Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Mar. 15, 2024 | |
Document Information [Line Items] | ||
Document Type | 10-K | |
Document Annual Report | true | |
Document Period End Date | Dec. 31, 2023 | |
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 Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
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 | |
ICFR Auditor Attestation Flag | false | |
Document Financial Statement Error Correction [Flag] | false | |
Entity Shell Company | false | |
Entity Public Float | $ 103.4 | |
Entity Common Stock, Shares Outstanding (in shares) | 37,958,000 | |
Auditor Firm ID | 23 | |
Auditor Name | Baker Tilly US, LLP | |
Auditor Location | Minneapolis, MN | |
Entity Central Index Key | 0001401040 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | FY | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 4,543 | $ 4,728 |
Marketable securities | 48,352 | 28,774 |
Prepaid expenses and other assets | 411 | 251 |
Amounts receivable | 369 | 82 |
Total current assets | 53,675 | 33,835 |
Non-current assets: | ||
Operating lease right-of-use asset | 354 | 424 |
Property and equipment, net | 131 | 136 |
Total non-current assets | 485 | 560 |
Total assets | 54,160 | 34,395 |
Current liabilities: | ||
Accounts payable | 926 | 734 |
Accrued liabilities | 1,777 | 1,365 |
Finance lease obligation | 3 | 6 |
Operating lease obligation | 80 | 63 |
Total current liabilities | 2,786 | 2,168 |
Non-current liabilities: | ||
Finance lease obligation, non-current | 1 | 4 |
Operating lease obligation, non-current | 316 | 396 |
Total non-current liabilities | 317 | 400 |
Commitments and Contingencies | ||
Shareholders' equity | ||
Common shares, no par value; unlimited authorized; 37,958,000 and 26,443,067 shares issued and outstanding, as of December 31, 2023 and 2022, respectively | 0 | 0 |
Paid-in capital | 166,609 | 128,078 |
Accumulated other comprehensive income (loss) | 6 | (74) |
Accumulated deficit | (115,558) | (96,177) |
Total shareholders’ equity | 51,057 | 31,827 |
Total liabilities and shareholders’ equity | $ 54,160 | $ 34,395 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares $ / shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Common Stock, No Par Value (in dollars per share) | $ 0 | $ 0 |
Common Stock, Shares Authorized, Unlimited [Fixed List] | Unlimited | Unlimited |
Common Stock, Shares, Issued (in shares) | 37,958,000 | 26,443,067 |
Common Stock, Shares, Outstanding (in shares) | 37,958,000 | 26,443,067 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Research and development | $ 13,110 | $ 7,839 |
General and administrative | 8,157 | 6,162 |
Total operating expenses | 21,267 | 14,001 |
Operating loss | (21,267) | (14,001) |
Other income, net | 1,929 | 353 |
Total other income, net | 1,929 | 353 |
Loss before income tax expense | (19,338) | (13,648) |
Income tax expense | (43) | (28) |
Net loss | (19,381) | (13,676) |
Unrealized gain (loss) on marketable securities | 80 | (23) |
Net loss and comprehensive loss | $ (19,301) | $ (13,699) |
Basic and diluted net loss per share (in dollars per share) | $ (0.6) | $ (0.52) |
Weighted average shares outstanding – basic and diluted (in shares) | 32,566,723 | 26,443,067 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - 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, 2021 | 26,443,067 | ||||
Balances at Dec. 31, 2021 | $ 126,576 | $ (51) | $ (82,501) | $ 44,024 | |
Share-based compensation expense | 1,502 | 0 | 0 | 1,502 | |
Unrealized gain (loss) on marketable securities | (23) | 0 | (23) | ||
Net loss | 0 | (13,676) | (13,676) | ||
Balance (in shares) at Dec. 31, 2022 | 26,443,067 | ||||
Balance at Dec. 31, 2022 | 128,078 | (74) | (96,177) | 31,827 | |
Share-based compensation expense | 1,683 | 1,683 | |||
Unrealized gain (loss) on marketable securities | 80 | 0 | 80 | ||
Net loss | 0 | 0 | (19,381) | (19,381) | |
Issuance of common shares, net of offering costs (in shares) | 11,480,156 | ||||
Issuance of common shares, net of offering costs | 36,848 | 0 | 0 | $ 36,848 | |
Issuance of common shares in settlement of deferred stock units (in shares) | 17,621 | 17,621 | |||
Issuance of common shares in settlement of restricted stock units (in shares) | 17,156 | 17,156 | |||
Issuance of common shares in settlement of restricted stock units | 0 | 0 | 0 | $ 0 | |
Balance (in shares) at Dec. 31, 2023 | 37,958,000 | ||||
Balance at Dec. 31, 2023 | $ 166,609 | $ 6 | $ (115,558) | $ 51,057 |
Consolidated Statements of Sh_2
Consolidated Statements of Shareholders' Equity (Parentheticals) $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 1.4 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Net loss | $ (19,381,000) | $ (13,676,000) |
Share-based compensation | 1,683,000 | 1,502,000 |
Amortization of premium (discount) on marketable securities | (1,223,000) | (11,000) |
Non-cash lease expense | 70,000 | 64,000 |
Depreciation | 30,000 | 25,000 |
Amounts receivable | (287,000) | 48,000 |
Prepaid expenses and other assets | (160,000) | (54,000) |
Accounts payable | 192,000 | 225,000 |
Accrued liabilities | 348,000 | 366,000 |
Net cash used in operating activities | (18,728,000) | (11,511,000) |
Purchase of marketable securities | (69,410,000) | (45,684,000) |
Maturities of marketable securities | 51,135,000 | 57,303,000 |
Purchase of property and equipment | (24,000) | (81,000) |
Net cash provided by (used in) investing activities | (18,299,000) | 11,538,000 |
Proceeds from issuance of common shares, net of offering costs | 36,848,000 | 0 |
Principal payments on finance lease obligations | (6,000) | (6,000) |
Net cash provided by (used in) financing activities | 36,842,000 | (6,000) |
Net increase (decrease) in cash and cash equivalents | (185,000) | 21,000 |
Cash and cash equivalents at beginning of period | 4,728,000 | 4,707,000 |
Cash and cash equivalents at end of period | 4,543,000 | 4,728,000 |
us-gaap_SupplementalCashFlowInformationAbstract | ||
Cash paid for income taxes | 33,000 | 27,000 |
Assets acquired under operating lease | $ 0 | $ 446,000 |
Note 1 - Business
Note 1 - Business | 12 Months Ended |
Dec. 31, 2023 | |
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.” |
Note 2 - Risks and Uncertaintie
Note 2 - Risks and Uncertainties | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Unusual Risks and Uncertainties [Table 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. On July 6, 2022, we announced that the FDA placed a clinical hold on the investigational new drug application (IND) for our Phase 2/3 ReMEDy2 trial. The clinical hold was issued following us voluntarily pausing participant enrollment in the trial to investigate three unexpected instances of clinically significant hypotension (low blood pressure) occurring shortly after initiation of the intravenous (IV) dose of DM199. In September 2022, we submitted our analysis of the events leading to and causing the hypotensive events, and proposed protocol modifications to address the mitigation of these events for future trial participants. Following review of this analysis, the FDA informed us that they were continuing the clinical hold and requesting, among other items, an additional in-use in vitro stability study of the IV administration of DM199, which includes testing the combination of the IV bag, IV tubing and mechanical infusion pump, to further rule out any other cause of the hypotension events. The requested in-use study was completed at an independent laboratory and the results were substantially consistent with our earlier testing of the IV bags. In May 2023, these additional supporting data were submitted to the FDA in our clinical hold response. In June 2023, the FDA completed review of our clinical hold response and informed us that the clinical hold was removed allowing us to resume our Phase 2/3 ReMEDy2 trial. Prior to the clinical hold of our ReMEDy2 trial, we had experienced slower than expected site activations and enrollment in our ReMEDy2 trial and may continue to experience these conditions as we activate additional clinical sites and enroll participants. We believe this was due primarily to clinical staff shortages resulting from layoffs and employee burnout, the reallocation of clinical nurses to COVID-19 care, particularly during surges in COVID-19 cases, a loss of study coordinators resulting from budget constraints and COVID-19 vaccination requirements and concerns managing logistics and protocol compliance for participants discharged from the hospital to an intermediate care facility. In an effort to mitigate the impact of these factors, we have worked with our contract research organization to develop alternative procedures to support study sites and potential participants as needed. We intend to continue to monitor the results of these efforts or 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. 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 December 31, 2023, we have incurred losses of $115.6 million since our inception in 2000. For the year ended December 31, 2023, we incurred a net loss of $19.4 million and negative cash flows from operating activities of $18.7 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 December 31, 2023, we had combined cash, cash equivalents and marketable securities of $52.9 million, working capital of $50.9 million and shareholders’ equity of $51.1 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 is 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 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 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 enrollment in the study, the potential expansion of our current development programs, potential new development programs, the effects of COVID-19, 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. |
Note 3 - Summary of Significant
Note 3 - Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Liquidity and Management Plans [Text Block] | 3. Summary of Significant Accounting Policies Basis of consolidation The accompanying consolidated financial statements include the assets, liabilities and expenses of DiaMedica Therapeutics Inc., and our wholly-owned subsidiaries, DiaMedica USA, Inc. and DiaMedica Australia Pty Ltd. All significant intercompany transactions and balances have been eliminated in consolidation. Functional currency The United States dollar is our functional currency as it represents the economic effects of the underlying transactions, events and conditions and various other factors including the currency of historical and future expenditures and the currency in which funds from financing activities are mostly generated by the Company. A change in the functional currency occurs only when there is a material change in the underlying transactions, events and condition. A change in functional currency could result in material differences in the amounts recorded in the consolidated statements of operations and comprehensive loss for foreign exchange gains and losses. All amounts in the accompanying consolidated financial statements are in U.S. dollars unless otherwise indicated. Use of estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ from those estimates. 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 date of purchase are included in current assets. Securities are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization or accretion is included in interest income. Realized gains and losses, if any, are calculated on the specific identification method and are included in other income in the 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, 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, are recorded within earnings as an impairment loss. There were no other-than-temporary unrealized losses as of December 31, 2023. Concentration of credit risk Financial instruments that potentially expose the Company to concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company maintains its cash balances primarily with two financial institutions. These balances generally exceed federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risk in cash and cash equivalents. The Company believes that the credit risk related to marketable securities is limited due to the adherence to an investment policy focused on the preservation of principal. 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 Level 2 Inputs Level 3 Inputs As of December 31, 2023, 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 Long-lived assets Property and equipment are stated at purchased cost less accumulated depreciation. Depreciation of property and equipment is computed using the straight-line method over their estimated useful lives of three to ten years for office equipment and four years for computer equipment. Upon retirement or sale, the cost and related accumulated depreciation are removed from the consolidated balance sheets and the resulting gain or loss is reflected in the consolidated statements of operations. Repairs and maintenance are expensed as incurred. Long-lived assets are evaluated for impairment when events or changes in circumstances indicate that the carrying amount of the asset or related group of assets may not be recoverable. If the expected future undiscounted cash flows are less than the carrying amount of the asset, an impairment loss is recognized at that time. Measurement of impairment may be based upon appraisal, market value of similar assets or discounted cash flows. Leases We determine if an arrangement is a lease at inception. We have made a policy election to not separate lease and non-lease components for our real estate leases to the extent they are fixed. Non-lease components that are not fixed are expensed as incurred as variable lease expense. Our facility lease includes variable non-lease components, such as common-area maintenance costs. Our operating lease is included in operating lease right-of-use (“ROU”) asset and operating lease obligations on our consolidated balance sheets. Our operating lease ROU asset represents our right to use an underlying asset for the lease term and operating lease liabilities represent our obligation to make lease payments arising from the lease. The operating lease ROU asset and operating lease obligation are recognized based on the present value of lease payments over the lease term. The lease does not provide an implicit rate and, due to the lack of a commercially salable product, we are generally considered unable to obtain commercial credit. Therefore, considering the quoted rates for the lowest investment-grade debt and the interest rates implicit in recent financing leases, we estimated our incremental borrowing rate. The operating lease ROU asset excludes lease incentives. Our lease includes an option to extend or terminate the lease; lease terms are only adjusted for these options when it is reasonably certain that we will exercise such options to extend or terminate the lease. Lease expense is recognized on a straight-line basis over the lease term. Assumptions made by us at the commencement date are re-evaluated upon occurrence of certain events, including a lease modification. A lease modification results in a separate contract when the modification grants the lessee an additional right of use not included in the original lease and when lease payments increase commensurate with the standalone price for the additional right of use. When a lease modification results in a separate contract, it is accounted for in the same manner as a new lease. Research and development costs Research and development (R&D) costs include expenses incurred in the conduct of human clinical trials such as fees paid to external service providers such as 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; and 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. We charge research and development costs, including clinical trial costs, to expense when incurred. Our human clinical trials are performed at clinical trial sites and are administered jointly by us with assistance from various contract research organizations. Costs of setting up clinical trial sites are accrued upon execution of the study agreement. Expenses related to the performance of clinical trials are recorded or accrued based on actual invoices received and estimates of work completed to date by clinical trial sites, contract research organizations and outside vendors that assist with management and performance of the trials, and those that manufacture the investigational product. While we utilize electronic data capture systems to facilitate the transmission and capture of clinical trial activity, such information is often incomplete or delayed. Therefore we are required to estimate the levels of performance under each significant contract, including, among other things, the extent of participant enrollment, the extent of supporting services performed and other activities through communications with the clinical trial sites, CROs and supporting vendors and adjust the estimates, if required, on a quarterly basis so that clinical expenses reflect the actual work performed at each clinical trial site and by each CRO or supporting vendor. Additionally, actual costs may be charged to us and are recognized as the tasks are completed by the clinical trial site. Accrued R&D costs may be subject to revisions as clinical trials, non-clinical research and DM199 development programs progress and any revisions are recorded in the period in which the facts that give rise to the revisions become known. Patent costs Costs associated with applying for, prosecuting and maintaining patents are expensed as incurred given the uncertainty of patent approval and, if approved, the resulting probable future economic benefit to the Company. Patent-related costs, consisting primarily of legal expenses and filing/maintenance fees, are included in general and administrative costs and were $318,000 and $146,000 for the years ended December 31, 2023 and 2022, respectively. Share-based compensation The cost of employee and non-employee services received in exchange for awards of equity instruments is measured and recognized based on the estimated grant date fair value of those awards. Compensation cost is recognized ratably using the straight-line attribution method over the vesting period, which is considered to be the requisite service period. We record forfeitures in the periods in which they occur. The fair value of option awards is estimated at the date of grant using the Black-Scholes option pricing model. The determination of the fair value of share-based awards is affected by our share price, as well as assumptions regarding a number of complex and subjective variables. Risk free interest rates are based upon United States Government bond rates appropriate for the expected term of each award. Expected volatility rates are based on the historical volatility over a period equal to the expected term of the option. The assumed dividend yield is zero, as we do not expect to declare any dividends in the foreseeable future. The expected term of options is estimated considering the vesting period at the grant date, the life of the option and the average length of time similar grants have remained outstanding in the past. Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted rates, for each of the jurisdictions in which the Company operates, expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to the amount that is more likely than not to be realized. The Company has provided a full valuation allowance against the gross deferred tax assets as of December 31, 2023 and 2022. See Note 14, “Income Taxes” for additional information. The Company’s policy is to classify interest and penalties related to income taxes as income tax expense. 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 the exclusion of common share equivalents as their effect would be 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): Year Ended December 31, 2023 2022 Net loss $ (19,381 ) $ (13,676 ) Weighted average shares outstanding—basic and diluted 32,566,723 26,443,067 Basic and diluted net loss per share $ (0.60 ) $ (0.52 ) The following outstanding potential common shares were not included in the diluted net loss per share calculations as their effects were not dilutive: Year Ended December 31, 2023 2022 Employee and non-employee stock options 3,871,013 2,782,248 Common shares issuable under common share purchase warrants — 265,000 Common shares issuable upon settlement of deferred stock units 213,905 134,402 4,084,918 3,181,650 Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board issued ASU No. 2016-13, Financial Instruments Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Note 4 - Marketable Securities
Note 4 - Marketable Securities | 12 Months Ended |
Dec. 31, 2023 | |
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 as of December 31, 2023 Using Inputs Considered as Fair Value Level 1 Level 2 Level 3 Commercial paper and corporate bonds $ 21,764 $ — $ 21,764 $ — Government securities 26,588 — 26,588 — Total marketable securities $ 48,352 $ — $ 48,352 $ — Fair Value Measurements as of December 31, 2022 Using Inputs Considered as Fair Value Level 1 Level 2 Level 3 Commercial paper and corporate bonds $ 14,209 $ — $ 14,209 $ — Government securities 14,565 — 14,565 — Total marketable securities $ 28,774 $ — $ 28,774 $ — Accrued interest receivable on available-for-sale securities was $298,000 and $80,000 for the years ended December 31, 2023 and 2022, respectively, and is included in amounts receivable. There were no transfers of assets between Level 1 and Level 2 of the fair value measurement hierarchy during the year ended December 31, 2023. Under the terms of the Company’s investment policy, purchases of marketable securities are limited to investment grade governmental and corporate obligations and bank certificates of deposit with a primary objective of principal preservation. Maturities of individual securities are less than one year, and the amortized cost of all securities approximated fair value as of December 31, 2023 and 2022. |
Note 5 - Amounts Receivable
Note 5 - Amounts Receivable | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Loans, Notes, Trade and Other Receivables Disclosure [Text Block] | 5. Amounts Receivable Amounts receivable consisted of the following (in thousands): December 31, 2023 December 31, 2022 Accrued interest receivable on marketable securities $ 298 $ 80 Other 71 2 Total amounts receivable $ 369 $ 82 |
Note 6 - Prepaid Expenses and O
Note 6 - Prepaid Expenses and Other Assets | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Other Assets Disclosure [Text Block] | 6. Prepaid Expenses and Other Assets Prepaid expenses and other assets consisted of the following (in thousands): December 31, 2023 December 31, 2022 Advances to vendors $ 317 $ 42 Prepaid expenses 94 209 Total prepaid expenses and other assets $ 411 $ 251 We periodically advance funds to vendors engaged to support the performance of our clinical trials and related supporting activities. The funds advanced are held, interest free, for varying periods of time and may be recovered by the Company through partial reductions of ongoing invoices, application against final study/project invoices or refunded upon completion of services to be provided. Deposits are classified as current or non-current based upon their expected recovery time. |
Note 7 - Property and Equipment
Note 7 - Property and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 7. Property and Equipment Property and equipment consisted of the following (in thousands): December 31, 2023 December 31, 2022 Furniture and equipment $ 128 $ 124 Computer equipment 87 76 Leasehold Improvements 16 16 231 216 Less accumulated depreciation (100 ) (80 ) Property and equipment, net $ 131 $ 136 Depreciation expense was $30,000 and $25,000 for each of the years ended December 31, 2023 and 2022, respectively. During 2023 and 2022, we disposed of $10,000 and $12,000 of equipment, respectively. |
Note 8 - Accrued Liabilities
Note 8 - Accrued Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | 8. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): December 31, 2023 December 31, 2022 Accrued compensation 766 667 Accrued research and other professional fees 730 215 Accrued clinical trial costs 258 472 Accrued other liabilities 23 11 Total accrued liabilities $ 1,777 $ 1,365 |
Note 9 - Operating Lease
Note 9 - Operating Lease | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | 9. Operating Lease In June 2022, we entered into an agreement to lease approximately 6,000 square feet of office space in Minneapolis, Minnesota, near our former office space. The lease commencement date was September 1, 2022, has a term of 65 months expiring on January 31, 2028 and includes an incentive of five months of full rent abatement. This incentive is subject to repayment if we default in performance of any material obligations under the lease prior to the 48 th Our operating lease costs were $104,000 and $78,000 for the years ended December 31, 2023 and 2022, respectively. Our variable lease costs were $92,000 and $25,000 for the years ended December 31, 2023 and 2022, 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 December 31, 2023 (in thousands): 2024 109 2025 113 2026 116 2027 119 2028 10 Total lease payments $ 467 Less interest portion (71 ) Present value of lease obligation $ 396 Former office lease We leased certain office space under a non-cancelable operating lease that terminated on August 31, 2022, and we did not renew it. This lease included lease (e.g., fixed rent) and non-lease components (e.g., common-area and other maintenance costs). The right-of-use asset for this lease was fully amortized as of August 31, 2022. |
Note 10 - Commitments and Conti
Note 10 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 10. Commitments and Contingencies Clinical trials and product development In the normal course of business, we incur obligations to make future payments as we execute our business plan. These obligations may relate to preclinical or clinical studies, manufacturing or manufacturing process development and other related or supporting activities. Currently, these obligations include costs to be incurred with contract research organizations, central laboratory and pharmacy services, clinical study sites, home nursing services, various other vendors supporting the performance of our clinical trials and contract manufacturing and development organizations. The contracts we enter into with these vendors and the commitments within these contracts are subject to significant variability based upon the actual activities/services performed by each vendor. As a result, the ultimate amounts due may be materially different as these obligations are affected by, among other factors, the number and pace of clinical study sites activated, the number of participants enrolled, the amount of time to complete trial enrollment and the time required to finalize, analyze and report our clinical trial results. Clinical research agreements are generally cancelable upon up to 60-90 days’ notice, with our obligation limited to costs incurred up to that date, including any non-cancelable costs. Cancelation terms for product manufacturing and process development contracts vary and are generally dependent upon timelines for sourcing research materials and reserving laboratory time. As of December 31, 2023, we estimate that our outstanding commitments, including such cancellable contracts, are approximately $15.3 million over the next 12 months and approximately $12.5 million in the following 12 months. Technology license We have entered into a license agreement with Catalent Pharma Solutions, LLC (Catalent) whereby we have licensed certain gene expression technology and we contract with Catalent for the manufacture of DM199. Under the terms of this license, certain milestone and royalty payments may become due under this agreement and are dependent upon, among other factors, clinical trials, regulatory approvals and ultimately the successful development of a new drug, the outcome and timing of which is uncertain. As of December 31, 2023, one milestone payment obligation remains which is due upon our first regulatory approval of DM199 for commercial sale. Following the launch of our first product, we will also incur a royalty of less than 1% on net sales. The royalty term is indefinite but the license agreement may be canceled by us on 90 days’ prior written notice. The license may not be terminated by Catalent unless we fail to make required milestone and royalty payments. Indemnification of directors and officers The Company, as permitted under laws of the BCBCA and in accordance with the Company’s Articles and indemnification agreements, will indemnify and advance expenses to its directors and officers to the fullest extent permitted by law and may choose to indemnify other employees or agents from time to time. The Company has secured insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or her actions in connection with their services to the Company. As of December 31, 2023, there was no pending litigation or proceeding involving any director or officer of the Company as to which indemnification is required or permitted, and we are not aware of any threatened litigation or proceeding that may result in a claim for indemnification. Insofar as indemnification for liabilities arising under the United States Securities Act of 1933, as amended (Securities Act) may be permitted to directors, officers and controlling persons of the Company, the Company has been advised that, in the opinion of the United States Securities and Exchange Commission (SEC), such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable. The Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company had not |
Note 11 - Shareholders' Equity
Note 11 - Shareholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | 11. Shareholders Equity Authorized capital stock DiaMedica has authorized share capital of an unlimited number of common voting 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 year ended December 31, 2023 On April 10, 2023, in conjunction with his appointment as Chief Business Officer of DiaMedica, David Wambeke purchased 468,750 of DiaMedica’s common shares at an aggregate purchase price of $750,000 or $1.60 per share. On June 21, 2023, we issued and sold an aggregate 11,011,406 common shares pursuant to a securities purchase agreement at a purchase price of $3.40 per share, or $3.91 per share in the case of our participating directors and officers, in a private placement. As a result of the offering, we received gross proceeds of $37.5 million, which resulted in net proceeds to us of approximately $36.1 million, after deducting the offering expenses. In connection with the June 2023 private placement, we entered into a registration rights agreement (Registration Rights Agreement) with the investors pursuant to which we agreed to file with the United States Securities and Exchange Commission (SEC) a registration statement registering the resale of the shares sold in the June 2023 private placement (Resale Registration Statement). The Resale Registration Statement was filed with the SEC on June 30, 2023 and declared effective by the SEC on July 7, 2023. Under the terms of the Registration Rights Agreement, we agreed to keep the Resale Registration Statement effective at all times until the shares are no longer considered “Registrable Securities” under the Registration Rights Agreement and if we fail to keep the Resale Registration Statement effective, subject to certain permitted exceptions, we will be required to pay liquidated damages to the investors in an amount of up to 10% of the invested capital, excluding interest. We also agreed, among other things, to indemnify the selling holders under the Resale Registration Statement from certain liabilities and to pay all fees and expenses incident to our performance of or compliance with the Registration Rights Agreement. During the year ended December 31, 2023, 17,621 common shares were issued in settlement of deferred share units and 17,156 common shares were issued in settlement of restricted stock units. Equity issued during the year ended December 31, 2022 During the year ended December 31, 2022, we did not Shares reserved Common shares reserved for future issuance are as follows: December 31, 2023 Employee and non-employee stock options 3,871,013 Common shares issuable upon settlement of deferred stock units 213,905 Common shares issuable under common share purchase warrants — Shares available for grant under the Amended and Restated 2019 Omnibus Incentive Plan 927,215 Shares available for grant under the 2021 Employment Inducement Incentive Plan 395,000 Total 5,407,133 |
Note 12 - Share-based Compensat
Note 12 - Share-based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
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 stock-based awards. We grant options to purchase common shares under the 2019 Plan at no less than the fair market value of the underlying common shares as of the date of grant. Options granted to employees and non-employee directors have a maximum term of ten one four five one 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 stock-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 December 31, 2023, options to purchase an aggregate of 605,000 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 December 31, 2023, 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 December 31, 2023, 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): December 31, 2023 December 31, 2022 Research and development $ 619 $ 460 General and administrative 1,064 1,042 Total share-based compensation $ 1,683 $ 1,502 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 as of December 31, 2021 1,896,600 $ 5.25 $ 169 Granted 1,014,398 2.58 Exercised — — Expired/cancelled (68,437 ) 4.25 Forfeited (60,313 ) 11.05 Balances as of December 31, 2022 2,782,248 $ 4.12 $ 17 Granted 1,172,515 2.59 Exercised — — Expired/cancelled (58,750 ) 8.08 Forfeited (25,000 ) 3.24 Balances as of December 31, 2023 3,871,013 $ 3.61 $ 832 A summary of the status of our unvested shares underlying options during the year ended and as of December 31, 2023 is as follows: Shares Underlying Options Weighted Average Grant Date Fair Value Per Share Unvested as of December 31, 2022 1,241,137 $ 2.31 Granted 1,172,515 2.09 Vested (723,968 ) 2.38 Forfeited (25,000 ) 2.65 Unvested as of December 31, 2023 1,664,684 $ 2.11 Information about stock options outstanding, vested and expected to vest as of December 31, 2023, 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 9.0 $ 1.55 78,112 8.9 $2.00 - $2.99 1,706,470 7.8 2.62 612,581 6.8 $3.00 - $3.99 448,726 6.8 3.75 282,324 5.7 $4.00 - $4.99 862,849 5.5 4.59 857,849 5.5 $5.00 - $16.00 509,525 6.5 6.56 375,463 6.1 3,871,013 7.1 $ 3.61 2,206,329 6.1 The cumulative grant date fair value of employee options vested during the years ended December 31, 2023 and 2022 was $1.7 million and $1.0 million, respectively. No options were exercised during the years ended December 31, 2023 and 2022. As of December 31, 2023, total compensation expense related to unvested employee stock options not yet recognized was $3.3 million, which is expected to be allocated to expenses over a weighted-average period of 2.7 years. The assumptions used in calculating the fair value under the Black-Scholes option valuation model are set forth in the following table for options issued by the Company for the years ended December 31, 2023 and 2022: 2023 2022 Common share fair value $1.57 – $3.24 $1.47 – $3.88 Risk-free interest rate 3.5 – 4.6% 1.4 – 3.6% Expected dividend yield 0% 0% Expected option life (years) 5.0 – 5.7 5.0 – 5.6 Expected stock price volatility 101.7 – 108.1% 102.1 – 104.0% Deferred Stock Units and Restricted Stock Units Under our non-employee director compensation program, non-employee directors may elect to receive RSUs or DSUs in lieu of all or a portion of the annual cash retainers payable to such director. Each RSU or DSU represents the right to receive one share of our common stock. These recipients receive a number of RSUs or DSUs equal to the amount of the elected portion of the annual cash retainers divided by the 10-trading day average closing sale price of the common stock as determined on the third (3 rd There were approximately 214,000 and 134,000 vested DSUs and no no |
Note 13 - Employee Benefit Plan
Note 13 - Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Compensation and Employee Benefit Plans [Text Block] | 13. Employee Benefit Plan We maintain an employee 401(k) retirement savings plan (401(k) Plan). The 401(k) Plan provides eligible employees with an opportunity to make tax-deferred contributions into a long-term investment and savings program. All employees over the age of 21 may elect to participate in the 401(k) Plan beginning on their hire date. The 401(k) Plan allows eligible employees to contribute a portion of their annual compensation, subject only to maximum limits required by law. We contribute an amount up to 4% of each employees’ compensation under the safe harbor provisions provided by the Internal Revenue Service rules governing 401(k) plans. Employee and employer safe harbor contributions vest immediately. We have recorded contribution expenses of $137,000 and $112,000 for the years ended December 31, 2023 and 2022, respectively. |
Note 14 - Income Taxes
Note 14 - Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 14. Income Taxes The Company has incurred net operating losses since inception. The Company has not reflected the benefit of net operating loss carryforwards in the accompanying consolidated financial statements and has established a full valuation allowance against its deferred tax assets. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes as well as operating losses and tax credit carryforwards. The significant components of our deferred tax assets and liabilities are as follows (in thousands): December 31, 2023 2022 Deferred tax assets (liabilities): Non-capital losses carried forward $ 26,044 $ 21,000 Research and development expenditures 817 817 Share issue costs 495 338 Patents and other 358 320 Accruals 214 213 Share-based compensation 212 166 Property and equipment (102 ) (117 ) Total deferred tax asset, net 28,038 22,737 Valuation allowance (28,038 ) (22,737 ) Net deferred tax asset $ — $ — Realization of the future tax benefits is dependent on our ability to generate sufficient taxable income within the carryforward period. Because of our history of operating losses, management believes that the deferred tax assets arising from the above-mentioned future tax benefits are currently not likely to be realized and, accordingly, we have provided a full valuation allowance. The reconciliation of the Canadian statutory income tax rate applied to the net loss for the year to the income tax expense is as follows (in thousands): December 31, 2023 2022 Statutory income tax rate 27.0 % 27.0 % Income tax recovery based on statutory rate $ (5,225 ) $ (3,685 ) Share-based compensation 409 340 Prior-year true-ups (388 ) (33 ) Share issuance costs (71 ) — Other 17 62 Change in valuation allowance 5,301 3,344 Income tax expense $ 43 $ 28 Net operating losses and tax credit carryforwards as of December 31, 2023, are as follows: Amount (In thousands) Expiration Years Non-capital income tax losses, net $ 92,955 Beginning 2026 Research and development expense carry forwards 3,027 Indefinitely Tax credits 474 Beginning 2024 |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended | 12 Months Ended |
Dec. 31, 2023 | Dec. 31, 2023 | |
Insider Trading Arr Line Items | ||
Material Terms of Trading Arrangement [Text Block] | Item 9B. Other Information Rule 10b5-1 Plan and Non-Rule 10b5-1 Trading Arrangement Adoptions, Terminations, and Modifications During the three months ended December 31, 2023, none | |
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 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of consolidation The accompanying consolidated financial statements include the assets, liabilities and expenses of DiaMedica Therapeutics Inc., and our wholly-owned subsidiaries, DiaMedica USA, Inc. and DiaMedica Australia Pty Ltd. All significant intercompany transactions and balances have been eliminated in consolidation. |
Functional Currency [Policy Text Block] | The United States dollar is our functional currency as it represents the economic effects of the underlying transactions, events and conditions and various other factors including the currency of historical and future expenditures and the currency in which funds from financing activities are mostly generated by the Company. A change in the functional currency occurs only when there is a material change in the underlying transactions, events and condition. A change in functional currency could result in material differences in the amounts recorded in the consolidated statements of operations and comprehensive loss for foreign exchange gains and losses. All amounts in the accompanying consolidated financial statements are in U.S. dollars unless otherwise indicated. |
Use of Estimates, Policy [Policy Text Block] | The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ from those estimates. |
Cash and Cash Equivalents, Policy [Policy Text Block] | 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 date of purchase are included in current assets. Securities are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization or accretion is included in interest income. Realized gains and losses, if any, are calculated on the specific identification method and are included in other income in the 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, 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, are recorded within earnings as an impairment loss. There were no other-than-temporary unrealized losses as of December 31, 2023. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of credit risk Financial instruments that potentially expose the Company to concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company maintains its cash balances primarily with two financial institutions. These balances generally exceed federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risk in cash and cash equivalents. The Company believes that the credit risk related to marketable securities is limited due to the adherence to an investment policy focused on the preservation of principal. |
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 Level 2 Inputs Level 3 Inputs As of December 31, 2023, 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 |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Property and equipment are stated at purchased cost less accumulated depreciation. Depreciation of property and equipment is computed using the straight-line method over their estimated useful lives of three to ten years for office equipment and four years for computer equipment. Upon retirement or sale, the cost and related accumulated depreciation are removed from the consolidated balance sheets and the resulting gain or loss is reflected in the consolidated statements of operations. Repairs and maintenance are expensed as incurred.Long-lived assets are evaluated for impairment when events or changes in circumstances indicate that the carrying amount of the asset or related group of assets may not be recoverable. If the expected future undiscounted cash flows are less than the carrying amount of the asset, an impairment loss is recognized at that time. Measurement of impairment may be based upon appraisal, market value of similar assets or discounted cash flows. |
Lessee, Leases [Policy Text Block] | Leases We determine if an arrangement is a lease at inception. We have made a policy election to not separate lease and non-lease components for our real estate leases to the extent they are fixed. Non-lease components that are not fixed are expensed as incurred as variable lease expense. Our facility lease includes variable non-lease components, such as common-area maintenance costs. Our operating lease is included in operating lease right-of-use (“ROU”) asset and operating lease obligations on our consolidated balance sheets. Our operating lease ROU asset represents our right to use an underlying asset for the lease term and operating lease liabilities represent our obligation to make lease payments arising from the lease. The operating lease ROU asset and operating lease obligation are recognized based on the present value of lease payments over the lease term. The lease does not provide an implicit rate and, due to the lack of a commercially salable product, we are generally considered unable to obtain commercial credit. Therefore, considering the quoted rates for the lowest investment-grade debt and the interest rates implicit in recent financing leases, we estimated our incremental borrowing rate. The operating lease ROU asset excludes lease incentives. Our lease includes an option to extend or terminate the lease; lease terms are only adjusted for these options when it is reasonably certain that we will exercise such options to extend or terminate the lease. Lease expense is recognized on a straight-line basis over the lease term. Assumptions made by us at the commencement date are re-evaluated upon occurrence of certain events, including a lease modification. A lease modification results in a separate contract when the modification grants the lessee an additional right of use not included in the original lease and when lease payments increase commensurate with the standalone price for the additional right of use. When a lease modification results in a separate contract, it is accounted for in the same manner as a new lease. |
Research and Development Expense, Policy [Policy Text Block] | Research and development costs Research and development (R&D) costs include expenses incurred in the conduct of human clinical trials such as fees paid to external service providers such as 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; and 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. We charge research and development costs, including clinical trial costs, to expense when incurred. Our human clinical trials are performed at clinical trial sites and are administered jointly by us with assistance from various contract research organizations. Costs of setting up clinical trial sites are accrued upon execution of the study agreement. Expenses related to the performance of clinical trials are recorded or accrued based on actual invoices received and estimates of work completed to date by clinical trial sites, contract research organizations and outside vendors that assist with management and performance of the trials, and those that manufacture the investigational product. While we utilize electronic data capture systems to facilitate the transmission and capture of clinical trial activity, such information is often incomplete or delayed. Therefore we are required to estimate the levels of performance under each significant contract, including, among other things, the extent of participant enrollment, the extent of supporting services performed and other activities through communications with the clinical trial sites, CROs and supporting vendors and adjust the estimates, if required, on a quarterly basis so that clinical expenses reflect the actual work performed at each clinical trial site and by each CRO or supporting vendor. Additionally, actual costs may be charged to us and are recognized as the tasks are completed by the clinical trial site. Accrued R&D costs may be subject to revisions as clinical trials, non-clinical research and DM199 development programs progress and any revisions are recorded in the period in which the facts that give rise to the revisions become known. |
Patent Costs [Policy Text Block] | Patent costs Costs associated with applying for, prosecuting and maintaining patents are expensed as incurred given the uncertainty of patent approval and, if approved, the resulting probable future economic benefit to the Company. Patent-related costs, consisting primarily of legal expenses and filing/maintenance fees, are included in general and administrative costs and were $318,000 and $146,000 for the years ended December 31, 2023 and 2022, respectively. |
Compensation Related Costs, Policy [Policy Text Block] | Share-based compensation The cost of employee and non-employee services received in exchange for awards of equity instruments is measured and recognized based on the estimated grant date fair value of those awards. Compensation cost is recognized ratably using the straight-line attribution method over the vesting period, which is considered to be the requisite service period. We record forfeitures in the periods in which they occur. The fair value of option awards is estimated at the date of grant using the Black-Scholes option pricing model. The determination of the fair value of share-based awards is affected by our share price, as well as assumptions regarding a number of complex and subjective variables. Risk free interest rates are based upon United States Government bond rates appropriate for the expected term of each award. Expected volatility rates are based on the historical volatility over a period equal to the expected term of the option. The assumed dividend yield is zero, as we do not expect to declare any dividends in the foreseeable future. The expected term of options is estimated considering the vesting period at the grant date, the life of the option and the average length of time similar grants have remained outstanding in the past. |
Income Tax, Policy [Policy Text Block] | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted rates, for each of the jurisdictions in which the Company operates, expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to the amount that is more likely than not to be realized. The Company has provided a full valuation allowance against the gross deferred tax assets as of December 31, 2023 and 2022. See Note 14, “Income Taxes” for additional information. The Company’s policy is to classify interest and penalties related to income taxes as income tax expense. |
Earnings Per Share, Policy [Policy Text Block] | 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 the exclusion of common share equivalents as their effect would be 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): Year Ended December 31, 2023 2022 Net loss $ (19,381 ) $ (13,676 ) Weighted average shares outstanding—basic and diluted 32,566,723 26,443,067 Basic and diluted net loss per share $ (0.60 ) $ (0.52 ) The following outstanding potential common shares were not included in the diluted net loss per share calculations as their effects were not dilutive: Year Ended December 31, 2023 2022 Employee and non-employee stock options 3,871,013 2,782,248 Common shares issuable under common share purchase warrants — 265,000 Common shares issuable upon settlement of deferred stock units 213,905 134,402 4,084,918 3,181,650 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board issued ASU No. 2016-13, Financial Instruments Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Note 3 - Summary of Significa_2
Note 3 - Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Year Ended December 31, 2023 2022 Net loss $ (19,381 ) $ (13,676 ) Weighted average shares outstanding—basic and diluted 32,566,723 26,443,067 Basic and diluted net loss per share $ (0.60 ) $ (0.52 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Year Ended December 31, 2023 2022 Employee and non-employee stock options 3,871,013 2,782,248 Common shares issuable under common share purchase warrants — 265,000 Common shares issuable upon settlement of deferred stock units 213,905 134,402 4,084,918 3,181,650 |
Note 4 - Marketable Securities
Note 4 - Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Fair Value, Marketable Securities Measured on a Recurring Basis [Table Text Block] | Fair Value Measurements as of December 31, 2023 Using Inputs Considered as Fair Value Level 1 Level 2 Level 3 Commercial paper and corporate bonds $ 21,764 $ — $ 21,764 $ — Government securities 26,588 — 26,588 — Total marketable securities $ 48,352 $ — $ 48,352 $ — Fair Value Measurements as of December 31, 2022 Using Inputs Considered as Fair Value Level 1 Level 2 Level 3 Commercial paper and corporate bonds $ 14,209 $ — $ 14,209 $ — Government securities 14,565 — 14,565 — Total marketable securities $ 28,774 $ — $ 28,774 $ — |
Note 5 - Amounts Receivable (Ta
Note 5 - Amounts Receivable (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Accounts, Notes, Loans and Financing Receivable [Table Text Block] | December 31, 2023 December 31, 2022 Accrued interest receivable on marketable securities $ 298 $ 80 Other 71 2 Total amounts receivable $ 369 $ 82 |
Note 6 - Prepaid Expenses and_2
Note 6 - Prepaid Expenses and Other Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | December 31, 2023 December 31, 2022 Advances to vendors $ 317 $ 42 Prepaid expenses 94 209 Total prepaid expenses and other assets $ 411 $ 251 |
Note 7 - Property and Equipme_2
Note 7 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, 2023 December 31, 2022 Furniture and equipment $ 128 $ 124 Computer equipment 87 76 Leasehold Improvements 16 16 231 216 Less accumulated depreciation (100 ) (80 ) Property and equipment, net $ 131 $ 136 |
Note 8 - Accrued Liabilities (T
Note 8 - Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 2023 December 31, 2022 Accrued compensation 766 667 Accrued research and other professional fees 730 215 Accrued clinical trial costs 258 472 Accrued other liabilities 23 11 Total accrued liabilities $ 1,777 $ 1,365 |
Note 9 - Operating Lease (Table
Note 9 - Operating Lease (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block] | 2024 109 2025 113 2026 116 2027 119 2028 10 Total lease payments $ 467 Less interest portion (71 ) Present value of lease obligation $ 396 |
Note 11 - Shareholders' Equity
Note 11 - Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Common Stock Reserved for Future Issuance [Table Text Block] | December 31, 2023 Employee and non-employee stock options 3,871,013 Common shares issuable upon settlement of deferred stock units 213,905 Common shares issuable under common share purchase warrants — Shares available for grant under the Amended and Restated 2019 Omnibus Incentive Plan 927,215 Shares available for grant under the 2021 Employment Inducement Incentive Plan 395,000 Total 5,407,133 |
Note 12 - Share-based Compens_2
Note 12 - Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | December 31, 2023 December 31, 2022 Research and development $ 619 $ 460 General and administrative 1,064 1,042 Total share-based compensation $ 1,683 $ 1,502 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Shares Underlying Options Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Balances as of December 31, 2021 1,896,600 $ 5.25 $ 169 Granted 1,014,398 2.58 Exercised — — Expired/cancelled (68,437 ) 4.25 Forfeited (60,313 ) 11.05 Balances as of December 31, 2022 2,782,248 $ 4.12 $ 17 Granted 1,172,515 2.59 Exercised — — Expired/cancelled (58,750 ) 8.08 Forfeited (25,000 ) 3.24 Balances as of December 31, 2023 3,871,013 $ 3.61 $ 832 Shares Underlying Options Weighted Average Grant Date Fair Value Per Share Unvested as of December 31, 2022 1,241,137 $ 2.31 Granted 1,172,515 2.09 Vested (723,968 ) 2.38 Forfeited (25,000 ) 2.65 Unvested as of December 31, 2023 1,664,684 $ 2.11 |
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 9.0 $ 1.55 78,112 8.9 $2.00 - $2.99 1,706,470 7.8 2.62 612,581 6.8 $3.00 - $3.99 448,726 6.8 3.75 282,324 5.7 $4.00 - $4.99 862,849 5.5 4.59 857,849 5.5 $5.00 - $16.00 509,525 6.5 6.56 375,463 6.1 3,871,013 7.1 $ 3.61 2,206,329 6.1 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2023 2022 Common share fair value $1.57 – $3.24 $1.47 – $3.88 Risk-free interest rate 3.5 – 4.6% 1.4 – 3.6% Expected dividend yield 0% 0% Expected option life (years) 5.0 – 5.7 5.0 – 5.6 Expected stock price volatility 101.7 – 108.1% 102.1 – 104.0% |
Note 14 - Income Taxes (Tables)
Note 14 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, 2023 2022 Deferred tax assets (liabilities): Non-capital losses carried forward $ 26,044 $ 21,000 Research and development expenditures 817 817 Share issue costs 495 338 Patents and other 358 320 Accruals 214 213 Share-based compensation 212 166 Property and equipment (102 ) (117 ) Total deferred tax asset, net 28,038 22,737 Valuation allowance (28,038 ) (22,737 ) Net deferred tax asset $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | December 31, 2023 2022 Statutory income tax rate 27.0 % 27.0 % Income tax recovery based on statutory rate $ (5,225 ) $ (3,685 ) Share-based compensation 409 340 Prior-year true-ups (388 ) (33 ) Share issuance costs (71 ) — Other 17 62 Change in valuation allowance 5,301 3,344 Income tax expense $ 43 $ 28 |
Summary of Operating Loss Carryforwards [Table Text Block] | Amount (In thousands) Expiration Years Non-capital income tax losses, net $ 92,955 Beginning 2026 Research and development expense carry forwards 3,027 Indefinitely Tax credits 474 Beginning 2024 |
Note 2 - Risks and Uncertaint_2
Note 2 - Risks and Uncertainties (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Retained Earnings (Accumulated Deficit), Total | $ (115,558) | $ (96,177) | |
Net Income (Loss) Attributable to Parent, Total | (19,381) | (13,676) | |
Net Cash Provided by (Used in) Operating Activities, Total | (18,728) | (11,511) | |
Cash, Cash Equivalents, and Short-Term Investments, Total | 52,900 | ||
Working Capital | 50,900 | ||
Stockholders' Equity Attributable to Parent, Ending Balance | $ 51,057 | $ 31,827 | $ 44,024 |
Note 3 - Summary of Significa_3
Note 3 - Summary of Significant Accounting Policies (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
General and Administrative Expense [Member] | ||
Patent Expense | $ 318,000 | $ 146,000 |
Note 3 - Summary of Significa_4
Note 3 - Summary of Significant Accounting Policies - Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Net loss | $ (19,381) | $ (13,676) |
Weighted average shares outstanding—basic and diluted (in shares) | 32,566,723 | 26,443,067 |
Basic and diluted net loss per share (in dollars per share) | $ (0.6) | $ (0.52) |
Note 3 - Summary of Significa_5
Note 3 - Summary of Significant Accounting Policies - Antidilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive securities (in shares) | 4,084,918 | 3,181,650 |
Employee and Non-employee Stock Options [Member] | ||
Antidilutive securities (in shares) | 3,871,013 | 2,782,248 |
Common Share Purchase Warrants [Member] | ||
Antidilutive securities (in shares) | 0 | 265,000 |
Common Stock, Deferred Stock Units Settlement [Member] | ||
Antidilutive securities (in shares) | 213,905 | 134,402 |
Note 4 - Marketable Securitie_2
Note 4 - Marketable Securities (Details Textual) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued Interest Receivable On Available For Sale Securities [Member] | ||
Interest Receivable | $ 298,000 | $ 80,000 |
Note 4 - Marketable Securitie_3
Note 4 - Marketable Securities - Fair Value of Marketable Securities (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Total marketable securities | $ 48,352 | $ 28,774 |
Fair Value, Inputs, Level 1 [Member] | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Total marketable securities | 48,352 | 28,774 |
Fair Value, Inputs, Level 3 [Member] | ||
Total marketable securities | 0 | 0 |
Commercial Paper and Corporate Bonds [Member] | ||
Total marketable securities | 21,764 | 14,209 |
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 | 21,764 | 14,209 |
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 | 26,588 | 14,565 |
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 | 26,588 | 14,565 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Total marketable securities | $ 0 | $ 0 |
Note 5 - Amounts Receivable - A
Note 5 - Amounts Receivable - Amounts Receivable (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued interest receivable on marketable securities | $ 298 | $ 80 |
Other | 71 | 2 |
Total amounts receivable | $ 369 | $ 82 |
Note 6 - Prepaid Expenses and_3
Note 6 - Prepaid Expenses and Other Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Supplies | $ 317 | $ 42 |
Prepaid expenses | 94 | 209 |
Total prepaid expenses and other assets | $ 411 | $ 251 |
Note 7 - Property and Equipme_3
Note 7 - Property and Equipment (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Depreciation | $ 30,000 | $ 25,000 |
Property, Plant and Equipment, Disposals | $ 10,000 | $ 12,000 |
Note 7 - Property and Equipme_4
Note 7 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, plant and equipment, gross | $ 231 | $ 216 |
Less accumulated depreciation | (100) | (80) |
Property and equipment, net | 131 | 136 |
Furniture and Fixtures [Member] | ||
Property, plant and equipment, gross | 128 | 124 |
Computer Equipment [Member] | ||
Property, plant and equipment, gross | 87 | 76 |
Leasehold Improvements [Member] | ||
Property, plant and equipment, gross | $ 16 | $ 16 |
Note 8 - Accrued Liabilities -
Note 8 - Accrued Liabilities - Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued compensation | $ 766 | $ 667 |
Accrued research and other professional fees | 730 | 215 |
Accrued clinical trial costs | 258 | 472 |
Accrued other liabilities | 23 | 11 |
Total accrued liabilities | $ 1,777 | $ 1,365 |
Note 9 - Operating Lease (Detai
Note 9 - Operating Lease (Details Textual) | 12 Months Ended | ||
Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) ft² | |
Operating Lease, Right-of-Use Asset | $ 354,000 | $ 424,000 | |
Operating Lease, Cost | 104,000 | 78,000 | |
Variable Lease, Cost | $ 92,000 | $ 25,000 | |
Minneapolis, MN [Member] | |||
Area of Real Estate Property | ft² | 6,000 | ||
Lessee, Operating Lease, Term of Contract (Month) | 65 months | ||
Operating Lease, Right-of-Use Asset | $ 446,000 |
Note 9 - Operating Lease - Matu
Note 9 - Operating Lease - Maturity of Operating Lease Liability (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Lessee, Operating Lease, Liability, to be Paid, Year One | $ 109 |
Lessee, Operating Lease, Liability, to be Paid, Year Two | 113 |
Lessee, Operating Lease, Liability, to be Paid, Year Three | 116 |
Lessee, Operating Lease, Liability, to be Paid, Year Four | 119 |
Lessee, Operating Lease, Liability, to be Paid, Year Five | 10 |
Total lease payments | 467 |
Less interest portion | (71) |
Present value of lease obligation | $ 396 |
Note 10 - Commitments and Con_2
Note 10 - Commitments and Contingencies (Details Textual) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Research and Development Contracts [Member] | ||
Contractual Obligation, to be Paid, Year One | $ 15,300 | |
Contractual Obligation, to be Paid, Year Two | 12,500 | |
Indemnification Agreements [Member] | ||
Contractual Obligation, Total | $ 0 | $ 0 |
Note 11 - Shareholders' Equit_2
Note 11 - Shareholders' Equity (Details Textual) - USD ($) | 12 Months Ended | |||
Jun. 21, 2023 | Apr. 10, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Stock Issued During Period, Value, New Issues | $ 36,848,000 | |||
Proceeds from Issuance of Private Placement | $ 36,100,000 | |||
Registration Rights Agreement, Liquidated Damages, Maximum Percentage of Invested Capital | 10% | |||
Stock Issued During Period, Shares Settlement of Deferred Stock Units (in shares) | 17,621 | |||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures (in shares) | 17,156 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in shares) | 0 | |||
Private Placement [Member] | ||||
Stock Issued During Period, Shares, New Issues (in shares) | 11,011,406 | |||
Stock Issued During Period, Value, New Issues | $ 37,500,000 | |||
Shares Issued, Price Per Share (in dollars per share) | $ 3.4 | |||
Chief Business Officer [Member] | ||||
Stock Issued During Period, Shares, New Issues (in shares) | 468,750 | |||
Stock Issued During Period, Value, New Issues | $ 750,000 | |||
Shares Issued, Price Per Share (in dollars per share) | $ 1.6 | |||
Directors and Officers [Member] | Private Placement [Member] | ||||
Shares Issued, Price Per Share (in dollars per share) | $ 3.91 |
Note 11 - Shareholders' Equit_3
Note 11 - Shareholders' Equity - Shares Reserved (Details) | Dec. 31, 2023 shares |
Employee and non-employee stock options (in shares) | 5,407,133 |
Stock Options Outstanding [Member] | |
Employee and non-employee stock options (in shares) | 3,871,013 |
Deferred Share Units [Member] | |
Employee and non-employee stock options (in shares) | 213,905 |
Common Share Purchase Warrants [Member] | |
Employee and non-employee stock options (in shares) | 0 |
The 2019 Omnibus Incentive Plan [Member] | |
Employee and non-employee stock options (in shares) | 927,215 |
The 2021 Employment Inducement Incentive Plan [Member] | |
Employee and non-employee stock options (in shares) | 395,000 |
Note 12 - Share-based Compens_3
Note 12 - Share-based Compensation (Details Textual) - USD ($) $ in Millions | 12 Months Ended | |||
May 18, 2022 | Dec. 03, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares) | 1,172,515 | |||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 5,407,133 | |||
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 3.3 | |||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 8 months 12 days | |||
Stock Issued During Period, Shares Settlement of Deferred Stock Units (in shares) | 17,621 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in shares) | 0 | |||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures (in shares) | 17,156 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Nonvested, Number of Shares, Ending Balance (in shares) | 1,664,684 | 1,241,137 | ||
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) | 2,818,103 | |||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 196,572 | |||
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 2021 Employment Inducement Incentive Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | |||
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) | 605,000 | |||
Stock Option Prior Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number, Ending Balance (in shares) | 447,910 | |||
The 2012 DSU Plan [Member] | ||||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 17,333 | |||
The 2019 Omnibus Incentive Plan, Stock Option Prior Plan, and the 2012 DSU Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested in Period, Fair Value | $ 1.7 | $ 1 | ||
Non-employee Director Compensation Program [Member] | Deferred Share Unit Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | 214,000 | 134,000 | ||
Stock Issued During Period, Shares Settlement of Deferred Stock Units (in shares) | 17,621 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in shares) | 17,621 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Nonvested, Number of Shares, Ending Balance (in shares) | 0 | 0 | ||
Non-employee Director Compensation Program [Member] | Restricted Stock Units (RSUs) [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | 0 | 0 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in shares) | 17,156 | |||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures (in shares) | 17,156 |
Note 12 - Share-based Compens_4
Note 12 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Total share-based compensation | $ 1,683 | $ 1,502 |
Research and Development Expense [Member] | ||
Total share-based compensation | 619 | 460 |
General and Administrative Expense [Member] | ||
Total share-based compensation | $ 1,064 | $ 1,042 |
Note 12 - Share-based Compens_5
Note 12 - Share-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Unvested (in shares) | 1,241,137 | ||
Unvested, weighted average grant-date fair value (in dollars per share) | $ 2.31 | ||
Granted (in shares) | 1,172,515 | ||
Granted, weighted average grant-date fair value (in dollars per share) | $ 2.09 | ||
Vested (in shares) | (723,968) | ||
Exercised (in shares) | 0 | ||
Vested, weighted average grant-date fair value (in dollars per share) | $ 2.38 | ||
Forfeited (in shares) | (25,000) | ||
Forfeited, weighted average grant-date fair value (in dollars per share) | $ 2.65 | ||
Unvested (in shares) | 1,664,684 | 1,241,137 | |
Unvested, weighted average grant-date fair value (in dollars per share) | $ 2.11 | $ 2.31 | |
Share-Based Payment Arrangement, Option [Member] | |||
Balance (in shares) | 2,782,248 | 1,896,600 | |
Balance, weighted average exercise price (in dollars per share) | $ 4.12 | $ 5.25 | |
Balance, aggregate intrinsic value | $ 832 | $ 17 | $ 169 |
Granted (in shares) | 1,172,515 | 1,014,398 | |
Granted, weighted average exercise price (in dollars per share) | $ 2.59 | $ 2.58 | |
Exercised (in shares) | 0 | 0 | |
Exercised, weighted average exercise price (in dollars per share) | $ 0 | $ 0 | |
Expired/cancelled (in shares) | (58,750) | (68,437) | |
Expired / cancelled, weighted average exercise price (in dollars per share) | $ 8.08 | $ 4.25 | |
Forfeited (in shares) | (25,000) | (60,313) | |
Forfeited, weighted average exercise price (in dollars per share) | $ 3.24 | $ 11.05 | |
Balance (in shares) | 3,871,013 | 2,782,248 | |
Balance, weighted average exercise price (in dollars per share) | $ 3.61 | $ 4.12 |
Note 12 - Share-based Compens_6
Note 12 - Share-based Compensation - Stock Options Outstanding (Details) | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Outstanding, shares (in shares) | shares | 3,871,013 |
Outstanding, weighted average remaining contractual life (Year) | 7 years 1 month 6 days |
Outstanding, weighted average exercise price (in dollars per share) | $ 3.61 |
Exercisable, shares (in shares) | shares | 2,206,329 |
Exercisable, weighted average remaining contractual life (Year) | 6 years 1 month 6 days |
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 |
Outstanding, shares (in shares) | shares | 343,443 |
Outstanding, weighted average remaining contractual life (Year) | 9 years |
Outstanding, weighted average exercise price (in dollars per share) | $ 1.55 |
Exercisable, shares (in shares) | shares | 78,112 |
Exercisable, weighted average remaining contractual life (Year) | 8 years 10 months 24 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 |
Outstanding, shares (in shares) | shares | 1,706,470 |
Outstanding, weighted average remaining contractual life (Year) | 7 years 9 months 18 days |
Outstanding, weighted average exercise price (in dollars per share) | $ 2.62 |
Exercisable, shares (in shares) | shares | 612,581 |
Exercisable, weighted average remaining contractual life (Year) | 6 years 9 months 18 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 |
Outstanding, shares (in shares) | shares | 448,726 |
Outstanding, weighted average remaining contractual life (Year) | 6 years 9 months 18 days |
Outstanding, weighted average exercise price (in dollars per share) | $ 3.75 |
Exercisable, shares (in shares) | shares | 282,324 |
Exercisable, weighted average remaining contractual life (Year) | 5 years 8 months 12 days |
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 |
Outstanding, shares (in shares) | shares | 862,849 |
Outstanding, weighted average remaining contractual life (Year) | 5 years 6 months |
Outstanding, weighted average exercise price (in dollars per share) | $ 4.59 |
Exercisable, shares (in shares) | shares | 857,849 |
Exercisable, weighted average remaining contractual life (Year) | 5 years 6 months |
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 |
Outstanding, shares (in shares) | shares | 509,525 |
Outstanding, weighted average remaining contractual life (Year) | 6 years 6 months |
Outstanding, weighted average exercise price (in dollars per share) | $ 6.56 |
Exercisable, shares (in shares) | shares | 375,463 |
Exercisable, weighted average remaining contractual life (Year) | 6 years 1 month 6 days |
Note 12 - Share-based Compens_7
Note 12 - Share-based Compensation - Stock Option Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Expected dividend yield | 0% | 0% |
Minimum [Member] | ||
Common share fair value (in dollars per share) | $ 1.57 | $ 1.47 |
Risk-free interest rate | 3.50% | 1.40% |
Expected option life (years) (Year) | 5 years | 5 years |
Expected stock price volatility | 101.70% | 102.10% |
Maximum [Member] | ||
Common share fair value (in dollars per share) | $ 3.24 | $ 3.88 |
Risk-free interest rate | 4.60% | 3.60% |
Expected option life (years) (Year) | 5 years 8 months 12 days | 5 years 7 months 6 days |
Expected stock price volatility | 108.10% | 104% |
Note 13 - Employee Benefit Pl_2
Note 13 - Employee Benefit Plan (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 4% | |
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 137,000 | $ 112,000 |
Note 15 - Income Taxes - Deferr
Note 15 - Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Non-capital losses carried forward | $ 26,044 | $ 21,000 |
Research and development expenditures | 817 | 817 |
Share issue costs | 495 | 338 |
Patents and other | 358 | 320 |
Accruals | 214 | 213 |
Share-based compensation | 212 | 166 |
Property and equipment | (102) | (117) |
Total deferred tax asset, net | 28,038 | 22,737 |
Valuation allowance | (28,038) | (22,737) |
Net deferred tax asset | $ 0 | $ 0 |
Note 15 - Income Taxes - Reconc
Note 15 - Income Taxes - Reconciliation of Income Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Statutory income tax rate | 27% | 27% |
Income tax recovery based on statutory rate | $ (5,225) | $ (3,685) |
Share-based compensation | 409 | 340 |
Prior-year true-ups | (388) | (33) |
Share issuance costs | (71) | 0 |
Other | 17 | 62 |
Change in valuation allowance | 5,301 | 3,344 |
Income tax expense | $ 43 | $ 28 |
Note 15 - Income Taxes - Net Op
Note 15 - Income Taxes - Net Operating Losses and Tax Credit Carryforwards (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Non-capital Income Tax Losses, Net [Member] | |
Tax credits | $ 92,955 |
Research Tax Credit Carryforward [Member] | |
Tax credits | 3,027 |
Tax Credits [Member] | |
Tax credits | $ 474 |