Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 09, 2022 | |
Document Information [Line Items] | ||
Entity Central Index Key | 0001626878 | |
Entity Registrant Name | XBiotech Inc. | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2022 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-37437 | |
Entity Incorporation, State or Country Code | CA | |
Entity Address, Address Line One | 5217 Winnebago Ln | |
Entity Address, City or Town | Austin | |
Entity Address, State or Province | TX | |
Entity Address, Postal Zip Code | 78744 | |
City Area Code | 512 | |
Local Phone Number | 386-2900 | |
Title of 12(b) Security | Common Stock, no par value | |
Trading Symbol | XBIT | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 30,439,277 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 160,568 | $ 236,983 |
Interest bearing time deposits | 59,532 | 0 |
Account receivable | 1,530 | 0 |
Income tax receivable | 1,176 | 8,953 |
Prepaid expenses and other current assets | 621 | 934 |
Total current assets | 223,427 | 246,870 |
Property and equipment, net | 26,635 | 28,307 |
Deferred tax assets | 772 | 0 |
Total assets | 250,834 | 275,177 |
Current liabilities: | ||
Accounts payable | 1,376 | 2,069 |
Accrued expenses | 1,988 | 1,374 |
Income tax payable | 214 | 10 |
Total current liabilities | 3,578 | 3,453 |
Long-term liabilities: | ||
Income tax payable | 1,575 | 1,466 |
Deferred tax liability | 872 | 873 |
Total liabilities | 6,025 | 5,792 |
Shareholders’ equity: | ||
Common stock and additional paid in capital, no par value, unlimited shares authorized, 30,439,277 shares outstanding at September 30, 2022 and December 31, 2021, respectively | 266,287 | 262,263 |
Accumulated other comprehensive income | 3,068 | 1,971 |
Accumulated (deficit) equity | (24,546) | 5,151 |
Total shareholders’ equity | 244,809 | 269,385 |
Total liabilities and shareholders’ equity | $ 250,834 | $ 275,177 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares $ / shares in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Common stock, no par value (in dollars per share) | $ 0 | $ 0 |
Common stock, shares authorized | Unlimited | Unlimited |
Common stock, shares outstanding (in shares) | 30,439,277 | 30,439,277 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue | ||||
Revenue | $ 1,680 | $ 4,519 | $ 3,710 | $ 13,894 |
Cost of goods sold | ||||
Cost of goods sold | 215 | 1,110 | 635 | 4,774 |
Gross margin | 1,465 | 3,409 | 3,075 | 9,120 |
Operating expenses: | ||||
Research and development | 7,014 | 5,599 | 24,227 | 19,486 |
General and administrative | 840 | 1,541 | 5,176 | 7,522 |
Total operating expenses | 7,854 | 7,140 | 29,403 | 27,008 |
Loss from operations | (6,389) | (3,731) | (26,328) | (17,888) |
Other (loss) income: | ||||
Interest income | 1,009 | 125 | 1,351 | 357 |
Other expense | 0 | (121) | (119) | (132) |
Foreign exchange (loss) gain | (4,877) | (1,328) | (5,867) | (127) |
Total other (loss) income | (3,868) | (1,324) | (4,635) | 98 |
Loss before income taxes | (10,257) | (5,055) | (30,963) | (17,790) |
Income tax (expense) benefit | (2,401) | 1,794 | 1,266 | 6,843 |
Net loss | $ (12,658) | $ (3,261) | $ (29,697) | $ (10,947) |
Net loss per share—basic and diluted (in dollars per share) | $ (0.42) | $ (0.11) | $ (0.98) | $ (0.37) |
Shares used to compute basic and diluted net loss per share (in shares) | 30,439,277 | 30,341,470 | 30,439,277 | 29,921,048 |
Manufacturing Revenue [Member] | ||||
Revenue | ||||
Revenue | $ 1,680 | $ 4,500 | $ 3,710 | $ 13,500 |
Cost of goods sold | ||||
Cost of goods sold | 215 | 1,095 | 635 | 4,471 |
Clinical Trial Service Revenue [Member] | ||||
Revenue | ||||
Revenue | 0 | 19 | 0 | 394 |
Cost of goods sold | ||||
Cost of goods sold | $ 0 | $ 15 | $ 0 | $ 303 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Net income (loss) | $ (12,658) | $ (3,261) | $ (29,697) | $ (10,947) |
Foreign currency translation adjustment | 544 | (240) | 1,097 | 397 |
Comprehensive loss | $ (12,114) | $ (3,501) | $ (28,600) | $ (10,550) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock Including Additional Paid in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2020 | 29,304,000 | |||
Balance at Dec. 31, 2020 | $ 249,805 | $ 1,266 | $ 97,568 | $ 348,639 |
Net income (loss) | 0 | 0 | (10,947) | (10,947) |
Foreign currency translation adjustment | 0 | 397 | 0 | 397 |
Share-based compensation expense | $ 3,109 | 0 | 0 | 3,109 |
Issuance of common stock under stock option plan (in shares) | 1,094 | |||
Issuance of common stock under stock option plan | $ 7,962 | 0 | 0 | 7,962 |
Dividends | 0 | 0 | (75,003) | (75,003) |
Balance at Sep. 30, 2021 | $ 260,876 | 1,663 | 11,618 | 274,157 |
Balance (in shares) at Sep. 30, 2021 | 30,398,000 | |||
Balance (in shares) at Jun. 30, 2021 | 30,024,000 | |||
Balance at Jun. 30, 2021 | $ 256,779 | 1,903 | 89,882 | 348,564 |
Net income (loss) | 0 | 0 | (3,261) | (3,261) |
Foreign currency translation adjustment | 0 | (240) | 0 | (240) |
Share-based compensation expense | $ 1,133 | 0 | 0 | 1,133 |
Issuance of common stock under stock option plan (in shares) | 374,000 | |||
Issuance of common stock under stock option plan | $ 2,964 | 0 | 0 | 2,964 |
Dividends | 0 | 0 | (75,003) | (75,003) |
Balance at Sep. 30, 2021 | $ 260,876 | 1,663 | 11,618 | 274,157 |
Balance (in shares) at Sep. 30, 2021 | 30,398,000 | |||
Balance (in shares) at Dec. 31, 2021 | 30,439,000 | |||
Balance at Dec. 31, 2021 | $ 262,263 | 1,971 | 5,151 | 269,385 |
Net income (loss) | 0 | 0 | (29,697) | (29,697) |
Foreign currency translation adjustment | 0 | 1,097 | 0 | 1,097 |
Share-based compensation expense | 4,024 | 0 | 0 | 4,024 |
Balance at Sep. 30, 2022 | $ 266,287 | 3,068 | (24,546) | 244,809 |
Balance (in shares) at Sep. 30, 2022 | 30,439,000 | |||
Balance (in shares) at Jun. 30, 2022 | 30,439,000 | |||
Balance at Jun. 30, 2022 | $ 265,159 | 2,524 | (11,888) | 255,795 |
Net income (loss) | 0 | 0 | (12,658) | (12,658) |
Foreign currency translation adjustment | 0 | 544 | 0 | 544 |
Share-based compensation expense | 1,128 | 0 | 0 | 1,128 |
Balance at Sep. 30, 2022 | $ 266,287 | $ 3,068 | $ (24,546) | $ 244,809 |
Balance (in shares) at Sep. 30, 2022 | 30,439,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities | ||
Net income (loss) | $ (29,697) | $ (10,947) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Depreciation | 2,171 | 1,946 |
Share-based compensation expense | 4,024 | 3,109 |
Changes in operating assets and liabilities: | ||
Account receivable | (1,530) | 4,069 |
Income tax receivable | 7,777 | (3,823) |
Deferred cost of goods sold | 0 | 1,633 |
Escrow receivable | 0 | 75,063 |
Prepaid expenses and other current assets | 314 | 207 |
Deferred tax assets | (772) | (108) |
Accounts payable | (741) | (1,679) |
Accrued expenses | 614 | 292 |
Income tax payable | 314 | 1,334 |
Deferred tax liability | (1) | 108 |
Net cash (used in) provided by operating activities | (17,527) | 71,204 |
Investing activities | ||
Purchase of property and equipment | (453) | (3,049) |
Purchase of interest bearing time deposits | (59,532) | 0 |
Net cash used in investing activities | (59,985) | (3,049) |
Financing activities | ||
Dividends | 0 | (75,003) |
Issuance of common stock under stock option plan | 0 | 7,962 |
Net cash used in financing activities | 0 | (67,041) |
Effect of foreign exchange rate on cash and cash equivalents | 1,097 | 397 |
Net change in cash and cash equivalents | (76,415) | 1,511 |
Cash and cash equivalents, beginning of period | 236,983 | 237,366 |
Cash and cash equivalents, end of period | 160,568 | 238,877 |
Accrued purchases of property and equipment | $ 46 | $ 202 |
Note 1 - Organization
Note 1 - Organization | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | 1. Organization XBiotech Inc. (XBiotech or the Company) was incorporated in Canada on March 22, 2005. November 2007. January 2014. Since its inception, XBiotech has focused on advancing technology to rapidly identify and clone antibodies from individuals that have resistance to disease. At the heart of the Company is a proprietary technical knowhow to translate natural human immunity into therapeutic product candidates. The Company has in its pipeline both anti-infective and anti-inflammatory candidate therapeutics derived from this technology. An area of medical focus for XBiotech are therapies that block a potent substance naturally produced by the body, known as interleukin- 1 1a 1a 1a may At the end of 2019, 1a February 2, 2022, 2019 December 2023. 1a 1a 1a 1a 1a one 1a, one 1a The Company continues to be subject to a number of risks common to companies in similar stages of development. Principal among these risks are the uncertainties of technological innovations, dependence on key individuals, development of the same or similar technological innovations by the Company’s competitors and protection of proprietary technology. The Company’s ability to fund its planned clinical operations, including completion of its planned trials, is expected to depend on the amount and timing of cash receipts from future collaboration or product sales and/or financing transactions. The Company believes that its cash and cash equivalents of $160.6 million at September 30, 2022, 12 |
Note 2 - Significant Accounting
Note 2 - Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 2. Significant Accounting Policies Basis of Presentation The condensed consolidated balance sheet as of September 30, 2022, three nine September 30, 2022 2021, nine September 30, 2022 Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Form 10 December 31, 2021. September 30, 2022 not may December 31, 2021 Basis of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions have been eliminated upon consolidation. Use of Estimates The preparation of financial statements in accordance with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the reported values of amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. Revenue Revenue from the Janssen Agreements The Company recognizes revenues from its Janssen Agreements as follows. The Company entered into its clinical manufacturing and clinical trial services arrangements in connection with its sale of certain intellectual property on December 30, 2019. January 1, 2020. December 2023. not XBiotech is still in the research and development phase; however, the eventual output of the Company’s intended ordinary activities will be the licensing of intellectual property and/or sale of commercialized compounds for use in pharmaceutical treatment of disease, not not not 606, Revenue from Contracts with Customers 606” Under ASC 606, 606 five five 606, Manufacturing Revenue The Company has a Clinical Manufacturing Agreement that it accounts for by analogy to ASC 606, 2020 2021. 2022 2019 December 2023. Research and Development Costs All research and development costs are charged to expense as incurred. Research and development costs include salaries and personnel-related costs, consulting fees, fees paid for contract clinical trial research services, the costs of laboratory consumables, equipment and facilities, license fees and other external costs. Costs incurred to acquire licenses for intellectual property to be used in research and development activities with no Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Clinical Trial Accruals Expense accruals related to clinical trials are based on the Company’s estimates of services received and efforts expended pursuant to contracts with third may Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company measures deferred tax assets and liabilities using the enacted tax rates for the years and jurisdictions in which the temporary differences are expected to be recovered. A change to the tax rates used to measure the Company’s deferred taxes is recognized in income during the period in which the new rate(s) were enacted. The Company recognizes deferred tax assets to the extent the Company’s assets are more likely than not not, not not not The Company recognizes and measure uncertain tax benefits in accordance with ASC 740 two 1 not 2 not fifty Share-Based Compensation The Company accounts for its share-based compensation awards in accordance with ASC Topic 718, Compensation-Stock Compensation 718” 718 Share-based compensation expense recognized for the three nine September 30, 2022 2021 Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 855 $ 436 $ 2,824 $ 1,233 General and administrative 273 628 1,200 1,673 Cost of goods sold - 69 - 203 Total share-based compensation expense $ 1,128 $ 1,133 $ 4,024 $ 3,109 The fair value of each option is estimated on the date of grant using the Black-Scholes method with the following assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Dividend yield - - - - Expected volatility 83% 84% - 91% 82% - 83% 84% - 91% Risk-free interest rate 2.9% - 3.3% 0.9% - 1.0% 1.5% - 3.5% 0.5% - 1.1% Expected life (in years) 6.25 6.25 5.38 - 6.25 5.38 - 6.25 Weighted-average grant date fair value per share 3.71 16.17 4.93 16.69 Cash and Cash Equivalents The Company considers highly liquid investments with a maturity of three Interest Bearing Time Deposit The Company holds guaranteed investment certificates with a financial institution. The guaranteed investment certificates have a 12 Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents. The Company holds these investments in highly-rated financial institutions, and limits the amounts of credit exposure to any one may not not no Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment may not not three nine September 30, 2022 2021. Foreign Currency Transactions Certain transactions are denominated in a currency other than the Company’s functional currency of the U.S. dollar, and the Company generates assets and liabilities that are fixed in terms of the amount of foreign currency that will be received or paid. At each balance sheet date, the Company adjusts the assets and liabilities to reflect the current exchange rate, resulting in a translation gain or loss. Transaction gains and losses are also realized upon a settlement of a foreign currency transaction in determining net loss for the period in which the transaction is settled. Comprehensive Income (Loss) ASC Topic 220, Comprehensive Income Segment and Geographic Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company and the chief operating decision maker view the Company’s operations and manage its business as one Net Loss Per Share Net loss per share (“EPS”) is computed by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted EPS is computed by dividing net loss by the weighted average number of common shares and common share equivalents outstanding (if dilutive) during each period. The number of common share equivalents, which include stock options, is computed using the treasury stock method. Subsequent Events The Company considered events or transactions occurring after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in its consolidated financial statements. We have evaluated subsequent events through the date of filing this Form 10 Recent Accounting Pronouncements Recently Issued Accounting Pronouncements In June 2016, No. 2016 13, 326 November 15, 2019, 326 December 15, 2022 not not |
Note 3 - Revenue
Note 3 - Revenue | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | 3. Revenue On February 2, 2022, 2019 December 2023. three nine September 30, 2022, February 2022 |
Note 4 - Property and Equipment
Note 4 - Property and Equipment | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 4. Property and Equipment Property and equipment consisted of the following as of September 30, 2022 December 31, 2021 ( September 30, 2022 December 31, 2021 Manufacturing equipment $ 2,941 $ 3,796 Winnebago building 21,259 21,587 Other fixed assets 2,435 2,924 Total property and equipment $ 26,635 $ 28,307 |
Note 5 - Common Stock
Note 5 - Common Stock | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 5. Common Stock Pursuant to its Articles, the Company has an unlimited number of shares available for issuance with no From January 1, 2021 December 31, 2021, No stock options were exercised from January 1, 2022 September 30,2022. |
Note 6 - Common Stock Options
Note 6 - Common Stock Options | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | 6. Common Stock Options On November 11, 2005, 2005 “2005 March 24, 2015, 2015 2015 may may All options under both Plans will be non-transferable and may first may The term of the options is at the discretion of the Compensation Committee, but may not three The number of common shares reserved for issuance to any one 2005 not, A summary of changes in common stock options issued under the 2005 2015 Options Exercise Price Weighted-Average Exercise Price Options outstanding at December 31, 2021 4,656,677 $2.71 - $21.74 $ 10.68 Granted 151,600 4.06 - 11.50 7.10 Exercised - - - Forfeitures (137,650 ) 3.27 - 21.74 13.46 Options outstanding at September 30, 2022 4,670,627 $2.71 - $21.74 $ 10.48 Options Exercise Price Weighted-Average Exercise Price Options outstanding at December 31, 2020 5,327,425 $2.71 - $21.99 $ 6.09 Granted 162,000 $15.29 - $20.20 16.69 Exercised (1,093,415 ) $3.27 - $15.00 7.28 Forfeitures (114,374 ) $4.14 - $21.99 9.75 Options outstanding at September 30, 2021 4,281,636 $2.71 - $21.74 $ 10.36 As of September 30, 2022, |
Note 7 - Net Income Loss Per Sh
Note 7 - Net Income Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 7. Net Income/Loss Per Share The following summarizes the computation of basic and diluted net income/loss per share for three nine September 30, 2022 2021 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net loss $ (12,658 ) $ (3,261 ) $ (29,697 ) $ (10,947 ) Weighted-average number of common shares—basic and diluted 30,439,277 30,341,470 30,439,277 29,921,048 Net loss per share—basic and diluted $ (0.42 ) $ (0.11 ) $ (0.98 ) $ (0.37 ) Potentially dilutive securities outstanding, prior to the use of the treasury stock method or if-converted method, in the amount of 4,610,627 and 4,281,636 have been excluded from the computation of diluted weighted-average common shares outstanding as of September 30, 2022 September 30, 2021, |
Note 8 - Income Taxes
Note 8 - Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 8. Income Taxes To calculate the interim tax provision, at the end of each interim period, the Company estimates the annual effective tax rate and applies that to its ordinary quarterly earnings. The effect of changes in the enacted tax laws or rates is recognized in the interim period in which the change occurs. The computation of the annual estimated effective tax rate at each interim period requires certain estimates and judgements including, but not may The Company's effective tax rates for the three September 30, 2022 September 30, 2021, three September 30, 2022 no three September 30, 2021 The Company's effective tax rates for the nine September 30, 2022 September 30, 2021, nine September 30, 2022 no nine September 30, 2021 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The condensed consolidated balance sheet as of September 30, 2022, three nine September 30, 2022 2021, nine September 30, 2022 Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Form 10 December 31, 2021. September 30, 2022 not may December 31, 2021 |
Consolidation, Policy [Policy Text Block] | Basis of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions have been eliminated upon consolidation. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in accordance with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the reported values of amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Revenue from Contract with Customer [Policy Text Block] | Revenue Revenue from the Janssen Agreements The Company recognizes revenues from its Janssen Agreements as follows. The Company entered into its clinical manufacturing and clinical trial services arrangements in connection with its sale of certain intellectual property on December 30, 2019. January 1, 2020. December 2023. not XBiotech is still in the research and development phase; however, the eventual output of the Company’s intended ordinary activities will be the licensing of intellectual property and/or sale of commercialized compounds for use in pharmaceutical treatment of disease, not not not 606, Revenue from Contracts with Customers 606” Under ASC 606, 606 five five 606, Manufacturing Revenue The Company has a Clinical Manufacturing Agreement that it accounts for by analogy to ASC 606, 2020 2021. 2022 2019 December 2023. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Costs All research and development costs are charged to expense as incurred. Research and development costs include salaries and personnel-related costs, consulting fees, fees paid for contract clinical trial research services, the costs of laboratory consumables, equipment and facilities, license fees and other external costs. Costs incurred to acquire licenses for intellectual property to be used in research and development activities with no Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. |
Clinical Trial Accruals [Policy Text Block] | Clinical Trial Accruals Expense accruals related to clinical trials are based on the Company’s estimates of services received and efforts expended pursuant to contracts with third may |
Income Tax, Policy [Policy Text Block] | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company measures deferred tax assets and liabilities using the enacted tax rates for the years and jurisdictions in which the temporary differences are expected to be recovered. A change to the tax rates used to measure the Company’s deferred taxes is recognized in income during the period in which the new rate(s) were enacted. The Company recognizes deferred tax assets to the extent the Company’s assets are more likely than not not, not not not The Company recognizes and measure uncertain tax benefits in accordance with ASC 740 two 1 not 2 not fifty |
Share-Based Payment Arrangement [Policy Text Block] | Share-Based Compensation The Company accounts for its share-based compensation awards in accordance with ASC Topic 718, Compensation-Stock Compensation 718” 718 Share-based compensation expense recognized for the three nine September 30, 2022 2021 Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 855 $ 436 $ 2,824 $ 1,233 General and administrative 273 628 1,200 1,673 Cost of goods sold - 69 - 203 Total share-based compensation expense $ 1,128 $ 1,133 $ 4,024 $ 3,109 The fair value of each option is estimated on the date of grant using the Black-Scholes method with the following assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Dividend yield - - - - Expected volatility 83% 84% - 91% 82% - 83% 84% - 91% Risk-free interest rate 2.9% - 3.3% 0.9% - 1.0% 1.5% - 3.5% 0.5% - 1.1% Expected life (in years) 6.25 6.25 5.38 - 6.25 5.38 - 6.25 Weighted-average grant date fair value per share 3.71 16.17 4.93 16.69 |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company considers highly liquid investments with a maturity of three |
Investment, Policy [Policy Text Block] | Interest Bearing Time Deposit The Company holds guaranteed investment certificates with a financial institution. The guaranteed investment certificates have a 12 |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents. The Company holds these investments in highly-rated financial institutions, and limits the amounts of credit exposure to any one may not not no |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment may not not three nine September 30, 2022 2021. |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Foreign Currency Transactions Certain transactions are denominated in a currency other than the Company’s functional currency of the U.S. dollar, and the Company generates assets and liabilities that are fixed in terms of the amount of foreign currency that will be received or paid. At each balance sheet date, the Company adjusts the assets and liabilities to reflect the current exchange rate, resulting in a translation gain or loss. Transaction gains and losses are also realized upon a settlement of a foreign currency transaction in determining net loss for the period in which the transaction is settled. |
Comprehensive Income, Policy [Policy Text Block] | Comprehensive Income (Loss) ASC Topic 220, Comprehensive Income |
Segment Reporting, Policy [Policy Text Block] | Segment and Geographic Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company and the chief operating decision maker view the Company’s operations and manage its business as one |
Earnings Per Share, Policy [Policy Text Block] | Net Loss Per Share Net loss per share (“EPS”) is computed by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted EPS is computed by dividing net loss by the weighted average number of common shares and common share equivalents outstanding (if dilutive) during each period. The number of common share equivalents, which include stock options, is computed using the treasury stock method. |
Subsequent Events, Policy [Policy Text Block] | Subsequent Events The Company considered events or transactions occurring after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in its consolidated financial statements. We have evaluated subsequent events through the date of filing this Form 10 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements Recently Issued Accounting Pronouncements In June 2016, No. 2016 13, 326 November 15, 2019, 326 December 15, 2022 not not |
Note 2 - Significant Accounti_2
Note 2 - Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 855 $ 436 $ 2,824 $ 1,233 General and administrative 273 628 1,200 1,673 Cost of goods sold - 69 - 203 Total share-based compensation expense $ 1,128 $ 1,133 $ 4,024 $ 3,109 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Dividend yield - - - - Expected volatility 83% 84% - 91% 82% - 83% 84% - 91% Risk-free interest rate 2.9% - 3.3% 0.9% - 1.0% 1.5% - 3.5% 0.5% - 1.1% Expected life (in years) 6.25 6.25 5.38 - 6.25 5.38 - 6.25 Weighted-average grant date fair value per share 3.71 16.17 4.93 16.69 |
Note 4 - Property and Equipme_2
Note 4 - 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 Manufacturing equipment $ 2,941 $ 3,796 Winnebago building 21,259 21,587 Other fixed assets 2,435 2,924 Total property and equipment $ 26,635 $ 28,307 |
Note 6 - Common Stock Options (
Note 6 - Common Stock Options (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Options Exercise Price Weighted-Average Exercise Price Options outstanding at December 31, 2021 4,656,677 $2.71 - $21.74 $ 10.68 Granted 151,600 4.06 - 11.50 7.10 Exercised - - - Forfeitures (137,650 ) 3.27 - 21.74 13.46 Options outstanding at September 30, 2022 4,670,627 $2.71 - $21.74 $ 10.48 Options Exercise Price Weighted-Average Exercise Price Options outstanding at December 31, 2020 5,327,425 $2.71 - $21.99 $ 6.09 Granted 162,000 $15.29 - $20.20 16.69 Exercised (1,093,415 ) $3.27 - $15.00 7.28 Forfeitures (114,374 ) $4.14 - $21.99 9.75 Options outstanding at September 30, 2021 4,281,636 $2.71 - $21.74 $ 10.36 |
Note 7 - Net Income Loss Per _2
Note 7 - Net Income 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 $ (12,658 ) $ (3,261 ) $ (29,697 ) $ (10,947 ) Weighted-average number of common shares—basic and diluted 30,439,277 30,341,470 30,439,277 29,921,048 Net loss per share—basic and diluted $ (0.42 ) $ (0.11 ) $ (0.98 ) $ (0.37 ) |
Note 1 - Organization (Details
Note 1 - Organization (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Sep. 30, 2022 | Dec. 31, 2021 | |
Cash and Cash Equivalents, at Carrying Value, Total | $ 160,568 | $ 236,983 | |
True Human [Member] | |||
Sale of Product, Consideration Received | $ 1,350,000 |
Note 2 - Significant Accounti_3
Note 2 - Significant Accounting Policies (Details Textual) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | 24 Months Ended | |||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2023 USD ($) | |
Revenue from Contract with Customer, Including Assessed Tax | $ 1,680 | $ 4,519 | $ 3,710 | $ 13,894 | |||
Impairment, Long-Lived Asset, Held-for-Use, Total | 0 | 0 | $ 0 | 0 | |||
Number of Operating Segments | 1 | ||||||
Manufacturing Revenue [Member] | |||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 1,680 | $ 4,500 | $ 3,710 | $ 13,500 | |||
Janssen [Member] | Manufacturing Revenue [Member] | |||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 4,500 | $ 4,500 | |||||
Janssen [Member] | Manufacturing Revenue [Member] | Forecast [Member] | |||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 4,700 |
Note 2 - Significant Accounti_4
Note 2 - Significant Accounting Policies - 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 | |
Share-based compensation expense | $ 1,128 | $ 1,133 | $ 4,024 | $ 3,109 |
Research and Development Expense [Member] | ||||
Share-based compensation expense | 855 | 436 | 2,824 | 1,233 |
General and Administrative Expense [Member] | ||||
Share-based compensation expense | 273 | 628 | 1,200 | 1,673 |
Cost of Sales [Member] | ||||
Share-based compensation expense | $ 0 | $ 69 | $ 0 | $ 203 |
Note 2 - Significant Accounti_5
Note 2 - Significant Accounting Policies - Stock Option Valuation Assumptions (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Expected volatility | 83% | |||
Expected life (Year) | 6 years 3 months | 6 years 3 months | ||
Weighted-average grant date fair value per share (in dollars per share) | $ 3.71 | $ 16.17 | $ 4.93 | $ 16.69 |
Minimum [Member] | ||||
Expected volatility | 84% | 82% | 84% | |
Risk-free interest rate | 2.90% | 0.90% | 1.50% | 0.50% |
Expected life (Year) | 5 years 4 months 17 days | 5 years 4 months 17 days | ||
Maximum [Member] | ||||
Expected volatility | 91% | 83% | 91% | |
Risk-free interest rate | 3.30% | 1% | 3.50% | 1.10% |
Expected life (Year) | 6 years 3 months | 6 years 3 months |
Note 3 - Revenue (Details Textu
Note 3 - Revenue (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue from Contract with Customer, Including Assessed Tax | $ 1,680 | $ 4,519 | $ 3,710 | $ 13,894 |
Note 4 - Property and Equipme_3
Note 4 - Property and Equipment - Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment, Net | $ 26,635 | $ 28,307 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment, Net | 2,941 | 3,796 |
Winnebago Building [Member] | ||
Property, Plant and Equipment, Net | 21,259 | 21,587 |
Property, Plant and Equipment, Other Types [Member] | ||
Property, Plant and Equipment, Net | $ 2,435 | $ 2,924 |
Note 5 - Common Stock (Details
Note 5 - Common Stock (Details Textual) - USD ($) $ / shares in Units, shares in Thousands, $ in Millions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Common Stock, No Par Value (in dollars per share) | $ 0 | $ 0 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) | 0 | 1,100 |
Proceeds from Issuance of Common Stock | $ 8 | |
Minimum [Member] | ||
Shares Issued, Price Per Share (in dollars per share) | $ 3.27 | |
Maximum [Member] | ||
Shares Issued, Price Per Share (in dollars per share) | $ 15 |
Note 6 - Common Stock Options_2
Note 6 - Common Stock Options (Details Textual) - USD ($) $ in Millions | 9 Months Ended | |
Oct. 01, 2022 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 4 | |
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 3 months 3 days | |
The Plan [Member] | Any One Person [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Percentage of Outstanding Stock Maximum | 5% | |
The Plan [Member] | Share-Based Payment Arrangement, Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year) | 10 years |
Note 6 - Common Stock Options -
Note 6 - Common Stock Options - Changes in Common Stock Options Issued (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Options outstanding (in shares) | 5,327,425 | 4,656,677 |
Granted (in shares) | 162,000 | 151,600 |
Exercised (in shares) | (1,093,415) | 0 |
Forfeitures (in shares) | (114,374) | (137,650) |
Options outstanding (in shares) | 4,281,636 | 4,670,627 |
Minimum [Member] | ||
Options outstanding, exercise price (in dollars per share) | $ 2.71 | $ 2.71 |
Granted, exercise price (in dollars per share) | 15.29 | 4.06 |
Exercised, exercise price (in dollars per share) | 3.27 | |
Forfeitures, exercise price (in dollars per share) | 4.14 | 3.27 |
Options outstanding, exercise price (in dollars per share) | 2.71 | 2.71 |
Maximum [Member] | ||
Options outstanding, exercise price (in dollars per share) | 21.99 | 21.74 |
Granted, exercise price (in dollars per share) | 20.20 | 11.50 |
Exercised, exercise price (in dollars per share) | 15 | |
Forfeitures, exercise price (in dollars per share) | 21.99 | 21.74 |
Options outstanding, exercise price (in dollars per share) | 21.74 | $ 21.74 |
Weighted Average [Member] | ||
Options outstanding, exercise price (in dollars per share) | 6.09 | |
Granted, exercise price (in dollars per share) | 16.69 | |
Exercised, exercise price (in dollars per share) | 7.28 | |
Forfeitures, exercise price (in dollars per share) | 9.75 | |
Options outstanding, exercise price (in dollars per share) | $ 10.36 |
Note 7 - Net Income Loss Per _3
Note 7 - Net Income Loss Per Share (Details Textual) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | 4,610,627 | 4,281,636 |
Note 7 - Net Income Loss Per _4
Note 7 - Net Income Loss Per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Net income (loss) | $ (12,658) | $ (3,261) | $ (29,697) | $ (10,947) |
Weighted-average number of common shares—basic and diluted (in shares) | 30,439,277 | 30,341,470 | 30,439,277 | 29,921,048 |
Net loss per share—basic and diluted (in dollars per share) | $ (0.42) | $ (0.11) | $ (0.98) | $ (0.37) |
Note 8 - Income Taxes (Details
Note 8 - Income Taxes (Details Textual) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Effective Income Tax Rate Reconciliation, Percent, Total | 23.40% | 35.50% | 4.10% | 38.50% |