DiaMedica Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Highlights
- Positive Phase 2 Interim Data Evaluating DM199 in Preeclampsia Showed Statistically Significant Reductions in Blood Pressure and Pulsatility Index as Well as No Placental Transfer
-
Private Placement Extends Cash Runway into H2 2027 and Enables Acceleration of Industry Leading Preeclampsia and Fetal Growth Restriction Pipeline$30 Million - Enrollment for ReMEDy2 Phase 2/3 Trial Progressing with Interim Data Anticipated in Q2 2026
- Inclusion in the Russell 2000® and 3000® Indexes
- Appointment of Julie Krop, MD, to Chief Medical Officer
- Conference Call and Webcast August 13 at 8:00 AM Eastern Time / 7:00 AM Central Time
“With the recent positive interim results from Part 1a of our Phase 2 study evaluating DM199 in preeclampsia followed by a
Recent Corporate Highlights
- Preeclampsia Phase 2 Part 1a Interim Results: Positive interim results (n=28) from Part 1a of the investigator-sponsored Phase 2 trial of DM199 for the treatment of preeclampsia were reported in July 2025. The study achieved pre-specified safety and efficacy endpoints. DM199 demonstrated highly statistically significant and clinically meaningful reductions in systolic and diastolic blood pressure for combined cohorts 6-9. DM199 also appeared to be safe and well tolerated with no evidence of placental transfer for any dose. Additionally, a highly statistically significant reduction in uterine artery pulsatility index suggested an improvement in uterine artery blood flow and placental perfusion, providing rationale for evaluation of DM199 in fetal growth restriction.
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Private Placement of Common Shares: In July 2025, DiaMedica raised$30.1 Million , increasing its June 30, 2025 proforma cash balance to$30.1 million . The capital raised is expected to fund operations for over two years and support upcoming milestones including the submission of an investigational new drug (IND) application for DM199 in$60 million the United States for preeclampsia and fetal growth restriction and, if accepted, a Phase 2b study to further evaluate DM199 in both indications. - Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2/3 Clinical Developments: Enrollment in the Company’s Phase 2/3 ReMEDy2 (the ReMEDy2 trial – NCT065216) trial is progressing and the Company expects to complete the interim analysis on the first 200 patients in the second quarter of 2026.
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Inclusion in the Russell 2000 and 3000 Indexes: In June 2025, DiaMedica was added as a member of the US small-cap Russell 2000 and Russell 3000 Indexes. The Russell 3000 Index encompasses the 3,000 largest
U.S. companies by market capitalization, representing approximately98% of the investableU.S. equity market. The Russell 2000 Index is a subset of the Russell 3000, measuring the performance of the small-cap segment. These indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. - Appointment of Julie Krop to Chief Medical Officer: In August 2025, DiaMedica announced the appointment of Julie Krop, MD, to Chief Medical Officer. Dr. Krop has over 20 years of experience as a strategic physician executive with leadership experience spanning multiple therapeutic and orphan indications in both pre-commercial and commercial organizations. Her track record of advancing innovative therapeutics from proof of concept to approval, as well as her prior experience working in preeclampsia drug development, will be beneficial as DiaMedica continues to advance DM199 toward late-stage clinical development.
Financial Results Highlights for the Quarter Ended June 30, 2025
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Cash Position and Runway – Cash, cash equivalents and short-term investments were
as of June 30, 2025, compared to$30.0 million as of December 31, 2024. Including net proceeds from the July private placement, the proforma cash, cash equivalents and short-term investments is approximately$44.1 million . 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 the second half of 2027.$60 million -
Cash Flows - Net cash used in operating activities for six months ended June 30, 2025 was
compared to$14.7 million for the same period in 2024. The increase in cash used in operating activities resulted primarily from the increased net loss in the first half of 2025 as compared with the prior year period.$11.2 million -
Research and Development (R&D) – R&D expenses were
and$5.8 million for the three and six months ended June 30, 2025, respectively, up from$11.5 million and$3.9 million for the three and six months ended June 30, 2024, respectively. The increase was due primarily to cost increases resulting from the continued progress of the ReMEDy2 clinical trial, including its global expansion and the expansion of the clinical team during the current and prior year periods. These increases were partially offset by cost reductions related to in-use study work performed and completed in the prior year period.$7.6 million -
General and Administrative (G&A) – G&A expenses were
and$2.2 million for the three and six months ended June 30, 2025, respectively, up from$4.7 million and$1.7 million for the three and six months ended June 30, 2024, respectively. This increase resulted primarily from additional non-cash share-based compensation and increased personnel costs, partially offset by a reduction in legal fees incurred in connection with our lawsuit against PRA Netherlands.$3.8 million -
Net Loss – Net losses were
and$7.7 million for the three and six months ended June 30, 2025, respectively, up from$15.4 million and$5.1 million for the three and six months ended June 30, 2024, respectively.$10.3 million
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 |
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Time: |
8:00 AM EDT / 7:00 AM CDT |
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Web access: |
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Dial In: |
(800) 836-8184 |
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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
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
DiaMedica Therapeutics Inc. |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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(In thousands, except share and per share amounts) |
|||||||||||||||
(Unaudited) |
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|
|
|
|
||||||||||||
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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 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
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 |
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(In thousands, except share amounts) |
|||||||
|
|
|
|
||||
|
June 30,
|
|
December 31,
|
||||
|
(unaudited) |
|
|
|
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ASSETS |
|
|
|
|
|
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Current assets: |
|
|
|
|
|
||
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 |
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(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 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20250812973500/en/
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
Source: DiaMedica Therapeutics Inc.