DiaMedica Therapeutics(DMAC) - 2020 Q2 - Quarterly Report

Cautionary Note Regarding Forward-Looking Statements This report contains forward-looking statements based on current expectations that are subject to significant risks and uncertainties - Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect business, operating results, financial condition, and share price[9] - Key areas of forward-looking statements include plans for DM199 development, regulatory approval, commercialization, clinical testing success, market acceptance, partnership potential, trial costs and timing, impact of COVID-19, commercialization strategy, regulatory requirements, competition, funding, intellectual property, and use of offering proceeds[10] - Readers should not rely on forward-looking statements as predictions of future events, and the company does not intend to update them except as required by law[11] Part I. Financial Information Item 1. Financial Statements This section presents the company's unaudited condensed consolidated financial statements for the period ended June 30, 2020 Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheets (In thousands) | Metric | June 30, 2020 (unaudited) | December 31, 2019 | | :--- | :--- | :--- | | ASSETS | | | | Cash and cash equivalents | $4,955 | $3,883 | | Marketable securities | $6,844 | $3,995 | | Total current assets | $12,399 | $8,836 | | Total assets | $12,581 | $9,053 | | LIABILITIES AND EQUITY | | | | Total current liabilities | $1,217 | $1,318 | | Total non-current liabilities | $92 | $118 | | Total shareholders' equity | $11,272 | $7,617 | | Total liabilities and shareholders' equity | $12,581 | $9,053 | Condensed Consolidated Statements of Operations and Comprehensive Loss Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $1,629 | $1,874 | $3,010 | $4,481 | | General and administrative | $1,079 | $867 | $2,102 | $1,681 | | Operating loss | $(2,708) | $(2,741) | $(5,112) | $(6,162) | | Total other income | $(243) | $(280) | $(231) | $(458) | | Net loss | $(2,474) | $(2,469) | $(4,899) | $(5,721) | | Basic and diluted net loss per share | $(0.17) | $(0.21) | $(0.36) | $(0.48) | Condensed Consolidated Statements of Shareholders' Equity Changes in Shareholders' Equity (In thousands) | Item | Six Months Ended June 30, 2020 | | :--- | :--- | | Balances at December 31, 2019 | $7,617 | | Issuance of common shares (net of costs) | $7,682 | | Exercise of common stock options | $16 | | Share-based compensation expense | $829 | | Unrealized gain on marketable securities | $27 | | Net loss | $(4,899) | | Balances at June 30, 2020 | $11,272 | Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows (In thousands) | Cash Flow Activity | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,822) | $(6,005) | | Net cash used in investing activities | $(2,801) | $(7,916) | | Net cash provided by financing activities | $7,695 | $72 | | Net increase (decrease) in cash and cash equivalents | $1,072 | $(13,849) | | Cash and cash equivalents at end of period | $4,955 | $2,974 | Notes to the Condensed Consolidated Financial Statements These notes provide essential context for the financial statements, covering business activities, risks, and accounting policies 1. Business - DiaMedica Therapeutics Inc. focuses on advancing the clinical and commercial development of a proprietary recombinant Kallikrein-1 protein (KLK1) for kidney and neurological diseases, primarily chronic kidney disease (CKD) and acute ischemic stroke (AIS)[27] 2. Risks and Uncertainties - The company operates in a highly regulated and competitive environment, with its initial product candidate, DM199, still in the clinical stage and not expected to be commercially available for at least three to five years, if at all[28] - Clinical testing is adversely impacted by the COVID-19 pandemic, causing slower than expected enrollment in the REDUX clinical trial due to safety concerns at study sites[29] - DiaMedica has incurred $61.5 million in losses since inception and expects to continue incurring significant operating losses until product sales or licensing revenues are generated[31] - Current cash resources are expected to fund operations through 2021, including completion of all three cohorts in the REDUX Phase II study, but substantial additional capital will be needed for further R&D and regulatory activities[32] 3. Summary of Significant Accounting Policies - Interim financial statements are prepared in accordance with US GAAP and SEC Form 10-Q instructions, reflecting normal recurring accruals[34] - Cash and cash equivalents include bank deposits, money market funds, and other investments with original maturities of three months or less[35] - Marketable securities, primarily government and corporate obligations and bank CDs, are classified as available-for-sale, carried at fair value, with unrealized gains/losses reported in accumulated other comprehensive income[37] - Fair value measurements are categorized into a three-level hierarchy based on input observability: Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1), and Level 3 (unobservable inputs)[40][41] 4. Marketable Securities Marketable Securities at Fair Value (In thousands) | Type of Security | June 30, 2020 (Total) | June 30, 2020 (Level 2) | December 31, 2019 (Total) | December 31, 2019 (Level 2) | | :--- | :--- | :--- | :--- | :--- | | Government securities | $4,841 | $4,841 | $1,998 | $1,998 | | Bank certificates of deposit | $2,003 | $2,003 | — | — | | Commercial paper and corporate bonds | — | — | $1,997 | $1,997 | | Total | $6,844 | $6,844 | $3,995 | $3,995 | - All marketable securities are classified as Level 2 in the fair value hierarchy, with maturities of individual securities less than one year, and the primary objective of the investment policy is principal preservation[42][44] 5. Amounts Receivable Amounts Receivable (In thousands) | Type of Receivable | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Research and development incentives | $264 | $793 | | Sales-based taxes receivable | $37 | $13 | | Other | $18 | $17 | | Total amounts receivable | $319 | $823 | 6. Deposits Deposits (In thousands) | Item | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Advances to vendors - current | $46 | $88 | - The company periodically advances interest-free funds to vendors supporting clinical trials, recoverable through invoice reductions, application against final invoices, or refunds[47] 7. Property and Equipment Property and Equipment, Net (In thousands) | Item | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Furniture and equipment | $51 | $51 | | Computer equipment | $58 | $56 | | Less accumulated depreciation | $(54) | $(43) | | Property and equipment, net | $55 | $64 | 8. Accrued Liabilities Accrued Liabilities (In thousands) | Type of Accrued Liability | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Accrued clinical study costs | $166 | $433 | | Accrued compensation | $232 | $419 | | Accrued research and other professional fees | $188 | $172 | | Accrued taxes and other liabilities | $23 | $52 | | Total accrued liabilities | $609 | $1,076 | 9. Operating Lease - The company leases office space under a non-cancelable operating lease that terminates on August 31, 2022, with no renewal option[50] - The estimated incremental borrowing rate used for lease valuation is 9%[51] Operating Lease Obligation Maturities (In thousands) | Year | Amount | | :--- | :--- | | 2020 | $33 | | 2021 | $68 | | 2022 | $46 | | Total lease payments | $147 | | Less interest portion | $(15) | | Present value of lease obligation | $132 | 10. Shareholders' Equity - On February 13, 2020, the company issued and sold 2,125,000 common shares in a public offering at $4.00 per share, generating net proceeds of approximately $7.7 million[56] - During the six months ended June 30, 2020, 7,200 common shares were issued from option exercises for $16,000[57] Common Shares Reserved for Future Issuance | Item | Number of Shares | | :--- | :--- | | Stock options outstanding | 1,413,988 | | Deferred share units outstanding | 47,237 | | Shares available for grant under the 2019 Omnibus Incentive Plan | 1,103,551 | | Common shares issuable under common share purchase warrants | 255,000 | | Total | 2,819,776 | 11. Net Loss Per Share Net Loss Per Common Share | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Net loss (in thousands) | $(2,474) | $(2,469) | $(4,899) | $(5,721) | | Weighted average shares outstanding | 14,139,074 | 11,979,401 | 13,623,400 | 11,968,200 | | Basic and diluted net loss per share | $(0.17) | $(0.21) | $(0.36) | $(0.48) | - Diluted EPS is the same as basic EPS because common equivalent shares (stock options, warrants, deferred units) were anti-dilutive[60][61] 12. Share-Based Compensation - The 2019 Omnibus Incentive Plan authorizes up to 2,000,000 common shares for various awards, with options generally vesting over one to three years for employees/directors and one year for non-employees[62] Share-Based Compensation Expense (In thousands) | Expense Category | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $131 | $67 | $238 | $125 | | General and administrative | $305 | $115 | $591 | $187 | | Total share-based compensation | $436 | $182 | $829 | $312 | Stock Option Activity Summary (In thousands, except share and per share amounts) | Item | Shares Underlying Options Outstanding | Weighted Average Exercise Price Per Share | | :--- | :--- | :--- | | Balances at December 31, 2019 | 1,220,359 | $5.26 | | Granted | 267,332 | $4.75 | | Exercised | (7,200) | $2.21 | | Expired/cancelled | (66,505) | $5.04 | | Balances at June 30, 2020 | 1,413,988 | $5.19 | 13. Subsequent Event - On August 10, 2020, the company issued and sold 4,600,000 common shares in a public offering at $5.00 per share, resulting in gross proceeds of $23.0 million and net proceeds of approximately $21.1 million[70] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial condition, operational results, liquidity, and the impact of the COVID-19 pandemic Business Overview - DiaMedica is a clinical-stage biopharmaceutical company focused on developing novel recombinant proteins, with a primary focus on chronic kidney disease (CKD) and acute ischemic stroke (AIS)[75] - The lead drug candidate, DM199, is a recombinant form of human tissue kallikrein-1 (KLK1), believed to have potential in treating diseases where KLK1 activity is crucial for local blood flow, vasodilation, inflammation, and oxidative stress[76] DM199 Product Candidate Clinical Development This section details the progress of DM199 clinical trials, including the REDUX trial for CKD and the ReMEDy trial for AIS REDUX Clinical Trial (CKD) - The REDUX trial is a multi-center, open-label Phase II clinical trial for CKD, enrolling approximately 90 participants across three cohorts: non-diabetic, hypertensive African Americans; participants with IgA Nephropathy (IgAN); and participants with Type II diabetes mellitus, CKD, hypertension, and albuminuria[77] - As of August 5, 2020, 18 subjects were enrolled, but enrollment is slower than expected due to the COVID-19 pandemic impacting clinical study site activities and patient concerns[79] - Primary endpoints include safety, tolerability, blood pressure, albuminuria, and kidney function (eGFR and urinary albumin to creatinine ratio)[77] ReMEDy Clinical Trial (AIS) - The ReMEDy study for acute ischemic stroke (AIS) concluded enrollment in October 2019 with 92 participants[80] - Positive top-line results announced May 13, 2020, showed achievement of primary safety and tolerability endpoints with no DM199-related serious adverse events[80] - A therapeutic effect was demonstrated in participants who received tissue plasminogen activator (tPA) prior to enrollment, but not in those receiving mechanical thrombectomy[80] Financial Overview - The company has not generated product sales revenue and has financed operations through equity sales, warrant/option exercises, interest income, and government grants, incurring an accumulated deficit of $61.5 million as of June 30, 2020[82] - Net losses were $4.9 million for the six months ended June 30, 2020, and $5.7 million for the same period in 2019[82] - A subsequent public offering on August 10, 2020, generated approximately $21.1 million in net proceeds, which, combined with current cash resources, is expected to fund operations through 2021 and complete the REDUX Phase II study[83][85] - Significant expenses and operating losses are expected to continue, particularly as DM199 advances in clinical development[84] Overview of Expense Components This section outlines the primary components of the company's R&D and G&A operating expenses and discusses expected trends Research and Development Expenses - R&D expenses primarily consist of fees to external service providers (CROs), clinical development obligations, manufacturing costs for DM199, and personnel costs (salaries, benefits, share-based compensation)[86] - A delay in the timing of R&D costs is expected due to the COVID-19 pandemic, but not a significant overall increase in costs[87] - R&D expenses are expected to increase in the future as DM199 progresses to advanced clinical development stages[87] General and Administrative Expenses - G&A expenses include salaries, benefits, share-based compensation for executive, finance, business development, and support functions, as well as insurance, rent, utilities, travel, and professional fees[88] - G&A expenses are expected to increase with the expansion of development and operating activities[88] - COVID-19 led to temporary office closure and telework, but no significant additional G&A expenses were incurred in Q2 2020, nor are they expected going forward, with non-essential travel restricted[89] Other (Income) Expense - Other (income) expense primarily comprises governmental assistance (research incentives), interest income, and foreign currency exchange gains and losses[91] Results of Operations This section analyzes operating results for the three and six months ended June 30, 2020, compared to the same period in 2019 Research and Development Expenses Research and Development Expenses (In thousands) | Period | 2020 | 2019 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $1,629 | $1,874 | $(245) | | Six Months Ended June 30 | $3,010 | $4,481 | $(1,471) | - The decrease for the six-month period was primarily due to non-recurring costs of approximately $1.3 million for a DM199 drug substance production run in H1 2019 and a net decrease in clinical study costs, partially offset by costs for the REDUX Phase II CKD study and increased non-cash share-based compensation[93] General and Administrative Expenses General and Administrative Expenses (In thousands) | Period | 2020 | 2019 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $1,079 | $867 | $212 | | Six Months Ended June 30 | $2,102 | $1,681 | $421 | - The increase for both periods was primarily due to increased non-cash share-based compensation costs[94] Total Other (Income) Expense Total Other (Income) Expense (In thousands) | Period | 2020 | 2019 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $243 | $280 | $(37) | | Six Months Ended June 30 | $231 | $458 | $(227) | - The decrease for the six-month period was primarily related to reduced R&D incentives associated with decreased ReMEDy stroke study costs in H1 2019, partially offset by reduced foreign currency transaction losses[95] Liquidity and Capital Resources This section details the company's financial liquidity, cash flow activities, and future capital requirements to support operations Working Capital Liquidity and Capital Resources (In thousands) | Metric | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $11,799 | $7,878 | | Total current liabilities | $1,217 | $1,318 | | Working capital | $11,182 | $7,518 | - The increases in combined cash, cash equivalents, marketable securities, and working capital are primarily due to the February 2020 public offering of common shares[99] Cash Flows Cash Flow Data (In thousands) | Cash Flow Activity | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Operating activities | $(3,822) | $(6,005) | | Investing activities | $(2,801) | $(7,916) | | Financing activities | $7,695 | $72 | | Net increase (decrease) in cash and cash equivalents | $1,072 | $(13,849) | - Net cash used in operating activities decreased primarily due to a lower net loss[100][101][102][103] Capital Requirements - The company has incurred losses since inception, has no product sales revenue, and expects development to regulatory approval to take at least an additional three to five years, leading to continued substantial operating losses[104] - Current cash resources, including $21.1 million net proceeds from the August 2020 public offering, are expected to fund operations through 2021 and complete all three cohorts of the REDUX Phase II study[108] - Substantial additional capital will be required for R&D, clinical trials, and regulatory activities, which may be sought through equity/debt financings, strategic collaborations, or licensing agreements[108][109] - Risks of inadequate funding include scaling back operations, delaying DM199 development, licensing rights on unfavorable terms, or divesting assets/ceasing operations[111] Off-Balance Sheet Arrangements - The company has no off-balance sheet arrangements that could have a current or reasonably likely future material effect on its financial condition, results of operations, liquidity, capital expenditures, or capital resources[113] Critical Accounting Policies and Estimates - There have been no material changes to the critical accounting policies and estimates from those disclosed in the annual report on Form 10-K for the fiscal year ended December 31, 2019[114] Item 3. Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, DiaMedica is not required to provide quantitative and qualitative disclosures about market risk - The company is not required to provide disclosure regarding quantitative and qualitative market risk as it qualifies as a smaller reporting company[115] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2020 - Management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective as of June 30, 2020, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[116] - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2020, despite most employees working remotely due to the COVID-19 pandemic[117] Part II. Other Information Item 1. Legal Proceedings This section details ongoing litigation initiated by DiaMedica against PRA Netherlands and PRA Health Sciences, Inc - DiaMedica initiated litigation against PRA Netherlands and PRA Health Sciences, Inc. in November 2017 (re-filed August 2018) for alleged breaches of a clinical research agreement[120] - The complaint alleges PRA failed to conduct a Type 2 diabetes mellitus study according to protocol, resulting in confounded secondary efficacy endpoints due to significant execution errors and protocol deviations[120] - PRA also allegedly refused to provide full study records, and a motion to transfer the case to the United States District Court, District of Minnesota, filed in February 2019, is still awaiting a decision[120] Item 1A. Risk Factors This section discloses additional risks, primarily focusing on clinical trial disruptions caused by the COVID-19 pandemic - The COVID-19 pandemic is significantly disrupting clinical trials, causing delays or difficulties in participant enrollment and retention, initiation of new clinical sites, supply chain, and participant compliance with protocols[123] - These disruptions could negatively impact the timeline for data readouts, delay regulatory approvals, increase operating expenses, and materially affect financial results[125] - Conducting clinical trials outside the United States carries risks, including potential non-acceptance of data by the FDA, the need for additional costly and time-consuming trials, and challenges related to foreign regulatory requirements, exchange fluctuations, and intellectual property protection[127][128][129] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section confirms no unregistered sales occurred and updates the use of proceeds from the December 2018 IPO - No unregistered equity securities were sold or purchased by the company during the quarter ended June 30, 2020[130][131] - The initial public offering in December 2018 generated approximately $14.7 million in net proceeds from the sale of 4,100,000 common shares at $4.00 per share[133] - As of June 30, 2020, approximately $12.9 million of the IPO proceeds have been used to fund clinical development of DM199, conduct research activities, and for working capital and general corporate purposes, with no material change in the planned use of proceeds[134] Item 3. Defaults Upon Senior Securities This section states that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities[135] Item 4. Mine Safety Disclosures This section indicates that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable to the company[136] Item 5. Other Information This section states that there is no other information to report - No other information is applicable[137] Item 6. Exhibits This section lists all exhibits filed with the quarterly report, including corporate governance and financial documents - Exhibits include corporate governance documents (Notice of Articles, Articles), a Deferred Stock Unit Award Agreement, and certifications from the Chief Executive Officer and Chief Financial Officer pursuant to the Sarbanes-Oxley Act[139][140][141][142] - The financial statements from the quarterly report are also filed in XBRL format[143]