DiaMedica第二季虧損擴大至1014萬美元 臨床階段研發持續推進

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

(Mark one)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2026

 

or

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934‐‐

For the transition period from ________________ to __________________

 

Commission File Number: 001-36291

 

 

DIAMEDICA THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

 

 
 
 British Columbia, Canada

 (State or other jurisdiction of incorporation or organization)

 
 
 Not Applicable

 (I.R.S. 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)

 

Securities registered pursuant to Section 12(b) of the Act:

 

 
 
 Title of each class

 
 
 Trading Symbol

 
 
 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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☒ NO ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

 
 
 Large accelerated filer ☐

 
 
 Accelerated filer ☐

 
 

 
 
 Non-accelerated filer ☒

 
 
 Smaller reporting company ☒

 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. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

As of August 3, 2026, there were 53,925,697 voting common shares of the registrant outstanding.

 

 

 

 

  

 

DiaMedica Therapeutics Inc.

FORM 10-Q

June 30, 2026

 

TABLE OF CONTENTS

 

 

 
 Description 
 Page
 

 
  
  
  
 

 
 
 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 
 
 1

 
 

 
  
  
  
 

 
 PART I.
 
 FINANCIAL INFORMATION

 
  
 

 
  
 
  

 
  
 

 
 Item 1. 
 
 Financial Statements

 
 
 3

 
 

 
 Item 2.
 
 Management’s Discussion and Analysis of Financial Condition and Results of Operations

 
 
 15

 
 

 
 Item 3.
 
 Quantitative and Qualitative Disclosures about Market Risk

 
 
 22

 
 

 
 Item 4.
 
 Controls and Procedures

 
 
 22

 
 

 
  
  
  
 

 
 PART II.
 
 OTHER INFORMATION

 
  
 

 
 Item 1.
 
 Legal Proceedings

 
 
 23

 
 

 
 Item 1A.
 
 Risk Factors

 
 
 23

 
 

 
 Item 2.
 
 Unregistered Sales of Equity Securities and Use of Proceeds

 
 
 23

 
 

 
 Item 3.
 
 Defaults Upon Senior Securities

 
 
 23

 
 

 
 Item 4.
 
 Mine Safety Disclosures

 
 
 23

 
 

 
 Item 5.
 
 Other Information

 
 
 23

 
 

 
 Item 6.
 
 Exhibits

 
 
 23

 
 

 
  
  
  
 

 
 
 SIGNATURE PAGE

 
 
 25

 
 

 

 

This quarterly report on Form 10-Q contains certain forward-looking statements that are within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created by those sections. For more information, see “Cautionary Note Regarding Forward-Looking Statements.”

 

As used in this report, references to “DiaMedica,” the “Company,” “we,” “our” or “us,” unless the context otherwise requires, refer to DiaMedica Therapeutics Inc. and its subsidiaries, all of which are consolidated in DiaMedica’s condensed consolidated financial statements. References in this report to “common shares” mean our voting common shares, no par value per share.

 

We own various unregistered trademarks and service marks, including our corporate logo. Solely for convenience, the trademarks and trade names in this report are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the owner of such trademarks and trade names will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

 

 

 

 

  

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

Statements in this report that are not descriptions of historical facts are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 that are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, prospects and share price. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” “will,” “would,” the negative of these terms or other comparable terminology and the use of future dates.

 

The forward-looking statements in this report are subject to risks and uncertainties and include, among other things:

 

 
  
 
 ●

 
 our plans to obtain U.S. Food and Drug Administration approval for the clinical study of DM199 for preeclampsia (PE) and fetal growth restriction (FGR) and ultimately to obtain regulatory approval for and commercialize our DM199 product candidate for the treatment of PE, FGR and acute ischemic stroke (AIS);
 

 

 
  
 
 ●

 
 
 our ability to conduct successful clinical testing of our DM199 product candidate for PE, FGR and AIS and meet certain anticipated or target milestones and dates thereof with respect to our clinical studies;

 
 

 

 
  
 
 ●

 
 
 the ability of our physician collaborators to successfully complete the current Phase 2, proof-of-concept investigator-sponsored clinical trial of DM199 for the treatment of PE and FGR, our reliance on these physician collaborators to conduct the study, and our expectations related to the timing of Part 1b and Parts 2 and 3 of this study;

 
 

 

 
  
 
 ●

 
 
 our ability to meet anticipated site activations, enrollment and interim analysis timing with respect to our Phase 2/3 ReMEDy2 clinical trial of DM199 for the treatment of AIS, especially in the light of slower than expected site activations and enrollment which we believe are due, in part, to hospital and medical facility staffing shortages; inclusion/exclusion criteria in the study protocol; concerns managing logistics and protocol compliance for participants discharged from the hospital to an intermediate care facility; concerns regarding the prior clinically significant hypotension events and circumstances surrounding the clinical hold which was lifted in June 2023; use of artificial intelligence and telemedicine which have enabled smaller hospitals to retain AIS patients not eligible for mechanical thrombectomy instead of sending these patients to the larger stroke centers which are more likely to be sites in our trial; and competition for research staff and trial subjects due to other pending stroke and neurological clinical trials;

 
 

 

 
  
 
 ●

 
 
 the success of the actions we are taking to mitigate the impact of the factors adversely affecting our ReMEDy2 trial site activations and enrollment rate, including significantly expanding our internal clinical team and bringing in-house certain trial activities, such as study site identification, qualification and activation, clinical site monitoring, supporting vendor management and overall program management; globally expanding the trial; and making certain changes to the study protocol; and risks associated with these mitigation actions;

 
 

 

 
  
 
 ●

 
 
 uncertainties relating to regulatory applications and related filing and approval timelines, especially in light of recent changes in funding and staffing levels for the U.S. Food and Drug Administration (FDA) and other government agencies;

 
 

 

 
  
 
 ●

 
 
 pending and future government agency requests for additional studies and uncertainty and potential delays in obtaining results from the same;

 
 

 

 
  
 
 ●

 
 the possible occurrence of future adverse events associated with or unfavorable results from current trials and their potential to adversely affect other current or future trials;
 

 

 
  
 
 ●

 
 
 the adaptive design of our ReMEDy2 trial, which is intended to enroll approximately 300 patients at up to 100 sites globally, and the possibility that the final sample size, which will be determined based upon the results of an interim analysis of 200 participants, may be up to 728 patients, according to a pre-determined statistical plan, other possible changes in the trial, including as a result of input from the FDA, and the results of the interim analysis as determined by our independent data safety monitoring board;

 
 

 

 
  
 
 ●

 
 
 our expectations regarding the perceived benefits of our DM199 product candidate over existing treatment options for PE, FGR and AIS;

 
 

 

 
  
 
 ●

 
 
 our ability to partner with and generate revenue from biopharmaceutical or pharmaceutical partners to develop, obtain regulatory approval for, and commercialize our DM199 product candidate for PE, FGR and AIS;

 
 

 

 
  
 
 ●

 
 
 the potential size of the markets for our DM199 product candidate for PE, FGR and AIS and our or any future partner’s ability to serve those markets, the rate and degree of market acceptance of and ability to obtain coverage and adequate reimbursement for, our DM199 product candidate for PE, FGR and AIS both in the United States and internationally;

 
 

 

1

 

 

 
  
 
 ●

 
 
 the success, cost and timing of our clinical trials, as well as our reliance on our key executives, clinical personnel, advisors and third parties in connection with our trials;

 
 

 

 
  
 
 ●

 
 
 our or any future partner’s ability to commercialize, market and manufacture DM199;

 
 

 

 
  
 
 ●

 
 
 expectations regarding U.S. federal, state and foreign regulatory requirements and developments affecting our pending and future clinical trials and regulatory approvals of our DM199 product candidate for PE, FGR and AIS and future commercialization and manufacturing of such products if required regulatory approvals are obtained;

 
 

 

 
  
 
 ●

 
 
 our expectations regarding our ability to obtain and maintain intellectual property protection for our DM199 product candidate;

 
 

 

 
  
 
 ●

 
 
 expectations regarding competition and our ability to obtain data exclusivity for our DM199 product candidate for PE, FGR and AIS; and

 
 

 

 
  
 
 ●

 
 
 our estimates regarding expenses, market opportunity for our product candidates, future revenue, and capital requirements; our anticipated use of the net proceeds from our prior private placements; how long our current cash resources will last; and our need for and ability to obtain additional financing to fund our operations, including funding necessary to complete our current clinical trials and obtain regulatory approvals for our DM199 product candidate for PE, FGR and/or AIS.

 
 

 

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under “Part I. Item 1A. Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2025 and those described above and that may appear elsewhere in this report, including under “Part II. Item 1A. Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Forward-looking statements should not be relied upon as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Except as required by law, including the securities laws of the United States, we do not intend to update any forward-looking statements to conform these statements to actual results or to changes in our expectations.

 

2

 

 

 

PART I - FINANCIAL INFORMATION

 

ITEM 1.       FINANCIAL STATEMENTS

 

DiaMedica Therapeutics Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share amounts)

 

 
  
  
 
 June 30, 2026

 
  
  
 
 December 31, 2025

 
  
 

 
  
  
 
 (unaudited)

 
  
  
  
  
  
 

 
 
 ASSETS

 
  
  
  
  
  
  
  
  
 

 
 
 Current assets:

 
  
  
  
  
  
  
  
  
 

 
 
 Cash and cash equivalents

 
  
 $
 5,129
  
  
 $
 15,647
  
 

 
 
 Marketable securities

 
  
  
 38,375
  
  
  
 44,243
  
 

 
 
 Prepaid expenses and other assets

 
  
  
 567
  
  
  
 481
  
 

 
 
 Amounts receivable

 
  
  
 244
  
  
  
 258
  
 

 
 
 Total current assets

 
  
  
 44,315
  
  
  
 60,629
  
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Non-current assets:

 
  
  
  
  
  
  
  
  
 

 
 
 Deferred offering costs

 
  
  
 400
  
  
  
 400
  
 

 
 
 Operating lease right-of-use asset, net

 
  
  
 153
  
  
  
 197
  
 

 
 
 Property and equipment, net

 
  
  
 133
  
  
  
 145
  
 

 
 
 Total non-current assets

 
  
  
 686
  
  
  
 742
  
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Total assets

 
  
 $
 45,001
  
  
 $
 61,371
  
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 LIABILITIES AND EQUITY

 
  
  
  
  
  
  
  
  
 

 
 
 Current liabilities:

 
  
  
  
  
  
  
  
  
 

 
 
 Accounts payable

 
  
 $
 2,812
  
  
 $
 1,475
  
 

 
 
 Accrued liabilities

 
  
  
 3,666
  
  
  
 3,545
  
 

 
 
 Operating lease obligation

 
  
  
 107
  
  
  
 101
  
 

 
 
 Finance lease obligation

 
  
  
 9
  
  
  
 11
  
 

 
 
 Total current liabilities

 
  
  
 6,594
  
  
  
 5,132
  
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Non-current liabilities:

 
  
  
  
  
  
  
  
  
 

 
 
 Operating lease obligation

 
  
  
 69
  
  
  
 124
  
 

 
 
 Finance lease obligation

 
  
  
 —
  
  
  
 4
  
 

 
 
 Total non-current liabilities

 
  
  
 69
  
  
  
 128
  
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Shareholders’ equity:

 
  
  
  
  
  
  
  
  
 

 
 
 Common shares, no par value; unlimited authorized; 53,925,697 and 53,742,370 shares issued and outstanding, as of June 30, 2026 and December 31, 2025, respectively

 
  
  
 —
  
  
  
 —
  
 

 
 
 Paid-in capital

 
  
  
 231,324
  
  
  
 228,829
  
 

 
 
 Accumulated other comprehensive income (loss)

 
  
  
 (37
 )
  
  
 50
  
 

 
 
 Accumulated deficit

 
  
  
 (192,949
 )
  
  
 (172,768
 )
 

 
 
 Total shareholders’ equity

 
  
  
 38,338
  
  
  
 56,111
  
 

 
 
 Total liabilities and shareholders’ equity

 
  
 $
 45,001
  
  
 $
 61,371
  
 

 

See accompanying notes to the condensed consolidated financial statements.

 

3

 

 

 

DiaMedica Therapeutics Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

 
  
  
 
 Three Months Ended June 30,

 
  
  
 
 Six Months Ended June 30,

 
  
 

 
  
  
 
 2026

 
  
  
 
 2025

 
  
  
 
 2026

 
  
  
 
 2025

 
  
 

 
 
 Operating expenses:

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Research and development

 
  
 $
 8,153
  
  
 $
 5,822
  
  
 $
 16,140
  
  
 $
 11,478
  
 

 
 
 General and administrative

 
  
  
 2,345
  
  
  
 2,185
  
  
  
 4,840
  
  
  
 4,673
  
 

 
 
 Operating loss

 
  
  
 (10,498
 )
  
  
 (8,007
 )
  
  
 (20,980
 )
  
  
 (16,151
 )
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Other income, net

 
  
  
 366
  
  
  
 314
  
  
  
 813
  
  
  
 757
  
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Loss before income tax expense

 
  
  
 (10,132
 )
  
  
 (7,693
 )
  
  
 (20,167
 )
  
  
 (15,394
 )
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Income tax expense

 
  
  
 (7
 )
  
  
 (6
 )
  
  
 (14
 )
  
  
 (12
 )
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Net loss

 
  
  
 (10,139
 )
  
  
 (7,699
 )
  
  
 (20,181
 )
  
  
 (15,406
 )
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Other comprehensive loss

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Unrealized loss on marketable securities

 
  
  
 (11
 )
  
  
 (19
 )
  
  
 (87
 )
  
  
 (37
 )
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Net loss and comprehensive loss

 
  
 $
 (10,150
 )
  
 $
 (7,718
 )
  
 $
 (20,268
 )
  
 $
 (15,443
 )
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Basic and diluted net loss per share

 
  
 $
 (0.19
 )
  
 $
 (0.18
 )
  
 $
 (0.38
 )
  
 $
 (0.36
 )
 

 
 
 Weighted average shares outstanding – basic and diluted

 
  
  
 53,894,295
  
  
  
 42,957,619
  
  
  
 53,844,171
  
  
  
 42,901,093
  
 

 

See accompanying notes to the condensed consolidated financial statements.

 

4

 

 

 

DiaMedica Therapeutics Inc.

Condensed Consolidated Statements of Shareholders’ Equity

For the Three and Six Months Ended June 30, 2026 and 2025

(In thousands, except share amounts)

(Unaudited)

 

 
  
  
 
 Common

 Shares

 
  
  
 
 Paid-In

 Capital

 
  
  
 
 Accumulated Other 

 Comprehensive 

 Income (Loss)

 
  
  
 
 Accumulated 

 Deficit

 
  
  
 
 Total 

 Shareholders’ 

 Equity

 
  
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Balances at December 31, 2025

 
  
  
 53,742,370
  
  
 $
 228,829
  
  
 $
 50
  
  
 $
 (172,768
 )
  
 $
 56,111
  
 

 
 
 Issuance of common shares upon the exercise of stock options

 
  
  
 140,136
  
  
  
 420
  
  
  
 —
  
  
  
 —
  
  
  
 420
  
 

 
 
 Issuance of common shares upon the vesting and settlement of restricted stock units

 
  
  
 839
  
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 —
  
 

 
 
 Share-based compensation expense

 
  
  
 —
  
  
  
 822
  
  
  
 —
  
  
  
 —
  
  
  
 822
  
 

 
 
 Unrealized loss on marketable securities

 
  
  
 —
  
  
  
 —
  
  
  
 (76
 )
  
  
 —
  
  
  
 (76
 )
 

 
 
 Net loss

 
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 (10,042
 )
  
  
 (10,042
 )
 

 
 
 Balances at March 31, 2026

 
  
  
 53,883,345
  
  
 $
 230,071
  
  
 $
 (26
 )
  
 $
 (182,810
 )
  
 $
 47,235
  
 

 
 
 Issuance of common shares upon the exercise of stock options

 
  
  
 41,513
  
  
  
 135
  
  
  
 —
  
  
  
 —
  
  
  
 135
  
 

 
 
 Issuance of common shares upon the vesting and settlement of restricted stock units

 
  
  
 839
  
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 —
  
 

 
 
 Share-based compensation expense

 
  
  
 —
  
  
  
 1,118
  
  
  
 —
  
  
  
 —
  
  
  
 1,118
  
 

 
 
 Unrealized loss on marketable securities

 
  
  
 —
  
  
  
 —
  
  
  
 (11
 )
  
  
 —
  
  
  
 (11
 )
 

 
 
 Net loss

 
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 (10,139
 )
  
  
 (10,139
 )
 

 
 
 Balances at June 30, 2026

 
  
  
 53,925,697
  
  
 $
 231,324
  
  
 $
 (37
 )
  
 $
 (192,949
 )
  
 $
 38,338
  
 

 

 

 
  
  
 
 Common

 Shares

 
  
  
 
 Paid-In 

 Capital

 
  
  
 
 Accumulated Other 

 Comprehensive

 Income (Loss)

 
  
  
 
 Accumulated

 Deficit

 
  
  
 
 Total 

 Shareholders’

 Equity

 
  
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Balances at December 31, 2024

 
  
  
 42,818,660
  
  
 $
 180,697
  
  
 $
 23
  
  
 $
 (140,002
 )
  
 $
 40,718
  
 

 
 
 Issuance of common shares upon the vesting and settlement of restricted stock units

 
  
  
 3,805
  
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 —
  
 

 
 
 Issuance of common shares upon the exercise of stock options

 
  
  
 37,000
  
  
  
 94
  
  
  
 —
  
  
  
 —
  
  
  
 94
  
 

 
 
 Share-based compensation expense

 
  
  
 —
  
  
  
 867
  
  
  
 —
  
  
  
 —
  
  
  
 867
  
 

 
 
 Unrealized loss on marketable securities

 
  
  
 —
  
  
  
 —
  
  
  
 (18
 )
  
  
 —
  
  
  
 (18
 )
 

 
 
 Net loss

 
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 (7,707
 )
  
  
 (7,707
 )
 

 
 
 Balances at March 31, 2025

 
  
  
 42,859,465
  
  
 $
 181,658
  
  
 $
 5
  
  
 $
 (147,709
 )
  
 $
 33,954
  
 

 
 
 Issuance of common shares in settlement of deferred stock units

 
  
  
 142,345
  
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 —
  
 

 
 
 Issuance of common shares upon the vesting and settlement of restricted stock units

 
  
  
 3,803
  
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 —
  
 

 
 
 Issuance of common shares upon the exercise of stock options

 
  
  
 66,875
  
  
  
 163
  
  
  
 —
  
  
  
 —
  
  
  
 163
  
 

 
 
 Share-based compensation expense

 
  
  
 —
  
  
  
 771
  
  
  
 —
  
  
  
 —
  
  
  
 771
  
 

 
 
 Unrealized loss on marketable securities

 
  
  
 —
  
  
  
 —
  
  
  
 (19
 )
  
  
 —
  
  
  
 (19
 )
 

 
 
 Net loss

 
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 (7,699
 )
  
  
 (7,699
 )
 

 
 
 Balances at June 30, 2025

 
  
  
 43,072,488
  
  
 $
 182,592
  
  
 $
 (14
 )
  
 $
 (155,408
 )
  
 $
 27,170
  
 

 

See accompanying notes to the condensed consolidated financial statements.

 

5

 

 

 

DiaMedica Therapeutics Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 
  
  
 
 Six Months Ended June 30, 

 
  
 

 
  
  
 
 2026

 
  
  
 
 2025

 
  
 

 
 
 Cash flows from operating activities:

 
  
  
  
  
  
  
  
  
 

 
 
 Net loss

 
  
 $
 (20,181
 
 )

 
  
 $
 (15,406
 
 )

 
 

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

 
  
  
  
  
  
  
  
  
 

 
 
 Share-based compensation

 
  
  
 1,940
  
  
  
 1,638
  
 

 
 
 Amortization of discounts on marketable securities

 
  
  
 (359
 )
  
  
 (441
 )
 

 
 
 Non-cash lease expense

 
  
  
 44
  
  
  
 40
  
 

 
 
 Depreciation

 
  
  
 23
  
  
  
 14
  
 

 
 
 Changes in operating assets and liabilities:

 
  
  
  
  
  
  
  
  
 

 
 
 Amounts receivable

 
  
  
 14
  
  
  
 75
  
 

 
 
 Prepaid expenses and other assets

 
  
  
 (86
 )
  
  
 (453
 )
 

 
 
 Deposits

 
  
  
 —
  
  
  
 1,108
  
 

 
 
 Accounts payable

 
  
  
 1,337
  
  
  
 321
  
 

 
 
 Accrued liabilities and operating lease liabilities

 
  
  
 72
  
  
  
 (1,643
 )
 

 
 
 Net cash used in operating activities

 
  
  
 (17,196
 )
  
  
 (14,747
 )
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Cash flows from investing activities:

 
  
  
  
  
  
  
  
  
 

 
 
 Purchase of marketable securities

 
  
  
 (23,650
 )
  
  
 (16,370
 )
 

 
 
 Maturities and sales of marketable securities

 
  
  
 29,790
  
  
  
 31,967
  
 

 
 
 Purchases of property and equipment

 
  
  
 (11
 
 )

 
  
  
 (18
 
 )

 
 

 
 
 Net cash provided by investing activities

 
  
  
 6,129
  
  
  
 15,579
  
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Cash flows from financing activities:

 
  
  
  
  
  
  
  
  
 

 
 
 Proceeds from the exercise of common stock options

 
  
  
 555
  
  
  
 257
  
 

 
 
 Principal payments on finance lease obligation

 
  
  
 (6
 
 )

 
  
  
 (5
 
 )

 
 

 
 
 Net cash provided by financing activities

 
  
  
 549
  
  
  
 252
  
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Net increase (decrease) in cash and cash equivalents

 
  
  
 (10,518
 )
  
  
 1,084
  
 

 
 
 Cash and cash equivalents at beginning of period

 
  
  
 15,647
  
  
  
 3,025
  
 

 
 
 Cash and cash equivalents at end of period

 
  
 $
 5,129
  
  
 $
 4,109
  
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Supplemental disclosure of non-cash transactions:

 
  
  
  
  
  
  
  
  
 

 
 
 Cash paid for income taxes

 
  
 $
 13
  
  
 $
 12
  
 

 

See accompanying notes to the condensed consolidated financial statements.

 

6

 

 

DiaMedica Therapeutics Inc.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

 

 

 
 
 1.

 
 
 Business

 
 

 

DiaMedica Therapeutics Inc. and its wholly owned subsidiaries, DiaMedica USA Inc. and DiaMedica Australia Pty Ltd. (collectively, we, us, our, DiaMedica and the Company), is a clinical stage biopharmaceutical company focused on developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS). DiaMedica’s lead product candidate, DM199, is the first pharmaceutically active, and clinically studied, recombinant (synthetic) form of the human tissue kallikrein-1 (KLK1) protein, an established therapeutic modality in Asia for the treatment of preeclampsia, acute ischemic stroke and other vascular diseases. Our common shares are publicly traded on The Nasdaq Capital Market under the symbol “DMAC.”

 

 

 
 
 2.

 
 
 Risks and Uncertainties

 
 

 

DiaMedica operates in a highly regulated and competitive environment. The development, manufacturing and marketing of pharmaceutical products require approval from, and are subject to ongoing oversight by, the United States Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in the European Union, and comparable agencies in other countries. We are in the clinical stage of development of our lead product candidate, DM199, for the treatment of PE, FGR and AIS. We have not completed the development of any product candidate and do not generate any revenues from the commercial sale of any product candidate. Our lead product candidate, DM199, requires significant additional clinical testing and investment prior to seeking marketing approval and is not expected to be commercially available for at least three to four years, if at all.

 

With respect to our PE clinical program, a Phase 2 open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept, investigator-sponsored trial (IST) of DM199 for the treatment of PE is currently being conducted at the Tygerberg Hospital in Cape Town, South Africa. This Phase 2 trial consists of three studies (Parts 1a, 1b and 2) in PE and a single study (Part 3) in FGR as follows:

 

Preeclampsia (PE)

 

 
  
 
 ●

 
 
 Part 1a: 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: 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 in September or October 2026.
 

 
  
 
 ●

 
 Part 2: evaluation of repeated SC dosing of DM199 in early-onset PE subjects until delivery (expectant management), using three dose levels identified in Part 1a; initial enrollment expected in September or October 2026.
 

 

Fetal Growth Restriction (FGR)

 

 
  
 
 ●

 
 Part 3: evaluation of a single IV and SC loading dose of DM199, followed by repeated SC dosing in FGR subjects until delivery (expectant management), using three dose levels identified in Part 1a; enrollment commenced in June 2026 and the first cohort of six participants has been enrolled.
 

 

Up to 90 women with PE and potentially an additional 30 subjects with FGR may be evaluated. Interim results from cohorts 1 through 9 (N=28) of Part 1a of the study were released in July 2025 and additional data from the extension cohort was released in August 2026. The interim results demonstrated that DM199 appears safe and well-tolerated with clinically-relevant pharmacodynamic activity with no evidence of placental transfer of DM199. In the combined final, highest-dose cohorts, which consisted of 15 PE subjects, three from the initial dose escalation phase and 12 additional subjects enrolled in the extension cohort, DM199 produced clinically meaningful and statistically significant, sustained reductions in maternal blood pressure at the pre-specified time point of five minutes after completion of the IV infusion. Systolic blood pressure (SBP) was maintained below 160 mmHg at all measured time points over 24 hours. Detailed Part 1a results, including pharmacokinetic and pharmacodynamic analyses, are expected to be presented at an upcoming medical conference and submitted for publication. The acceptance by the FDA of study data from clinical trials conducted outside the United States, including this IST, may be subject to certain conditions or may not be accepted at all. If the FDA does not accept such data, it would result in the need for additional participants or trials, which would be costly and time-consuming and delay regulatory approval and commercialization of our DM199 product candidate.

 

7

 

 

With respect to our AIS clinical program, we are currently conducting a Phase 2/3, adaptive design, randomized, double-blind, placebo-controlled trial of DM199 for the treatment of AIS, (the ReMEDy2 trial). Our ReMEDy2 trial is intended to enroll approximately 300 participants at up to 100 sites globally. The adaptive design component includes an interim analysis by our independent data safety monitoring board to be conducted after the first 200 participants have completed the trial. Based on the results of the interim analysis, the study may then be stopped for futility or the final sample size will be determined, ranging between 300 and 728 patients, according to a pre-determined statistical plan. We are currently conducting the trial in the United States, Canada, the United Kingdom and the European Union. Earlier this year, we commenced site initiations and enrollments in six European countries. We have experienced and continue to experience slower than expected site activations and enrollment in our ReMEDy2 trial. We believe these conditions may be due to hospital and medical facility staffing shortages; inclusion/exclusion criteria in the study protocol; concerns managing logistics and protocol compliance for participants discharged from the hospital to an intermediate care facility; concerns regarding prior clinically significant hypotension events; use of artificial intelligence and telemedicine which have enabled smaller hospitals to retain AIS patients not eligible for mechanical thrombectomy instead of sending these patients to the larger stroke centers which are more likely to be sites in our trial; and competition for research staff and trial subjects due to other pending stroke and neurological trials. We continue to reach out to our study sites to understand the specific issues at each study site. To mitigate the impact of these factors, we have significantly expanded our internal clinical team and have brought in-house certain trial activities, including site identification, qualification and activation, clinical site monitoring, supporting vendor management and overall program management. We continue to work closely with our contract research organizations and other supporting vendors to develop procedures to support both U.S. and global study sites and potential participants as needed. We intend to continue to monitor the results of these efforts and, if necessary, implement additional actions to enhance site activations and enrollment in our ReMEDy2 trial; however, no assurances can be provided as to the success of these actions and if or when these issues will resolve. Failure to resolve these issues may result in further delays in our ReMEDy2 trial and increase the difficulty in forecasting enrollment. As we approach enrollment of the 200th participant, we estimate that the interim analysis will be completed in the first quarter of 2027.

 

Our future success is dependent upon the success of our development efforts, our ability to demonstrate clinical progress for our DM199 product candidate in the United States or other markets, our ability, or the ability of any future partner, to obtain required governmental approvals of our product candidate, our ability to license or market and sell our DM199 product candidate and our ability to obtain additional financing to fund these efforts.

 

As of June 30, 2026, we have incurred losses of $192.9 million since our inception in 2000. For the six months ended June 30, 2026, we incurred a net loss of $20.2 million and negative cash flows from operating activities of $17.2 million. We expect to continue to incur substantial operating losses until such time as any future product sales, licensing fees, milestone payments and/or royalty payments generate revenue sufficient to fund our continuing operations. For the foreseeable future, we expect to incur significant operating losses as we continue the development and clinical study of, and to seek regulatory approval for, our DM199 product candidate. As of June 30, 2026, we had combined cash, cash equivalents and marketable securities of $43.5 million, working capital of $37.7 million and shareholders’ equity of $38.3 million.

 

Our principal source of cash has been net proceeds from the issuance of equity securities. Although we have previously been successful in obtaining financing through equity securities offerings, there is no assurance that we will be able to do so in the future. This is particularly true if our clinical data are not positive or if economic and market conditions deteriorate.

 

We expect that we will need substantial additional capital to further our research and development activities and complete the required clinical studies, regulatory activities and manufacturing development for our product candidate, DM199, or any future product candidates, to a point where they may be licensed or commercially sold. We expect our current cash, cash equivalents and marketable securities to be sufficient to fund our planned operations for at least the next 12 months from the date of issuance of these condensed consolidated financial statements. The amount and timing of our future funding requirements will depend on many factors, including, but not limited to, timing and results of our ongoing development efforts; our current ReMEDy2 trial and the rate of site activation and participant enrollment in the study; the Phase 2 PE trial; the potential expansion of our current development programs; and other factors on our clinical trials and our operating expenses. We may require significant additional funds earlier than we currently expect and there is no assurance that we will not need or seek additional funding prior to such time, especially if market conditions for raising capital are favorable.

 

 

 

 
 
 3.

 
 
 Summary of Significant Accounting Policies

 
 

 

Interim financial statements

 

We have prepared the accompanying condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States (US GAAP) for interim financial information and with the instructions to Form 10-Q and Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, the condensed consolidated financial statements do not include all of the information and footnotes required by US GAAP for complete financial statements. These condensed consolidated financial statements reflect all adjustments consisting of normal recurring accruals which, in the opinion of management, are necessary to present fairly our condensed consolidated financial position, condensed consolidated results of operations and comprehensive loss, condensed consolidated statement of shareholders’ equity and condensed consolidated cash flows for the periods and as of the dates presented. Our fiscal year ends on December 31. The condensed consolidated balance sheet as of December 31, 2025 was derived from our audited consolidated financial statements. These condensed consolidated financial statements should be read in conjunction with our annual consolidated financial statements and the notes thereto. The nature of our business is such that the results of any interim period may not be indicative of the results to be expected for the entire year.

 

8

 

 

Segments

 

We operate in a single segment focusing on developing potentially transformative treatments for severe ischemic diseases. Consistent with our operational structure, our chief operating decision maker manages and allocates resources for the Company at a consolidated level. Therefore, results of our operations are reported on a consolidated basis for purposes of segment reporting. Substantially all of our tangible assets are held in the United States.

 

Cash and cash equivalents

 

We consider all bank deposits, including money market funds and other investments, purchased with an original maturity to the Company of three months or less, to be cash and cash equivalents. The carrying amount of our cash equivalents approximates fair value due to the short maturity of the investments.

 

Marketable securities

 

Our marketable securities may consist of obligations of the United States government and its agencies, bank certificates of deposit and investment grade corporate obligations, which are classified as available-for-sale. Marketable securities which mature within 12 months from their purchase date are included in current assets. Securities are generally valued based on market prices for similar assets using third-party certified pricing sources and are carried at fair value. The amortized cost of marketable securities is adjusted for amortization of premiums or accretion of discounts to maturity. Such amortization or accretion is included in interest income. Realized gains and losses, if any, are calculated on the specific identification method. Interest income is included in other income in the condensed consolidated statements of operations.

 

We conduct periodic reviews to identify and evaluate each available-for-sale debt security that is in an unrealized loss position in order to determine whether an other-than-temporary impairment exists. An unrealized loss exists when the current fair valu