DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q4 2021 Earnings Conference Call March 15, 2022 8:00 AM ET Company Participants Rick Pauls - President & Chief Executive Officer Kirsten Gruis - Chief Medical Officer Dominic Cundari - Chief Commercial Officer Scott Kellen - Chief Financial Officer Conference Call Participants Alex Nowak - Craig-Hallum Capital Group Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Fourth Quarter 2021 Conference Call. An audio recording of the we ...

Financial Performance - Net losses for the years ended December 31, 2021, and 2020 were $13.6 million and $12.3 million, respectively, with an accumulated deficit of $82.5 million as of December 31, 2021[451]. - The company has not generated any revenues from product sales and relies on financing from equity sales and government grants[451]. - The company expects to incur substantial operating losses until product sales can generate sufficient revenues, with no revenue expected for at least three to five years[479]. - Net cash used in operating activities was $12.3 million in 2021, up from $9.2 million in 2020, reflecting increased net loss and changes in operating assets and liabilities[476]. - Net cash provided by financing activities increased to $30.1 million in 2021 from $28.8 million in 2020, driven by greater net proceeds from the September 2021 private placement[478]. Clinical Trials - The ReMEDy2 trial aims to enroll approximately 350 patients at 75 sites in the U.S., focusing on AIS patients who do not have treatment options due to tPA limitations[441]. - The Phase 2 REDUX trial for CKD completed enrollment with 79 subjects, including 21 African American subjects, 25 with IgAN, and 33 with Type 2 diabetes[446]. - Interim results from the REDUX trial indicated a -55% geometric mean decrease in UACR for African American patients with moderate to severe albuminuria[448]. - DM199 demonstrated clinically significant reductions in blood pressure for hypertensive patients in the REDUX trial, with a mean decrease of -19/-13 mmHg[448]. - Dosing the first patient in the ReMEDy2 trial triggered a $185,000 milestone payment to Catalent Pharma Solutions[444]. - A milestone payment of $185,000 was made in Q4 2021 for the initiation of dosing in the ReMEDy2 trial, with another milestone payment of $185,000 due upon the first regulatory approval of DM199[489]. Expenses and Funding - Research and development (R&D) expenses increased to $8.8 million in 2021 from $8.2 million in 2020, primarily due to costs for the Phase 2/3 ReMEDy2 trial and increased personnel costs[469]. - General and administrative (G&A) expenses rose to $4.9 million in 2021 from $4.5 million in 2020, driven by higher professional service costs and milestone payments[471]. - Significant expenses are expected to continue as the company activates sites and enrolls subjects in ongoing clinical trials[453]. - The company anticipates needing additional funding earlier than expected due to ongoing development efforts and potential new programs[454]. Cash and Assets - Cash, cash equivalents, and marketable securities increased to $45.1 million as of December 31, 2021, compared to $27.5 million in 2020, attributed to net proceeds from a private placement[474]. - Net cash used in investing activities was $20.5 million in 2021, compared to $16.1 million in 2020, primarily due to investments in marketable securities from the private placement proceeds[477]. - Future operating lease commitments total approximately $45,000 over the remainder of the lease, due within the next 12 months[488]. - Other income decreased to $0.1 million in 2021 from $0.4 million in 2020, mainly due to the cessation of R&D incentive receivables from the Australian Government[472].

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q3 2021 Earnings Conference Call November 11, 2021 8:00 AM ET Company Participants Rick Pauls - President, CEO & Director Scott Kellen - CFO & Company Secretary Conference Call Participants Alex Nowak - Craig-Hallum Capital Group Thomas Flaten - Lake Street Capital Markets Francois Brisebois - Oppenheimer Operator Good morning, ladies and gentlemen and welcome to the DiaMedica Therapeutics Third Quarter 2021 Conference Call. An audio recording of the webcast will be ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________ FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934‐‐ For the transition period from ________________ to __________________. Commission File Number: 001-36291 ____________________ DIAMEDICA THERAPEUTICS INC ...

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q2 2021 Earnings Conference Call August 12, 2021 8:00 AM ET Company Participants Rick Pauls - President, CEO & Director Scott Kellen - CFO & Company Secretary Conference Call Participants Etzer Darout - Guggenheim Securities Alex Nowak - Craig-Hallum Capital Thomas Flaten - Lake Street Capital Francois Brisebois - Oppenheimer Operator Good morning, ladies and gentlemen. And welcome to the DiaMedica Therapeutics Second Quarter 2021 Conference Call. An audio recording ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol Name of each exchange on which registered Voting common shares, no par value per share DMAC The Nasdaq Stock Market LLC FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934‐‐ For the transition period from __ ...

Financial Data and Key Metrics Changes - The net loss for Q1 2021 was $3.6 million or $0.19 per share, compared to a net loss of $2.4 million or $0.19 per share for the same period in the prior year [18] - Research and development expenses increased to $2.4 million from $1.4 million year-over-year, attributed to costs for the REDUX Phase 2 CKD study and increased staffing [19] - General and administrative expenses rose slightly to $1.2 million from $1.1 million, primarily due to higher insurance premiums and personnel costs [20] - Cash, cash equivalents, and marketable securities at the end of Q1 2021 were $23.4 million, down from $27.5 million at the end of 2020 [21][22] Business Line Data and Key Metrics Changes - The Acute Ischemic Stroke program is advancing with a Phase 2/3 study of DM199, with the IND submitted on April 16, 2021 [8][9] - Enrollment in the REDUX study reached 70 participants, with full enrollment of the diabetic kidney disease cohort and 70% completion in the IgA Nephropathy cohort [15][16] Market Data and Key Metrics Changes - The company is preparing for discussions with the FDA regarding stroke recurrence as a clinically significant endpoint, following positive results from the ReMEDy Phase 2 study [11][12] Company Strategy and Development Direction - The company plans to submit an application for fast-track designation for DM199 as part of the study initiation [13] - The strategy includes engaging a contract research organization to identify and qualify clinical sites for the upcoming studies [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the timelines for the Phase 2/3 study and does not anticipate significant issues with the IND submission [10][25] - The company expects to report preliminary top-line data from the diabetic kidney disease cohorts during the current quarter [15][28] Other Important Information - The company has sufficient drug supply for the study, with a shelf-life extending two years [49] - The current capital position is expected to fund operations through mid-2022, allowing completion of the REDUX study and initiation of the Phase 2/3 study [22] Q&A Session Summary Question: Status of fast-track designation submission - Management confirmed that the fast-track designation has not yet been submitted but plans to do so after receiving approval to proceed with the study [23][24] Question: Insights on kidney readout data - Management indicated that they would like to see a decrease in UACR proteinuria while maintaining or increasing eGFR [26][27] Question: Patient disposition in DKD trial - Management stated they prefer to wait for complete data before analyzing individual patient outcomes [30] Question: Implications of DKD data for IgA Nephropathy - Management discussed the potential for DM199 to improve kidney function across different causes of kidney disease, with a focus on differences among cohorts [39][40] Question: Timing for FDA approach regarding stroke recurrence - Management is exploring multiple pathways for stroke recurrence, including potential sub-studies or co-primary endpoints [35][36] Question: Activation of study sites - Management confirmed that they are in the process of identifying and activating clinical study sites, aiming for up to 75 sites [46] Question: Initial data readout expectations - Management anticipates interim results in 2022, with the study completion expected in 2023 [51]

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of $3.6 million in Q1 2021, up from $2.4 million, driven by higher R&D, with $23.4 million in cash and no revenue [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,329 | $7,409 | | Marketable securities | $20,072 | $20,098 | | Total current assets | $24,195 | $27,921 | | **Total assets** | **$24,356** | **$28,095** | | **Liabilities & Equity** | | | | Total current liabilities | $1,178 | $2,028 | | Total liabilities | $1,211 | $2,081 | | Total shareholders' equity | $23,145 | $26,014 | | **Total liabilities and shareholders' equity** | **$24,356** | **$28,095** | - Total assets decreased from **$28.1 million** at year-end 2020 to **$24.4 million** as of March 31, 2021, primarily due to a decrease in cash and cash equivalents used to fund operations[18](index=18&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Research and development | $2,406 | $1,349 | | General and administrative | $1,213 | $1,055 | | **Operating loss** | **($3,619)** | **($2,404)** | | **Net loss** | **($3,622)** | **($2,425)** | | **Net loss per share** | **($0.19)** | **($0.19)** | - The net loss increased by approximately **50%** year-over-year, primarily driven by a **78%** increase in Research and Development expenses[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,313) | ($2,978) | | Net cash used in investing activities | ($9) | ($5,301) | | Net cash provided by financing activities | $242 | $7,696 | | **Net decrease in cash and cash equivalents** | **($4,080)** | **($583)** | - Cash used in operating activities increased to **$4.3 million** in Q1 2021 from **$3.0 million** in Q1 2020, reflecting higher operating losses[26](index=26&type=chunk) - Financing activities in Q1 2021 consisted of **$244,000** from stock option exercises, compared to **$7.7 million** raised from a public offering in Q1 2020[26](index=26&type=chunk)[57](index=57&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage entity focused on developing DM199 for acute ischemic stroke (AIS) and chronic kidney disease (CKD) and has not yet generated any revenue from product sales[29](index=29&type=chunk)[30](index=30&type=chunk) - As of March 31, 2021, the company had an accumulated deficit of **$72.5 million** and management expects current cash, cash equivalents, and marketable securities to be sufficient to fund operations for at least the next twelve months[31](index=31&type=chunk)[32](index=32&type=chunk) - During Q1 2021, the company engaged a consulting firm owned by its Vice President of Regulatory Affairs, incurring charges of approximately **$107,000** for quality and regulatory support services[72](index=72&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses DM199's clinical progress for AIS and CKD, attributing increased net loss to R&D, and confirms sufficient capital for 12 months, with future funding required [Business Overview and Clinical Development](index=16&type=section&id=Business%20Overview%20and%20Clinical%20Development) - The company's primary focus is developing DM199, a recombinant human tissue kallikrein-1 (KLK1) protein, for the treatment of acute ischemic stroke (AIS) and chronic kidney disease (CKD)[76](index=76&type=chunk)[77](index=77&type=chunk) - **AIS Program (ReMEDy2 Study):** Following positive FDA feedback, the company has filed an Investigational New Drug (IND) application for a Phase 2/3 adaptive trial and anticipates starting enrollment in the summer of 2021[79](index=79&type=chunk) - **CKD Program (REDUX Trial):** As of April 30, 2021, **70** of approximately **90** participants have been enrolled across three cohorts, with enrollment slower than expected due to COVID-19, but topline results from Cohort III (Type 2 diabetes) are expected in Q2 2021[80](index=80&type=chunk)[81](index=81&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Research and development | $2,406 | $1,349 | | General and administrative | $1,213 | $1,055 | - R&D expenses increased by **$1.0 million** year-over-year due to increased costs for the REDUX Phase 2 CKD study and preparation for the ReMEDy2 Phase 2/3 stroke study[93](index=93&type=chunk) - G&A expenses increased slightly, primarily due to higher costs for directors and officers liability insurance, personnel, and non-cash share-based compensation[94](index=94&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) Key Liquidity Metrics (in thousands) | Metric | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $23,400 | $27,507 | | Working capital | $23,017 | $25,893 | - The company expects its current cash resources to be sufficient to complete the REDUX Phase 2 study, initiate the ReMEDy2 Phase 2/3 study, and fund planned operations for at least the next twelve months[104](index=104&type=chunk) - Substantial additional capital will be required to further R&D activities and clinical trials, with future funding potentially sought through equity or debt financings or strategic collaborations[104](index=104&type=chunk)[105](index=105&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, DiaMedica is not required to provide this disclosure - The company is exempt from this disclosure requirement as it qualifies as a smaller reporting company[110](index=110&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2021, with no material changes to internal controls during the quarter - 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[111](index=111&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[112](index=112&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company refiled claims against PRA Netherlands in a Dutch Court in November 2020 after a U.S. court dismissed its 2013 clinical study dispute - The company is in a legal dispute with PRA Netherlands over alleged execution errors in a 2013 clinical trial for DM199[114](index=114&type=chunk) - After its case in U.S. District Court was dismissed, the company has ceased action in the United States and filed a complaint against PRA Netherlands in a Dutch Court in November 2020[114](index=114&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, DiaMedica is not required to provide this disclosure - The company is exempt from this disclosure requirement as it qualifies as a smaller reporting company[116](index=116&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not sell any unregistered equity securities during the quarter ended March 31, 2021 - There were no sales of unregistered equity securities during the first quarter of 2021[117](index=117&type=chunk) [Defaults Upon Senior Securities](index=23&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None - The company reported no defaults upon senior securities[118](index=118&type=chunk) [Mine Safety Disclosures](index=24&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - This item is not applicable to the company[120](index=120&type=chunk) [Other Information](index=24&type=section&id=Item%205.%20Other%20Information) Not applicable - This item is not applicable to the company[121](index=121&type=chunk) [Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate articles and officer certifications - A list of exhibits filed with the quarterly report is provided, including certifications from the CEO and CFO as required by the Sarbanes-Oxley Act[122](index=122&type=chunk)

Financial Data and Key Metrics Changes - The net loss for the full year of 2020 was $12.3 million or $0.78 per share, compared to a net loss of $10.6 million or $0.89 per share for the prior year, indicating a worsening in financial performance [20] - Research and development expenses increased to $8.3 million in 2020 from $7.9 million in 2019, primarily due to costs associated with the REDUX Phase 2 CKD study [20][21] - General and administrative expenses rose to $4.4 million in 2020 from $3.7 million in 2019, driven by increased non-cash share-based compensation and professional services [23] - Total other income decreased to $0.4 million in 2020 from $1 million in 2019, primarily due to reduced R&D incentives from the Australian Government [24] - Cash, cash equivalents, and marketable securities at the end of Q4 2020 were $27.5 million, up from $7.9 million at the end of 2019, reflecting successful public offerings [25][26] Business Line Data and Key Metrics Changes - The REDUX trial for DM199 in chronic kidney disease (CKD) has enrolled 68 participants, with full enrollment in the diabetic kidney disease cohort and 70% enrollment in the IgA Nephropathy cohort [16][17] - The company anticipates preliminary top-line results from the DKD cohort in Q2 2021, with completion of the IgA Nephropathy and African American cohorts expected in the second half of 2021 [17][18] Market Data and Key Metrics Changes - The FDA accepted the company's request for a pre-IND meeting for the Acute Ischemic Stroke program, indicating a positive regulatory environment for the company's stroke treatment initiatives [6][7] - AstraZeneca's label expansion for Brilinta to reduce stroke recurrence is viewed as a potential opportunity for DM199, which showed an 86% reduction in severe stroke recurrence in prior studies [11][12] Company Strategy and Development Direction - The company is focused on advancing its Acute Ischemic Stroke program and chronic kidney disease studies, with plans to submit an investigational new drug application for the Phase 2/3 study later in March 2021 [8][9] - The strategy includes pursuing IgA Nephropathy as an orphan indication while considering partnerships for broader CKD indications in the future [34][42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's guidance for the stroke program, believing it provides a clear path forward [8] - The company is preparing for potential partnerships to support the development of DM199 for both stroke and kidney disease indications, with a focus on obtaining more data before finalizing partnerships [42] Other Important Information - The company plans to host a Stroke Key Opinion Leader Webinar on March 19, 2021, to discuss the treatment landscape for Acute Ischemic Stroke [10] - The company is on track to complete significant milestones, including data readouts for the REDUX study and initiating the Phase 2/3 study in Acute Ischemic Stroke [27] Q&A Session Summary Question: Could you speak to the label expansion for stroke recurrence? - The company plans to reach out to the FDA after filing the IND to discuss clinical paths and powering for the pivotal study [29] Question: Any update on the timing for the pivotal stroke study? - The study is expected to start in summer 2021, with an estimated cost of around $30 million for 350 patients [31] Question: What are the exclusion criteria for the stroke study? - The protocol will exclude patients on tPA or those who have undergone mechanical thrombectomy [38] Question: How will the company handle potential pricing differentials for different indications? - The company is considering distinct product positioning for stroke and kidney disease, with a focus on finding the right partner for both indications [41][42] Question: What new data is anticipated at the upcoming Stroke Conference? - Potential new data may be presented, but specifics will be withheld until the event [43]

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q3 2020 Earnings Conference Call November 5, 2020 8:00 AM ET Company Participants Rick Pauls - President & CEO Scott Kellen - CFO Harry Alcorn - Chief Medical Officer Conference Call Participants Alex Nowak - Craig-Hallum Capital Group Thomas Flaten - Lake Street Capital Markets Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Third Quarter 2020 Conference Call. An audio recording of the webcast will be available shortly after t ...