Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 07, 2022 | |
Document Information [Line Items] | ||
Entity Central Index Key | 0001401040 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
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 | Minnetonka | |
Entity Address, State or Province | MN | |
Entity Address, Postal Zip Code | 55305 | |
City Area Code | 763 | |
Local Phone Number | 312-6755 | |
Title of 12(b) Security | Voting common shares, no par value per share | |
Trading Symbol | DMAC | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,443,067 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 2,771 | $ 4,707 |
Marketable securities | 33,313 | 40,405 |
Prepaid expenses and other assets | 322 | 84 |
Amounts receivable | 75 | 130 |
Deposits | 9 | 113 |
Total current assets | 36,490 | 45,439 |
Non-current assets: | ||
Operating lease right-of-use asset | 441 | 42 |
Property and equipment, net | 110 | 70 |
Total non-current assets | 551 | 112 |
Total assets | 37,041 | 45,551 |
Current liabilities: | ||
Accounts payable | 864 | 509 |
Accrued liabilities | 637 | 966 |
Operating lease obligation | 34 | 45 |
Financing lease obligation | 7 | 4 |
Total current liabilities | 1,542 | 1,524 |
Non-current liabilities: | ||
Operating lease obligation, non-current | 415 | 0 |
Finance lease obligation, non-current | 5 | 3 |
Total non-current liabilities | 420 | 3 |
Shareholders’ equity: | ||
Common shares, no par value; unlimited authorized; 26,443,067 shares issued and outstanding as of September 30, 2022 and December 31, 2021 | 0 | 0 |
Paid-in capital | 127,667 | 126,576 |
Accumulated other comprehensive loss | (162) | (51) |
Accumulated deficit | (92,426) | (82,501) |
Total shareholders’ equity | 35,079 | 44,024 |
Total liabilities and shareholders’ equity | $ 37,041 | $ 45,551 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited)-parentheticals (Parentheticals) - $ / shares $ / shares in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Common shares, par value (in dollars per share) | $ 0 | $ 0 |
Common shares, authorized | Unlimited | Unlimited |
Common Stock, Shares, Issued (in shares) | 26,443,067 | 26,443,067 |
Common Stock, Shares, Outstanding, Ending Balance (in shares) | 26,443,067 | 26,443,067 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 1,640 | $ 2,332 | $ 5,569 | $ 6,894 |
General and administrative | 1,488 | 1,084 | 4,459 | 3,506 |
Operating loss | (3,128) | (3,416) | (10,028) | (10,400) |
Other income: | ||||
Other income (loss), net | 76 | (27) | 124 | 75 |
Loss before income tax expense | (3,052) | (3,443) | (9,904) | (10,325) |
Income tax expense | (7) | (7) | (21) | (21) |
Net loss | (3,059) | (3,450) | (9,925) | (10,346) |
Other comprehensive income (loss) | ||||
Unrealized gain (loss) on marketable securities | 5 | (2) | (111) | (3) |
Net loss and comprehensive loss | $ (3,054) | $ (3,452) | $ (10,036) | $ (10,349) |
Basic and diluted net loss per share (in dollars per share) | $ (0.12) | $ (0.18) | $ (0.38) | $ (0.55) |
Weighted average shares outstanding – basic and diluted (in shares) | 26,443,067 | 19,035,713 | 26,443,067 | 18,863,829 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balances at December 31, 2021 (in shares) at Dec. 31, 2020 | 18,746,157 | ||||
Balances at December 31, 2021 at Dec. 31, 2020 | $ 94,925,000 | $ (2,000) | $ (68,909,000) | $ 26,014,000 | |
Share-based compensation expense | 511,000 | 511,000 | |||
Unrealized loss on marketable securities | (2,000) | (2,000) | |||
Net loss | (3,622,000) | (3,622,000) | |||
Exercise of common stock options (in shares) | 40,000 | ||||
Exercise of common stock options | 244,000 | 244,000 | |||
Balances at March 31, 2022 (in shares) at Mar. 31, 2021 | 18,786,157 | ||||
Balances at March 31, 2022 at Mar. 31, 2021 | 95,680,000 | (4,000) | (72,531,000) | 23,145,000 | |
Balances at December 31, 2021 (in shares) at Dec. 31, 2020 | 18,746,157 | ||||
Balances at December 31, 2021 at Dec. 31, 2020 | 94,925,000 | (2,000) | (68,909,000) | 26,014,000 | |
Unrealized loss on marketable securities | (3,000) | ||||
Net loss | $ (10,346,000) | ||||
Exercise of common stock options (in shares) | 40,000 | ||||
Exercise of common stock options | $ 244,000 | ||||
Balances at March 31, 2022 (in shares) at Sep. 30, 2021 | 26,439,217 | ||||
Balances at March 31, 2022 at Sep. 30, 2021 | 126,296,000 | (5,000) | (79,255,000) | 47,036,000 | |
Balances at December 31, 2021 (in shares) at Mar. 31, 2021 | 18,786,157 | ||||
Balances at December 31, 2021 at Mar. 31, 2021 | 95,680,000 | (4,000) | (72,531,000) | 23,145,000 | |
Share-based compensation expense | 446,000 | 446,000 | |||
Unrealized loss on marketable securities | 1,000 | 1,000 | |||
Net loss | (3,274,000) | (3,274,000) | |||
Balances at March 31, 2022 (in shares) at Jun. 30, 2021 | 18,786,157 | ||||
Balances at March 31, 2022 at Jun. 30, 2021 | 96,126,000 | (3,000) | (75,805,000) | 20,318,000 | |
Share-based compensation expense | $ 0 | 303,000 | 0 | 0 | 303,000 |
Unrealized loss on marketable securities | (2,000) | (2,000) | |||
Net loss | (3,450,000) | (3,450,000) | |||
Issuance of common shares net of offering costs of $0.1 million (in shares) | 7,653,060 | ||||
Issuance of common shares net of offering costs of $0.1 million | 29,867,000 | 29,867,000 | |||
Balances at March 31, 2022 (in shares) at Sep. 30, 2021 | 26,439,217 | ||||
Balances at March 31, 2022 at Sep. 30, 2021 | 126,296,000 | (5,000) | (79,255,000) | 47,036,000 | |
Balances at December 31, 2021 (in shares) at Dec. 31, 2021 | 26,443,067 | ||||
Balances at December 31, 2021 at Dec. 31, 2021 | 126,576,000 | (51,000) | (82,501,000) | 44,024,000 | |
Share-based compensation expense | 308,000 | 308,000 | |||
Unrealized loss on marketable securities | (56,000) | (56,000) | |||
Net loss | (3,508,000) | (3,508,000) | |||
Balances at March 31, 2022 (in shares) at Mar. 31, 2022 | 26,443,067 | ||||
Balances at March 31, 2022 at Mar. 31, 2022 | 126,884,000 | (107,000) | (86,009,000) | 40,768,000 | |
Balances at December 31, 2021 (in shares) at Dec. 31, 2021 | 26,443,067 | ||||
Balances at December 31, 2021 at Dec. 31, 2021 | 126,576,000 | (51,000) | (82,501,000) | 44,024,000 | |
Unrealized loss on marketable securities | (111,000) | ||||
Net loss | (9,925,000) | ||||
Balances at March 31, 2022 (in shares) at Sep. 30, 2022 | 26,443,067 | ||||
Balances at March 31, 2022 at Sep. 30, 2022 | 127,667,000 | (162,000) | (92,426,000) | 35,079,000 | |
Balances at December 31, 2021 (in shares) at Mar. 31, 2022 | 26,443,067 | ||||
Balances at December 31, 2021 at Mar. 31, 2022 | 126,884,000 | (107,000) | (86,009,000) | 40,768,000 | |
Share-based compensation expense | 365,000 | 365,000 | |||
Unrealized loss on marketable securities | (60,000) | (60,000) | |||
Net loss | (3,358,000) | (3,358,000) | |||
Balances at March 31, 2022 (in shares) at Jun. 30, 2022 | 26,443,067 | ||||
Balances at March 31, 2022 at Jun. 30, 2022 | 127,249,000 | (167,000) | (89,367,000) | 37,715,000 | |
Share-based compensation expense | $ 0 | 418,000 | 0 | 0 | 418,000 |
Unrealized loss on marketable securities | $ 0 | 0 | 5,000 | 0 | 5,000 |
Net loss | (3,059,000) | (3,059,000) | |||
Balances at March 31, 2022 (in shares) at Sep. 30, 2022 | 26,443,067 | ||||
Balances at March 31, 2022 at Sep. 30, 2022 | $ 127,667,000 | $ (162,000) | $ (92,426,000) | $ 35,079,000 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Shareholders' Equity (Unaudited)-parentheticals (Parentheticals) $ in Millions | 3 Months Ended |
Sep. 30, 2021 USD ($) | |
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 0.1 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (9,925) | $ (10,346) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 1,091 | 1,260 |
Amortization of premium on marketable securities | 118 | 51 |
Non-cash lease expense | 47 | 43 |
Depreciation | 19 | 18 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (238) | (129) |
Amounts receivable | 55 | 236 |
Deposits | 104 | (133) |
Accounts payable | 355 | (400) |
Accrued liabilities | (371) | (48) |
Net cash used in operating activities | (8,745) | (9,448) |
Cash flows from investing activities: | ||
Purchase of marketable securities | (35,895) | (47,740) |
Maturities of marketable securities | 42,758 | 35,905 |
Purchases of property and equipment | (49) | (15) |
Proceeds from disposition of property and equipment | 0 | 2 |
Net cash provided by (used in) investing activities | 6,814 | (11,848) |
Cash flows from financing activities: | ||
Proceeds from issuance of common shares, net of offering costs | 0 | 29,867 |
Proceeds from the exercise of stock options | 0 | 244 |
Principal payments on finance lease obligations | (5) | (5) |
Net cash (used in) provided by financing activities | (5) | 30,106 |
Net (decrease) increase in cash and cash equivalents | (1,936) | 8,810 |
Cash and cash equivalents at beginning of period | 4,707 | 7,409 |
Cash and cash equivalents at end of period | 2,771 | 16,219 |
Supplemental disclosure of non-cash transactions: | ||
Assets acquired under operating lease | 446 | 0 |
Assets acquired under financing lease | $ 10 | $ 0 |
Note 1 - Business
Note 1 - Business | 9 Months Ended |
Sep. 30, 2022 | |
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 kidney 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 chronic kidney disease (CKD). Our parent company is governed under British Columbia’s Business Corporations Act, and our common shares are publicly traded on The Nasdaq Capital Market under the symbol “DMAC.” |
Note 2 - Risks and Uncertaintie
Note 2 - Risks and Uncertainties | 9 Months Ended |
Sep. 30, 2022 | |
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 CKD. The Company has not completed the development of any product candidate and does not generate any revenues from the commercial sale of any product candidate. DM199 requires significant additional clinical testing and investment prior to seeking marketing approval and is not expected to be commercially available for at least three years, if at all. On July 6, 2022, we announced that the FDA placed a clinical hold on the Company’s Phase 2/3 ReMEDy2 trial. The clinical hold was issued following the Company voluntarily pausing patient 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. The acutely low blood pressure levels in the three patients recovered back to their baseline blood pressure within minutes after the IV infusion was stopped, and the patients suffered no injuries. In response to the FDA’s clinical hold letter, on September 16, 2022, we submitted to the FDA supporting in-vitro data that the etiology (cause) of the hypotensive events is likely related to switching the type of IV bag used in the prior ReMEDy 1 trial, where no hypotensive episodes were reported, versus the current ReMEDy 2 trial. We observed significant differences in DM199 binding between the two types of IV bags used in the studies that we believe altered, and unintentionally elevated, the total amount of DM199 being administered to patients in the ReMEDy2 trial triggering the hypotensive events. In addition to our analysis of the events leading to and causing the hypotensive events, we also included in this FDA submission, proposed protocol modifications to address the mitigation of these events, including a reduction in the DM199 dose level for the initial IV dose to effectively match the well tolerated IV dose administered in the ReMEDy1 trial. Following review of this data, the FDA responded to our submission, indicating that the FDA was 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 the IV tubing and mechanical infusion pump, to further rule out any other cause of the hypotension events. There can be no assurance that our belief as to the cause of the hypotension events or our response to prevent future events is correct, or that we will be able to fully respond to the FDA’s latest questions sufficiently for the FDA to lift the clinical hold on a timely basis or at all. It is also possible that the FDA may subsequently make additional requests that we would need to fulfill prior to the lifting of the clinical hold, such as requiring us to complete additional clinical testing or imposing stricter approval conditions than we recently proposed for our DM199 product candidate. We may not enroll any additional patients in the ReMEDy2 trial until we provide the FDA with the requested data and the FDA notifies us that the FDA has lifted the clinical hold and we may resume enrollment in the clinical trial. Prior to voluntarily halting enrollment, we had experienced slower than expected site activations and enrollment in our ReMEDy2 trial and may continue to experience these conditions if and when we are able to resume enrollment. We believe this was due to a number of factors, including the reduction or suspension of research activities at our current and targeted clinical study sites, as well as staffing shortages, due to COVID-19 and concerns managing logistics and protocol compliance for patients discharged from the hospital to an intermediate care facility. While we have taken and intend to continue to take certain actions to assist study sites in overcoming these issues, if and when we resume enrollment in the ReMEDy2 trial, 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 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 September 30, 2022, we have incurred losses of $92.4 million since our inception in 2000. For the nine months ended September 30, 2022, we incurred a net loss of $9.9 million and negative cash flows from operating activities of $8.7 million. We expect to continue to incur operating losses until such time as any future product sales, royalty payments, licensing fees and/or milestone 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 September 30, 2022, DiaMedica had combined cash, cash equivalents and marketable securities of $36.1 million, working capital of $35.0 million and shareholders’ equity of $35.1 million. Our principal source of cash has been net proceeds from the issuance of equity securities. Although the Company has 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 we are unable to resolve the clinical hold on our ReMEDy2 trial, if our clinical data is not positive, or if economic and market conditions do not improve or further 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 fund our planned operations for at least the next twelve months from the date of issuance of these condensed consolidated financial statements. The amount and timing of our future funding requirements will depend on many factors, including the timing and results of our ongoing development efforts, including the duration of the current clinical hold, the rate of site activation and enrollment in our clinical study, the potential expansion of our current development programs, potential new development programs, the effects of the COVID-19 pandemic, staffing shortages and other factors on our clinical 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 | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Liquidity and Management Plans [Text Block] | 3. Summary of Significant Accounting Policies Interim financial statements We have prepared the accompanying condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States (US GAAP) for interim financial information and with the instructions to Form 10-Q and Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and footnotes required by US GAAP for complete financial statements. These condensed consolidated financial statements reflect all adjustments consisting of normal recurring accruals which, in the opinion of management, are necessary to present fairly our consolidated financial position, consolidated results of operations, consolidated statement of shareholders’ equity and consolidated cash flows for the periods and as of the dates presented. Our fiscal year ends on December 31. The condensed consolidated balance sheet as of December 31, 2021 was derived from our audited consolidated financial statements. Certain prior year amounts have been reclassified to conform to the current year presentation. These condensed consolidated financial statements should be read in conjunction with our annual consolidated financial statements and the notes thereto. The nature of our business is such that the results of any interim period may not be indicative of the results to be expected for the entire year. Cash and cash equivalents The Company considers all bank deposits, including money market funds and other investments, purchased with an original maturity to the Company of three months or less, to be cash and cash equivalents. The carrying amount of our cash equivalents approximates fair value due to the short maturity of the investments. Concentration of credit risk Financial instruments that potentially expose the Company to concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company maintains its cash balances primarily with two financial institutions. These balances generally exceed federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risk in cash and cash equivalents. The Company believes that the credit risk related to marketable securities is limited due to the adherence to an investment policy focused on the preservation of principal. Marketable securities The Company’s marketable securities typically consist of obligations of the United States government and its agencies and investment grade corporate obligations, which are classified as available-for-sale and included in current assets as they are intended to fund current operations. Securities are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value with unrealized gains and losses reported as a component of shareholders’ equity in accumulated other comprehensive loss. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization or accretion is included in interest income. Realized gains and losses, if any, are calculated on the specific identification method and are included in other income in the condensed consolidated statements of operations. Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis, impairment is indicated and it must be determined whether it is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported in earnings. Subsequent increases or decreases in fair value are reported as a component of shareholders’ equity in accumulated other comprehensive loss. There were no other-than-temporary unrealized losses as of September 30, 2022. Fair value measurements Under the authoritative guidance for fair value measurements, fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date. The authoritative guidance also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use in valuing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability developed based upon the best information available in the circumstances. The categorization of financial assets and financial liabilities within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The hierarchy is broken down into three levels defined as follows: Level 1 Inputs Level 2 Inputs Level 3 Inputs As of September 30, 2022, the Company believes that the carrying amounts of its other financial instruments, including amounts receivable, accounts payable and accrued liabilities, approximate their fair value due to the short-term maturities of these instruments. See Note 4, titled “ Marketable Securities 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 $109,000 and $89,000 for the nine months ended September 30, 2022 and 2021, respectively. |
Note 4 - Marketable Securities
Note 4 - Marketable Securities | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block] | 4. Marketable Securities The available-for-sale marketable securities are primarily comprised of investments in commercial paper, corporate bonds and government securities and consist of the following, measured at fair value on a recurring basis (in thousands): Fair Value Measurements Using Inputs Considered as of: September 30, 2022 December 31, 2021 Total Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Commercial paper and corporate bonds $ 18,779 $ — $ 18,779 $ — $ 29,421 $ — $ 29,421 $ — Government securities 14,534 — 14,534 — 10,984 — 10,984 — Total $ 33,313 $ — $ 33,313 $ — $ 40,405 $ — $ 40,405 $ — Accrued interest receivable on available-for-sale securities is included in amounts receivable and was $73,000 and $130,000 as of September 30, 2022 and December 31, 2021, respectively. There were no transfers of assets between Level 1 and Level 2 of the fair value measurement hierarchy during the nine months ended September 30, 2022. Under the terms of the Company’s investment policy, purchases of marketable securities are limited to investment grade governmental and corporate obligations and bank certificates of deposit with a primary objective of principal preservation. Maturities of individual securities are less than one year and the amortized cost of all securities approximated fair value as of September 30, 2022 and December 31, 2021. |
Note 5 - Amounts Receivable
Note 5 - Amounts Receivable | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Loans, Notes, Trade and Other Receivables Disclosure [Text Block] | 5. Amounts Receivable Amounts receivable consisted of accrued interest receivable on marketable securities of $73,000 and $130,000 as of September 30, 2022 and December 31, 2021, respectively. |
Note 6 - Deposits
Note 6 - Deposits | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Other Assets Disclosure [Text Block] | 6. Deposits Deposits consisted of the following (in thousands): September 30, 2022 December 31, 2021 Advances to vendors, current $ 9 $ 113 We periodically advance funds to vendors engaged to support the performance of our clinical trials and related supporting activities. The funds advanced are held, interest free, for varying periods of time and may be recovered by DiaMedica through full or partial reductions of ongoing invoices, application against final study/project invoices or refunded upon completion of services to be provided. Deposits are classified as current based upon their expected recovery time. |
Note 7 - Property and Equipment
Note 7 - Property and Equipment | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 7. Property and Equipment Property and equipment consisted of the following (in thousands): September 30, 2022 December 31, 2021 Furniture and equipment $ 111 $ 70 Computer equipment 72 67 183 137 Less accumulated depreciation (73 ) (67 ) Property and equipment, net $ 110 $ 70 |
Note 8 - Accrued Liabilities
Note 8 - Accrued Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | 8. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): September 30, 2022 December 31, 2021 Accrued compensation $ 303 $ 484 Accrued clinical trial costs 230 284 Accrued research and other professional fees 97 191 Other 7 7 Total accrued liabilities $ 637 $ 966 |
Note 9 - Operating Lease
Note 9 - Operating Lease | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | 9. Operating Lease New office lease In June 2022, we entered into an agreement to lease approximately 6,000 square feet of office space in Minneapolis, MN, 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 48th month of the lease and the landlord terminates the lease. This lease includes both lease (e.g., fixed rent) and variable non-lease components (e.g., common-area and other maintenance costs). Non-lease components are deemed to be executory costs and are therefore excluded from the minimum lease payments used to determine the present value of the operating lease obligation and related right-of-use asset. 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 to be 8%. We used our estimated incremental borrowing rate and other information available at the lease commencement date in determining the present value of the lease payments. Upon lease commencement, the Company recognized an operating lease right-of-use asset and a corresponding operating lease obligation of $446,000, respectively. Our operating lease cost and variable lease costs were $52,000 and $25,000, respectively, for the nine months ended September 30, 2022. 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 September 30, 2022 (in thousands): 2022 — 2023 97 2024 109 2025 113 2026 116 2027 119 2028 10 Total lease payments $ 564 Less interest portion (115 ) Present value of lease obligation $ 449 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 - Shareholders' Equity
Note 10 - Shareholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 10. Shareholders Equity Authorized capital stock The Company has authorized share capital of an unlimited number of voting common shares, and the shares do not have a stated par value. Common shareholders are entitled to receive dividends as declared by the Company, if any, and are entitled to one vote per share at the Company's annual general meeting and any special meeting. Equity issued during the nine months ended September 30, 2022 During the nine months ended September 30, 2022, we did not issue any common shares or other equity securities other than stock options and deferred stock units. Equity issued during the nine months ended September 30, 2021 On September 26, 2021, we issued and sold an aggregate 7,653,060 common shares in a securities purchase agreement at a purchase price of $3.92 per share in a private placement to ten accredited investors. As a result of the offering, we received gross proceeds of $30.0 million, which resulted in net proceeds to us of approximately $29.9 million, after deducting the offering expenses. In connection with the September 2021 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 private placement (Resale Registration Statement). The Resale Registration Statement was filed with the SEC on October 5, 2021 and declared effective by the SEC on October 14, 2021. 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 nine months ended September 30, 2021, 40,000 common shares were issued upon the exercise of options for gross proceeds of $244,000, with an aggregate intrinsic value of $132,000, and no warrants were exercised. Shares reserved Common shares reserved for future issuance are as follows: September 30, 2022 Common shares issuable upon exercise of employee and non-employee stock options 2,775,998 Common shares issuable upon settlement of deferred stock units 134,402 Common shares issuable upon exercise of common share purchase warrants 265,000 Shares available for grant under the 2019 Omnibus Incentive Plan 2,014,010 Shares available for grant under the 2021 Employment Inducement Incentive Plan 535,000 Total 5,724,410 |
Note 11 - Net Loss Per Share
Note 11 - Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 11. Net Loss Per Share We compute net loss per share by dividing our net loss (the numerator) by the weighted-average number of common shares outstanding (the denominator) during the period. Shares issued during the period and shares reacquired during the period, if any, are weighted for the portion of the period that they were outstanding. The computation of diluted earnings per share, or EPS, is similar to the computation of basic EPS except that the denominator is increased to include the number of additional common shares that would have been outstanding if the dilutive potential common shares had been issued. Our diluted EPS is the same as basic EPS due to common equivalent shares being excluded from the calculation, as their effect is anti-dilutive. The following table summarizes our calculation of net loss per common share for the periods (in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net loss $ (3,059 ) $ (3,450 ) $ (9,925 ) $ (10,346 ) Weighted average shares outstanding—basic and diluted 26,443,067 19,035,713 26,443,067 18,863,829 Basic and diluted net loss per share $ (0.12 ) $ (0.18 ) $ (0.38 ) $ (0.55 ) The following outstanding potential common shares were not included in the diluted net loss per share calculations as their effects were not dilutive: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Employee and non-employee stock options 2,775,998 1,959,100 2,775,998 1,959,100 Common shares issuable under common share purchase warrants 265,000 265,000 265,000 265,000 Common shares issuable under deferred stock units 134,402 71,509 134,402 71,509 |
Note 12 - Share-based Compensat
Note 12 - Share-based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | 12. Share-Based Compensation Amended and Restated 2019 Omnibus Incentive Plan At the 2022 Annual General Meeting of Shareholders on May 18, 2022, our shareholders, upon recommendation of our Board of Directors (Board), approved the DiaMedica Therapeutics Inc. Amended and Restated 2019 Omnibus Incentive Plan (the 2019 Plan). The Board approved the 2019 Plan, subject to approval by our shareholders, on March 10, 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, 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 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. 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. As of September 30, 2022, options to purchase an aggregate of 465,000 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 September 30, 2022, options to purchase an aggregate of 465,410 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 September 30, 2022, there were 17,333 common shares reserved for issuance upon settlement of DSUs outstanding under the Prior DSU Plan. Share-based compensation expense for each of the periods presented is as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 126 $ 100 $ 325 $ 371 General and administrative 292 203 766 889 Total share-based compensation $ 418 $ 303 $ 1,091 $ 1,260 We recognize share-based compensation based on the fair value of each award as estimated using the Black-Scholes option valuation model. Ultimately, the actual expense recognized over the vesting period will only be for those shares that actually vest. A summary of option activity is as follows (in thousands, except share and per share amounts): Shares Underlying Options Outstanding Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Balances at December 31, 2021 1,896,600 $ 5.22 $ 169 Granted 989,398 2.61 Expired/cancelled (57,813 ) 8.78 Forfeited (52,187 ) 4.94 Balances at September 30, 2022 2,775,998 $ 4.15 $ — Information about stock options outstanding, vested and expected to vest as of September 30, 2022, is as follows: Outstanding, Vested and Expected to Vest Options Vested and Exercisable Per Share Exercise Price Shares Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Options Exercisable Weighted Average Remaining Contractual Life (Years) $1.00 - $1.99 152,000 9.9 $ 1.50 — — $2.00 - $2.99 800,398 8.3 2.50 170,852 4.7 $3.00 - $3.99 409,393 7.5 3.80 193,766 5.8 $4.00 - $4.99 862,182 6.7 4.57 805,349 6.6 $5.00 - $24.00 552,025 7.4 6.85 294,525 6.2 2,775,998 7.6 $ 4.15 1,464,492 6.2 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Interim financial statements |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and cash equivalents |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of credit risk |
Marketable Securities, Policy [Policy Text Block] | Marketable securities |
Fair Value Measurement, Policy [Policy Text Block] | Fair value measurements Level 1 Inputs Level 2 Inputs Level 3 Inputs Marketable Securities |
Patent Costs [Policy Text Block] | Patent costs |
Note 4 - Marketable Securities
Note 4 - Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Fair Value, Marketable Securities Measured on a Recurring Basis [Table Text Block] | Fair Value Measurements Using Inputs Considered as of: September 30, 2022 December 31, 2021 Total Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Commercial paper and corporate bonds $ 18,779 $ — $ 18,779 $ — $ 29,421 $ — $ 29,421 $ — Government securities 14,534 — 14,534 — 10,984 — 10,984 — Total $ 33,313 $ — $ 33,313 $ — $ 40,405 $ — $ 40,405 $ — |
Note 6 - Deposits (Tables)
Note 6 - Deposits (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | September 30, 2022 December 31, 2021 Advances to vendors, current $ 9 $ 113 |
Note 7 - Property and Equipme_2
Note 7 - Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | September 30, 2022 December 31, 2021 Furniture and equipment $ 111 $ 70 Computer equipment 72 67 183 137 Less accumulated depreciation (73 ) (67 ) Property and equipment, net $ 110 $ 70 |
Note 8 - Accrued Liabilities (T
Note 8 - Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | September 30, 2022 December 31, 2021 Accrued compensation $ 303 $ 484 Accrued clinical trial costs 230 284 Accrued research and other professional fees 97 191 Other 7 7 Total accrued liabilities $ 637 $ 966 |
Note 9 - Operating Lease (Table
Note 9 - Operating Lease (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | 2022 — 2023 97 2024 109 2025 113 2026 116 2027 119 2028 10 Total lease payments $ 564 Less interest portion (115 ) Present value of lease obligation $ 449 |
Note 10 - Shareholders' Equity
Note 10 - Shareholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Common Stock Reserved for Future Issuance [Table Text Block] | September 30, 2022 Common shares issuable upon exercise of employee and non-employee stock options 2,775,998 Common shares issuable upon settlement of deferred stock units 134,402 Common shares issuable upon exercise of common share purchase warrants 265,000 Shares available for grant under the 2019 Omnibus Incentive Plan 2,014,010 Shares available for grant under the 2021 Employment Inducement Incentive Plan 535,000 Total 5,724,410 |
Note 11 - Net Loss Per Share (T
Note 11 - Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net loss $ (3,059 ) $ (3,450 ) $ (9,925 ) $ (10,346 ) Weighted average shares outstanding—basic and diluted 26,443,067 19,035,713 26,443,067 18,863,829 Basic and diluted net loss per share $ (0.12 ) $ (0.18 ) $ (0.38 ) $ (0.55 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Employee and non-employee stock options 2,775,998 1,959,100 2,775,998 1,959,100 Common shares issuable under common share purchase warrants 265,000 265,000 265,000 265,000 Common shares issuable under deferred stock units 134,402 71,509 134,402 71,509 |
Note 12 - Share-based Compens_2
Note 12 - Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 126 $ 100 $ 325 $ 371 General and administrative 292 203 766 889 Total share-based compensation $ 418 $ 303 $ 1,091 $ 1,260 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Shares Underlying Options Outstanding Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Balances at December 31, 2021 1,896,600 $ 5.22 $ 169 Granted 989,398 2.61 Expired/cancelled (57,813 ) 8.78 Forfeited (52,187 ) 4.94 Balances at September 30, 2022 2,775,998 $ 4.15 $ — |
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 - $1.99 152,000 9.9 $ 1.50 — — $2.00 - $2.99 800,398 8.3 2.50 170,852 4.7 $3.00 - $3.99 409,393 7.5 3.80 193,766 5.8 $4.00 - $4.99 862,182 6.7 4.57 805,349 6.6 $5.00 - $24.00 552,025 7.4 6.85 294,525 6.2 2,775,998 7.6 $ 4.15 1,464,492 6.2 |
Note 2 - Risks and Uncertaint_2
Note 2 - Risks and Uncertainties (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Retained Earnings (Accumulated Deficit), Total | $ (92,426) | $ (92,426) | $ (82,501) | |||||||
Net Income (Loss) Attributable to Parent, Total | (3,059) | $ (3,358) | $ (3,508) | $ (3,450) | $ (3,274) | $ (3,622) | (9,925) | $ (10,346) | ||
Net Cash Provided by (Used in) Operating Activities, Total | (8,745) | (9,448) | ||||||||
Cash, Cash Equivalents, and Short-Term Investments, Total | 36,100 | 36,100 | ||||||||
Working Capital | 35,000 | 35,000 | ||||||||
Stockholders' Equity Attributable to Parent, Ending Balance | $ 35,079 | $ 37,715 | $ 40,768 | $ 47,036 | $ 20,318 | $ 23,145 | $ 35,079 | $ 47,036 | $ 44,024 | $ 26,014 |
Note 3 - Summary of Significa_2
Note 3 - Summary of Significant Accounting Policies (Details Textual) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
General and Administrative Expense [Member] | ||
Patent Expense | $ 109,000 | $ 89,000 |
Note 4 - Marketable Securitie_2
Note 4 - Marketable Securities (Details Textual) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued Interest Receivable On Available For Sale Securities [Member] | ||
Interest Receivable | $ 73,000 | $ 130,000 |
Note 4 - Marketable Securitie_3
Note 4 - Marketable Securities - Fair Value of Marketable Securities (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Total marketable securities | $ 33,313 | $ 40,405 |
Fair Value, Inputs, Level 1 [Member] | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Total marketable securities | 33,313 | 40,405 |
Fair Value, Inputs, Level 3 [Member] | ||
Total marketable securities | 0 | 0 |
Commercial Paper and Corporate Bonds [Member] | ||
Total marketable securities | 18,779 | 29,421 |
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 | 18,779 | 29,421 |
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 | 14,534 | 10,984 |
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 | 14,534 | 10,984 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Total marketable securities | $ 0 | $ 0 |
Note 5 - Amounts Receivable (De
Note 5 - Amounts Receivable (Details Textual) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Interest Payable, Current | $ 73,000 | $ 130,000 |
Note 6 - Deposits - Deposits (D
Note 6 - Deposits - Deposits (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Advances to vendors, current | $ 9 | $ 113 |
Note 7 - Property and Equipme_3
Note 7 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property, plant and equipment, gross | $ 183 | $ 137 |
Less accumulated depreciation | (73) | (67) |
Property and equipment, net | 110 | 70 |
Furniture and Fixtures [Member] | ||
Property, plant and equipment, gross | 111 | 70 |
Computer Equipment [Member] | ||
Property, plant and equipment, gross | $ 72 | $ 67 |
Note 8 - Accrued Liabilities -
Note 8 - Accrued Liabilities - Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued compensation | $ 303 | $ 484 |
Accrued clinical trial costs | 230 | 284 |
Accrued research and other professional fees | 97 | 191 |
Other liabilities | 7 | 7 |
Total accrued liabilities | $ 637 | $ 966 |
Note 9 - Operating Lease (Detai
Note 9 - Operating Lease (Details Textual) | 9 Months Ended | ||
Sep. 30, 2022 USD ($) | Jun. 30, 2022 ft² | Dec. 31, 2021 USD ($) | |
Operating Lease, Incremental Borrowing Rate | 8% | ||
Operating Lease, Right-of-Use Asset | $ 441,000 | $ 42,000 | |
Operating Lease, Liability, Total | 449,000 | ||
Operating Lease, Cost | 52,000 | ||
Variable Lease, Cost | 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 | ||
Operating Lease, Liability, Total | $ 446,000 |
Note 9 - Operating Lease - Matu
Note 9 - Operating Lease - Maturity of Operating Lease Liability (Details) | Sep. 30, 2022 USD ($) |
2022 | $ 0 |
2023 | 97,000 |
2024 | 109,000 |
2025 | 113,000 |
2026 | 116,000 |
2027 | 119,000 |
2028 | 10 |
Total lease payments | 564,000 |
Less interest portion | 0 |
Present value of lease obligation | $ 449,000 |
Note 10 - Shareholders' Equit_2
Note 10 - Shareholders' Equity (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 26, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Stock Issued During Period, Shares, New Issues | 7,653,060 | |||
Shares Issued, Price Per Share | $ 3.92 | |||
Proceeds from Issuance of Common Stock | $ 30,000,000 | $ 0 | $ 29,867,000 | |
Proceeds from Issuance of Common Stock, Net | $ 29,900,000 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period | 40,000 | |||
Stock Issued During Period, Value, Stock Options Exercised | $ 244,000 | $ 244,000 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 132,000 |
Note 10 - Shareholders' Equit_3
Note 10 - Shareholders' Equity - Shares Reserved (Details) | Sep. 30, 2022 shares |
Common stock reserved for future issuance (in shares) | 5,724,410 |
Stock Options Outstanding [Member] | |
Common stock reserved for future issuance (in shares) | 2,775,998 |
Deferred Share Units [Member] | |
Common stock reserved for future issuance (in shares) | 134,402 |
Common Share Purchase Warrants [Member] | |
Common stock reserved for future issuance (in shares) | 265,000 |
The 2019 Omnibus Incentive Plan [Member] | |
Common stock reserved for future issuance (in shares) | 2,014,010 |
The 2021 Employment Inducement Incentive Plan [Member] | |
Common stock reserved for future issuance (in shares) | 535,000 |
Note 11 - Net Loss Per Share -
Note 11 - Net Loss Per Share - Summary of Significant Accounting Policies - Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Net loss | $ (3,059) | $ (3,358) | $ (3,508) | $ (3,450) | $ (3,274) | $ (3,622) | $ (9,925) | $ (10,346) |
Weighted average shares outstanding—basic and diluted (in shares) | 26,443,067 | 19,035,713 | 26,443,067 | 18,863,829 | ||||
Basic and diluted net loss per share (in dollars per share) | $ (0.12) | $ (0.18) | $ (0.38) | $ (0.55) |
Note 11 - Net Loss Per Share _2
Note 11 - Net Loss Per Share - Schedule of Antidilutive Shares Excluded from Computation of Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Employee and Non-employee Stock Options [Member] | ||||
Antidilutive Securities (in shares) | 2,775,998 | 1,959,100 | 2,775,998 | 1,959,100 |
Warrant [Member] | ||||
Antidilutive Securities (in shares) | 265,000 | 265,000 | 265,000 | 265,000 |
Common Stock, Deferred Stock Units Settlement [Member] | ||||
Antidilutive Securities (in shares) | 134,402 | 71,509 | 134,402 | 71,509 |
Note 12 - Share-based Compens_3
Note 12 - Share-based Compensation (Details Textual) - shares | 9 Months Ended | ||
May 18, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares) | 989,398 | ||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 5,724,410 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number, Ending Balance (in shares) | 2,775,998 | 1,896,600 | |
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) | 1,845,588 | ||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 117,069 | ||
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] | Phantom Share Units (PSUs) [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, 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) | 465,000 | ||
Stock Option Prior Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number, Ending Balance (in shares) | 465,410 | ||
The 2012 DSU Plan [Member] | |||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 17,333 |
Note 12 - Share-based Compens_4
Note 12 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Total share-based compensation | $ 418 | $ 303 | $ 1,091 | $ 1,260 |
Research and Development Expense [Member] | ||||
Total share-based compensation | 126 | 100 | 325 | 371 |
General and Administrative Expense [Member] | ||||
Total share-based compensation | $ 292 | $ 203 | $ 766 | $ 889 |
Note 12 - Share-based Compens_5
Note 12 - Share-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Balance (in shares) | 1,896,600 | |
Balance, weighted average exercise price (in dollars per share) | $ 5.22 | |
Balance, aggregate intrinsic value | $ 169 | |
Granted (in shares) | 989,398 | |
Granted, weighted average exercise price (in dollars per share) | $ 2.61 | |
Expired/cancelled (in shares) | (57,813) | |
Expired / cancelled, weighted average exercise price (in dollars per share) | $ 8.78 | |
Forfeited (in shares) | (52,187) | |
Forfeited, weighted average exercise price (in dollars per share) | $ 4.94 | |
Balance (in shares) | 2,775,998 | |
Balance, weighted average exercise price (in dollars per share) | $ 4.15 |
Note 12 - Share-based Compens_6
Note 12 - Share-based Compensation - Stock Options Outstanding (Details) | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Outstanding, shares (in shares) | shares | 2,775,998 |
Outstanding, weighted average remaining contractual life (Year) | 7 years 7 months 6 days |
Outstanding, weighted average exercise price (in dollars per share) | $ 4.15 |
Exercisable, shares (in shares) | shares | 1,464,492 |
Exercisable, weighted average remaining contractual life (Year) | 6 years 2 months 12 days |
Exercise Price Range 1 [Member] | |
Per share exercise price, lower range (in dollars per share) | $ 1 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit (in dollars per share) | $ 1.99 |
Outstanding, shares (in shares) | shares | 152,000 |
Outstanding, weighted average remaining contractual life (Year) | 9 years 10 months 24 days |
Outstanding, weighted average exercise price (in dollars per share) | $ 1.50 |
Exercise Price Range 2 [Member] | |
Per share exercise price, lower range (in dollars per share) | 2 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit (in dollars per share) | $ 2.99 |
Outstanding, shares (in shares) | shares | 800,398 |
Outstanding, weighted average remaining contractual life (Year) | 8 years 3 months 18 days |
Outstanding, weighted average exercise price (in dollars per share) | $ 2.50 |
Exercisable, shares (in shares) | shares | 170,852 |
Exercisable, weighted average remaining contractual life (Year) | 4 years 8 months 12 days |
Exercise Price Range 3 [Member] | |
Per share exercise price, lower range (in dollars per share) | $ 3 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit (in dollars per share) | $ 3.99 |
Outstanding, shares (in shares) | shares | 409,393 |
Outstanding, weighted average remaining contractual life (Year) | 7 years 6 months |
Outstanding, weighted average exercise price (in dollars per share) | $ 3.80 |
Exercisable, shares (in shares) | shares | 193,766 |
Exercisable, weighted average remaining contractual life (Year) | 5 years 9 months 18 days |
Exercise Price Range 4 [Member] | |
Per share exercise price, lower range (in dollars per share) | $ 4 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit (in dollars per share) | $ 4.99 |
Outstanding, shares (in shares) | shares | 862,182 |
Outstanding, weighted average remaining contractual life (Year) | 6 years 8 months 12 days |
Outstanding, weighted average exercise price (in dollars per share) | $ 4.57 |
Exercisable, shares (in shares) | shares | 805,349 |
Exercisable, weighted average remaining contractual life (Year) | 6 years 7 months 6 days |
Exercise Price Range 5 [Member] | |
Per share exercise price, lower range (in dollars per share) | $ 5 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit (in dollars per share) | $ 24 |
Outstanding, shares (in shares) | shares | 552,025 |
Outstanding, weighted average remaining contractual life (Year) | 7 years 4 months 24 days |
Outstanding, weighted average exercise price (in dollars per share) | $ 6.85 |
Exercisable, shares (in shares) | shares | 294,525 |
Exercisable, weighted average remaining contractual life (Year) | 6 years 2 months 12 days |