Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 11, 2022 | |
Document Information [Line Items] | ||
Entity Central Index Key | 0001434647 | |
Entity Registrant Name | KEMPHARM, INC | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2022 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-36913 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-5894398 | |
Entity Address, Address Line One | 1180 Celebration Boulevard, Suite 103 | |
Entity Address, City or Town | Celebration | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 34747 | |
City Area Code | 321 | |
Local Phone Number | 939-3416 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | KMPH | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 34,493,634 |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Assets | ||
Cash and cash equivalents | $ 76,779 | $ 112,346 |
Short-term investments | 4,199 | 0 |
Accounts and other receivables | 2,820 | 1,528 |
Prepaid expenses and other current assets | 3,637 | 1,182 |
Total current assets | 87,435 | 115,056 |
Inventories | 779 | 0 |
Property and equipment, net | 904 | 884 |
Operating lease right-of-use assets | 1,165 | 1,141 |
Long-term investments | 33,535 | 15,422 |
Other long-term assets | 440 | 438 |
Total assets | 124,258 | 132,941 |
Liabilities and stockholders' equity | ||
Accounts payable and accrued expenses | 3,600 | 3,038 |
Current portion of operating lease liabilities | 469 | 356 |
Current portion of discount and rebate liabilities | 1,796 | 0 |
Other current liabilities | 1,294 | 836 |
Total current liabilities | 7,159 | 4,230 |
Line of credit payable | 12,800 | 0 |
Derivative and warrant liability | 57 | 330 |
Operating lease liabilities, less current portion | 1,082 | 1,232 |
Discount and rebate liabilities, less current portion | 3,900 | 0 |
Other long-term liabilities | 27 | 31 |
Total liabilities | 25,025 | 5,823 |
Commitments and contingencies (Note D) | ||
Stockholders’ equity: | ||
Common stock, $0.0001 par value, 250,000,000 shares authorized, 35,399,267 shares issued and 34,489,314 shares outstanding as of June 30, 2022; 35,325,801 shares issued and 35,005,640 shares outstanding as of December 31, 2021 | 3 | 4 |
Additional paid-in capital | 399,701 | 396,957 |
Treasury stock, at cost | (7,536) | (2,814) |
Accumulated deficit | (292,935) | (267,029) |
Total stockholders' equity | 99,233 | 127,118 |
Total liabilities and stockholders' equity | 124,258 | 132,941 |
Undesignated Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Undesignated preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of June 30, 2022 or December 31, 2021 | $ 0 | $ 0 |
Unaudited Condensed Consolida_2
Unaudited Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 35,399,267 | 35,325,801 |
Common stock, shares outstanding (in shares) | 34,489,314 | 35,005,640 |
Undesignated Preferred Stock [Member] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Unaudited Condensed Consolida_3
Unaudited Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue, net | $ 1,300 | $ 11,986 | $ 5,265 | $ 24,103 |
Operating expenses: | ||||
Cost of revenue | 51 | 1,000 | 59 | 2,000 |
Research and development | 4,795 | 2,848 | 7,877 | 5,113 |
General and administrative | 3,558 | 2,305 | 6,292 | 4,197 |
Acquired in-process research and development | 17,663 | 0 | 17,663 | 0 |
Total operating expenses | 26,067 | 6,153 | 31,891 | 11,310 |
(Loss) income from operations | (24,767) | 5,833 | (26,626) | 12,793 |
Other income (expense): | ||||
Gain (loss) on extinguishment of debt | 0 | 789 | 0 | (16,096) |
Interest expense related to amortization of debt issuance costs and discount | 0 | 0 | 0 | (150) |
Interest expense on principal | (36) | (16) | (41) | (215) |
Fair value adjustment related to derivative and warrant liability | 32 | (394) | 273 | (424) |
Interest and other income (expense), net | 14 | (9) | (231) | (1) |
Total other income (expense) | 10 | 370 | 1 | (16,886) |
(Loss) income before income taxes | (24,757) | 6,203 | (26,625) | (4,093) |
Income tax benefit | 715 | 0 | 719 | 0 |
Net (loss) income | (24,042) | 6,203 | (25,906) | (4,093) |
Deemed dividend | 0 | (16,898) | 0 | (54,342) |
Net loss attributable to common stockholders | $ (24,042) | $ (10,695) | $ (25,906) | $ (58,435) |
Basic and diluted net loss per share of common stock: | ||||
Net loss attributable to common stockholders (in dollars per share) | $ (0.70) | $ (0.40) | $ (0.75) | $ (2.42) |
Weighted average number of shares of common stock outstanding: | ||||
Basic and diluted (in shares) | 34,447,206 | 29,174,565 | 34,476,737 | 24,187,484 |
Unaudited Condensed Consolida_4
Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Preferred Stock [Member] Series A Convertible Preferred Stock [Member] Underwritten Public Offering [Member] | Preferred Stock [Member] Series A Convertible Preferred Stock [Member] January 2021 Inducement Warrants [Member] | Preferred Stock [Member] Series A Convertible Preferred Stock [Member] Warrants to Purchase Common Stock [Member] | Preferred Stock [Member] Series A Convertible Preferred Stock [Member] Exchange Warrants [Member] | Preferred Stock [Member] Series A Convertible Preferred Stock [Member] Conversion of Facility Notes into Series B-2 Preferred Stock [Member] | Preferred Stock [Member] Series A Convertible Preferred Stock [Member] Conversion of Series B-2 Preferred Stock into Common Stock [Member] | Preferred Stock [Member] Series A Convertible Preferred Stock [Member] | Preferred Stock [Member] Series B-1 Convertible Preferred Stock [Member] Underwritten Public Offering [Member] | Preferred Stock [Member] Series B-1 Convertible Preferred Stock [Member] January 2021 Inducement Warrants [Member] | Preferred Stock [Member] Series B-1 Convertible Preferred Stock [Member] Warrants to Purchase Common Stock [Member] | Preferred Stock [Member] Series B-1 Convertible Preferred Stock [Member] Exchange Warrants [Member] | Preferred Stock [Member] Series B-1 Convertible Preferred Stock [Member] Conversion of Facility Notes into Series B-2 Preferred Stock [Member] | Preferred Stock [Member] Series B-1 Convertible Preferred Stock [Member] Conversion of Series B-2 Preferred Stock into Common Stock [Member] | Preferred Stock [Member] Series B-1 Convertible Preferred Stock [Member] | Preferred Stock [Member] Series B-2 Convertible Preferred Stock [Member] Underwritten Public Offering [Member] | Preferred Stock [Member] Series B-2 Convertible Preferred Stock [Member] January 2021 Inducement Warrants [Member] | Preferred Stock [Member] Series B-2 Convertible Preferred Stock [Member] Warrants to Purchase Common Stock [Member] | Preferred Stock [Member] Series B-2 Convertible Preferred Stock [Member] Exchange Warrants [Member] | Preferred Stock [Member] Series B-2 Convertible Preferred Stock [Member] Conversion of Facility Notes into Series B-2 Preferred Stock [Member] | Preferred Stock [Member] Series B-2 Convertible Preferred Stock [Member] Conversion of Series B-2 Preferred Stock into Common Stock [Member] | Preferred Stock [Member] Series B-2 Convertible Preferred Stock [Member] | Preferred Stock [Member] Undesignated Preferred Stock [Member] | Undesignated Preferred Stock [Member] Underwritten Public Offering [Member] | Undesignated Preferred Stock [Member] January 2021 Inducement Warrants [Member] | Undesignated Preferred Stock [Member] Warrants to Purchase Common Stock [Member] | Undesignated Preferred Stock [Member] Exchange Warrants [Member] | Undesignated Preferred Stock [Member] Conversion of Facility Notes into Series B-2 Preferred Stock [Member] | Undesignated Preferred Stock [Member] Conversion of Series B-2 Preferred Stock into Common Stock [Member] | Undesignated Preferred Stock [Member] | Common Stock [Member] Underwritten Public Offering [Member] | Common Stock [Member] January 2021 Inducement Warrants [Member] | Common Stock [Member] Warrants to Purchase Common Stock [Member] | Common Stock [Member] Exchange Warrants [Member] | Common Stock [Member] Conversion of Facility Notes into Series B-2 Preferred Stock [Member] | Common Stock [Member] Conversion of Series B-2 Preferred Stock into Common Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] Underwritten Public Offering [Member] | Additional Paid-in Capital [Member] January 2021 Inducement Warrants [Member] | Additional Paid-in Capital [Member] Warrants to Purchase Common Stock [Member] | Additional Paid-in Capital [Member] Exchange Warrants [Member] | Additional Paid-in Capital [Member] Conversion of Facility Notes into Series B-2 Preferred Stock [Member] | Additional Paid-in Capital [Member] Conversion of Series B-2 Preferred Stock into Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] Underwritten Public Offering [Member] | Retained Earnings [Member] January 2021 Inducement Warrants [Member] | Retained Earnings [Member] Warrants to Purchase Common Stock [Member] | Retained Earnings [Member] Exchange Warrants [Member] | Retained Earnings [Member] Conversion of Facility Notes into Series B-2 Preferred Stock [Member] | Retained Earnings [Member] Conversion of Series B-2 Preferred Stock into Common Stock [Member] | Retained Earnings [Member] | Treasury Stock [Member] | Underwritten Public Offering [Member] | January 2021 Inducement Warrants [Member] | Warrants to Purchase Common Stock [Member] | Exchange Warrants [Member] | Conversion of Facility Notes into Series B-2 Preferred Stock [Member] | Conversion of Series B-2 Preferred Stock into Common Stock [Member] | Total |
Balance at Dec. 31, 2020 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 192,062 | $ (258,474) | $ (66,412) | ||||||||||||||||||||||||||||||||||||||||||||||||||
Net Income (loss) | 0 | 0 | 0 | 0 | 0 | 0 | (10,296) | (10,296) | ||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 0 | 0 | 0 | 0 | 0 | 675 | 0 | 675 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 0 | 0 | 0 | 0 | 82 | 0 | 82 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | 0 | 0 | 0 | 0 | 0 | 0 | (10,296) | (10,296) | ||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in connection with Public Offering, net of discounts and commissions | $ 0 | $ 0 | $ 0 | $ 0 | $ 1 | $ 49,284 | $ 0 | $ 49,285 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in connection with the exercise of warrants in the Inducement Transaction, net of discounts and commissions | $ 0 | $ 0 | $ 0 | $ 0 | $ 1 | $ 40,390 | $ 0 | $ 40,391 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in connection with the exercise of common stock warrants | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 25,593 | $ 0 | $ 25,593 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Fair value of warrants issued | 0 | $ 0 | 0 | $ 0 | 0 | $ 0 | 0 | $ 0 | 0 | $ 0 | 38,437 | $ 15,990 | 0 | $ 0 | 38,437 | $ 15,990 | ||||||||||||||||||||||||||||||||||||||||||
Issuance of stock as a result of conversion | $ 0 | $ 0 | $ 0 | $ 0 | $ 29,056 | $ (29,056) | $ 0 | $ 0 | $ 0 | $ 1 | $ 0 | $ 29,055 | $ 0 | $ 0 | $ 0 | $ 29,056 | ||||||||||||||||||||||||||||||||||||||||||
Deemed dividend related the Inducement Transaction | 0 | 0 | 0 | 0 | 0 | (37,444) | 0 | (37,444) | ||||||||||||||||||||||||||||||||||||||||||||||||||
Offering expenses charged to equity | 0 | 0 | 0 | 0 | 0 | (1,106) | 0 | (1,106) | ||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2021 | 0 | 0 | 0 | 0 | 3 | 353,018 | (268,770) | 84,251 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2020 | 0 | 0 | 0 | 0 | 0 | 192,062 | (258,474) | (66,412) | ||||||||||||||||||||||||||||||||||||||||||||||||||
Net Income (loss) | (4,093) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (4,093) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2021 | 0 | 0 | 0 | 0 | 3 | 393,227 | (262,567) | 130,663 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2021 | 0 | 0 | 0 | 0 | 3 | 353,018 | (268,770) | 84,251 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Net Income (loss) | 0 | 0 | 0 | 0 | 0 | 0 | 6,203 | 6,203 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 0 | 0 | 0 | 0 | 0 | 318 | 0 | 318 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 0 | 0 | 0 | 0 | 72 | 0 | 72 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | 0 | 0 | 0 | 0 | 0 | 0 | 6,203 | 6,203 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in connection with Public Offering, net of discounts and commissions | 0 | 0 | 0 | 0 | 0 | 35,455 | 0 | 35,455 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in connection with the exercise of common stock warrants | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 4,191 | $ 0 | $ 4,191 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Fair value of warrants issued | 0 | 0 | 0 | 0 | 0 | 17,089 | 0 | 17,089 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Deemed dividend related the Inducement Transaction | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ (16,898) | $ 0 | $ (16,898) | ||||||||||||||||||||||||||||||||||||||||||||||||||
Offering expenses charged to equity | 0 | 0 | 0 | 0 | 0 | (18) | 0 | (18) | ||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2021 | $ 0 | $ 0 | $ 0 | $ 0 | 3 | 393,227 | (262,567) | 130,663 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2021 | $ 0 | 4 | 396,957 | (267,029) | $ (2,814) | 127,118 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Income (loss) | 0 | 0 | 0 | (1,864) | 0 | (1,864) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 0 | 0 | 918 | 0 | 0 | 918 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares repurchased as part of the Share Repurchase Program | 0 | (1) | 0 | 0 | (4,722) | (4,723) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 0 | 50 | 0 | 0 | 50 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | 0 | 0 | 0 | (1,864) | 0 | (1,864) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2022 | 0 | 3 | 397,925 | (268,893) | (7,536) | 121,499 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2021 | 0 | 4 | 396,957 | (267,029) | (2,814) | 127,118 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Income (loss) | (25,906) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (25,906) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2022 | 0 | 3 | 399,701 | (292,935) | (7,536) | 99,233 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2022 | 0 | 3 | 397,925 | (268,893) | (7,536) | 121,499 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Income (loss) | 0 | 0 | 0 | (24,042) | 0 | (24,042) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 0 | 0 | 1,510 | 0 | 0 | 1,510 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in exchange for consulting services | 0 | 0 | 50 | 0 | 0 | 50 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | 0 | 0 | 0 | (24,042) | 0 | (24,042) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock as part of the Employee Stock Purchase Plan | 0 | 0 | 216 | 0 | 0 | 216 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2022 | $ 0 | $ 3 | $ 399,701 | $ (292,935) | $ (7,536) | $ 99,233 |
Unaudited Condensed Consolida_5
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (25,906) | $ (4,093) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Loss on extinguishment of debt | 0 | 16,096 |
Stock-based compensation expense | 2,428 | 993 |
Non-cash interest expense | 0 | 8 |
Amortization of debt issuance costs and debt discount | 0 | 150 |
Depreciation and amortization expense | 246 | 128 |
Fair value adjustment related to derivative and warrant liability | (273) | 424 |
Fair value adjustment related to investments | 495 | 0 |
Loss on sublease and disposal of property and equipment | 9 | 76 |
Consulting fees paid in common stock | 100 | 154 |
Acquired in-process research and development | 17,663 | 0 |
Change in assets and liabilities: | ||
Accounts and other receivables | (1,292) | 691 |
Prepaid expenses and other assets | (1,892) | (1,330) |
Inventories | 39 | 0 |
Operating lease right-of-use assets | (24) | 87 |
Accounts payable and accrued expenses | 630 | (1,702) |
Discount and rebate liabilities | 496 | 0 |
Operating lease liabilities | (37) | (159) |
Other liabilities | (339) | 2,494 |
Net cash (used in) provided by operating activities | (7,657) | 14,017 |
Cash flows from investing activities: | ||
Acquisitions, net | (14,090) | 0 |
Purchases of property and equipment | (31) | (81) |
Purchases of investments | (23,832) | 0 |
Maturities of investments | 1,025 | 0 |
Net cash used in investing activities | (36,928) | (81) |
Cash flows from financing activities: | ||
Proceeds from issuance of debt | 12,800 | 0 |
Proceeds from Public Offering, net of discounts and commissions | 0 | 49,285 |
Proceeds from Inducement Transaction, net of discounts and commissions | 0 | 35,646 |
Proceeds from insurance financing arrangements | 1,273 | 0 |
Proceeds from Employee Stock Purchase Plan | 216 | 0 |
Payments of principal on insurance financing arrangements | (469) | 0 |
Payment to repurchase shares as part of the Share Repurchase Program | (4,723) | 0 |
Payment of offering costs | (68) | (1,124) |
Repayment of principal on finance lease liabilities | (11) | (133) |
Payment of debt issuance costs | 0 | (2,881) |
Repayment of principal on convertible notes | 0 | (37,924) |
Net proceeds from exercise of common stock warrants | 0 | 29,784 |
Net cash provided by financing activities | 9,018 | 114,037 |
Net (decrease) increase in cash and cash equivalents | (35,567) | 127,973 |
Cash and cash equivalents, beginning of period | 112,346 | 4,322 |
Cash and cash equivalents, end of period | 76,779 | 132,295 |
Supplemental cash flow information: | ||
Cash paid for interest | 41 | 207 |
Amounts due for property and equipment included in accounts payable and accrued expenses | 0 | 22 |
Amounts due for deferred offering costs included in accounts payable and accrued expenses | 0 | 107 |
Fair value of warrants issued to underwriters in connection with Public Offering | 0 | 3,485 |
Conversion of Facility Notes into Series B-2 Preferred Stock [Member] | ||
Supplemental cash flow information: | ||
Facility Notes principal converted to Series B-2 Preferred Stock | 0 | 31,477 |
Warrants Issued in Connection with January 2021 Inducement Transaction [Member] | ||
Cash flows from financing activities: | ||
Proceeds from Inducement Transaction, net of discounts and commissions | $ 0 | $ 41,384 |
Note A - Description of Busines
Note A - Description of Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
Notes to Financial Statements | |
Business Description and Basis of Presentation [Text Block] | A. Description of Business and Basis of Presentation Organization KemPharm, Inc. (the "Company") is a specialty pharmaceutical company focused on the discovery and development of treatments for central nervous system ("CNS") and rare disease indications that allow the Company to target high-value areas with significant unmet needs. The Company's core competency is the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary Ligand Activated Therapy ("LAT ® may ® KP415, six KP1077, KP879. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial information and with the instructions to Form 10 8 03 X. not three six June 30, 2022, not may December 31, 2022. This interim information should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 10 December 31, 2021, March 31, 2022. Basis of Presentation The Company prepared the financial statements in accordance with United States generally accepted accounting principles (“GAAP”) and the rules and regulations of the United States Securities and Exchange Commission (the "SEC") and, in the Company's opinion, reflect all adjustments, including normal recurring items that are necessary. Arimoclomol Acquisition On May 15, 2022, May 31, 2022. The Company accounted for the arimoclomol acquisition as an asset acquisition as the majority of the value of the assets acquired related to the arimoclomol acquired in-process research and development (“IPR&D”) asset. The intangible asset associated with IPR&D relates to arimoclomol. The estimated fair value of $17.7 million was determined using the excess earnings valuation method, a variation of the income valuation approach. The excess earnings valuation method estimates the value of an intangible asset equal to the present value of the incremental after-tax cash flows attributable to that intangible asset over its remaining economic life. Some of the more significant assumptions utilized in our asset valuations included the estimated net cash flows for asset, including net revenues, cost of sales, research and development and other operating expenses, the potential regulatory and commercial success rates, competitive trends impacting the assets, and tax rates, and were based on our most recent strategic plan. The fair value using the excess earnings valuation method was determined using an estimated weighted average cost of capital of 42%, which reflects the risks inherent in future cash flow projections and represents a rate of return that a market participant would expect for this asset. This fair value measurement was based on significant inputs not 3 In accordance with Accounting Standards Codification, Subtopic 730 10 25, Accounting for Research and Development Costs not no three six June 30, 2022 The following represents the consideration paid and purchase price allocation for the acquisition of arimoclomol (in thousands): Cash $ 12,800 Assumed reserve liability 5,200 Total consideration $ 18,000 Total consideration $ 18,000 Direct transaction costs associated with the acquisition (1) 1,290 Total purchase price to be allocated $ 19,290 Property and equipment, inventory and assembled workforce acquired $ 1,627 IPR&D (2) 17,663 Total allocated purchase price $ 19,290 (1) As a result of the asset acquisition accounting, the transaction costs associated with the acquisition should be included in the costs of the assets acquired and allocated amongst qualifying assets using the relative fair value basis. The transaction costs primarily included financial advisor fees, legal expenses and auditor expenses. (2) The primary asset acquired, the IPR&D asset, was expensed and the allocated transaction related costs were included with and expensed with this asset. Underwriting Agreement On January 8, 2021, 1 No. 333 250945 On January 8, 2021, February 1, 2021, On January 12, 2021, On January 25, 2022, 1 No. 333 250945 3 February 1, 2022. Listing on the Nasdaq Stock Market On January 7, 2021, January 8, 2021, On October 19, 2021, October 19, 2021, January 2021. Entry into 2021 ATM Agreement On July 2, 2021, "2021 may 2021 3. may 415 1933, may 2021 3 2021 July 12, 2021. June 30, 2022, 2021 Share Repurchase Program On December 20, 2021, may December 31, 2023. KP415 may 10b 18 1934, not may not June 30, 2022, |
Note B - Summary of Significant
Note B - Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | B. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, the fair value of long-term investments and the fair value of the derivative and warrant liability, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities. Revenue Recognition The Company commenced recognizing revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers 606” January 1, 2018. Arrangements with Multiple-Performance Obligations From time to time, the Company enters into arrangements for research and development, manufacturing and/or commercialization services. Such arrangements may In arrangements involving more than one not The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods or services is transferred. Consideration associated with at-risk substantive performance milestones is recognized as revenue when it is probable that a significant reversal of the cumulative revenue recognized will not Licensing Agreements The Company enters into licensing agreements with licensees that fall under the scope of ASC 606. The terms of the Company’s licensing agreements typically include one may As part of the accounting for these agreements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. Generally, the estimation of the stand-alone selling price may Up-front Fees: Milestone Payments: not not not may KP415 In September 2019, “KP415 KP415 KP484, KP879, KP922 KP484, KP415 KP484; KP415 KP415 In April 2021, No. 1 KP415 "KP415 KP415 KP415 KP415 KP415 March 2, 2021. May 7, 2021. KP415 KP415 KP415 Pursuant to the KP415 first KP922, no Commave also agreed to be responsible for and reimburse the Company for all of the development, commercialization and regulatory expenses incurred on the licensed products, subject to certain limitations as set forth in the KP415 In accordance with the terms of the Company’s March 20, 2012 KP484, KP879 KP1077 KP415 The KP415 606, not KP415 606, third two $10.0 KP415 The consideration allocated to the grant of the exclusive, worldwide license was $10.0 KP415 KP415 Under the KP415 first 1 may may KP415 KP415 not third 606 not not The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to AZSTARYS and KP484 KP415 KP415 not not not Per the KP415 March 2021, May 2021. two 2021, first second 2021, 340 40, Contracts with Customers first second 2021. For the three six June 30, 2022, KP415 three six June 30, 2021, KP415 June 30, 2022, December 31, 2021. Consulting Arrangements The Company enters into consulting arrangements with third 606. may third Corium Consulting Agreement In July 2020, KP415 Under the Corium Consulting Agreement, the Company was entitled to receive payments from Corium of up to $15.6 million, $13.6 million of which was earned in monthly installments through March 31, 2022 first 2022. The Corium Consulting Agreement is within the scope of ASC 606, not 606, third third not not not The Company determined that the performance of consulting services, including reimbursement of third third 606 March 31, 2022, third For the three June 30, 2021, three June 30, 2022. six June 30, 2022, 2021, June 30, 2022, December 31, 2021, Other Consulting Arrangements For the three June 30, 2022, 2021, six June 30, 2022, 2021, June 30, 2022, December 31, 2021. Arimoclomol Early Access Program The Company recognizes revenue when fulfilling its performance obligation under the Arimoclomol Early Access Program ("Arimoclomol EAP") by transferring control of promised goods or services to its customer, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. Revenue is recognized net of sales deductions, including discounts, rebates, applicable distributor fees, and revenue-based taxes. The Company recognizes revenue in accordance with ASC 606 five 1 2 3 4 5 Net revenue comprises revenue from the sale of arimoclomol for the treatment of Niemann-Pick Disease Type C ("NPC") under the remunerated early access compassionate use program (“nATU”) in France. An early access compassionate use program is a program giving specific patients access to a drug, which is not Only drugs targeting serious or rare indications and for which there is currently no Revenue is recognized when the drug products are sold to the customer, i.e., at the time when control over the drug product is transferred to the third All sales and distributions of arimoclomol are included in the service agreement with Clinigen Health Limited, who keep goods on a consignment stock until it is transferred to the third An estimate of net revenue and clawback liability are recognized using the ‘expected value’ method. Accounting for net revenue and clawback liability requires determination of the most appropriate method for the expected final transaction price, which depends on the terms and conditions in the contracts with the French Health Authorities, and is subject to price negotiations with the French Health Authorities, following a market approval. This estimate also requires assumptions with respect to inputs into the method, including current pricing of comparable marketed products within the rare disease area in France. Management has considered the expected final sales price as well as the price of similar drug products. Management has based their initial sales prices on comparable drug products for arimoclomol, and the estimate of the clawback liability on the basis of the average cost of treatment which the authorities are expected to cover. In the estimate for clawback liability, management applied relevant available market data. Management’s assumptions are based on available relevant market information regarding average treatment cost of the most comparable drugs possible in the rare disease area in Europe. The Company is operating within a rare disease therapeutic area where there is unmet treatment need and hence a limited number of comparable commercialized drugs products. The limited available relevant market information for directly comparable commercialized drugs within rare disease increases the uncertainty in management's estimate. The Company records revenues from product sales when there is a transfer of control of the product from the Company to the customer. The Company typically determines transfer of control based on when the product is shipped or delivered and title passes to the customer. In determining when the customer obtains control of the product, the Company considers certain indicators, including whether the Company has a present right to payment from the customer, whether title and/or significant risks and rewards of ownership have transferred to the customer and whether customer acceptance has been received. For the three six June 30, 2022, As part of the Arimoclomol Purchase Agreement the Company assumed an estimated reserve liability of $5.2 million related to revenue generated from the Arimoclomol EAP in France. The total estimate reserve liability as of June 30, 2022, three June 30, 2022, June 30, 2022, Accounts and Other Receivables Accounts and other receivables consist of receivables under the KP415 KP415 third June 30, 2022, KP415 December 31, 2021, KP415 June 30, 2022, December 31, 2021, no Application of New or Revised Accounting Standards—Adopted From time to time, the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies issue accounting standards that are adopted by the Company as of the specified effective date. In August 2020, 2020 06, Debt Debt with Conversion and Other Options (Subtopic 470 20 and Derivatives and Hedging Contracts in Entity s Own Equity (Subtopic 815 40 Accounting for Convertible Instruments and Contracts in an Entity s Own Equity 2020 06” December 15, 2021, 2020 06 not In May 2021, 2021 04, Earnings Per Share (Topic 260 470 50 718 815 40 2021 04” December 15, 2021, 2021 04 not |
Note C - Debt Obligations
Note C - Debt Obligations | 6 Months Ended |
Jun. 30, 2022 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | C. Debt Obligations As of June 30, 2022 December 31, 2021, Deerfield Facility Agreement In June 2014, first December 2020, The Deerfield Convertible Note originally bore interest at 9.75% per annum but was subsequently reduced to 6.75%. Interest accrued on the outstanding balance under the Deerfield Convertible Note was due quarterly in arrears. The Company originally had to repay one third fourth fifth June 2018 June 2019). June 2018, September 2019, June 1, 2020 “2021 September 2019”). December 2019, March 31, 2021, “2021 December 2019”). March 31, 2021. not Pursuant to the Deerfield Facility Agreement, the Company issued to Deerfield a warrant to purchase 14,423,076 shares of Series D Preferred at an initial exercise price of $0.78 per share, which is exercisable until June 2, 2024 December 2020, January 2021 June 2021 January 2021 June 2021 260, may The Company recorded the fair value of the shares of Series D Preferred to debt issuance costs on the date of issuance. The Company also recorded the fair value of the Deerfield Warrant and the embedded Warrant Put Option to debt discount on the date of issuance. The debt issuance costs and debt discount were amortized over the term of the related debt and the expense was recorded as interest expense related to amortization of debt issuance costs and discount in the statements of operations. In the first 2021, 2 Pursuant to the Deerfield Facility Agreement, the Company was not Issuance of 5.50% Senior Convertible Notes and Third Amendment to Senior Secured Convertible Note and Warrant In February 2016, 2021 “2021 2021 144A 1933, The 2021 February 9, 2016 2021 February 1 August 1 August 1, 2016, 5.50% 2021 February 1, 2021 The net proceeds from the Note Offering were approximately $82.8 million, after deducting the Initial Purchasers’ discount and estimated offering expenses. Concurrent with the Note Offering, the Company used approximately $18.6 million of the net proceeds from the Note Offering to repay in full the Term Note, plus all accrued but unpaid interest, a make-whole interest payment and a prepayment premium on the Term Note. The 2021 not 2021 2021 2021 December 2020, 2021 2021 If the Company underwent a “fundamental change” (as defined in the Indenture), holders could have required that the Company repurchase for cash all or any portion of their 2021 2021 The Indenture included customary terms and covenants, including certain events of default after which the 2021 may As described in more detail below, in multiple exchanges occurring in December 2019 January 2020, 2021 2021 December 2019 In December 2019, December 2019 “December 2019 “December 2019 December 2019 “December 2019 2021 December 2019 December 2019 December 18, 2019, 2021 December 2019 December 2019 The December 2019 December 2019 2021 December 2019 December 2020, December 2019 December 2019 December 2019 December 2019 415 December 2019 $93.60 not x 2020 September 2019 December 2019 not December 2019 December 2019 December 2019 December 2019 4.985% December 2019 December 2019 December 2019 March 31, 2021, not December 2019 December 2019 December 2019 December 2019 December 2019 December 2019 The December 2019 December 2019 December 2019 December 2019 February 14, 2020 June 1, 2020, March 31, 2021, March 31, 2021 may The December 2019 December 2019 December 2019 $93.60 December 2019 The December 2019 December 2019 The December 2019 December 2019 may one In connection with entering into the December 2019 December 18, 2019, June 2, 2014, In connection with entering into the December 2019 “September 2019 September 2019 September 2019 December 2019 September 2019 September 2019 x 15 no September 2019 2 September 2019 may September 2019 September 2019 September December 2020, 15 In connection with entering into the September 2019 2 2 2 2 September 2019 $9.60 15 As of September 30, 2020, December 2019 The Company determined the changes to the Deerfield Convertible Note met the definition of a troubled debt restructuring under ASC 470 60, no The changes to the 2021 December 2019 December 2019 December 2019 2021 January 2020 In January 2020, January 2020 “January 2020 January 2020 “January 2020 2021 January 2020 January 13, 2020, 2021 January 2020 The January 2020 December 2019 In connection with entering into the January 2020 December 2019 “December 2019 December 2019 December 2019 December 2019 December 2019 x 2020 December 2020, The changes to the 2021 January 2020 January 2020 January 2020 December 2020 Rights Agreement In December 2020, December 2020 “December 2020 December 2020 December 2019 January 2020 January 1, 2021, December 2020 2 Q4 December 2020 “December 2020 The December 2020 not March 31, 2023. Subject to the satisfaction or waiver of certain conditions specified in the December 2020 December 2020 June 2, 2014, March 31, 2023, ( July 1, 2021, The December 2020 February 19, 2015 ( December 2020 The Exchange Warrants issued pursuant to the December 2020 75% 2 1 No. 333 250945 4.985% In anticipation of the Public Offering, and to meet the Nasdaq Listing Requirements, the Company agreed in December 2020 December 2019 January 2020 December 31, 2020. Under the terms of the December 2020 January 12, 2021, ● Exchanged $31.5 million of the outstanding principal and accrued interest on the Facility Notes for (i) 31,476.98412 shares of Series B- 2 ● Made a payment of $30.3 million (the "Debt Payment"), in partial repayment of the remaining outstanding principal and accrued interest of the Facility Notes. Following the completion of these transactions, the aggregate balance of principal and accrued interest remaining outstanding under the Facility Notes was approximately $7.6 million. With respect to this remaining outstanding balance under the Facility Notes, the December 2020 ● The maturity date was changed to March 31, 2023, ● Interest would accrue at the rate of 6.75% per annum, payable quarterly, would be added to principal until June 30, 2021, The changes to the Facility Notes, under the December 2020 December 2020 December 2020 not three March 31, 2021, The transactions contemplated under the December 2020 2 2 As a condition to closing of the December 2020 2 2 2 Each share of Series B- 2 $1,000 The Series B- 2 2 2 4.985% 2 not 2 $1,000 2 2 2 2 2 2 not 2 not not 2 2 2 2 Payoff of Facility Agreement Notes and Termination of Facility Agreement On February 8, 2021, Pursuant to the payoff letter, the Company paid a total of $8.0 million to the Facility Agreement Note Holders, representing the principal balance, accrued interest outstanding and a prepayment fee in repayment of the Company’s outstanding obligations under the Facility Agreement. Pursuant to the payoff letter, all outstanding indebtedness and obligations of the Company owing to the Facility Agreement Note Holders under the Facility Agreement have been paid in full. The Facility Agreement and the notes thereunder, as well as the security interests in the assets of the Company securing the Facility Agreement and note obligations, have been terminated. The Facility Agreement Note Holders will retain the warrants previously issued to them by the Company. The Company determined the payoff letter met the liability derecognition threshold under ASC 405 20, Liabilities - Extinguishment of Liabilities no three March 31, 2021. PPP Loan On April 23, 2020, may May 2021, Line of Credit On May 31, 2022, 0.00%. The revolving facility under the Line of Credit is secured by a perfected security interest in deposit accounts. The revolving facility under the Line of Credit is subject to customary affirmative and negative covenants. The latest maturity date of the loans under the Line of Credit is May 31, 2025. June 30, 2022, June 30, 2022. |
Note D - Commitments and Contin
Note D - Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | D. Commitments and Contingencies From time to time, the Company is involved in various legal proceedings arising in the normal course of business. For some matters, a liability is not not June 30, 2022 December 31, 2021 |
Note E - Preferred Stock and Wa
Note E - Preferred Stock and Warrants | 6 Months Ended |
Jun. 30, 2022 | |
Notes to Financial Statements | |
Preferred Stock [Text Block] | E. Preferred Stock and Warrants Authorized, Issued, and Outstanding Preferred Stock As of June 30, 2022, December 31, 2021, In June 2021, 1 1 2 2 June 30, 2022, December 31, 2021, Series B- 2 Pursuant to the December 2020 January 12, 2021, 2 The Series B- 2 No 2 2 Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of the Series B- 2 Convertible Preferred Stock On January 11, 2021, December 2020 2 2 2 Immediately following, the closing of the Public Offering, pursuant to the terms of the December 2020 ● Exchanged approximately $31.5 million (the "Exchange") of the outstanding principal and accrued interest on the Facility Notes for (i) the Series B- 2 ● made a payment of approximately $30.3 million (the “Debt Payment”) in partial repayment of the remaining outstanding principal and accrued interest on the Facility Notes. Upon the closing of the Exchange and related Debt Payment, the amendments to the Facility Agreement, the Notes and the Investors’ Rights Agreement, dated as of February 19, 2015, December 2020 2 2 January 12, 2021. In March 2021, 2 |
Note F - Common Stock and Warra
Note F - Common Stock and Warrants | 6 Months Ended |
Jun. 30, 2022 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | F. Common Stock and Warrants Authorized, Issued, and Outstanding Common Shares As of June 30, 2022 December 31, 2021 June 30, 2022, December 31, 2021, June 30, 2022 December 31, 2021 As of June 30, 2022 December 31, 2021 June 30, 2022 December 31, 2021 Outstanding awards under equity incentive plans 2,529,569 1,273,879 Outstanding common stock warrants 4,252,600 4,252,600 Possible future issuances under equity incentive plans 4,354,470 4,209,935 Possible future issuances under employee stock purchase plans 1,445,213 1,500,000 Total common shares reserved for future issuance 12,581,852 11,236,414 Common Stock Activity The following table summarizes common stock activity for the six June 30, 2022 : Shares of Common Stock Balance as of January 1, 2022 35,005,640 Common stock issued as compensation to third-parties 7,649 Common stock repurchased as a result of the Stock Repurchase Plan (589,792 ) Balance as of March 31, 2022 34,423,497 Common stock issued as compensation to third-parties 11,030 Common stock issued as a result of the Employee Stock Purchase Plan 54,787 Balance as of June 30, 2022 34,489,314 Warrants On June 2, 2014, June 2, 2024, December 2020, January 2021 $93.60 June 2021 $46.25 February 2021 The Company determined that the Deerfield Warrant should be recorded as a liability and stated at fair value at each reporting period upon inception. As stated above, upon completion of the IPO, the Deerfield Warrant automatically converted into warrants to purchase the Company’s common stock. The Deerfield Warrant remains classified as a liability and is recorded at fair value at each reporting period since it can be settled in cash. Changes to the fair value of the warrant liability are recorded through the unaudited condensed statements of operations as a fair value adjustment (Note H). In connection with the APADAZ License Agreement, in October 2018, not four October 24, 2023. may December 2020, The Company determined that, since KVK qualifies as a customer under ASC 606, 815 815 606 June 30, 2022, December 31, 2021, Pre-Funded Warrants On January 12, 2021, January 2021, Warrants to Purchase Common Stock On January 12, 2021, December 2020 December 2020 fifth may may not 13 not 50% 50% not June 30, 2022, January 2021 Underwriter Warrant On January 12, 2021, February 3, 2021, June 30, 2022, January 2021 Warrant Exercise Inducement Letters and Issuance of Warrants On January 26, 2021, “January 2021 “January 2021 January 2021 January 2021 January 2021 January 2021 January 2021 The January 2021 fifth January 2021 January 2021 may may not January 2021 13 January 2021 January 2021 January 2021 not January 2021 January 2021 January 2021 January 2021 50% 50% January 2021 January 2021 January 2021 January 2021 January 2021 January 2021 not January 2021 January 2021 January 2021 June 30, 2022, January 2021 January 2021 June 2021 In accordance with the January 2021 January 2021 January 2021 June 2021 Warrant Exercise Inducement Letters and Issuance of Warrants On June 18, 2021, “June 2021 January 2021 "January 2021 “June 2021 January 2021 “June 2021 January 2021 January 2021 June 2021 June 2021 June 2021 January 2021 June 2021 June 2021 January 2021 June 2021 June 2021 $46.25 The June 2021 December 31, 2026, June 2021 June 2021 may may not June 2021 13 June 2021 June 2021 June 2021 not June 2021 June 2021 June 2021 June 2021 50% 50% June 2021 June 2021 June 2021 June 2021 June 2021 June 2021 not June 2021 June 2021 June 2021 June 30, 2022, June 2021 In accordance with the June 2021 June 2021 June 2021 |
Note G - Stock-based Compensati
Note G - Stock-based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | G. Stock-Based Compensation The Company maintains a stock-based compensation plan (the “Incentive Stock Plan”) that governs stock awards made to employees and directors prior to completion of the IPO. In November 2014, April 2015, 2014 “2014 April 2015. 2014 June 2021, 2014 2014 April 2021, January 1, 2031 2014 162 may 2014 June 30, 2022. 2014 January 1 January 1, 2016, January 1, 2031, December 31 2014 January 1, 2022, 2014 During the three six June 30, 2022, 2021, In June 2021, April 2021. may first October 1, 2021, first May 31, 2022. June 30, 2022, Stock-based compensation expense recorded under the 2014 2014 Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Research and development $ 422 $ 133 $ 733 $ 429 General and administrative 1,088 185 1,695 564 Total stock-based compensation expense $ 1,510 $ 318 $ 2,428 $ 993 There was $0.4 million of stock-based compensation expense related to performance-based awards recognized during the three six June 30, 2022, six June 30, 2021. three June 30, 2021. |
Note H - Fair Value of Financia
Note H - Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2022 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | H. Fair Value of Financial Instruments The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three three ● Level 1—Observable ● Level 2—Observable ● Level 3—Unobservable no The carrying amounts of certain financial instruments, including cash and cash equivalents, investments and accounts payable and accrued expenses, approximate their respective fair values due to the short-term nature of such instruments. Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made. The following table summarizes the conclusions reached regarding fair value measurements as of June 30, 2022, December 31, 2021 ( Balance as of June 30, 2022 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Deerfield Warrant liability $ 52 $ — $ — $ 52 Embedded Warrant Put Option 4 — — 4 KVK Warrant liability 1 — 1 — Total liabilities $ 57 $ — $ 1 $ 56 — Securities: U.S. government-sponsored agency securities $ 7,266 $ — $ 7,266 $ — Corporate notes and commercial paper 304 — 304 — Certificates of deposit 20,473 20,473 — — U.S. Treasury securities 9,691 9,691 — — Total assets $ 37,734 $ 30,164 $ 7,570 $ — Balance as of December 31, 2021 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Deerfield Warrant liability $ 288 $ — $ — $ 288 Embedded Warrant Put Option 18 — — 18 KVK Warrant liability 24 — 24 — Total liabilities $ 330 $ — $ 24 $ 306 Securities: U.S. government-sponsored agency securities $ 4,997 $ — $ 4,997 $ — Certificates of deposit 490 490 — — U.S. Treasury securities 9,935 9,935 — — Total assets $ 15,422 $ 10,425 $ 4,997 $ — The Company’s Deerfield Warrant liability, embedded Warrant Put Option and securities are measured at fair value on a recurring basis. As of June 30, 2022, December 31, 2021, June 30, 2022, December 31, 2021, three six June 30, 2022, 2021, The derivative liability for the Deerfield Warrant was $52,000 and $288,000 at June 30, 2022, December 31, 2021, June 30, 2022, December 31, 2021, 10% second 2023. The Company’s KVK Warrant liability is measured at fair value on a recurring basis. As of June 30, 2022, December 31, 2021, no not not three six June 30, 2022, 2021, A reconciliation of the beginning and ending balances for the derivative and warrant liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3 Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Balance as of beginning of period $ 84 $ 292 $ 306 $ 255 Adjustment to fair value (28 ) 374 (250 ) 411 Balance as of end of period $ 56 $ 666 $ 56 $ 666 |
Note I - Net Loss Per Share
Note I - Net Loss Per Share | 6 Months Ended |
Jun. 30, 2022 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | I. Net Loss Per Share During the three June 30, 2022, six June 30, 2022 2021, not two not two Under the two No no two two two As noted above, for the three June 30, 2022, six June 30, 2022 2021, not two no The following securities, presented on a common stock equivalent basis, have been excluded from the calculation of weighted average number of shares of common stock outstanding because their effect is anti-dilutive: Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Awards under equity incentive plans 2,529,569 414,869 2,529,569 414,869 Common stock warrants 4,252,600 4,584,889 4,252,600 4,584,889 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 6,782,169 4,999,758 6,782,169 4,999,758 A reconciliation from net loss to basic and diluted net loss attributable to common stockholders per share of common stock for the three six June 30, 2022, 2021, Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Basic and diluted net loss per share of common stock: Net (loss) income $ (24,042 ) $ 6,203 $ (25,906 ) $ (4,093 ) Less: Dividends declared or accumulated — (16,898 ) — (54,342 ) Net (loss) income attributable to shares of common stockholders, basic and diluted $ (24,042 ) $ (10,695 ) $ (25,906 ) $ (58,435 ) Less: Net income attributable to participating securities — (838 ) — — Undistributed net loss attributable to common stockholders, basic and diluted $ (24,042 ) $ (11,533 ) $ (25,906 ) $ (58,435 ) Weighted average number of shares of common stock outstanding, basic and diluted 34,447 29,175 34,477 24,187 Basic and diluted net loss attributable to common stockholders per share of common stock $ (0.70 ) $ (0.40 ) $ (0.75 ) $ (2.42 ) |
Note J - Leases
Note J - Leases | 6 Months Ended |
Jun. 30, 2022 | |
Notes to Financial Statements | |
Lease Disclosure [Text Block] | J. Leases The Company has operating and finance leases for office space, laboratory facilities and various laboratory equipment, furniture and office equipment and leasehold improvements. The Company's leases have remaining lease terms of less than 1 year to approximately 4 years, some of which include options to extend the leases for up to 5 years, and some which include options to terminate the leases within 1 year. Effective June 1, 2021, one two February 2026. The components of lease expense were as follows (in thousands): Three months ended June 30, Six months ended June 30, Lease Cost 2022 2021 2022 2021 Finance lease cost: Amortization of right-of-use assets $ 32 $ 32 $ 64 $ 64 Interest on lease liabilities 0 3 1 7 Total finance lease cost 32 35 65 71 Operating lease cost 99 92 190 183 Short-term lease cost 52 49 102 99 Variable lease cost 13 8 26 21 Less: sublease income (39 ) (13 ) (78 ) (13 ) Total lease costs $ 157 $ 171 $ 305 $ 361 Supplemental cash flow information related to leases was as follows (in thousands): Six months ended June 30, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 1 $ 7 Financing cash flows from finance leases 11 133 Operating cash flows from operating leases 241 228 Operating cash flows from short-term leases 102 99 Operating cash flows from variable lease costs 26 21 Right-of-use assets obtained in exchange for lease liabilities: Finance leases $ — $ — Operating leases 146 — Supplemental balance sheet information related to leases was as follows (in thousands, except weighted average remaining lease term and weighted average discount rate): June 30, December 31, 2022 2021 Finance Leases Property and equipment, at cost $ 1,031 $ 1,031 less: accumulated depreciation and amortization (715 ) (651 ) Property and equipment, net $ 316 $ 380 Other current liabilities $ 7 $ 15 Other long-term liabilities 3 6 Total finance lease liabilities $ 10 $ 21 Operating Leases Operating lease right-of-use assets $ 1,165 $ 1,141 Total operating lease right-of-use assets $ 1,165 $ 1,141 Current portion of operating lease liabilities $ 469 $ 356 Operating lease liabilities, less current portion 1,082 1,232 Total operating lease liabilities $ 1,551 $ 1,588 Weighted Average Remaining Lease Term Finance leases (years) 2 1 Operating leases (years) 3 4 Weighted Average Discount Rate Finance leases 14.3 % 12.0 % Operating leases 7.2 % 7.5 % Maturities of lease liabilities were as follows (in thousands): Finance Operating Year Ending December 31, Leases Leases 2022 (excluding the six months ended June 30, 2022) $ 4 $ 279 2023 6 563 2024 — 488 2025 — 390 2026 — 30 Total lease payments 10 1,750 Less: future interest expense 0 (199 ) Lease liabilities $ 10 $ 1,551 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, the fair value of long-term investments and the fair value of the derivative and warrant liability, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities. |
Revenue from Contract with Customer [Policy Text Block] | Revenue Recognition The Company commenced recognizing revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers 606” January 1, 2018. Arrangements with Multiple-Performance Obligations From time to time, the Company enters into arrangements for research and development, manufacturing and/or commercialization services. Such arrangements may In arrangements involving more than one not The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods or services is transferred. Consideration associated with at-risk substantive performance milestones is recognized as revenue when it is probable that a significant reversal of the cumulative revenue recognized will not Licensing Agreements The Company enters into licensing agreements with licensees that fall under the scope of ASC 606. The terms of the Company’s licensing agreements typically include one may As part of the accounting for these agreements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. Generally, the estimation of the stand-alone selling price may Up-front Fees: Milestone Payments: not not not may KP415 In September 2019, “KP415 KP415 KP484, KP879, KP922 KP484, KP415 KP484; KP415 KP415 In April 2021, No. 1 KP415 "KP415 KP415 KP415 KP415 KP415 March 2, 2021. May 7, 2021. KP415 KP415 KP415 Pursuant to the KP415 first KP922, no Commave also agreed to be responsible for and reimburse the Company for all of the development, commercialization and regulatory expenses incurred on the licensed products, subject to certain limitations as set forth in the KP415 In accordance with the terms of the Company’s March 20, 2012 KP484, KP879 KP1077 KP415 The KP415 606, not KP415 606, third two $10.0 KP415 The consideration allocated to the grant of the exclusive, worldwide license was $10.0 KP415 KP415 Under the KP415 first 1 may may KP415 KP415 not third 606 not not The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to AZSTARYS and KP484 KP415 KP415 not not not Per the KP415 March 2021, May 2021. two 2021, first second 2021, 340 40, Contracts with Customers first second 2021. For the three six June 30, 2022, KP415 three six June 30, 2021, KP415 June 30, 2022, December 31, 2021. Consulting Arrangements The Company enters into consulting arrangements with third 606. may third Corium Consulting Agreement In July 2020, KP415 Under the Corium Consulting Agreement, the Company was entitled to receive payments from Corium of up to $15.6 million, $13.6 million of which was earned in monthly installments through March 31, 2022 first 2022. The Corium Consulting Agreement is within the scope of ASC 606, not 606, third third not not not The Company determined that the performance of consulting services, including reimbursement of third third 606 March 31, 2022, third For the three June 30, 2021, three June 30, 2022. six June 30, 2022, 2021, June 30, 2022, December 31, 2021, Other Consulting Arrangements For the three June 30, 2022, 2021, six June 30, 2022, 2021, June 30, 2022, December 31, 2021. Arimoclomol Early Access Program The Company recognizes revenue when fulfilling its performance obligation under the Arimoclomol Early Access Program ("Arimoclomol EAP") by transferring control of promised goods or services to its customer, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. Revenue is recognized net of sales deductions, including discounts, rebates, applicable distributor fees, and revenue-based taxes. The Company recognizes revenue in accordance with ASC 606 five 1 2 3 4 5 Net revenue comprises revenue from the sale of arimoclomol for the treatment of Niemann-Pick Disease Type C ("NPC") under the remunerated early access compassionate use program (“nATU”) in France. An early access compassionate use program is a program giving specific patients access to a drug, which is not Only drugs targeting serious or rare indications and for which there is currently no Revenue is recognized when the drug products are sold to the customer, i.e., at the time when control over the drug product is transferred to the third All sales and distributions of arimoclomol are included in the service agreement with Clinigen Health Limited, who keep goods on a consignment stock until it is transferred to the third An estimate of net revenue and clawback liability are recognized using the ‘expected value’ method. Accounting for net revenue and clawback liability requires determination of the most appropriate method for the expected final transaction price, which depends on the terms and conditions in the contracts with the French Health Authorities, and is subject to price negotiations with the French Health Authorities, following a market approval. This estimate also requires assumptions with respect to inputs into the method, including current pricing of comparable marketed products within the rare disease area in France. Management has considered the expected final sales price as well as the price of similar drug products. Management has based their initial sales prices on comparable drug products for arimoclomol, and the estimate of the clawback liability on the basis of the average cost of treatment which the authorities are expected to cover. In the estimate for clawback liability, management applied relevant available market data. Management’s assumptions are based on available relevant market information regarding average treatment cost of the most comparable drugs possible in the rare disease area in Europe. The Company is operating within a rare disease therapeutic area where there is unmet treatment need and hence a limited number of comparable commercialized drugs products. The limited available relevant market information for directly comparable commercialized drugs within rare disease increases the uncertainty in management's estimate. The Company records revenues from product sales when there is a transfer of control of the product from the Company to the customer. The Company typically determines transfer of control based on when the product is shipped or delivered and title passes to the customer. In determining when the customer obtains control of the product, the Company considers certain indicators, including whether the Company has a present right to payment from the customer, whether title and/or significant risks and rewards of ownership have transferred to the customer and whether customer acceptance has been received. For the three six June 30, 2022, As part of the Arimoclomol Purchase Agreement the Company assumed an estimated reserve liability of $5.2 million related to revenue generated from the Arimoclomol EAP in France. The total estimate reserve liability as of June 30, 2022, three June 30, 2022, June 30, 2022, |
Receivable [Policy Text Block] | Accounts and Other Receivables Accounts and other receivables consist of receivables under the KP415 KP415 third June 30, 2022, KP415 December 31, 2021, KP415 June 30, 2022, December 31, 2021, no |
New Accounting Pronouncements, Policy [Policy Text Block] | Application of New or Revised Accounting Standards—Adopted From time to time, the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies issue accounting standards that are adopted by the Company as of the specified effective date. In August 2020, 2020 06, Debt Debt with Conversion and Other Options (Subtopic 470 20 and Derivatives and Hedging Contracts in Entity s Own Equity (Subtopic 815 40 Accounting for Convertible Instruments and Contracts in an Entity s Own Equity 2020 06” December 15, 2021, 2020 06 not In May 2021, 2021 04, Earnings Per Share (Topic 260 470 50 718 815 40 2021 04” December 15, 2021, 2021 04 not |
Note A - Description of Busin_2
Note A - Description of Business and Basis of Presentation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Notes Tables | |
Asset Acquisition [Table Text Block] | Cash $ 12,800 Assumed reserve liability 5,200 Total consideration $ 18,000 Total consideration $ 18,000 Direct transaction costs associated with the acquisition (1) 1,290 Total purchase price to be allocated $ 19,290 Property and equipment, inventory and assembled workforce acquired $ 1,627 IPR&D (2) 17,663 Total allocated purchase price $ 19,290 (1) As a result of the asset acquisition accounting, the transaction costs associated with the acquisition should be included in the costs of the assets acquired and allocated amongst qualifying assets using the relative fair value basis. The transaction costs primarily included financial advisor fees, legal expenses and auditor expenses. (2) The primary asset acquired, the IPR&D asset, was expensed and the allocated transaction related costs were included with and expensed with this asset. |
Note F - Common Stock and War_2
Note F - Common Stock and Warrants (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Notes Tables | |
Schedule of Authorized Shares of Common Stock Reserved for Future Issuance [Table Text Block] | June 30, 2022 December 31, 2021 Outstanding awards under equity incentive plans 2,529,569 1,273,879 Outstanding common stock warrants 4,252,600 4,252,600 Possible future issuances under equity incentive plans 4,354,470 4,209,935 Possible future issuances under employee stock purchase plans 1,445,213 1,500,000 Total common shares reserved for future issuance 12,581,852 11,236,414 |
Schedule of Common Stock Outstanding Roll Forward [Table Text Block] | Shares of Common Stock Balance as of January 1, 2022 35,005,640 Common stock issued as compensation to third-parties 7,649 Common stock repurchased as a result of the Stock Repurchase Plan (589,792 ) Balance as of March 31, 2022 34,423,497 Common stock issued as compensation to third-parties 11,030 Common stock issued as a result of the Employee Stock Purchase Plan 54,787 Balance as of June 30, 2022 34,489,314 |
Note G - Stock-based Compensa_2
Note G - Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Research and development $ 422 $ 133 $ 733 $ 429 General and administrative 1,088 185 1,695 564 Total stock-based compensation expense $ 1,510 $ 318 $ 2,428 $ 993 |
Note H - Fair Value of Financ_2
Note H - Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Balance as of June 30, 2022 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Deerfield Warrant liability $ 52 $ — $ — $ 52 Embedded Warrant Put Option 4 — — 4 KVK Warrant liability 1 — 1 — Total liabilities $ 57 $ — $ 1 $ 56 — Securities: U.S. government-sponsored agency securities $ 7,266 $ — $ 7,266 $ — Corporate notes and commercial paper 304 — 304 — Certificates of deposit 20,473 20,473 — — U.S. Treasury securities 9,691 9,691 — — Total assets $ 37,734 $ 30,164 $ 7,570 $ — Balance as of December 31, 2021 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Deerfield Warrant liability $ 288 $ — $ — $ 288 Embedded Warrant Put Option 18 — — 18 KVK Warrant liability 24 — 24 — Total liabilities $ 330 $ — $ 24 $ 306 Securities: U.S. government-sponsored agency securities $ 4,997 $ — $ 4,997 $ — Certificates of deposit 490 490 — — U.S. Treasury securities 9,935 9,935 — — Total assets $ 15,422 $ 10,425 $ 4,997 $ — |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Balance as of beginning of period $ 84 $ 292 $ 306 $ 255 Adjustment to fair value (28 ) 374 (250 ) 411 Balance as of end of period $ 56 $ 666 $ 56 $ 666 |
Note I - Net Loss Per Share (Ta
Note I - Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Awards under equity incentive plans 2,529,569 414,869 2,529,569 414,869 Common stock warrants 4,252,600 4,584,889 4,252,600 4,584,889 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 6,782,169 4,999,758 6,782,169 4,999,758 |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Basic and diluted net loss per share of common stock: Net (loss) income $ (24,042 ) $ 6,203 $ (25,906 ) $ (4,093 ) Less: Dividends declared or accumulated — (16,898 ) — (54,342 ) Net (loss) income attributable to shares of common stockholders, basic and diluted $ (24,042 ) $ (10,695 ) $ (25,906 ) $ (58,435 ) Less: Net income attributable to participating securities — (838 ) — — Undistributed net loss attributable to common stockholders, basic and diluted $ (24,042 ) $ (11,533 ) $ (25,906 ) $ (58,435 ) Weighted average number of shares of common stock outstanding, basic and diluted 34,447 29,175 34,477 24,187 Basic and diluted net loss attributable to common stockholders per share of common stock $ (0.70 ) $ (0.40 ) $ (0.75 ) $ (2.42 ) |
Note J - Leases (Tables)
Note J - Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Three months ended June 30, Six months ended June 30, Lease Cost 2022 2021 2022 2021 Finance lease cost: Amortization of right-of-use assets $ 32 $ 32 $ 64 $ 64 Interest on lease liabilities 0 3 1 7 Total finance lease cost 32 35 65 71 Operating lease cost 99 92 190 183 Short-term lease cost 52 49 102 99 Variable lease cost 13 8 26 21 Less: sublease income (39 ) (13 ) (78 ) (13 ) Total lease costs $ 157 $ 171 $ 305 $ 361 |
Schedule of Leases Cash Flow Information [Table Text Block] | Six months ended June 30, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 1 $ 7 Financing cash flows from finance leases 11 133 Operating cash flows from operating leases 241 228 Operating cash flows from short-term leases 102 99 Operating cash flows from variable lease costs 26 21 Right-of-use assets obtained in exchange for lease liabilities: Finance leases $ — $ — Operating leases 146 — |
Schedule of Leases Balance Sheet Information [Table Text Block] | June 30, December 31, 2022 2021 Finance Leases Property and equipment, at cost $ 1,031 $ 1,031 less: accumulated depreciation and amortization (715 ) (651 ) Property and equipment, net $ 316 $ 380 Other current liabilities $ 7 $ 15 Other long-term liabilities 3 6 Total finance lease liabilities $ 10 $ 21 Operating Leases Operating lease right-of-use assets $ 1,165 $ 1,141 Total operating lease right-of-use assets $ 1,165 $ 1,141 Current portion of operating lease liabilities $ 469 $ 356 Operating lease liabilities, less current portion 1,082 1,232 Total operating lease liabilities $ 1,551 $ 1,588 Weighted Average Remaining Lease Term Finance leases (years) 2 1 Operating leases (years) 3 4 Weighted Average Discount Rate Finance leases 14.3 % 12.0 % Operating leases 7.2 % 7.5 % |
Operating and Finance Lease, Liability, Maturity [Table Text Block] | Finance Operating Year Ending December 31, Leases Leases 2022 (excluding the six months ended June 30, 2022) $ 4 $ 279 2023 6 563 2024 — 488 2025 — 390 2026 — 30 Total lease payments 10 1,750 Less: future interest expense 0 (199 ) Lease liabilities $ 10 $ 1,551 |
Note A - Description of Busin_3
Note A - Description of Business and Basis of Presentation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||||||
May 15, 2022 | Jul. 12, 2021 | Feb. 01, 2021 | Jan. 12, 2021 | Jan. 08, 2021 | Jun. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | Dec. 20, 2021 | Jul. 02, 2021 | Feb. 03, 2021 | ||
Sale of Stock, Authorized Amount | $ 350,000 | |||||||||||
Stock Repurchase Program, Authorized Amount | $ 50,000 | |||||||||||
Treasury Stock, Value, Total | $ 7,536 | $ 7,536 | $ 2,814 | |||||||||
Share Repurchase Program [Member] | ||||||||||||
Treasury Stock, Shares, Total (in shares) | 909,953 | 909,953 | ||||||||||
Treasury Stock, Value, Total | $ 7,500 | $ 7,500 | ||||||||||
Roth Capital Partners, LLC [Member] | Pre-funded Warrants [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 926,844 | 926,844 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.0001 | |||||||||||
Roth Capital Partners, LLC [Member] | Public Offering Warrants [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 12,078,361 | 7,692,307 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 6.50 | $ 6.50 | ||||||||||
Class of Warrant or Right, Offering Price, Per Related Warrant (in dollars per share) | $ 0.0001 | |||||||||||
Roth Capital Partners, LLC [Member] | Underwriter Warrants [Member] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 806,932 | 754,035 | 18,702 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 8.125 | |||||||||||
Over Allotment Options, Number of Shares for Warrants (in shares) | 1,153,846 | |||||||||||
Underwriting Agreement [Member] | Roth Capital Partners, LLC [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 6,765,463 | |||||||||||
Shares and Warrants Issued, Price Per Share (in dollars per share) | $ 6.50 | |||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 6.4999 | |||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 52,400 | |||||||||||
Over-Allotment Option [Member] | Roth Capital Partners, LLC [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 374,035 | |||||||||||
Purchase Agreement Optional Period to Shares (Day) | 45 days | |||||||||||
Purchase Agreement, Maximum, Additional Shares Available for Purchase During the Optional Period (in shares) | 1,153,846 | |||||||||||
ATM Agreement Sales [Member] | JMP and RBCCM [Member] | ||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 0 | |||||||||||
Equity Distribution Agreement, Maximum Aggregate Offering Price | $ 75,000 | |||||||||||
Equity Distribution Agreement, Commission Fee, Percentage of Gross Sales | 3% | |||||||||||
Stock Issued During Period, Value, New Issues | $ 75,000 | |||||||||||
Arimoclomol Purchase Agreement [Member] | ||||||||||||
Payments to Acquire Productive Assets, Total | $ 12,800 | |||||||||||
Asset Acquisition, Consideration Transferred, Estimated Reserve Liability | $ 5,200 | 5,700 | ||||||||||
Estimated Weighted Average Cost of Capital | 42% | |||||||||||
Effective Income Tax Rate Reconciliation, Tax Credit, Research, Amount | $ 700 | |||||||||||
Arimoclomol Purchase Agreement [Member] | In Process Research and Development [Member] | ||||||||||||
Asset Acquisition, Recognized Identifiable Assets, Finite-Lived Intangibles | [1] | $ 17,663 | ||||||||||
[1]The primary asset acquired, the IPR&D asset, was expensed and the allocated transaction related costs were included with and expensed with this asset. |
Note A - Description of Busin_4
Note A - Description of Business and Basis of Presentation - Consideration Paid and Purchase Price Allocation for the Acquisition of Arimoclomol (Details) - Arimoclomol Purchase Agreement [Member] - USD ($) $ in Thousands | 3 Months Ended | ||
May 15, 2022 | Jun. 30, 2022 | ||
Cash | $ 12,800 | ||
Assumed reserve liability | 5,200 | $ 5,700 | |
Total consideration | 18,000 | ||
Total consideration | 18,000 | ||
Direct transaction costs associated with the acquisition (1) | [1] | 1,290 | |
Total purchase price to be allocated | 19,290 | ||
Property and equipment, inventory and assembled workforce acquired | 1,627 | ||
Total allocated purchase price | 19,290 | ||
In Process Research and Development [Member] | |||
IPR&D (2) | [2] | $ 17,663 | |
[1]As a result of the asset acquisition accounting, the transaction costs associated with the acquisition should be included in the costs of the assets acquired and allocated amongst qualifying assets using the relative fair value basis. The transaction costs primarily included financial advisor fees, legal expenses and auditor expenses.[2]The primary asset acquired, the IPR&D asset, was expensed and the allocated transaction related costs were included with and expensed with this asset. |
Note B - Summary of Significa_2
Note B - Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||||||||
May 15, 2022 | May 07, 2021 | Apr. 08, 2021 | Mar. 02, 2021 | Sep. 03, 2019 | Mar. 20, 2012 | Jun. 30, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Mar. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jul. 31, 2020 | |
Revenue from Contract with Customer, Including Assessed Tax | $ 1,300 | $ 11,986 | $ 5,265 | $ 24,103 | |||||||||||
Income Taxes Receivable | 700 | 700 | $ 100 | ||||||||||||
Accounts Receivable, Allowance for Credit Loss, Ending Balance | 0 | 0 | 0 | ||||||||||||
Arimoclomol Purchase Agreement [Member] | |||||||||||||||
Contract with Customer, Liability, Revenue Recognized | 900 | 900 | |||||||||||||
Contract with Customer, Clawback Liability | 500 | 500 | |||||||||||||
Asset Acquisition, Consideration Transferred, Estimated Reserve Liability | $ 5,200 | 5,700 | |||||||||||||
Accounts Receivable, after Allowance for Credit Loss, Current, Total | 1,400 | 1,400 | |||||||||||||
Consulting Services [Member] | |||||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | 300 | 300 | 300 | 800 | |||||||||||
Deferred Revenue, Total | 100 | 100 | 0 | $ 0 | |||||||||||
Accounts Receivable, after Allowance for Credit Loss, Current, Total | 300 | 300 | 100 | ||||||||||||
Other Receivables | 300 | 300 | |||||||||||||
GPC Member | License [Member] | |||||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 10,000 | $ 10,000 | $ 10,000 | $ 10,000 | |||||||||||
Revenue Recognition, Milestone Method, Revenue to be Recognized | $ 10,000 | 63,000 | |||||||||||||
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized | $ 590,000 | $ 420,000 | |||||||||||||
Contract with Customer, Liability, Revenue Recognized | $ 10,000 | ||||||||||||||
Deferred Revenue, Total | $ 0 | 0 | |||||||||||||
Accounts Receivable, after Allowance for Credit Loss, Current, Total | 100 | 100 | 100 | ||||||||||||
Aquestive Therapeutics [Member] | License [Member] | |||||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | 100 | 10,000 | 200 | 20,000 | |||||||||||
Royalty Revenue, Percent | 10% | ||||||||||||||
Royalty Expense | $ 1,000 | ||||||||||||||
Corium, Inc [Member] | |||||||||||||||
Accounts Receivable, after Allowance for Credit Loss, Current, Total | 1,200 | ||||||||||||||
Corium, Inc [Member] | Consulting Services [Member] | |||||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 0 | $ 1,600 | $ 3,900 | $ 3,200 | |||||||||||
Deferred Revenue, Total | $ 0 | $ 400 | |||||||||||||
Consulting Agreement, Maximum Amount to be Received | $ 15,600 | ||||||||||||||
Contract with Customer, Asset, after Allowance for Credit Loss, Total | 13,600 | ||||||||||||||
Consulting Agreement, Conditional Milestone Achievement to be Received | $ 2,000 |
Note C - Debt Obligations (Deta
Note C - Debt Obligations (Details Textual) - USD ($) | 1 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||||||||
May 31, 2022 | Feb. 08, 2021 | Jan. 12, 2021 | Jan. 01, 2021 | Apr. 23, 2020 | Jan. 13, 2020 | Dec. 18, 2019 | Feb. 09, 2016 | Jun. 02, 2014 | Jun. 30, 2018 | Jun. 30, 2022 | Jun. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2021 | Jun. 18, 2021 | Mar. 31, 2021 | Jan. 26, 2021 | Dec. 31, 2019 | Sep. 30, 2019 | Sep. 02, 2019 | Jun. 30, 2016 | |
Convertible Notes Payable, Total | $ 0 | $ 0 | ||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 20,000,000 | 20,000,000 | ||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | 1,777,437 | |||||||||||||||||||||
Interest Paid, Excluding Capitalized Interest, Operating Activities | 41,000 | $ 207,000 | ||||||||||||||||||||
Debt Instrument, Convertible, Minimum Conversion Price (in dollars per share) | $ 9.328 | |||||||||||||||||||||
Line of Credit Facility, Maximum Amount Outstanding During Period | 12,800,000 | |||||||||||||||||||||
Certificates of Deposit, at Carrying Value | 12,800,000 | |||||||||||||||||||||
Line of Credit Facility, Remaining Borrowing Capacity | $ 7,200,000 | |||||||||||||||||||||
Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | ||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 1.60% | |||||||||||||||||||||
Conversion from Deerfield Convertible Note to Common Stock [Member] | ||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ 3,300,000 | |||||||||||||||||||||
Debt Conversion, Accrued Interest | $ 200,000 | |||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | 37,410 | |||||||||||||||||||||
Conversion of December 2019 Notes into Common Stock [Member] | ||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ 17,100,000 | |||||||||||||||||||||
December 2020 Exchange Agreement [Member] | ||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ 31,500,000 | |||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | 31,476.98412 | |||||||||||||||||||||
Debt Conversion, Converted Instrument, Warrants or Options Issued (in shares) | 3,632,019 | |||||||||||||||||||||
Deerfield Convertible Notes [Member] | ||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | 93.60 | |||||||||||||||||||||
2021 Notes [Member] | ||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 17.11 | $ 273.76 | ||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ 1,000 | $ 1,000 | ||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | 58.4454 | 3.6528 | ||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.50% | |||||||||||||||||||||
Debt Instrument, Face Amount | $ 86,300,000 | |||||||||||||||||||||
Proceeds from Debt, Net of Issuance Costs | 82,800,000 | |||||||||||||||||||||
Repayments of Long-term Debt, Total | 18,600,000 | |||||||||||||||||||||
Debt Instrument, Sinking Fund Payment | $ 0 | |||||||||||||||||||||
Debt Instrument Repurchase Price Equal to Percentage of Principal Amount | 100% | |||||||||||||||||||||
Debt Instrument, Cancellation of Debt, Amount | $ 3,000,000 | $ 71,400,000 | ||||||||||||||||||||
Interest Paid, Excluding Capitalized Interest, Operating Activities | $ 37,000 | $ 700,000 | ||||||||||||||||||||
Debt Instrument, Percentage of Accrued Interest Paid | 50% | |||||||||||||||||||||
The 2019 Notes [Member] | ||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 5.85 | $ 17.11 | $ 93.60 | 273.76 | ||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 6.75% | |||||||||||||||||||||
Debt Instrument, Face Amount | $ 71,400,000 | |||||||||||||||||||||
Debt Instrument, Percentage of Accrued Interest Paid | 50% | |||||||||||||||||||||
Debt Instrument, Convertible, Minimum Conversion Price (in dollars per share) | $ 0.583 | $ 0.38 | ||||||||||||||||||||
Debt Instrument, Convertible, Conversion Restriction Percentage of Common Stock | 4.985% | |||||||||||||||||||||
Beneficial Ownership, Cap Limit, Percentage | 19.985% | |||||||||||||||||||||
Debt Instrument, Convertible, Floor Price (in dollars per share) | $ 9.328 | |||||||||||||||||||||
January 2020 Note [Member] | ||||||||||||||||||||||
Debt Instrument, Face Amount | $ 3,000,000 | |||||||||||||||||||||
The December 2020 Exchange Agreement [Member] | ||||||||||||||||||||||
Repayments of Debt | $ 30,300,000 | |||||||||||||||||||||
The December 2019 and January 2020 Notes [Member] | ||||||||||||||||||||||
Long-term Debt, Gross | $ 60,800,000 | |||||||||||||||||||||
Deerfield Facility Agreement [Member] | ||||||||||||||||||||||
Long-term Debt, Gross | 7,500,000 | |||||||||||||||||||||
The Facility Notes [Member] | ||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 6.75% | |||||||||||||||||||||
Repayments of Long-term Debt, Total | $ 30,300,000 | |||||||||||||||||||||
Long-term Debt, Total | $ 7,600,000 | $ 69,400,000 | ||||||||||||||||||||
Paycheck Protection Program CARES Act [Member] | ||||||||||||||||||||||
Proceeds from Issuance of Long-term Debt, Total | $ 800,000 | |||||||||||||||||||||
Deerfield Facility Agreement [Member] | ||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 60,000,000 | |||||||||||||||||||||
Line of Credit Facility, Interest Rate at Period End | 9.75% | 6.75% | ||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 6.75% | 9.75% | ||||||||||||||||||||
Convertible Notes Payable, Current | $ 7,000,000 | |||||||||||||||||||||
Debt Covenant, Debt Financing Restriction | $ 750,000 | |||||||||||||||||||||
Repayments of Long-term Debt, Total | $ 8,000,000 | |||||||||||||||||||||
Debt Instrument, Convertible, Minimum Conversion Price (in dollars per share) | $ 0.60 | |||||||||||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | 28,439,015 | |||||||||||||||||||||
Debt Instrument, Convertible, Optional Conversion Feature, Exchange Price (in dollars per share) | $ 9.60 | |||||||||||||||||||||
Debt Instrument, Convertible Optional Conversion Feature Shares Issuable Upon Exchange (in shares) | 1,777,437 | |||||||||||||||||||||
Deerfield Facility Agreement [Member] | Deerfield Warrant [Member] | ||||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.78 | |||||||||||||||||||||
Deerfield Facility Agreement [Member] | Deerfield Warrant [Member] | IPO [Member] | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,923,077 | |||||||||||||||||||||
Deerfield Facility Agreement [Member] | Series D Redeemable Convertible Preferred Stock [Member] | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 14,423,076 | |||||||||||||||||||||
Deerfield Facility Agreement [Member] | Term Notes [Member] | ||||||||||||||||||||||
Proceeds from Secured Notes Payable | $ 15,000,000 | |||||||||||||||||||||
Deerfield Facility Agreement [Member] | Deerfield Convertible Notes [Member] | ||||||||||||||||||||||
Proceeds from Secured Notes Payable | $ 10,000,000 | |||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 5.85 | $ 93.60 | ||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 120,192 | |||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 5.85 | $ 93.60 | $ 38.34 | $ 46.25 |
Note D - Commitments and Cont_2
Note D - Commitments and Contingencies (Details Textual) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Loss Contingency Accrual, Ending Balance | $ 0 | $ 0 |
Note E - Preferred Stock and _2
Note E - Preferred Stock and Warrants (Details Textual) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 9 Months Ended | ||||
Jan. 12, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2022 | Dec. 31, 2021 | |
Preferred Stock, Shares Authorized (in shares) | 10,000,000 | 10,000,000 | ||||
Preferred Stock, Shares Issued, Total (in shares) | 0 | 0 | ||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | 0 | 0 | ||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | 1,777,437 | |||||
Conversion of Series B-2 Preferred Stock into Common Stock [Member] | ||||||
Conversion of Stock, Shares Issued (in shares) | 4,842,699 | |||||
The Facility Notes [Member] | ||||||
Repayments of Long-term Debt, Total | $ 30.3 | |||||
December 2020 Exchange Agreement [Member] | ||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | 31,476.98412 | |||||
Debt Conversion, Converted Instrument, Warrants or Options Issued (in shares) | 3,632,019 | |||||
Debt Conversion, Original Debt, Amount | $ 31.5 | |||||
Series A Preferred Stock [Member] | ||||||
Preferred Stock, Shares Authorized (in shares) | 9,578 | |||||
Series B-1 Convertible Preferred Stock [Member] | ||||||
Preferred Stock, Shares Issued, Total (in shares) | 1,576 | |||||
Series B-2 Convertible Preferred Stock [Member] | ||||||
Preferred Stock, Shares Authorized, Elimated (in shares) | 31,480 | |||||
Preferred Stock, Convertible, Shares Issuable (in shares) | 4,842,690 | |||||
Preferred Stock, Convertible, Conversion Price (in dollars per share) | $ 6.4999 |
Note F - Common Stock and War_3
Note F - Common Stock and Warrants (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||||||
Jan. 26, 2021 | Jan. 12, 2021 | Oct. 25, 2018 | Jun. 02, 2014 | Jan. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 18, 2021 | Mar. 31, 2022 | Dec. 31, 2021 | Feb. 03, 2021 | Jan. 08, 2021 | Dec. 31, 2020 | |
Common Stock, Shares Authorized (in shares) | 250,000,000 | 250,000,000 | 250,000,000 | ||||||||||||
Common Stock, Shares, Issued (in shares) | 35,399,267 | 35,399,267 | 35,325,801 | ||||||||||||
Common Stock, Shares, Outstanding, Ending Balance (in shares) | 34,489,314 | 34,489,314 | 34,423,497 | 35,005,640 | |||||||||||
Proceeds from Warrant Exercises | $ 0 | $ 29,784 | |||||||||||||
Preferred Stock Dividends and Other Adjustments, Total | $ 0 | $ 16,898 | $ 0 | $ 54,342 | |||||||||||
Other Noncurrent Assets [Member] | |||||||||||||||
Contract with Customer, Asset, after Allowance for Credit Loss, Total | $ 400 | ||||||||||||||
Deerfield Warrant [Member] | |||||||||||||||
Class of Warrant or Right Issued (in shares) | 14,423,076 | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 46.25 | $ 38.34 | $ 93.60 | ||||||||||||
Deerfield Warrant [Member] | Common Stock [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,923,077 | 120,192 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 46.25 | $ 5.85 | $ 38.34 | $ 93.60 | |||||||||||
Warrant Issued to KVK [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 500,000 | 31,250 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.30 | $ 36.80 | |||||||||||||
Class of Warrant or Right, Additional Shares Exercisable for Each Milestones (in shares) | 125,000 | ||||||||||||||
Pre-funded Warrants [Member] | Roth Capital Partners, LLC [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 926,844 | 926,844 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.0001 | ||||||||||||||
Stock Issued During Period, Shares, Warrant Exercises (in shares) | 926,841 | ||||||||||||||
Proceeds from Warrant Exercises | $ 72,000 | ||||||||||||||
Public Offering Warrants [Member] | Roth Capital Partners, LLC [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 12,078,361 | 7,692,307 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 6.50 | $ 6.50 | |||||||||||||
Stock Issued During Period, Shares, Warrant Exercises (in shares) | 3,030,881 | ||||||||||||||
Proceeds from Warrant Exercises | $ 16,900 | ||||||||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | ||||||||||||||
Maximum Percent of Common Stock Ownership Allowed Per Holder Upon Warrant Exercise | 4.99% | ||||||||||||||
Class of Warrants or Right, Exercised During Period (in shares) | 3,461,858 | ||||||||||||||
Underwriter Warrants [Member] | Roth Capital Partners, LLC [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 806,932 | 18,702 | 754,035 | ||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 8.125 | ||||||||||||||
Stock Issued During Period, Shares, Warrant Exercises (in shares) | 400,000 | ||||||||||||||
Proceeds from Warrant Exercises | $ 3,300 | ||||||||||||||
Class of Warrants or Right, Exercised During Period (in shares) | 400,000 | ||||||||||||||
Over Allotment Options, Percentage of Common Stock Outstanding for Warrants | 5% | ||||||||||||||
Existing Warrants [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 6,620,358 | ||||||||||||||
Proceeds from Warrant Exercises | $ 44,000 | ||||||||||||||
Placement Agent Fee, Percentage | 6% | ||||||||||||||
January 2021 Inducement Warrants [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 7,944,430 | 6,117,509 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 6.36 | ||||||||||||||
Stock Issued During Period, Shares, Warrant Exercises (in shares) | 1,676,921 | ||||||||||||||
Proceeds from Warrant Exercises | $ 10,700 | $ 39,100 | |||||||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | ||||||||||||||
Maximum Percent of Common Stock Ownership Allowed Per Holder Upon Warrant Exercise | 4.99% | ||||||||||||||
Class of Warrants or Right, Exercised During Period (in shares) | 1,676,921 | ||||||||||||||
Warrants Issued Upon Exchange, Percentage of Shares Issued Upon Exercise | 120% | ||||||||||||||
Class of Warrant, Purchase Price Per Warrant (in dollars per share) | $ 0.125 | ||||||||||||||
Placement Agent Fee, Percentage | 6% | ||||||||||||||
Maximum Percent of Common Stock Ownership Allowed Per Holder After Warrant Exercise Upon Holders Selection | 9.99% | ||||||||||||||
Preferred Stock Dividends and Other Adjustments, Total | $ 37,400 | ||||||||||||||
June 2021 Inducement Warrants [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,529,379 | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 16.50 | ||||||||||||||
Maximum Percent of Common Stock Ownership Allowed Per Holder Upon Warrant Exercise | 4.99% | ||||||||||||||
Class of Warrants or Right, Exercised During Period (in shares) | 0 | ||||||||||||||
Warrants Issued Upon Exchange, Percentage of Shares Issued Upon Exercise | 25% | ||||||||||||||
Class of Warrant, Purchase Price Per Warrant (in dollars per share) | $ 0.125 | ||||||||||||||
Maximum Percent of Common Stock Ownership Allowed Per Holder After Warrant Exercise Upon Holders Selection | 9.99% | ||||||||||||||
Preferred Stock Dividends and Other Adjustments, Total | $ 16,900 |
Note F - Common Stock and War_4
Note F - Common Stock and Warrants - Reserved Authorized Shares of Common Stock for Future Issuance (Details) - shares | Jun. 30, 2022 | Dec. 31, 2021 |
Common shares reserved for future issuance (in shares) | 12,581,852 | 11,236,414 |
Warrant [Member] | ||
Common shares reserved for future issuance (in shares) | 4,252,600 | 4,252,600 |
Share-Based Payment Arrangement [Member] | ||
Common shares reserved for future issuance (in shares) | 2,529,569 | 1,273,879 |
Possible Future Issuances Under Equity Incentive Plans [Member] | ||
Common shares reserved for future issuance (in shares) | 4,354,470 | 4,209,935 |
Possible Future Issuances Under Employee Stock Purchase Plans [Member] | ||
Common shares reserved for future issuance (in shares) | 1,445,213 | 1,500,000 |
Note F - Common Stock and War_5
Note F - Common Stock and Warrants - Common Stock Activity (Details) - shares | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2022 | |
Balance (in shares) | 34,423,497 | 35,005,640 | 35,005,640 |
Common stock issued as compensation to third-parties (in shares) | 11,030 | 7,649 | |
Common stock repurchased as a result of the Stock Repurchase Plan (in shares) | (589,792) | ||
Common stock issued as compensation to third-parties (in shares) | 11,030 | 7,649 | |
Common stock issued as a result of the Employee Stock Purchase Plan (in shares) | 54,787 | 54,787 | |
Balance (in shares) | 34,489,314 | 34,423,497 | 34,489,314 |
Note G - Stock-based Compensa_3
Note G - Stock-based Compensation (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jan. 01, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Employee Stock Purchase Plan, Maximum Number of Issuable Shares (in shares) | 1,500,000 | 1,500,000 | |||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans (in shares) | 54,787 | 54,787 | |||||
Share-Based Payment Arrangement, Expense | $ 1,510 | $ 318 | $ 2,428 | $ 993 | |||
Performance Shares [Member] | |||||||
Share-Based Payment Arrangement, Expense | $ 400 | $ 0 | $ 400 | $ 400 | |||
2014 Equity Incentive Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 4,900,000 | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 6,889,885 | 6,889,885 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Reserved for Issuance, Incremental Percentage of Capital Stock Outstanding | 4% | ||||||
Increase in Common Stock Reserved for Issuance (in shares) | 1,400,225 | ||||||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total (in shares) | 0 |
Note G - Stock-based Compensa_4
Note G - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Stock based compensation expense | $ 1,510 | $ 318 | $ 2,428 | $ 993 |
Research and Development Expense [Member] | ||||
Stock based compensation expense | 422 | 133 | 733 | 429 |
General and Administrative Expense [Member] | ||||
Stock based compensation expense | $ 1,088 | $ 185 | $ 1,695 | $ 564 |
Note H - Fair Value of Financ_3
Note H - Fair Value of Financial Instruments (Details Textual) | 6 Months Ended | |
Jun. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Deerfield Warrant Liability [Member] | ||
Liabilities, Fair Value Disclosure, Total | $ 52,000 | $ 288,000 |
Liabilities, Fair Value Disclosure, Increase from Ten Percent Increase in Enterprise Value | 12,000 | |
Liabilities, Fair Value Disclosure, Estimated Amount of Weighted-average Probability of Liquidity Event | 30,000,000 | |
Liabilities, Fair Value Disclosure, Estimated Amount of Weighted-average Probability of Fundamental Change | $ 380,000,000 | |
Deerfield Warrant Liability [Member] | Weighted Average Probability of Liquidity Event [Member] | ||
Derivative Liability, Measurement Input | 0.25 | |
Deerfield Warrant Liability [Member] | Weighted Average Probability of Fundamental Change [Member] | ||
Derivative Liability, Measurement Input | 0.28 | |
Embedded Put Option [Member] | ||
Liabilities, Fair Value Disclosure, Total | $ 4,000 | $ 18,000 |
Liabilities, Fair Value Disclosure, Increase from Ten Percent Increase in Enterprise Value | $ 1,000 |
Note H - Fair Value of Financ_4
Note H - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value, Recurring [Member] | ||
Total assets | $ 37,734,000 | $ 15,422,000 |
Fair Value, Recurring [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 7,266,000 | 4,997,000 |
Fair Value, Recurring [Member] | Corporate Debt Securities [Member] | ||
Total assets | 304,000 | |
Fair Value, Recurring [Member] | Certificates of Deposit [Member] | ||
Total assets | 20,473,000 | 490,000 |
Fair Value, Recurring [Member] | US Treasury Securities [Member] | ||
Total assets | 9,691,000 | 9,935,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Total assets | 30,164,000 | 10,425,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Corporate Debt Securities [Member] | ||
Total assets | 0 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] | ||
Total assets | 20,473,000 | 490,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | ||
Total assets | 9,691,000 | 9,935,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Total assets | 7,570,000 | 4,997,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 7,266,000 | 4,997,000 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member] | ||
Total assets | 304,000 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Certificates of Deposit [Member] | ||
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] | ||
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | US Government Agencies Debt Securities [Member] | ||
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Corporate Debt Securities [Member] | ||
Total assets | 0 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Certificates of Deposit [Member] | ||
Total assets | 0 | 0 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] | ||
Total assets | 0 | 0 |
Deerfield Warrant Liability [Member] | ||
Financial liabilities measured at fair value on recurring basis | 52,000 | 288,000 |
Deerfield Warrant Liability [Member] | Fair Value, Recurring [Member] | ||
Financial liabilities measured at fair value on recurring basis | 52,000 | 288,000 |
Deerfield Warrant Liability [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 0 | 0 |
Deerfield Warrant Liability [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 0 | 0 |
Deerfield Warrant Liability [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 52,000 | 288,000 |
Embedded Put Option [Member] | ||
Financial liabilities measured at fair value on recurring basis | 4,000 | 18,000 |
Embedded Put Option [Member] | Fair Value, Recurring [Member] | ||
Financial liabilities measured at fair value on recurring basis | 4,000 | 18,000 |
Embedded Put Option [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 0 | 0 |
Embedded Put Option [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 0 | 0 |
Embedded Put Option [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 4,000 | 18,000 |
KVK Warrant Liability [Member] | Fair Value, Recurring [Member] | ||
Financial liabilities measured at fair value on recurring basis | 1,000 | 24,000 |
KVK Warrant Liability [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 0 | 0 |
KVK Warrant Liability [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 1,000 | 24,000 |
KVK Warrant Liability [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 0 | 0 |
Optional Exchange Principal Amount Conversion Feature [Member[ | Fair Value, Recurring [Member] | ||
Financial liabilities measured at fair value on recurring basis | 57,000 | 330,000 |
Optional Exchange Principal Amount Conversion Feature [Member[ | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 0 | 0 |
Optional Exchange Principal Amount Conversion Feature [Member[ | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Financial liabilities measured at fair value on recurring basis | 1,000 | 24,000 |
Optional Exchange Principal Amount Conversion Feature [Member[ | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Financial liabilities measured at fair value on recurring basis | $ 56,000 | $ 306,000 |
Note H - Fair Value of Financ_5
Note H - Fair Value of Financial Instruments - Reconciliation of Beginning and Ending Balances for Derivative and Warrant Liability Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Balance as of beginning of period | $ 84 | $ 292 | $ 306 | $ 255 |
Adjustment to fair value | (28) | 374 | (250) | 411 |
Balance as of end of period | $ 56 | $ 666 | $ 56 | $ 666 |
Note I - Net Income (Loss) Per
Note I - Net Income (Loss) Per Share - Anti-dilutive Securities (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive securities (in shares) | 6,782,169 | 4,999,758 | 6,782,169 | 4,999,758 |
Share-Based Payment Arrangement [Member] | ||||
Antidilutive securities (in shares) | 2,529,569 | 414,869 | 2,529,569 | 414,869 |
Warrants to Purchase Common Stock [Member] | ||||
Antidilutive securities (in shares) | 4,252,600 | 4,584,889 | 4,252,600 | 4,584,889 |
Note I - Net Income (Loss) Pe_2
Note I - Net Income (Loss) Per Share - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Net loss | $ (24,042) | $ (1,864) | $ 6,203 | $ (10,296) | $ (25,906) | $ (4,093) |
Less: Dividends declared or accumulated | 0 | (16,898) | 0 | (54,342) | ||
Net (loss) income attributable to shares of common stockholders, basic and diluted | (24,042) | (10,695) | (25,906) | (58,435) | ||
Less: Net income attributable to participating securities | 0 | (838) | 0 | 0 | ||
Undistributed net loss attributable to common stockholders, basic and diluted | $ (24,042) | $ (11,533) | $ (25,906) | $ (58,435) | ||
Basic and diluted (in shares) | 34,447,206 | 29,174,565 | 34,476,737 | 24,187,484 | ||
Basic and diluted net loss attributable to common stockholders per share of common stock (in dollars per share) | $ (0.70) | $ (0.40) | $ (0.75) | $ (2.42) |
Note J - Leases (Details Textua
Note J - Leases (Details Textual) | 3 Months Ended |
Mar. 31, 2022 | |
Lessee, Lease, Option to Extend, Maximum Term (Year) | 5 years |
Lessee, Lease, Option to Terminate, Term (Year) | 1 year |
Minimum [Member] | |
Lessee, Lease, Remaining Term of Contract (Year) | 1 year |
Maximum [Member] | |
Lessee, Lease, Remaining Term of Contract (Year) | 4 years |
Note J - Leases - Lease Cost (D
Note J - Leases - Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Amortization of right-of-use assets | $ 32 | $ 32 | $ 64 | $ 64 |
Interest on lease liabilities | 0 | 3 | 1 | 7 |
Total finance lease cost | 32 | 35 | 65 | 71 |
Operating lease cost | 99 | 92 | 190 | 183 |
Short-term lease cost | 52 | 49 | 102 | 99 |
Variable lease cost | 13 | 8 | 26 | 21 |
Less: sublease income | (39) | (13) | (78) | (13) |
Total lease costs | $ 157 | $ 171 | $ 305 | $ 361 |
Note J - Leases - Supplement Ca
Note J - Leases - Supplement Cash Flow Information Related to Leases (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating cash flows from finance leases | $ 1 | $ 7 |
Financing cash flows from finance leases | 11 | 133 |
Operating cash flows from operating leases | 241 | 228 |
Operating cash flows from short-term leases | 102 | 99 |
Operating cash flows from variable lease costs | 26 | 21 |
Finance leases | 0 | 0 |
Operating leases | $ 146 | $ 0 |
Note J - Leases - Supplement Ba
Note J - Leases - Supplement Balance Sheet Information Related to Lease (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Lease liabilities, finance leases | $ 10 | $ 21 |
Operating lease right-of-use assets | 1,165 | 1,141 |
Total operating lease right-of-use assets | 1,165 | 1,141 |
Current portion of operating lease liabilities | 469 | 356 |
Operating lease liabilities, less current portion | 1,082 | 1,232 |
Total operating lease liabilities | $ 1,551 | $ 1,588 |
Finance leases (years) (Year) | 2 years | 1 year |
Operating leases (years) (Year) | 3 years | 4 years |
Finance leases | 14.30% | 12% |
Operating leases | 7.20% | 7.50% |
Property and Equipment, At Cost [Member] | ||
Property and equipment, at cost | $ 1,031 | $ 1,031 |
Accumulated Depreciation and Amortization [Member] | ||
less: accumulated depreciation and amortization | (715) | (651) |
Property and Equipment, Net [Member] | ||
Property and equipment, net | 316 | 380 |
Other Current Liabilities [Member] | ||
Other current liabilities | 7 | 15 |
Other Noncurrent Liabilities [Member] | ||
Other long-term liabilities | 3 | 6 |
Operating Lease Right-of-Use Assets [Member] | ||
Operating lease right-of-use assets | 1,165 | 1,141 |
Total operating lease right-of-use assets | 1,165 | 1,141 |
Current Portion of Operating Lease Liabilities [Member] | ||
Current portion of operating lease liabilities | 469 | 356 |
Operating Lease Liabilities, Less Current Portion [Member] | ||
Operating lease liabilities, less current portion | $ 1,082 | $ 1,232 |
Note J - Leases - Maturities of
Note J - Leases - Maturities of lease Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
2022 (excluding the three months ended June 30, 2022), finance leases | $ 4 | |
2022 (excluding the three months ended March 31, 2021), operating leases | 279 | |
2023, finance leases | 6 | |
2023, operating leases | 563 | |
2024, finance leases | 0 | |
2024, operating leases | 488 | |
2025, finance leases | 0 | |
2025, operating leases | 390 | |
2026, finance leases | 0 | |
2026, operating leases | 30 | |
Total lease payments, finance leases | 10 | |
Total lease payments, operating leases | 1,750 | |
Less: future interest expense, finance leases | 0 | |
Less: future interest expense, operating leases | (199) | |
Lease liabilities, finance leases | 10 | $ 21 |
Lease liabilities, operating leases | $ 1,551 | $ 1,588 |