[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures for the reporting period [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended September 30, 2023, show a significant increase in total assets and shareholders' equity, primarily due to proceeds from a private placement, while the net loss widened due to increased research and development expenses, with no revenue from product sales Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $2,232 | $4,728 | | Total current assets | $47,886 | $33,835 | | Total assets | $58,139 | $34,395 | | Total current liabilities | $2,170 | $2,168 | | Total shareholders' equity | $55,629 | $31,827 | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,272 | $1,640 | $9,433 | $5,569 | | General and administrative | $1,885 | $1,488 | $5,986 | $4,459 | | Operating loss | ($5,157) | ($3,128) | ($15,419) | ($10,028) | | Net loss | ($4,471) | ($3,059) | ($14,220) | ($9,925) | | Basic and diluted net loss per share | ($0.12) | ($0.12) | ($0.46) | ($0.38) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($14,916) | ($8,745) | | Net cash (used in) provided by investing activities | ($24,423) | $6,814 | | Net cash provided by (used in) financing activities | $36,843 | ($5) | | Net decrease in cash and cash equivalents | ($2,496) | ($1,936) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing its lead candidate, DM199, for acute ischemic stroke (AIS) and cardio-renal disease (CRD), highlighting the recent lifting of the FDA clinical hold on the ReMEDy2 trial, the financial impact of increased R&D and G&A expenses, and the significant boost to liquidity from private placements in April and June 2023, providing sufficient capital for at least the next 12 months - The company's primary focus is advancing its lead candidate **DM199**, a recombinant form of human tissue kallikrein-1 (KLK1), for the treatment of acute ischemic stroke (AIS) and cardio-renal disease (CRD)[67](index=67&type=chunk) - In June 2023, the FDA lifted the clinical hold on the Phase 2/3 ReMEDy2 trial for DM199 in AIS, allowing the company to resume preparations for the trial[70](index=70&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,272 | $1,640 | $9,433 | $5,569 | | General and administrative | $1,885 | $1,488 | $5,986 | $4,459 | - The company raised **$36.8 million** in net proceeds from private placements in April and June 2023, which is expected to fund planned operations for at least the next 12 months[74](index=74&type=chunk)[94](index=94&type=chunk) Liquidity and Capital Resources Summary (in thousands) | Metric | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $56,212 | $33,502 | | Working capital | $45,716 | $31,667 | [Quantitative and Qualitative Disclosures about Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, DiaMedica Therapeutics Inc. is not required to provide disclosure for this item - The company is not required to provide disclosure pursuant to this item as it qualifies as a smaller reporting company[99](index=99&type=chunk) [Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2023, with no material changes to the company's internal control over financial reporting 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**[100](index=100&type=chunk) - No changes in internal control over financial reporting occurred during the third quarter of 2023 that have materially affected, or are reasonably likely to materially affect, these controls[101](index=101&type=chunk) [PART II. OTHER INFORMATION](index=27&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section details legal proceedings, new risk factors related to financial institution stability, unregistered equity sales, and a list of exhibits filed with the report [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in litigation with Pharmaceutical Research Associates Group B.V. (ICON/PRA Netherlands), where a Dutch court ruled in DiaMedica's favor affirming its ownership of clinical study documents, a decision that ICON/PRA Netherlands has appealed with a primary case hearing scheduled for December 2023 - The company is in a legal dispute with ICON/PRA Netherlands regarding the possession of clinical study documents[103](index=103&type=chunk) - On April 21, 2023, the Netherlands Commercial Court (NCC) issued a judgment affirming DiaMedica's ownership of the documents; ICON/PRA Netherlands filed an appeal on June 15, 2023, and a hearing for the primary case is scheduled for **December 7, 2023**[104](index=104&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor has been added regarding the potential impact of financial institution instability, acknowledging that disruptions in the banking sector could adversely affect the company's ability to access cash deposits, obtain financing, and meet liquidity requirements following bank failures in early 2023 - A new risk factor was disclosed concerning the stability of financial institutions, prompted by the bank failures of Silicon Valley Bank, Signature Bank, and First Republic Bank in early 2023[106](index=106&type=chunk) - The risk highlights that future disruptions could adversely affect the company's ability to access its cash, obtain financing, or meet liquidity requirements, and could also impact its suppliers and vendors[106](index=106&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported that it did not sell any unregistered equity securities during the third quarter ended September 30, 2023 - No unregistered equity securities were sold during the quarter ended September 30, 2023[107](index=107&type=chunk) [Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the quarterly report, including corporate governance documents, material contracts, and certifications by the CEO and CFO as required by the Sarbanes-Oxley Act - The report includes a list of exhibits filed, such as the Notice of Articles, Amended and Restated Articles, a Consulting Services Agreement, a Separation Agreement, and various officer certifications[111](index=111&type=chunk)[112](index=112&type=chunk)

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q2 2023 Earnings Call Transcript August 15, 2023 8:00 AM ET Company Participants Rick Pauls - President and CEO Scott Kellen - CFO Conference Call Participants Thomas Flaten - Lake Street Capital Alex Nowak - Craig-Hallum Capital Group Dan Hultberg - Oppenheimer Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Second Quarter 2023 Conference Call. An audio recording of the webcast will be available shortly after the call today on ...

Financial Performance - For the six months ended June 30, 2023, the net loss was $9.7 million, compared to $6.9 million for the same period in 2022, reflecting an increase in operating expenses primarily due to R&D activities [80]. - The company reported a net cash used in operating activities of $10.1 million for the six months ended June 30, 2023, compared to $6.4 million for the same period in 2022 [93]. - Net cash used in investing activities was $25.6 million for the six months ended June 30, 2023, compared to net cash provided of $4.7 million in 2022, primarily due to the timing of marketable securities transactions [94]. - Net cash provided by financing activities was $36.8 million for the six months ended June 30, 2023, compared to a net cash usage of $3 thousand for the same period in 2022 [95]. Research and Development - Research and Development (R&D) expenses increased to $2.5 million for the three months ended June 30, 2023, up from $2.0 million for the same period in 2022, and $6.2 million for the six months ended June 30, 2023, up from $3.9 million in 2022 [89]. - The company has incurred losses while advancing the R&D of its DM199 product candidate and has not generated any revenues from product sales [96]. - The company expects substantial additional capital will be needed to further R&D activities and clinical studies for DM199 [97]. Cash Position and Funding - As of June 30, 2023, the company had cash, cash equivalents, and marketable securities totaling $60.7 million, an increase from $33.5 million as of December 31, 2022 [92]. - The company generated $36.9 million in net proceeds from private placements in April and June 2023, which contributed to the increase in cash resources [80]. - The company expects its monthly negative cash flow to increase as it resumes the ReMEDy2 trial, but current cash resources are projected to be sufficient for at least the next 12 months [81]. - Current cash resources are expected to be sufficient to resume the ReMEDy2 trial and fund operations for at least the next twelve months [97]. - The company has historically financed operations primarily through sales of equity securities and expects to continue this practice [99]. - If additional capital is raised through equity or convertible debt securities, shareholder ownership interests will be diluted [100]. - The company may need to scale back operations if adequate funding is not available, which could include cost reduction strategies and licensing rights to third parties [101]. Clinical Trials - The ReMEDy2 trial aims to enroll approximately 350 patients across 75 sites in the U.S., focusing on patients with acute ischemic stroke who currently have limited treatment options [75]. - The FDA lifted the clinical hold on the ReMEDy2 trial in June 2023, allowing the company to resume preparations for the trial [76]. Administrative Expenses - General and Administrative (G&A) expenses were $2.2 million for the three months ended June 30, 2023, up from $1.4 million in 2022, and $4.1 million for the six months ended June 30, 2023, compared to $3.0 million in 2022 [90]. Accounting Policies - There have been no material changes to critical accounting policies and estimates from the previous annual report [102].

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q1 2023 Earnings Conference Call May 16, 2023 8:00 AM ET Company Participants Rick Pauls - President and Chief Executive Officer Scott Kellen - Chief Financial Officer Conference Call Participants Thomas Flaten - Lake Street Capital Alex Nowak - Craig-Hallum Daniel Hultberg - Oppenheimer Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter 2023 Conference Call. An audio recording of the webcast will be available shortl ...

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 March 31, 2023 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. (Exac ...

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q4 2022 Earnings Conference Call March 29, 2023 8:00 AM ET Company Participants Rick Pauls - President and Chief Executive Officer Scott Kellen - Chief Financial Officer Kirsten Gruis - Chief Medical Officer Conference Call Participants Thomas Flaten - Lake Street Capital Markets Alexander Nowak - Craig-Hallum Capital Group Daniel Hultberg - Oppenheimer Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics ReMEDy2 Update Conference C ...

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to __________________. 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, 2022 or Commission file number: 001-36291 DIAMEDICA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Britis ...

Financial Performance - For the nine months ended September 30, 2022, net losses were $9.9 million compared to $10.3 million for the same period in 2021, resulting in an accumulated deficit of $92.4 million as of September 30, 2022[88]. - Net cash used in operating activities for the nine months ended September 30, 2022, was $8.7 million, a slight decrease from $9.4 million in the same period of 2021[105]. - Net cash provided by investing activities was $6.8 million for the nine months ended September 30, 2022, compared to a net cash used of $11.8 million in the prior year[106]. - Net cash used in financing activities was $5,000 for the nine months ended September 30, 2022, down from $30.1 million provided in the same period of 2021[107]. - The company has incurred losses while advancing the R&D of its DM199 product candidate and has not generated any revenues from product sales[108]. - The company expects to continue incurring substantial operating losses in the near term as it advances research and clinical studies for DM199[108]. Research and Development - Research and Development (R&D) expenses decreased to $1.6 million for the three months ended September 30, 2022, down from $2.3 million for the same period in 2021, and decreased to $5.6 million for the nine months ended September 30, 2022, down from $6.9 million in 2021[99]. - The company has identified a potential new treatment for inflammatory diseases, DM300, which is in the preclinical stage of development[87]. - The company anticipates needing substantial additional capital to further R&D activities and clinical studies for DM199[110]. Clinical Trials - The ReMEDy2 trial aims to enroll approximately 350 patients and is designed to serve as a pivotal registration study for DM199 in treating acute ischemic stroke[82]. - The FDA placed a clinical hold on the ReMEDy2 trial due to three instances of clinically significant hypotension, which the company is currently addressing[84]. - The company completed patient enrollment in the REDUX clinical trial for chronic kidney disease (CKD) with a total of 79 patients as of December 31, 2021[86]. Cash Resources and Funding - As of September 30, 2022, cash, cash equivalents, and marketable securities totaled $36.1 million, down from $45.1 million as of December 31, 2021[104]. - The company anticipates that its current cash resources will be sufficient to continue operations for at least the next twelve months, but may require additional funding earlier than expected[91]. - Current cash resources are expected to be sufficient for at least the next twelve months to continue operations and clinical trials[110]. - The company has historically financed operations primarily through sales of equity securities and expects to continue this practice[111]. - If additional capital is raised through equity or convertible debt, shareholder ownership interests will be diluted[112]. - Inadequate funding may require the company to scale back operations or implement cost reduction strategies[113]. Operating Expenses - General and Administrative (G&A) expenses increased to $1.5 million for the three months ended September 30, 2022, up from $1.1 million in 2021, and increased to $4.5 million for the nine months ended September 30, 2022, up from $3.5 million in 2021[100]. - The company expects to incur significant expenses and increased operating losses for at least the next several years as it advances clinical programs, particularly if the clinical hold on the ReMEDy2 trial is lifted[90].

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)