UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark one)
For the quarterly period ended
or
For the transition period from ________________ to __________________.
Commission File Number:
DIAMEDICA THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | Not Applicable (I.R.S. Employer Identification No.) |
|
(Address of principal executive offices) (Zip code) | |
(
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| | | The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ |
| | Smaller reporting company Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of May 3, 2022, there were
DiaMedica Therapeutics Inc.
FORM 10-Q
March 31, 2022
TABLE OF CONTENTS
| Description | Page | |
| CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS | 1 | |
| PART I. | FINANCIAL INFORMATION | |
| Item 1. | Financial Statements | 2 |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 13 |
| Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 19 |
| Item 4. | Controls and Procedures | 19 |
| PART II. | OTHER INFORMATION | |
| Item 1. | Legal Proceedings | 20 |
| Item 1A. | Risk Factors | 20 |
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 20 |
| Item 3. | Defaults Upon Senior Securities | 20 |
| Item 4. | Mine Safety Disclosures | 20 |
| Item 5. | Other Information | 20 |
| Item 6. | Exhibits | 21 |
| SIGNATURE PAGE | 22 | |
This quarterly report on Form 10-Q 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 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 condensed 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.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Statements in this report that are not descriptions of historical facts are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 that are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and share price. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” “will,” “would,” the negative of these terms or other comparable terminology, and the use of future dates.
The forward-looking statements in this report are subject to risks and uncertainties and include, among other things:
| ● |
our plans to develop, obtain regulatory approval for and commercialize our DM199 product candidate for the treatment of acute ischemic stroke (AIS) and chronic kidney disease (CKD) and our expectations regarding the benefits of our DM199 product candidate; |
| ● |
our ability to conduct successful clinical testing of our DM199 product candidate for AIS and CKD and certain anticipated or target dates, site activations and enrollment numbers with respect to our clinical studies, especially in the light of the novel strain of coronavirus, or COVID-19 pandemic on site activations and enrollment, and the effect of hospital and medical facility staffing shortages and concerns managing logistics and compliance for patients discharged from the hospital to an intermediate care facility on site activations and enrollment in our ReMEDy2 trial, and the effect of worldwide global supply chain shortages; |
| ● |
the adaptive design of our ReMEDy2 trial, which is intended to enroll approximately 350 patients at 75 sites in the United States, and the possibility that these numbers and other aspects of the study could change depending upon certain factors, including additional input from the United States Food and Drug Administration (FDA) and the blinded interim analysis; |
| ● |
our expectations regarding the final results of our REDUX trial and timing of the release thereof; |
| ● |
the perceived benefits of our DM199 product candidate over existing treatment options for AIS and CKD; |
| ● |
the potential size of the markets for our DM199 product candidate for AIS and CKD and our ability to serve those markets, and the rate and degree of market acceptance of our DM199 product candidate for AIS and CKD both in the United States and internationally; |
| ● |
our ability to partner with and generate revenue from biopharmaceutical or pharmaceutical partners to develop, obtain regulatory approval for and commercialize our DM199 product candidate for AIS and CKD; |
| ● |
the success, cost and timing of planned clinical studies, as well as our reliance on collaboration with third parties to conduct our clinical studies; |
| ● |
our expectations regarding the impact of the COVID-19 pandemic on our business, including in particular our progress with site activation and patient enrollment in our clinical studies and our ability to hire additional personnel; |
| ● |
our commercialization, marketing and manufacturing capabilities and strategy; |
| ● |
expectations regarding federal, state, and foreign regulatory requirements and developments, such as potential FDA regulation of our DM199 product candidate for AIS and CKD; |
| ● |
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
| ● |
our expectations regarding our ability to obtain and maintain intellectual property protection for our DM199 product candidate; |
| ● |
expectations regarding competition and our ability to obtain data exclusivity for our DM199 product candidate for AIS and CKD; |
| ● |
our ability to obtain funding for our operations, including funding necessary to complete planned clinical trials and obtain regulatory approvals for our DM199 product candidate for AIS and CKD; and |
| ● |
our anticipated use of the net proceeds from our underwritten public offerings and September 2021 private placement. |
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under “Part I. Item 1A. Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2021 and those described above and elsewhere in this report. Moreover, we operate in a very competitive and rapidly-changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Forward-looking statements should not be relied upon as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Except as required by law, including the securities laws of the United States, we do not intend to update any forward-looking statements to conform these statements to actual results or to changes in our expectations.
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
DiaMedica Therapeutics Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share amounts)
| March 31, 2022 | December 31, 2021 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Marketable securities | ||||||||
| Amounts receivable | ||||||||
| Deposits | ||||||||
| Prepaid expenses and other assets | ||||||||
| Total current assets | ||||||||
| Non-current assets: | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use asset | ||||||||
| Total non-current assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued liabilities | ||||||||
| Finance lease obligation | ||||||||
| Operating lease obligation | ||||||||
| Total current liabilities | ||||||||
| Non-current liabilities: | ||||||||
| Finance lease obligation, non-current | ||||||||
| Total non-current liabilities | ||||||||
| Shareholders’ equity: | ||||||||
| Common shares, par value; authorized; shares issued and outstanding as of March 31, 2022 and December 31, 2021 | ||||||||
| Paid-in capital | ||||||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total shareholders’ equity | ||||||||
| Total liabilities and shareholders’ equity | $ | $ | ||||||
See accompanying notes to the condensed consolidated financial statements.
DiaMedica Therapeutics Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended March 31, |
||||||||
| 2022 |
2021 |
|||||||
| Operating expenses: |
||||||||
| Research and development |
$ | $ | ||||||
| General and administrative |
||||||||
| Operating loss |
( |
) |
( |
) |
||||
| Other income: |
||||||||
| Other income, net |
||||||||
| Total other income, net |
||||||||
| Loss before income tax expense |
( |
) |
( |
) |
||||
| Income tax expense |
( |
) |
( |
) | ||||
| Net loss |
( |
) |
( |
) |
||||
| Other comprehensive loss |
||||||||
| Unrealized loss on marketable securities |
( |
) |
( |
) | ||||
| Net loss and comprehensive loss |
$ | ( |
) |
$ | ( |
) |
||
| Basic and diluted net loss per share |
$ | ( |
) |
$ | ( |
) |
||
| Weighted average shares outstanding – basic and diluted |
||||||||
See accompanying notes to the condensed consolidated financial statements.
DiaMedica Therapeutics Inc.
Condensed Consolidated Statements of Shareholders’ Equity
For the Three Months Ended March 31, 2022 and 2021
(In thousands, except share and per share amounts)
(Unaudited)
| Common Shares |
Paid-In Capital |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Total Shareholders’ Equity |
||||||||||||||||
| Balances at December 31, 2021 |
$ | $ | ( |
) | $ | ( |
) | $ | ||||||||||||
| Share-based compensation expense |
— | — | — | |||||||||||||||||
| Unrealized loss on marketable securities |
— | — | ( |
) | — | ( |
) | |||||||||||||
| Net loss |
— | — | — | ( |
) | ( |
) | |||||||||||||
| Balances at March 31, 2022 |
$ | $ | ( |
) | $ | ( |
) | $ | ||||||||||||
| Common Shares |
Paid-In Capital |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Total Shareholders’ Equity |
||||||||||||||||
| Balances at December 31, 2020 |
$ | $ | ( |
) | $ | ( |
) | $ | ||||||||||||
| Exercise of common stock options |
— | — | ||||||||||||||||||
| Share-based compensation expense |
— | — | — | |||||||||||||||||
| Unrealized loss on marketable securities |
— | — | ( |
) | — | ( |
) | |||||||||||||
| Net loss |
— | — | — | ( |
) | ( |
) | |||||||||||||
| Balances at March 31, 2021 |
$ | $ | ( |
) | $ | ( |
) | $ | ||||||||||||
See accompanying notes to the condensed consolidated financial statements.
DiaMedica Therapeutics Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Share-based compensation | ||||||||
| Amortization of discount on marketable securities | ||||||||
| Non-cash lease expense | ||||||||
| Depreciation | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Amounts receivable | ( | ) | ||||||
| Deposits | ||||||||
| Prepaid expenses and other assets | ( | ) | ( | ) | ||||
| Accounts payable | ( | ) | ( | ) | ||||
| Accrued liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchase of marketable securities | ( | ) | ( | ) | ||||
| Maturities of marketable securities | ||||||||
| Purchases of property and equipment | ( | ) | ||||||
| Proceeds from disposition of property and equipment | ||||||||
| Net cash provided by (used in) investing activities | ( | ) | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from the exercise of stock options | ||||||||
| Principal payments on finance lease obligations | ( | ) | ( | ) | ||||
| Net cash provided by (used in) financing activities | ( | ) | ||||||
| Net decrease in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents at beginning of period | ||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||
| Supplemental disclosure of non-cash transactions: | ||||||||
| Assets acquired under financing lease | $ | $ | ||||||
See accompanying notes to the condensed consolidated financial statements.
DiaMedica Therapeutics Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. Business
DiaMedica Therapeutics Inc. and its wholly-owned subsidiaries, DiaMedica USA, Inc. and DiaMedica Australia Pty Ltd. (collectively we, us, our, DiaMedica and the Company), exists for the primary purpose of advancing the clinical and commercial development of our proprietary recombinant KLK1 protein, DM199, for the treatment of neurological and kidney diseases. Currently, our primary focus is on developing DM199, a proprietary recombinant form of the human tissue kallikrein-1 (KLK1) protein for the treatment of acute ischemic stroke (AIS) and chronic kidney disease (CKD). Our parent company is governed under British Columbia’s Business Corporations Act, and our common shares are publicly traded on The Nasdaq Capital Market under the symbol “DMAC.”
2. Risks and Uncertainties
DiaMedica operates in a highly regulated and competitive environment. The development, manufacturing and marketing of pharmaceutical products require approval from, and are subject to ongoing oversight by, the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in the European Union and comparable agencies in other countries. We are in the clinical stage of development of our initial product candidate, DM199, for the treatment of AIS and CKD. The Company has not completed the development of any product candidate and does not generate any revenues from the commercial sale of any product candidate. DM199 requires significant additional clinical testing and investment prior to seeking marketing approval and is not expected to be commercially available for at least three to four years, if at all. Additionally, our clinical trial has been adversely impacted by the COVID-19 pandemic and other factors. Specifically, we have experienced and continue to experience slower than expected site activations and enrollment in our ReMEDy2 trial, which is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of DM199 to treat AIS patients. We believe this may be due to a number of factors, including the reduction or suspension of research activities at our current and targeted clinical study sites due to COVID-19, as well as staffing shortages and concerns managing logistics and compliance for patients discharged from the hospital to an intermediate care facility. While we are encouraged that COVID-19 related hospitalizations are down compared to prior periods and while we are taking certain actions to assist study sites in overcoming these issues, no assurances can be provided as to if and when these issues will resolve. The Company’s future success is dependent upon the success of its development efforts, its ability to demonstrate clinical progress for its DM199 product candidate in the United States or other markets, its ability to obtain required governmental approvals of its product candidate, its ability to license or market and sell its DM199 product candidate and its ability to obtain additional financing to fund these efforts.
As of March 31, 2022, we have incurred losses of $
Notwithstanding the completion of our September 2021 private placement in which we received net proceeds of $
3. Summary of Significant Accounting Policies
Interim financial statements
We have prepared the accompanying condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States (US GAAP) for interim financial information and with the instructions to Form 10-Q and Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and footnotes required by US GAAP for complete financial statements. These condensed consolidated financial statements reflect all adjustments consisting of normal recurring accruals which, in the opinion of management, are necessary to present fairly our consolidated financial position, consolidated results of operations, consolidated statement of shareholders’ equity and consolidated cash flows for the periods and as of the dates presented. Our fiscal year ends on December 31. The condensed consolidated balance sheet as of December 31, 2021 was derived from our audited consolidated financial statements. These condensed consolidated financial statements should be read in conjunction with our annual consolidated financial statements and the notes thereto. The nature of our business is such that the results of any interim period may not be indicative of the results to be expected for the entire year.
Cash and cash equivalents
The Company considers all bank deposits, including money market funds, and other investments, purchased with an original maturity to the Company of three months or less, to be cash and cash equivalents. The carrying amount of our cash equivalents approximates fair value due to the short maturity of the investments.
Concentration of credit risk
Financial instruments that potentially expose the Company to concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company maintains its cash balances primarily with two financial institutions. These balances generally exceed federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risk in cash and cash equivalents. The Company believes that the credit risk related to marketable securities is limited due to the adherence to an investment policy focused on the preservation of principal.
Marketable securities
The Company’s marketable securities typically consist of obligations of the United States government and its agencies and investment grade corporate obligations, which are classified as available-for-sale and included in current assets as they are intended to fund current operations. Securities are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value with unrealized gains and losses reported as a component of shareholders’ equity in accumulated other comprehensive loss. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization or accretion is included in interest income. Realized gains and losses, if any, are calculated on the specific identification method and are included in other income in the condensed consolidated statements of operations.
Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis, impairment is indicated and it must be determined whether it is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported in earnings. Subsequent increases or decreases in fair value are reported as a component of shareholders’ equity in accumulated other comprehensive loss. There were no other-than-temporary unrealized losses as of March 31, 2022.
Fair value measurements
Under the authoritative guidance for fair value measurements, fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date. The authoritative guidance also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use in valuing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability developed based upon the best information available in the circumstances. The categorization of financial assets and financial liabilities within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.
The hierarchy is broken down into three levels defined as follows:
Level 1 Inputs — quoted prices in active markets for identical assets and liabilities
Level 2 Inputs — observable inputs other than quoted prices in active markets for identical assets and liabilities
Level 3 Inputs — unobservable inputs
As of March 31, 2022, the Company believes that the carrying amounts of its other financial instruments, including amounts receivable, accounts payable and accrued liabilities, approximate their fair value due to the short-term maturities of these instruments. See Note 4, titled “Marketable Securities” for additional information.
Patent costs
Costs associated with applying for, prosecuting and maintaining patents are expensed as incurred given the uncertainty of patent approval and, if approved, the resulting probable future economic benefit to the Company. Patent-related costs, consisting primarily of legal expenses and filing/maintenance fees, are included in general and administrative costs and were $
4. Marketable Securities
The available-for-sale marketable securities are primarily comprised of investments in commercial paper, corporate bonds and government securities and consist of the following, measured at fair value on a recurring basis (in thousands):
| Fair Value Measurements Using Inputs Considered as of: | ||||||||||||||||||||||||||||||||
| March 31, 2022 | December 31, 2021 | |||||||||||||||||||||||||||||||
| Total | Level 1 | Level 2 | Level 3 | Total | Level 1 | Level 2 | Level 3 | |||||||||||||||||||||||||
| Government securities |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
| Commercial paper and corporate bonds |
||||||||||||||||||||||||||||||||
| Total |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
Accrued interest receivable on available-for-sale securities is included in amounts receivable and was $
There were no transfers of assets between Level 1 and Level 2 of the fair value measurement hierarchy during the three months ended March 31, 2022.
Under the terms of the Company’s investment policy, purchases of marketable securities are limited to investment grade governmental and corporate obligations and bank certificates of deposit with a primary objective of principal preservation. Maturities of individual securities are less than one year and the amortized cost of all securities approximated fair value as of March 31, 2022 and December 31, 2021.
5. Amounts Receivable
Amounts receivable consisted of the following (in thousands):
| March 31, 2022 |
December 31, 2021 |
|||||||
| Accrued interest receivable |
$ | $ | ||||||
| Other |
||||||||
| Total amounts receivable |
$ | $ | ||||||
6. Deposits
Deposits consisted of the following (in thousands):
| March 31, 2022 |
December 31, 2021 |
|||||||
| Advances to vendors, current |
$ | $ | ||||||
We periodically advance funds to vendors engaged to support the performance of our clinical trials and related supporting activities. The funds advanced are held, interest free, for varying periods of time and may be recovered by DiaMedica through partial reductions of ongoing invoices, application against final study/project invoices or refunded upon completion of services to be provided. Deposits are classified as current based upon their expected recovery time.
7. Property and Equipment
Property and equipment consisted of the following (in thousands):
| March 31, 2022 |
December 31, 2021 |
|||||||
| Furniture and equipment |
$ | $ | ||||||
| Computer equipment |
||||||||
| Less accumulated depreciation |
( |
) | ( |
) | ||||
| Property and equipment, net |
$ | $ | ||||||
8. Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
| March 31, 2022 |
December 31, 2021 |
|||||||
| Accrued clinical trial costs |
$ | $ | ||||||
| Accrued research and other professional fees |
||||||||
| Accrued compensation |
||||||||
| Other liabilities |
||||||||
| Total accrued liabilities |
$ | $ | ||||||
9. Operating Lease
We lease certain office space under a non-cancelable operating lease. This lease does not have significant rent escalation holidays, concessions, leasehold improvement incentives or other build-out clauses. Further this lease does not contain contingent rent provisions. This lease terminates on August 31, 2022 and we do not have an option to renew. This lease does include both lease (e.g., fixed rent) and non-lease components (e.g., common-area and other maintenance costs). The non-lease components are deemed to be executory costs and are therefore excluded from the minimum lease payments used to determine the present value of the operating lease obligation and related right-of-use asset.
Our operating lease cost and variable lease costs were $
| 2022 |
||||
| Total lease payments |
$ | |||
| Less interest portion |
( |
) | ||
| Present value of lease obligation |
$ |
10. Shareholders’ Equity
Authorized capital stock
The Company has authorized share capital of an unlimited number of voting common shares and the shares do not have a stated par value.
Common shareholders are entitled to receive dividends as declared by the Company, if any, and are entitled to one vote per share at the Company's annual general meeting and any special meeting.
Equity issued during the three months ended March 31, 2022
During the three months ended March 31,2022, we did not issue any common shares.
Equity issued during the three months ended March 31, 2021
During the three months ended March 31, 2021,
Shares reserved
Common shares reserved for future issuance are as follows:
| March 31, 2021 |
||||
| Common shares issuable upon exercise of employee and non-employee stock options |
||||
| Common shares issuable upon settlement of deferred stock units |
||||
| Common shares issuable upon exercise of common share purchase warrants |
||||
| Shares available for grant under the 2019 Omnibus Incentive Plan |
||||
| Shares available for grant under the 2021 Employment Inducement Incentive Plan |
||||
| Total |
||||
11. Net Loss Per Share
We compute net loss per share by dividing our net loss (the numerator) by the weighted-average number of common shares outstanding (the denominator) during the period. Shares issued during the period and shares reacquired during the period, if any, are weighted for the portion of the period that they were outstanding. The computation of diluted earnings per share, or EPS, is similar to the computation of basic EPS except that the denominator is increased to include the number of additional common shares that would have been outstanding if the dilutive potential common shares had been issued. Our diluted EPS is the same as basic EPS due to common equivalent shares being excluded from the calculation, as their effect is anti-dilutive.
The following table summarizes our calculation of net loss per common share for the periods (in thousands, except share and per share data):
| Three Months Ended March 31, |
||||||||
| 2022 |
2021 |
|||||||
| Net loss |
$ | ( |
) |
$ | ( |
) |
||
| Weighted average shares outstanding—basic and diluted |
||||||||
| Basic and diluted net loss per share |
$ | ( |
) |
$ | ( |
) |
||
The following outstanding potential common shares were not included in the diluted net loss per share calculations as their effects were not dilutive:
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Employee and non-employee stock options | ||||||||
| Common shares issuable under common share purchase warrants | ||||||||
| Common shares issuable under deferred stock units | ||||||||
12. Share-Based Compensation
2019 Omnibus Incentive Plan
The DiaMedica Therapeutics Inc. 2019 Omnibus Incentive Plan (2019 Plan) was adopted by the Board of Directors in March 2019 and approved by our shareholders at our annual general and special meeting of shareholders held on May 22, 2019. The 2019 Plan permits the Board, or a committee or subcommittee thereof, to grant to the Company’s eligible employees, non-employee directors and consultants non-statutory and incentive stock options (ISO), stock appreciation rights (SAR), restricted stock awards (RSA), restricted stock units (RSU), deferred stock units (DSU), performance awards, non-employee director awards and other stock-based awards. We grant options to purchase common shares under the 2019 Plan at no less than the fair market value of the underlying common shares as of the date of grant. Options granted to employees and non-employee directors have a maximum term of years and generally vest over to years. Options granted to non-employees have a maximum term of years and generally vest in approximately equal quarterly installments over year. Subject to adjustment as provided in the 2019 Plan, the maximum number of the Company’s common shares authorized for issuance under the 2019 Plan is
2021 Employment Inducement Incentive Plan
On December 3, 2021, the Board adopted the DiaMedica Therapeutics Inc. 2021 Employment Inducement Incentive Plan (Inducement Plan), to facilitate the granting of equity awards as an inducement material to new employees joining the Company. The Inducement Plan is administered by the Compensation Committee of the Board of Directors. The Board reserved
Prior Stock Option Plan
The DiaMedica Therapeutics Inc. Stock Option Plan, Amended and Restated November 6, 2018 (Prior Plan), was terminated by the Board of Directors in conjunction with the shareholder approval of the 2019 Plan. Awards outstanding under the Prior Plan remain outstanding in accordance with and pursuant to the terms thereof. Options granted under the Prior Plan have terms similar to those used under the 2019 Plan. As of March 31, 2022, options to purchase an aggregate of
Prior Deferred Stock Unit Plan
The DiaMedica Therapeutics Inc. Amended and Restated Deferred Stock Unit Plan (Prior DSU Plan) was terminated by the Board of Directors in conjunction with the shareholder approval of the 2019 Plan. Awards outstanding under the Prior DSU Plan remain outstanding in accordance with and pursuant to the terms thereof. As of March 31, 2022, there were
Share-based compensation expense for each of the periods presented is as follows (in thousands):
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Research and development | $ | $ | ||||||
| General and administrative | ||||||||
| Total share-based compensation | $ | $ | ||||||
We recognize share-based compensation based on the fair value of each award as estimated using the Black-Scholes option valuation model. Ultimately, the actual expense recognized over the vesting period will only be for those shares that actually vest.
A summary of option activity is as follows (in thousands except share and per share amounts):
| Shares Underlying Options Outstanding | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Balances at December 31, 2021 | $ | $ | ||||||||||
| Granted | ||||||||||||
| Exercised | ||||||||||||
| Expired/cancelled | ( | ) | ||||||||||
| Forfeited | ( | ) | ||||||||||
| Balances at March 31, 2022 | $ | $ | ||||||||||
Information about stock options outstanding, vested and expected to vest as of March 31, 2022, is as follows:
| Outstanding, Vested and Expected to Vest | Options Vested and Exercisable | |||||||||||||||||||||
| Per Share Exercise Price | Shares | Weighted Average Remaining Contractual Life (Years) | Weighted Average Exercise Price | Options Exercisable | Weighted Average Remaining Contractual Life (Years) | |||||||||||||||||
| $2.00 | $ | $ | ||||||||||||||||||||
| $3.00 | $ | |||||||||||||||||||||
| $4.00 | $ | |||||||||||||||||||||
| $5.00 | $ | |||||||||||||||||||||
| $10.00 | $ | |||||||||||||||||||||
| $ | ||||||||||||||||||||||
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is based upon accounting principles generally accepted in the United States of America and discusses the financial condition and results of operations for DiaMedica Therapeutics Inc. and its subsidiaries for the three months ended March 31, 2022 and 2021.
This discussion should be read in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this report and our Annual Report on Form 10-K for the year ended December 31, 2021. The following discussion contains forward-looking statements that involve numerous risks and uncertainties. Our actual results could differ materially from the forward-looking statements as a result of these risks and uncertainties. See “Cautionary Note Regarding Forward-Looking Statements” for additional cautionary information.
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, is the first pharmaceutically active recombinant (synthetic) form of the human tissue kallikrein-1 (KLK1) protein to be studied in patients. KLK1 is an established therapeutic modality for the treatment of acute ischemic stroke and chronic kidney disease. Our 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 chronic kidney disease (CKD). We plan to advance DM199 through required clinical trials to create shareholder value by establishing its clinical and commercial potential as a therapy for AIS and CKD.
KLK1 is a serine protease (protein) produced primarily in the kidneys, pancreas and salivary glands, which plays a critical role in the regulation of local blood flow and vasodilation (the widening of blood vessels which decreases vascular resistance) in the body, as well as an important role in inflammation and oxidative stress (an imbalance between potentially damaging reactive oxygen species, or free radicals, and antioxidants in your body). We believe DM199 has the potential to treat a variety of diseases where healthy functioning requires sufficient activity of KLK1 and its system, the kallikrein-kinin system.
Our product development pipeline is as follows:
Neuro: AIS Phase 2/3 ReMEDy2 Study of DM199
Our ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial intended to enroll approximately 350 patients at 75 sites in the United States. Patients enrolled in the trial will be treated with either DM199 or placebo within 24 hours of the onset of AIS symptoms. The trial excludes patients treated with tissue plasminogen activator (tPA) and those with large vessel occlusions. The study population is representative of the approximately 80% of AIS patients who do not have treatment options today, primarily due to the limitations on treatment with tPA or mechanical thrombectomy. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.
We have experienced and continue to experience slower than expected site activations and enrollment in our ReMEDy2 trial. We believe this may be due to a number of factors, including the reduction or suspension of research activities at our current and targeted clinical study sites due to COVID-19, as well as staffing shortages and concerns managing logistics and compliance for patients discharged from the hospital to an intermediate care facility. While we are encouraged that COVID-19 related hospitalizations are down compared to prior periods and while we are taking certain actions to assist study sites in overcoming these issues, no assurances can be provided as to if and when these issues will resolve.
Renal: CKD Phase 2 REDUX Clinical Trial of DM199
As of December 31, 2021, we completed patient enrollment in our REDUX clinical trial for the treatment of CKD with a total of 79 patients enrolled and initiating treatment, including 21 African American patients into Cohort 1, 25 patients with IgAN into Cohort 2 and 33 patients with Type 2 diabetes in Cohort 3. As of March 31, 2022, all patients have completed their treatment periods. We are currently evaluating next steps for our CKD program.
Other: DM300
We have identified a potential novel new treatment for inflammatory diseases, DM300, currently in the preclinical stage of development.
Financial Overview
We have not generated any revenues from product sales. Historically, we have financed our operations from the sales of equity securities and the exercise of warrants and stock options. We have incurred losses in each year since our inception. Our net losses were $3.5 million and $3.6 million for the three months ended March 31, 2022 and 2021, respectively. As of March 31, 2022, we had an accumulated deficit of $86.0 million. Substantially all of our operating losses resulted from expenses incurred in connection with the development of our DM199 product candidate, our primary research and development (R&D) activities, and general and administrative (G&A) support costs associated with our operations.
We expect to continue to incur significant expenses and generally increased operating losses compared to prior periods as we advance our clinical programs. In the near term, we anticipate that our expenses will increase as compared to prior periods as we:
| ● |
continue site activations and enrollment of patients in our pivotal ReMEDy2 Phase 2/3 trial of DM199 for AIS; |
| ● |
complete patient follow-up in our REDUX Phase 2 trial of DM199 for CKD; |
| ● |
expand our team to provide support for our operations; and |
| ● |
maintain, expand and protect our intellectual property portfolio. |
While we expect our rate of future negative cash flow per month will vary due to the timing of site activations and patient enrollment expenses, we expect our current cash resources will be sufficient to allow us to continue our ReMEDy2 Phase 2/3 trial in patients with AIS, complete patient follow-up in our REDUX Phase 2 trial in patients with CKD, and otherwise fund our planned operations for at least the next twelve months from the date of issuance of the condensed consolidated financial statements included in this report. However, the amount and timing of future funding requirements will depend on many factors, including the timing and results of our ongoing development efforts, including site activations and enrollment in our clinical studies, the potential expansion of our current development programs, potential new development programs, related G&A support and the effects of the COVID-19 pandemic. We may require significant additional funds earlier than we currently expect and there is no assurance that we will not need or seek additional funding prior to such time, especially if market conditions for raising additional capital are favorable.
Overview of Expense Components
Research and Development Expenses
R&D expenses consist primarily of fees paid to external service providers such as contract research organizations; contractual obligations for clinical development including clinical sites, outside nursing services and laboratory testing, and preclinical trials; development of manufacturing processes, costs for production runs of DM199; salaries, benefits, and share-based compensation and other personnel costs.
At this time, due to the risks inherent in the clinical development process and the clinical stage of our product development programs, we are unable to estimate with any certainty the costs we will incur in the continued development of DM199 or any of our preclinical development programs. We have experienced and continue to experience slower than expected site activations and enrollment in our ReMEDy2 trial. We believe this may be due to a number of factors, including the reduction or suspension of research activities at our current and targeted clinical study sites due to COVID-19, as well as staffing shortages and concerns managing logistics and compliance for patients discharged from the hospital to an intermediate care facility. While we are encouraged that COVID-19 related hospitalizations are down compared to prior periods and while we are taking certain actions to assist study sites in overcoming these issues, no assurances can be provided as to if and when these issues will resolve. We expect that our R&D expenses will increase in the future if we are successful in advancing DM199, or any of our preclinical programs, into advanced stages of clinical development. The process of conducting clinical trials necessary to obtain regulatory approval and manufacturing scale-up to support expanded development and potential future commercialization is costly and time consuming. Any failure by us or delay in completing clinical trials, manufacturing scale-up or in obtaining regulatory approvals could lead to increased R&D expenses and, in turn, have a material adverse effect on our results of operations.
General and Administrative Expenses
G&A expenses consist primarily of salaries and employee benefits, including share-based compensation related to our executive, finance, business development and support functions. G&A expenses also include insurance, including directors and officers liability coverage, rent and utilities, travel expenses, patent costs, professional fees, including for auditing, tax and legal services and milestone payments under our technology license agreement with Catalent Pharma Solutions, LLC.
Other Income
Other income, net, consists primarily of interest income and foreign currency exchange gains.
Results of Operations
Comparison of the Three Months ended March 31, 2022 and 2021
The following table summarizes our unaudited results of operations for the three months ended March 31, 2022 and 2021 (in thousands):
| Three Months Ended March 31, |
||||||||
| 2022 |
2021 |
|||||||
| Operating expenses: |
||||||||
| Research and development |
$ | 1,974 | $ | 2,406 | ||||
| General and administrative |
1,562 | 1,213 | ||||||
Research and Development Expenses
R&D expenses were $2.0 million for the three months ended March 31, 2022, compared with $2.4 million for the three months ended March 31, 2021, a decrease of $0.4 million. This decrease was driven mainly by a reduction in costs related to our REDUX CKD trial and a lower level of DM199 manufacturing process development work in the current year quarter as compared to the prior year quarter. These decreases were partially offset by increased costs incurred in our ReMEDy2 AIS trial and higher personnel costs related to the expansion of our clinical team in the current year period.
General and Administrative Expenses
G&A expenses were $1.6 million for the three months ended March 31, 2022, up from $1.2 million for the three months ended March 31, 2021. This $0.4 million increase resulted mainly from a combination of increased professional services costs, directors’ and officers’ liability insurance and personnel costs incurred in support of expanding our operations and clinical programs.
Liquidity and Capital Resources
The following tables summarize our liquidity and capital resources as of March 31, 2022 and December 31, 2021, and our sources and uses of cash for each of the three month periods ended March 31, 2022 and 2021, and are intended to supplement the more detailed discussion that follows (in thousands):
| Liquidity and Capital Resources |
March 31, 2022 |
December 31, 2021 |
||||||
| Cash, cash equivalents and marketable securities |
$ | 41,047 | $ | 45,112 | ||||
| Total assets |
42,211 | 45,551 | ||||||
| Total current liabilities |
1,434 | 1,524 | ||||||
| Total shareholders’ equity |
40,768 | 44,024 | ||||||
| Working capital |
40,680 | 43,915 | ||||||
| Three Months Ended March 31, |
||||||||
| Cash Flow Data |
2022 |
2021 |
||||||
| Cash flow provided by (used in): |
||||||||
| Operating activities |
$ | (3,888 | ) | $ | (4,313 | ) | ||
| Investing activities |
2,214 | (9 | ) | |||||
| Financing activities |
(1 | ) | 242 | |||||
| Net decrease in cash |
$ | (1,675 | ) | $ | (4,080 | ) | ||
Working Capital
We had cash and cash equivalents of $3.0 million, marketable securities of $38.0 million, current liabilities of $1.4 million and working capital of $40.7 million as of March 31, 2022, compared to $4.7 million in cash and cash equivalents, marketable securities of $40.4 million, $1.5 million in current liabilities and $43.9 million in working capital as of December 31, 2021. The decreases in our combined cash, cash equivalents and marketable securities and in our working capital are due primarily to cash used to fund our operating activities during the quarter ended March 31, 2022.
Cash Flows
Operating Activities
Net cash used in operating activities for the three months ended March 31, 2022 was $3.9 million compared to $4.3 million for the three months ended March 31, 2021. This decrease relates primarily to the effects of the changes in operating assets and liabilities.
Investing Activities
Investing activities consist primarily of purchases and maturities of marketable securities. Net cash provided by investing activities was $2.2 million for the three months ended March 31, 2022 compared to a net use of $9,000 for the three months ended March 31, 2021. This year-over-year change was due to the transfer of proceeds from investment maturities to our operating accounts to fund operating activities.
Financing Activities
Financing activities in the current quarter consist of principal payments on finance lease obligations. The prior year period includes net proceeds from the exercise of stock options.
Capital Requirements
Since our inception, we have incurred losses while advancing the R&D of our DM199 product candidate. We have not generated any revenues from product sales and do not know when or if, we will generate any revenues from product sales of our DM199 product candidate or any future product candidate. We expect to continue to incur substantial operating losses until such time as any future product sales, royalty payments, licensing fees and/or milestone payments are sufficient to generate revenues to fund our continuing operations. We expect our operating losses to increase in the near term as compared to prior periods as we continue the research, development and clinical studies of our DM199 product candidate. In the long-term, subject to obtaining regulatory approval of our DM199 product candidate, or any future product candidate, the absence of the assistance of a strategic partner, would further require us to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution.
Accordingly, we expect we will need substantial additional capital to further our R&D activities, planned clinical studies, regulatory activities and otherwise develop our product candidate, DM199, or any future product candidate to a point where the product candidate may be licensed or commercially sold. Although we are striving to achieve these plans, there is no assurance that these and other strategies will be achieved, that additional funding will be required after licensing or that additional funding will be obtained on favorable terms or at all. We expect our rate of future negative cash flow per month will vary depending on our clinical activities and the timing of expenses incurred. We expect our current cash resources will be sufficient to allow us to continue our ReMEDy2 Phase 2/3 trial in patients with AIS, complete patient follow-up in our REDUX Phase 2 trial in patients with CKD, and otherwise fund our planned operations for at least the next twelve months from the date of issuance of the condensed consolidated financial statements included in this report. However, the amount and timing of our future funding requirements will depend on many factors, including the timing and results of our ongoing development efforts, and specifically the initiation of new sites and enrollment in our clinical studies, the potential expansion of our current development programs, potential new development programs, the effects of the COVID-19 pandemic, staffing shortages and other factors on our clinical programs and operations, and related G&A support. We may require significant additional funds earlier than we currently expect and there is no assurance that we will not need or seek additional funding prior to such time, especially if market conditions for raising additional capital are favorable.
Historically we have financed our operations primarily from sales of equity securities and the exercise of warrants and stock options, and we expect to continue this practice for the foreseeable future. We do not have any existing credit facilities under which we could borrow funds. We may seek to raise additional funds through various sources, such as equity or debt financings, or through strategic collaborations and license agreements. We can give no assurances that we will be able to secure additional sources of funds to support our operations, or if such funds are available to us, that such additional financing will be sufficient to meet our needs or on terms acceptable to us. This is particularly true if our clinical data is not positive or economic and market conditions deteriorate.
To the extent we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our shareholders will be diluted. Debt financing, if available, may involve agreements that include conversion discounts or covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, marketing and distribution arrangements or other collaborations, or strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. The availability of financing will be affected by our clinical data and other results of scientific and clinical research; the ability to attain regulatory approvals; market acceptance of our product candidates; the state of the capital markets generally with particular reference to pharmaceutical, biotechnology and medical companies; the status of strategic alliance agreements; and other relevant commercial considerations.
If adequate funding is not available when needed, we may be required to scale back our operations by taking actions that may include, among other things, implementing cost reduction strategies, such as reducing use of outside professional service providers, reducing the number of our employees or employee compensation, modifying or delaying the development of our DM199 product candidate; licensing to third parties the rights to commercialize our DM199 product candidate for AIS, CKD or other indications that we would otherwise seek to pursue, or otherwise relinquishing significant rights to our technologies, future revenue streams, research programs or product candidates or granting licenses on terms that may not be favorable to us; and/or divesting assets or ceasing operations through a merger, sale, or liquidation of our company.
Critical Accounting Policies and Estimates
There have been no material changes to our critical accounting policies and estimates from the information provided in “Part II. Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies,” included in our annual report on Form 10-K for the fiscal year ended December 31, 2021.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a smaller reporting company, we are not required to provide disclosure pursuant to this item.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the United States Securities Exchange Act of 1934, as amended (Exchange Act)) that are designed to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management evaluated, with the participation of our Chief Executive Officer and Chief Financial Officer, the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered in this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of such period to provide reasonable assurance that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting that occurred during the three months ended March 31, 2022 that has materially affected or is reasonably likely to materially affect our internal control over financial reporting.
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, we may be subject to various ongoing or threatened legal actions and proceedings, including those that arise in the ordinary course of business, which may include employment matters and breach of contract disputes. Such matters are subject to many uncertainties and to outcomes that are not predictable with assurance and that may not be known for extended periods of time. We are not currently engaged in or aware of any threatened legal actions which we believe could have a material adverse effect on our consolidated result of operations or financial position.
ITEM 1A. RISK FACTORS
As a smaller reporting company, we are not required to provide disclosure pursuant to this item.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
We did not sell any unregistered equity securities of our Company during the quarter ended March 31, 2022.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Not applicable.
ITEM 6. EXHIBITS
The following exhibits are being filed or furnished with this quarterly report on Form 10-Q:
| Exhibit No. |
Description |
Manner of Filing |
||
| 3.1 |
Notice of Articles of DiaMedica Therapeutics Inc. dated May 31, 2019 |
|||
| 3.2 |
Articles of DiaMedica Therapeutics Inc. dated May 31, 2019 |
|||
| 31.1 |
|
Filed herewith |
||
| 31.2 |
|
Filed herewith |
||
| 32.1 |
|
Furnished herewith |
||
| 32.2 |
|
Furnished herewith |
||
| 101 |
Financial statements from the quarterly report on Form 10-Q of DiaMedica Therapeutics Inc. for the quarter ended March 31, 2022, formatted in Inline XBRL: (i) the Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Operations and Comprehensive Loss, (iii) Condensed Consolidated Statements of Shareholders’ Equity, (iv) Condensed Consolidated Statements of Cash Flows, and (v) Notes to the Condensed Consolidated Financial Statements.
|
Filed herewith |
||
| 104 |
Cover Page Interactive Data File |
Embedded within the Inline XBRL document and contained in exhibit 101 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| DIAMEDICA THERAPEUTICS INC. |
|
| Date: May 4, 2022 |
/s/ Rick Pauls |
| Rick Pauls President and Chief Executive Officer |
|
| (Principal Executive Officer) |
|
| Date: May 4, 2022 |
/s/ Scott Kellen |
| Scott Kellen Chief Financial Officer |
|
| (Principal Financial Officer and Principal Accounting Officer) |