0001437749-22-026683 | 10-Q | XBRL Viewer

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Document And Entity Information - shares	9 Months Ended
Document And Entity Information - shares	Sep. 30, 2022	Nov. 08, 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	Q3
Document Fiscal Year Focus	2022
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2022
Document Transition Report	false
Entity File Number	001-36913
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		34,504,862

Unaudited Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Assets
Cash and cash equivalents	$ 70,059	$ 112,346
Short-term investments	5,832	0
Accounts and other receivables	6,583	1,528
Prepaid expenses and other current assets	2,659	1,182
Total current assets	85,133	115,056
Inventories	596	0
Property and equipment, net	852	884
Operating lease right-of-use assets	1,068	1,141
Long-term investments	31,463	15,422
Other long-term assets	439	438
Total assets	119,551	132,941
Liabilities and stockholders' equity
Accounts payable and accrued expenses	4,279	3,038
Current portion of operating lease liabilities	474	356
Current portion of discount and rebate liabilities	2,825	0
Other current liabilities	853	836
Total current liabilities	8,431	4,230
Line of credit payable	12,800	0
Derivative and warrant liability	35	330
Operating lease liabilities, less current portion	956	1,232
Discount and rebate liabilities, less current portion	3,509	0
Other long-term liabilities	26	31
Total liabilities	25,757	5,823
Commitments and contingencies (Note D)
Stockholders’ equity:
Common stock, $0.0001 par value, 250,000,000 shares authorized, 35,411,097 shares issued and 34,501,144 shares outstanding as of September 30, 2022; 35,325,801 shares issued and 35,005,640 shares outstanding as of December 31, 2021	3	4
Additional paid-in capital	400,677	396,957
Treasury stock, at cost	(7,536)	(2,814)
Accumulated deficit	(299,551)	(267,029)
Accumulated other comprehensive income	201	0
Total stockholders' equity	93,794	127,118
Total liabilities and stockholders' equity	119,551	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 September 30, 2022 or December 31, 2021	$ 0	$ 0

Unaudited Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares	Sep. 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)	35,411,097	35,325,801
Common stock, shares outstanding (in shares)	34,501,144	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 Consolidated Statements of Operations - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenue, net	$ 2,874	$ 1,965	$ 8,139	$ 26,068
Operating expenses:
Cost of revenue	141	0	200	2,000
Research and development	5,385	2,239	13,262	7,352
General and administrative	3,974	1,948	10,266	6,145
Acquired in-process research and development	0	0	17,663	0
Total operating expenses	9,500	4,187	41,391	15,497
(Loss) income from operations	(6,626)	(2,222)	(33,252)	10,571
Other (expense) income:
Loss on extinguishment of debt	0	0	0	(16,096)
Interest expense related to amortization of debt issuance costs and discount	0	0	0	(150)
Interest expense on principal	(124)	(6)	(165)	(221)
Fair value adjustment related to derivative and warrant liability	22	332	295	(92)
Interest and other (expense) income, net	79	137	(152)	136
Total other (expense) income	(23)	463	(22)	(16,423)
Loss before income taxes	(6,649)	(1,759)	(33,274)	(5,852)
Income tax benefit	33	0	752	0
Net income (loss)	(6,616)	(1,759)	(32,522)	(5,852)
Deemed dividend	0	0	0	(54,342)
Net loss attributable to common stockholders	$ (6,616)	$ (1,759)	$ (32,522)	$ (60,194)
Basic and diluted net loss per share of common stock:
Net loss attributable to common stockholders (in dollars per share)	$ (0.19)	$ (0.05)	$ (0.94)	$ (2.16)
Weighted average number of shares of common stock outstanding:
Basic and diluted (in shares)	34,494,702	35,217,953	34,482,791	27,904,711

Unaudited Condensed Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Net loss attributable to common stockholders	$ (6,616)	$ (1,759)	$ (32,522)	$ (60,194)
Other comprehensive income:
Foreign currency translation adjustment	201	0	201	0
Other comprehensive income	201	0	201	0
Comprehensive loss	$ (6,415)	$ (1,759)	$ (32,321)	$ (60,194)

- Definition

Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

+ References

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+ Details

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]	AOCI Attributable to Parent [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)																																																											(5,852)
Net loss																																																											(5,852)
Other comprehensive income																																																											0
Balance at Sep. 30, 2021							0							0							0								0							4							396,059							(264,326)									131,737
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
Net Income (loss)							0							0							0								0							0							0							(1,759)									(1,759)
Stock-based compensation expense							0							0							0								0							0							620							0									620
Issuance of common stock in exchange for consulting services							0							0							0								0							0							73							0									73
Net loss							0							0							0								0							0							0							(1,759)									(1,759)
Other comprehensive income																																																											0
Issuance of common stock in connection with Public Offering, net of discounts and commissions							0							0							0								0							1							1,104							0									1,105
Issuance of common stock in connection with the exercise of common stock warrants							0							0							0								0							0							1,035							0									1,035
Balance at Sep. 30, 2021							$ 0							$ 0							$ 0								$ 0							4							396,059							(264,326)									131,737
Balance at Dec. 31, 2021																						$ 0														4							396,957							(267,029)	$ (2,814)	$ 0							127,118
Net Income (loss)																						0														0							0							(1,864)	0	0							(1,864)
Stock-based compensation expense																						0														0							918							0	0	0							918
Shares repurchased as part of the Share Repurchase Program																						0														(1)							0							0	(4,722)	0							(4,723)
Issuance of common stock in exchange for consulting services																						0														0							50							0	0	0							50
Net loss																						0														0							0							(1,864)	0	0							(1,864)
Balance at Mar. 31, 2022																						0														3							397,925							(268,893)	(7,536)	0							121,499
Balance at Dec. 31, 2021																						0														4							396,957							(267,029)	(2,814)	0							127,118
Net Income (loss)																																																											(32,522)
Net loss																																																											(32,522)
Other comprehensive income																																																											201
Balance at Sep. 30, 2022																						0														3							400,677							(299,551)	(7,536)	201							93,794
Balance at Mar. 31, 2022																						0														3							397,925							(268,893)	(7,536)	0							121,499
Net Income (loss)																						0														0							0							(24,042)	0	0							(24,042)
Stock-based compensation expense																						0														0							1,510							0	0	0							1,510
Issuance of common stock in exchange for consulting services																						0														0							50							0	0	0							50
Net loss																						0														0							0							(24,042)	0	0							(24,042)
Issuance of common stock as part of the Employee Stock Purchase Plan																						0														0							216							0	0	0							216
Balance at Jun. 30, 2022																						0														3							399,701							(292,935)	(7,536)	0							99,233
Net Income (loss)																						0														0							0							(6,616)	0	0							(6,616)
Stock-based compensation expense																						0														0							911							0	0	0							911
Issuance of common stock in exchange for consulting services																						0														0							65							0	0	0							65
Net loss																						0														0							0							(6,616)	0	0							(6,616)
Other comprehensive income																						0														0							0							0	0	201							201
Balance at Sep. 30, 2022																						$ 0														$ 3							$ 400,677							$ (299,551)	$ (7,536)	$ 201							$ 93,794

Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash flows from operating activities:
Net loss	$ (32,522)	$ (5,852)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Loss on extinguishment of debt	0	16,096
Stock-based compensation expense	3,339	1,613
Non-cash interest expense	0	8
Amortization of debt issuance costs and debt discount	(0)	150
Depreciation and amortization expense	644	193
Fair value adjustment related to derivative and warrant liability	(295)	92
Fair value adjustment related to investments	634	0
Loss on sublease and disposal of property and equipment	9	76
Consulting fees paid in common stock	165	227
Acquired in-process research and development	17,663	0
Change in assets and liabilities:
Accounts and other receivables	(4,646)	960
Prepaid expenses and other assets	(1,196)	(1,366)
Inventories	280	0
Operating lease right-of-use assets	82	88
Accounts payable and accrued expenses	1,262	(1,891)
Discount and rebate liabilities	858	0
Operating lease liabilities	(160)	(241)
Other liabilities	(372)	1,134
Net cash (used in) provided by operating activities	(14,255)	11,287
Cash flows from investing activities:
Acquisitions, net	(14,090)	0
Purchases of property and equipment	(59)	(85)
Purchases of investments	(23,832)	0
Maturities of investments	1,325	0
Net cash used in investing activities	(36,656)	(85)
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	36,751
Proceeds from insurance financing arrangements	1,273	0
Proceeds from Employee Stock Purchase Plan	216	0
Payments of principal on insurance financing arrangements	(876)	0
Payment to repurchase shares as part of the Share Repurchase Program	(4,723)	0
Payment of offering costs	(68)	(1,299)
Repayment of principal on finance lease liabilities	(13)	(156)
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	30,819
Net cash provided by financing activities	8,609	115,979
Effect of exchange rate changes on cash and cash equivalents	15	0
Net (decrease) increase in cash and cash equivalents	(42,287)	127,181
Cash and cash equivalents, beginning of period	112,346	4,322
Cash and cash equivalents, end of period	70,059	131,503
Supplemental cash flow information:
Cash paid for interest	165	213
Amounts due for property and equipment included in accounts payable and accrued expenses	0	0
Amounts due for deferred offering costs included in accounts payable and accrued expenses	0	70
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 Business, Basis of Presentation and Significant Transactions

9 Months Ended

Sep. 30, 2022

Notes to Financial Statements

Business Description and Basis of Presentation [Text Block]

A.	Description of Business, Basis of Presentation and Significant Transactions

Organization

KemPharm, Inc. (the "Company") is a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare central nervous system ("CNS") and neurodegenerative diseases, lysosomal storage disorders and related treatment areas. The Company has a diverse product portfolio, combining a clinical-stage pipeline with new drug application ("NDA") stage and commercial assets. The Company's pipeline includes arimoclomol, an orally-delivered, first-in-class investigational product candidate for Niemann-Pick disease type C ("NPC"), and KP1077, which the Company is developing as a treatment for idiopathic hypersomnia ("IH"), a rare neurological sleep disorder, and narcolepsy. In addition, the U.S. Food and Drug Administration ("FDA") has approved AZSTARYS^®, formally referred to as KP415, a once-daily treatment for attention deficit hyperactivity disorder ("ADHD") in patients age six years and older containing the Company's prodrug, serdexmethylphenidate ("SDX"), which is being commercialized by Corium, Inc. ("Corium"), an affiliate of Gurnet Point Capital, L.P., in the U.S. The FDA has also approved APADAZ^®, an immediate-release combination product containing benzhydrocodone, the Company's prodrug of hydrocodone, and acetaminophen, which is being commercialized by KVK-Tech, Inc. in the U.S.

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-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the information and related notes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included in the accompanying financial statements. Operating results for the three and nine months ended September 30, 2022, are not necessarily indicative of the results that may be expected for the full year ending 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-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 31, 2022.

Basis of Presentation

The Company prepared the financial statements in accordance with U.S. 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, the Company and KemPharm Denmark A/S (“KemPharm DK”), a newly formed Danish company and wholly-owned subsidiary of KemPharm, Inc., entered into an asset purchase agreement (the “Arimoclomol Purchase Agreement”) with Orphazyme A/S in restructuring, a Danish public limited liability company (“Orphazyme”). The Arimoclomol Purchase Agreement closed on May 31, 2022. Under the terms of the Arimoclomol Purchase Agreement, KemPharm DK purchased all of the assets and operations of Orphazyme related to arimoclomol and settled all of Orphazyme’s actual outstanding liabilities to its creditors with a cash payment of $12.8 million. In addition, KemPharm DK agreed to assume an estimated reserve liability of $5.2 million related to revenue generated from Orphazyme’s Early Access Program in France.

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 i) net cash flows, including net revenues, cost of sales, research and development and other operating expenses, ii) the potential regulatory and commercial success rates, iii) market penetration and pricing assumptions, and iv) 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 observable in the market and thus represent Level 3 fair value measurement.

In accordance with Accounting Standards Codification, Subtopic 730-10-25, Accounting for Research and Development Costs, the up-front payments to acquire a new drug compound, as well as future milestone payments when paid or payable, are immediately expensed as acquired IPR&D in transactions other than a business combination provided that the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. Therefore, the portion of the purchase price that was allocated to the IPR&D assets acquired was immediately expensed. Other assets acquired and liabilities assumed, were recorded at fair value. The company also recorded a $0.7 million income tax benefit for the three and nine months ended September 30, 2022, related to research and development credits that are expected to be realized from the local jurisdiction in Denmark.

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 and legal 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, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Roth Capital Partners, LLC (the “Underwriter” or "Roth"), to issue and sell 6,765,463 shares of common stock of the Company, pre-funded warrants to purchase 926,844 shares of common stock and warrants to purchase 7,692,307 shares of common stock at an exercise price per share of $6.50 in an underwritten public offering (the “Public Offering”) pursuant to a registration statement on Form S-1 (File No. 333-250945) and a related prospectus, in each case filed with the Securities and Exchange Commission (the “SEC”). The offering price to the public was $6.50 per share of common stock and accompanying warrant, representing a public offering price of $6.4999 per share of common stock and $0.0001 per related warrant. In addition, the Company granted the Underwriter an option to purchase, for a period of 45 days, up to an additional 1,153,846 shares of the Company’s common stock and/or warrants to purchase up to an additional 1,153,846 shares of the Company’s common stock.

On January 8, 2021, the Underwriter exercised its over-allotment option, in part, for warrants to purchase 754,035 shares of the Company’s common stock. Further on February 1, 2021, the Underwriter again exercised its over-allotment option to purchase 374,035 shares of common stock.

On January 12, 2021, the Company closed the Public Offering. The aggregate gross proceeds to the Company from the Public Offering, including over-allotment, totaled approximately $52.4 million, before deducting underwriting discounts and commissions and offering expenses payable by the Company.

On January 25, 2022, the Company filed an amendment to the registration statement on Form S-1 (File No. 333-250945) on Form S-3 covering the issuance of the shares of our common stock issuable upon the exercise of the warrants issued in the Public Offering and remaining unexercised as of the date of the amendment, which was declared effective on February 1, 2022.

Listing on the Nasdaq Stock Market

On January 7, 2021, the Company’s common stock was approved for listing on the Nasdaq Capital Market. The Company’s common stock began trading on the Nasdaq Capital Market on January 8, 2021, under the ticker symbol “KMPH”.

On October 19, 2021, the Company announced that its shares of common stock were approved for listing to the Nasdaq Global Select Market. Trading on the Nasdaq Global Select Market commenced effective with the open of business on October 19, 2021, under the Company’s ticker symbol, “KMPH”. The Company was previously listed on the Nasdaq Capital Market, following its uplisting to the exchange in January 2021.

Entry into 2021 ATM Agreement

On July 2, 2021, the Company entered into an equity distribution agreement (the "2021 ATM Agreement") with JMP Securities LLC ("JMP") and RBC Capital Markets, LLC ("RBCCM") under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $75.0 million through JMP and RBCCM as its sales agents. The issuance and sale, if any, of common stock by the Company under the 2021 ATM Agreement will be made pursuant to a registration statement on Form S-3. JMP and RBCCM may sell the common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act of 1933, as amended. JMP and RBCCM will use commercially reasonable efforts to sell the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay JMP and RBCCM a commission equal to 3.0% in the aggregate of the gross sales proceeds of any common stock sold through JMP and RBCCM under the 2021 ATM Agreement. The Company filed a registration statement on Form S-3 covering the sale of the shares of its common stock up to $350.0 million, $75.0 million of which was allocated to the sales of the shares of common stock issuable under the 2021 ATM Agreement, which was declared effective on July 12, 2021. As of September 30, 2022, no shares have been issued or sold under the 2021 ATM Agreement.

Share Repurchase Program

On December 20, 2021, the Company initiated a share repurchase program (the "Share Repurchase Program") pursuant to which the Company may repurchase up to $50 million of shares of its common stock through December 31, 2023. Capital allocation to the Share Repurchase Program will be based on a variety of factors, including our business results, the receipt of royalties and sales milestones under the AZSTARYS License Agreement (refer to Note B), and potentially other sources of non-dilutive capital that may become available to the Company. Repurchases will be made in compliance with Rule 10b-18 of the Securities Exchange Act of 1934, as amended, subject to a variety of factors, including the market price of the Company’s common stock, general market and economic conditions and applicable legal requirements. The exact number of shares to be repurchased by the Company is not guaranteed and the program may be suspended, modified, or discontinued at any time without prior notice. The Company does not currently intend to retire the repurchased treasury shares, rather all repurchased treasury shares will remain authorized but unissued. As of September 30, 2022, the Company has repurchased 909,953 shares of its common stock for approximately $7.5 million under the Share Repurchase Program.

Note B - Summary of Significant Accounting Policies

9 Months Ended

Sep. 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, discount and rebate liabilities, 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 (“ASC 606”), starting 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 require the Company to deliver various rights, services, including intellectual property rights/licenses, research and development services, and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments, consulting fees and/or profit sharing.

In arrangements involving more than one performance obligation, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available.

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 occur. Should there be royalties, the Company utilizes the sales and usage-based royalty exception in arrangements that resulted from the license of intellectual property, recognizing revenues generated from royalties or profit sharing as the underlying sales occur.

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 or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments may result in licensing revenues.

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 include such estimates as, independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the licensee which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

Up-front Fees: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time.

Milestone Payments: At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as non-operational developmental and regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or the licensee’s control, such as operational developmental milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price may also result in negative licensing revenues and earnings in the period of adjustment.

AZSTARYS License Agreement

In September 2019, the Company entered into a Collaboration and License Agreement (the “AZSTARYS License Agreement”) with Commave Therapeutics SA, an affiliate of Gurnet Point Capital (“Commave”). Under the AZSTARYS License Agreement, the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-methylphenidate (“d-MPH”), including AZSTARYS, KP484, and, at the option of Commave, KP879, KP922 or any other product candidate developed by the Company containing SDX and developed to treat ADHD or any other CNS disorder (the “Additional Product Candidates” and, collectively with AZSTARYS and KP484, the “Licensed Product Candidates”). Pursuant to the AZSTARYS License Agreement, Commave (i) paid the Company an upfront payment of $10.0 million; (ii) agreed to pay milestone payments of up to $63.0 million upon the occurrence of specified regulatory milestones related to AZSTARYS and KP484; (iii) agreed to pay additional payments of up to $420.0 million upon the achievement of specified U.S. sales milestones; and (iv) has agreed to pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to the mid-twenties of Net Sales (as defined in the AZSTARYS License Agreement) in the United States and a percentage in the low to mid-single digits of Net Sales in each country outside the United States, in each case subject to specified reductions under certain conditions as described in the AZSTARYS License Agreement. Commave is obligated to make such royalty payments on a product-by-product basis until expiration of the royalty term for the applicable product.

In April 2021, the Company entered into Amendment No. 1 to the AZSTARYS Amendment (the "AZSTARYS Amendment"). Pursuant to the AZSTARYS Amendment, the Company and Commave agreed to modify the compensation terms of the AZSTARYS License Agreement. Pursuant to the AZSTARYS Amendment, Commave paid the Company $10.0 million in connection with the entry into the AZSTARYS Amendment as a result of the regulatory approval of AZSTARYS in the United States which occurred on March 2, 2021. Commave also paid the Company $10.0 million following the receipt of the scheduling determination of the compound SDX by the U.S. Drug Enforcement Agency (the "DEA"), which occurred on May 7, 2021. In addition, the AZSTARYS Amendment increased the total remaining future regulatory and sales milestone payments related to AZSTARYS to up to an aggregate of $590.0 million in payments upon the occurrence of specified regulatory milestones related to AZSTARYS and upon the achievement of specified U.S. net sales milestones. Further, under the AZSTARYS Amendment, Commave agreed to pay the Company quarterly, tiered royalty payments that are calculated from a base royalty rate percentage in the high single digits to the mid-twenties of net sales in the United States, subject to adjustment based on annual net sales, and a percentage in the low to mid-single digits of Net Sales in each country outside the United States, in each case subject to specified reductions under certain conditions, including with respect to the final approval label, as described in the AZSTARYS License Agreement. Commave is obligated to make such royalty payments on a product-by-product basis until expiration of the royalty term for the applicable product.

Pursuant to the AZSTARYS Amendment, Commave and the Company also agreed to modify Commave’s right of first refusal ("ROFR") such that the Company’s product candidate, KP922, is no longer subject to Commave’ ROFR to acquire, license or commercialize any Additional Product Candidate. Commave’s ROFR shall only apply to any Additional Product Candidate which contains SDX, with such ROFR expiring upon the acceptance of an NDA for such Additional Product Candidate containing SDX.

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 AZSTARYS License Agreement. As part of this agreement the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products.

In accordance with the terms of the Company’s March 20, 2012 Termination Agreement with Aquestive Therapeutics (formerly known as MonoSol Rx, LLC), Aquestive Therapeutics has the right to receive an amount equal to 10% of any royalty or milestone payments made to the Company related to AZSTARYS, KP484, KP879 or KP1077 under the AZSTARYS License Agreement.

The AZSTARYS License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the AZSTARYS License Agreement. Using the concepts of ASC 606, the Company identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket third-party research and development costs, as its only two performance obligations at inception. The Company further determined that the transaction price, at inception, under the agreement was $10.0 million upfront payment plus the fair value of the Development Costs (as defined in the AZSTARYS License Agreement) which was allocated among the performance obligations based on their respective related stand-alone selling price.

The consideration allocated to the grant of the exclusive, worldwide license was $10.0 million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type of transaction. The Company determined that the intellectual property licensed under the AZSTARYS License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at a point in time at the inception of the AZSTARYS License Agreement.

Under the AZSTARYS License Agreement, Commave was granted an exclusive right to first negotiation whereby upon completion of a Phase 1 proof-of-concept study, the Company and Commave may negotiate the economic terms under which certain Additional Products may be included as a Product (both as defined in the AZSTARYS License Agreement) under the AZSTARYS License Agreement (the “Additional Product Option”). In addition to the Additional Product Option, Commave was also granted a ROFR to acquire, license and/or commercialize any of the Additional Product Candidates should they choose not to exercise the Additional Product Option. Should Commave choose to exercise the Additional Product Option on any Additional Product Candidates, Commave and the Company shall negotiate in good faith regarding the economic terms of such Additional Product Candidate. Further, should Commave exercise the ROFR on any Additional Product Candidate, the economic terms of the agreement shall be the same as those offered to the third-party. Under ASC 606 an option to acquire additional goods or services gives rise to a performance obligation if the option provides a material right to the customer. The Company concluded that the above-described Additional Product Option and ROFR do not constitute material rights to the customer as Commave would acquire the goods or services at a to be negotiated price, which the Company expects to approximate fair value and therefore Commave would not receive a material discount on these goods or services compared to market rates.

The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to AZSTARYS and KP484 and the achievement of certain U.S. sales milestones. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the AZSTARYS License Agreement) in the United States and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the AZSTARYS License Agreement. The Company concluded that these regulatory milestones, sales milestones and royalty payments each contain a significant uncertainty associated with a future event. As such, these milestone and royalty payments are constrained at contract inception and are not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments. At the end of each reporting period, the Company updates its assessment of whether the milestone and royalty payments are constrained by considering both the likelihood and magnitude of the potential revenue reversal.

Per the AZSTARYS Amendment, the Company earned a regulatory milestone payment of $10.0 million following the FDA’s approval of the AZSTARYS NDA, in March 2021, as well as $10.0 million following the DEA's scheduling of SDX in May 2021. Since the FDA approved the NDA for AZSTARYS and the DEA scheduled SDX, the constraints were removed and revenue recognized. The associated revenue was allocated among the two performance obligations identified at contract inception. Since both performance obligations were satisfied as of the end of each respective quarter of 2021, the full $10.0 million for each milestone was recognized as revenue in the statements of operations for the first quarter and second quarter of 2021, respectively. In accordance with ASC 340-40, Contracts with Customers, the Company recognized $1.0 million, respectively, of royalty costs due to payment to Aquestive related to the regulatory milestones earned and recorded it in the item titled royalty and direct contract acquisition costs in the unaudited condensed statements of operations for first and second quarter of 2021.

For the three months ended September 30, 2022, the Company recognized $0.2 million of revenue under the AZSTARYS License Agreement. For the three months ended September 30, 2021, the Company recognized minimal revenue under the AZSTARYS License Agreement. For the nine months ended September 30, 2022, and 2021, the Company recognized revenue under the AZSTARYS License Agreement of $0.4 million and $20.0 million, respectively. There was no deferred revenue related to this agreement as of September 30, 2022, or December 31, 2021.

Consulting Arrangements

The Company enters into consulting arrangements with third parties that fall under the scope of ASC 606. These arrangements may require the Company to deliver various rights, services, including research and development services, regulatory services and/or commercialization support services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of consulting fees and reimbursements of out-of-pocket third-party research and development, regulatory and commercial costs.

Corium Consulting Agreement

In July 2020, the Company entered into a consultation services arrangement (the “Corium Consulting Agreement”) with Corium, Inc. (“Corium”) under which Corium engaged the Company to guide the product development and regulatory activities for certain current and potential future products in Corium’s portfolio, as well as continue supporting preparation for the potential commercial launch of AZSTARYS (together, “Corium Consulting Services”). Corium is a portfolio company of Gurnet Point Capital and was tasked by Commave to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement, as discussed above.

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, and paid in arrears. The remaining $2.0 million was conditioned upon the approval by the FDA of the NDA for Corium's product candidate, ADLARITY, which was approved by the FDA in the first quarter of 2022. Corium also agreed to be responsible for and reimburse the Company for all development, commercialization and regulatory expenses incurred as part of the performance of the Corium Consulting Services.

The Corium Consulting Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the Corium Consulting Agreement. Using the concepts of ASC 606, the Company identified the performance of consulting services, which includes the reimbursement to the Company of third-party pass-through costs, as its only performance obligation at inception. The Company further determined that the transaction price, at inception, under the agreement was $13.6 million which is the fair value of the consulting services, including the reimbursement of third-party pass-through costs. The Company concluded that the regulatory milestone contains a significant uncertainty associated with a future event. As such, this milestone is constrained at contract inception and is not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments. At the end of each reporting period, the Company updates its assessment of whether the milestone is constrained by considering both the likelihood and magnitude of the potential revenue reversal.

The Company determined that the performance of consulting services, including reimbursement of third-party pass-through costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable third-party pass-through costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity’s right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity’s performance completed to date. As of March 31, 2022, the Company had recognized approximately all of the consulting services and third-party pass-through costs under the Corium Consulting Agreement.

For the three months ended September 30, 2022, the Company recognized no revenue under the Corium Consulting Agreement related to ADLARITY. For the three months ended September 30, 2021, the Company recognized revenue under the Corium Consulting Agreement related to ADLARITY of $2.0 million. For the nine months ended September 30, 2022, and 2021 the Company recognized revenue under the Corium Consulting Agreement related to ADLARITY of $3.5 million and $5.9 million, respectively. As of September 30, 2022, the Company had no deferred revenue related to this agreement. As of December 31, 2021, the Company had deferred revenue related to this agreement of $0.4 million.

Other Consulting Arrangements

For the three months ended September 30, 2022, the Company recognized revenue under other consulting arrangements of $0.3 million. For the three months ended September 30, 2021, the Company recognized no revenue under other consulting arrangements. For the nine months ended September 30, 2022, and 2021, the Company recognized revenue under other consulting arrangements of $0.6 million and $0.2 million, respectively. There was no deferred revenue from other consulting arrangements as of September 30, 2022, or 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 and, as a result, follows the five-step model when recognizing revenue: 1) identifying a contract; 2) identifying the performance obligations; 3) determining the transaction price; 4) allocating the price to the performance obligations; and 5) recognizing revenue when the performance obligations have been fulfilled.

Net revenue includes 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 yet approved for commercial sale.

Only drugs targeting serious or rare indications and for which there is currently no appropriate treatment are considered for early access compassionate use programs. Further, to be considered for the early access compassionate use program, the drug must have proven efficacy and safety and must either be undergoing price negotiations or seeking marketing approval.

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-party customer. Under the French nATU, the manufacturer can set its own price for the drug products until a price agreement with the authorities is in place. Any excess in the price charged by the manufacturer compared to the price agreed with the health authorities once the drug product is approved in France must be repaid. The repayment is considered in the clawback liability.

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.

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 months ended September 30, 2022, the Company recognized revenue related to the Arimoclomol EAP in France of $2.3 million, which is net of a clawback liability of $1.2 million. For the nine months ended September 30, 2022, the Company recognized revenue related to the Arimoclomol EAP in France of $3.2 million, which is net of a clawback liability of $1.7 million.

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 September 30, 2022, including the additional clawback liability for the three and nine months ended September 30, 2022, was $6.3 million. As of September 30, 2022, this estimated reserve liability is recorded as discount and rebate liabilities in the unaudited condensed consolidated balance sheet and is separated into current and long-term based upon the timing of the expected payment to the French regulators.

Accounts and Other Receivables

Accounts and other receivables consist of receivables under the AZSTARYS License Agreement and Arimoclomol EAP, as well as receivables related to consulting arrangements, income tax receivables and other receivables due to the Company. Receivables under the AZSTARYS License Agreement are recorded for amounts due to the Company related to reimbursable third-party costs and royalties on product sales. Receivables under the Arimoclomol EAP are recorded for product sales under the program in France. These receivables, as well as the receivables related to consulting arrangements, are evaluated to determine if any reserve or allowance should be established at each reporting date. As of September 30, 2022, the Company had receivables related to the Arimoclomol EAP of $4.9 million, consulting arrangements of $0.6 million, income tax receivables of $0.7 million and other receivables of $0.4 million. As of December 31, 2021, the Company had receivables related to the Corium Consulting Agreement of $1.2 million, AZSTARYS License Agreement of $0.1 million, income tax receivables of $0.1 million and other consulting arrangements of $0.1 million. As of September 30, 2022, and December 31, 2021, no reserve or allowance for doubtful accounts has been established.

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, the FASB issued ASU 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 (“ASU 2020-06”), which addresses issues identified as a result of the complexities associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. This update addresses, among other things, the number of accounting models for convertible debt instruments and convertible preferred stock, targeted improvements to the disclosures for convertible instruments and earnings-per-share (“EPS”) guidance and amendments to the guidance for the derivatives scope exception for contracts in an entity’s own equity, as well as the related EPS guidance. This update applies to all entities that issue convertible instruments and/or contracts in an entity’s own equity. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. FASB specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The adoption of ASU 2020-06 did not have a material impact on the Company’s unaudited condensed financial statements and disclosures.

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt— Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40); Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options, a consensus of the FASB Emerging Issues Task Force (“ASU 2021-04”), which aims to clarify and reduce diversity in issuer's accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. This update applies to all entities that issue freestanding written call options that are classified in equity. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. FASB specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The adoption of ASU 2021-04 did not have a material impact on the Company’s unaudited condensed financial statements and disclosures.

Note C - Debt Obligations

9 Months Ended

Sep. 30, 2022

Notes to Financial Statements

Debt Disclosure [Text Block]

C.	Debt Obligations

As of September 30, 2022, and December 31, 2021, the Company had no convertible notes outstanding.

Deerfield Facility Agreement

In June 2014, the Company entered into a $60 million multi-tranche credit facility (the “Deerfield Facility Agreement”) with Deerfield Private Design Fund III, LP (“Deerfield”). At the time the Company entered into the Deerfield Facility Agreement, the Company borrowed the first tranche, which consisted of a term loan of $15 million (the “Term Note”) and a senior secured loan of $10 million (the “Deerfield Convertible Note”). Deerfield was able to convert any portion of the outstanding principal and any accrued but unpaid interest on the Deerfield Convertible Note into shares of the Company’s common stock at an initial conversion price of $5.85 per share (the “Deerfield Note Put Option”). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price became $93.60.

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 of the outstanding principal amount of the Deerfield Convertible Note on the fourth and fifth anniversaries of the Deerfield Facility Agreement ( June 2018 and June 2019). In June 2018, Deerfield agreed to convert approximately $3.3 million of the principal amount then due, plus approximately $0.2 million of accrued interest, into 37,410 shares of our common stock (as discussed below in the section entitled “Facility Agreement Waiver and Fifth Amendment to Senior Secured Convertible Note”). In September 2019, the Company entered into an amendment with Deerfield in order to (i) reduce the interest rate applicable under the Deerfield Facility Agreement from 9.75% to 6.75%, (ii) provide for “payment in kind” of interest on the Loans (as defined in the Deerfield Facility Agreement), and (iii) defer the Loan payments due pursuant to the Deerfield Facility Agreement until June 1, 2020 (as discussed below in the section entitled “2021 Note Exchange Effected in September 2019”). In December 2019, the Company entered into another amendment with Deerfield in order to (i) defer the Loan payments due pursuant to the Deerfield Facility Agreement until March 31, 2021, and (ii) allow for the entries of additional debt and debt holders under the Deerfield Facility Agreement (as discussed below in the section entitled “2021 Note Exchange Effected in December 2019”). The Company was also obligated to repay principal of the Deerfield Convertible Note in the amount of approximately $7.0 million plus any capitalized interest to date on March 31, 2021. Prepayment of the outstanding balance was not allowed without written consent of Deerfield.

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 (the “Deerfield Warrant”). Upon completion of the Company’s initial public offering, the Deerfield Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock at an exercise price of $5.85 per share. After giving effect to the Reverse Stock Split effected in December 2020, the shares issuable upon conversion of the warrant became 120,192 shares of common stock, and the exercise price of the Deerfield Warrant became $93.60 per share, which in January 2021 and June 2021 was further adjusted to $46.25 and $38.34 per share, respectively, in connection with the Company entering into the January 2021 and June 2021 Inducement Transactions (as defined in Note F) each of which triggered the anti-dilution provisions of the Deerfield Warrant. This warrant qualifies as a participating security under ASC Topic 260, Earnings per Share, and is treated as such in the net loss per share calculation (Note I). If a Major Transaction occurs (as defined in the Deerfield Facility Agreement) Deerfield may require the Company to redeem the Deerfield Warrant for a cash amount equal to the Black-Scholes value of the portion of the Deerfield Warrant to be redeemed (the “Warrant Put Option”).

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 quarter of 2021, the debt was extinguished, through a series of debt payments and a conversion of debt principal and interest to Series B-2 Preferred Stock. As a result of the debt extinguishment, the associated discount and debt issuance costs were written off and recorded as a loss on extinguishment.

Pursuant to the Deerfield Facility Agreement, the Company was not able to enter into specified transactions, including a debt financing in the aggregate value of $750,000 or more, other than permitted indebtedness under the Deerfield Facility Agreement, a merger, an asset sale or any other change of control transaction or any joint venture, partnership or other profit-sharing arrangement, without the prior approval of the Required Lenders (as defined in the Deerfield Facility Agreement). Additionally, if the Company were to enter into a major transaction, including a merger, consolidation, sale of substantially all of its assets or other change of control transaction, Deerfield would have had the ability to demand that prior to consummation of such transaction the Company repay all outstanding principal and accrued interest of any notes issued under the Deerfield Facility Agreement. Under each warrant issued pursuant to the Deerfield Facility Agreement, Deerfield has the right to demand that the Company redeem the warrant for a cash amount equal to the Black-Scholes value of a portion of the warrant upon the occurrence of specified events, including a merger, an asset sale or any other change of control transaction.

Issuance of 5.50% Senior Convertible Notes and Third Amendment to Senior Secured Convertible Note and Warrant

In February 2016, the Company issued $86.3 million aggregate principal amount of its 5.50% Senior Convertible Notes due 2021 (the “2021 Notes”) to Cowen and RBC Capital Markets, LLC, as representatives of the several initial purchasers (the “Initial Purchasers”), who subsequently resold the 2021 Notes to qualified institutional buyers (the “Note Offering”) in reliance on the exemption from registration provided by Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).

The 2021 Notes were issued pursuant to an indenture, dated as of February 9, 2016 (the “Indenture”), between the Company and U.S. Bank National Association, as trustee (the “Trustee”). Interest on the 2021 Notes was payable semi-annually in cash in arrears on February 1 and August 1 of each year, beginning on August 1, 2016, at a rate of 5.50% per year. The 2021 Notes had an original maturity of February 1, 2021 unless earlier converted or repurchased.

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 Notes were not redeemable prior to the maturity date, and no sinking fund was provided for the 2021 Notes. The 2021 Notes were convertible at an initial conversion rate of 58.4454 shares of the Company’s common stock per $1,000 principal amount of the 2021 Notes, subject to adjustment under the Indenture, which is equal to an initial conversion price of approximately $17.11 per share of common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion rate of the 2021 Notes would have been approximately 3.6528 shares of the Company’s common stock per $1,000 principal amount of the 2021 Notes, which is equal to a conversion price of approximately $273.76 per share.

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 Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2021 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The Indenture included customary terms and covenants, including certain events of default after which the 2021 Notes may have become due and payable immediately.

As described in more detail below, in multiple exchanges occurring in December 2019 and January 2020, all outstanding 2021 Notes were exchanged by the holders thereof for either shares of our common stock or senior secured convertible promissory notes issued under the terms of the Deerfield Facility Agreement.

2021 Note Exchange Effected in December 2019

In December 2019, the Company entered into the December 2019 Exchange Agreement and Amendment to Facility Agreement, Senior Secured Convertible Notes and Warrants (the “December 2019 Exchange Agreement”) with the Deerfield Lenders and Delaware Street Capital Master Fund, L.P. (“DSC” and, collectively with the Deerfield Lenders, the “December 2019 Holders”). Under the December 2019 Exchange Agreement, the Company issued senior secured convertible promissory notes under the Deerfield Facility Agreement in the aggregate principal amount of approximately $71.4 million (the “December 2019 Notes”), in exchange for the cancellation of an aggregate of approximately $71.4 million principal amount and accrued interest of the Company’s 2021 Notes. Upon entering into the December 2019 Exchange Agreement, the Company agreed to pay the December 2019 Holders, in the aggregate, an interest payment of approximately $0.7 million which represents 50% of the accrued interest, as of December 18, 2019, on the 2021 Notes owned by the December 2019 Holders. The remainder of such interest was included in the principal amount of the December 2019 Notes.

The December 2019 Notes bore interest at 6.75% per annum. The December 2019 Notes were convertible into shares of the Company’s common stock at an initial conversion price of $17.11 per share (which represented the conversion price of the 2021 Notes), subject to adjustment in accordance with the terms of the December 2019 Notes. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the December 2019 Notes would have been $273.76 per share. The Company subsequently amended the December 2019 Notes to provide that such notes would have been convertible into shares of the Company’s common stock at a conversion price of $93.60 per share (which represented the conversion price of the Deerfield Convertible Note). The conversion price of the December 2019 Notes would have been adjusted downward if the Company issued or sold any shares of common stock, convertible securities, warrants or options at a sale or exercise price per share less than the greater of the December 2019 Notes’ conversion price or the closing sale price of the Company’s common stock on the last trading date immediately prior to such issuance, or, in the case of a firm commitment underwritten offering, on the date of execution of the underwriting agreement between the Company and the underwriters for such offering. However, if the Company effected an “at the market offering” as defined in Rule 415 of the Securities Act, of its common stock, the conversion price of the December 2019 Notes would have been adjusted downward pursuant to this anti-dilution adjustment only if such sales were made at a price less than $93.60 per share, provided that this anti-dilution adjustment would not have applied to any sales made under (x) the 2020 ELOC Agreement, (y) the ATM Agreement, or (z) the September 2019 Exchange Agreement (as amended). Notwithstanding anything to the contrary in the December 2019 Notes, the anti-dilution adjustment of such notes would not have resulted in the conversion price of the December 2019 Notes being less than $9.328 per share. The December 2019 Notes were convertible at any time at the option of the holders thereof, provided that a holder of a December 2019 Note was prohibited from converting such note into shares of the Company’s common stock if, as a result of such conversion, such holder (together with certain affiliates and “group” members) would have beneficially owned more than 4.985% of the total number of shares of common stock then issued and outstanding. However, the December 2019 Note issued to DSC, due to the fact DSC was a beneficial owner of more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding, had a beneficial ownership cap equal to 19.985% of the total number of shares of the Company’s common stock then issued and outstanding. Pursuant to the December 2019 Notes, the December 2019 Holders had the option to demand repayment of all outstanding principal, and any unpaid interest accrued thereon, in connection with a Major Transaction (as defined in the December 2019 Notes), which included, among others, any acquisition or other change of control of the Company; a liquidation, bankruptcy or other dissolution of the Company; or if at any time after March 31, 2021, shares of the Company’s common stock are not listed on an Eligible Market (as defined in the December 2019 Notes). The December 2019 Notes were subject to specified events of default, the occurrence of which would have entitled the December 2019 Holders to immediately demand repayment of all outstanding principal and accrued interest on the December 2019 Notes. Such events of default included, among others, failure to make any payment under the December 2019 Notes when due, failure to observe or perform any covenant under the Deerfield Facility Agreement (as defined below) or the other transaction documents related thereto (subject to a standard cure period), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgement levied against the Company and a material default by the Company under the Deerfield Warrant, the December 2019 Notes or the Deerfield Convertible Note.

The December 2019 Exchange Agreement amended the Deerfield Facility Agreement in order to, among other things, (i) provide for the Deerfield Facility Agreement to govern the December 2019 Notes received by the December 2019 Holders pursuant to the December 2019 Exchange Agreement, (ii) extend the maturity of the Deerfield Convertible Note from February 14, 2020 and June 1, 2020, as applicable, to March 31, 2021, (iii) defer interest payments on the Deerfield Convertible Note until March 31, 2021 (which such interest shall accrue as “payment-in-kind” interest), (iv) designate DSC as a Lender under (and as defined in the Deerfield Facility Agreement), (v) name Deerfield as the “Collateral Agent” for all Lenders and (vi) modify the terms and conditions under which the Company may issue additional pari passu and subordinated indebtedness under the Deerfield Facility Agreement (subject to certain conditions specified in the Deerfield Facility Agreement).

The December 2019 Exchange Agreement also amended and restated the Deerfield Convertible Note to conform the definitions of “Eligible Market” and “Major Transactions” to the definition in the December 2019 Notes, to remove provisions that were only applicable prior to the Company’s initial public offering and to make certain other changes to conform to the December 2019 Notes. The conversion price for the Deerfield Convertible Note remained $93.60 per share, subject to adjustment on the same basis as the December 2019 Notes.

The December 2019 Exchange Agreement also amended the Deerfield Warrant to conform the definitions of “Eligible Market” and “Major Transaction” in the Deerfield Warrant with the definitions of such terms in the December 2019 Notes.

The December 2019 Exchange Agreement contained customary representations, warranties and covenants made by the Company and the December 2019 Holders, including a covenant of the Company to, upon request, use commercially reasonable efforts to use its technology to discover a product based upon a compound that may be identified by the Deerfield Lenders in a manner that is reasonably acceptable to the Deerfield Lenders, or one of their affiliates, with the terms of such discovery plan, including the Company’s compensation thereunder, to be mutually agreed to by the parties.

In connection with entering into the December 2019 Exchange Agreement, on December 18, 2019, the Company amended and restated that certain Guaranty and Security Agreement, dated June 2, 2014, by and between the Company and the other parties thereto (the “GSA”) to, among other things, (i) provide that all of the notes will be secured by the liens securing the indebtedness under the Deerfield Facility Agreement, and (ii) name Deerfield as the “Collateral Agent” under the GSA.

In connection with entering into the December 2019 Exchange Agreement, the Company also entered into an amendment (the “September 2019 Exchange Agreement Amendment”) to the September 2019 Exchange Agreement to, among other things, (i) amend and restate Annex I of the September 2019 Exchange Agreement to allow the Deerfield Lenders to effect optional exchanges of the December 2019 Notes and the Deerfield Convertible Note under the terms of the September 2019 Exchange Agreement; (ii) amend the common stock exchange price under the September 2019 Exchange Agreement to be a per share price equal to the greater of (x) $0.60, subject to adjustment to reflect stock splits and similar events, or (y) the average of the volume-weighted average prices of the Company’s common stock on each of the 15 trading days immediately preceding such exchange, (iii) provide that no more than 28,439,015 of shares of the Company’s common stock shall be issued pursuant to optional exchanges under the September 2019 Exchange Agreement (whether by common stock exchange or upon conversion of Series B-2 Shares (as defined in the September 2019 Exchange Agreement Amendment)), subject to adjustment to reflect stock splits and similar events and (iv) eliminate limitations regarding the timing and aggregate amount of principal which may be exchanged under the September 2019 Exchange Agreement. These changes in the September 2019 Exchange Agreement Amendment significantly modified the Optional Exchange Principal Amount, as such after giving effect to the September Exchange Agreement Amendment the Optional Exchange Principal Amount ceases to exist the new optional exchanges are referred to as the Deerfield Optional Conversion Feature. After giving effect to the Reverse Stock Split effected in December 2020, the exchange price of the Deerfield Optional Conversion Feature would have been $9.60 per share or the average of the volume-weighted average price of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange and the shares of the Company’s common stock issued pursuant to the optional exchanges would have been 1,777,437 shares of common stock.

In connection with entering into the September 2019 Amendment, the Company filed an amendment to the Series B-2 Certificate of Designation (the “Series B-2 Certificate of Designation Amendment”) with the Secretary of State of the State Delaware. The Series B-2 Certificate of Designation Amendment provides that each share of the Company’s Series B-2 preferred stock is convertible into shares of the Company’s common stock at a per share price equal to the common stock exchange price under the September 2019 Exchange Agreement, which equals the greater of (i) $9.60 (subject to adjustment to reflect stock splits and similar events), or (ii) the average of the volume-weighted average prices of the Company’s common stock on each of the 15 trading days immediately preceding such exchange.

As of September 30, 2020, the Deerfield Lenders had converted all $17.1 million of principal under the December 2019 Notes into all 1,777,437 shares of common stock available under the Deerfield Optional Conversion Feature.

The Company determined the changes to the Deerfield Convertible Note met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors, as the Company was experiencing financial difficulties and Deerfield granted a concession. The amendments to the terms of the Deerfield Convertible Note resulted in no gain on restructuring because the total cash outflows required under the amended Deerfield Convertible Note exceeded the carrying value of the original Deerfield Convertible Note immediately prior to amendment. Prospectively, the Deerfield Convertible Note will continue to be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments.

The changes to the 2021 Notes, under the December 2019 Exchange Agreement, referred to after as the December 2019 Notes, were accounted for as a debt modification, prospectively, the December 2019 Notes will be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments.

2021 Note Exchange Effected in January 2020

In January 2020, the Company entered into the January 2020 Exchange Agreement (the “January 2020 Exchange Agreement”) with M. Kingdon Offshore Master Fund, LP (“Kingdon”). Under the January 2020 Exchange Agreement, the Company issued a senior secured convertible note in the aggregate principal amount of approximately $3.0 million (the “January 2020 Note”) in exchange for the cancellation of an aggregate of $3.0 million principal amount and accrued interest of the 2021 Note then owned by Kingdon. Upon entering into the January 2020 Exchange Agreement, the Company agreed to pay Kingdon an interest payment of approximately $37,000, which represents 50% of the accrued and unpaid interest, as of January 13, 2020, on Kingdon’s 2021 Note. The remainder of such interest was included in the principal amount of the January 2020 Note.

The January 2020 Note was issued with substantially the same terms and conditions as the December 2019 Notes (as amended by the amendment described in more detail below).

In connection with entering into the January 2020 Exchange Agreement, the Company entered into an Amendment to Facility Agreement and December 2019 Notes and Consent (the “December 2019 Note Amendment”) with the December 2019 Holders that, among other things, (i) amended the December 2019 Notes to (a) reduce the Conversion Price (as defined in the December 2019 Notes) from $17.11 to $5.85 per share and (b) increased the Floor Price (as defined in the December 2019 Notes) from $0.38 to $0.583 per share, and (ii) amended the Deerfield Facility Agreement to (x) provide for Kingdon to join the Deerfield Facility Agreement as a Lender (as defined in the Deerfield Facility Agreement) and (y) provide that the 2020 Note and shall constitute a “Senior Secured Convertible Note” (as defined in the Deerfield Facility Agreement) for purposes of the Deerfield Facility Agreement and other Transaction Documents (as defined in the Deerfield Facility Agreement). After giving effect to the Reverse Stock Split effected in December 2020, the Conversion Price became $93.60 per share and the Floor Price became $9.328 per share.

The changes to the 2021 Note, under the January 2020 Exchange Agreement, referred to after as the January 2020 Note, were accounted for as a debt modification, prospectively, the January 2020 Note will be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments.

December 2020 Exchange Agreement and Amendment to Facility Agreement, Notes and Investors’ Rights Agreement

In December 2020, the Company entered into a December 2020 Exchange Agreement and Amendment to Facility Agreement, Notes and Investors’ Rights Agreement, as amended (the “December 2020 Exchange Agreement”) with the Deerfield Lenders, DSC and Kingdon (collectively, the “Facility Agreement Note Holders”). Under the December 2020 Exchange Agreement, the Company and the Facility Agreement Note Holders agreed that (a) the Company will make a cash pre-payment of a portion of principal amount of the Deerfield Convertible Note, the December 2019 Notes and the January 2020 Note (collectively, the “Facility Agreement Notes”) to the Facility Agreement Note Holders (the “Debt Payment”) equal to approximately $30.3 million, plus accrued interest if such payment is made on or after January 1, 2021, and (b) subject to the satisfaction or waiver of certain conditions specified in the December 2020 Exchange Agreement, including the making of the Debt Payment, issue shares of its Series B-2 Preferred Stock and warrants exercisable for shares of its common stock (the “Exchange Warrants”), in exchange for the cancellation of a portion of the principal amount of the Facility Agreement Notes owned by the Facility Agreement Note Holders in an aggregate amount equal to the Debt Payment, plus the Q4 PIK Interest Payment (as defined in the December 2020 Exchange Agreement) (such transaction, the “December 2020 Exchange”).

The December 2020 Exchange Agreement amended the Facility Agreement Notes to provide that the failure of the Company’s common stock to remain listed on an eligible securities market will not constitute a “Major Transaction” unless such failure occurs after March 31, 2023.

Subject to the satisfaction or waiver of certain conditions specified in the December 2020 Exchange Agreement, including the making of the Debt Payment and the consummation of the exchange, the December 2020 Exchange Agreement amended that certain Facility Agreement dated as of June 2, 2014, as amended (the “Facility Agreement”), by and among the Company and the Facility Agreement Note Holders in order to, among other things, (i) extend the maturity date of the Facility Agreement Notes to March 31, 2023, (ii) provide for cash payments of interest on the Loans (as defined in the Facility Agreement) for the periods following July 1, 2021, and (iii) provide for specified prepayment terms on the Loans.

The December 2020 Exchange Agreement amended that certain Amended and Restated Investors’ Rights Agreement, dated as of February 19, 2015 (the “IRA”), by and among the Company, Deerfield and the other parties signatory thereto in order to, among other things, add Deerfield Special Situations Fund, L.P. as a party thereto and to give effect to the issuance of the Exchange Warrants and the Company’s registration obligations under the December 2020 Exchange Agreement (as described in more detail below).

The Exchange Warrants issued pursuant to the December 2020 Exchange Agreement were exercisable for a number of shares of the Company’s common stock equal to 75% of the shares of common stock issuable upon conversion of the Series B-2 Preferred Stock issued in the Exchange (without regard for any beneficial ownership limitations included therein). The Exercise Warrants were subject to substantially the same terms and conditions as the warrants issued to the public in the public offering of the Company’s securities contemplated pursuant to a registration statement on Form S-1 (File No. 333-250945) (the “Public Offering”), with an exercise price equal to the exercise price per share of the warrants issued in the Public Offering and provided that the Facility Agreement Note Holders will be limited from exercising such Exchange Warrants if, as a result of such exercise, such holders (together with certain affiliates and “group” members of such holders) would beneficially own more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding.

In anticipation of the Public Offering, and to meet the Nasdaq Listing Requirements, the Company agreed in December 2020 to restructure the December 2019 Notes and the January 2020 Note in the aggregate principal amount of $60.8 million and the Deerfield Note in the principal amount of $7.5 million (collectively the "the Facility Notes"). The total outstanding principal and accrued interest under the Facility Notes was $69.4 million as of December 31, 2020.

Under the terms of the December 2020 Exchange Agreement, the Company, on January 12, 2021, in connection with the closing of the Public Offering:

	●	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 Preferred Stock, and (ii) Exchange Warrants exercisable for 3,632,019 shares of the Company's common stock, and

	●	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 Exchange Agreement amended the terms of that debt to provide that:

	●	The maturity date was changed to March 31, 2023, and the debt was prepayable upon specified conditions, and

	●	Interest would accrue at the rate of 6.75% per annum, payable quarterly, would be added to principal until June 30, 2021, and then be payable in cash thereafter.

The changes to the Facility Notes, under the December 2020 Exchange Agreement, were accounted for as a debt extinguishment as the cash flows immediately after the December 2020 Exchange Agreement were substantially different from the cash flows immediately prior to the December 2020 Exchange Agreement and while the Company was experiencing financial difficulties it was determined that the lender did not grant a concession. As such, a loss of extinguishment related to the extinguishment of the old notes was recorded in the unaudited condensed statement of operations for the three months ended March 31, 2021, and additional debt issuance costs related the new notes were capitalized and amortized using the effective interest method through the Payoff of Facility Agreement Notes (discussed below).

The transactions contemplated under the December 2020 Exchange Agreement, including the obligation to pre-pay any portion of the Facility Agreement Notes or to complete the Exchange and the effectiveness of the amendments to the Facility Agreement, the Notes and the IRA, were subject to specified conditions of closing, including certain closing of the Public Offering, the filing of the Restated Series B-2 Certificate of Designation (as defined below) and the approval for listing of the Company’s common stock, including the shares issuable upon conversion of the Series B-2 Preferred Stock and exercise of the Exchange Warrants, on the Nasdaq Capital Market.

As a condition to closing of the December 2020 Exchange Agreement, the Company filed an Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series B-2 Convertible Preferred Stock (the “Restated Series B-2 Certificate of Designation”) with the Secretary of State of the State Delaware, setting forth the preferences, rights and limitations of the Series B-2 Preferred Stock.

Each share of Series B-2 Preferred Stock had an aggregate stated value of $1,000 and was convertible into shares of the Company’s common stock at a per share price equal to the price per share to the public of the Company’s common stock in the Public Offering (subject to adjustment to reflect stock splits and similar events).

The Series B-2 Preferred Stock was convertible at any time on or after the PDUFA Date (as defined in the Restated Series B-2 Certificate of Designation) at the option of the holders thereof; provided that the holders thereof will be prohibited from converting shares of Series B-2 Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, such holders (together with certain affiliates and “group” members of such Holders) would beneficially own more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding. The Series B-2 Preferred Stock is not redeemable. In the event of the Company’s liquidation, dissolution or winding up or a change in control of the Company (each, a “Liquidation Event”), the holders of Series B-2 Preferred Stock will receive, prior to any distribution or payment on our common stock, an amount equal to the greater of (i) $1,000 per share (in the case of a change in control, transaction consideration with such value), or (ii) the amount (in the case of a change in control, in the form of the transaction consideration) per share each such holder would have been entitled to receive if every share of Series B-2 Preferred Stock had been converted into common stock immediately prior to such Liquidation Event, in each case, plus any declared but unpaid dividends thereon. With respect to rights upon liquidation, the Series B-2 Preferred Stock ranks senior to the common stock, on parity with any Parity Securities (as defined in the Restated Series B-2 Certificate of Designation) and junior to existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions involving the Company’s organizational documents that adversely affect the holders of Series B-2 Preferred Stock and other specified matters regarding the rights, preferences and privileges of the Series B-2 Preferred Stock), the Series B-2 Preferred Stock did not have voting rights. The Series B-2 Preferred Stock is not subject to any price-based anti-dilution protections and does not provide for any accruing dividends but provides that holders of Series B-2 Preferred Stock will participate in any dividends on the Company’s common stock on an as-converted basis (without giving effect to the limitation on conversion described above). The Restated Series B-2 Certificate of Designation also provides for partial liquidated damages in the event that the Company fails to timely convert shares of Series B-2 Preferred Stock into common stock in accordance with the Restated Series B-2 Certificate of Designation.

Payoff of Facility Agreement Notes and Termination of Facility Agreement

On February 8, 2021, the Company entered into a payoff letter with the Facility Agreement Note Holders, pursuant to which the Company agreed to pay off and thereby terminate the Facility Agreement.

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, as the Company repaid the debt (and has been relieved of the related obligation) without entering into new debt with the Facility Agreement Note Holders and there is no other continuing debt with the Facility Agreement Note Holders. The payoff letter resulted in a loss on extinguishment of debt which was shown within other (expense) income in the unaudited condensed statements of operations for the three months ended March 31, 2021.

PPP Loan

On April 23, 2020, the Company received proceeds of $0.8 million from the PPP Loan under the PPP of the CARES Act, a portion of which may be forgiven, which the Company used to retain current employees, maintain payroll and make lease and utility payments. In May 2021, the Company received notice from the U.S. Small Business Administration that the principal and interest due under its PPP Loan had been forgiven in full.

Line of Credit

On May 31, 2022, the Company and Ameris Bank, as lender, entered into a $20.0 million revolving loan agreement (the “Line of Credit”). Proceeds of the revolving facility provided by the Line of Credit are to be used for general corporate purposes. Loans under the Line of Credit bear interest at the Secured Overnight Financing Rate ("SOFR") plus 1.60%, with a SOFR floor of 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. The Line of Credit contains customary events of default that could lead to an acceleration of the loans, including cross-default, bankruptcy and payment defaults. As of September 30, 2022, the Company has drawn $12.8 million from the Line of Credit to finance the transactions under the Arimoclomol Purchase Agreement, and this amount is supported by a $12.8 million certificate of deposit which is shown as long-term investments in the unaudited condensed consolidated balance sheets. The remaining $7.2 million under the Line of Credit is in a separate interest-bearing certificate of deposit and is also recorded as long-term investments in the unaudited condensed consolidated balance sheet as of September 30, 2022. These certificates of deposit are pledged as collateral against the Line of Credit and cannot be redeemed so long as the $20.0 million remains available under the Line of Credit. The total value of the certificates of deposit held with Ameris Banks must meet or exceed the amount available to borrow under the Line of Credit so long as the Line of Credit remains active.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Note D - Commitments and Contingencies

9 Months Ended

Sep. 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 probable, or the amount cannot be reasonably estimated and, therefore, an accrual has not been made. However, for such matters when it is probable that the Company has incurred a liability and can reasonably estimate the amount, the Company accrues and discloses such estimates. As of September 30, 2022, and December 31, 2021, no accruals have been made related to commitments and contingencies.

Note E - Preferred Stock and Warrants

9 Months Ended

Sep. 30, 2022

Notes to Financial Statements

Preferred Stock [Text Block]

E.	Preferred Stock and Warrants

Authorized, Issued, and Outstanding Preferred Stock

As of September 30, 2022, and December 31, 2021, the Company had 10,000,000 shares of authorized, unallocated and unissued preferred stock.

In June 2021, the Company filed with the Secretary of State of the State of Delaware: (i) a Certificate of Elimination of Series A Convertible Preferred Stock, eliminating from the Company’s Certificate of Incorporation the 9,578 shares designated as Series A Convertible Preferred Stock; (ii) a Certificate of Elimination of Series B-1 Convertible Preferred Stock, eliminating from the Company’s Certificate of Incorporation the 1,576 shares designated as Series B-1 Convertible Preferred Stock; and (iii) a Certificate of Elimination of Series B-2 Convertible Preferred Stock, eliminating from the Company’s Certificate of Incorporation the 31,480 shares designated as Series B-2 Convertible Preferred Stock. As of September 30, 2022, and December 31, 2021, no shares of preferred stock were designated, issued or outstanding.

Series B-2 Preferred Stock

Pursuant to the December 2020 Exchange Agreement, on January 12, 2021, the Company issued to the Facility Note Holders an aggregate of 31,476.98412 shares of its Series B-2 Preferred Stock and warrants exercisable for an aggregate of 3,632,019 shares of the Company’s common stock (the “Exchange Warrants”).

The Series B-2 Preferred Stock was convertible into an aggregate of 4,842,690 shares of the Company’s common stock upon issuance at a conversion price equal to $6.4999. No fractional shares of common stock will be issued in connection with the conversion of the Series B-2 Preferred Stock. Instead, for any such fractional share that would have otherwise been issued upon conversion of a share of Series B-2 Preferred Stock, the Company will round such fraction up to the next whole share.

Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of the Series B-2 Convertible Preferred Stock

On January 11, 2021, as a condition to closing of the transactions contemplated by the December 2020 Exchange Agreement, the Company filed an Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series B-2 Convertible Preferred Stock (the “Series B-2 Certificate of Designation”) with the Secretary of State of the State Delaware, setting forth the preferences, rights and limitations of the Series B-2 Preferred Stock.

Immediately following, the closing of the Public Offering, pursuant to the terms of the December 2020 Exchange Agreement, the Company:

	●	Exchanged approximately $31.5 million (the "Exchange") of the outstanding principal and accrued interest on the Facility Notes for (i) the Series B-2 Preferred Stock and (ii) the Exchange Warrants; and

	●	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, by and among the Company, Deerfield and the other parties signatory thereto, contemplated by the December 2020 Exchange Agreement that were conditional upon, among other things, the closing of the Public Offering, the filing of the Series B-2 Certificate of Designation and/or the approval for listing of the Company’s common stock, including the shares issuable upon conversion of the Series B-2 Preferred Stock and exercise of the Exchange Warrants, on the Nasdaq Capital Market, became effective on January 12, 2021.

In March 2021, all shares of Series B-2 Preferred Stock converted into 4,842,699 shares of common stock.

Note F - Common Stock and Warrants

9 Months Ended

Sep. 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 September 30, 2022, and December 31, 2021, the Company had authorized 250,000,000 shares of common stock. Of the authorized shares, 35,411,097 and 35,325,801 shares of common stock were issued as of September 30, 2022, and December 31, 2021, respectively, and 34,501,144 and 35,005,640 shares of common stock were outstanding as of September 30, 2022, and December 31, 2021, respectively.

As of September 30, 2022, and December 31, 2021, the Company had reserved authorized shares of common stock for future issuance as follows:

	*September 30, 2022*		*December 31, 2021*
Outstanding awards under equity incentive plans		2,463,509		1,273,879
Outstanding common stock warrants		4,252,600		4,252,600
Possible future issuances under equity incentive plans		4,414,406		4,209,935
Possible future issuances under employee stock purchase plans		1,445,213		1,500,000
Total common shares reserved for future issuance		12,575,728		11,236,414

Common Stock Activity

The following table summarizes common stock activity for the nine months ended September 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
Common stock issued as compensation to third-parties		11,830
Balance as of September 30, 2022		34,501,144

Warrants

On June 2, 2014, pursuant to the terms of the Deerfield Facility Agreement, the Company issued the Deerfield Warrant to purchase 14,423,076 shares of Series D Preferred (Note C). The Company recorded the fair value of the Deerfield Warrant as a debt discount and a warrant liability. The Deerfield Warrant, if unexercised, expires on the earlier of June 2, 2024, or upon a liquidation event. Upon completion of the Company’s initial public offering (the “IPO”), the Deerfield Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock at an exercise price of $5.85 per share. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the Deerfield Warrant became $93.60 and the shares of the Company’s common stock issuable upon exercise of the Deerfield Warrant became 120,192 shares of common stock. As a result of the January 2021 Inducement Transaction (discussed below) the anti-dilution provisions within the Deerfield Warrant were triggered and the exercise price was reduced from $93.60 per share to $46.25 per share. In addition, as a result of the June 2021 Inducement Transaction (discussed below) the anti-dilution provision within the Deerfield Warrant were triggered and the exercise price was reduced from $46.25 per share to $38.34 per share. The Company amortized the debt discount over the term of the Deerfield Convertible Note and the expense was recorded as interest expense related to amortization of debt issuance costs and discount in the statements of operations. The Deerfield Convertible Note was extinguished in February 2021 and the remaining debt discount was written off and recognized as a loss on extinguishment of debt.

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, the Company issued to KVK a warrant to purchase up to 500,000 shares of common stock of the Company at an exercise price of $2.30 per share, which reflected the closing price of the Company’s common stock on the Nasdaq Stock Market on the execution date of the APADAZ License Agreement (the “KVK Warrant”). The KVK Warrant is initially not exercisable for any shares of common stock. Upon the achievement of each of four specified milestones under the KVK Warrant, the KVK Warrant will become exercisable for an additional 125,000 shares, up to an aggregate of 500,000 shares of the Company’s common stock. The exercise price and the number and type of shares underlying the KVK Warrant are subject to adjustment in the event of specified events, including a reclassification of the Company’s common stock, a subdivision or combination of the Company’s common stock, or in the event of specified dividend payments. The KVK Warrant is exercisable until October 24, 2023. Upon exercise, the aggregate exercise price may be paid, at KVK’s election, in cash or on a net issuance basis, based upon the fair market value of the Company’s common stock at the time of exercise. After giving effect to the reverse stock split effected in December 2020, the exercise price of the KVK Warrant became $36.80 and the shares of common stock issuable upon exercise of the KVK Warrant became 31,250 shares of common stock.

The Company determined that, since KVK qualifies as a customer under ASC 606, the KVK Warrant should be recorded as a contract asset and recognized as contra-revenue as the Company recognizes revenue from the APADAZ License Agreement. In addition, the Company determined that the KVK Warrant qualifies as a derivative under ASC 815 and should be recorded as a liability and stated at fair value each reporting period. The Company calculates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option pricing model. Changes in fair value resulting from changes in the inputs to the Black Scholes model are accounted for as changes in the fair value of the derivative under ASC 815 and are recorded as fair value adjustment related to derivative and warrant liability in the unaudited condensed statements of operations. Changes in the number of shares that are expected to be issued are treated as changes in variable consideration under ASC 606 and are recorded as a change in contract asset on the unaudited condensed balance sheets. As of September 30, 2022, and December 31, 2021, a contract asset of $0.4 million is recorded in other long-term assets on the unaudited condensed consolidated balance sheets related to the KVK Warrant.

Pre-Funded Warrants

On January 12, 2021, pursuant to the terms of the Underwriting Agreement, the Company issued pre-funded warrants to purchase 926,844 shares of the Company’s common stock to specified investors in the Public Offering. Each pre-funded warrant had an initial exercise price per share equal to $0.0001. The pre-funded warrants were immediately exercisable. The pre-funded warrants were exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice accompanied by payment in full for the number of shares of common stock purchased upon such exercise. In lieu of making the cash payment otherwise contemplated to be made to the Company upon such exercise in payment of the aggregate exercise price, the holder was able to elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the pre-funded warrants. In January 2021, all pre-funded warrants were exercised for 926,841 shares of common stock and gross proceeds of approximately $72.

Warrants to Purchase Common Stock

On January 12, 2021, pursuant to the terms of the Underwriting Agreement and December 2020 Exchange Agreement, the Company issued warrants to purchase 12,078,361 shares of the Company’s common stock (collectively, the “Offering Warrants”) in the Public Offering and in connection with the transactions contemplated under the December 2020 Exchange Agreement. The Offering Warrants were immediately exercisable and expire on the fifth anniversary of their issuance date, at an exercise price per share of common stock equal to $6.50 per share. The Offering Warrants are exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice, provided that payment in full for the number of shares of the Company’s common stock purchased upon such exercise is delivered to the Company in accordance with the terms of the Offering Warrants. In lieu of making the cash payment otherwise contemplated to be made to the Company upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the Offering Warrants. A holder (together with its affiliates) may not exercise any portion of the Offering Warrant to the extent that the holder and its affiliates and any other person or entities with which such holder would constitute a Section 13(d) “group” would own more than 4.99% of the Company’s outstanding common stock immediately after exercise. Except as otherwise provided in the Offering Warrants or by virtue of such holder’s ownership of shares of the Company’s common stock, the holders of the Offering Warrants do not have the rights or privileges of holders of common stock with respect to the shares of common stock underlying the Offering Warrants, including any voting rights, until they exercise their Offering Warrants. The Offering Warrants provide that holders have the right to participate in distributions or dividends paid on the Company’s common stock. In the event of a fundamental transaction, as described in the Offering Warrants and generally including any reorganization, recapitalization or reclassification of the Company’s common stock, the sale, transfer or other disposition of all or substantially all of the Company’s properties or assets, the Company’s consolidation or merger with or into another person, the acquisition of more than 50% of the Company’s outstanding common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by the Company’s outstanding common stock, the holders of the Offering Warrants will be entitled to receive upon exercise of the Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the Offering Warrants immediately prior to such fundamental transaction. In addition, in the event of a fundamental transaction which is approved by the Company’s board of directors, the holders of the warrants have the right to require the Company or a successor entity to redeem the Offering Warrants for cash in the amount of the Black Scholes value of the unexercised portion of the Offering Warrants on the date of the consummation of the fundamental transaction. In the event of a fundamental transaction which is not approved by the Company’s board of directors, the holders of the Offering Warrants have the right to require the Company or a successor entity to redeem the Offering Warrants in the amount of the Black Scholes value of the unexercised portion of the Offering Warrants on the date of the consummation of the fundamental transaction payable in the form of consideration paid to the holders of common stock in such fundamental transaction. The Offering Warrants meet the equity classification requirements and thus are recorded in additional paid-in capital on the unaudited condensed balance sheets. As of September 30, 2022, 3,461,858 Offering Warrants have been exercised for 3,030,881 shares of common stock and gross proceeds of approximately $16.9 million. These amounts are exclusive of the Offering Warrants exercised as part of the January 2021 Inducement Transaction discussed below.

Underwriter Warrant

On January 12, 2021, pursuant to the terms of the Underwriting Agreement, the Company issued to the Underwriter a warrant to purchase 806,932 shares of the Company’s common stock (the “Underwriter Warrant”). The Underwriter Warrant is subject to substantially the same terms and conditions as the Warrants, provided that the exercise price for the Underwriter Warrant is $8.125 per share. If the Underwriter exercises any additional portion of its over-allotment option, then the Company shall issue the Underwriter an additional Underwriter Warrant exercisable for a number of shares of common stock equal to 5.0% of the number of shares of common stock issued in such over-allotment exercise (including the shares of common stock issuable upon the exercise of any Warrants issued in connection therewith). In connection with the closing of the Underwriter's partial exercise of its over-allotment option, on February 3, 2021, the Underwriter was issued an additional warrant to purchase 18,702 shares of common stock. As of September 30, 2022, 400,000 Underwriter Warrants have been exercised for 400,000 shares of common stock and gross proceeds of approximately $3.3 million.

January 2021 Warrant Exercise Inducement Letters and Issuance of Warrants

On January 26, 2021, the Company entered into warrant exercise inducement offer letters ( “January 2021 Inducement Transaction”) with certain holders of warrants issued in the Public Offering discussed above (the "Existing Warrants") (collectively, the “Exercising Holders”) pursuant to which such holders agreed to exercise for cash their Existing Warrants to purchase 6,620,358 shares of the Company’s common stock in exchange for the Company’s agreement to issue new warrants (the “January 2021 Inducement Warrants”) on substantially the same terms as the Existing Warrants, except as set forth in the following sentence, to purchase up to 7,944,430 shares of the Company’s common stock, which is equal to 120% of the number of shares of the Company’s common stock issued upon exercise of the Existing Warrants. The purchase price of the January 2021 Inducement Warrants was $0.125 per share underlying each January 2021 Inducement Warrant, and the January 2021 Inducement Warrants have an exercise price of $6.36 per share. The Company received aggregate gross proceeds of approximately $44.0 million from the exercise of the Existing Warrants by the Exercising Holders and the sale of the January 2021 Inducement Warrants. The Company engaged Roth as its exclusive placement agent in connection with these transactions and paid Roth a fee equal to 6% of gross proceeds from the exercise of the Existing Warrants by the Exercising Holders and the sale of the January 2021 Inducement Warrants. As a result of this transaction the anti-dilution provisions contained with the Deerfield Warrant were triggered and the exercise price of the Deerfield Warrant was reduced from $93.60 per share to $46.25 per share.

The January 2021 Inducement Warrants were immediately exercisable and expire on the fifth anniversary of their issuance date, at an exercise price per share of common stock equal to $6.36 per share. The January 2021 Inducement Warrants are exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice, provided that payment in full for the number of shares of the Company’s common stock purchased upon such exercise is delivered to the Company in accordance with the terms of the January 2021 Inducement Warrants. In lieu of making the cash payment otherwise contemplated to be made to the Company upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the warrants. A holder (together with its affiliates) may not exercise any portion of the January 2021 Inducement Warrant to the extent that the holder and its affiliates and any other person or entities with which such holder would constitute a Section 13(d) “group” would own more than 4.99% (or, upon election by a holder prior to the issuance of its January 2021 Inducement Warrants, 9.99%) of the Company’s outstanding common stock immediately after exercise. Except as otherwise provided in the January 2021 Inducement Warrants or by virtue of such holder’s ownership of shares of the Company’s common stock, the holders of the January 2021 Inducement Warrants do not have the rights or privileges of holders of common stock with respect to the shares of common stock underlying the January 2021 Inducement Warrants, including any voting rights, until they exercise their January 2021 Inducement Warrants. The January 2021 Inducement Warrants provide that holders have the right to participate in distributions or dividends paid on the Company’s common stock. In the event of a fundamental transaction, as described in the January 2021 Inducement Warrants and generally including any reorganization, recapitalization or reclassification of the Company’s common stock, the sale, transfer or other disposition of all or substantially all of the Company’s properties or assets, the Company’s consolidation or merger with or into another person, the acquisition of more than 50% of the Company’s outstanding common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by the Company’s outstanding common stock, the holders of the January 2021 Inducement Warrants will be entitled to receive upon exercise of the January 2021 Inducement Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the January 2021 Inducement Warrants immediately prior to such fundamental transaction. In addition, in the event of a fundamental transaction which is approved by the Company’s board of directors, the holders of the January 2021 Inducement Warrants have the right to require the Company or a successor entity to redeem the January 2021 Inducement Warrants for cash in the amount of the Black Scholes value of the unexercised portion of the January 2021 Inducement Warrants on the date of the consummation of the fundamental transaction. In the event of a fundamental transaction which is not approved by the Company’s board of directors, the holders of the January 2021 Inducement Warrants have the right to require the Company or a successor entity to redeem the January 2021 Inducement Warrants in the amount of the Black Scholes value of the unexercised portion of the January 2021 Inducement Warrants on the date of the consummation of the fundamental transaction payable in the form of consideration paid to the holders of common stock in such fundamental transaction. As of September 30, 2022, 1,676,921 January 2021 Inducement Warrants have been exercised for 1,676,921 shares of common stock and gross proceeds of approximately $10.7 million. These amounts are exclusive of the January 2021 Inducement Warrants exercised as part of the June 2021 Inducement Transaction discussed below.

In accordance with the January 2021 Inducement Transaction we recognized a deemed dividend of $37.4 million which is the difference between the grant date fair value of the January 2021 Inducement Warrants and the purchase price of the January 2021 Inducement Warrants. This deemed dividend is added to net loss to arrive at net loss attributable to common stockholders on the statements of operations.

June 2021 Warrant Exercise Inducement Letters and Issuance of Warrants

On June 18, 2021, the Company entered into warrant exercise inducement offer letters ( “June 2021 Inducement Transaction”) with certain holders of warrants issued in the January 2021 Inducement Transaction discussed above (the "January 2021 Inducement Warrants") (collectively, the “June 2021 Exercising Holders”) pursuant to which such holders agreed to exercise for cash their January 2021 Inducement Warrants to purchase 6,117,509 shares of the Company’s common stock in exchange for the Company’s agreement to issue new warrants (the “June 2021 Inducement Warrants”) on substantially the same terms as the January 2021 Inducement Warrants, except as set forth in the following sentence, to purchase up to 1,529,379 shares of the Company’s common stock, which is equal to 25% of the number of shares of the Company’s common stock issued upon exercise of the January 2021 Inducement Warrants. The purchase price of the June 2021 Inducement Warrants was $0.125 per share underlying each June 2021 Inducement Warrant, and the June 2021 Inducement Warrants have an exercise price of $16.50 per share. The Company received aggregate gross proceeds of approximately $39.1 million from the exercise of the January 2021 Inducement Warrants by the June 2021 Exercising Holders and the sale of the June 2021 Inducement Warrants. The Company engaged Roth as its exclusive placement agent in connection with these transactions and paid Roth a fee equal to 6% of gross proceeds from the exercise of the January 2021 Inducement Warrants by the June 2021 Exercising Holders and the sale of the June 2021 Inducement Warrants. As a result of this transaction the anti-dilution provisions contained with the Deerfield Warrant were triggered and the exercise price of the Deerfield Warrant was reduced from $46.25 per share to $38.34 per share.

The June 2021 Inducement Warrants were immediately exercisable and expire on December 31, 2026, at an exercise price per share of common stock equal to $16.50 per share. The June 2021 Inducement Warrants are exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice, provided that payment in full for the number of shares of the Company’s common stock purchased upon such exercise is delivered to the Company in accordance with the terms of the June 2021 Inducement Warrants. In lieu of making the cash payment otherwise contemplated to be made to the Company upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the warrants. A holder (together with its affiliates) may not exercise any portion of the June 2021 Inducement Warrant to the extent that the holder and its affiliates and any other person or entities with which such holder would constitute a Section 13(d) “group” would own more than 4.99% (or, upon election by a holder prior to the issuance of its June 2021 Inducement Warrants, 9.99%) of the Company’s outstanding common stock immediately after exercise. Except as otherwise provided in the June 2021 Inducement Warrants or by virtue of such holder’s ownership of shares of the Company’s common stock, the holders of the June 2021 Inducement Warrants do not have the rights or privileges of holders of common stock with respect to the shares of common stock underlying the June 2021 Inducement Warrants, including any voting rights, until they exercise their June 2021 Inducement Warrants. The June 2021 Inducement Warrants provide that holders have the right to participate in distributions or dividends paid on the Company’s common stock. In the event of a fundamental transaction, as described in the June 2021 Inducement Warrants and generally including any reorganization, recapitalization or reclassification of the Company’s common stock, the sale, transfer or other disposition of all or substantially all of the Company’s properties or assets, the Company’s consolidation or merger with or into another person, the acquisition of more than 50% of the Company’s outstanding common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by the Company’s outstanding common stock, the holders of the June 2021 Inducement Warrants will be entitled to receive upon exercise of the June 2021 Inducement Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the June 2021 Inducement Warrants immediately prior to such fundamental transaction. In addition, in the event of a fundamental transaction which is approved by the Company’s board of directors, the holders of the June 2021 Inducement Warrants have the right to require the Company or a successor entity to redeem the June 2021 Inducement Warrants for cash in the amount of the Black Scholes value of the unexercised portion of the June 2021 Inducement Warrants on the date of the consummation of the fundamental transaction. In the event of a fundamental transaction which is not approved by the Company’s board of directors, the holders of the June 2021 Inducement Warrants have the right to require the Company or a successor entity to redeem the June 2021 Inducement Warrants in the amount of the Black Scholes value of the unexercised portion of the June 2021 Inducement Warrants on the date of the consummation of the fundamental transaction payable in the form of consideration paid to the holders of common stock in such fundamental transaction. As of September 30, 2022, no June 2021 Inducement Warrants have been exercised.

In accordance with the June 2021 Inducement Transaction we recognized a deemed dividend of $16.9 million which is the difference between the grant date fair value of the June 2021 Inducement Warrants and the purchase price of the June 2021 Inducement Warrants. This deemed dividend is added to net loss to arrive at net loss attributable to common stockholders on the unaudited condensed consolidated statements of operations.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

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+ Details

Note G - Stock-based Compensation

9 Months Ended

Sep. 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, the Board of Directors of the Company ("the Board"), and in April 2015, the Company’s stockholders, approved the Company’s 2014 Equity Incentive Plan (the “2014 Plan”), which became effective in April 2015. The 2014 Plan provides for the grant of stock options, other forms of equity compensation, and performance cash awards. In June 2021, the Company's stockholders approved an Amended and Restated 2014 Equity Incentive Plan (the "A&R 2014 Plan"), following its adoption by the Board in April 2021, which among other things added 4,900,000 shares to the maximum number of shares of common stock to be issued under the plan and extended the annual automatic increases (discussed further below) until January 1, 2031 and eliminated individual grant limits that applied under the 2014 Plan to awards that were intended to comply with the exemption for "performance-based compensation" under Code Section 162(m). The maximum number of shares of common stock that may be issued under the A&R 2014 Plan is 6,889,885 as of September 30, 2022. The number of shares of common stock reserved for issuance under the A&R 2014 Plan will automatically increase on January 1 of each year, beginning on January 1, 2016, and ending on and including January 1, 2031, by 4% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Board. Pursuant to the terms of the 2014 Plan, on January 1, 2022, the common stock reserved for issuance under the 2014 Plan automatically increased by 1,400,225 shares.

During the three and nine months ended September 30, 2022, and 2021, no stock options were exercised.

In June 2021, the Company's stockholders approved an Employee Stock Purchase Plan (the "ESPP"), following its adoption by the Board in April 2021. The maximum number of shares of common stock that may be issued under the ESPP is 1,500,000. The first offering period under the ESPP began on October 1, 2021, and the first purchase date occurred on May 31, 2022. As of September 30, 2022, 54,787 shares have been issued under the ESPP.

Stock-based compensation expense recorded under the 2014 Plan, A&R 2014 Plan and ESPP is included in the following line items in the accompanying unaudited condensed consolidated statements of operations (in thousands):

	*Three months ended September 30,*				*Nine months ended September 30,*
	*2022*		*2021*		*2022*		*2021*
Research and development	$	360	$	201	$	1,093	$	630
General and administrative		551		419		2,246		983
Total stock-based compensation expense	$	911	$	620	$	3,339	$	1,613

There was no stock-based compensation expense related to performance-based awards recognized during the three months ended September 30, 2022, or 2021. There was $0.4 million of stock-based compensation expense related to performance-based awards recognized during the nine months ended September 30, 2022, and $0.4 million of stock-based compensation expense related to performance-based awards recognized during the nine months ended September 30, 2021.

Note H - Fair Value of Financial Instruments

9 Months Ended

Sep. 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-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The three tiers are defined as follows:

	●	Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;
	●	Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and
	●	Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

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 September 30, 2022, and December 31, 2021 (in thousands):

	*Balance as of September 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	$	30	$	—	$	—	$	30
Embedded Warrant Put Option		4		—		—		4
KVK Warrant liability		1		—		1		—
Total liabilities	$	35	$	—	$	1	$	34
		—
Securities:
U.S. government-sponsored agency securities	$	7,171	$	—	$	7,171	$	—
Certificates of deposit		20,475		20,475		—		—
U.S. Treasury securities		9,649		9,649		—		—
Total assets	$	37,295	$	30,124	$	7,171	$	—

	*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 September 30, 2022, and December 31, 2021, the Deerfield Warrant liability and the embedded Warrant Put Option are reported on the unaudited condensed consolidated balance sheets in derivative and warrant liability. As of September 30, 2022, and December 31, 2021, the securities are reported on the unaudited condensed consolidated balance sheets in short-term and long-term investments. The Company used a Monte Carlo simulation to value the Deerfield Warrant liability and embedded Warrant Put Option for all periods presented herein. Significant unobservable inputs used in measuring the fair value of these financial instruments included the Company’s estimated enterprise value, an estimate of the timing of a liquidity or fundamental change event and a present value discount rate. Changes in the fair value of the Deerfield Warrant liability and embedded Warrant Put Option are reflected in the unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2022, and 2021, as a fair value adjustment related to derivative and warrant liability.

The derivative liability for the Deerfield Warrant was $30,000 and $288,000 at September 30, 2022, and December 31, 2021, respectively. The derivative liability for the embedded Warrant Put Option was $4,000 and $18,000 at September 30, 2022, and December 31, 2021, respectively. A 10% increase in the enterprise value would result in an increase of $13,000 in the estimated fair value of the Deerfield Warrant liability and an increase of $1,000 in the estimated fair value of the embedded Warrant Put Option liability. In addition, the Company assumed a weighted-average probability of a liquidity event occurring of approximately 25% with an estimated probability-weighted value of approximately $40.0 million and a weighted-average probability of a fundamental change event occurring of approximately 29% with an estimated probability-weighted value of approximately $555.0 million, respectively, with estimated timing in each scenario of the third quarter of 2023.

The Company’s KVK Warrant liability is measured at fair value on a recurring basis. As of September 30, 2022, and December 31, 2021, the KVK Warrant liability is reported on the unaudited condensed consolidated balance sheets in derivative and warrant liability. The Company estimates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the warrant, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the warrant. The expected term represents the period of time the warrant is expected to be outstanding. For the KVK Warrant, the Company used an expected term equal to the contractual term of the warrant. Expected volatility is based on the Company's historical volatility since the IPO. The Company assumes no dividend yield because dividends are not expected to be paid in the near future, which is consistent with the Company’s history of not paying dividends. Changes in the fair value of the KVK Warrant liability are reflected in the unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2022, and 2021, as a fair value adjustment related to derivative and warrant liability.

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) is as follows (in thousands):

	*Three months ended September 30,*						*Nine months ended September 30,*
	*2022*			*2021*			*2022*			*2021*
Balance as of beginning of period	$	56		$	666		$	306		$	255
Adjustment to fair value		(22	)		(305	)		(272	)		106
Balance as of end of period	$	34		$	361		$	34		$	361

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Note I - Net Loss Per Share

9 Months Ended

Sep. 30, 2022

Notes to Financial Statements

Earnings Per Share [Text Block]

I.	Net Loss Per Share

For all periods presented herein, the Company did not use the two-class method to compute net loss attributable to common stockholders per share of common stock, even though it had issued securities, other than common stock, that contractually entitled the holders to participate in dividends and earnings, because these holders are not obligated to participate in a loss. The two-class method requires earnings for the period to be allocated between common stock and participating securities based upon their respective rights to receive distributed and undistributed earnings.

Under the two-class method, for periods with net income attributable to common stockholders, basic net income attributable to common stockholders per share of common stock is computed by dividing the undistributed net income attributable to shares of common stockholders by the weighted average number of shares of common stock outstanding during the period. Undistributed net income attributable to shares of common stockholders is computed by subtracting from net income the portion of current period earnings that participating securities would have been entitled to receive pursuant to their dividend rights had all of the period’s earnings been distributed and subtracting the actual or deemed dividends declared. No such adjustment to earnings is made during periods with a net loss as the holders of the participating securities have no obligation to fund losses. Diluted net income attributable to common stockholders per share of common stock is computed under the two-class method by using the weighted average number of shares of common stock outstanding plus the potential dilutive effects of stock options, warrants and other outstanding convertible securities. In addition to analyzing under the two-class method, the Company analyzes the potential dilutive effect of stock options and warrants, under the treasury-stock method and other outstanding convertible securities under the if-converted method when calculating diluted income (loss) attributable to common stockholders per share of common stock, in which it is assumed that the stock options, warrants and other outstanding convertible securities convert into common stock at the beginning of the period or date of issuance, if the stock option, warrant or other outstanding convertible security was issued during the period. The Company reports the more dilutive of the approaches (two-class or treasury-stock/if-converted) as its diluted net income (loss) attributable to common stockholders per share of common stock during the period.

As noted above, for all periods presented herein, the Company did not utilize the two-class approach as the Company was in a net loss position and the holders of the participating securities have no obligation to fund losses. The Company did analyze diluted net loss attributable to common stockholders per share of common stock under the treasury-stock/if-converted method and noted that all outstanding stock options and warrants were anti-dilutive for the periods presented. For all period presented, basic net loss attributable to common stockholders per share of common stock was the same as diluted net loss attributable to common stockholders per share of common stock.

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 September 30,*				*Nine months ended September 30,*
	*2022*		*2021*		*2022*		*2021*
Awards under equity incentive plans		2,463,509		1,169,379		2,463,509		1,169,379
Common stock warrants		4,252,600		4,221,350		4,252,600		4,221,350
Total securities excluded from the calculation of weighted average number of shares of common stock outstanding		6,716,109		5,390,729		6,716,109		5,390,729

A reconciliation from net loss to basic and diluted net loss attributable to common stockholders per share of common stock for the three and nine months ended September 30, 2022, and 2021, is as follows (in thousands):

	*Three months ended September 30,*						*Nine months ended September 30,*
	*2022*			*2021*			*2022*			*2021*
Basic and diluted net loss per share of common stock:

Net income (loss)	$	(6,616	)	$	(1,759	)	$	(32,522	)	$	(5,852	)
Less: Dividends declared or accumulated		—			—			—			(54,342	)
Net (loss) income attributable to shares of common stockholders, basic and diluted	$	(6,616	)	$	(1,759	)	$	(32,522	)	$	(60,194	)
Less: Net income attributable to participating securities		—			—			—			—
Undistributed net (loss) income attributable to common stockholders, basic and diluted	$	(6,616	)	$	(1,759	)	$	(32,522	)	$	(60,194	)
Weighted average number of shares of common stock outstanding, basic and diluted		34,495			35,218			34,483			27,905
Basic and diluted net loss attributable to common stockholders per share of common stock	$	(0.19	)	$	(0.05	)	$	(0.94	)	$	(2.16	)

Note J - Leases

9 Months Ended

Sep. 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, the Company agreed to sublease office space in Florida, comprised of one of the two contiguous suites, under a non-cancelable operating lease, which expires in February 2026.

The components of lease expense were as follows (in thousands):

	*Three months ended September 30,*						*Nine months ended September 30,*
Lease Cost	*2022*			*2021*			*2022*			*2021*
Finance lease cost:
Amortization of right-of-use assets	$	32		$	32		$	96		$	96
Interest on lease liabilities		0			2			1			9
Total finance lease cost		32			34			97			105
Operating lease cost		114			91			304			274
Short-term lease cost		53			50			155			149
Variable lease cost		13			13			39			34
Less: sublease income		(39	)		(39	)		(117	)		(52	)
Total lease costs	$	173		$	149		$	478		$	510

Supplemental cash flow information related to leases was as follows (in thousands):

	*Nine months ended September 30,*
	*2022*		*2021*
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	1	$	9
Financing cash flows from finance leases		13		156
Operating cash flows from operating leases		381		344
Operating cash flows from short-term leases		155		149
Operating cash flows from variable lease costs		39		34

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):

	*September 30,*			*December 31,*
	*2022*			*2021*
Finance Leases
Property and equipment, at cost	$	1,031		$	1,031
less: accumulated depreciation and amortization		(747	)		(651	)
Property and equipment, net	$	284		$	380

Other current liabilities	$	7		$	15
Other long-term liabilities		1			6
Total finance lease liabilities	$	8		$	21

Operating Leases
Operating lease right-of-use assets	$	1,068		$	1,141
Total operating lease right-of-use assets	$	1,068		$	1,141

Current portion of operating lease liabilities	$	474		$	356
Operating lease liabilities, less current portion		956			1,232
Total operating lease liabilities	$	1,430		$	1,588

Weighted Average Remaining Lease Term
Finance leases (years)		1			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 nine months ended September 30, 2022)	$	2	$	131
2023		6		563
2024		—		488
2025		—		390
2026		—		30
Total lease payments		8		1,602
Less: future interest expense		0		(172	)
Lease liabilities	$	8	$	1,430

Significant Accounting Policies (Policies)	9 Months Ended
Significant Accounting Policies (Policies)	Sep. 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, discount and rebate liabilities, 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 (“ASC 606”), starting 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 require the Company to deliver various rights, services, including intellectual property rights/licenses, research and development services, and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments, consulting fees and/or profit sharing. In arrangements involving more than one performance obligation, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available. 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 occur. Should there be royalties, the Company utilizes the sales and usage-based royalty exception in arrangements that resulted from the license of intellectual property, recognizing revenues generated from royalties or profit sharing as the underlying sales occur. 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 or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments may result in licensing revenues. 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 include such estimates as, independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the licensee which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Up-front Fees: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. Milestone Payments: At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as non-operational developmental and regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or the licensee’s control, such as operational developmental milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price may also result in negative licensing revenues and earnings in the period of adjustment. AZSTARYS License Agreement In September 2019, the Company entered into a Collaboration and License Agreement (the “AZSTARYS License Agreement”) with Commave Therapeutics SA, an affiliate of Gurnet Point Capital (“Commave”). Under the AZSTARYS License Agreement, the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-methylphenidate (“d-MPH”), including AZSTARYS, KP484, and, at the option of Commave, KP879, KP922 or any other product candidate developed by the Company containing SDX and developed to treat ADHD or any other CNS disorder (the “Additional Product Candidates” and, collectively with AZSTARYS and KP484, the “Licensed Product Candidates”). Pursuant to the AZSTARYS License Agreement, Commave (i) paid the Company an upfront payment of $10.0 million; (ii) agreed to pay milestone payments of up to $63.0 million upon the occurrence of specified regulatory milestones related to AZSTARYS and KP484; (iii) agreed to pay additional payments of up to $420.0 million upon the achievement of specified U.S. sales milestones; and (iv) has agreed to pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to the mid-twenties of Net Sales (as defined in the AZSTARYS License Agreement) in the United States and a percentage in the low to mid-single digits of Net Sales in each country outside the United States, in each case subject to specified reductions under certain conditions as described in the AZSTARYS License Agreement. Commave is obligated to make such royalty payments on a product-by-product basis until expiration of the royalty term for the applicable product. In April 2021, the Company entered into Amendment No. 1 to the AZSTARYS Amendment (the "AZSTARYS Amendment"). Pursuant to the AZSTARYS Amendment, the Company and Commave agreed to modify the compensation terms of the AZSTARYS License Agreement. Pursuant to the AZSTARYS Amendment, Commave paid the Company $10.0 million in connection with the entry into the AZSTARYS Amendment as a result of the regulatory approval of AZSTARYS in the United States which occurred on March 2, 2021. Commave also paid the Company $10.0 million following the receipt of the scheduling determination of the compound SDX by the U.S. Drug Enforcement Agency (the "DEA"), which occurred on May 7, 2021. In addition, the AZSTARYS Amendment increased the total remaining future regulatory and sales milestone payments related to AZSTARYS to up to an aggregate of $590.0 million in payments upon the occurrence of specified regulatory milestones related to AZSTARYS and upon the achievement of specified U.S. net sales milestones. Further, under the AZSTARYS Amendment, Commave agreed to pay the Company quarterly, tiered royalty payments that are calculated from a base royalty rate percentage in the high single digits to the mid-twenties of net sales in the United States, subject to adjustment based on annual net sales, and a percentage in the low to mid-single digits of Net Sales in each country outside the United States, in each case subject to specified reductions under certain conditions, including with respect to the final approval label, as described in the AZSTARYS License Agreement. Commave is obligated to make such royalty payments on a product-by-product basis until expiration of the royalty term for the applicable product. Pursuant to the AZSTARYS Amendment, Commave and the Company also agreed to modify Commave’s right of first refusal ("ROFR") such that the Company’s product candidate, KP922, is no longer subject to Commave’ ROFR to acquire, license or commercialize any Additional Product Candidate. Commave’s ROFR shall only apply to any Additional Product Candidate which contains SDX, with such ROFR expiring upon the acceptance of an NDA for such Additional Product Candidate containing SDX. 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 AZSTARYS License Agreement. As part of this agreement the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products. In accordance with the terms of the Company’s March 20, 2012 Termination Agreement with Aquestive Therapeutics (formerly known as MonoSol Rx, LLC), Aquestive Therapeutics has the right to receive an amount equal to 10% of any royalty or milestone payments made to the Company related to AZSTARYS, KP484, KP879 or KP1077 under the AZSTARYS License Agreement. The AZSTARYS License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the AZSTARYS License Agreement. Using the concepts of ASC 606, the Company identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket third-party research and development costs, as its only two performance obligations at inception. The Company further determined that the transaction price, at inception, under the agreement was $10.0 million upfront payment plus the fair value of the Development Costs (as defined in the AZSTARYS License Agreement) which was allocated among the performance obligations based on their respective related stand-alone selling price. The consideration allocated to the grant of the exclusive, worldwide license was $10.0 million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type of transaction. The Company determined that the intellectual property licensed under the AZSTARYS License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at a point in time at the inception of the AZSTARYS License Agreement. Under the AZSTARYS License Agreement, Commave was granted an exclusive right to first negotiation whereby upon completion of a Phase 1 proof-of-concept study, the Company and Commave may negotiate the economic terms under which certain Additional Products may be included as a Product (both as defined in the AZSTARYS License Agreement) under the AZSTARYS License Agreement (the “Additional Product Option”). In addition to the Additional Product Option, Commave was also granted a ROFR to acquire, license and/or commercialize any of the Additional Product Candidates should they choose not to exercise the Additional Product Option. Should Commave choose to exercise the Additional Product Option on any Additional Product Candidates, Commave and the Company shall negotiate in good faith regarding the economic terms of such Additional Product Candidate. Further, should Commave exercise the ROFR on any Additional Product Candidate, the economic terms of the agreement shall be the same as those offered to the third-party. Under ASC 606 an option to acquire additional goods or services gives rise to a performance obligation if the option provides a material right to the customer. The Company concluded that the above-described Additional Product Option and ROFR do not constitute material rights to the customer as Commave would acquire the goods or services at a to be negotiated price, which the Company expects to approximate fair value and therefore Commave would not receive a material discount on these goods or services compared to market rates. The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to AZSTARYS and KP484 and the achievement of certain U.S. sales milestones. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the AZSTARYS License Agreement) in the United States and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the AZSTARYS License Agreement. The Company concluded that these regulatory milestones, sales milestones and royalty payments each contain a significant uncertainty associated with a future event. As such, these milestone and royalty payments are constrained at contract inception and are not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments. At the end of each reporting period, the Company updates its assessment of whether the milestone and royalty payments are constrained by considering both the likelihood and magnitude of the potential revenue reversal. Per the AZSTARYS Amendment, the Company earned a regulatory milestone payment of $10.0 million following the FDA’s approval of the AZSTARYS NDA, in March 2021, as well as $10.0 million following the DEA's scheduling of SDX in May 2021. Since the FDA approved the NDA for AZSTARYS and the DEA scheduled SDX, the constraints were removed and revenue recognized. The associated revenue was allocated among the two performance obligations identified at contract inception. Since both performance obligations were satisfied as of the end of each respective quarter of 2021, the full $10.0 million for each milestone was recognized as revenue in the statements of operations for the first quarter and second quarter of 2021, respectively. In accordance with ASC 340-40, Contracts with Customers, the Company recognized $1.0 million, respectively, of royalty costs due to payment to Aquestive related to the regulatory milestones earned and recorded it in the item titled royalty and direct contract acquisition costs in the unaudited condensed statements of operations for first and second quarter of 2021. For the three months ended September 30, 2022, the Company recognized $0.2 million of revenue under the AZSTARYS License Agreement. For the three months ended September 30, 2021, the Company recognized minimal revenue under the AZSTARYS License Agreement. For the nine months ended September 30, 2022, and 2021, the Company recognized revenue under the AZSTARYS License Agreement of $0.4 million and $20.0 million, respectively. There was no deferred revenue related to this agreement as of September 30, 2022, or December 31, 2021. Consulting Arrangements The Company enters into consulting arrangements with third parties that fall under the scope of ASC 606. These arrangements may require the Company to deliver various rights, services, including research and development services, regulatory services and/or commercialization support services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of consulting fees and reimbursements of out-of-pocket third-party research and development, regulatory and commercial costs. Corium Consulting Agreement In July 2020, the Company entered into a consultation services arrangement (the “Corium Consulting Agreement”) with Corium, Inc. (“Corium”) under which Corium engaged the Company to guide the product development and regulatory activities for certain current and potential future products in Corium’s portfolio, as well as continue supporting preparation for the potential commercial launch of AZSTARYS (together, “Corium Consulting Services”). Corium is a portfolio company of Gurnet Point Capital and was tasked by Commave to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement, as discussed above. 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, and paid in arrears. The remaining $2.0 million was conditioned upon the approval by the FDA of the NDA for Corium's product candidate, ADLARITY, which was approved by the FDA in the first quarter of 2022. Corium also agreed to be responsible for and reimburse the Company for all development, commercialization and regulatory expenses incurred as part of the performance of the Corium Consulting Services. The Corium Consulting Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the Corium Consulting Agreement. Using the concepts of ASC 606, the Company identified the performance of consulting services, which includes the reimbursement to the Company of third-party pass-through costs, as its only performance obligation at inception. The Company further determined that the transaction price, at inception, under the agreement was $13.6 million which is the fair value of the consulting services, including the reimbursement of third-party pass-through costs. The Company concluded that the regulatory milestone contains a significant uncertainty associated with a future event. As such, this milestone is constrained at contract inception and is not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments. At the end of each reporting period, the Company updates its assessment of whether the milestone is constrained by considering both the likelihood and magnitude of the potential revenue reversal. The Company determined that the performance of consulting services, including reimbursement of third-party pass-through costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable third-party pass-through costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity’s right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity’s performance completed to date. As of March 31, 2022, the Company had recognized approximately all of the consulting services and third-party pass-through costs under the Corium Consulting Agreement. For the three months ended September 30, 2022, the Company recognized no revenue under the Corium Consulting Agreement related to ADLARITY. For the three months ended September 30, 2021, the Company recognized revenue under the Corium Consulting Agreement related to ADLARITY of $2.0 million. For the nine months ended September 30, 2022, and 2021 the Company recognized revenue under the Corium Consulting Agreement related to ADLARITY of $3.5 million and $5.9 million, respectively. As of September 30, 2022, the Company had no deferred revenue related to this agreement. As of December 31, 2021, the Company had deferred revenue related to this agreement of $0.4 million. Other Consulting Arrangements For the three months ended September 30, 2022, the Company recognized revenue under other consulting arrangements of $0.3 million. For the three months ended September 30, 2021, the Company recognized no revenue under other consulting arrangements. For the nine months ended September 30, 2022, and 2021, the Company recognized revenue under other consulting arrangements of $0.6 million and $0.2 million, respectively. There was no deferred revenue from other consulting arrangements as of September 30, 2022, or 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 and, as a result, follows the five-step model when recognizing revenue: 1) identifying a contract; 2) identifying the performance obligations; 3) determining the transaction price; 4) allocating the price to the performance obligations; and 5) recognizing revenue when the performance obligations have been fulfilled. Net revenue includes 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 yet approved for commercial sale. Only drugs targeting serious or rare indications and for which there is currently no appropriate treatment are considered for early access compassionate use programs. Further, to be considered for the early access compassionate use program, the drug must have proven efficacy and safety and must either be undergoing price negotiations or seeking marketing approval. 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-party customer. Under the French nATU, the manufacturer can set its own price for the drug products until a price agreement with the authorities is in place. Any excess in the price charged by the manufacturer compared to the price agreed with the health authorities once the drug product is approved in France must be repaid. The repayment is considered in the clawback liability. 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. 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 months ended September 30, 2022, the Company recognized revenue related to the Arimoclomol EAP in France of $2.3 million, which is net of a clawback liability of $1.2 million. For the nine months ended September 30, 2022, the Company recognized revenue related to the Arimoclomol EAP in France of $3.2 million, which is net of a clawback liability of $1.7 million. 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 September 30, 2022, including the additional clawback liability for the three and nine months ended September 30, 2022, was $6.3 million. As of September 30, 2022, this estimated reserve liability is recorded as discount and rebate liabilities in the unaudited condensed consolidated balance sheet and is separated into current and long-term based upon the timing of the expected payment to the French regulators.
Receivable [Policy Text Block]	Accounts and Other Receivables Accounts and other receivables consist of receivables under the AZSTARYS License Agreement and Arimoclomol EAP, as well as receivables related to consulting arrangements, income tax receivables and other receivables due to the Company. Receivables under the AZSTARYS License Agreement are recorded for amounts due to the Company related to reimbursable third-party costs and royalties on product sales. Receivables under the Arimoclomol EAP are recorded for product sales under the program in France. These receivables, as well as the receivables related to consulting arrangements, are evaluated to determine if any reserve or allowance should be established at each reporting date. As of September 30, 2022, the Company had receivables related to the Arimoclomol EAP of $4.9 million, consulting arrangements of $0.6 million, income tax receivables of $0.7 million and other receivables of $0.4 million. As of December 31, 2021, the Company had receivables related to the Corium Consulting Agreement of $1.2 million, AZSTARYS License Agreement of $0.1 million, income tax receivables of $0.1 million and other consulting arrangements of $0.1 million. As of September 30, 2022, and December 31, 2021, no reserve or allowance for doubtful accounts has been established.
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, the FASB issued ASU 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 (“ASU 2020-06”), which addresses issues identified as a result of the complexities associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. This update addresses, among other things, the number of accounting models for convertible debt instruments and convertible preferred stock, targeted improvements to the disclosures for convertible instruments and earnings-per-share (“EPS”) guidance and amendments to the guidance for the derivatives scope exception for contracts in an entity’s own equity, as well as the related EPS guidance. This update applies to all entities that issue convertible instruments and/or contracts in an entity’s own equity. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. FASB specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The adoption of ASU 2020-06 did not have a material impact on the Company’s unaudited condensed financial statements and disclosures. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt— Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40); Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options, a consensus of the FASB Emerging Issues Task Force (“ASU 2021-04”), which aims to clarify and reduce diversity in issuer's accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. This update applies to all entities that issue freestanding written call options that are classified in equity. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. FASB specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The adoption of ASU 2021-04 did not have a material impact on the Company’s unaudited condensed financial statements and disclosures.

- Definition

Disclosure of accounting policy for revenue from contract with customer.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 17
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130561-203045

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 20
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130566-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130563-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI https://asc.fasb.org/topic&trid=49130388

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 20
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130566-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130563-203045

Reference 7: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (e)
-URI https://asc.fasb.org/extlink&oid=126899994&loc=d3e18823-107790

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 20
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130566-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 19
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130564-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 20
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130566-203045

+ Details

Note A - Description of Business, Basis of Presentation and Significant Transactions (Tables)

9 Months Ended

Sep. 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

Note F - Common Stock and Warrants (Tables)

9 Months Ended

Sep. 30, 2022

Notes Tables

Schedule of Authorized Shares of Common Stock Reserved for Future Issuance [Table Text Block]

	*September 30, 2022*		*December 31, 2021*
Outstanding awards under equity incentive plans		2,463,509		1,273,879
Outstanding common stock warrants		4,252,600		4,252,600
Possible future issuances under equity incentive plans		4,414,406		4,209,935
Possible future issuances under employee stock purchase plans		1,445,213		1,500,000
Total common shares reserved for future issuance		12,575,728		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
Common stock issued as compensation to third-parties		11,830
Balance as of September 30, 2022		34,501,144

Note G - Stock-based Compensation (Tables)

9 Months Ended

Sep. 30, 2022

Notes Tables

Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]

	*Three months ended September 30,*				*Nine months ended September 30,*
	*2022*		*2021*		*2022*		*2021*
Research and development	$	360	$	201	$	1,093	$	630
General and administrative		551		419		2,246		983
Total stock-based compensation expense	$	911	$	620	$	3,339	$	1,613

Note H - Fair Value of Financial Instruments (Tables)

9 Months Ended

Sep. 30, 2022

Notes Tables

Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]

	*Balance as of September 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	$	30	$	—	$	—	$	30
Embedded Warrant Put Option		4		—		—		4
KVK Warrant liability		1		—		1		—
Total liabilities	$	35	$	—	$	1	$	34
		—
Securities:
U.S. government-sponsored agency securities	$	7,171	$	—	$	7,171	$	—
Certificates of deposit		20,475		20,475		—		—
U.S. Treasury securities		9,649		9,649		—		—
Total assets	$	37,295	$	30,124	$	7,171	$	—

	*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 September 30,*						*Nine months ended September 30,*
	*2022*			*2021*			*2022*			*2021*
Balance as of beginning of period	$	56		$	666		$	306		$	255
Adjustment to fair value		(22	)		(305	)		(272	)		106
Balance as of end of period	$	34		$	361		$	34		$	361

Note I - Net Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2022

Notes Tables

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]

	*Three months ended September 30,*				*Nine months ended September 30,*
	*2022*		*2021*		*2022*		*2021*
Awards under equity incentive plans		2,463,509		1,169,379		2,463,509		1,169,379
Common stock warrants		4,252,600		4,221,350		4,252,600		4,221,350
Total securities excluded from the calculation of weighted average number of shares of common stock outstanding		6,716,109		5,390,729		6,716,109		5,390,729

Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]

	*Three months ended September 30,*						*Nine months ended September 30,*
	*2022*			*2021*			*2022*			*2021*
Basic and diluted net loss per share of common stock:

Net income (loss)	$	(6,616	)	$	(1,759	)	$	(32,522	)	$	(5,852	)
Less: Dividends declared or accumulated		—			—			—			(54,342	)
Net (loss) income attributable to shares of common stockholders, basic and diluted	$	(6,616	)	$	(1,759	)	$	(32,522	)	$	(60,194	)
Less: Net income attributable to participating securities		—			—			—			—
Undistributed net (loss) income attributable to common stockholders, basic and diluted	$	(6,616	)	$	(1,759	)	$	(32,522	)	$	(60,194	)
Weighted average number of shares of common stock outstanding, basic and diluted		34,495			35,218			34,483			27,905
Basic and diluted net loss attributable to common stockholders per share of common stock	$	(0.19	)	$	(0.05	)	$	(0.94	)	$	(2.16	)

Note J - Leases (Tables)

9 Months Ended

Sep. 30, 2022

Notes Tables

Lease, Cost [Table Text Block]

	*Three months ended September 30,*						*Nine months ended September 30,*
Lease Cost	*2022*			*2021*			*2022*			*2021*
Finance lease cost:
Amortization of right-of-use assets	$	32		$	32		$	96		$	96
Interest on lease liabilities		0			2			1			9
Total finance lease cost		32			34			97			105
Operating lease cost		114			91			304			274
Short-term lease cost		53			50			155			149
Variable lease cost		13			13			39			34
Less: sublease income		(39	)		(39	)		(117	)		(52	)
Total lease costs	$	173		$	149		$	478		$	510

Schedule of Leases Cash Flow Information [Table Text Block]

	*Nine months ended September 30,*
	*2022*		*2021*
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	1	$	9
Financing cash flows from finance leases		13		156
Operating cash flows from operating leases		381		344
Operating cash flows from short-term leases		155		149
Operating cash flows from variable lease costs		39		34

Right-of-use assets obtained in exchange for lease liabilities:
Finance leases	$	—	$	—
Operating leases		146		—

Schedule of Leases Balance Sheet Information [Table Text Block]

	*September 30,*			*December 31,*
	*2022*			*2021*
Finance Leases
Property and equipment, at cost	$	1,031		$	1,031
less: accumulated depreciation and amortization		(747	)		(651	)
Property and equipment, net	$	284		$	380

Other current liabilities	$	7		$	15
Other long-term liabilities		1			6
Total finance lease liabilities	$	8		$	21

Operating Leases
Operating lease right-of-use assets	$	1,068		$	1,141
Total operating lease right-of-use assets	$	1,068		$	1,141

Current portion of operating lease liabilities	$	474		$	356
Operating lease liabilities, less current portion		956			1,232
Total operating lease liabilities	$	1,430		$	1,588

Weighted Average Remaining Lease Term
Finance leases (years)		1			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 nine months ended September 30, 2022)	$	2	$	131
2023		6		563
2024		—		488
2025		—		390
2026		—		30
Total lease payments		8		1,602
Less: future interest expense		0		(172	)
Lease liabilities	$	8	$	1,430

Note A - Description of Business, Basis of Presentation and Significant Transactions (Details Textual) - USD ($)
$ / shares in Units, $ in Thousands

3 Months Ended

9 Months Ended

May 15, 2022

Jul. 12, 2021

Feb. 01, 2021

Jan. 12, 2021

Jan. 08, 2021

Sep. 30, 2022

Sep. 30, 2021

Sep. 30, 2022

Dec. 31, 2021

Dec. 20, 2021

Jul. 02, 2021

Feb. 03, 2021

Sale of Stock, Authorized Amount

$ 350,000

Stock Issued During Period, Value, New Issues

$ 1,105

Stock Repurchase Program, Authorized Amount

$ 50,000

Treasury Stock, Value, Total

$ 7,536

$ 2,814

Share Repurchase Program [Member]

Treasury Stock, Shares, Total (in shares)

909,953

Treasury Stock, Value, Total

$ 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

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

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)

Equity Distribution Agreement, Maximum Aggregate Offering Price

$ 75,000

Equity Distribution Agreement, Commission Fee, Percentage of Gross Sales

3.00%

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

6,300

$ 6,300

Estimated Weighted Average Cost of Capital

42.00%

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 Business, Basis of Presentation and Significant Transactions - Consideration Paid and Purchase Price Allocation for the Acquisition of Arimoclomol (Details) - Arimoclomol Purchase Agreement [Member] - USD ($)
$ in Thousands

3 Months Ended

9 Months Ended

May 15, 2022

Sep. 30, 2022

Cash

$ 12,800

Assumed reserve liability

5,200

$ 6,300

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 Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands							3 Months Ended			9 Months Ended
	May 15, 2022	May 07, 2021	Apr. 08, 2021	Mar. 02, 2021	Sep. 03, 2019	Mar. 20, 2012	Sep. 30, 2022	Sep. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021	Jul. 31, 2020
Revenue from Contract with Customer, Including Assessed Tax							$ 2,874	$ 1,965		$ 8,139	$ 26,068
Income Taxes Receivable												$ 100
Accounts Receivable, Allowance for Credit Loss, Ending Balance							0			0		0
Arimoclomol Purchase Agreement [Member]
Contract with Customer, Liability, Revenue Recognized							2,300			3,200
Contract with Customer, Clawback Liability							1,200			1,700
Asset Acquisition, Consideration Transferred, Estimated Reserve Liability	$ 5,200						6,300			6,300
Accounts Receivable, after Allowance for Credit Loss, Current, Total							4,900			4,900
Consulting Services [Member]
Accounts Receivable, after Allowance for Credit Loss, Current, Total							600			600
Consulting Services [Member]
Revenue from Contract with Customer, Including Assessed Tax							300			600	200
Deferred Revenue, Total							0			0		0
Accounts Receivable, after Allowance for Credit Loss, Current, Total												100
Income Taxes Receivable							700			700
Other Receivables							400			400
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		0
Accounts Receivable, after Allowance for Credit Loss, Current, Total												100
Aquestive Therapeutics [Member] \| License [Member]
Revenue from Contract with Customer, Including Assessed Tax							200			400	20,000
Royalty Revenue, Percent						10.00%
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			3,500	5,900
Deferred Revenue, Total							$ 0			$ 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			$ 2,000		$ 2,000

Note C - Debt Obligations (Details Textual) - USD ($)										1 Months Ended	9 Months Ended			12 Months Ended
Note C - Debt Obligations (Details Textual) - USD ($)	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	Sep. 30, 2022	Sep. 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	$ 20,000,000.0										20,000,000.0
Debt Conversion, Converted Instrument, Shares Issued (in shares)													1,777,437
Interest Paid, Excluding Capitalized Interest, Operating Activities											165,000	$ 213,000
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								100.00%
Debt Instrument, Cancellation of Debt, Amount						$ 3,000,000.0	$ 71,400,000
Interest Paid, Excluding Capitalized Interest, Operating Activities						$ 37,000	$ 700,000
Debt Instrument, Percentage of Accrued Interest Paid							50.00%
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						50.00%
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						$ 3,000,000.0
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																	$ 7,000,000.0
Debt Covenant, Debt Financing Restriction									$ 750,000
Repayments of Long-term Debt, Total		$ 8,000,000.0
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 Contingencies (Details Textual) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Loss Contingency Accrual, Ending Balance	$ 0	$ 0

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	Sep. 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 Warrants (Details Textual) - USD ($) $ / shares in Units, $ in Thousands					1 Months Ended	3 Months Ended		6 Months Ended	9 Months Ended
	Jan. 26, 2021	Jan. 12, 2021	Oct. 25, 2018	Jun. 02, 2014	Jan. 31, 2021	Sep. 30, 2022	Sep. 30, 2021	Jun. 18, 2021	Sep. 30, 2022	Sep. 30, 2021	Jun. 30, 2022	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)						35,411,097			35,411,097				35,325,801
Common Stock, Shares, Outstanding, Ending Balance (in shares)						34,501,144			34,501,144		34,489,314	34,423,497	35,005,640
Proceeds from Warrant Exercises									$ 0	$ 30,819
Preferred Stock Dividends and Other Adjustments, Total						$ (0)	$ (0)		(0)	$ 54,342
Other Noncurrent Assets [Member]
Contract with Customer, Asset, after Allowance for Credit Loss, Total						$ 400			$ 400				$ 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		5.00%
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	6.00%
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								$ 39,100	$ 10,700
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	120.00%
Class of Warrant, Purchase Price Per Warrant (in dollars per share)	$ 0.125
Placement Agent Fee, Percentage								6.00%
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								25.00%
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 Warrants - Reserved Authorized Shares of Common Stock for Future Issuance (Details) - shares	Sep. 30, 2022	Dec. 31, 2021
Common shares reserved for future issuance (in shares)	12,575,728	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)	2,463,509	1,273,879
Possible Future Issuances Under Equity Incentive Plans [Member]
Common shares reserved for future issuance (in shares)	4,414,406	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 Warrants - Common Stock Activity (Details) - shares	3 Months Ended			9 Months Ended
	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2022
Balance (in shares)	34,489,314	34,423,497	35,005,640	35,005,640
Common stock issued as compensation to third-parties (in shares)	11,830	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)	11,830	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)	34,501,144	34,489,314	34,423,497	34,501,144

Note G - Stock-based Compensation (Details Textual) - USD ($) $ in Thousands		1 Months Ended	3 Months Ended			9 Months Ended
	Jan. 01, 2022	Jun. 30, 2021	Sep. 30, 2022	Jun. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 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			$ 911		$ 620	$ 3,339	$ 1,613
Performance Shares [Member]
Share-Based Payment Arrangement, Expense			$ 0		$ 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
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Reserved for Issuance, Incremental Percentage of Capital Stock Outstanding		4.00%
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		0	0	0

Note G - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Stock based compensation expense	$ 911	$ 620	$ 3,339	$ 1,613
Research and Development Expense [Member]
Stock based compensation expense	360	201	1,093	630
General and Administrative Expense [Member]
Stock based compensation expense	$ 551	$ 419	$ 2,246	$ 983

Note H - Fair Value of Financial Instruments (Details Textual)	9 Months Ended
	Sep. 30, 2022 USD ($)	Dec. 31, 2021 USD ($)
Deerfield Warrant Liability [Member]
Liabilities, Fair Value Disclosure, Total	$ 30,000	$ 288,000
Liabilities, Fair Value Disclosure, Increase from Ten Percent Increase in Enterprise Value	13,000
Liabilities, Fair Value Disclosure, Estimated Amount of Weighted-average Probability of Liquidity Event	40,000,000.0
Liabilities, Fair Value Disclosure, Estimated Amount of Weighted-average Probability of Fundamental Change	$ 555,000,000.0
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	29
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 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		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Balance as of beginning of period	$ 56	$ 666	$ 306	$ 255
Adjustment to fair value	(22)	(305)	(272)	106
Balance as of end of period	$ 34	$ 361	$ 34	$ 361

Note I - Net Loss Per Share - Anti-dilutive Securities (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Antidilutive securities (in shares)	6,716,109	5,390,729	6,716,109	5,390,729
Share-Based Payment Arrangement [Member]
Antidilutive securities (in shares)	2,463,509	1,169,379	2,463,509	1,169,379
Warrants to Purchase Common Stock [Member]
Antidilutive securities (in shares)	4,252,600	4,221,350	4,252,600	4,221,350

Note I - Net Loss Per Share - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021
Net loss	$ (6,616)	$ (24,042)	$ (1,864)	$ (1,759)	$ 6,203	$ (10,296)	$ (32,522)	$ (5,852)
Less: Dividends declared or accumulated	0			0			0	(54,342)
Net loss attributable to common stockholders	(6,616)			(1,759)			(32,522)	(60,194)
Less: Net income attributable to participating securities	0			0			0	0
Undistributed net (loss) income attributable to common stockholders, basic and diluted	$ (6,616)			$ (1,759)			$ (32,522)	$ (60,194)
Basic and diluted (in shares)	34,494,702			35,217,953			34,482,791	27,904,711
Basic and diluted net loss attributable to common stockholders per share of common stock (in dollars per share)	$ (0.19)			$ (0.05)			$ (0.94)	$ (2.16)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

+ References

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- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

- Definition

Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

+ References

+ Details

Note J - Leases (Details Textual)	9 Months Ended
Note J - Leases (Details Textual)	Sep. 30, 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 (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Amortization of right-of-use assets	$ 32	$ 32	$ 96	$ 96
Interest on lease liabilities	0	2	1	9
Total finance lease cost	32	34	97	105
Operating lease cost	114	91	304	274
Short-term lease cost	53	50	155	149
Variable lease cost	13	13	39	34
Less: sublease income	(39)	(39)	(117)	(52)
Total lease costs	$ 173	$ 149	$ 478	$ 510

Note J - Leases - Supplement Cash Flow Information Related to Leases (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Operating cash flows from finance leases	$ 1	$ 9
Financing cash flows from finance leases	13	156
Operating cash flows from operating leases	381	344
Operating cash flows from short-term leases	155	149
Operating cash flows from variable lease costs	39	34
Finance leases	0	0
Operating leases	$ 146	$ 0

Note J - Leases - Supplement Balance Sheet Information Related to Lease (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Lease liabilities, finance leases	$ 8	$ 21
Operating lease right-of-use assets	1,068	1,141
Total operating lease right-of-use assets	1,068	1,141
Current portion of operating lease liabilities	474	356
Operating lease liabilities, less current portion	956	1,232
Total operating lease liabilities	$ 1,430	$ 1,588
Finance leases (years) (Year)	1 year	1 year
Operating leases (years) (Year)	3 years	4 years
Finance leases	14.30%	12.00%
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	(747)	(651)
Property and Equipment, Net [Member]
Property and equipment, net	284	380
Other Current Liabilities [Member]
Other current liabilities	7	15
Other Noncurrent Liabilities [Member]
Other long-term liabilities	1	6
Operating Lease Right-of-Use Assets [Member]
Operating lease right-of-use assets	1,068	1,141
Total operating lease right-of-use assets	1,068	1,141
Current Portion of Operating Lease Liabilities [Member]
Current portion of operating lease liabilities	474	356
Operating Lease Liabilities, Less Current Portion [Member]
Operating lease liabilities, less current portion	$ 956	$ 1,232

Note J - Leases - Maturities of lease Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
2022 (excluding the three months ended June 30, 2022), finance leases	$ 2
2022 (excluding the three months ended March 31, 2021), operating leases	131
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	8
Total lease payments, operating leases	1,602
Less: future interest expense, finance leases	0
Less: future interest expense, operating leases	(172)
Lease liabilities, finance leases	8	$ 21
Lease liabilities, operating leases	$ 1,430	$ 1,588

Note H - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Fair Value, Recurring [Member]
Total assets	$ 37,295,000	$ 15,422,000
Fair Value, Recurring [Member] \| US Government Agencies Debt Securities [Member]
Total assets	7,171,000	4,997,000
Fair Value, Recurring [Member] \| Certificates of Deposit [Member]
Total assets	20,475,000	490,000
Fair Value, Recurring [Member] \| US Treasury Securities [Member]
Total assets	9,649,000	9,935,000
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 1 [Member]
Total assets	30,124,000	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] \| Certificates of Deposit [Member]
Total assets	20,475,000	490,000
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 1 [Member] \| US Treasury Securities [Member]
Total assets	9,649,000	9,935,000
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 2 [Member]
Total assets	7,171,000	4,997,000
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 2 [Member] \| US Government Agencies Debt Securities [Member]
Total assets	7,171,000	4,997,000
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] \| 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	30,000	288,000
Deerfield Warrant Liability [Member] \| Fair Value, Recurring [Member]
Financial liabilities measured at fair value on recurring basis	30,000	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	30,000	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	35,000	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	$ 34,000	$ 306,000