DMAC DiaMedica Therapeutics Inc

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, prospects 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 cardio-renal disease (CRD);

 

●

our ability to conduct successful clinical testing of our DM199 product candidate for AIS or CRD and meet certain anticipated or target dates with respect to our clinical studies, including in particular our Phase 2/3 ReMEDy2 clinical trial of DM199 for the treatment of AIS, or ReMEDy2 trial;

 

●

our ability to meet anticipated site activations, enrollment and interim analysis timing with respect to our ReMEDy2 trial, especially in the light of slower than expected site activations and enrollment which we believe are due, in part, to hospital and medical facility staffing shortages; concerns regarding the prior clinically significant hypotension events and circumstances surrounding the clinical hold which was lifted in June 2023; concerns managing protocol compliance, including managing logistics and protocol compliance for participants discharged from the hospital to another hospital or an intermediate care facility; our revised inclusion/exclusion criteria in the study protocol; and competition for research staff and trial subjects due to other pending stroke and neurological trials;

 

●

uncertainties relating to regulatory applications and related filing and approval timelines and the possibility of additional future adverse events associated with or unfavorable results from our ReMEDy2 trial;

 

●

the adaptive design of our ReMEDy2 trial, which is intended to enroll approximately 350 participants at up to 100 sites globally, and the possibility that these numbers and other aspects of the study could increase depending upon certain factors, including additional input from the United States Food and Drug Administration (FDA) and results of the interim analysis as determined by the independent data safety monitoring board;

 

●

our expectations regarding the perceived benefits of our DM199 product candidate over existing treatment options for AIS and CRD;

 

●

the potential size of the markets for our DM199 product candidate for AIS and CRD and our ability to serve those markets and the rate and degree of market acceptance of, and our ability to obtain coverage and adequate reimbursement for, our DM199 product candidate for AIS and CRD 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 CRD;

 

●

the success, cost and timing of our ReMEDy2 trial, as well as our reliance on third parties in connection with our ReMEDy2 trial and any other clinical trials we conduct;

 

●

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 CRD;

 

●

our estimates regarding expenses, market opportunity for our product candidates, future revenue, capital requirements, how long our current cash resources will last and need 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 CRD; and

 

●

our ability to obtain additional funding for our operations, including funding necessary to complete planned clinical trials and obtain regulatory approvals for our DM199 product candidate for AIS and CRD.

 

 

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, 2023 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)

 

 

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)

 

 

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, 2024 and 2023

(In thousands, except share amounts)

(Unaudited)

 

 

 

See accompanying notes to the condensed consolidated financial statements.

 

 

DiaMedica Therapeutics Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

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), exist for the primary purpose of advancing the clinical and commercial development of our proprietary recombinant KLK1 protein called DM199, for the treatment of neurological and cardio-renal diseases. Currently, our primary focus is on developing DM199, a recombinant form of the human tissue kallikrein-1 (KLK1) protein, for the treatment of acute ischemic stroke (AIS) and cardio-renal disease (CRD). 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 United States 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 CRD. We have not completed the development of any product candidate and do 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 years, if at all.

 

Prior to the clinical hold of our ReMEDy2 trial, announced in July 2022 and lifted in June 2023, we had experienced and are now continuing to experience slower than expected site activations and enrollment in our ReMEDy2 trial. We believe these conditions may be due to hospital and medical facility staffing shortages; concerns regarding the prior clinically significant hypotension events and circumstances surrounding the previous clinical hold; concerns managing protocol compliance, including managing logistics and protocol compliance for participants discharged from the hospital to another hospital or an intermediate care facility; our revised inclusion/exclusion criteria in the study protocol; and competition for research staff and trial subjects due to other pending stroke and neurological trials. In an effort to mitigate the impact of these factors, we made the decision to globally expand the trial and we are in the process of preparing regulatory submissions and identifying and engaging study sites in Canada, Australia, the United Kingdom and Europe. We are working closely with our contract research organization to develop procedures to support both U.S. and global study sites and potential participants as needed. We intend to continue to monitor the results of these efforts and, if necessary, implement additional actions to mitigate the impact of these factors on our ReMEDy2 trial; however, no assurances can be provided as to if and when these issues will resolve. The failure to resolve these issues will result in delays in our ReMEDy2 trial.

 

Our future success is dependent upon the success of our development efforts, our ability to demonstrate clinical progress for our DM199 product candidate in the United States or other markets, our ability, or the ability of any future partner, to obtain required governmental approvals of our product candidate, our ability to license or market and sell our DM199 product candidate and our ability to obtain additional financing to fund these efforts.

 

As of March 31, 2024, we have incurred losses of $120.7 million since our inception in 2000. For the three months ended March 31, 2024, we incurred a net loss of $5.2 million and negative cash flows from operating activities of $6.7 million. We expect to continue to incur operating losses until such time as any future product sales, licensing fees, milestone payments and/or royalty payments generate revenue sufficient to fund our continuing operations. For the foreseeable future, we expect to incur significant operating losses as we continue the development and clinical study of, and to seek regulatory approval for, our DM199 product candidate. As of March 31, 2024, we had combined cash, cash equivalents and marketable securities of $46.5 million, working capital of $44.9 million and shareholders’ equity of $46.3 million.

 

Our principal source of cash has been net proceeds from the issuance of equity securities. Although we have previously been successful in obtaining financing through equity securities offerings, there is no assurance that we will be able to do so in the future. This is particularly true if our clinical data are not positive or if economic and market conditions deteriorate.

 

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We expect that we will need substantial additional capital to further our research and development activities, complete the required clinical studies, regulatory activities and manufacturing development for our product candidate, DM199, or any future product candidates, to a point where they may be licensed or commercially sold. We expect our current cash, cash equivalents and marketable securities are sufficient to continue our ReMEDy2 trial and otherwise fund our planned operations for at least the next 12 months from the date of issuance of these condensed consolidated financial statements. The amount and timing of our future funding requirements will depend on many factors, including timing and results of our ongoing development efforts, including our current ReMEDy2 trial and the rate of site activation and participant enrollment in the study, the potential expansion of our current development programs, potential new development programs, the effects of ongoing site staffing shortages and other factors on our clinical trials and our operating expenses. 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 capital are favorable.

 

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 condensed consolidated financial position, condensed consolidated results of operations, condensed consolidated statement of shareholders’ equity and condensed 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, 2023 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.

 

Marketable securities

 

The Company’s marketable securities may consist of obligations of the United States government and its agencies, bank certificates of deposit and/or investment grade corporate obligations, which are classified as available-for-sale. Marketable securities which mature within 12 months from their purchase date are included in current assets. Securities are generally valued based on market prices for similar assets using third party certified pricing sources and are carried at fair value. The amortized cost of marketable securities is adjusted for amortization of premiums or 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. Interest income is included in other income in the condensed consolidated statements of operations.

 

We conduct periodic reviews to identify and evaluate each available-for-sale debt security that is in an unrealized loss position in order to determine whether an other-than-temporary impairment exists. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. Declines in fair value considered to be temporary and caused by noncredit-related factors of the issuer, are recorded in accumulated other comprehensive loss, which is a separate component of shareholders’ equity. Declines in fair value that are other than temporary or caused by credit-related factors of the issuer, are recorded within earnings as an impairment loss. There were no other-than-temporary unrealized losses as of March 31, 2024.

 

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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, 2024, 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.

 

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, 2024																December 31, 2023
		Total				Level 1				Level 2				Level 3				Total				Level 1				Level 2				Level 3
Commercial paper and corporate bonds		$	22,781			$	—			$	22,781			$	—			$	21,764			$	—			$	21,764			$	—
Government securities			21,638				—				21,638				—				26,588				—				26,588				—
Total		$	44,419			$	—			$	44,419			$	—			$	48,352			$	—			$	48,352			$	—

 

Maturities of individual securities are less than one year, and the amortized cost of all securities approximated fair value as of March 31, 2024 and December 31, 2023. Accrued interest receivable on marketable securities is included in amounts receivable and was $391,000 and $298,000 as of March 31, 2024 and December 31, 2023, respectively.

 

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, 2024.

 

5.	Amounts Receivable

 

Amounts receivable consisted primarily of accrued interest receivable on marketable securities of $391,000 and $298,000 as of March 31, 2024 and December 31, 2023, respectively.

 

6.

Deposits

 

We periodically advance funds to vendors engaged to support the performance of our clinical trials and related activities. The funds advanced are held, interest free, for varying periods of time and are generally recovered by the Company through application against final study/project invoices or refunded upon completion of services to be provided. Deposits are non-current when their expected recovery is not within the next twelve months.

 

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7.	Property and Equipment

 

Property and equipment consisted of the following (in thousands):

 

		March 31, 2024				December 31, 2023
Furniture and equipment		$	128			$	128
Computer equipment			94				87
Leasehold improvements			16				16
			238				231
Less accumulated depreciation			(106	)			(100	)
Property and equipment, net		$	132			$	131

 

8.	Accrued Liabilities

 

Accrued liabilities consisted of the following (in thousands):

 

		March 31, 2024				December 31, 2023
Clinical trial costs		$	689			$	258
Research and development services			637				632
Compensation			317				766
Professional services fees			150				98
Other			22				23
Total accrued liabilities		$	1,815			$	1,777

 

9.	Operating Lease

 

Office lease

 

Our operating lease costs were $26,000 for the three months ended March 31, 2024 and 2023. Our variable lease costs were $13,000 and $15,000 for the three months ended March 31, 2024 and 2023, respectively. Variable lease costs consist primarily of common area maintenance costs, insurance and taxes which are paid based upon actual costs incurred by the lessor.

 

Maturities of our operating lease obligation are as follows as of March 31, 2024 (in thousands):

 

2024		$	82
2025			113
2026			116
2027			119
2028			10
Total lease payments		$	440
Less interest portion			(63	)
Present value of operating lease obligation		$	377

 

10.	Shareholders’ Equity

 

Authorized capital shares

 

DiaMedica 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 extraordinary or special general meeting.

 

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Equity issued during the three months ended March 31, 2024

 

During the three months ended March 31, 2024, 5,916 common shares were issued upon the vesting and settlement of restricted stock units.

 

Equity issued during the three months ended March 31, 2023

 

During the three months ended March 31, 2023, 17,621 common shares were issued in settlement of deferred share units and 4,289 common shares were issued upon the vesting and settlement of restricted stock units.

 

Shares reserved

 

Common shares reserved for future issuance are as follows:

 

		March 31, 2024
Common shares issuable upon exercise of employee and non-employee stock options			4,259,763
Common shares issuable upon settlement of deferred stock units			284,886
Common shares issuable upon vesting and settlement of restricted stock units			17,744
Shares available for grant under the Amended and Restated 2019 Omnibus Incentive Plan			732,574
Shares available for grant under the 2021 Employment Inducement Incentive Plan			110,000
Total			5,404,967

 

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 presented (in thousands, except share and per share data):

 

		Three Months Ended March 31,
		2024				2023
Net loss		$	(5,151	)		$	(5,272	)
Weighted average shares outstanding—basic and diluted			37,958,000				26,448,941
Basic and diluted net loss per share		$	(0.14	)		$	(0.20	)

 

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,
		2024				2023
Employee and non-employee stock options			4,259,763				2,773,498
Common shares issuable under common share purchase warrants			—				265,000
Common shares issuable under deferred stock units			284,886				213,905
Common shares issuable upon vesting and settlement of restricted stock units			17,744				12,867

 

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12.	Share-Based Compensation

 

Amended and Restated 2019 Omnibus Incentive Plan

 

The DiaMedica Therapeutics Inc. Amended and Restated 2019 Omnibus Incentive Plan (the 2019 Plan) was adopted by the Board of Directors (Board) on March 10, 2022 and approved by our shareholders at our 2022 Annual General Meeting of Shareholders held on May 18, 2022.

 

The 2019 Plan permits the Board, or a committee or subcommittee thereof, to grant to the Company’s eligible employees, non-employee directors and certain consultants non-statutory and incentive stock options, stock appreciation rights, restricted stock awards, restricted stock units (RSUs), deferred stock units (DSUs), performance awards, non-employee director awards and other share-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 ten years and generally vest over one to four years. Options granted to non-employees have a maximum term of five years and generally vest over one 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 4,000,000 shares. As of March 31, 2024, options to purchase an aggregate of 2,921,853 common shares were outstanding, 267,553 common shares were reserved for issuance upon settlement of DSUs and 17,744 shares were reserved for issuance upon the vesting and settlement of RSUs under the 2019 Plan.

 

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 was adopted without shareholder approval pursuant to Nasdaq Listing Rule 5635(c)(4) and is administered by the Compensation Committee of the Board of Directors. The Board reserved 1,000,000 common shares of the Company for issuance under the Inducement Plan, which permits the grant of non-statutory options, stock appreciation rights, restricted stock awards, restricted stock units, performance awards and other share-based awards, to eligible recipients. The only persons eligible to receive awards under the Inducement Plan are individuals who are new employees and satisfy the standards for inducement grants under Nasdaq Listing Rule 5635(c)(4) or 5635(c)(3), as applicable. Also on December 3, 2021, the Compensation Committee adopted a form of notice of option grant and option award agreement for use under the Inducement Plan, which contains terms substantially identical to the form of notice of option grant and option award agreement for use under the shareholder-approved 2019 Plan. The Inducement Plan has a term of 10 years. The share reserve under the Inducement Plan may be increased at the discretion of and approval by the Board. As of March 31, 2024, options to purchase an aggregate of 890,000 common shares were outstanding under the Inducement Plan.

 

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, 2024, options to purchase an aggregate of 447,910 common shares were outstanding under the Prior Plan.

 

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, 2024, there were 17,333 common shares reserved for issuance upon settlement of DSUs outstanding under the Prior DSU Plan.

 

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Share-based compensation expense for each of the periods presented is as follows (in thousands):

 

		Three Months Ended March 31
		2024				2023
Research and development		$	195			$	132
General and administrative			293				290
Total share-based compensation		$	488			$	422

 

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				Weighted Average Exercise Price Per Share				Aggregate Intrinsic Value
Balances at December 31, 2023			3,871,013			$	3.61			$	832
Granted			435,000				2.76
Expired/cancelled			—				—
Forfeited			(46,250	)			2.97
Balances at March 31, 2024			4,259,763			$	3.52			$	732

 

Information about stock options outstanding, vested and expected to vest as of March 31, 2024, 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)
$1.00	-	$1.99			343,443				8.7			$	1.55				100,128				8.7
$2.00	-	$2.99			2,097,720				8.0				2.64				715,715				6.9
$3.00	-	$3.99			449,393				6.5				3.73				299,016				5.5
$4.00	-	$4.99			862,182				5.3				4.58				858,432				5.3
$5.00	-	$16.00			507,025				6.2				6.49				396,400				5.9
					4,259,763				7.1			$	3.52				2,369,691				6.0

 

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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 our subsidiaries for the three months ended March 31, 2024 and 2023.

 

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, 2023. 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. Our 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 (AIS) and porcine KLK1 for the treatment of cardio renal disease (CRD), 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 AIS and CRD. 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 CRD.

 

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 reducing inflammation and oxidative stress (an imbalance between potentially damaging reactive oxygen species, or free radicals and antioxidants in the 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 (KKS).

 

Our product development pipeline is as follows:

 

 

 

AIS Phase 2/3 ReMEDy2 Trial

 

We are currently conducting our ReMEDy2 clinical trial of DM199 for the treatment of AIS. Our ReMEDy2 clinical trial is a Phase 2/3, adaptive design, randomized, double-blind, placebo-controlled trial intended to enroll approximately 350 patients at up to 100 sites globally. 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), a thrombolytic agent intended to dissolve blood clots, 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 and/or mechanical thrombectomy. The primary endpoint of the ReMEDy2 trial is physical recovery from stroke as measured by the well-established modified Rankin Scale (mRS) at day 90, specifically recovering to an mRS score of 0-1 (mRS range of 0-6). We believe that our ReMEDy2 trial has the potential to serve as a pivotal registration study of DM199 in this patient population.

 

Prior to the clinical hold of our ReMEDy2 trial, announced in July 2022 and lifted in June 2023, we had experienced and are now continuing to experience slower than expected site activations and enrollment in our ReMEDy2 trial. We believe these conditions may be due to hospital and medical facility staffing shortages; concerns regarding the prior clinically significant hypotension events and circumstances surrounding the previous clinical hold; concerns managing protocol compliance, including managing logistics and protocol compliance for participants discharged from the hospital to another hospital or an intermediate care facility; our revised inclusion/exclusion criteria in the study protocol; and competition for research staff and trial subjects due to other pending stroke and neurological trials. In an effort to mitigate the impact of these factors, we made the decision to globally expand the trial and we are in the process of preparing regulatory submissions and identifying and engaging study sites in Canada, Australia, the United Kingdom and Europe. We are working closely with our contract research organization to develop procedures to support both U.S. and global study sites and potential participants as needed. We intend to continue to monitor the results of these efforts and, if necessary, implement additional actions to mitigate the impact of these factors on our ReMEDy2 trial; however, no assurances can be provided as to if and when these issues will resolve. The failure to resolve these issues will result in delays in our ReMEDy2 trial.

 

Cardio-Renal Program

 

We currently expect to disclose our plans for our cardio renal program in the second half of 2024.

 

Financial Overview

 

We have not generated any revenues from product sales. Since our inception, we have financed our operations from public and private sales of equity, the exercise of warrants and stock options, interest income on funds available for investment and government grants. We have incurred losses in each year since our inception. Our net losses were $5.2 million and $5.3 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $120.7 million. Substantially all of our operating losses resulted from expenses incurred in connection with our product candidate development programs, our research and development (R&D) activities, and general and administrative (G&A) support costs associated with our operations and status as a publicly listed company.

 

We expect to continue to incur significant expenses and increased operating losses for at least the next several years. We anticipate that our quarterly expenses will increase relative to recent prior periods as we expand our ReMEDy2 trial globally and as enrollment increases. Our efforts to expand our team to provide support for our operations and maintaining, expanding and protecting our intellectual property portfolio will also likely contribute to such increases.

 

While we expect our rate of future negative cash flow per month will generally increase relative to recent prior periods as we resume our ReMEDy2 trial, including our global expansion, we expect our current cash resources will be sufficient to allow us to continue our ReMEDy2 trial and otherwise fund our planned operations for at least the next 12 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 the global expansion of our ReMEDy2 trial, specifically the rate of site activations and enrollment. The rate of site activation and participant enrollment is dependent upon, in part, site staffing shortages, and competition for research staff due to other stroke and neurological trials. Other factors, such as the potential expansion of our current and new development programs, and operating expenses incurred in connection with such activities also may contribute to fluctuations in the amount and timing of our future funding requirements. We may require or otherwise seek significant additional funds earlier than we currently expect. We may elect to raise additional funds even before we need them if market conditions for raising additional capital are favorable.

 

 

Components of Our Results of Operations

 

Research and Development Expenses

 

R&D costs include expenses incurred in the conduct of human clinical trials such as fees paid to external service providers including contract research organizations; clinical support services; clinical development including clinical site costs; outside nursing services; and laboratory testing. R&D costs also include non-clinical research studies; fees paid to contract manufacturing and development organizations and outside laboratories for the development of DM199 and related manufacturing processes; costs to produce sufficient amounts of the DM199 compound for use in our clinical studies; consulting resources with specialized expertise related to execution of our development plan for our DM199 product candidate; and personnel costs, including salaries, benefits and share-based compensation.

 

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 developing DM199 through marketing approval or any of our preclinical development programs. The process of conducting clinical studies 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 studies, 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.

 

We expect that our R&D expenses will increase in the future relative to recent prior periods if we are successful in advancing DM199, or any of our preclinical programs, through the required 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.

 

General and Administrative Expenses

 

G&A expenses consist primarily of salaries, employee benefits, share-based compensation and other personnel costs 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, and professional fees, including for auditing, tax and legal services.

 

Other Income, Net

 

Other income, net consists primarily of interest income earned on marketable securities.

 

Results of Operations

 

Comparison of the Three Months Ended March 31, 2024 and 2023

 

The following table summarizes our unaudited results of operations for the three months ended March 31, 2024 and 2023 (in thousands):

 

		Three Months Ended March 31,
		2024				2023
Research and development expenses		$	3,676			$	3,618
General and administrative expenses			2,065				1,903
Other income, net			(597	)			(256	)

 

 

Research and Development Expenses

 

R&D expenses increased to $3.7 million for the three months ended March 31, 2024, compared to $3.6 million for the three months ended March 31, 2023. This increase was impacted by a number of offsetting factors. Increased costs related to the continuation of our ReMEDy2 clinical trial were partially offset by cost reductions related to clinical trial work completed in 2023, our Phase 1C and REDUX trials, and the completion in 2023 of in-use study work performed to address the clinical hold on our ReMEDy2 trial. We expect our R&D expenses to increase moderately relative to recent prior periods as we globally expand the ReMEDy2 trial and site activations and participant enrollments continue. We expect these anticipated increases will be moderated by the clinical trial work and in-use studies completed in 2023.

 

General and Administrative Expenses

 

G&A expenses increased $0.2 million to $2.1 million for the three months ended March 31, 2024, up from $1.9 million for the three months ended March 31, 2023. This increase was primarily driven by increased personnel costs, incurred in conjunction with expanding our team, partially offset by a reduction in the cost of directors and officers liability insurance premiums. We expect G&A expenses to remain steady as compared to prior periods.

 

Other Income, Net

 

Other income, net was $597 thousand for the three months ended March 31, 2024 compared to $256 thousand for the three months ended March 31, 2023. This increase was driven by increased interest income recognized during the three months ended March 31, 2024 related to increased marketable securities balances during the current year period as compared to the same prior year period.

 

Liquidity and Capital Resources

 

The following tables summarize our liquidity and capital resources as of March 31, 2024 and December 31, 2023, and our cash flows for each of the three month periods ended March 31, 2024 and 2023, and are intended to supplement the more detailed discussion that follows (in thousands):

 

		March 31, 2024				December 31, 2023
Cash, cash equivalents and marketable securities		$	46,516			$	52,895
Total assets			49,260				54,160
Total current liabilities			2,617				2,786
Total shareholders’ equity			46,349				51,057
Working capital			44,867				50,889

 

		Three Months Ended March 31,
		2024				2023
Cash Flow Data
Cash flow provided by (used in):
Operating activities		$	(6,653	)		$	(5,089	)
Investing activities			4,208				2,509
Financing activities			(1	)			(1	)
Net decrease in cash		$	(2,446	)		$	(2,581	)

 

Working Capital

 

We had aggregate cash, cash equivalents and marketable securities of $46.5 million, current liabilities of $2.6 million and working capital of $44.9 million as of March 31, 2024, compared to aggregate cash, cash equivalents and marketable securities of $52.9 million, $2.8 million in current liabilities and $50.9 million in working capital as of December 31, 2023. The decreases in our combined cash, cash equivalents and marketable securities and in our working capital are due primarily to the net cash used to fund our current operations.

 

 

Cash Flows

 

Operating Activities

 

Net cash used in operating activities for the three months ended March 31, 2024 was $6.7 million compared to $5.1 million for the three months ended March 31, 2023. The increase in cash used in operating activities was driven primarily by the advance of deposit funds to vendors supporting our ReMEDy2 clinical trial during the current year period.

 

Investing Activities

 

Investing activities consist primarily of purchases and maturities of marketable securities. Net cash provided by investing activities was $4.2 million and $2.5 million for the three months ended March 31, 2024 and 2023, respectively. This change resulted primarily from the timing of maturities and investments in marketable securities.

 

Financing Activities

 

Net cash used in financing activities was $1.0 thousand for each of the three months ended March 31, 2024 and 2023, comprised of principal payments on finance lease obligations in each period.

 

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 expect to do so for at least three to four years. We do not know when or if, we will generate any revenues from product sales or out-licensing of our DM199 product candidate or any future product candidate. We do not expect to generate any revenue from product sales unless and until we obtain required regulatory approvals. We expect to continue to incur substantial operating losses until such time as any future product sales, licensing fees, milestone payments and/or royalty payments are sufficient to generate revenues to fund our continuing operations. We expect our operating losses to increase as compared to prior periods as we continue the research, development and clinical studies of, and seek regulatory approval for, our DM199 product candidate, including, in particular, the continuation and global expansion of our ReMEDy2 trial. In the long-term, subject to obtaining regulatory approval of our DM199 product candidate, or any future product candidate, and in the absence of the assistance of a strategic partner, we expect 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, current and anticipated future 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 out-licensed or commercially sold. Although we are striving to achieve these plans, there is no assurance that these and other strategies will be achieved 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 and will increase relative to recent prior periods as we continue and globally expand our ReMEDy2 trial. We expect our current cash resources will be sufficient to continue our ReMEDy2 trial 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 our ReMEDy2 trial, the rate of site activation and enrollment in such trial, the effects of site staffing shortages, competition for research staff and trial subjects due to other stroke and neurological trials on the ReMEDy2 trial, as well as the potential expansion of our current and potential new development programs, and operating expenses incurred in connection with such activities. 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, pledging our intellectual property as collateral or covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. 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 and other regulatory actions; 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, CRD 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, 2023.

 

 

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, 2024 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

 

Litigation with Pharmaceutical Research Associates Group B.V., acquired by ICON plc as of July 1, 2021, (ICON/PRA Netherlands)

 

On November 23, 2022, we filed a petition requesting leave for a prejudgment attachment of all relevant documents in possession of Pharmaceutical Research Associates Group B.V., acquired by ICON plc as of July 1, 2021, (ICON/PRA Netherlands), which was granted on November 28, 2022, by the District Court of Northern Netherlands. A representative of the District Court served ICON/PRA Netherlands with the prejudgment attachment on or about December 7 and 8, 2022. The case was formally introduced to the Netherlands Commercial Court (NCC) on December 28, 2022 and a hearing by the NCC to determine whether we are entitled to take possession of the records seized was scheduled and held on March 16, 2023.

 

On April 21, 2023, the NCC issued a judgement affirming our ownership of the physical documents, including 51 hardcopy folders and certain digital files, related to the clinical studies performed by ICON/PRA Netherlands and seized by the Dutch courts in December 2022. The NCC further ordered ICON/PRA Netherlands to allow and tolerate the surrender of the documents, including digital and source data. Additionally, the NCC found that we are not in breach of any obligation under the clinical study agreement and ICON/PRA Netherlands had no basis to suspend the fulfillment of its obligations under the clinical study agreement to provide us all clinical data and access to perform an audit of the study. On June 15, 2023, ICON/PRA Netherlands filed an appeal of this decision and requested a hearing with the NCC, which has been scheduled for September 23, 2024.

 

The hearing addressing our claims for damages was conducted on December 7, 2023. On February 7, 2024, the NCC issued a judgement in which they found that, although all data related to the study is the rightful property of DiaMedica, they found that there was an insufficient causal link between ICON/PRA Netherlands withholding study data and the damages claimed by us. We have notified the NCC and ICON/PRA Netherlands of our intent to appeal this decision.

 

From time to time, we may be subject to other 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. Other than the ICON/PRA Netherlands matter noted above, we are not currently engaged in or aware of any threatened legal actions.

 

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, 2024.

 

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

 

Not applicable.

 

ITEM 4.

MINE SAFETY DISCLOSURES

 

Not applicable.

 

 

ITEM 5.

OTHER INFORMATION

 

Rule 10b5-1 Plan and Non-Rule 10b5-1 Trading Arrangement Adoptions, Terminations, and Modifications

 

During the three months ended March 31, 2024, none of our directors or “officers” (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) and 408(c) respectively of SEC Regulation S-K.

 

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		Incorporated by reference to Exhibit 3.1 to DiaMedica’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 4, 2019 (File No. 001-36291)
3.2		Amended and Restated Articles of DiaMedica Therapeutics Inc. Effective May 17, 2023		Incorporated by reference to Exhibit 3.1 to DiaMedica’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on May 18, 2023 (File No. 001-36291)
31.1		Certification of Chief Executive Officer Pursuant to Exchange Act Rules 13a-14(a)/15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002		Filed herewith
31.2		Certification of Chief Financial Officer Pursuant to Exchange Act Rules 13a-14(a)/15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002		Filed herewith
32.1		Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002		Furnished herewith
32.2		Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002		Furnished herewith
101		Financial statements from the quarterly report on Form 10-Q of DiaMedica Therapeutics Inc. for the three months ended March 31, 2024, 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

 

 

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 8, 2024	/s/ Rick Pauls
	Rick Pauls
	President and Chief Executive Officer
	(Principal Executive Officer)
Date: May 8, 2024	/s/ Scott Kellen
	Scott Kellen
	Chief Financial Officer
	(Principal Financial Officer and Principal Accounting Officer)

 

 

Exhibit 31.1

 

CERTIFICATION PURSUANT TO RULE 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES

EXCHANGE ACT OF 1934, AS AMENDED, AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Rick Pauls, certify that:

 

1.	I have reviewed this Quarterly Report on Form 10-Q of DiaMedica Therapeutics Inc.;

 

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.	Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a.

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b.

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c.

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a.

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b.

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

Dated: May 8, 2024	/s/ Rick Pauls
	Rick Pauls
	President and Chief Executive Officer
	(Principal Executive Officer)

 

 

Exhibit 31.2

 

CERTIFICATION PURSUANT TO RULE 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES

EXCHANGE ACT OF 1934, AS AMENDED, AS ADOPTED PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Scott Kellen, certify that:

 

1.	I have reviewed this Quarterly Report on Form 10-Q of DiaMedica Therapeutics Inc.;

 

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.	Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a.

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b.

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c.

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a.

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b.

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

Dated: May 8, 2024	/s/ Scott Kellen
	Scott Kellen
	Chief Financial Officer
	(Principal Financial Officer)

 

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Rick Pauls, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

(1)

the Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024 of DiaMedica Therapeutics Inc. (the Report) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of DiaMedica Therapeutics Inc.

 

Dated: May 8, 2024

 

 

	/s/ Rick Pauls
	Rick Pauls
	President and Chief Executive Officer
	(Principal Executive Officer)

 

 

Exhibit 32.2

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Scott Kellen, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

(1)

the Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024 of DiaMedica Therapeutics Inc. (the Report) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of DiaMedica Therapeutics Inc.

 

Dated: May 8, 2024

 

 

	/s/ Scott Kellen
	Scott Kellen
	Chief Financial Officer
	(Principal Financial Officer)

 

v3.24.1.u1

Document And Entity Information - shares	3 Months Ended
	Mar. 31, 2024	May 03, 2024
Document Information [Line Items]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2024
Document Transition Report	false
Entity File Number	001-36291
Entity Registrant Name	DIAMEDICA THERAPEUTICS INC.
Entity Incorporation, State or Country Code	A1
Entity Address, Address Line One	301 Carlson Parkway, Suite 210
Entity Address, City or Town	Minneapolis
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	55305
City Area Code	763
Local Phone Number	496-5454
Title of 12(b) Security	Voting common shares, no par value per share
Trading Symbol	DMAC
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding (in shares)		37,963,916
Entity Central Index Key	0001401040
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q1
Amendment Flag	false

v3.24.1.u1

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 2,097	$ 4,543
Marketable securities	44,419	48,352
Prepaid expenses and other assets	569	411
Amounts receivable	399	369
Total current assets	47,484	53,675
Non-current assets:
Deposits	1,308	0
Operating lease right-of-use asset, net	336	354
Property and equipment, net	132	131
Total non-current assets	1,776	485
Total assets	49,260	54,160
Current liabilities:
Accounts payable	716	926
Accrued liabilities	1,815	1,777
Operating lease obligation	83	80
Finance lease obligation	3	3
Total current liabilities	2,617	2,786
Non-current liabilities:
Operating lease obligation	294	316
Finance lease obligation	0	1
Total non-current liabilities	294	317
Shareholders’ equity:
Common shares, no par value; unlimited authorized; 37,963,916 and 37,958,000 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively	0	0
Paid-in capital	167,097	166,609
Accumulated other comprehensive income (loss)	(39)	6
Accumulated deficit	(120,709)	(115,558)
Total shareholders’ equity	46,349	51,057
Total liabilities and shareholders’ equity	$ 49,260	$ 54,160

v3.24.1.u1

Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares $ / shares in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2024	Dec. 31, 2022	Dec. 31, 2023
Common shares, par value (in dollars per share)	$ 0		$ 0
Common shares, authorized	Unlimited	Unlimited
Common Stock, Shares, Outstanding (in shares)	37,963,916		37,958,000
Common shares, issued (in shares)	37,963,916		37,958,000

v3.24.1.u1

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Operating expenses:
Research and development	$ 3,676	$ 3,618
General and administrative	2,065	1,903
Total operating expenses	(5,741)	(5,521)
Other income, net	597	256
Loss before income tax expense	(5,144)	(5,265)
Income tax expense	(7)	(7)
Net loss	(5,151)	(5,272)
Other comprehensive (loss) gain
Unrealized gain (loss) on marketable securities	(45)	45
Net loss and comprehensive loss	$ (5,196)	$ (5,227)
Basic and diluted net loss per share (in dollars per share)	$ (0.14)	$ (0.2)
Weighted average shares outstanding – basic and diluted (in shares)	37,958,000	26,448,941

v3.24.1.u1

Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) $ in Thousands	Common Stock [Member]	Additional Paid-in Capital [Member]	AOCI Attributable to Parent [Member]	Retained Earnings [Member]	Total
Balances (in shares) at Dec. 31, 2022	26,443,067
Balances at Dec. 31, 2022		$ 128,078	$ (74)	$ (96,177)	$ 31,827
Issuance of common shares upon the vesting and settlement of restricted stock units (in shares)	4,289
Issuance of common shares upon the vesting and settlement of restricted stock units		0	0	0	0
Share-based compensation expense		422	0	0	422
Unrealized gain (loss) on marketable securities		0	45	0	45
Net loss		0	0	(5,272)	$ (5,272)
Issuance of common shares in settlement of deferred stock units (in shares)	17,621				17,621
Net loss		0	0	(5,272)	$ (5,272)
Balances (in shares) at Mar. 31, 2023	26,464,977
Balances at Mar. 31, 2023		128,500	(29)	(101,449)	27,022
Balances (in shares) at Dec. 31, 2023	37,958,000
Balances at Dec. 31, 2023		166,609	6	(115,558)	51,057
Issuance of common shares upon the vesting and settlement of restricted stock units (in shares)	5,916
Issuance of common shares upon the vesting and settlement of restricted stock units		0	0	0	0
Share-based compensation expense		488			488
Unrealized gain (loss) on marketable securities			(45)		(45)
Net loss				(5,151)	(5,151)
Net loss				(5,151)	(5,151)
Balances (in shares) at Mar. 31, 2024	37,963,916
Balances at Mar. 31, 2024		$ 167,097	$ (39)	$ (120,709)	$ 46,349

v3.24.1.u1

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Cash flows from operating activities:
Net loss	$ (5,151)	$ (5,272)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation	488	422
Amortization of discount on marketable securities	(329)	(205)
Non-cash lease expense	18	17
Depreciation	8	7
Changes in operating assets and liabilities:
Amounts receivable	(30)	25
Prepaid expenses and other assets	(158)	(711)
Deposits	(1,308)	0
Accounts payable	(210)	1,046
Accrued liabilities	19	(418)
Net cash used in operating activities	(6,653)	(5,089)
Cash flows from investing activities:
Purchase of marketable securities	(9,783)	(9,824)
Maturities of marketable securities	14,000	12,340
Purchases of property and equipment	(9)	(7)
Net cash provided by investing activities	4,208	2,509
Cash flows from financing activities:
Principal payments on finance lease obligation	(1)	(1)
Net cash used in financing activities	(1)	(1)
Net decrease in cash and cash equivalents	(2,446)	(2,581)
Cash and cash equivalents at beginning of period	4,543	4,728
Cash and cash equivalents at end of period	2,097	2,147
Supplemental disclosure of non-cash transactions:
Cash paid for income taxes	$ 7	$ 14

v3.24.1.u1

Note 1 - Business	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Business Description and Basis of Presentation [Text Block]	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), exist for the primary purpose of advancing the clinical and commercial development of our proprietary recombinant KLK1 protein called DM199, for the treatment of neurological and cardio-renal diseases. Currently, our primary focus is on developing DM199, a recombinant form of the human tissue kallikrein-1 (KLK1) protein, for the treatment of acute ischemic stroke (AIS) and cardio-renal disease (CRD). 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.”

v3.24.1.u1

Note 2 - Risks and Uncertainties	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Risks and Uncertainties [Text Block]	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 United States 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 CRD. We have not completed the development of any product candidate and do 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 years, if at all.   Prior to the clinical hold of our ReMEDy2 trial, announced in July 2022 and lifted in June 2023, we had experienced and are now continuing to experience slower than expected site activations and enrollment in our ReMEDy2 trial. We believe these conditions may be due to hospital and medical facility staffing shortages; concerns regarding the prior clinically significant hypotension events and circumstances surrounding the previous clinical hold; concerns managing protocol compliance, including managing logistics and protocol compliance for participants discharged from the hospital to another hospital or an intermediate care facility; our revised inclusion/exclusion criteria in the study protocol; and competition for research staff and trial subjects due to other pending stroke and neurological trials. In an effort to mitigate the impact of these factors, we made the decision to globally expand the trial and we are in the process of preparing regulatory submissions and identifying and engaging study sites in Canada, Australia, the United Kingdom and Europe. We are working closely with our contract research organization to develop procedures to support both U.S. and global study sites and potential participants as needed. We intend to continue to monitor the results of these efforts and, if necessary, implement additional actions to mitigate the impact of these factors on our ReMEDy2 trial; however, no assurances can be provided as to if and when these issues will resolve. The failure to resolve these issues will result in delays in our ReMEDy2 trial.   Our future success is dependent upon the success of our development efforts, our ability to demonstrate clinical progress for our DM199 product candidate in the United States or other markets, our ability, or the ability of any future partner, to obtain required governmental approvals of our product candidate, our ability to license or market and sell our DM199 product candidate and our ability to obtain additional financing to fund these efforts.   As of March 31, 2024, we have incurred losses of $120.7 million since our inception in 2000. For the three months ended March 31, 2024, we incurred a net loss of $5.2 million and negative cash flows from operating activities of $6.7 million. We expect to continue to incur operating losses until such time as any future product sales, licensing fees, milestone payments and/or royalty payments generate revenue sufficient to fund our continuing operations. For the foreseeable future, we expect to incur significant operating losses as we continue the development and clinical study of, and to seek regulatory approval for, our DM199 product candidate. As of March 31, 2024, we had combined cash, cash equivalents and marketable securities of $46.5 million, working capital of $44.9 million and shareholders’ equity of $46.3 million.   Our principal source of cash has been net proceeds from the issuance of equity securities. Although we have previously been successful in obtaining financing through equity securities offerings, there is no assurance that we will be able to do so in the future. This is particularly true if our clinical data are not positive or if economic and market conditions deteriorate.     We expect that we will need substantial additional capital to further our research and development activities, complete the required clinical studies, regulatory activities and manufacturing development for our product candidate, DM199, or any future product candidates, to a point where they may be licensed or commercially sold. We expect our current cash, cash equivalents and marketable securities are sufficient to continue our ReMEDy2 trial and otherwise fund our planned operations for at least the next 12 months from the date of issuance of these condensed consolidated financial statements. The amount and timing of our future funding requirements will depend on many factors, including timing and results of our ongoing development efforts, including our current ReMEDy2 trial and the rate of site activation and participant enrollment in the study, the potential expansion of our current development programs, potential new development programs, the effects of ongoing site staffing shortages and other factors on our clinical trials and our operating expenses. 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 capital are favorable.

v3.24.1.u1

Note 3 - Summary of Significant Accounting Policies	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Liquidity and Management Plans [Text Block]	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 condensed consolidated financial position, condensed consolidated results of operations, condensed consolidated statement of shareholders’ equity and condensed 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, 2023 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.   Marketable securities   The Company’s marketable securities may consist of obligations of the United States government and its agencies, bank certificates of deposit and/or investment grade corporate obligations, which are classified as available-for-sale. Marketable securities which mature within 12 months from their purchase date are included in current assets. Securities are generally valued based on market prices for similar assets using third party certified pricing sources and are carried at fair value. The amortized cost of marketable securities is adjusted for amortization of premiums or 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. Interest income is included in other income in the condensed consolidated statements of operations.   We conduct periodic reviews to identify and evaluate each available-for-sale debt security that is in an unrealized loss position in order to determine whether an other-than-temporary impairment exists. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. Declines in fair value considered to be temporary and caused by noncredit-related factors of the issuer, are recorded in accumulated other comprehensive loss, which is a separate component of shareholders’ equity. Declines in fair value that are other than temporary or caused by credit-related factors of the issuer, are recorded within earnings as an impairment loss. There were no other-than-temporary unrealized losses as of March 31, 2024.     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, 2024, 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.

v3.24.1.u1

Note 4 - Marketable Securities	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block]	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, 2024     December 31, 2023       Total     Level 1     Level 2     Level 3     Total     Level 1     Level 2     Level 3   Commercial paper and corporate bonds   $ 22,781     $ —     $ 22,781     $ —     $ 21,764     $ —     $ 21,764     $ —   Government securities     21,638       —       21,638       —       26,588       —       26,588       —   Total   $ 44,419     $ —     $ 44,419     $ —     $ 48,352     $ —     $ 48,352     $ —     Maturities of individual securities are less than one year, and the amortized cost of all securities approximated fair value as of March 31, 2024 and December 31, 2023. Accrued interest receivable on marketable securities is included in amounts receivable and was $391,000 and $298,000 as of March 31, 2024 and December 31, 2023, respectively.   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, 2024.

v3.24.1.u1

Note 5 - Amounts Receivable	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Loans, Notes, Trade and Other Receivables Disclosure [Text Block]	5. Amounts Receivable   Amounts receivable consisted primarily of accrued interest receivable on marketable securities of $391,000 and $298,000 as of March 31, 2024 and December 31, 2023, respectively.

v3.24.1.u1

Note 6 - Deposits	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Deposit Assets [Text Block]	6. Deposits   We periodically advance funds to vendors engaged to support the performance of our clinical trials and related activities. The funds advanced are held, interest free, for varying periods of time and are generally recovered by the Company through application against final study/project invoices or refunded upon completion of services to be provided. Deposits are non-current when their expected recovery is not within the next twelve months.

v3.24.1.u1

Note 7 - Property and Equipment	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Property, Plant and Equipment Disclosure [Text Block]	7. Property and Equipment   Property and equipment consisted of the following (in thousands):       March 31, 2024     December 31, 2023   Furniture and equipment   $ 128     $ 128   Computer equipment     94       87   Leasehold improvements     16       16         238       231   Less accumulated depreciation     (106 )     (100 ) Property and equipment, net   $ 132     $ 131

v3.24.1.u1

Note 8 - Accrued Liabilities	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Accounts Payable and Accrued Liabilities Disclosure [Text Block]	8. Accrued Liabilities   Accrued liabilities consisted of the following (in thousands):       March 31, 2024     December 31, 2023   Clinical trial costs   $ 689     $ 258   Research and development services     637       632   Compensation     317       766   Professional services fees     150       98   Other     22       23   Total accrued liabilities   $ 1,815     $ 1,777

v3.24.1.u1

Note 9 - Operating Lease	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Lessee, Operating Leases [Text Block]	9. Operating Lease   Office lease   Our operating lease costs were $26,000 for the three months ended March 31, 2024 and 2023. Our variable lease costs were $13,000 and $15,000 for the three months ended March 31, 2024 and 2023, respectively. Variable lease costs consist primarily of common area maintenance costs, insurance and taxes which are paid based upon actual costs incurred by the lessor.   Maturities of our operating lease obligation are as follows as of March 31, 2024 (in thousands):   2024   $ 82   2025     113   2026     116   2027     119   2028     10   Total lease payments   $ 440   Less interest portion     (63 ) Present value of operating lease obligation   $ 377

v3.24.1.u1

Note 10 - Shareholders' Equity	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Equity [Text Block]	10. Shareholders’ Equity   Authorized capital shares   DiaMedica 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 extraordinary or special general meeting.     Equity issued during the three months ended March 31, 2024   During the three months ended March 31, 2024, 5,916 common shares were issued upon the vesting and settlement of restricted stock units.   Equity issued during the three months ended March 31, 2023   During the three months ended March 31, 2023, 17,621 common shares were issued in settlement of deferred share units and 4,289 common shares were issued upon the vesting and settlement of restricted stock units.   Shares reserved   Common shares reserved for future issuance are as follows:       March 31, 2024   Common shares issuable upon exercise of employee and non-employee stock options     4,259,763   Common shares issuable upon settlement of deferred stock units     284,886   Common shares issuable upon vesting and settlement of restricted stock units     17,744   Shares available for grant under the Amended and Restated 2019 Omnibus Incentive Plan     732,574   Shares available for grant under the 2021 Employment Inducement Incentive Plan     110,000   Total     5,404,967

v3.24.1.u1

Note 11 - Net Loss Per Share	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Earnings Per Share [Text Block]	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 presented (in thousands, except share and per share data):       Three Months Ended March 31,       2024     2023   Net loss   $ (5,151 )   $ (5,272 ) Weighted average shares outstanding—basic and diluted     37,958,000       26,448,941   Basic and diluted net loss per share   $ (0.14 )   $ (0.20 )   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,       2024     2023   Employee and non-employee stock options     4,259,763       2,773,498   Common shares issuable under common share purchase warrants     —       265,000   Common shares issuable under deferred stock units     284,886       213,905   Common shares issuable upon vesting and settlement of restricted stock units     17,744       12,867

v3.24.1.u1

Note 12 - Share-based Compensation	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Share-Based Payment Arrangement [Text Block]	12. Share-Based Compensation   Amended and Restated 2019 Omnibus Incentive Plan   The DiaMedica Therapeutics Inc. Amended and Restated 2019 Omnibus Incentive Plan (the 2019 Plan) was adopted by the Board of Directors (Board) on March 10, 2022 and approved by our shareholders at our 2022 Annual General Meeting of Shareholders held on May 18, 2022.   The 2019 Plan permits the Board, or a committee or subcommittee thereof, to grant to the Company’s eligible employees, non-employee directors and certain consultants non-statutory and incentive stock options, stock appreciation rights, restricted stock awards, restricted stock units (RSUs), deferred stock units (DSUs), performance awards, non-employee director awards and other share-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 ten years and generally vest over one to four years. Options granted to non-employees have a maximum term of five years and generally vest over one 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 4,000,000 shares. As of March 31, 2024, options to purchase an aggregate of 2,921,853 common shares were outstanding, 267,553 common shares were reserved for issuance upon settlement of DSUs and 17,744 shares were reserved for issuance upon the vesting and settlement of RSUs under the 2019 Plan.   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 was adopted without shareholder approval pursuant to Nasdaq Listing Rule 5635(c)(4) and is administered by the Compensation Committee of the Board of Directors. The Board reserved 1,000,000 common shares of the Company for issuance under the Inducement Plan, which permits the grant of non-statutory options, stock appreciation rights, restricted stock awards, restricted stock units, performance awards and other share-based awards, to eligible recipients. The only persons eligible to receive awards under the Inducement Plan are individuals who are new employees and satisfy the standards for inducement grants under Nasdaq Listing Rule 5635(c)(4) or 5635(c)(3), as applicable. Also on December 3, 2021, the Compensation Committee adopted a form of notice of option grant and option award agreement for use under the Inducement Plan, which contains terms substantially identical to the form of notice of option grant and option award agreement for use under the shareholder-approved 2019 Plan. The Inducement Plan has a term of 10 years. The share reserve under the Inducement Plan may be increased at the discretion of and approval by the Board. As of March 31, 2024, options to purchase an aggregate of 890,000 common shares were outstanding under the Inducement Plan.   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, 2024, options to purchase an aggregate of 447,910 common shares were outstanding under the Prior Plan.   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, 2024, there were 17,333 common shares reserved for issuance upon settlement of DSUs outstanding under the Prior DSU Plan.     Share-based compensation expense for each of the periods presented is as follows (in thousands):       Three Months Ended March 31       2024     2023   Research and development   $ 195     $ 132   General and administrative     293       290   Total share-based compensation   $ 488     $ 422     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     Weighted Average Exercise Price Per Share     Aggregate Intrinsic Value   Balances at December 31, 2023     3,871,013     $ 3.61     $ 832   Granted     435,000       2.76           Expired/cancelled     —       —           Forfeited     (46,250 )     2.97           Balances at March 31, 2024     4,259,763     $ 3.52     $ 732     Information about stock options outstanding, vested and expected to vest as of March 31, 2024, 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)   $1.00 - $1.99     343,443       8.7     $ 1.55       100,128       8.7   $2.00 - $2.99     2,097,720       8.0       2.64       715,715       6.9   $3.00 - $3.99     449,393       6.5       3.73       299,016       5.5   $4.00 - $4.99     862,182       5.3       4.58       858,432       5.3   $5.00 - $16.00     507,025       6.2       6.49       396,400       5.9             4,259,763       7.1     $ 3.52       2,369,691       6.0

v3.24.1.u1

Insider Trading Arrangements	3 Months Ended
	Mar. 31, 2024
Insider Trading Arr Line Items
Material Terms of Trading Arrangement [Text Block]	ITEM 5. OTHER INFORMATION   Rule 10b5-1 Plan and Non-Rule 10b5-1 Trading Arrangement Adoptions, Terminations, and Modifications   During the three months ended March 31, 2024, none of our directors or “officers” (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) and 408(c) respectively of SEC Regulation S-K.
Rule 10b5-1 Arrangement Adopted [Flag]	false
Non-Rule 10b5-1 Arrangement Adopted [Flag]	false
Rule 10b5-1 Arrangement Terminated [Flag]	false
Non-Rule 10b5-1 Arrangement Terminated [Flag]	false

v3.24.1.u1

Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2024
Accounting Policies [Abstract]
Cash and Cash Equivalents, Policy [Policy Text Block]	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.
Marketable Securities, Policy [Policy Text Block]	Marketable securities   The Company’s marketable securities may consist of obligations of the United States government and its agencies, bank certificates of deposit and/or investment grade corporate obligations, which are classified as available-for-sale. Marketable securities which mature within 12 months from their purchase date are included in current assets. Securities are generally valued based on market prices for similar assets using third party certified pricing sources and are carried at fair value. The amortized cost of marketable securities is adjusted for amortization of premiums or 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. Interest income is included in other income in the condensed consolidated statements of operations.   We conduct periodic reviews to identify and evaluate each available-for-sale debt security that is in an unrealized loss position in order to determine whether an other-than-temporary impairment exists. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. Declines in fair value considered to be temporary and caused by noncredit-related factors of the issuer, are recorded in accumulated other comprehensive loss, which is a separate component of shareholders’ equity. Declines in fair value that are other than temporary or caused by credit-related factors of the issuer, are recorded within earnings as an impairment loss. There were no other-than-temporary unrealized losses as of March 31, 2024.
Fair Value Measurement, Policy [Policy Text Block]	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, 2024, 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.

v3.24.1.u1

Note 4 - Marketable Securities (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Fair Value, Marketable Securities Measured on a Recurring Basis [Table Text Block]	Fair Value Measurements Using Inputs Considered as of:       March 31, 2024     December 31, 2023       Total     Level 1     Level 2     Level 3     Total     Level 1     Level 2     Level 3   Commercial paper and corporate bonds   $ 22,781     $ —     $ 22,781     $ —     $ 21,764     $ —     $ 21,764     $ —   Government securities     21,638       —       21,638       —       26,588       —       26,588       —   Total   $ 44,419     $ —     $ 44,419     $ —     $ 48,352     $ —     $ 48,352     $ —

v3.24.1.u1

Note 7 - Property and Equipment (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Property, Plant and Equipment [Table Text Block]	March 31, 2024     December 31, 2023   Furniture and equipment   $ 128     $ 128   Computer equipment     94       87   Leasehold improvements     16       16         238       231   Less accumulated depreciation     (106 )     (100 ) Property and equipment, net   $ 132     $ 131

v3.24.1.u1

Note 8 - Accrued Liabilities (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Schedule of Accrued Liabilities [Table Text Block]	March 31, 2024     December 31, 2023   Clinical trial costs   $ 689     $ 258   Research and development services     637       632   Compensation     317       766   Professional services fees     150       98   Other     22       23   Total accrued liabilities   $ 1,815     $ 1,777

v3.24.1.u1

Note 9 - Operating Lease (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block]	2024   $ 82   2025     113   2026     116   2027     119   2028     10   Total lease payments   $ 440   Less interest portion     (63 ) Present value of operating lease obligation   $ 377

v3.24.1.u1

Note 10 - Shareholders' Equity (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Common Stock Reserved for Future Issuance [Table Text Block]	March 31, 2024   Common shares issuable upon exercise of employee and non-employee stock options     4,259,763   Common shares issuable upon settlement of deferred stock units     284,886   Common shares issuable upon vesting and settlement of restricted stock units     17,744   Shares available for grant under the Amended and Restated 2019 Omnibus Incentive Plan     732,574   Shares available for grant under the 2021 Employment Inducement Incentive Plan     110,000   Total     5,404,967

v3.24.1.u1

Note 11 - Net Loss Per Share (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]	Three Months Ended March 31,       2024     2023   Net loss   $ (5,151 )   $ (5,272 ) Weighted average shares outstanding—basic and diluted     37,958,000       26,448,941   Basic and diluted net loss per share   $ (0.14 )   $ (0.20 )
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]	Three Months Ended March 31,       2024     2023   Employee and non-employee stock options     4,259,763       2,773,498   Common shares issuable under common share purchase warrants     —       265,000   Common shares issuable under deferred stock units     284,886       213,905   Common shares issuable upon vesting and settlement of restricted stock units     17,744       12,867

v3.24.1.u1

Note 12 - Share-based Compensation (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]	Three Months Ended March 31       2024     2023   Research and development   $ 195     $ 132   General and administrative     293       290   Total share-based compensation   $ 488     $ 422
Share-Based Payment Arrangement, Option, Activity [Table Text Block]	Shares Underlying Options     Weighted Average Exercise Price Per Share     Aggregate Intrinsic Value   Balances at December 31, 2023     3,871,013     $ 3.61     $ 832   Granted     435,000       2.76           Expired/cancelled     —       —           Forfeited     (46,250 )     2.97           Balances at March 31, 2024     4,259,763     $ 3.52     $ 732
Share-Based Payment Arrangement, Option, Exercise Price Range [Table Text Block]	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)   $1.00 - $1.99     343,443       8.7     $ 1.55       100,128       8.7   $2.00 - $2.99     2,097,720       8.0       2.64       715,715       6.9   $3.00 - $3.99     449,393       6.5       3.73       299,016       5.5   $4.00 - $4.99     862,182       5.3       4.58       858,432       5.3   $5.00 - $16.00     507,025       6.2       6.49       396,400       5.9             4,259,763       7.1     $ 3.52       2,369,691       6.0

v3.24.1.u1

Note 2 - Risks and Uncertainties (Details Textual) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023	Dec. 31, 2022
Retained Earnings (Accumulated Deficit), Total	$ (120,709)		$ (115,558)
Net Income (Loss) Attributable to Parent, Total	(5,151)	$ (5,272)
Net Cash Provided by (Used in) Operating Activities, Total	(6,653)	(5,089)
Cash, Cash Equivalents, and Short-Term Investments, Total	46,500
Working Capital	44,900
Stockholders' Equity Attributable to Parent, Ending Balance	$ 46,349	$ 27,022	$ 51,057	$ 31,827

v3.24.1.u1

Note 4 - Marketable Securities (Details Textual) - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Accrued Interest Receivable On Available For Sale Securities [Member]
Interest Receivable	$ 391,000	$ 298,000

v3.24.1.u1

Note 4 - Marketable Securities - Fair Value of Marketable Securities (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Total marketable securities	$ 44,419	$ 48,352
Fair Value, Inputs, Level 1 [Member]
Total marketable securities	0	0
Fair Value, Inputs, Level 2 [Member]
Total marketable securities	44,419	48,352
Fair Value, Inputs, Level 3 [Member]
Total marketable securities	0	0
Commercial Paper and Corporate Bonds [Member]
Total marketable securities	22,781	21,764
Commercial Paper and Corporate Bonds [Member] | Fair Value, Inputs, Level 1 [Member]
Total marketable securities	0	0
Commercial Paper and Corporate Bonds [Member] | Fair Value, Inputs, Level 2 [Member]
Total marketable securities	22,781	21,764
Commercial Paper and Corporate Bonds [Member] | Fair Value, Inputs, Level 3 [Member]
Total marketable securities	0	0
US Government Agencies Debt Securities [Member]
Total marketable securities	21,638	26,588
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member]
Total marketable securities	0	0
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member]
Total marketable securities	21,638	26,588
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member]
Total marketable securities	$ 0	$ 0

v3.24.1.u1

Note 5 - Amounts Receivable (Details Textual) - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Interest Receivable, Current	$ 391,000	$ 298,000

v3.24.1.u1

Note 7 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Property, plant and equipment, gross	$ 238	$ 231
Less accumulated depreciation	(106)	(100)
Property and equipment, net	132	131
Furniture and Fixtures [Member]
Property, plant and equipment, gross	128	128
Computer Equipment [Member]
Property, plant and equipment, gross	94	87
Leasehold Improvements [Member]
Property, plant and equipment, gross	$ 16	$ 16

v3.24.1.u1

Note 8 - Accrued Liabilities - Accrued Liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Clinical trial costs	$ 689	$ 258
Research and development services	637	632
Compensation	317	766
Professional services fees	150	98
Other	22	23
Total accrued liabilities	$ 1,815	$ 1,777

v3.24.1.u1

Note 9 - Operating Lease (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Operating Lease, Cost	$ 26,000	$ 26,000
Variable Lease, Cost	$ 13,000	$ 15,000

v3.24.1.u1

Note 9 - Operating Lease - Maturity of Operating Lease Liability (Details) $ in Thousands	Mar. 31, 2024 USD ($)
2024	$ 82
2025	113
2026	116
2027	119
2028	10
Total lease payments	440
Less interest portion	(63)
Present value of lease obligation	$ 377

v3.24.1.u1

Note 10 - Shareholders' Equity (Details Textual) - shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Stock Issued During Period, Shares, Restricted Stock Units	5,916	4,289
Stock Issued During Period, Shares Settlement of Deferred Stock Units		17,621

v3.24.1.u1

Note 10 - Shareholders' Equity - Shares Reserved (Details)	Mar. 31, 2024 shares
Common shares issuable upon exercise of employee and non-employee stock options (in shares)	5,404,967
Stock Options Outstanding [Member]
Common shares issuable upon exercise of employee and non-employee stock options (in shares)	4,259,763
Deferred Share Units [Member]
Common shares issuable upon exercise of employee and non-employee stock options (in shares)	284,886
Restricted Stock Units (RSUs) [Member]
Common shares issuable upon exercise of employee and non-employee stock options (in shares)	17,744
The 2019 Omnibus Incentive Plan [Member]
Common shares issuable upon exercise of employee and non-employee stock options (in shares)	732,574
The 2021 Employment Inducement Incentive Plan [Member]
Common shares issuable upon exercise of employee and non-employee stock options (in shares)	110,000

v3.24.1.u1

Note 11 - Net Loss Per Share - Summary of Significant Accounting Policies - Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Net loss	$ (5,151)	$ (5,272)
Weighted average shares outstanding—basic and diluted (in shares)	37,958,000	26,448,941
Basic and diluted net loss per share (in dollars per share)	$ (0.14)	$ (0.2)

v3.24.1.u1

Note 11 - Net Loss Per Share - Schedule of Antidilutive Shares Excluded from Computation of Net Loss Per Share (Details) - shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Employee and Non-employee Stock Options [Member]
Antidilutive Securities (in shares)	4,259,763	2,773,498
Warrant [Member]
Antidilutive Securities (in shares)	0	265,000
Deferred Share Units [Member]
Antidilutive Securities (in shares)	284,886	213,905
Restricted Stock Units (RSUs) [Member]
Antidilutive Securities (in shares)	17,744	12,867

v3.24.1.u1

Note 12 - Share-based Compensation (Details Textual) - shares	May 18, 2022	Mar. 31, 2024	Dec. 03, 2021
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)		4,259,763
Common Stock, Capital Shares Reserved for Future Issuance (in shares)		5,404,967
Deferred Share Units [Member]
Common Stock, Capital Shares Reserved for Future Issuance (in shares)		284,886
Restricted Stock Units (RSUs) [Member]
Common Stock, Capital Shares Reserved for Future Issuance (in shares)		17,744
The 2019 Omnibus Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)	4,000,000
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)		2,921,853
The 2019 Omnibus Incentive Plan [Member] | Employee and Non-employee Stock Options [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year)	10 years
The 2019 Omnibus Incentive Plan [Member] | Employee and Non-employee Stock Options [Member] | Minimum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year)	1 year
The 2019 Omnibus Incentive Plan [Member] | Employee and Non-employee Stock Options [Member] | Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year)	4 years
The 2019 Omnibus Incentive Plan [Member] | Nonemployee Stock Options [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year)	5 years
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year)	1 year
The 2019 Omnibus Incentive Plan [Member] | Deferred Share Units [Member]
Common Stock, Capital Shares Reserved for Future Issuance (in shares)		267,553
The 2019 Omnibus Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member]
Common Stock, Capital Shares Reserved for Future Issuance (in shares)		17,744
The 2021 Employment Inducement Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)			1,000,000
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)		890,000
Stock Option Prior Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)		447,910
The 2012 DSU Plan [Member]
Common Stock, Capital Shares Reserved for Future Issuance (in shares)		17,333

v3.24.1.u1

Note 12 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Total share-based compensation	$ 488	$ 422
Research and Development Expense [Member]
Total share-based compensation	195	132
General and Administrative Expense [Member]
Total share-based compensation	$ 293	$ 290

v3.24.1.u1

Note 12 - Share-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2024	Dec. 31, 2023
Balances, aggregate intrinsic value	$ 732
Balances, shares underlying options outstanding (in shares)	4,259,763
Balances, weighted average exercise price per share (in dollars per share)	$ 3.52
Share-Based Payment Arrangement, Option [Member]
Balances, shares underlying options outstanding (in shares)	3,871,013
Balances, weighted average exercise price per share (in dollars per share)	$ 3.61
Balances, aggregate intrinsic value		$ 832
Granted, shares underlying options outstanding (in shares)	435,000
Granted, weighted average exercise price per share (in dollars per share)	$ 2.76
Expired/cancelled, shares underlying options outstanding (in shares)	0
Expired/cancelled, weighted average exercise price per share (in dollars per share)	$ 0
Forfeited, shares underlying options outstanding (in shares)	(46,250)
Forfeited, weighted average exercise price per share (in dollars per share)	$ 2.97

v3.24.1.u1

Note 12 - Share-based Compensation - Stock Options Outstanding (Details) - $ / shares	3 Months Ended	6 Months Ended
	Mar. 31, 2024	Jun. 30, 2023
Shares Outstanding (in shares)	4,259,763
Weighted Average Remaining Contractual Life (Year)	7 years 1 month 6 days
Weighted Average Exercise Price (in dollars per share)	$ 3.52
Options Exercisable (in shares)	2,369,691
Weighted Average Remaining Contractual Life, exercisable (Year)	6 years
Exercise Price Range 1 [Member]
Per share exercise price, lower range (in dollars per share)		$ 1
Per share exercise price, upper range (in dollars per share)	$ 1.99
Shares Outstanding (in shares)	343,443
Weighted Average Remaining Contractual Life (Year)	8 years 8 months 12 days
Weighted Average Exercise Price (in dollars per share)	$ 1.55
Options Exercisable (in shares)	100,128
Weighted Average Remaining Contractual Life, exercisable (Year)	8 years 8 months 12 days
Exercise Price Range 2 [Member]
Per share exercise price, lower range (in dollars per share)		2
Per share exercise price, upper range (in dollars per share)	$ 2.99
Shares Outstanding (in shares)	2,097,720
Weighted Average Remaining Contractual Life (Year)	8 years
Weighted Average Exercise Price (in dollars per share)	$ 2.64
Options Exercisable (in shares)	715,715
Weighted Average Remaining Contractual Life, exercisable (Year)	6 years 10 months 24 days
Exercise Price Range 3 [Member]
Per share exercise price, lower range (in dollars per share)		3
Per share exercise price, upper range (in dollars per share)	$ 3.99
Shares Outstanding (in shares)	449,393
Weighted Average Remaining Contractual Life (Year)	6 years 6 months
Weighted Average Exercise Price (in dollars per share)	$ 3.73
Options Exercisable (in shares)	299,016
Weighted Average Remaining Contractual Life, exercisable (Year)	5 years 6 months
Exercise Price Range 4 [Member]
Per share exercise price, lower range (in dollars per share)		4
Per share exercise price, upper range (in dollars per share)	$ 4.99
Shares Outstanding (in shares)	862,182
Weighted Average Remaining Contractual Life (Year)	5 years 3 months 18 days
Weighted Average Exercise Price (in dollars per share)	$ 4.58
Options Exercisable (in shares)	858,432
Weighted Average Remaining Contractual Life, exercisable (Year)	5 years 3 months 18 days
Exercise Price Range 5 [Member]
Per share exercise price, lower range (in dollars per share)		$ 5
Per share exercise price, upper range (in dollars per share)	$ 16
Shares Outstanding (in shares)	507,025
Weighted Average Remaining Contractual Life (Year)	6 years 2 months 12 days
Weighted Average Exercise Price (in dollars per share)	$ 6.49
Options Exercisable (in shares)	396,400
Weighted Average Remaining Contractual Life, exercisable (Year)	5 years 10 months 24 days

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