnancies worldwide, preeclampsia can pose significant risks to both the mother and baby, including risk of stroke, placental abruption, progression to eclampsia, premature delivery, and death. Preeclampsia occurs in two stages. First, in early pregnancy, the placenta fails to embed properly in the wall of the uterus, and the spiral arteries in the uterine wall that are supposed to dilate to promote healthy blood flow to the placenta do not widen. Stage 2 then occurs after 20 weeks of pregnancy as the placenta, which has been chronically starved of oxygen from the blood, begins to release noxious factors into the mother’s circulation, inflicting widespread damage to her blood vessels and causing systemic endothelial dysfunction. Symptoms may include severe headaches, vision changes, upper abdominal pain and swelling in the hands and face. Delivery of the baby, often very prematurely, is the only available option for stopping the progression of preeclampsia. Women who have had preeclampsia have three to four times the risk of high blood pressure and double the risk for heart disease and stroke.

 


 

About Acute Ischemic Stroke

 

Acute ischemic stroke (AIS) occurs when a blood clot blocks a vessel supplying blood to the brain, leading to a sudden loss of oxygen and nutrients and, if not corrected, ultimately neuronal cell death. According to the U.S. Centers for Disease Control and Prevention, stroke causes approximately one out of every 20 deaths in the U.S. each year, and nearly nine out of 10 strokes are ischemic. No new therapeutics have been approved for acute ischemic stroke in over 25 years. When a blood vessel in the brain becomes blocked during a stroke, a core area of the affected brain tissue will typically suffer a nearly complete loss of blood flow, while the surrounding area (the “ischemic penumbra”) receives only about 20-40% of normal blood flow. Cells in the core area are rapidly depleted of their oxygen and glucose stores, leading, often within minutes, to cell death. The cells in the penumbral area may remain viable for several hours but are eventually at risk of damage.

 

About DiaMedica Therapeutics Inc.

 

DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information visit the Company’s website at www.diamedica.com.

 


 

Cautionary Note Regarding Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management’s current expectations. When used in this press release, the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” or “would,” the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this press release include statements regarding the timing, nature and requirements for regulatory applications and approvals, including the application for an IND for the study of DM199 as a treatment for preeclampsia, the submission of data to FDA and the potential expansion of the Phase 2 early-onset preeclampsia study to new jurisdictions; the timing and scope of enrollment in clinical trials; the content of the planned KOL event and preliminary results from the Phase 2 early-onset fetal growth restriction trial; ReMEDy2 trial enrollment, the timing and potential outcomes of the interim analysis and the final sample size of the trial; anticipated clinical benefits and success of DM199 for the treatment of preeclampsia, fetal growth restriction and acute ischemic stroke; future R&D and G&A expenses and the Company’s projected cash runway. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, risks and uncertainties relating to the timing and outcomes of nonclinical studies, including whether FDA will determine that the completed rat reproductive toxicity study is adequate to support IND clearance; risks and uncertainties relating to the timing of studies and trials; risks and uncertainties relating to the clinical expansion into preeclampsia and associated trials; the risk that preliminary, interim or topline data, including the preliminary results from the first two fetal growth restriction cohorts, may change as more data become available and are subject to audit and verification procedures; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the risk that the ReMEDy2 interim analysis may result in a recommendation to stop the trial for futility or to increase the sample size, which could increase costs and delay completion; risks relating to the conditional nature of regulatory authorizations and the ability to obtain additional authorizations in other jurisdictions; DiaMedica’s plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of preeclampsia, fetal growth restriction and acute ischemic stroke and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199 and within its anticipated parameters, site activations, enrollment numbers, costs and timeframes; the perceived benefits of DM199 over existing treatment options; the potential direct or indirect impact of hospital and medical facility staffing shortages, increased tariffs and worldwide global supply chain shortages on DiaMedica’s business and clinical trials, including its ability to meet its site activation and enrollment goals; DiaMedica’s reliance on collaboration with third parties, including investigators conducting investigator-sponsored trials, to conduct clinical trials; DiaMedica’s ability to continue to obtain funding for its operations, including funding necessary to complete current and planned clinical trials and obtain regulatory approvals for DM199 for preeclampsia, fetal growth restriction and acute ischemic stroke; and the risks identified under the heading “Risk Factors” in DiaMedica’s annual report on Form 10-K for the fiscal year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (SEC) and subsequent SEC reports, including our most recent quarterly report on Form 10-Q. The forward-looking information contained in this press release represents the expectations of DiaMedica as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While DiaMedica may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws.

 

Contact:

Scott Kellen

Chief Financial Officer

Phone: (763) 496-5118
skellen@diamedica.com

 

For Investor Inquiries:
Mike Moyer
Managing Director, LifeSci Advisors, LLC

Phone: (617) 308-4306
mmoyer@lifesciadvisors.com

 

Media Contact:
Madelin Hawtin
LifeSci Communications
mhawtin@lifescicomms.com

 


 

DiaMedica Therapeutics Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

 

​

​

Three Months Ended

September 30,

​

​

Nine Months Ended

September 30,

​

​

​

2026

​

​

2025

​

​

2026

​

​

2025

​

Operating expenses:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Research and development

​

$

9,243

​

​

$

6,437

​

​

$

25,383

​

​

$

17,915

​

General and administrative

​

​

2,378

​

​

​

2,596

​

​

​

7,218

​

​

​

7,269

​

Operating loss

​

​

(11, 621

)

​

​

(9,033

)

​

​

(32,601

)

​

​

(25,184

)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Other income, net

​

​

319

​

​

​

419

​

​

​

1,132

​

​

​

1,176

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Loss before income tax expense

​

​

(11,302

)

​

​

(8,614

)

​

​

(31,469

)

​

​

(24,008

)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Income tax expense

​

​

(8

)

​

​

(6

)

​

​

(22

)

​

​

(18

)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Net loss

​

​

(11,310

)

​

​

(8,620

)

​

​

(31,491

)

​

​

(24,026

)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Other comprehensive loss

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Unrealized gain (loss) on marketable securities

​

​

(18

)

​

​

64

​

​

​

(105

)

​

​

27

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Net loss and comprehensive loss

​

$

(11,328

)

​

$

(8,556

)

​

$

(31,596

)

​

$

(23,999

)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Basic and diluted net loss per share

​

$

(0.21

)

​

$

(0.17

)

​

$

(0.58

)

​

$

(0.53

)

Weighted average shares outstanding – basic and diluted

​

​

53,943,455

​

​

​

49,630,119

​

​

​

53,877,630

​

​

​

45,168,749

​

 


 

DiaMedica Therapeutics Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share amounts)

 

​

​

September 30, 2026

​

​

December 31, 

2025

​

​

​

(unaudited)

​

​

​

​

​

ASSETS

​

​

​

​

​

​

​

​

Current assets:

​

​

​

​

​

​

​

​

Cash and cash equivalents

​

$

6,800

​

​

$

15,647

​

Marketable securities

​

​

28,105

​

​

​

44,243

​

Prepaid expenses and other assets

​

​

411

​

​

​

481

​

Amounts receivable

​

​

176

​

​

​

258

​

Total current assets

​

​

35,492

​

​

​

60,629

​

​

​

​

​

​

​

​

​

​

Non-current assets:

​

​

​

​

​

​

​

​

Deferred offering costs

​

​

400

​

​

​

400

​

Property and equipment, net

​

​

131

​

​

​

145

​

Operating lease right-of-use asset, net

​

​

130

​

​

​

197

​

Total non-current assets

​

​

661

​

​

​

742

​

​

​

​

​

​

​

​

​

​

Total assets

​

$

36,153

​

​

$

61,371

​

​

​

​

​

​

​

​

​

​

LIABILITIES AND EQUITY

​

​

​

​

​

​

​

​

Current liabilities:

​

​

​

​

​

​

​

​

Accounts payable

​

$

2,646

​

​

$

1,475

​

Accrued liabilities

​

​

4,691

​

​

​

3,545

​

Operating lease obligation

​

​

110

​

​

​

101

​

Finance lease obligation

​

​

7

​

​

​

11

​

Total current liabilities

​

​

7,454

​

​

​

5,132

​

​

​

​

​

​

​

​

​

​

Non-current liabilities:

​

​

​

​

​

​

​

​

Operating lease obligation

​

​

40

​

​

​

124

​

Finance lease obligation

​

​

—

​

​

​

4

​

Total non-current liabilities

​

​

40

​

​

​

128

​

​

​

​

​

​

​

​

​

​

Shareholders’ equity:

​

​

​

​

​

​

​

​

Common shares, no par value; unlimited authorized; 53,957,474 and 53,742,370 shares issued and outstanding, as of September 30, 2026 and December 31, 2025, respectively

​

​

—

​

​

​

—

​

Paid-in capital

​

​

232,973

​

​

​

228,829

​

Accumulated other comprehensive income (loss)

​

​

(55

)

​

​

50

​

Accumulated deficit

​

​

(204,259

)

​

​

(172,768

)

Total shareholders’ equity

​

​

28,659

​

​

​

56,111

​

Total liabilities and shareholders’ equity

​

$

36,153

​

​

$

61,371

​

 


 

DiaMedica Therapeutics Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

​

​

Nine Months Ended September 30,

​

​

​

2026

​

​

2025

​

Cash flows from operating activities:

​

​

​

​

​

​

​

​

Net loss

​

$

(31,491

)

​

$

(24,026

)

Adjustments to reconcile net loss to net cash used in operating activities:

​

​

​

​

​

​

​

​

Share-based compensation

​

​

3,473

​

​

​

2,654

​

Amortization of discounts on marketable securities

​

​

(506

)

​

​

(690

)

Non-cash lease expense

​

​

67

​

​

​

61

​

Depreciation

​

​

35

​

​

​

32

​

Changes in operating assets and liabilities:

​

​

​

​

​

​

​

​

Amounts receivable

​

​

82

​

​

​

(24

)

Prepaid expenses and other assets

​

​

70

​

​

​

(218

)

Deposits

​

​

—

​

​

​

1,108

​

Accounts payable

​

​

1,171

​

​

​

980

​

Accrued liabilities and operating lease liabilities

​

​

1,071

​

​

​

(1,174

)

Net cash used in operating activities

​

​

(26,028

)

​

​

(21,297

)

​

​

​

​

​

​

​

​

​

Cash flows from investing activities:

​

​

​

​

​

​

​

​

Purchase of marketable securities

​

​

(29,566

)

​

​

(51,224

)

Maturities and sales of marketable securities

​

​

46,105

​

​

​

41,071

​

Purchases of property and equipment

​

​

(21

)

​

​

(34

)

Net cash provided by (used in) investing activities

​

​

16,518

​

​

​

(10,187

)

​

​

​

​

​

​

​

​

​

Cash flows from financing activities:

​

​

​

​

​

​

​

​

Proceeds from the sale of common shares, net of offering costs

​

​

—

​

​

​

31,527

​

Proceeds from the exercise of common stock options

​

​

671

​

​

​

722

​

Deferred offering costs

​

​

—

​

​

​

(456

)

Principal payments on finance lease obligation

​

​

(8

)

​

​

(8

)

Net cash provided by financing activities

​

​

663

​

​

​

31,785

​

​

​

​

​

​

​

​

​

​

Net increase (decrease) in cash and cash equivalents

​

​

(8,847

)

​

​

301

​

Cash and cash equivalents at beginning of period

​

​

15,647

​

​

​

3,025

​

Cash and cash equivalents at end of period

​

$

6,800

​

​

$

3,326

​

​

​

​

​

​

​

​

​

​

Supplemental disclosure of cash flow information:

​

​

​

​

​

​

​

​

Cash paid for income taxes

​

$

20

​

​

$

18

​

 

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