DiaMedica Therapeutics(DMAC) - 2025 Q2 - Quarterly Results

Executive Summary & Business Update 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 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][3][9] - The lead candidate, DM199, is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein[3][9] - 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] Recent Corporate and Clinical Highlights 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 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] - DM199 demonstrated highly statistically significant and clinically meaningful reductions in systolic and diastolic blood pressure for combined cohorts 6-9[4][5] - DM199 appeared safe and well tolerated with no evidence of placental transfer for any dose[4][5] - A highly statistically significant reduction in uterine artery pulsatility index suggested an improvement in uterine artery blood flow and placental perfusion[4] Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2/3 Trial Progress 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][7] - Interim analysis on the first 200 patients in the ReMEDy2 trial is expected to be completed in the second quarter of 2026[5][7] Key Corporate Milestones 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][7] - Included in the Russell 2000® and 3000® Indexes in June 2025[5][7] - Appointed Julie Krop, MD, as Chief Medical Officer in August 2025, bringing over 20 years of experience in therapeutic and orphan indications[5][7] Second Quarter 2025 Financial Results This section details DiaMedica's second quarter 2025 financial performance, including cash position, operating expenses, net loss, and comprehensive financial statements Financial Highlights 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 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] - 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] 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 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] - The increase in G&A expenses resulted primarily from additional non-cash share-based compensation and increased personnel costs[10] Net Loss Overview 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 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 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 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 This section provides supplementary information, including conference call details, company background, forward-looking statements, and contact information Conference Call and Webcast Information 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][5][8] - The webcast will remain available for playback on the Company's website under investor relations - events and presentations for 12 months[8] About DiaMedica Therapeutics Inc. 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] - 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] - DM199, the lead candidate, is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein[9] Cautionary Note Regarding Forward-Looking Statements 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] - Applicable risks include those related to preclinical and clinical data, regulatory approvals, trial enrollment, adverse events, funding, and global supply chain issues[11] - DiaMedica undertakes no obligation to update or revise any forward-looking statements or information, except as required by applicable laws[11] Contact Information 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] - Contact for Investor Inquiries: Mike Moyer, Managing Director, LifeSci Advisors, LLC, Phone: (617) 308-4306, Email: mmoyer@lifesciadvisors.com[12] - Contact for Media: Madelin Hawtin, LifeSci Communications, Email: mhawin@lifescicomms.com[12]