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Financial Data and Key Metrics Changes - As of June 30, 2025, the company's cash, cash equivalents, and short-term investments were $30 million, down from $44.1 million as of December 31, 2024. However, including net proceeds from a July private placement, the pro forma cash position is approximately $60 million, which is expected to fund planned clinical studies and operations into 2027 [14][15][17] - The net loss for the three and six months ending June 30, 2025, was $7.7 million and $15.4 million, respectively, compared to $5.1 million and $10.3 million for the same periods in 2024, indicating an increase in net loss year-over-year [17] Business Line Data and Key Metrics Changes - Research and Development (R&D) expenses increased to $5.8 million and $11.5 million for the three and six months ended June 30, 2025, compared to $3.9 million and $7.6 million for the same periods in 2024, primarily due to costs associated with the REMEDY two clinical trial and expansion of the clinical team [15] - General and administrative expenses also rose to $2.2 million and $4.7 million for the three and six months ended June 30, 2025, compared to $1.7 million and $3.8 million in the prior year, driven by increased personnel costs and non-cash share-based compensation [16] Market Data and Key Metrics Changes - DiaMedica was added to the US small cap Russell 2000 and Russell 3000 indexes, enhancing visibility among institutional investors and the broader investment community [12] Company Strategy and Development Direction - The company is advancing its DM199 program for preeclampsia, with plans to conduct a Phase 2B trial in the US and other countries, and is preparing an FDA IND application [8][9] - The company aims to finalize a dosing regimen for the ongoing clinical trials and expand its indications to include fetal growth restriction [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the current cash position and its ability to fund clinical studies into 2027, despite an increase in net losses [14][17] - The interim results from the preeclampsia program were described as highly promising, with DM199 showing significant efficacy in managing maternal hypertension [6][9] Other Important Information - The company completed a $30 million private placement of common shares, which extends its cash runway into 2027 [9] - The new Chief Medical Officer, Dr. Julie Krop, brings extensive experience in the biopharma industry, particularly in women's health and preeclampsia [12][13] Q&A Session Summary Question: Why did Dr. Krop join the company, and what are her thoughts on the stroke program? - Dr. Krop expressed a strong commitment to women's health and excitement about the company's programs, highlighting the unmet needs in preeclampsia and ischemic stroke [20][21] Question: Can the company provide a timeline for the upcoming cohorts in the preeclampsia study? - Management indicated that Cohort 10 of Part 1B would start soon, with plans to push dosing higher and move into Part 2 and the fetal growth restriction cohort concurrently [25][27] Question: What is the current status of enrollment in the stroke study? - The company is currently at approximately 40 sites and is seeing an encouraging uptick in enrollment, with expectations for interim analysis to be completed in Q2 2026 [33][34] Question: Will the Phase 2B study have a primary endpoint that reflects pivotal regulatory endpoints for Phase 3? - Management stated that they are finalizing the protocol and are confident about the primary endpoint based on recent FDA feedback, but details will be shared once finalized [40]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) The company presents its unaudited financial statements, reporting a net loss of $15.4 million for the six months ended June 30, 2025, and a subsequent capital raise of $29.9 million Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2025 ($ in thousands) | December 31, 2024 ($ in thousands) | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | 4,109 | 3,025 | | Marketable securities | 25,929 | 41,122 | | Total current assets | 31,079 | 44,610 | | **Total Assets** | **31,470** | **46,345** | | **Current Liabilities** | | | | Accounts payable | 1,261 | 940 | | Accrued liabilities | 2,747 | 4,347 | | Total current liabilities | 4,116 | 5,390 | | **Total Shareholders' Equity** | **27,170** | **40,718** | Condensed Consolidated Statements of Operations (Unaudited) | Metric ($ in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | 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)** | | **Net loss** | **(7,699)** | **(5,119)** | **(15,406)** | **(10,270)** | | **Net loss per share** | **(0.18)** | **(0.13)** | **(0.36)** | **(0.27)** | - The company is a clinical-stage biopharmaceutical firm focused on developing its lead candidate, DM199, a recombinant form of human tissue kallikrein-1 (KLK1), for treating preeclampsia (PE) and acute ischemic stroke (AIS)[20](index=20&type=chunk) - The company's ReMEDy2 trial for AIS is experiencing **slower than expected site activations and enrollment** due to factors like hospital staffing shortages, protocol criteria, and competition from other trials[23](index=23&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$155.4 million**, but management expects current cash to be **sufficient to fund operations for at least the next 12 months**[25](index=25&type=chunk)[26](index=26&type=chunk) - In July 2025, the company completed a private placement, selling 8,606,425 common shares at $3.50 per share, resulting in gross proceeds of $30.1 million and **net proceeds of approximately $29.9 million**[59](index=59&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical program progress, financial performance, and capital resources, confirming sufficient funding for the next 12 months post-fundraising [Business Overview](index=20&type=section&id=Business%20Overview) DiaMedica is a clinical-stage biopharmaceutical company developing DM199 for Preeclampsia and Acute Ischemic Stroke, leveraging an established therapeutic approach in Asia - The company's lead candidate, DM199, is the first pharmaceutically active recombinant form of the human tissue kallikrein-1 (KLK1) protein being clinically studied for Preeclampsia (PE) and Acute Ischemic Stroke (AIS)[64](index=64&type=chunk) - DM199 has been granted **Fast Track designation by the FDA** for the treatment of AIS, based on the naturally occurring KLK1 protein approved in Asia for decades[65](index=65&type=chunk) - The proposed mechanism of action for DM199 involves enhancing blood flow and tissue perfusion by increasing production of nitric oxide (NO) and other vasodilators[66](index=66&type=chunk) [Clinical Programs](index=21&type=section&id=Clinical%20Programs) The Preeclampsia program shows promising interim results, while the Acute Ischemic Stroke trial faces enrollment delays that are being actively addressed - Interim results from the Phase 2 PE study showed DM199 was safe, well-tolerated, and produced **rapid, statistically significant reductions in blood pressure**[70](index=70&type=chunk) - Based on positive interim PE data, DiaMedica plans to submit an Investigational New Drug (IND) application in the United States in the **second half of 2025**[71](index=71&type=chunk) - The Phase 2/3 ReMEDy2 trial for AIS is experiencing **slower than expected enrollment**, which the company is mitigating by expanding its clinical team and the trial globally[72](index=72&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Operating expenses increased year-over-year due to expanded clinical trial activities and higher personnel costs, while other income declined Comparison of Operating Results ($ in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development expenses | 11,478 | 7,604 | | General and administrative expenses | 4,673 | 3,775 | | Other income, net | (757) | (1,123) | - The increase in R&D expenses was primarily driven by costs associated with the **continuation and global expansion of the ReMEDy2 clinical trial**[81](index=81&type=chunk) - The increase in G&A expenses was mainly due to **higher non-cash share-based compensation** and increased personnel costs from team expansion[82](index=82&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $30.0 million in cash and securities, with a recent $29.9 million capital raise ensuring sufficient funds for operations for at least the next year Liquidity and Capital Resources Summary ($ in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | 30,038 | 44,147 | | Working capital | 26,963 | 39,220 | - Net cash used in operating activities increased to **$14.7 million** for the six months ended June 30, 2025, compared to $11.2 million for the same period in 2024[86](index=86&type=chunk) - The company expects its current cash resources, including the **$29.9 million net proceeds** from the July 2025 private placement, will be **sufficient to fund planned operations for at least the next 12 months**[90](index=90&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, disclosure for this item is not required - As a smaller reporting company, DiaMedica is not required to provide disclosure pursuant to this item[95](index=95&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Based on an evaluation as of the end of the reporting period, the Chief Executive Officer and Chief Financial Officer concluded that the company's **disclosure controls and procedures were effective**[96](index=96&type=chunk) - There were **no changes in the company's internal control over financial reporting** during the six months ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[97](index=97&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) Following a court ruling in favor of ICON/PRA Netherlands, the company has decided to discontinue its pursuit of the legal matter - The company was involved in litigation with Pharmaceutical Research Associates Group B.V. (ICON/PRA Netherlands) regarding clinical study documents and data[99](index=99&type=chunk) - On June 24, 2025, a Netherlands Commercial Court (NCC) ruling found that **ICON/PRA Netherlands was not in default** under the agreement[101](index=101&type=chunk) - Following the court's ruling, DiaMedica has decided to **discontinue its pursuit of this legal matter**[101](index=101&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) New risks include the potential non-replication of promising interim data and delays from changes in FDA funding or staffing - A new risk factor was disclosed: Promising interim data from the ongoing investigator-sponsored Phase 2 study of DM199 for preeclampsia **may not be replicated in future studies or trials**[104](index=104&type=chunk) - Success in early-stage clinical trials **does not ensure success in later trials**, and failure to replicate promising results could prevent regulatory approval[105](index=105&type=chunk)[106](index=106&type=chunk) - A new risk factor was disclosed regarding potential changes in funding and staffing for the FDA and other government agencies, which could **delay product review and approval processes**[107](index=107&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity securities were sold during the quarter ended June 30, 2025 - The company did not sell any unregistered equity securities during the quarterly period ended June 30, 2025[108](index=108&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable - Not applicable[109](index=109&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable - Not applicable[110](index=110&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter - During the quarterly period ended June 30, 2025, no directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement[111](index=111&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including corporate articles, certifications, and financial statements in Inline XBRL format - The report includes several exhibits, such as the Notice of Articles, certifications from the CEO and CFO pursuant to Sarbanes-Oxley Sections 302 and 906, and financial statements in Inline XBRL format[112](index=112&type=chunk)

[Executive Summary & Business Update](index=1&type=section&id=1.%20Executive%20Summary%20%26%20Business%20Update) DiaMedica Therapeutics Inc. provides an overview of its clinical-stage biopharmaceutical focus on ischemic diseases, highlighting recent positive clinical results and corporate milestones [Company Overview and Strategic Direction](index=1&type=section&id=1.1%20Company%20Overview%20and%20Strategic%20Direction) DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel treatments for ischemic diseases, with positive interim results for DM199 in preeclampsia - DiaMedica Therapeutics Inc. is a **clinical-stage biopharmaceutical company** focused on developing novel treatments for **preeclampsia, fetal growth restriction, and acute ischemic stroke**[2](index=2&type=chunk)[3](index=3&type=chunk)[9](index=9&type=chunk) - The lead candidate, **DM199**, is the first pharmaceutically active recombinant (synthetic) form of the **KLK1 protein**[3](index=3&type=chunk)[9](index=9&type=chunk) - CEO Rick Pauls noted **positive interim results** from Part 1a of the **Phase 2 study** evaluating **DM199** in preeclampsia and a **$30M capital raise**, expressing eagerness to advance the candidate for ischemic diseases[3](index=3&type=chunk) [Recent Corporate and Clinical Highlights](index=1&type=section&id=1.2%20Recent%20Corporate%20and%20Clinical%20Highlights) DiaMedica achieved key milestones, including positive preeclampsia trial results, progress in AIS trial, a $30.1 million private placement, and a new CMO appointment [Preeclampsia Phase 2 Part 1a Interim Results](index=1&type=section&id=1.2.1%20Preeclampsia%20Phase%202%20Part%201a%20Interim%20Results) Positive interim results from the Phase 2 Part 1a trial of DM199 for preeclampsia demonstrated safety and efficacy - **Positive interim results** (n=28) from Part 1a of the investigator-sponsored **Phase 2 trial** of **DM199** for preeclampsia were reported in July 2025, achieving pre-specified **safety and efficacy endpoints**[4](index=4&type=chunk) - **DM199** demonstrated **highly statistically significant** and **clinically meaningful reductions** in systolic and diastolic **blood pressure** for combined cohorts 6-9[4](index=4&type=chunk)[5](index=5&type=chunk) - **DM199** appeared **safe and well tolerated** with **no evidence of placental transfer** for any dose[4](index=4&type=chunk)[5](index=5&type=chunk) - A **highly statistically significant reduction** in **uterine artery pulsatility index** suggested an **improvement in uterine artery blood flow and placental perfusion**[4](index=4&type=chunk) [Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2/3 Trial Progress](index=1&type=section&id=1.2.2%20Acute%20Ischemic%20Stroke%20%28AIS%29%20ReMEDy2%20Phase%202%2F3%20Trial%20Progress) Enrollment for the ReMEDy2 Phase 2/3 trial for Acute Ischemic Stroke is progressing, with interim analysis expected in Q2 2026 - **Enrollment** in the Company's **Phase 2/3 ReMEDy2 trial** for **Acute Ischemic Stroke (AIS)** is progressing[5](index=5&type=chunk)[7](index=7&type=chunk) - **Interim analysis** on the **first 200 patients** in the ReMEDy2 trial is expected to be completed in the **second quarter of 2026**[5](index=5&type=chunk)[7](index=7&type=chunk) [Key Corporate Milestones](index=2&type=section&id=1.2.3%20Key%20Corporate%20Milestones) Recent corporate milestones include a $30.1 million private placement, Russell Index inclusion, and a new Chief Medical Officer appointment - Completed a **$30.1 million private placement** in **July 2025**, extending **cash runway into H2 2027**[5](index=5&type=chunk)[7](index=7&type=chunk) - Included in the **Russell 2000® and 3000® Indexes** in **June 2025**[5](index=5&type=chunk)[7](index=7&type=chunk) - Appointed **Julie Krop, MD**, as **Chief Medical Officer** in **August 2025**, bringing over 20 years of experience in therapeutic and orphan indications[5](index=5&type=chunk)[7](index=7&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=2.%20Second%20Quarter%202025%20Financial%20Results) This section details DiaMedica's second quarter 2025 financial performance, including cash position, operating expenses, net loss, and comprehensive financial statements [Financial Highlights](index=2&type=section&id=2.1%20Financial%20Highlights) DiaMedica's proforma cash balance reached **$60 million** after a **$30.1 million** private placement, extending its cash runway despite increased operating expenses and net loss [Capital Raise and Cash Position](index=2&type=section&id=2.1.1%20Capital%20Raise%20and%20Cash%20Position) A **$30.1 million** private placement boosted the proforma cash balance to **$60 million**, extending the operational runway into H2 2027 - A **$30.1 million private placement** in July 2025 increased the **proforma cash balance to approximately $60 million**[7](index=7&type=chunk) - The capital raised is expected to **fund operations for over two years**, supporting upcoming milestones and planned clinical studies into the **second half of 2027**[7](index=7&type=chunk) Cash Position Overview | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------------------ | :------------ | :------------------ | :----- | | Cash, cash equivalents and short-term investments | $30.0 million | $44.1 million | -$14.1 million | [Operating Expenses Analysis](index=2&type=section&id=2.1.2%20Operating%20Expenses%20Analysis) Research and development and general and administrative expenses increased year-over-year, driven by clinical trial expansion and personnel costs Operating Expenses (in thousands) | Expense Category | Q2 2025 (3 months) | Q2 2024 (3 months) | YoY Change | H1 2025 (6 months) | H1 2024 (6 months) | YoY Change | | :----------------------- | :----------------- | :----------------- | :--------- | :----------------- | :----------------- | :--------- | | Research and development | $5,822 | $3,928 | +$1,894 | $11,478 | $7,604 | +$3,874 | | General and administrative | $2,185 | $1,710 | +$475 | $4,673 | $3,775 | +$898 | - The **increase in R&D expenses** was primarily due to the continued progress and global expansion of the **ReMEDy2 clinical trial** and the **expansion of the clinical team**[7](index=7&type=chunk) - The **increase in G&A expenses** resulted primarily from additional **non-cash share-based compensation** and **increased personnel costs**[10](index=10&type=chunk) [Net Loss Overview](index=3&type=section&id=2.1.3%20Net%20Loss%20Overview) The company reported an increased net loss for both the three and six months ended June 30, 2025, impacting basic and diluted net loss per share Net Loss (in thousands) | Metric | Q2 2025 (3 months) | Q2 2024 (3 months) | YoY Change | H1 2025 (6 months) | H1 2024 (6 months) | YoY Change | | :------- | :----------------- | :----------------- | :--------- | :----------------- | :----------------- | :--------- | | Net Loss | $(7,699) | $(5,119) | -$(2,580) | $(15,406) | $(10,270) | -$(5,136) | Basic and Diluted Net Loss Per Share | Metric | Q2 2025 (3 months) | Q2 2024 (3 months) | H1 2025 (6 months) | H1 2024 (6 months) | | :----------------------------- | :----------------- | :----------------- | :----------------- | :----------------- | | Basic and diluted net loss per share | $(0.18) | $(0.13) | $(0.36) | $(0.27) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=2.2%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section presents unaudited condensed consolidated statements of operations and comprehensive loss for Q2 2025 and 2024, detailing expenses, income, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) | | | | Three Months Ended June | | Six Months Ended June | | | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | | 30, | | | 2024 | 30, | | 2024 | | | 2025 | | | | 2025 | | | | 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 | [Condensed Consolidated Balance Sheets](index=6&type=section&id=2.3%20Condensed%20Consolidated%20Balance%20Sheets) This section presents unaudited condensed consolidated balance sheets, showing total assets decreased from **$46.3 million** to **$31.5 million** due to reduced marketable securities Condensed Consolidated Balance Sheets (in thousands, except share amounts) | | | June 30, 2025 | | December 31, 2024 | | :--- | :--- | :--- | :--- | :--- | | | | (unaudited) | | | | ASSETS | | | | | | 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 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=2.4%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details unaudited cash flows, showing increased net cash used in operating activities to **$14.7 million** and increased net cash from investing activities to **$15.6 million** Condensed Consolidated Statements of Cash Flows (in thousands) | | | 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 | [Additional Information](index=1&type=section&id=3.%20Additional%20Information) This section provides supplementary information, including conference call details, company background, forward-looking statements, and contact information [Conference Call and Webcast Information](index=1&type=section&id=3.1%20Conference%20Call%20and%20Webcast%20Information) DiaMedica hosted a conference call and webcast on August 13, 2025, to discuss its business update and Q2 2025 financial results - A conference call and webcast were hosted on Wednesday, **August 13, 2025**, at **8:00 AM Eastern Time / 7:00 AM Central Time**[2](index=2&type=chunk)[5](index=5&type=chunk)[8](index=8&type=chunk) - The webcast will remain **available for playback** on the Company's website under investor relations - events and presentations for **12 months**[8](index=8&type=chunk) [About DiaMedica Therapeutics Inc.](index=3&type=section&id=3.2%20About%20DiaMedica%20Therapeutics%20Inc.) DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on ischemic diseases, with DM199 as its lead recombinant KLK1 protein candidate - DiaMedica Therapeutics Inc. is a **clinical-stage biopharmaceutical company**[9](index=9&type=chunk) - The company is committed to improving the lives of people suffering from **serious ischemic diseases**, focusing on **preeclampsia, fetal growth restriction, and acute ischemic stroke**[9](index=9&type=chunk) - **DM199**, the lead candidate, is the first pharmaceutically active **recombinant (synthetic) form of the KLK1 protein**[9](index=9&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=3.3%20Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section highlights that forward-looking statements are subject to known and unknown risks and uncertainties, and the company is not obligated to update them - The press release contains **forward-looking statements** subject to **known and unknown risks, uncertainties, and other factors**[11](index=11&type=chunk) - Applicable risks include those related to **preclinical and clinical data, regulatory approvals, trial enrollment, adverse events, funding, and global supply chain issues**[11](index=11&type=chunk) - DiaMedica undertakes **no obligation to update or revise** any forward-looking statements or information, **except as required by applicable laws**[11](index=11&type=chunk) [Contact Information](index=4&type=section&id=3.4%20Contact%20Information) This section provides essential contact information for DiaMedica's Chief Financial Officer, investor relations, and media inquiries - Contact for **Chief Financial Officer**: **Scott Kellen**, Phone: (763) 496-5118, Email: skellen@diamedica.com[12](index=12&type=chunk) - Contact for **Investor Inquiries**: **Mike Moyer**, Managing Director, LifeSci Advisors, LLC, Phone: (617) 308-4306, Email: mmoyer@lifesciadvisors.com[12](index=12&type=chunk) - Contact for **Media**: **Madelin Hawtin**, LifeSci Communications, Email: mhawin@lifescicomms.com[12](index=12&type=chunk)

Summary of DiaMedica Therapeutics Conference Call Company and Industry - **Company**: DiaMedica Therapeutics - **Industry**: Biotechnology, specifically focusing on treatments for hypertensive disorders during pregnancy, such as preeclampsia Core Points and Arguments 1. **Clinical Trial Overview**: The call discussed the interim results from the Phase II Part 1a clinical trial of DM199 for preeclampsia, marking a critical milestone in addressing hypertensive disorders during pregnancy [3][6][34] 2. **Preeclampsia Statistics**: Preeclampsia affects over 10 million women globally each year, with nearly 200,000 cases in the US annually, particularly in early onset cases [5][6] 3. **Treatment Challenges**: Common treatments like ACE inhibitors and ARBs are contraindicated in pregnancy due to risks to the fetus, highlighting the need for safe alternatives like DM199 [6][26] 4. **Trial Objectives and Results**: - **Safety**: No placental transfer of DM199 was observed, confirming its safety profile [7][26] - **Blood Pressure Reduction**: Achieved significant reductions in both systolic (up to 35 mmHg) and diastolic blood pressure (up to 15 mmHg) at various time points [8][9][28] - **Intrauterine Artery Dilation**: A 13% reduction in the pulsatility index was noted, indicating improved placental perfusion [10][32] 5. **Future Directions**: Plans to expand research into fetal growth restriction, a related condition with no current FDA-approved treatments [6][35] Important but Overlooked Content 1. **Demographics of Participants**: The trial included women with severe hypertension, with a median gestation of around 37 weeks, primarily from black and mixed-race backgrounds [16][17] 2. **Cesarean Section Rates**: Approximately 70% of participants underwent cesarean sections due to the severity of their condition [20] 3. **Adverse Events**: While some expected complications occurred, the incidence was lower than anticipated, with no serious adverse events linked to DM199 [22][23] 4. **Pharmacokinetics and Future Dosing**: Ongoing analysis of pharmacokinetics will inform future dosing strategies, including potential titration based on individual patient needs [39][56] 5. **FDA Engagement**: Plans to submit data to the FDA later in the year for potential larger Phase II/III studies [69] This summary encapsulates the key findings and future directions discussed during the conference call, emphasizing the potential of DM199 as a breakthrough treatment for preeclampsia and related conditions.

Preeclampsia Overview and Unmet Need - Preeclampsia affects 5-8% of all pregnancies in the U S, impacting 180,000 to 300,000 patients annually[10] - Refractory hypertension drives approximately 50% of deliveries in early-onset preeclampsia cases[51] - Current anti-hypertensives primarily target vascular smooth muscle cells, managing symptoms but not addressing the underlying endothelial dysfunction[53] DM199 Mechanism of Action and Potential Benefits - DM199 aims to increase placental perfusion and repair endothelium, potentially reducing blood pressure[44] - DM199 is not expected to cross the placental barrier, offering a potential safety advantage compared to small molecules[46] - DM199 targets both upstream hypoxia and downstream endothelial dysfunction and blood pressure[44] - DM199 has the potential to safely extend gestation and accelerate fetal growth[45] DM199 Phase 2 Trial - The ongoing Phase 2, Part 1A investigator-sponsored trial is recruiting preeclampsia patients with planned delivery in less than 72 hours[58, 60] - The trial includes dose escalation to identify the optimal dose based on blood pressure reductions[59, 62] - Key endpoints include safety and tolerability, placental transfer analysis, blood pressure reduction, and dilation of intrauterine arteries[62]

Summary of DiaMedica Therapeutics Virtual KOL Event Company and Industry Overview - **Company**: DiaMedica Therapeutics - **Industry**: Pharmaceutical, specifically focusing on treatments for preeclampsia, a serious pregnancy-related condition Key Points and Arguments 1. **Unmet Medical Need**: Preeclampsia affects 5-8% of pregnancies in the U.S., with 180,000 to 300,000 cases annually, leading to severe complications for mothers and babies [3][11][12] 2. **Current Treatment Limitations**: The only definitive treatment is delivery of the placenta, often resulting in premature births. Current medications only manage symptoms rather than address the underlying disease [51][52] 3. **DM199 Potential**: DM199 is a synthetic version of tissue kallikrein that may reduce blood pressure and improve blood flow to the placenta, potentially transforming preeclampsia treatment [5][42][47] 4. **Mechanism of Action**: DM199 may enhance bradykinin signaling, leading to vasodilation and improved endothelial function, which is crucial for managing preeclampsia [34][36][39] 5. **Safety Profile**: DM199 is not expected to cross the placental barrier, reducing concerns about fetal exposure to the drug, which is a significant advantage over small molecule drugs [44][46][47] 6. **Clinical Trial Design**: Ongoing phase two clinical trials are assessing the safety, tolerability, and efficacy of DM199 in pregnant women with preeclampsia, focusing on blood pressure control and uterine artery blood flow [58][61][62] Important but Overlooked Content 1. **Economic Impact**: The cost of managing preterm infants in NICUs can range from $5,000 to $10,000 per day, leading to total costs of $2-3 million for prolonged care, highlighting the economic burden of preeclampsia [77][78] 2. **Long-term Morbidity**: Survivors of preeclampsia-related complications may face long-term health issues, including cerebral palsy and other disabilities, affecting their quality of life and family dynamics [14][78] 3. **Clinical Implications of Blood Pressure Control**: Maintaining systolic blood pressure below 160 mmHg is critical for prolonging pregnancy and reducing the risk of preterm delivery [82][84] 4. **Exploratory Endpoints**: The trials will also measure uterine artery blood flow resistance, which could indicate improved placental perfusion and better outcomes for both mother and baby [61][62] This summary encapsulates the critical insights from the DiaMedica Therapeutics event, emphasizing the significance of DM199 in addressing the unmet needs in preeclampsia treatment and its potential impact on maternal and neonatal health.

Financial Data and Key Metrics Changes - DiaMedica Therapeutics is in a pivotal phase two/three for ischemic stroke and simultaneously conducting a phase two study for preeclampsia, with key data expected in the next sixty days [3][34] - The company estimates a market opportunity of about 30,000 patients for early onset preeclampsia in the U.S., with a focus on severe cases that require hospitalization [13][14] Business Line Data and Key Metrics Changes - The primary asset, DM199, is a recombinant human tissue kallikrein-1 enzyme aimed at treating ischemic diseases, specifically targeting preeclampsia and ischemic stroke [1][3] - Current treatment options for preeclampsia are described as antiquated and ineffective, highlighting the potential for DM199 to fill a significant unmet need [14][19] Market Data and Key Metrics Changes - In the U.S., early onset preeclampsia occurs in up to 1% of pregnancies, translating to approximately 30,000 patients annually [13] - The company anticipates a high penetration rate for DM199 in the market due to the lack of effective current treatments [13][15] Company Strategy and Development Direction - DiaMedica aims to position DM199 as a disease-modifying therapy that is endothelial protective and lowers blood pressure, addressing the underlying dysfunction in preeclampsia [19][30] - The company is also exploring the acute ischemic stroke market, targeting patients who are not eligible for existing treatments like mechanical thrombectomy or tPA [43][49] Management's Comments on Operating Environment and Future Outlook - Management emphasizes the critical need for effective treatments in preeclampsia, noting that current medications often fail to manage symptoms effectively [19][54] - The company believes that the unique properties of DM199, such as its large molecular size, will provide a safety advantage by not crossing the placental barrier [15][30] Other Important Information - The clinical trial for preeclampsia is being conducted in South Africa due to high rates of the condition and access to experienced investigators [21][23] - Upcoming key opinion leader (KOL) event scheduled for May 28, 2025, to discuss the unmet need in preeclampsia and the trial design [58][60] Q&A Session Summary Question: Can you discuss the clinical development of DM199 for preeclampsia? - The company is in a pivotal phase two/three for ischemic stroke and a phase two for preeclampsia, with data expected in the next sixty days [3][34] Question: What is the market opportunity for DM199? - The estimated market opportunity for early onset preeclampsia in the U.S. is about 30,000 patients, with a focus on severe cases [13][14] Question: Why was South Africa chosen for the preeclampsia trial? - South Africa was selected due to high rates of preeclampsia and access to leading investigators who can conduct rigorous clinical trials [21][23] Question: How does DM199 differ from current treatments? - DM199 is a large molecule that does not cross the placental barrier, providing a safety advantage over current small molecule treatments [15][30] Question: What are the next steps for the company? - The company is preparing for a KOL event to discuss the unmet need in preeclampsia and the trial design, with data readouts expected in late June to early July [58][60]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported total combined cash and investments of $37.3 million, down from $44.1 million as of December 31, 2024, indicating a decrease due to net cash used to fund operations [11] - Current liabilities were reported at $4.7 million, compared to $5.4 million in the previous quarter, while working capital decreased to $32.8 million from $39.2 million [11] - Net cash used in operating activities for Q1 2025 was $7.1 million, an increase from $6.7 million in Q1 2024, primarily due to an increased net loss [12] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5.7 million for Q1 2025, up from $3.7 million in Q1 2024, driven by costs associated with the REMEDY two clinical trial and global expansion [12][13] - General and administrative expenses rose to $2.5 million from $2.1 million, mainly due to additional non-cash share-based compensation [13] Market Data and Key Metrics Changes - The company is currently engaged in two clinical development programs: preeclampsia and stroke, with significant progress reported in both areas [4][8] - Enrollment for the stroke program is progressing steadily, with participant enrollment now between the 20th and 25th percentile mark for the interim analysis [9] Company Strategy and Development Direction - The company aims to advance its clinical development programs, particularly focusing on the preeclampsia program, which is currently the only novel agent being studied in pregnant women with this condition [8] - The management is also working on expanding the stroke program's enrollment and maintaining momentum through site engagement [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in both clinical programs and highlighted the importance of upcoming milestones, including preliminary results from the preeclampsia trial and interim analysis from the stroke program [43] - The company anticipates that its current cash and investments will provide a runway into Q3 2026, indicating a focus on sustaining operations while advancing clinical trials [12] Other Important Information - A key opinion leader call regarding preeclampsia is scheduled for May 28, 2025, to educate stakeholders about the disease and the company's clinical trial design [6][8] - The company is actively engaging with high-volume sites to drive enrollment in the stroke program, with a focus on maintaining relationships and expanding geographic reach [33] Q&A Session Summary Question: Clarification on laboratory test results for DM199 - Management confirmed that the main variable affecting the timeline for results is the placental transfer assay, which is being finalized [17] Question: Triggers for Parts 2 and 3 of the preeclampsia study - Management indicated that dilation of intrauterine arteries would trigger the fetal growth restriction cohort, with more details to be shared after upcoming results [19][20] Question: Anticipated read-through from preeclampsia data to AIS development - Management noted that while the indications are unique, positive results in preeclampsia would confirm the activity of the protein being studied [25] Question: Update on stroke program enrollment - Management reported that high-enrolling sites are seeing one to two patients per month, and overall enrollment is above plan, with encouraging momentum [31][32] Question: Expansion of the preeclampsia study to the U.S. - Management confirmed plans to expand the study to the U.S. in the future, but the current focus remains on completing Part 1a and moving into Part 1b [39]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported total combined cash and investments of $37.3 million, down from $44.1 million as of December 31, 2024, indicating a decrease due to net cash used to fund operations [10] - Current liabilities decreased to $4.7 million from $5.4 million, while working capital fell to $32.8 million from $39.2 million [10] - Net cash used in operating activities for Q1 2025 was $7.1 million, compared to $6.7 million for Q1 2024, reflecting an increase in net loss [11] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5.7 million for Q1 2025, up from $3.7 million in Q1 2024, primarily due to costs associated with the REMEDY two clinical trial and global expansion [11][12] - General and administrative expenses rose to $2.5 million from $2.1 million, mainly due to additional non-cash share-based compensation [12] Market Data and Key Metrics Changes - The company is currently engaged in two clinical development programs: preeclampsia and stroke, with significant progress reported in both areas [4][8] - Enrollment for the stroke program is progressing steadily, with participant enrollment now between the 20th and 25th percentile mark for the interim analysis [8] Company Strategy and Development Direction - The company aims to advance its clinical development programs, particularly focusing on the preeclampsia program, which is expected to release preliminary top-line results between June and July [5][6] - The company plans to sponsor a preeclampsia key opinion leader call to educate stakeholders on the disease and treatment options [6][7] - Future expansion of the preeclampsia study to the U.S. is planned, with a focus on obtaining results from Part 1a before moving to Parts 1b, 2, and 3 [36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in both the preeclampsia and stroke programs, highlighting the importance of upcoming milestones [39] - The company anticipates that its current cash and investments will provide a runway into Q3 2026, indicating a stable financial position for ongoing operations [11] Other Important Information - The company has engaged an experienced stroke neurologist to support site engagement during a key team member's medical leave, ensuring continued enrollment momentum [8] Q&A Session Summary Question: Clarification on laboratory test results timing - Management confirmed that the main variable affecting the timing of results is the placental transfer assay, which is being finalized [15][16] Question: Triggers for advancing to Part 2 and 3 of the preeclampsia study - Management indicated that dilation of intrauterine arteries would trigger movement to the fetal growth restriction cohort [17][18] Question: Anticipated read-through from preeclampsia data to stroke development - Management noted that positive preeclampsia data would confirm the activity of the protein being studied, which is also used in stroke treatment [22][24] Question: Update on stroke program enrollment and high-volume centers - Management reported that some high-enrolling sites are achieving one to two patients per month, with overall enrollment momentum building [26][28] Question: Future expansion of the preeclampsia study to the U.S. - Management confirmed plans to expand the study to the U.S. in the future, contingent on results from the current phases [34][36]