DiaMedica Therapeutics Files 2023 Annual Report on Form 10-K

TL;DR

<b>DiaMedica Therapeutics Inc. has submitted its 2023 annual 10-K filing to the SEC, detailing its financial performance and business operations.</b>

AI Summary

DiaMedica Therapeutics Inc. (DMAC) filed a Annual Report (10-K) with the SEC on March 19, 2024. DiaMedica Therapeutics Inc. filed its annual report for the fiscal year ending December 31, 2023. The filing is a Form 10-K, a comprehensive report filed by public companies with the SEC. The company's principal business address is in Minneapolis, MN. The report covers the fiscal period from January 1, 2023, to December 31, 2023. DiaMedica Therapeutics Inc. was formerly known as DiaMedica Inc. until May 25, 2007.

Why It Matters

For investors and stakeholders tracking DiaMedica Therapeutics Inc., this filing contains several important signals. This 10-K filing provides investors with a detailed overview of DiaMedica's financial health, operational activities, and strategic direction for the fiscal year 2023. The comprehensive report allows stakeholders to assess the company's performance, risks, and future prospects in the pharmaceutical preparations industry.

Risk Assessment

Risk Level: medium — DiaMedica Therapeutics Inc. shows moderate risk based on this filing. The company operates in the highly regulated pharmaceutical industry, facing risks related to clinical trials, regulatory approvals, and market competition, as evidenced by the nature of a 10-K filing for a company in this sector.

Analyst Insight

Investors should review the detailed financial statements and risk factors within the 10-K to understand DiaMedica's current financial position and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-19 — Filing Date (As of date)
• 001-36291 — SEC File Number (SEC file number)

Key Players & Entities

• DiaMedica Therapeutics Inc. (company) — Filer name
• SEC (regulator) — Regulator receiving the filing
• 2023 (date) — Fiscal year end
• Minneapolis, MN (location) — Company business address
• 2024-03-19 (date) — Filing date
• DiaMedica Inc. (company) — Former company name

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, including the FDA, which can impact product development, manufacturing, and marketing.
• Market Competition [high — market]: The pharmaceutical market is highly competitive, with potential for new therapies and existing competitors impacting market share and pricing.
• Funding and Liquidity [medium — financial]: The company's ability to fund its operations and clinical development programs depends on its access to capital, which may be limited.
• Clinical Trial Risks [high — operational]: Clinical trials are inherently uncertain and may not demonstrate the safety or efficacy of the company's drug candidates, leading to delays or discontinuation.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-19: Filing Date — Date the 10-K was officially submitted to the SEC.

Filing Documents

• dmtp20231231_10k.htm (10-K) — 1528KB
• ex_640349.htm (EX-4.1) — 29KB
• ex_640350.htm (EX-10.23) — 10KB
• ex_637827.htm (EX-23.1) — 2KB
• ex_637809.htm (EX-31.1) — 10KB
• ex_637808.htm (EX-31.2) — 10KB
• ex_637803.htm (EX-32.1) — 7KB
• ex_637802.htm (EX-32.2) — 7KB
• ex_640351.htm (EX-97.1) — 50KB
• a01.jpg (GRAPHIC) — 26KB
• a02.jpg (GRAPHIC) — 18KB
• a03.jpg (GRAPHIC) — 67KB
• a04.jpg (GRAPHIC) — 50KB
• a05.jpg (GRAPHIC) — 79KB
• a06.jpg (GRAPHIC) — 57KB
• chart1.jpg (GRAPHIC) — 31KB
• logo01.jpg (GRAPHIC) — 18KB
• 0001437749-24-008522.txt (&nbsp;) — 7002KB
• dmac-20231231.xsd (EX-101.SCH) — 53KB
• dmac-20231231_def.xml (EX-101.DEF) — 346KB
• dmac-20231231_lab.xml (EX-101.LAB) — 298KB
• dmac-20231231_pre.xml (EX-101.PRE) — 379KB
• dmac-20231231_cal.xml (EX-101.CAL) — 41KB
• dmtp20231231_10k_htm.xml (XML) — 787KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 29 Item 1B. Unresolved Staff Comments 63 Item 1C. Cybersecurity 63 Item 2.

Properties

Properties 64 Item 3.

Legal Proceedings

Legal Proceedings 65 Item 4. Mine Safety Disclosures 65 PART II 66 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 66 Item 6. [Reserved] 76 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 77 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 85 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 86 Item 9. Changes In and Disagreements With Accountants on Accounting and Financial Disclosure 108 Item 9A.

Controls and Procedures

Controls and Procedures 108 Item 9B. Other Information 109 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 109 PART III 110 Item 10. Directors, Executive Officers and Corporate Governance 110 Item 11.

Executive Compensation

Executive Compensation 110 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 110 Item 13. Certain Relationships and Related Transactions, and Director Independenc 112 Item 14. Principal Accountant Fees and Services 112 PART IV 113 Item 15. Exhibits and Financial Statement Schedules 113 Item 16. Form 10-K Summary 117

SIGNATURES

SIGNATURES 118 i This annual report on Form 10-K contains certain forward-looking statements that are within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created by those sections. For more information, see " Cautionary Note Regarding Forward-Looking Statements. " As used in this report, references to " DiaMedica, " the " Company, " " we, " " our " or " us, " unless the context otherwise requires, refer to DiaMedica Therapeutics Inc. and its subsidiaries, all of which are consolidated in DiaMedica ' s consolidated financial statements. References in this report to " common shares " mean our voting common shares, no par value per share. We own various unregistered trademarks and service marks, including our corporate logo. Solely for convenience, the trademarks and trade names in this report are referred to without the and symbols, but such references should not be construed as any indicator that the owner of such trademarks and trade names will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend the use or display of other companies ' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. ii CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Business

Business Overview We are a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious diseases. DiaMedica's lead candidate DM199 (rinvecalinase alfa) is the first pharmaceutically active recombinant (synthetic) form of the human tissue kallikrein-1 (KLK1) protein to be clinically studied in patients. KLK1 is an established therapeutic modality in Asia, with human urinary KLK1, for the treatment of acute ischemic stroke and cardio renal disease, including hypertension. We have also produced a potential novel treatment for severe inflammatory diseases, DM300, which is currently in the early preclinical stage of development. Our long-term goal is to use our patented and in-licensed technologies to establish our Company as a leader in the development and commercialization of therapeutic treatments from novel recombinant proteins. Our current focus is on the treatment of acute ischemic stroke (AIS) and currently, to a lesser extent, cardio renal disease (CRD). We plan to advance DM199, our lead drug candidate, through required clinical trials to create shareholder value by establishing its clinical and commercial potential as a therapy for AIS and CRD. In September 2021, the FDA granted Fast Track designation to DM199 for the treatment of AIS where tPA and/or mechanical thrombectomy are not indicated or medically appropriate. AIS and CRD patients suffer from impaired blood flow in the brain, kidneys, and throughout the body. Many of these patients also exhibit lower than normal levels of endogenous (produced by the body) KLK1 protein, which is produced primarily in the kidneys, pancreas and salivary glands. We believe treatment with DM199 could augment endogenous KLK1 to enhance the function of the kallikrein-kinin system (KKS) to preferentially relax smooth muscle cells in ischemic arteries, thereby vasodilating these arteries and increasing blood flow and oxygen. We are currently conducting our ReMEDy2 clinical tria

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View this 10-K filing on SEC EDGAR