MINNEAPOLIS / Aug 12, 2025 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia, fetal growth restriction and acute ischemic stroke, today provided a business update and reported financial results for the second quarter ended June 30, 2025. Management will host a conference call Wednesday, August 13, 2025, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and second quarter 2025 financial results.
“With the recent positive interim results from Part 1a of our Phase 2 study evaluating DM199 in preeclampsia followed by a $30M capital raise, we’re eager to continue advancement of this promising candidate to address ischemic diseases in the second half of this year,” said Rick Pauls, President and CEO of DiaMedica. “Preeclampsia and fetal growth restriction are areas with high unmet medical need due to the lack of approved treatment options, and we believe DM199 has the potential to provide a disease-modifying solution for patients suffering from these ischemic conditions. We look forward to submitting an investigational new drug application for DM199 in the U.S. to further evaluate its potential in preeclampsia and fetal growth restriction, while initiating subsequent parts of the ongoing investigator-sponsored Phase 2 trial in these indications.”
Recent Corporate Highlights
Financial Results Highlights for the Quarter Ended June 30, 2025
Conference Call and Webcast Information
DiaMedica Management will host a conference call and webcast to discuss its business update and first quarter 2025 financial results on Wednesday, August 13, 2025, at 8:00 AM Eastern Time / 7:00 AM Central Time:
Date: | Wednesday, August 13, 2025 | ||
Time: | 8:00 AM EDT / 7:00 AM CDT | ||
Web access: | |||
Dial In: | (800) 836-8184 | ||
Conference ID: | 29006 |
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 August 20, 2025, by dialing (888) 660-6345 (US Toll Free) and entering the replay passcode: 29006#.
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 “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” or “will,” 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 Company’s expectations regarding its application for an IND for the study of DM199 as a treatment for preeclampsia and fetal growth restriction and its conducting a Phase 2 trial in these indications; continued ReMEDy2 trial enrollment and the timing of the interim analysis on the first 200 participants in the second quarter of 2026; 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 cash runway into the second half of 2027. Such statements and information reflect management’s current view and DiaMedica undertakes no obligation to update or revise any of these statements or information. 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 risk that existing preclinical and clinical data from DM199 as a treatment for preeclampsia may not be predictive of the results of ongoing or later clinical trials; DiaMedica’s plans to develop, obtain an IND for the clinical study of DM199 for PE and fetal growth restriction and ultimately regulatory approval for and commercialize its DM199 product candidate for the treatment of preeclampsia, fetal growth restriction and acute ischemic stroke, the timing of ReMEDy2 trial enrollment, regulatory applications and related filing and approval timelines; the possibility that enrollment in the ReMEDy2 trial will not continue to increase as anticipated; the possible occurrence of future adverse events associated with or unfavorable results from DiaMedica’s current trials and their potential to adversely effect current of future trials; the possibility of unfavorable results from DiaMedica’s other ongoing or future clinical trials of DM199; 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 adaptive design of the ReMEDy2 trial and the possibility that the targeted enrollment and other aspects of the trial could change depending upon certain factors, including additional input from the FDA and the blinded interim analysis; 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 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 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, 2024 filed with the U.S. Securities and Exchange Commission (SEC) and subsequent SEC reports, including the most recent quarterly report on Form 10-Q for the quarterly period ended June 30, 2025. 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.
DiaMedica Therapeutics Inc. | |||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
(In thousands, except share and per share amounts) | |||||||||||||||
(Unaudited) | |||||||||||||||
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| Three Months Ended June 30, |
| Six Months Ended June 30, | ||||||||||||
| 2025 |
| 2024 |
| 2025 |
| 2024 | ||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
| ||||
Research and development | $ | 5,822 |
|
| $ | 3,928 |
|
| $ | 11,478 |
|
| $ | 7,604 |
|
General and administrative |
| 2,185 |
|
|
| 1,710 |
|
|
| 4,673 |
|
|
| 3,775 |
|
Operating loss |
| (8,007 | ) |
|
| (5,638 | ) |
|
| (16,151 | ) |
|
| (11,379 | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Other income, net |
| 314 |
|
|
| 526 |
|
|
| 757 |
|
|
| 1,123 |
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Loss before income tax expense |
| (7,693 | ) |
|
| (5,112 | ) |
|
| (15,394 | ) |
|
| (10,256 | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Income tax expense |
| (6 | ) |
|
| (7 | ) |
|
| (12 | ) |
|
| (14 | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Net loss |
| (7,699 | ) |
|
| (5,119 | ) |
|
| (15,406 | ) |
|
| (10,270 | ) |
|
|
|
|
|
|
|
|
|
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|
| ||||
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
| ||||
Unrealized loss on marketable securities |
| (19 | ) |
|
| (12 | ) |
|
| (37 | ) |
|
| (57 | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Net loss and comprehensive loss | $ | (7,718 | ) |
| $ | (5,131 | ) |
| $ | (15,443 | ) |
| $ | (10,327 | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Basic and diluted net loss per share | $ | (0.18 | ) |
| $ | (0.13 | ) |
| $ | (0.36 | ) |
| $ | (0.27 | ) |
Weighted average shares outstanding – basic and diluted |
| 42,957,619 |
|
|
| 38,068,378 |
|
|
| 42,901,093 |
|
|
| 38,013,189 |
|
DiaMedica Therapeutics Inc. | |||||||
Condensed Consolidated Balance Sheets | |||||||
(In thousands, except share amounts) | |||||||
|
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| June 30, |
| December 31, | ||||
| (unaudited) |
|
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| |||
ASSETS |
|
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| ||
Current assets: |
|
|
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| ||
Cash and cash equivalents | $ | 4,109 |
|
| $ | 3,025 |
|
Marketable securities |
| 25,929 |
|
|
| 41,122 |
|
Prepaid expenses and other assets |
| 680 |
|
|
| 227 |
|
Deposits |
| 200 |
|
|
| — |
|
Amounts receivable |
| 161 |
|
|
| 236 |
|
Total current assets |
| 31,079 |
|
|
| 44,610 |
|
|
|
|
|
|
| ||
Non-current assets: |
|
|
|
|
| ||
Operating lease right-of-use asset, net |
| 239 |
|
|
| 279 |
|
Property and equipment, net |
| 152 |
|
|
| 148 |
|
Deposits |
| — |
|
|
| 1,308 |
|
Total non-current assets |
| 391 |
|
|
| 1,735 |
|
|
|
|
|
|
| ||
Total assets | $ | 31,470 |
|
| $ | 46,345 |
|
|
|
|
|
|
| ||
LIABILITIES AND EQUITY |
|
|
|
|
| ||
Current liabilities: |
|
|
|
|
| ||
Accounts payable | $ | 1,261 |
|
| $ | 940 |
|
Accrued liabilities |
| 2,747 |
|
|
| 4,347 |
|
Operating lease obligation |
| 96 |
|
|
| 90 |
|
Finance lease obligation |
| 12 |
|
|
| 13 |
|
Total current liabilities |
| 4,116 |
|
|
| 5,390 |
|
|
|
|
|
|
| ||
Non-current liabilities: |
|
|
|
|
| ||
Operating lease obligation |
| 176 |
|
|
| 225 |
|
Finance lease obligation |
| 8 |
|
|
| 12 |
|
Total non-current liabilities |
| 184 |
|
|
| 237 |
|
|
|
|
|
|
| ||
Shareholders’ equity: |
|
|
|
|
| ||
Common shares, no par value; unlimited authorized; 43,072,488 and 42,818,660 shares issued and outstanding, as of June 30, 2025 and December 31, 2024, respectively |
| — |
|
|
| — |
|
Paid-in capital |
| 182,592 |
|
|
| 180,697 |
|
Accumulated other comprehensive income (loss) |
| (14 | ) |
|
| 23 |
|
Accumulated deficit |
| (155,408 | ) |
|
| (140,002 | ) |
Total shareholders’ equity |
| 27,170 |
|
|
| 40,718 |
|
Total liabilities and shareholders’ equity | $ | 31,470 |
|
| $ | 46,345 |
|
DiaMedica Therapeutics Inc. | |||||||
Condensed Consolidated Statements of Cash Flows | |||||||
(In thousands) | |||||||
(Unaudited) | |||||||
|
| ||||||
| Six Months Ended June 30, | ||||||
| 2025 |
| 2024 | ||||
Cash flows from operating activities: |
|
|
|
|
| ||
Net loss | $ | (15,406 | ) |
| $ | (10,270 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
| ||||
Share-based compensation |
| 1,638 |
|
|
| 931 |
|
Amortization of discounts on marketable securities |
| (441 | ) |
|
| (648 | ) |
Non-cash lease expense |
| 40 |
|
|
| 37 |
|
Depreciation |
| 14 |
|
|
| 18 |
|
Changes in operating assets and liabilities: |
|
|
| ||||
Amounts receivable |
| 75 |
|
|
| (22 | ) |
Prepaid expenses and other assets |
| (453 | ) |
|
| (156 | ) |
Deposits |
| 1,108 |
|
|
| (1,308 | ) |
Accounts payable |
| 321 |
|
|
| (167 | ) |
Accrued liabilities and operating lease liabilities |
| (1,643 | ) |
|
| 413 |
|
Net cash used in operating activities |
| (14,747 | ) |
|
| (11,172 | ) |
|
|
| |||||
Cash flows from investing activities: |
|
|
| ||||
Purchase of marketable securities |
| (16,370 | ) |
|
| (18,047 | ) |
Maturities of marketable securities |
| 31,967 |
|
|
| 27,000 |
|
Purchases of property and equipment |
| (18 | ) |
|
| (9 | ) |
Net cash provided by investing activities |
| 15,579 |
|
|
| 8,944 |
|
|
|
| |||||
Cash flows from financing activities: |
|
|
| ||||
Proceeds from issuance of common shares, net of offering costs |
| — |
|
|
| 11,747 |
|
Proceed from the exercise of common stock options |
| 257 |
|
|
| 7 |
|
Principal payments on finance lease obligation |
| (5 | ) |
|
| (3 | ) |
Net cash provided by financing activities |
| 252 |
|
|
| 11,751 |
|
|
|
| |||||
Net increase in cash and cash equivalents |
| 1,084 |
|
|
| 9,523 |
|
Cash and cash equivalents at beginning of period |
| 3,025 |
|
|
| 4,543 |
|
Cash and cash equivalents at end of period | $ | 4,109 |
|
| $ | 14,066 |
|
|
|
|
|
| |||
Supplemental disclosure of non-cash transactions: |
|
|
|
|
| ||
Assets acquired under financing lease | $ | — |
|
| $ | 30 |
|
Cash paid for income taxes | $ | 12 |
|
| $ | 14 |
|
Last Trade: | US$6.00 |
Daily Change: | 0.78 14.94 |
Daily Volume: | 1,133,820 |
Market Cap: | US$308.940M |
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