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 September 30, 2022 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 - As of June 30, 2022, the company's combined cash and investments totaled $38.4 million, down $2.6 million from $41 million at the end of Q1 2022 and down $6.7 million from $45.1 million at the prior year-end [18] - Research and development expenses for Q2 were $2 million, compared to $2.2 million in the same period last year, while year-to-date expenses were $3.9 million versus $4.6 million in the prior year [20] - General and administrative expenses for Q2 were $1.4 million, up from $1.2 million in the same period last year, with year-to-date expenses at $3 million compared to $2.4 million previously [22] Business Line Data and Key Metrics Changes - The enrollment in the ReMEDy2 stroke trial was paused due to three incidents of clinically significant hypotension, which were not reported in the prior Phase II ReMEDy1 trial [3][5] - The company plans to propose a revision of IV dose levels to match those in the ReMEDy1 trial, where DM199 was well tolerated [12] Market Data and Key Metrics Changes - The company noted that there were no similar hypotensive events reported with subcutaneous dosing, indicating that the issue was related to the IV bag used in the ReMEDy2 trial [15] Company Strategy and Development Direction - The company is focused on addressing the clinical hold imposed by the FDA and plans to submit a response in September, with the hope of resuming enrollment shortly thereafter [13][24] - The company aims to adjust the dosing strategy based on findings from the IV bag compatibility study, which indicated that the previous IV bags caused significant binding of the DM199 protein [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that the hypotensive events were related to the IV bag change rather than a problem with DM199 itself, suggesting that the drug is biologically active [14] - The company remains optimistic about resuming the trial and believes that adequate clinical monitoring can mitigate risks associated with hypotension [16] Other Important Information - The company highlighted that cash usage was lower than planned due to the enrollment halt, but current cash reserves are expected to support operations into early 2024 [19] Q&A Session Summary Question: How variable was the drug binding to the IV bag? - Management indicated that the binding was dependent on patient body weight, and they plan to drop the dosing in half to 0.5 micrograms per kg for all patients [26] Question: How have site activation discussions proceeded during the hold? - Management has maintained communication with sites and continued pre-activation activities, including budget discussions and staffing assessments [27] Question: How was enrollment pacing before the hold? - Management noted that enrollment was slow initially but showed a significant uptick in the month prior to the hold, indicating positive momentum [28] Question: Were there any issues with the IV bags during the Phase II trial? - Management acknowledged that binding was noted in earlier trials but deemed it not significant at that time [31] Question: What are the potential outcomes from the FDA feedback? - Management believes the issue is solely related to the IV bag and plans to adjust the dose accordingly, aiming for a clear path to lift the clinical hold [50]

PART I. FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and management's analysis for DiaMedica Therapeutics Inc [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Unaudited condensed consolidated financial statements as of June 30, 2022, report a **$6.9 million net loss** for the first six months, with total assets at **$39.3 million** and shareholders' equity at **$37.7 million** [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2022, total assets decreased to **$39.3 million** from **$45.6 million**, primarily due to reduced cash and marketable securities, while shareholders' equity declined to **$37.7 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,062 | $4,707 | | Marketable securities | $35,381 | $40,405 | | Total current assets | $39,173 | $45,439 | | Total assets | $39,258 | $45,551 | | **Liabilities & Equity** | | | | Total current liabilities | $1,536 | $1,524 | | Total shareholders' equity | $37,715 | $44,024 | | Total liabilities and shareholders' equity | $39,258 | $45,551 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net losses for the three and six months ended June 30, 2022, were **$3.4 million** and **$6.9 million** respectively, driven by R&D and G&A expenses, with no revenue generated Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $1,955 | $2,156 | $3,929 | $4,562 | | General and administrative | $1,409 | $1,209 | $2,971 | $2,422 | | Operating loss | ($3,364) | ($3,365) | ($6,900) | ($6,984) | | Net loss | ($3,358) | ($3,274) | ($6,866) | ($6,896) | | Basic and diluted net loss per share | ($0.13) | ($0.17) | ($0.26) | ($0.37) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$6.4 million** for the six months ended June 30, 2022, with a net decrease in cash and cash equivalents of **$1.6 million** Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($6,384) | ($6,402) | | Net cash provided by investing activities | $4,742 | $980 | | Net cash provided by (used in) financing activities | ($3) | $241 | | **Net decrease in cash and cash equivalents** | **($1,645)** | **($5,181)** | [Notes to the Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes detail **DM199** development, the FDA clinical hold on the ReMEDy2 trial, sufficient cash for the next twelve months, and accounting policies - The company's primary focus is developing **DM199**, a proprietary recombinant form of human tissue kallikrein-1 (KLK1) protein, for treating acute ischemic stroke (AIS) and chronic kidney disease (CKD)[29](index=29&type=chunk) - On July 6, 2022, the FDA placed a clinical hold on the Phase 2/3 ReMEDy2 trial for AIS after three patients experienced significant hypotension, with the company planning to submit a revised protocol in September 2022[31](index=31&type=chunk) - As of June 30, 2022, the company had **$38.4 million** in cash, cash equivalents, and marketable securities, expected to fund planned operations for at least the next twelve months[35](index=35&type=chunk)[36](index=36&type=chunk) - In June 2022, the company entered into a new 65-month lease for approximately **6,000 square feet** of office space in Minneapolis, MN, commencing September 1, 2022[58](index=58&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the clinical-stage biopharmaceutical focus on **DM199**, the FDA clinical hold on ReMEDy2, and financial performance, reporting a **$6.9 million net loss** for the first half of 2022 [Business and Clinical Pipeline Overview](index=18&type=section&id=Business%20and%20Clinical%20Pipeline%20Overview) DiaMedica is a clinical-stage biopharmaceutical company developing **DM199** for AIS and CKD, with the ReMEDy2 trial on FDA clinical hold and REDUX trial data being finalized - The Phase 2/3 ReMEDy2 trial for AIS is on an FDA clinical hold issued July 6, 2022, following a voluntary pause due to three instances of hypotension, with a revised protocol planned for submission in September 2022[82](index=82&type=chunk) - The REDUX Phase 2 clinical trial for CKD has completed patient treatment as of March 31, 2022, and the company is finalizing data and evaluating next steps[84](index=84&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2022, R&D expenses decreased by **$0.7 million** to **$3.9 million**, while G&A expenses increased by **$0.6 million** to **$3.0 million** Comparison of Operating Expenses (in thousands) | Expense Category | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $3,929 | $4,562 | ($633) | | General and administrative | $2,971 | $2,422 | $549 | - The decrease in R&D expenses for the six-month period was attributed to reduced costs from the wrap-up of the REDUX Phase 2 CKD trial and lower non-clinical testing and manufacturing development costs[97](index=97&type=chunk) - The increase in G&A expenses was primarily due to higher directors' and officers' liability insurance, personnel, and professional services costs to support expanding clinical programs[98](index=98&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2022, the company held **$38.4 million** in cash and marketable securities, sufficient for the next twelve months, but substantial additional capital is required for long-term development Liquidity and Capital Resources Summary (in thousands) | Metric | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $38,443 | $45,112 | | Working capital | $37,637 | $43,915 | - The company expects its current cash resources to be sufficient to fund operations for at least the next twelve months from the report's issuance date[106](index=106&type=chunk) - Future funding needs are substantial, and the company may seek additional capital through equity or debt financings or strategic collaborations, with the ability to raise funds dependent on clinical results, regulatory approvals, and market conditions[108](index=108&type=chunk)[109](index=109&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, DiaMedica Therapeutics Inc. is exempt from providing this disclosure - The company is not required to provide disclosure for this item as it qualifies as a smaller reporting company[112](index=112&type=chunk) [Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2022, with no material changes in internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[113](index=113&type=chunk) - No changes occurred in the company's internal control over financial reporting during the three months ended June 30, 2022, that materially affected or are reasonably likely to materially affect it[114](index=114&type=chunk) PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, and other disclosures for DiaMedica Therapeutics Inc [Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no current or threatened legal actions expected to have a material adverse effect on its financial position or operations - The company reports no current or threatened legal proceedings that are expected to have a material adverse effect[116](index=116&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor highlights the uncertainty and potential adverse impact of the FDA clinical hold on the Phase 2/3 ReMEDy2 trial - A new risk factor highlights the uncertainty surrounding the FDA clinical hold on the ReMEDy2 trial, noting it may take considerable time and expense to resolve[117](index=117&type=chunk) - There is no assurance that the company's proposed protocol modifications will be sufficient to convince the FDA to lift the clinical hold, and the FDA may require additional trials or impose stricter conditions[118](index=118&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=25&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, 2022 - No unregistered equity securities were sold during the quarter ended June 30, 2022[119](index=119&type=chunk) [Defaults Upon Senior Securities](index=25&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - This item is not applicable[120](index=120&type=chunk) [Mine Safety Disclosures](index=25&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[121](index=121&type=chunk) [Other Information](index=25&type=section&id=Item%205.%20Other%20Information) This item is not applicable to the company - This item is not applicable[122](index=122&type=chunk) [Exhibits](index=26&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate articles, incentive plans, agreements, and CEO/CFO certifications - Exhibits filed include the Amended and Restated 2019 Omnibus Incentive Plan, a new office lease agreement, and CEO/CFO certifications[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk)

Financial Data and Key Metrics Changes - As of March 31, 2022, the company's combined cash and investments totaled $41 million, down $4.1 million from $45.1 million at December 31, 2021, indicating a strong balance sheet that supports operations into early 2024 [18] - Research and development expenses for Q1 2022 were $2 million, a decrease of $400,000 from $2.4 million in Q1 2021, primarily due to reduced costs related to the REDUX CKD trial and lower DM199 manufacturing costs [19] - General and administrative expenses increased to $1.6 million in Q1 2022 from $1.2 million in Q1 2021, reflecting higher professional services costs and personnel expenses [20] Business Line Data and Key Metrics Changes - The ReMEDy2 stroke trial is progressing with nine hospital sites activated, up from four since the last call, with a target of approximately 17 sites activated by June [7] - The company is focusing on clinical study sites with the highest enrollment potential, aiming for a target of one patient per site per month [12][22] Market Data and Key Metrics Changes - The company is addressing staffing challenges at study sites by engaging a clinical support service firm to assist with patient recruitment and management [10][11] - The ongoing COVID-19 pandemic has impacted site staffing, but the reduction in cases is contributing to an increase in site activity [26] Company Strategy and Development Direction - The company is committed to advancing DM199, a synthetic form of KLK1 protein, which has the potential to improve recovery and reduce recurrence in stroke patients [13] - The focus remains on the stroke program while also preparing for the chronic kidney disease (CKD) program, with plans to select a lead cause of CKD for further development [15][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in the ReMEDy2 trial and the potential for DM199, citing positive results from previous studies [14] - The interim analysis for the ReMEDy2 trial is expected to be completed in 2023, with guidance indicating a focus on the first half of the year [23] Other Important Information - The company has made key personnel investments, including the hiring of a new Chief Commercial Officer to prepare for future product launches [28] - The company is exploring opportunities in both IG nephropathy and hypertensive African-American patient populations for CKD treatment [38] Q&A Session Summary Question: Enrollment rates at activated sites - Management indicated that it is still early to assess enrollment rates, targeting 0.25 patients per site per month for the interim analysis [22] Question: Cash runway and CKD investment - The cash runway primarily focuses on the stroke trial, with minimal investment in CKD development anticipated [23] Question: Support service for the stroke study - The support service went live in the last few weeks, with incremental costs expected to be several hundred thousand dollars, included in the current budget [25] Question: Total number of sites for the trial - The plan remains to activate up to 75 sites, focusing on those with higher enrollment potential [31] Question: Competing programs at study sites - Management does not foresee any competing programs interfering with enrollment, as ongoing studies target different treatment windows [36]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) 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 March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________ FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 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. (Exact na ...

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 ...