0000950170-22-022333 | 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. 02, 2022
Document Information [Line Items]
Entity Registrant Name	CLENE INC.
Trading Symbol	CLNN
Document Type	10-Q
Current Fiscal Year End Date	--12-31
Entity Common Stock, Shares Outstanding		73,820,010
Amendment Flag	false
Entity Central Index Key	0001822791
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Document Period End Date	Sep. 30, 2022
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Shell Company	false
Entity Ex Transition Period	false
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	01-39834
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	85-2828339
Entity Address, Address Line One	6550 South Millrock Drive
Entity Address, Address Line Two	Suite G50
Entity Address, City or Town	Salt Lake City
Entity Address, State or Province	UT
Entity Address, Postal Zip Code	84121
City Area Code	801
Local Phone Number	676-9695
Title of 12(b) Security	Common Stock, $0.0001 par value
Security Exchange Name	NASDAQ
Entity Interactive Data Current	Yes

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 7,267	$ 50,288
Marketable securities	8,966	0
Accounts receivable	126	49
Inventory	38	41
Prepaid expenses and other current assets	5,089	4,205
Total current assets	21,486	54,583
Restricted cash	58	58
Right-of-use assets	4,707	3,250
Property and equipment, net	9,753	5,172
Total assets	36,004	63,063
Current liabilities:
Accounts payable	3,454	1,923
Accrued liabilities	2,136	3,610
Operating lease obligations, current portion	467	347
Finance lease obligations, current portion	97	146
Total current liabilities	6,154	6,026
Operating lease obligations, net of current portion	5,711	4,370
Finance lease obligations, net of current portion	45	97
Notes payable	15,726	14,484
Convertible notes payable	4,763	4,598
Common stock warrant liability	18	474
Clene Nanomedicine contingent earn-out liability	11,438	18,100
Initial Shareholders contingent earn-out liability	1,468	2,317
TOTAL LIABILITIES	45,323	50,466
Commitments and contingencies (Note 11)
Stockholders’ equity:
Common stock, $0.0001 par value: 150,000,000 shares authorized; 63,541,984 and 62,312,097 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively	6	6
Additional paid-in capital	182,760	175,659
Accumulated deficit	(192,165)	(163,301)
Accumulated other comprehensive income	80	233
TOTAL STOCKHOLDERS' EQUITY (DEFICIT)	(9,319)	12,597
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)	$ 36,004	$ 63,063

Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Common stock, par value (in Dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized	150,000,000	150,000,000
Common stock, shares issued	63,541,984	62,312,097
Common stock, shares outstanding	63,541,984	62,312,097

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenue:
Total revenue	$ 174	$ 110	$ 239	$ 524
Operating expenses:
Cost of revenue	19	14	19	812
Research and development	6,403	6,146	24,149	18,893
General and administrative	3,557	4,400	12,807	16,739
Total operating expenses	9,979	10,560	36,975	36,444
Loss from operations	(9,805)	(10,450)	(36,736)	(35,920)
Other income (expense), net:
Interest Expense	(857)	80	(2,390)	(497)
Gain on extinguishment of notes payable	0	0	0	647
Gain on termination of lease	0	0	420	0
Change in fair value of common stock warrant liability	149	414	151	547
Change in fair value of Clene Nanomedicine contingent earn-out liability	(1,591)	35,042	6,662	18,072
Change in fair value of Initial Shareholders contingent earn-out liability	(205)	3,439	849	1,710
Australia research and development credit	1,346	364	2,001	1,078
Other income (expense), net	(13)	(14)	179	(13)
Total other income (expense), net	(1,171)	39,325	7,872	21,544
Net income (loss) before income taxes	(10,976)	28,875	(28,864)	(14,376)
Income tax benefit	0	69	0	213
Net income (loss)	(10,976)	28,944	(28,864)	(14,163)
Other comprehensive loss:
Unrealized gain (loss) on available-for-sale securities	33	0	(54)	0
Foreign currency translation adjustments	(39)	(87)	(99)	(124)
Total other comprehensive loss	(6)	(87)	(153)	(124)
Comprehensive income (loss)	$ (10,982)	$ 28,857	$ (29,017)	$ (14,287)
Net income (loss) per share (Note 16) Basic	$ (0.17)	$ 0.47	$ (0.46)	$ (0.23)
Net income (loss) per share (Note 16) Diluted	$ (0.17)	$ 0.42	$ (0.46)	$ (0.23)
Weighted average common shares outstanding (Note16) Basic	63,508,928	62,071,754	63,234,757	61,307,699
Weighted average common shares outstanding (Note16) Diluted	63,508,928	70,038,634	63,234,757	61,307,699
Product revenue
Revenue:
Total revenue	$ 130	$ 63	$ 139	$ 400
Royalty revenue
Revenue:
Total revenue	$ 44	$ 47	$ 100	$ 124

Condensed Consolidated Statements Of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Accumulated Other Comprehensive Income (Loss)
Balances at Dec. 31, 2020	$ 341	$ 6	$ 153,571	$ (153,561)	$ 325
Balances (in Shares) at Dec. 31, 2020		59,526,171
Exercise of stock options	50	$ 0	50	0	0
Exercise of stock options (in Shares)		48,211
Stock-based compensation expense	3,265	$ 0	3,265	0	0
Foreign currency translation adjustment	24	0	0	0	24
Net income (loss)	(39,756)	0	0	(39,756)	0
Balance at Mar. 31, 2021	(36,076)	$ 6	156,886	(193,317)	349
Balance (in Shares) at Mar. 31, 2021		59,574,382
Balances at Dec. 31, 2020	341	$ 6	153,571	(153,561)	325
Balances (in Shares) at Dec. 31, 2020		59,526,171
Reclassification of common stock warrant liability to permanent equity	0
Balance at Sep. 30, 2021	5,686	$ 6	173,203	(167,724)	201
Balance (in Shares) at Sep. 30, 2021		62,177,020
Balances at Mar. 31, 2021	(36,076)	$ 6	156,886	(193,317)	349
Balances (in Shares) at Mar. 31, 2021		59,574,382
Issuance of common stock, net of issuance costs and private offering	9,250	$ 0	9,250	0	0
Issuance of common stock, net of issuance costs and private offering (Shares)		960,540
Exercise of stock options	58	$ 0	58	0	0
Exercise of stock options (in Shares)		124,680
Stock-based compensation expense	4,255	$ 0	4,255	0	0
Issuance of common stock upon vesting of restricted stock awards	0	$ 0	0	0	0
Issuance of common stock upon vesting of restricted stock awards (in Shares)		21,989
Foreign currency translation adjustment	(61)	$ 0	0	0	(61)
Net income (loss)	(3,351)	0	0	(3,351)	0
Balance at Jun. 30, 2021	(25,925)	$ 6	170,449	(196,668)	288
Balance (in Shares) at Jun. 30, 2021		60,681,591
Exercise of stock options	319	$ 0	319	0	0
Exercise of stock options (in Shares)		236,976
Exercise of warrants	10	$ 0	10	0	0
Exercise of warrants (in Shares)		1,002,250
Exercise of underwriter's option	0	$ 0	0	0	0
Exercise of underwriter's option (in Shares)		54,083
Stock-based compensation expense	2,425	$ 0	2,425	0	0
Issuance of common stock upon vesting of restricted stock awards	0	$ 0	0	0	0
Issuance of common stock upon vesting of restricted stock awards (in Shares)		202,120
Foreign currency translation adjustment	(87)	$ 0	0	0	(87)
Net income (loss)	28,944	0	0	28,944	0
Balance at Sep. 30, 2021	5,686	$ 6	173,203	(167,724)	201
Balance (in Shares) at Sep. 30, 2021		62,177,020
Balances at Dec. 31, 2021	12,597	$ 6	175,659	(163,301)	233
Balances (in Shares) at Dec. 31, 2021		62,312,097
Reclassification of common stock warrant liability to permanent equity	305		305	0	0
Exercise of stock options	267	$ 0	267	0	0
Exercise of stock options (in Shares)		934,448
Stock-based compensation expense	2,202	$ 0	2,202	0	0
Unrealized gain (loss) on available-for-sale securities	(50)	0	0	0	(50)
Foreign currency translation adjustment	50	0	0	0	50
Net income (loss)	(13,354)	0	0	(13,354)	0
Balance at Mar. 31, 2022	2,017	$ 6	178,433	(176,655)	233
Balance (in Shares) at Mar. 31, 2022		63,246,545
Balances at Dec. 31, 2021	12,597	$ 6	175,659	(163,301)	233
Balances (in Shares) at Dec. 31, 2021		62,312,097
Reclassification of common stock warrant liability to permanent equity	305
Balance at Sep. 30, 2022	(9,319)	$ 6	182,760	(192,165)	80
Balance (in Shares) at Sep. 30, 2022		63,541,984
Balances at Mar. 31, 2022	2,017	$ 6	178,433	(176,655)	233
Balances (in Shares) at Mar. 31, 2022		63,246,545
Exercise of stock options	17	$ 0	17	0	0
Exercise of stock options (in Shares)		110,000
Stock-based compensation expense	2,184	$ 0	2,184	0	0
Issuance of common stock upon vesting of restricted stock awards	0	$ 0	0	0	0
Issuance of common stock upon vesting of restricted stock awards (in Shares)		65,363
Unrealized gain (loss) on available-for-sale securities	(37)	$ 0	0	0	(37)
Offering costs	(100)	0	(100)	0	0
Foreign currency translation adjustment	(110)	0	0	0	(110)
Net income (loss)	(4,534)	0	0	(4,534)	0
Balance at Jun. 30, 2022	(563)	$ 6	180,534	(181,189)	86
Balance (in Shares) at Jun. 30, 2022		63,421,908
Issuance of common stock, net of issuance costs and private offering	128	$ 0	128	0	0
Issuance of common stock, net of issuance costs and private offering (Shares)		40,000
Stock-based compensation expense	2,098	$ 0	2,098	0	0
Issuance of common stock upon vesting of restricted stock awards	0	$ 0	0	0	0
Issuance of common stock upon vesting of restricted stock awards (in Shares)		80,076
Unrealized gain (loss) on available-for-sale securities	33	$ 0	0	0	33
Foreign currency translation adjustment	(39)	0	0	0	(39)
Net income (loss)	(10,976)	0	0	(10,976)	0
Balance at Sep. 30, 2022	$ (9,319)	$ 6	$ 182,760	$ (192,165)	$ 80
Balance (in Shares) at Sep. 30, 2022		63,541,984

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash flows from operating activities:
Net loss	$ (28,864)	$ (14,163)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	715	734
Non-cash lease expense	285	81
Change in fair value of common stock warrant liability	(151)	(547)
Change in fair value of Clene Nanomedicine contingent earn-out liability	(6,662)	(18,072)
Change in fair value of Initial Stockholders contingent earn-out liability	(849)	(1,710)
Stock-based compensation expense	6,484	9,945
Gain on extinguishment of notes payable	0	(647)
Gain on termination of lease	(420)	0
Loss on sale of marketable securities	2	0
Accretion of debt discount	661	0
Non-cash interest expense	83	(134)
Changes in operating assets and liabilities:
Accounts receivable	(77)	(48)
Inventory	3	150
Prepaid expenses and other current assets	(884)	(1,230)
Accounts payable	213	446
Accrued liabilities	(1,474)	511
Deferred income tax	0	(192)
Operating lease obligations	(360)	(142)
Net cash used in operating activities	(31,295)	(25,018)
Cash flows from investing activities:
Purchases of marketable securities	(24,582)	0
Proceeds from maturity of marketable securities	8,000	0
Proceeds from sale of marketable securities	7,614	0
Purchases of property and equipment	(3,478)	(661)
Net cash used in investing activities	(12,446)	(661)
Cash flows from financing activities:
Proceeds from exercise of stock options	284	427
Proceeds from exercise of warrants	0	10
Proceeds from at-the-market offering	132	0
Payments of at-the-market offering commissions	(4)	0
Payments of finance lease obligations	(101)	(117)
Proceeds from the issuance of notes payable	694	20,000
Payments of debt issuance costs	(30)	(534)
Payments of notes payable	0	(5)
Proceeds from the private placement	0	9,250
Payment of deferred offering costs	(100)	(1,901)
Net cash provided by financing activities	875	27,130
Effect of foreign exchange rate changes on cash and restricted cash	(155)	(116)
Net increase (decrease) in cash, cash equivalents and restricted cash	(43,021)	1,335
Cash, cash equivalents and restricted cash beginning of period	50,346	59,275
Cash, cash equivalents and restricted cash end of period	7,325	60,610
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets
Cash and cash equivalents	7,267	60,552
Restricted cash	58	58
Cash, cash equivalents and restricted cash	7,325	60,610
Supplemental disclosure of non-cash investing and financing activities:
Lease liability arising from obtaining right-of-use assets, leasehold improvements, and lease incentives	2,343	2,492
Lease incentive realized	500	0
Lease liability settled through termination of lease	602	0
Reclassification of common stock warrant liability to permanent equity	305	0
Purchases of property and equipment in accounts payable	1,318
Common stock warrant liability recorded at issuance of notes payable	0	1,457
Supplemental cash flow information:
Cash paid for interest expense	$ 1,646	$ 631

Nature of the Business

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

Nature of the Business

Note 1. Nature of the Business

Clene Inc. (the “Company,” “we,” “us,” or similar such references) is a clinical-stage pharmaceutical company pioneering the discovery, development, and commercialization of novel clean-surfaced nanotechnology therapeutics. We have developed an electro-crystal-chemistry drug development platform which enables production of concentrated, stable, highly active, clean-surfaced nanocrystal suspensions. We have multiple drug assets currently in development for applications in neurology, infectious disease, and oncology. Our efforts are currently focused on addressing the high unmet medical needs in two areas: first, those related to central nervous system disorders including Amyotrophic Lateral Sclerosis (“ALS”), Multiple Sclerosis (“MS”), and Parkinson’s Disease (“PD”); and second, those related to COVID-19, a highly infectious viral respiratory disease with serious and sometimes fatal co-morbidities. Our patented electro-crystal-chemistry manufacturing platform further enables us to develop very low concentration dietary supplements to advance the health and well-being of broad populations. These dietary supplements can vary greatly and include nanocrystals of varying composition, shapes and sizes as well as ionic solutions with diverse metallic constituents. Dietary supplements are marketed and distributed through our wholly owned subsidiary, dOrbital, Inc., or through an exclusive license with 4Life Research LLC (“4Life”), a related party (see Note 17).

Going Concern

We incurred a loss from operations of $9.8 million and $10.5 million for the three months ended September 30, 2022 and 2021, respectively; and $36.7 million and $35.9 million for the nine months ended September 30, 2022 and 2021, respectively. Our accumulated deficit was $192.2 million and $163.3 million as of September 30, 2022 and December 31, 2021, respectively. Our cash, cash equivalents, and marketable securities totaled $16.2 million and $50.3 million as of September 30, 2022 and December 31, 2021, respectively, and net cash used in operating activities was $31.3 million and $25.0 million for the nine months ended September 30, 2022 and 2021, respectively.

We have incurred significant losses and negative cash flows from operations since our inception. We have not generated significant revenues since our inception, and we do not anticipate generating significant revenues unless we successfully complete development and obtain regulatory approval for commercialization of a drug candidate. We expect to incur additional losses in the future, particularly as we advance the development of our clinical-stage drug candidates, continue research and development of our preclinical drug candidates, and initiate additional clinical trials of, and seek regulatory approval for, these and other future drug candidates.

Our management performs strategic reviews of our operating plans and budgets, considering the status of our product development programs, human capital, capital needs and resources, and current capital market conditions. Based on these reviews, our Board of Directors (the “Board”) and management make adjustments to our operating plans and budgets to allocate our projected cash expenditures. Notwithstanding these ongoing adjustments, we project that within the next twelve months, we will not have sufficient cash and other resources on hand to sustain our current operations or meet our obligations as they become due, and we must obtain additional financing. Additionally, pursuant to our term loan with Avenue Venture Opportunities Fund, L.P. (“Avenue”), we must maintain unrestricted cash and cash equivalents of at least $5.0 million to avoid acceleration of the full balance of the loan. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

To mitigate our funding needs, we intend to implement plans to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as well as potentially utilizing additional funds available under our term loan with Avenue, subject to certain contingent conditions (see Note 9), as well as our existing at-the-market facility. These plans are subject to market conditions and reliance on third parties, and there is no assurance that effective implementation of our plans will result in the necessary funding to continue current operations. In October 2022, we announced an equity offering which provided net cash proceeds of $10.8 million. We are also in the process of implementing cost-saving initiatives, including potentially delaying or reducing research and development programs and commercialization efforts, reduction in executive compensation, a hiring freeze, and elimination of certain staff positions. We have concluded that our plans do not alleviate the substantial doubt about our ability to continue as a going concern beyond one year from the date the condensed consolidated financial statements are issued.

The accompanying condensed consolidated financial statements have been prepared assuming we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. As a result, the accompanying condensed consolidated financial statements do not include any adjustments relating to the recoverability and

classification of assets and their carrying amounts, or the amounts and classification of liabilities that may result should we be unable to continue as a going concern.

Impact of the COVID-19 Pandemic

The COVID-19 pandemic, which began in December 2019 and has spread worldwide, has caused many governments to implement measures to slow the spread of the COVID-19 outbreak. The COVID-19 pandemic and government measures taken in response have had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred, supply chains have been disrupted, and facilities and production have been suspended. The future progression of the COVID-19 pandemic and its effects on our business and operations remains uncertain. The COVID-19 pandemic may affect our ability to initiate and complete preclinical studies and clinical trials, delay the initiation of future clinical trials, disrupt regulatory activities, or have other adverse effects on our business and operations. In particular, we and our third-party contract research organizations (“CROs”) have faced disruptions that have affected our ability to initiate and complete preclinical studies, caused manufacturing disruptions, and created delays at clinical trial site initiation and clinical trial enrollment, leading to the early conclusion of an ongoing clinical trial. The COVID-19 pandemic has already caused significant disruptions in the financial markets, and may continue to cause such disruptions, which could impact our ability to raise additional funds to support our operations. Moreover, the COVID-19 pandemic has significantly impacted economies worldwide and could result in adverse effects on our business and operations.

We are monitoring the potential impact of the COVID-19 pandemic on our business, financial condition, results of operations, and cash flows. While the COVID-19 pandemic has led to various research restrictions and led to pauses and early conclusion of certain of our clinical trials, these impacts have been temporary and to date we have not experienced material business disruptions or incurred impairment losses in the carrying values of our assets as a result of the COVID-19 pandemic and we are not aware of any specific related event or circumstance that would require us to revise the estimates reflected in these condensed consolidated financial statements. The extent to which the COVID-19 pandemic will directly or indirectly impact our business, financial condition, results of operations, and cash flows, including planned and future clinical trials and research and development costs, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, the actions taken to contain or treat it, and the duration and intensity of the related effects.

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Note 2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements include the accounts of Clene Inc. and our wholly-owned subsidiaries, Clene Nanomedicine, Inc. (“Clene Nanomedicine”), a subsidiary incorporated in Delaware, Clene Australia Pty Ltd (“Clene Australia”), a subsidiary incorporated in Australia, Clene Netherlands B.V. (“Clene Netherlands”), a subsidiary incorporated in the Netherlands, and dOrbital, Inc., a subsidiary incorporated in Delaware, after elimination of all intercompany accounts and transactions. We have prepared the accompanying condensed consolidated financial statements in accordance with United States (“U.S.”) Generally Accepted Accounting Principles (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. The condensed consolidated financial statements have been prepared on the same basis as our audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation. The financial data and other information disclosed in the condensed consolidated financial statements and related notes for the three and nine months ended September 30, 2022 and 2021 are unaudited.

Results of operations for the three and nine months ended September 30, 2022 and 2021 are not necessarily indicative of the results for the entire fiscal year or any other period. The condensed consolidated financial statements for the three and nine months ended September 30, 2022 and 2021 should be read in conjunction with the audited consolidated financial statements included in our Annual Report on Form 10-K.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and disclosure of contingent assets and liabilities, and the reported amounts of expenses. We base our estimates on historical experience and various other assumptions that we believe to be reasonable. Actual results may differ from those estimates or assumptions. Estimates are periodically reviewed in light of changes in circumstances, facts, and experience, and any changes in estimates will be recorded in future periods as they develop.

Risks and Uncertainties

The product candidates we develop require approvals from regulatory agencies prior to commercial sales. There can be no assurance that our current and future product candidates will receive the necessary approvals or be commercially successful. If we are denied approval or approval is delayed, it will have a material adverse impact on our business and our condensed consolidated financial statements.

We are subject to certain risks and uncertainties and believe that changes in any of the following areas could have a material adverse effect on future financial condition, results of operations, or cash flows: ability to obtain additional financing; regulatory approval and market acceptance of, and reimbursement for, product candidates; performance of third-party CROs and manufacturers upon which we rely; protection of our intellectual property; litigation or claims against us based on intellectual property, patent, product, regulatory, or other factors; and our ability to attract and retain employees necessary to support our growth.

Concentrations of Credit Risk

Financial instruments which potentially subject us to significant concentrations of credit risk consist primarily of cash. Our cash is mainly held in financial institutions. Amounts on deposit may at times exceed federally insured limits. We have not experienced any losses on our deposits of cash and do not believe that we are subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

Cash and Cash Equivalents

We consider all short-term investments with original maturities of 90 days or less when purchased to be cash equivalents.

Restricted Cash

We classify cash as restricted when it is unavailable for withdrawal or use in our general operating activities. Restricted cash and investments are classified as current and noncurrent in the condensed consolidated balance sheets based on the nature of the restriction. Our restricted cash balance includes contractually restricted deposits related to our corporate credit card.

Marketable Securities

Marketable securities are investments with original maturities of more than 90 days when purchased. We do not invest in securities with original maturities of more than one year. Marketable securities are considered available-for-sale, and are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income (loss) until realized. Realized gains and losses are included in other income (expense), net, on the basis of specific identification. The cost of marketable securities is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in other income (expense), net.

Inventory

Inventory is stated at historic cost on a first-in first-out basis. Our inventory consisted of $24,000 in raw materials and $14,000 in finished goods as of September 30, 2022, and $26,000 in raw material and $15,000 in finished goods as of December 31, 2021. Inventory primarily relates to our Supplements segment.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Property and equipment consist of laboratory and office equipment, computer software, and leasehold improvements. Depreciation is calculated using the straight-line method over the estimated economic useful lives of the assets, which are 3-5 years for laboratory equipment, 3-7 years for furniture and fixtures, and 2-5 years for computer software. Leasehold improvements are amortized over the lesser of the estimated lease term or the estimated useful life of the assets. Costs for capital assets not yet placed into service are capitalized as construction in progress and depreciated or amortized in accordance with the above useful lives once placed into service. Upon retirement or sale, the related cost and accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in the condensed consolidated statements of operations and comprehensive income (loss). Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred.

We capitalize costs to obtain or develop computer software for internal use, including development costs incurred during the software development stage and costs to obtain software for access and conversion of historical data. We also capitalize costs to modify,

upgrade, or enhance existing internal-use software that result in additional functionality. We expense costs incurred during the preliminary project stage, training costs, data conversion costs, and maintenance costs.

Contingent Earn-Out Liabilities

In connection with the Reverse Recapitalization, certain stockholders are entitled to receive additional shares of Clene Inc. common stock, par value $0.0001 (“Common Stock”) (the “Contingent Earn-outs”) upon us achieving certain milestones (see Note 3). In accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging (“ASC 815”), the Contingent Earn-outs are not indexed to our own stock and therefore are accounted for as a liability at the Reverse Recapitalization date and subsequently remeasured at each reporting date with changes in fair value recorded as a component of other income (expense), net.

Common Stock Warrants

We account for common stock warrants as either equity-classified instruments or liability-classified instruments based on an assessment of the warrant terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to our Common Stock, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and, for liability-classified warrants, as of each subsequent quarterly period end date while the warrants are outstanding.

Grant Funding

We may submit applications to receive grant funding from governmental and non-governmental entities. We account for grants by analogizing to the grant accounting model under IAS 20, Accounting for Government Grants and Disclosure of Government Assistance.

We recognize grant funding without conditions or continuing performance obligations, including the Australia research and development credit, as other income in the condensed consolidated statements of operations and comprehensive income (loss). We accrue the Australia research and development credit receivable in other current assets (see Note 5) in the condensed consolidated balance sheets in an amount equal to the qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage and we recognize other income in the condensed consolidated statements of operations and comprehensive income (loss). After submission of our Australia tax return, we receive a cash refund of the Australia research and development credit and relieve the receivable.

We recognize grant funding with conditions or continuing performance obligations as a reduction in research and development expenses in the condensed consolidated statements of operations and comprehensive income (loss) in the period during which the related qualifying expenses are incurred and as the conditions or performance obligations are fulfilled. Any amount received in advance of fulfilling such conditions or performance obligations is recorded in accrued liabilities in the condensed consolidated balance sheets if the conditions or performance obligations are expected to be met within the next twelve months. We recorded grants as a reduction of research and development expenses of $0 and $0 for the three months ended September 30, 2022 and 2021, respectively; and $0 and $0.2 million for the nine months ended September 30, 2022 and 2021, respectively.

Foreign Currency Translation and Transactions

Our functional currency is the U.S. dollar. Clene Australia determined its functional currency to be the Australian dollar and Clene Netherlands determined its functional currency to be the Euro. We use the U.S. dollar as our reporting currency for the condensed consolidated financial statements. The results of our non-U.S. dollar based functional currency operations are translated to U.S. dollars at the average exchange rates during the period. Our assets and liabilities are translated using the current exchange rate as of the balance sheet date and stockholders’ equity is translated using historical rates.

Adjustments resulting from the translation of the condensed consolidated financial statements of our foreign functional currency subsidiaries into U.S. dollars are excluded from the determination of net loss and are accumulated in a separate component of stockholders’ equity.

We also incur foreign exchange transaction gains and losses for purchases denominated in foreign currencies. Foreign exchange transaction gains and losses are included in other income (expense), net, as incurred.

Comprehensive Income (Loss)

Comprehensive income (loss) includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. The only elements of other comprehensive income (loss) in any periods presented were translation of foreign currency denominated balances of Clene Australia and Clene Netherlands to U.S. dollars for consolidation and unrealized gain (loss) on available-for-sale securities.

Segment Information

We have determined that our chief executive officer is the chief operating decision maker (“CODM”). Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the CODM in making decisions regarding resource allocation and assessing performance. We view our operations and manage our business in two operating segments, which are our reportable segments: (1) the development and commercialization of novel clean-surfaced nanotechnology therapeutics (“Drugs”), and (2) the development and commercialization of dietary supplements (“Supplements”).

Income Taxes

We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the condensed consolidated financial statements or in our tax returns. Deferred tax assets and liabilities are determined based on the differences between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. We assess the likelihood that our deferred tax assets will be recovered from future taxable income and, to the extent we believe, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies.

We account for uncertainty in income taxes recognized in the condensed consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the condensed consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, which are considered appropriate as well as the related net interest and penalties.

Stock-Based Compensation

We account for stock-based compensation arrangements using a fair value-based method for costs related to all share-based payments including stock options and stock awards. Stock-based compensation expense is recorded in research and development and general and administrative expenses based on the classification of the work performed by the grantees.

The fair value is recognized over the period during which a grantee is required to provide services in exchange for the option award and service-based stock awards, known as the requisite service period (usually the vesting period), on a straight-line basis. For stock awards with market conditions, the fair value is recognized over the period based on the expected milestone achievement dates as the derived service period (usually the vesting period), on a straight-line basis. For stock awards with performance conditions, the grant-date fair value of these awards is the market price on the applicable grant date, and compensation expense will be recognized when the conditions become probable of being satisfied. We recognize a cumulative true-up adjustment once the conditions become probable of being satisfied as the related service period had been completed in a prior period.

Stock-based compensation expense is recognized at fair value. We elect to account for forfeitures as they occur, rather than estimating expected forfeitures.

We determine the fair value of each share of Common Stock underlying stock-based awards using a Black-Scholes option pricing model based on the closing price of our Common Stock as reported by the Nasdaq Capital Market (“Nasdaq”) on the date of grant. The fair value of stock awards with market conditions are determined using a Monte Carlo valuation model.

Recently Adopted Accounting Pronouncements

In May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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). The amendments in this update relate to the recognition and measurement of earnings per share for certain modifications or exchanges of equity-classified written call options or warrants. The guidance was effective for our fiscal year and interim periods within our fiscal year beginning after December 15, 2021. The adoption of this guidance did not have an impact on our condensed consolidated financial statements.

Recent Accounting Pronouncements Not Yet Adopted

In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The amendments in this update, among other things, require the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. As a smaller reporting company, the guidance is effective for our fiscal years beginning after December 15, 2022. We are currently evaluating the expected impact, if any, of the new guidance as a result of this extended deadline of implementation for smaller reporting companies.

In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. The amendments in this update add disclosure requirements for transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy, including disclosure about the nature of the transactions, accounting policy, affected line items in the balance sheet and income statement, amounts applicable to each financial statement line item, and significant terms and conditions of the transactions including commitments and contingencies. The guidance is effective for all entities for financial statements issued for annual periods beginning after December 15, 2021, with early adoption permitted. We are currently evaluating the expected impact, if any, of the new guidance.

Reverse Recapitalization with Tottenham and Clene Nanomedicine

9 Months Ended

Sep. 30, 2022

Reverse Recapitalization With Tottenham And Clene Nanomedicine [Abstract]

Reverse Recapitalization with Tottenham and Clene Nanomedicine

Note 3. Reverse Recapitalization with Tottenham and Clene Nanomedicine

On December 30, 2020 (the “Closing Date”), Chelsea Worldwide Inc., our predecessor, consummated the Reverse Recapitalization by and among Clene Nanomedicine, Tottenham Acquisition I Limited (“Tottenham”), Chelsea Worldwide Inc. (“PubCo”), a Delaware corporation and wholly-owned subsidiary of Tottenham, Creative Worldwide Inc. (“Merger Sub”), a Delaware corporation and wholly-owned subsidiary of PubCo, and Fortis Advisors LLC, a Delaware limited liability company as the representative of our stockholders. The Reverse Recapitalization was effected in two steps: (i) Tottenham was reincorporated to the state of Delaware by merging with and into PubCo (the “Reincorporation Merger”); and (ii) promptly following the Reincorporation Merger, Merger Sub was merged with and into Clene Nanomedicine, resulting in Clene Nanomedicine becoming a wholly-owned subsidiary of PubCo (the “Acquisition Merger”). On the Closing Date, PubCo changed its name from Chelsea Worldwide Inc. to Clene Inc. and listed its shares of Common Stock, par value $0.0001 per share on Nasdaq under the symbol “CLNN.”

We received gross proceeds of $9.4 million from the Reverse Recapitalization and incurred offering costs of $5.9 million, which excludes the fair value of Common Stock issued as payment of certain offering costs, resulting in net proceeds of $3.5 million. We paid LifeSci Capital LLC, an advisor to Clene Nanomedicine, 644,164 shares of Common Stock as consideration for its services.

The transaction was accounted for as a “reverse recapitalization” in accordance with GAAP. Under this method of accounting, Tottenham was treated as the “acquired” company for financial reporting purposes. This determination was primarily based on the fact that subsequent to the Reverse Recapitalization, Clene Nanomedicine’s stockholders have a majority of the voting power of the Company, Clene Nanomedicine comprises all of the ongoing operations of the Company, Clene Nanomedicine comprises a majority of the governing body of the Company, and Clene Nanomedicine’s senior management comprises all of the senior management of the Company. Accordingly, for accounting purposes, this transaction was treated as the equivalent of Clene Nanomedicine issuing shares for the net assets of Tottenham, accompanied by a recapitalization.

Earn-Out Shares

Certain of Clene Nanomedicine’s stockholders are entitled to receive earn-out shares (the “Clene Nanomedicine Contingent Earn-out”) as follows : (i) 3,333,333 shares of Common Stock if (a) the volume-weighted average price (“VWAP”) of the shares of our Common Stock equals or exceeds $15.00 (the “Milestone 1 Price”) in any twenty trading days within a thirty trading day period within three years of the closing of the Reverse Recapitalization or (b) the change of control price equals or exceeds the Milestone 1 Price if a change of control transaction occurs within three years of the closing of the Reverse Recapitalization (the requirements in (a) and (b) collectively, “Milestone 1”); (ii) 2,500,000 shares of Common Stock if (a) the VWAP of our Common Stock equals or exceeds $20.00

(the “Milestone 2 Price”) in any twenty trading days within a thirty trading day period within five years of the closing of the Reverse Recapitalization or (b) the change of control price equals or exceeds the Milestone 2 Price if a change of control transaction occurs within five years of the closing of the Reverse Recapitalization (the requirements in (a) and (b) collectively, “Milestone 2”); and (iii) 2,500,000 shares of Common Stock if Clene Nanomedicine completed a randomized placebo-controlled clinical trial for treatment of COVID-19 which results in a statistically significant finding of clinical efficacy within twelve months of the closing of the Reverse Recapitalization (“Milestone 3”), which was not achieved. If Milestone 1 is not achieved but Milestone 2 is achieved, the Clene Nanomedicine stockholders will receive an issuance equal to the shares issued upon satisfaction of Milestone 1. As of the Closing Date, the Clene Nanomedicine Contingent Earn-out shares increased to 8,346,185 shares of Common Stock due to exercises of stock options during November 2020.

Tottenham’s former officers and directors, sponsor, and public stockholders (the “Initial Stockholders”) may be entitled to receive earn-out shares as follows (the “Initial Stockholders Contingent Earn-out”): (i) 375,000 shares of Common Stock upon satisfaction of the requirements of Milestone 1; and (ii) 375,000 shares of Common Stock upon satisfaction of the requirements of Milestone 2. If Milestone 1 is not achieved but Milestone 2 is achieved, the Initial Stockholders will receive an issuance equal to the shares issued upon satisfaction of Milestone 1.

The Contingent Earn-outs shares have been classified as liabilities in the condensed consolidated balance sheets and are remeasured to fair value at each reporting date. We did not achieve Milestone 3 and the 2,503,851 Milestone 3 Contingent Earn-out shares were cancelled as of December 31, 2021.

Marketable Securities

9 Months Ended

Sep. 30, 2022

Marketable Securities [Abstract]

Marketable Securities

Note 4. Marketable Securities

Available-for-Sale Securities

Available-for-sale securities are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income (loss) until realized. Available-for-sale securities as of September 30, 2022 were as follows:


	September 30, 2022
(in thousands)	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Commercial paper	$	4,984	$	—	$	(37	)	$	4,947
Corporate debt securities		4,036		—		(17	)		4,019
Total	$	9,020	$	—	$	(54	)	$	8,966

As of December 31, 2021, there were no outstanding available-for-sale securities. Proceeds from the sale and maturity of available-for-sale securities were as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Proceeds from maturity of marketable securities	$	5,500	$	—	$	8,000	$	—
Proceeds from sale of marketable securities	$	4,597		—	$	7,614		—
Total	$	10,097	$	—	$	15,614	$	—

Realized gains and losses included in earnings from the sale of available-for-sale securities were insignificant. All available-for-sale securities had a contractual maturity within one year. As of September 30, 2022, we did not have any allowance for credit losses or impairments of available-for-sale securities.

Prepaid Expenses and Other Current Assets

9 Months Ended

Sep. 30, 2022

Prepaid Expenses And Other Current Assets [Abstract]

Prepaid expenses and other current assets

Note 5. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets as of September 30, 2022 and December 31, 2021 were as follows:


	September 30,		December 31,
(in thousands)	2022		2021
Australia research and development credit receivable	$	1,598	$	1,564
Metals to be used in research and development		2,493		2,237
Other		998		404
Total prepaid expenses and other current assets	$	5,089	$	4,205

Property and Equipment, Net

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment [Abstract]

Property and Equipment, Net

Note 6. Property and Equipment, Net

Property and equipment, net, as of September 30, 2022 and December 31, 2021 were as follows:


	September 30,			December 31,
(in thousands)	2022			2021
Lab equipment	$	3,410		$	3,327
Office equipment		177			147
Computer software		459			—
Leasehold improvements		3,956			3,943
Construction in progress		6,684			2,052
		14,686			9,469
Less accumulated depreciation		(4,933	)		(4,297	)
Total property and equipment, net	$	9,753		$	5,172

Depreciation expense recorded in research and development expense and general and administrative expense for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
General and administrative	$	67	$	29	$	163	$	86
Research and development		166		206		552		648
Total depreciation expense	$	233	$	235	$	715	$	734

Accrued Liabilities

9 Months Ended

Sep. 30, 2022

Disclosure Text Block Supplement [Abstract]

Accrued Liabilities

Note 7. Accrued Liabilities

Accrued liabilities as of September 30, 2022 and December 31, 2021 were as follows:


	September 30,		December 31,
(in thousands)	2022		2021
Accrued compensation and benefits	$	764	$	2,049
Accrued CRO and clinical fees		744		718
Deferred grant funds		520		520
Other		108		323
Total accrued liabilities	$	2,136	$	3,610

Leases

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Leases

Note 8. Leases

We lease laboratory and office space and certain laboratory equipment under non-cancellable operating and finance leases. The carrying value of our right-of-use lease assets is substantially concentrated in our real estate leases, while the volume of lease agreements is primarily concentrated in equipment leases.

Operating Leases

In September 2021, we commenced an operating lease for laboratory space and recorded a right-of-use asset of $2.4 million and lease liability of $2.4 million, net of a lease incentive of $1.0 million which represents an allowance from the lessor for facility alterations. As the lease incentive is payable based on events within our control and are deemed reasonably certain to occur, we recorded the lease incentive as a reduction of the right-of-use asset and lease liability at the lease commencement. As of September 30, 2022 and December 31, 2021, we incurred $1.0 million and $0.5 million, respectively, of costs related to the lease incentive which we recorded as construction in progress, with a corresponding increase to the lease liability, and the construction in progress will be capitalized as leasehold improvements when the facility is placed into service. The lease has an initial ten-year term and provides us the right and option to extend or renew for two periods of five years each. In accordance with ASC 842, Leases, the payments to be made in option periods have not been recognized as part of the right-of-use asset or lease liability because we do not assess the exercise of the option to be reasonably certain.

In February 2022, we commenced an operating lease for existing laboratory space and recorded a right-of-use asset of $2.3 million and lease liability of $2.3 million and terminated the previous right-of-use asset of $0.6 million and lease liability of $1.0 million. We

recorded a gain on termination of lease of $0.4 million in the condensed consolidated statements of operations and comprehensive income (loss) for the nine months ended September 30, 2022.

Our right-of-use assets pertain to operating leases. As of September 30, 2022 and December 31, 2021, our operating lease obligations had a weighted-average discount rate of 9.6% and 9.6%, respectively, and a weighted-average remaining term of 7.5 years and 8.1 years, respectively.

Finance Leases

Assets recorded under finance lease obligations and included with property and equipment as of September 30, 2022 and December 31, 2021 were as follows:


	September 30,			December 31,
(in thousands)	2022			2021
Lab equipment	$	408		$	408
Work in process		228			228
Total		636			636
Less accumulated depreciation		(305	)		(244	)
Net	$	331		$	392

As of September 30, 2022 and December 31, 2021, our finance lease obligations had a weighted-average interest rate of 9.6% and 8.8%, respectively, and a weighted-average remaining term of 1.3 years and 1.9 years, respectively.

Maturity Analysis of Leases

The maturity analysis of our finance and operating leases as of September 30, 2022 was as follows:


(in thousands)	Finance Leases			Operating Leases
2022 (remainder)	$	37		$	188
2023		96			1,145
2024		27			1,171
2025		—			1,202
2026		—			1,231
2027		—			1,129
Thereafter		—			2,786
Total undiscounted cash flows		160			8,852
Less amount representing interest/discounting		(18	)		(2,674	)
Present value of future lease payments		142			6,178
Less lease obligations, current portion		(97	)		(467	)
Lease obligations, long term portion	$	45		$	5,711

We expect that, in the normal course of business, the existing leases will be renewed or replaced by similar leases.

Components of Lease Cost

The components of finance and operating lease costs for the three and nine months ended September 30, 2022 and 2021 were as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Finance lease costs:
Amortization	$	20	$	37	$	61	$	110
Interest on lease liabilities		6		6		12		21
Operating lease costs		256		107		695		247
Short-term lease costs		—		98		—		214
Variable lease costs		65		32		238		71
Total lease costs	$	347	$	280	$	1,006	$	663

Supplemental Cash Flow Information


	Nine Months Ended September 30,
(in thousands)	2022			2021
Operating cash flows from operating leases	$	(933	)	$	(533	)
Operating cash flows from finance leases	$	(12	)	$	(21	)
Financing cash flows from finance leases	$	(101	)	$	(117	)

Notes Payable

9 Months Ended

Sep. 30, 2022

Debt Disclosure [Abstract]

Notes Payable

Note 9. Notes Payable

Our long-term debt, net of original issue discount and unamortized debt issuance costs, as of September 30, 2022 and December 31, 2021 was as follows:


	Stated			September 30,			December 31,
(in thousands, except interest rates)	Interest Rate			2022			2021
Maryland DHCD (commenced 2019)		8.00	%	$	644		$	614
Maryland DHCD (commenced 2022)		6.00	%		694			—
Advance Cecil, Inc. (commenced 2019)		8.00	%		128			122
Avenue Venture Opportunities Fund, L.P. (commenced 2021)		12.85	%		20,000			20,000
					21,466			20,736
Less unamortized debt issuance costs and original issue discounts					(977	)		(1,654	)
Less convertible notes payable, net of unamortized debt discount and issuance costs					(4,763	)		(4,598	)
Total notes payable				$	15,726		$	14,484

Maryland DHCD Loans

In February 2019, we entered into a loan agreement (the “2019 MD Loan”) with the Department of Housing and Community Development (“DHCD”), a principal department of the State of Maryland. The agreement provides for a term loan of $0.5 million bearing simple interest at an annual rate of 8.00%. We are subject to affirmative and negative covenants until maturity, including providing information about the Company and our operations; limitations on our ability to retire, repurchase, or redeem our common or preferred stock, options, and warrants other than per the terms of the securities; and limitations on our ability to pay dividends of cash or property. There are no financial covenants associated with the 2019 MD Loan. We are not in violation of any covenants. The 2019 MD Loan established “Phantom Shares” at issuance based on 119,907 shares of Common Stock. Repayment of the full balance is due on February 22, 2034, with the repayment amount and carrying value equal to the greater of the balance of principal plus accrued interest or the value of the Phantom Shares. The value of the Phantom Shares is based on the closing price of our Common Stock on Nasdaq at the end of each reporting period. As of September 30, 2022 and December 31, 2021, the note was recorded at principal plus accrued interest in the condensed consolidated balance sheets. We recognized interest expense of $10,000 and $30,000 for the three and nine months ended September 30, 2022, respectively; and interest income of $0.5 million and $0.3 million for the three and nine months ended September 30, 2021, respectively.

In May 2022, we entered into a loan agreement (the “2022 MD Loan”) with DHCD which provides for a term loan of up to $3.0 million bearing simple interest at an annual rate of 6.00% for the purchase of certain personal property (the “Assets”) related to the production of pharmaceutical drugs. As of September 30, 2022, we had drawn $0.7 million under the term loan, with the remainder available upon our submission of disbursement requests to purchase the Assets. The 2022 MD Loan matures on July 1, 2027 (the “Maturity Date”). The first twelve payments, commencing on July 1, 2022, are deferred. Immediately thereafter, there shall be eighteen monthly installments of interest-only based on the actual amount advanced under the loan, each up to a maximum amount of $15,000; followed by thirty monthly installments of principal and interest, each in the amount of $33,306, which is due and payable even if the entire loan has not been advanced prior to the date such monthly payment is due and payable, with a balloon payment of all accrued and unpaid interest and principal due on the Maturity Date. We recorded $31,000 of debt issuance costs that are being amortized over the contractual term using the effective interest method. Pursuant to the 2022 MD Loan, DHCD was granted a continuing security interest in the Assets as collateral. Under a priority of liens agreement by and between DHCD and Avenue, an existing secured creditor of the Company, DHCD’s continuing security interest in the Assets shall be a first priority lien. We recognized interest expense of $10,000 and $12,000 for the three and nine months ended September 30, 2022, respectively.

Advance Cecil Inc. Loan

In April 2019, we entered into a loan agreement (the “2019 Cecil Loan”) with Advance Cecil Inc., a non-stock corporation formed under the laws of the state of Maryland. The agreement provides for a term loan of $0.1 million bearing simple interest at an annual rate

of 8.00%. We are subject to affirmative covenants until maturity, including providing information about the Company and our operations. There are no financial covenants associated with the 2019 Cecil Loan. We are not in violation of any covenants. The 2019 Cecil Loan established “Phantom Shares” at issuance based on 23,981 shares of Common Stock. Repayment of the full balance is due on April 30, 2034, with the repayment amount and carrying value equal to the greater of the balance of principal plus accrued interest or the value of the Phantom Shares. The value of the Phantom Shares is based on the closing price of our Common Stock on Nasdaq at the end of each reporting period. As of September 30, 2022 and December 31, 2021, the note was recorded at principal plus accrued interest in the condensed consolidated balance sheets. We recognized interest expense of $2,000 and $6,000 for the three and nine months ended September 30, 2022, respectively; and interest income of $106,000 and $52,000 for the three and nine months ended September 30, 2021, respectively.

PPP Loan

In May 2020, we entered into a note payable in the amount of $0.6 million (the “PPP Loan”) under the Paycheck Protection Program of the CARES Act. The Paycheck Protection Program permits forgiveness of amounts loaned for payments of payroll and other qualifying expenses, subject to certain conditions. In January 2021, the full balance of the PPP Loan was forgiven and we recorded a gain on extinguishment of notes payable for the nine months ended September 30, 2021.

Avenue Loan

In May 2021, we entered into a loan agreement (the “2021 Avenue Loan”) with Avenue. The agreement provides for a 42-month term loan of up to $30.0 million. The first tranche is $20.0 million (“Tranche 1”), of which $15.0 million was funded at close and $5.0 million was funded in September 2021. We incurred issuance costs of $0.6 million of which $46,951 was expensed immediately. The remaining unfunded tranche of $10.0 million (“Tranche 2”) is available until December 31, 2022. Funding of Tranche 2 is subject to (a) our receipt of $5.0 million financing through the state of Maryland; (b) our achievement of a statistically significant result in certain clinical trials (“Performance Milestone 1”); (c) our receipt of net proceeds of at least $30.0 million from the sale and issuance of our equity securities between May 2, 2021 and December 31, 2022; and (d) mutual agreement of us and Avenue. The 2021 Avenue Loan bears interest at a variable rate equal to the sum of (i) the greater of (a) the prime rate or (b) 3.25%, plus (ii) 6.60%. As of September 30, 2022 and December 31, 2021, the interest rate was 12.85% and 9.85%, respectively. Payments are interest-only for the first 12 months and have been extended an additional 12 months (the “First Interest-only Period Extension”) based on our achievement of Performance Milestone 1. Payments may be extended up to 36 months if we (i) achieve the First Interest-only Period Extension and (b) draw from Tranche 2. The loan principal will amortize equally from the end of the interest period to the expiration of the 42-month term on December 1, 2024. On the maturity date, an additional payment equal to 4.25% of the funded loans, currently equal to $0.9 million (the “Final Payment”), is due in addition to the remaining unpaid principal and accrued interest. The Final Payment was recorded as a debt premium and is being amortized over the contractual term using the effective interest method. The Final Payment is related to the loan host and is not bifurcated pursuant to ASC 815. We are subject to affirmative and negative covenants until maturity in the absence of prepayments, including providing information about the Company and our operations; limitation on our ability to retire, repurchase, or redeem our Common Stock, options, and warrants other than per the terms of the securities; and limitations on our ability to pay dividends of cash or property. Also pursuant to the 2021 Avenue Loan, we are required to maintain unrestricted cash and cash equivalents of at least $5.0 million, provided that upon our (i) achievement of Performance Milestone 1, and (ii) receiving of net proceeds of at least $30.0 million from the sale and issuance of our equity securities, we shall no longer be subject to financial covenants. We are not in violation of any covenants. Avenue also has the ability to make all obligations under the 2021 Avenue Loan immediately due and payable upon occurrence of certain events of default or material adverse effects, as outlined in the loan agreement. The 2021 Avenue Loan is collateralized by substantially all of our assets other than intellectual property, including our capital stock and the capital stock of our subsidiaries, in which Avenue is granted a continuing security interest.

Pursuant to the agreement, we granted Avenue a warrant to purchase 115,851 shares of Common Stock (the “Avenue Warrant”) at an exercise price of $8.63 per share. Upon the funding of Tranche 2, the Avenue Warrant shall be adjusted to include an additional estimated 184,133 shares of Common Stock, which is equal to 5% of the principal amount of Tranche 2, divided by the five (5)-day VWAP per share as of the end of trading on the last trading day before the issuance of Tranche 2. We accounted for the Tranche 2 contingently-issuable warrant at inception of the 2021 Avenue Loan in accordance with ASC 815 and the fair value and issuable shares are remeasured at each reporting period.

Avenue has the right, in its discretion, but not the obligation, at any time between May 21, 2022 through May 21, 2024, while the loan is outstanding, to convert up to $5.0 million of principal into Common Stock (the “Conversion Feature”) at a price per share equal to 120% of the Avenue Warrant exercise price. Exercise of the Conversion Feature is subject to certain minimum price and volume conditions of our Common Stock on Nasdaq. The Conversion Feature did not meet the requirements for separate accounting and is not accounted for as a derivative instrument. The number of shares of Common Stock contingently issuable upon conversion is 482,703 shares. We classified $5.0 million of the 2021 Avenue Loan as convertible notes payable as of September 30, 2022 and December 31, 2021, with unamortized debt discount and issuance costs of $0.2 million and $0.4 million, respectively. For the convertible notes payable

for the three and nine months ended September 30, 2022, we recognized (i) total interest expense of $0.2 million and $0.6 million, respectively; (ii) coupon interest expense of $0.2 million and $0.4 million, respectively; and (iii) amortization of debt discount and issuance costs of $0.1 million and $0.2 million, respectively; and the effective interest rate was 18.41%. For the three and nine months ended September 30, 2021, we recognized (i) total interest expense of $0.2 million and $0.3 million, respectively; (ii) coupon interest expense of $0.1 million and $0.2 million, respectively; and (iii) amortization of debt discount and issuance costs of $41,000 and $64,000, respectively; and the effective interest rate was 15.46%.

The net proceeds from the issuance of the loan were initially allocated to the warrant at an amount equal to their fair value of $1.5 million and the remainder to the loan. The allocation of incurred financing costs of $0.5 million, which together with the fair value of the Avenue Warrant and the Final Payment, are recorded as a debt discount and debt premium, respectively, and are being amortized over the contractual term using the effective interest method. We recognized interest expense of $0.8 million and $2.3 million for the three and nine months ended September 30, 2022, respectively; and interest expense of $0.6 million and $0.8 million for the three and nine months ended September 30, 2021, respectively.

Future principal payments under the 2021 Avenue Loan, net of unamortized debt discounts, if Avenue does not exercise the Conversion Feature, and under the 2022 MD Loan, net of unamortized debt discounts, are as follows:


(in thousands)	2021 Avenue Loan			2022 MD Loan
2022 (remainder)	$	—		$	—
2023		6,667			—
2024		13,333			—
2025		—			369
2026		—			313
2027		—			—
Thereafter		—			—
Subtotal of future principal payments		20,000			682
Accrued and unpaid interest		—			13
Less unamortized debt issuance costs and original issue discounts		(948	)		(29	)
Total	$	19,052		$	666

- 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.

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+ Details

Common Stock Warrants

9 Months Ended

Sep. 30, 2022

Common Stock Warrants Disclosure [Abstract]

Common Stock Warrants

Note 10. Common Stock Warrants

As of September 30, 2022 and December 31, 2021, outstanding warrants to purchase shares of Common Stock were as follows:


Date Exercisable	Number of Shares Issuable			Exercise Price		Exercisable for	Classification	Expiration
December 2020		2,407,500	(1)	$	11.50	Common Stock	Equity	December 2025
December 2020		24,583	(2)	$	11.50	Common Stock	Equity	December 2025
December 2020		1,929,111	(3)	$	1.97	Common Stock	Equity	April 2023
May 2021		115,851	(4)	$	8.63	Common Stock	Equity	May 2026
Total		4,477,045

(1)

Consists of 2,407,500 shares of Common Stock underlying warrants to purchase one-half (1/2) of one share of Common Stock, issued in connection with Tottenham’s initial public offering. We may redeem the outstanding warrants, in whole and not in part, at $0.01 per warrant if the last sales price of our Common Stock equals or exceeds $16.50 per share for any twenty trading days within a thirty-trading day period. As of September 30, 2022 and December 31, 2021, no warrants had been exercised.

(2)

Consists of 24,583 shares of Common Stock underlying warrants to purchase one-half (1/2) of one share of Common Stock, issued to Chardan Capital Markets, LLC (“Chardan”) upon exercise of their unit purchase option, which was issued in connection with Tottenham’s initial public offering. As of September 30, 2022 and December 31, 2021, no warrants had been exercised.

(3)

Consists of 1,929,111 shares of Common Stock underlying warrants to purchase one share of Common Stock, issued by Clene Nanomedicine as Series A preferred stock warrants and senior equity warrants in August 2013. As of September 30, 2022 and December 31, 2021, no warrants had been exercised.

(4)

Consists of 115,851 shares of Common Stock underlying the Avenue Warrant. As of September 30, 2022 and December 31, 2021, the warrant had not been exercised.

Commitments and Contingencies

9 Months Ended

Sep. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

Note 11. Commitments and Contingencies

Commitments

We enter into agreements in the normal course of business with CROs for clinical trials and with vendors for preclinical studies and other services and products for operating purposes, which are cancelable at any time by us, subject to payment of our remaining obligations under binding purchase orders and, in certain cases, nominal early termination fees. These commitments are not deemed significant.

As of September 30, 2022 and December 31, 2021, we had commitments under various agreements for capital expenditures totaling $1.7 million and $0.6 million, respectively, related to the construction of our manufacturing facilities.

Contingencies

From time to time, we may have certain contingent legal liabilities that arise in the ordinary course of business activities. We accrue a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. We are not aware of any current material pending legal matters or claims.

In September 2019, we received grant funding of approximately $0.3 million from the National Multiple Sclerosis Society (“NMSS”) to fund biomarker research related our VISIONARY-MS Phase 2 clinical trial. Pursuant to a Sponsored Research Agreement with NMSS, if we make future commercial sales of CNM-Au8 for the treatment of MS, we agreed to repay certain amounts based upon the following milestones: (i) 50% of the grant upon the first commercial product sale, (ii) an additional 50% of the grant upon cumulative sales of $10.0 million, (iii) an additional 150% of the grant upon cumulative sales of $50.0 million, and (iv) an additional 200% of the grant upon cumulative sales of $100.0 million, with the maximum repayment equal to 450% of the grant funding if all milestones are achieved. Additionally, if NMSS has not yet received repayments equal in the aggregate to 300% of the grant funding, then upon the closing of any of the following events we will repay 300% of the grant funding, or $1.0 million, less any amounts previously paid by us: (i) sale of all or substantially all of our assets and business, (ii) a public offering that occurs more than twelve months after completion of the biomarker research, (iii) sale of any portion of our assets and business including CNM-Au8 for the treatment of MS, (iv) exclusive licensing of our intellectual property claiming CNM-Au8 for the treatment of MS, and (v) a collaboration with a third-party to develop CNM-Au8 for the treatment of MS. As of September 30, 2022, we have not met any of the above milestones and the biomarker research has not been completed. We accounted for this contingency in accordance with ASC 450, Contingencies. Management has assessed the likelihood of occurrence of each contingent event as less than probable and therefore no contingent liability is recognized in the condensed consolidated balance sheets. Management’s estimate of the possible range of loss is between the minimum and maximum repayment amounts, equal to 50% and 450% of the grant funding, or approximately $0.2 million and $1.5 million, respectively. However, it is at least reasonably possible that Management’s estimate of the probability of occurrence of each contingent event and the possible range of loss will change in the near term.

Income Taxes

9 Months Ended

Sep. 30, 2022

Income Tax Disclosure [Abstract]

Income Taxes

Note 12. Income Taxes

We have not recorded income tax benefits for the net operating losses incurred during the three and nine months ended September 30, 2022 and 2021 or for research and development tax credits or other deferred tax assets due to uncertainty of realizing benefits from these items.

The components of loss before income taxes for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,						Nine Months Ended September 30,
(in thousands)	2022			2021			2022			2021
United States	$	(9,432	)	$	29,860		$	(25,787	)	$	(11,435	)
Foreign		(1,544	)		(985	)		(3,077	)		(2,941	)
Income (loss) before provision for income taxes	$	(10,976	)	$	28,875		$	(28,864	)	$	(14,376	)

We are subject to taxation in the U.S., Australia, Netherlands, and various state jurisdictions. Our tax returns from 2015 to present are subject to examination by the U.S. and state authorities due to the carry forward of unutilized net operating losses and research and development credits. There are currently no pending examinations. We compute our quarterly income tax provision by using a forecasted annual effective tax rate and adjusts for any discrete items arising during the quarter. The primary difference between the effective tax rate and the federal statutory tax rate relates to the full valuation allowance on our net operating losses and other deferred tax assets.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

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+ Details

Benefit Plans

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

Benefit Plans

Note 13. Benefit Plans

401(k) Plan

Our 401(k) plan is a deferred salary arrangement under Section 401(k) of the Internal Revenue Code. Under the 401(k) plan, participating U.S. employees may defer a portion of their pretax earnings, up to the U.S. Internal Revenue Service annual contribution limit. We match 100% of a participating employee’s deferral contributions up to 3% of annual compensation, limited to $4,500 of matching contributions. Our contributions to the 401(k) plan totaled $34,000 and $28,000 for the three months ended September 30, 2022 and 2021, respectively, and $0.2 million and $0.1 million for the nine months ended September 30, 2022 and 2021, respectively.

2020 Stock Plan

The 2020 Stock Plan reserves 12,000,000 shares of Common Stock for issuance thereunder, all of which may be issued pursuant to incentive stock options or any other type of award under the 2020 Stock Plan. Selected employees, officers, directors, and consultants of the Company are eligible to participate in the 2020 Stock Plan. The purpose of the 2020 Stock Plan is to enable us to offer competitive equity compensation packages in order to attract and retain talent and align the interests of management with those of stockholders. The 2020 Stock Plan is administered by the Board. The exercise prices, vesting periods, and other restrictions are determined at the discretion of the Board, except that the exercise price per share of stock options may not be less than 100% of the fair market value of the Common Stock on the date of grant. Stock options expire ten years after the grant date unless the Board sets a shorter term. Stock options granted to employees, officers, directors, and consultants generally vest over a four-year period. If an option or award granted under the 2020 Stock Plan expires, or is terminated, forfeited, repurchased, or cancelled, the unissued shares subject to that option or award shall again be available under the 2020 Stock Plan. As of September 30, 2022, the Board has granted a total of 7,683,138 stock options and rights to restricted stock awards under the 2020 Stock Plan, and 4,316,862 shares remained available for future grant.

2014 Stock Plan

The 2014 Stock Plan is administered by the Board. Stock options granted under the 2014 Stock Plan expire ten years after the grant date. Stock options and restricted stock awards granted to employees, officers, directors, and consultants generally vest over a four-year period. Effective as of the closing of the Reverse Recapitalization, no additional awards may be granted under the 2014 Stock Plan and as a result, if any award granted under the 2014 Stock Plan expires, or is terminated, forfeited, repurchased, cancelled, or tendered by a participant to us to exercise an award, the unissued shares subject to that award will not be available for future awards.

Stock-Based Compensation Expense

Stock-based compensation expense recorded in research and development expense and general and administrative expense for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
General and administrative	$	1,247	$	1,567	$	4,056	$	6,084
Research and development		851		858		2,428		3,861
Total stock-based compensation expense	$	2,098	$	2,425	$	6,484	$	9,945

Stock-based compensation expense by award type for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Stock options	$	2,098	$	1,583	$	6,484	$	3,096
Restricted stock awards		—		842		—		6,849
Total stock-based compensation expense	$	2,098	$	2,425	$	6,484	$	9,945

Stock Options

Outstanding stock options and related activity for the nine months ended September 30, 2022 was as follows:


(in thousands, except share, per share, and term data)	Number of Options			Weighted Average Exercise Price Per Share		Weighted Average Remaining Term (Years)		Intrinsic Value
Outstanding – December 31, 2021		10,395,027			3.35		6.32	$	21,082
Granted		2,865,411			3.01		9.41		—
Exercised		(1,044,448	)		0.27		—		2,641
Forfeited		(42,420	)		5.06		—		—
Outstanding – September 30, 2022		12,173,570		$	3.53		6.75	$	10,225
Vested and exercisable – September 30, 2022		6,529,233		$	2.33		4.81	$	10,120
Vested, exercisable or expected to vest – September 30, 2022		12,173,570		$	3.53		6.75	$	10,225

As of September 30, 2022 and December 31, 2021, we had approximately $18.1 million and $18.3 million, respectively, of unrecognized stock-based compensation costs related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.62 years and 3.05 years, respectively.

Stock options are valued using a Black-Scholes option-pricing model. Due to the limited trading history of our Common Stock, the expected volatility is derived from the average historical stock volatilities of several unrelated comparable public companies within our industry, over a period equivalent to the expected term of the stock option grants. The risk-free interest rate for periods within the contractual life of the stock options is based on the U.S. Treasury yield curve in effect on the grant date. The expected dividend is assumed to be zero as we have never paid a dividend and have no plans to do so. The expected term represents the period the stock options are expected to be outstanding. For stock options that are considered to be in the ordinary course, we determine the expected term using the simplified method, which considers the term to be the average of the time-to-vesting and the contractual life of the stock options. For other stock option grants, we estimate the expected term using historical data on employee exercises and post-vesting employment termination behavior, while also considering the contractual life of the award.

The assumptions used to calculate the fair value of stock options granted during the nine months ended September 30, 2022 and 2021 were as follows:


	Nine Months Ended September 30,
	2022	2021
Expected stock price volatility	89.57% – 98.13%	84.80% – 87.40%
Risk-free interest rate	1.65% – 3.00%	0.59% – 0.94%
Expected dividend yield	0.00%	0.00%
Expected term of options	5.00 – 6.98 years	6.00 years

The weighted-average grant-date fair value of stock options granted during the nine months ended September 30, 2022 and 2021 was $2.24 and $8.85, respectively.

Restricted Stock Awards

In connection with the Reverse Recapitalization, the following outstanding and unvested rights to restricted stock awards were granted to various employees and non-employee directors:

•

454,781 shares which are eligible to vest based on certain market conditions, subject to the holder’s continuous employment through such vesting date. The award complements the Milestone 1 earn-out share entitlement of Clene Nanomedicine stockholders and vests based on the same market condition (see Note 3). The grant-date fair value of these awards, using a Monte Carlo valuation model, was $4.3 million. Based on the outcome of the market condition as of the September 30, 2022 and December 31, 2021 measurement dates, no shares were vested.

•

341,090 shares which are eligible to vest based on certain market conditions, subject to the holder’s continuous employment through such vesting date. The award complements the Milestone 2 earn-out share entitlement of Clene Nanomedicine stockholders and vests based on the same market condition (see Note 3). The grant-date fair value of these awards, using a Monte Carlo valuation model, was $3.5 million. Based on the outcome of the market condition as of the September 30, 2022 and December 31, 2021 measurement dates, no shares were vested.

Outstanding rights to restricted stock awards and related activity for the nine months ended September 30, 2022 was as follows:


	Number of Restricted Stock Awards			Weighted Average Grant Date Fair Value
Unvested balance – December 31, 2021		916,603		$	10.00
Converted to shares of Common Stock upon vesting		(145,439	)		—
Forfeited		(2,025	)		9.84
Unvested balance – September 30, 2022		769,139		$	9.84

As of September 30, 2022 and December 31, 2021, there was no unrecognized compensation cost related to unvested rights to restricted stock awards.

Fair Value

9 Months Ended

Sep. 30, 2022

Fair Value Disclosures [Abstract]

Fair Value

Note 14. Fair Value

Cash and cash equivalents are carried at fair value. Financial instruments, including accounts receivable, accounts payable, and accrued expenses are carried at cost, which approximates fair value given their short-term nature. Marketable securities, the Avenue Warrant, and the Contingent Earn-outs are carried at fair value. The 2019 MD Loan and the 2019 Cecil Loan are carried at the greater of principal plus accrued interest or the value of Phantom Shares, which approximates fair value. The 2021 Avenue Loan, including the convertible notes payable and Conversion Feature, and the 2022 MD Loan are carried at amortized cost, which approximate fair value due to our credit risk and market interest rates.

Financial Instruments with Fair Value Measurements on a Recurring Basis

The fair value hierarchy for financial instruments measured at fair value on a recurring basis as of September 30, 2022 is as follows:


	September 30, 2022
(in thousands)	Level 1		Level 2		Level 3		Total
Cash equivalents
Money market funds	$	4,724	$	—	$	—	$	4,724
Marketable securities
Commercial paper		—		4,947		—		4,947
Corporate debt securities		—		4,019		—		4,019
Common stock warrant liability		—		—		18		18
Clene Nanomedicine contingent earn-out liability		—		—		11,438		11,438
Initial Stockholders contingent earn-out liability		—		—		1,468		1,468

The fair value hierarchy for financial instruments measured at fair value on a recurring basis as of December 31, 2021 is as follows:


	December 31, 2021
(in thousands)	Level 1		Level 2		Level 3		Total
Notes payable	$	736	$	—	$	—	$	736
Common stock warrant liability		—		—		474		474
Clene Nanomedicine contingent earn-out liability		—		—		18,100		18,100
Initial Stockholders contingent earn-out liability		—		—		2,317		2,317

There were no transfers between Level 1, Level 2, or Level 3 during any of the periods above.

Changes in the fair value of our Level 3 financial instruments for the nine months ended September 30, 2022 were as follows:


(in thousands)	Common Stock Warrant Liability			Clene Nanomedicine Contingent Earn-out			Initial Stockholders Contingent Earn-out
Balance – December 31, 2021	$	474		$	18,100		$	2,317
Change in fair value		(151	)		(6,662	)		(849	)
Reclassification from liability to equity		(305	)		—			—
Balance – September 30, 2022	$	18		$	11,438		$	1,468

Changes in the fair value of our Level 3 financial instruments for the nine months ended September 30, 2021 were as follows:


(in thousands)	Common Stock Warrant Liability			Clene Nanomedicine Contingent Earn-out			Initial Stockholders Contingent Earn-out
Balance – December 31, 2020	$	—		$	52,053		$	5,906
Initial fair value of instrument		1,457			—			—
Change in fair value		(547	)		(18,072	)		(1,710	)
Balance – September 30, 2021	$	910		$	33,981		$	4,196

Valuation of Notes Payable and Convertible Notes Payable

As of September 30, 2022 and December 31, 2021, the carrying value of the 2019 MD Loan was $0.6 million and $0.6 million, respectively; and the carrying value of the 2019 Cecil Loan was $0.1 million and $0.1 million, respectively. In all periods presented, the loans were recorded at principal plus accrued interest in the condensed consolidated balance sheets.

As of September 30, 2022, the amortized cost of the 2021 Avenue Loan was $19.1 million, which included notes payable carried at $14.3 million; and convertible notes payable and embedded Conversion Feature, carried at $4.8 million. As of December 31, 2021, the amortized cost of the 2021 Avenue Loan was $18.3 million, which included notes payable carried at $13.7 million; and convertible notes payable and embedded Conversion Feature, carried at $4.6 million. The valuation of the Conversion Feature is discussed below. As of September 30, 2022, the amortized cost of the 2022 MD Loan was $0.7 million.

Valuation of Conversion Feature

The Conversion Feature of the convertible notes payable from the 2021 Avenue Loan is carried at amortized cost and did not meet the requirements for separate accounting as a derivative instrument. As of September 30, 2022 and December 31, 2021, the estimated fair value of the Conversion Feature was $0.3 million and $0.8 million, respectively, and was determined using a Black-Scholes option-pricing model. The unobservable inputs to the Black-Scholes option-pricing model were as follows:


	September 30,			December 31,
	2022			2021
Expected stock price volatility		105.00	%		105.00	%
Risk-free interest rate		4.20	%		0.70	%
Expected dividend yield		0.00	%		0.00	%
Expected term	1.64 years			2.39 years

Valuation of the Common Stock Warrant Liability

The common stock warrant liability associated with the Avenue Warrant is comprised of the contingently issuable Tranche 2 warrant to purchase an estimated 184,133 shares of Common Stock, which was classified as a liability and recorded at fair value at issuance. The fair value and number of underlying shares will be remeasured at each reporting period.

The estimated fair value was determined using a Black-Scholes option-pricing model. The carrying amount of the liability may fluctuate significantly and actual amounts may be materially different from the liabilities’ estimated value. The unobservable inputs to the Black-Scholes option-pricing model were as follows:


	September 30,			December 31,
	2022			2021
Expected stock price volatility		115.00	%		105.00	%
Risk-free interest rate		4.20	%		1.20	%
Expected dividend yield		0.00	%		0.00	%
Expected term	3.47 years			3.89 – 4.39 years
Probability of drawing Tranche 2		5.00	%		50.00	%

As we did not complete a bona fide round of equity financing by March 31, 2022, the exercise price and underlying shares of the Tranche 1 warrant became fixed and therefore qualified for equity classification. We remeasured the Tranche 1 warrant liability to fair value as of March 31, 2022 and recognized the change in fair value in the condensed consolidated statements of operations and comprehensive income (loss) and the Tranche 1 warrant liability was reclassified to additional paid-in-capital.

Valuation of the Contingent Earn-Out Liabilities

The Clene Nanomedicine and Initial Stockholders Contingent Earn-outs were recorded at fair value at the closing of the Reverse Recapitalization and are remeasured at each reporting period. As of September 30, 2022 and December 31, 2021, Clene Nanomedicine’s common stockholders were entitled to receive up to 5,842,334 shares of Common Stock and the Initial Stockholders were entitled to receive up to 750,000 shares of Common Stock. As of December 31, 2021, we did not achieve Milestone 3 and the 2,503,851 Milestone 3 Contingent Earn-out shares were cancelled (see Note 3).

The estimated fair value of the Contingent Earn-outs is determined using a Monte Carlo valuation model in order to simulate the future path of our stock price over the earn-out periods. The carrying amount of the liabilities may fluctuate significantly and actual amounts paid may be materially different from the liabilities’ estimated value. The unobservable inputs to the Monte Carlo valuation model were as follows:


	September 30,			December 31,
	2022			2021
Expected stock price volatility		115.00	%		105.00	%
Risk-free interest rate		4.20	%		1.10	%
Expected dividend yield		0.00	%		0.00	%
Expected term	3.25 years			4.00 years

- 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

Common Stock

9 Months Ended

Sep. 30, 2022

Stockholders' Equity Note [Abstract]

Common Stock

Note 15. Common Stock

As of September 30, 2022 and December 31, 2021, our amended and restated certificate of incorporation authorized us to issue 150,000,000 shares of Common Stock, par value $0.0001 per share, and 1,000,000 shares of preferred stock, par value $0.0001 per share.

Our common stockholders are entitled to one vote per share and to notice of any stockholders’ meeting. Voting, dividend, and liquidation rights of the holders of Common Stock are subject to the prior rights of holders of all classes of stock and are qualified by the rights, powers, preferences, and privileges of the holders of preferred stock. No distributions shall be made with respect to Common Stock until all declared dividends to preferred stock have been paid or set aside for payment. Common Stock is not redeemable at the option of the holder.

As of September 30, 2022 and December 31, 2021, our Common Stock issued and outstanding was 63,541,984 and 62,312,097 shares, respectively. As of September 30, 2022 and December 31, 2021, there was no preferred stock issued or outstanding.

Private Placements

Prior to the completion of the Reverse Recapitalization, we entered into subscription agreements with various investors (the “2020 PIPE”) for the sale and issuance of 2,239,500 shares of Common Stock at a price of $10.00 per share, generating net proceeds of $22.2 million. In addition, investors in the 2020 PIPE also received warrants (the “PIPE Warrants”) to purchase a number of shares equal to one-half (1/2) of the number of 2020 PIPE shares, totaling 1,119,750 shares of Common Stock, at $0.01 per share and subject to a 180-day holding period. Between July 1, 2021 and December 20, 2021, the PIPE Warrants were exercised in full for 1,119,750 shares of Common Stock. We received cash proceeds of $11,198.

In May 2021, we entered into subscription agreements with various investors (the “2021 PIPE”) for the sale and issuance of 960,540 shares of Common Stock at a price of $9.63 per share, generating net proceeds of $9.3 million.

At-the-Market Facility

On April 14, 2022, we entered into an Equity Distribution Agreement (the “ATM Facility”) with Canaccord Genuity LLC and Oppenheimer & Co. Inc., as placement agents (the “Placement Agents”). In accordance with the terms of the ATM Facility, we may offer and sell shares of Common Stock having an aggregate offering price of up to $50.0 million from time to time through the Placement Agents. The issuance and sale of Common Stock, if any, by us under the ATM Facility will be made pursuant to our registration statement on Form S-3 (file number 333-264299), which was declared effective by the Securities and Exchange Commission (the “SEC”) on April 26, 2022, and our prospectus supplement relating to the offering.

Subject to terms of the ATM Facility, the Placement Agents are not required to sell any specific number or dollar amount of Common Stock but will act as our placement agents, using commercially reasonable efforts to sell, on our behalf, all of the Common Stock requested by us to be sold, consistent with the Placement Agents’ normal trading and sales practices, on terms mutually agreed

between the Placement Agents and us. The Placement Agents will be entitled to compensation under the terms of the ATM Facility at a fixed commission rate of 3.0% of the gross proceeds from each issuance and sale of Common Stock, if any.

During the three and nine months ended September 30, 2022, we sold 40,000 shares of Common Stock under the ATM Facility and generated gross proceeds of $0.1 million. Commissions paid to the Placement Agents were insignificant.

- 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

Net Loss Per Share

9 Months Ended

Sep. 30, 2022

Earnings Per Share [Abstract]

Net Loss Per Share

Note 16. Net Loss Per Share

The computation of basic and diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,					Nine Months Ended September 30,
(in thousands, except share and per share data)	2022			2021		2022			2021
Numerator:
Net income (loss) attributable to common stockholders – Basic	$	(10,976	)	$	28,944	$	(28,864	)	$	(14,163	)
Less interest expense on potentially dilutive convertible notes payable	$	—		$	196	$	—		$	—
Net income (loss) attributable to common stockholders – Diluted	$	(10,976	)	$	29,140	$	(28,864	)	$	(14,163	)

Denominator:
Weighted average common shares outstanding – Basic		63,508,928			62,071,754		63,234,757			61,307,699
Weighted average effect of potentially dilutive securities:
Stock options		—			5,791,023		—			—
Common stock warrants		—			1,485,049		—			—
Convertible notes payable		—			482,703		—			—
Restricted stock awards		—			208,105		—			—
Weighted average common shares outstanding – Diluted		63,508,928			70,038,634		63,234,757			61,307,699

Net income (loss) per share attributable to common stockholders
Basic	$	(0.17	)	$	0.47	$	(0.46	)	$	(0.23	)
Diluted	$	(0.17	)	$	0.42	$	(0.46	)	$	(0.23	)

The following shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2022 and 2021 because they were antidilutive, out-of-the-money, or the issuance of such shares is contingent upon certain conditions which were not satisfied by the end of the period:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Convertible notes payable (see Note 9)		482,703		—		482,703		482,703
Common stock warrants (see Note 10)		4,477,045		2,547,934		4,477,045		4,594,545
Options to purchase common stock (see Note 13)		12,173,570		2,685,575		12,173,570		9,063,423
Unvested restricted stock awards (see Note 13)		769,139		1,100,050		769,139		1,245,489
Contingent earn-out shares (see Note 3)		6,592,334		9,096,185		6,592,334		9,096,185
Total		24,494,791		15,429,744		24,494,791		24,482,345

Related Party Transactions

9 Months Ended

Sep. 30, 2022

Related Party Transactions

Note 17. Related Party Transactions

License and Supply Agreements

In August 2018, we entered into a license agreement and exclusive supply agreement (collectively, the “4Life Agreement”) in conjunction with 4Life’s investment in our Series C preferred stock and warrants. Pursuant to the 4Life Agreement, we granted 4Life an exclusive license to sell certain dietary supplements. The term of the exclusive license is five years from the commencement of product sales under the 4Life Agreement, which was in April 2021, with options to renew for additional five-year terms. We provide non-pharmaceutical product to 4Life for development, and 4Life pays royalties of 3% of incremental sales. 4Life is subject to an annual minimum sales requirement. If the minimum sales are unmet, 4Life may pay us an additional fee to maintain exclusivity or have the license converted to non-exclusive. Total revenue under the 4Life Agreement for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Product revenue from related parties	$	127	$	51	$	127	$	376
Royalty revenue from related parties		44		47		100		124
Total revenue from related parties	$	171	$	98	$	227	$	500

Geographic and Segment Information

9 Months Ended

Sep. 30, 2022

Segment Reporting [Abstract]

Geographic and Segment Information

Note 18. Geographic and Segment Information

Geographic Information

Long-lived assets, which were composed of property and equipment, net by location, as of September 30, 2022 and December 31, 2021, were as follows:


	September 30,		December 31,
(in thousands)	2022		2021
United States	$	9,753	$	5,142
Australia		—		30
Total property and equipment, net	$	9,753	$	5,172

Segment Information

Our operating segment profit measure is segment loss from operations, which is calculated as revenue less cost of revenue, research and development, and general and administrative expenses. Profit and loss information by reportable segment for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,						Nine Months Ended September 30,
(in thousands)	2022			2021			2022			2021
Drugs:
Revenue from external customers	$	—		$	—		$	—		$	—
Depreciation expense		(222	)		(223	)		(681	)		(700	)
Stock compensation expense		2,098			2,425			6,484			9,945
Loss from operations		(10,073	)		(10,546	)		(37,012	)		(35,632	)
Supplements:
Revenue from external customers	$	174		$	110		$	239		$	524
Depreciation expense		(11	)		(12	)		(34	)		(34	)
Stock compensation expense		—			—			—			—
Income (loss) from operations		268			96			276			(288	)
Consolidated:
Revenue from external customers	$	174		$	110		$	239		$	524
Depreciation expense		(233	)		(235	)		(715	)		(734	)
Stock compensation expense		2,098			2,425			6,484			9,945
Loss from operations		(9,805	)		(10,450	)		(36,736	)		(35,920	)

A reconciliation of the total of the reportable segments’ loss from operations to consolidated net loss before income taxes for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,						Nine Months Ended September 30,
(in thousands)	2022			2021			2022			2021
Segment loss from operations	$	(9,805	)	$	(10,450	)	$	(36,736	)	$	(35,920	)
Total other income (expense), net		(1,171	)		39,325			7,872			21,544
Net income (loss) before income taxes	$	(10,976	)	$	28,875		$	(28,864	)	$	(14,376	)

Segment assets exclude corporate assets, such as cash, restricted cash, and corporate facilities. Total assets by reportable segment as of September 30, 2022 and December 31, 2021, were as follows:


	September 30,		December 31,
(in thousands)	2022		2021
Total assets:
Drugs	$	19,106	$	12,052
Supplements		331		337
Corporate		16,567		50,674
Consolidated	$	36,004	$	63,063

Additions to long-lived assets were through cash expenditure, accounts payable, and a lease incentive representing an allowance for facility alterations. For the nine months ended September 30, 2022 and 2021, total additions were as follows:


	Nine Months Ended September 30,
(in thousands)	2022		2021
Drugs	$	5,296	$	661
Supplements		—		—
Corporate		—		—
Consolidated	$	5,296	$	661

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

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+ Details

Subsequent Events

9 Months Ended

Sep. 30, 2022

Subsequent Events [Abstract]

Subsequent Events

Note 19. Subsequent Events

We have executed a non-binding Commitment Letter with DHCD to borrow $5.0 million, conditioned on the Company matching the $5.0 million loan with at least $5.0 million of new equity capital. We are targeting December 1, 2022 as the tentative closing date for the Loan Facility.

On October 3, 2022, we sold 318,769 shares of Common Stock under the ATM Facility and generated gross proceeds of $0.6 million. Commissions paid to the Placement Agents were insignificant. The issuance and sale of Common Stock under the ATM Facility was made pursuant to our registration statement on Form S-3 (file number 333-264299), which was declared effective by the SEC on April 26, 2022, and our prospectus supplement relating to the offering.

On October 31, 2022, we entered into securities purchase agreement with certain of our existing stockholders, including stockholders affiliated with our directors, pursuant to which we agreed to issue and sell, in a registered direct offering (the “Offering”), 10,723,926 shares of Common Stock at a sale price of $1.01 per share. The Offering was made without a placement agent, underwriter, broker or dealer and the Company is not paying underwriting discounts or commissions. The aggregate gross proceeds, before expenses, were $10.8 million. The estimated total expenses of the Offering were approximately $20,000. The Offering was made pursuant to our registration statement on Form S-3 (file number 333-264299), which was declared effective by the SEC on April 26, 2022, and our prospectus supplement relating to the Offering.

Accounting Policies, by Policy (Policies)	9 Months Ended
Accounting Policies, by Policy (Policies)	Sep. 30, 2022
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying condensed consolidated financial statements include the accounts of Clene Inc. and our wholly-owned subsidiaries, Clene Nanomedicine, Inc. (“Clene Nanomedicine”), a subsidiary incorporated in Delaware, Clene Australia Pty Ltd (“Clene Australia”), a subsidiary incorporated in Australia, Clene Netherlands B.V. (“Clene Netherlands”), a subsidiary incorporated in the Netherlands, and dOrbital, Inc., a subsidiary incorporated in Delaware, after elimination of all intercompany accounts and transactions. We have prepared the accompanying condensed consolidated financial statements in accordance with United States (“U.S.”) Generally Accepted Accounting Principles (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. The condensed consolidated financial statements have been prepared on the same basis as our audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation. The financial data and other information disclosed in the condensed consolidated financial statements and related notes for the three and nine months ended September 30, 2022 and 2021 are unaudited. Results of operations for the three and nine months ended September 30, 2022 and 2021 are not necessarily indicative of the results for the entire fiscal year or any other period. The condensed consolidated financial statements for the three and nine months ended September 30, 2022 and 2021 should be read in conjunction with the audited consolidated financial statements included in our Annual Report on Form 10-K.
Use of Estimates	Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and disclosure of contingent assets and liabilities, and the reported amounts of expenses. We base our estimates on historical experience and various other assumptions that we believe to be reasonable. Actual results may differ from those estimates or assumptions. Estimates are periodically reviewed in light of changes in circumstances, facts, and experience, and any changes in estimates will be recorded in future periods as they develop.
Risks and Uncertainties	Risks and Uncertainties The product candidates we develop require approvals from regulatory agencies prior to commercial sales. There can be no assurance that our current and future product candidates will receive the necessary approvals or be commercially successful. If we are denied approval or approval is delayed, it will have a material adverse impact on our business and our condensed consolidated financial statements. We are subject to certain risks and uncertainties and believe that changes in any of the following areas could have a material adverse effect on future financial condition, results of operations, or cash flows: ability to obtain additional financing; regulatory approval and market acceptance of, and reimbursement for, product candidates; performance of third-party CROs and manufacturers upon which we rely; protection of our intellectual property; litigation or claims against us based on intellectual property, patent, product, regulatory, or other factors; and our ability to attract and retain employees necessary to support our growth.
Concentrations of Credit Risk	Concentrations of Credit Risk Financial instruments which potentially subject us to significant concentrations of credit risk consist primarily of cash. Our cash is mainly held in financial institutions. Amounts on deposit may at times exceed federally insured limits. We have not experienced any losses on our deposits of cash and do not believe that we are subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
Cash and Cash Equivalents	Cash and Cash Equivalents We consider all short-term investments with original maturities of 90 days or less when purchased to be cash equivalents.
Restricted Cash	Restricted Cash We classify cash as restricted when it is unavailable for withdrawal or use in our general operating activities. Restricted cash and investments are classified as current and noncurrent in the condensed consolidated balance sheets based on the nature of the restriction. Our restricted cash balance includes contractually restricted deposits related to our corporate credit card.
Marketable Securities	Marketable Securities Marketable securities are investments with original maturities of more than 90 days when purchased. We do not invest in securities with original maturities of more than one year. Marketable securities are considered available-for-sale, and are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income (loss) until realized. Realized gains and losses are included in other income (expense), net, on the basis of specific identification. The cost of marketable securities is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in other income (expense), net.
Inventory	Inventory Inventory is stated at historic cost on a first-in first-out basis. Our inventory consisted of $24,000 in raw materials and $14,000 in finished goods as of September 30, 2022, and $26,000 in raw material and $15,000 in finished goods as of December 31, 2021. Inventory primarily relates to our Supplements segment.
Property and Equipment	Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Property and equipment consist of laboratory and office equipment, computer software, and leasehold improvements. Depreciation is calculated using the straight-line method over the estimated economic useful lives of the assets, which are 3-5 years for laboratory equipment, 3-7 years for furniture and fixtures, and 2-5 years for computer software. Leasehold improvements are amortized over the lesser of the estimated lease term or the estimated useful life of the assets. Costs for capital assets not yet placed into service are capitalized as construction in progress and depreciated or amortized in accordance with the above useful lives once placed into service. Upon retirement or sale, the related cost and accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in the condensed consolidated statements of operations and comprehensive income (loss). Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred. We capitalize costs to obtain or develop computer software for internal use, including development costs incurred during the software development stage and costs to obtain software for access and conversion of historical data. We also capitalize costs to modify, upgrade, or enhance existing internal-use software that result in additional functionality. We expense costs incurred during the preliminary project stage, training costs, data conversion costs, and maintenance costs.
Contingent Earn-out Liabilities	Contingent Earn-Out Liabilities In connection with the Reverse Recapitalization, certain stockholders are entitled to receive additional shares of Clene Inc. common stock, par value $0.0001 (“Common Stock”) (the “Contingent Earn-outs”) upon us achieving certain milestones (see Note 3). In accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging (“ASC 815”), the Contingent Earn-outs are not indexed to our own stock and therefore are accounted for as a liability at the Reverse Recapitalization date and subsequently remeasured at each reporting date with changes in fair value recorded as a component of other income (expense), net.
Common Stock Warrants	Common Stock Warrants We account for common stock warrants as either equity-classified instruments or liability-classified instruments based on an assessment of the warrant terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to our Common Stock, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and, for liability-classified warrants, as of each subsequent quarterly period end date while the warrants are outstanding.
Grant Funding	Grant Funding We may submit applications to receive grant funding from governmental and non-governmental entities. We account for grants by analogizing to the grant accounting model under IAS 20, Accounting for Government Grants and Disclosure of Government Assistance. We recognize grant funding without conditions or continuing performance obligations, including the Australia research and development credit, as other income in the condensed consolidated statements of operations and comprehensive income (loss). We accrue the Australia research and development credit receivable in other current assets (see Note 5) in the condensed consolidated balance sheets in an amount equal to the qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage and we recognize other income in the condensed consolidated statements of operations and comprehensive income (loss). After submission of our Australia tax return, we receive a cash refund of the Australia research and development credit and relieve the receivable. We recognize grant funding with conditions or continuing performance obligations as a reduction in research and development expenses in the condensed consolidated statements of operations and comprehensive income (loss) in the period during which the related qualifying expenses are incurred and as the conditions or performance obligations are fulfilled. Any amount received in advance of fulfilling such conditions or performance obligations is recorded in accrued liabilities in the condensed consolidated balance sheets if the conditions or performance obligations are expected to be met within the next twelve months. We recorded grants as a reduction of research and development expenses of $0 and $0 for the three months ended September 30, 2022 and 2021, respectively; and $0 and $0.2 million for the nine months ended September 30, 2022 and 2021, respectively.
Foreign Currency Translation and Transactions	Foreign Currency Translation and Transactions Our functional currency is the U.S. dollar. Clene Australia determined its functional currency to be the Australian dollar and Clene Netherlands determined its functional currency to be the Euro. We use the U.S. dollar as our reporting currency for the condensed consolidated financial statements. The results of our non-U.S. dollar based functional currency operations are translated to U.S. dollars at the average exchange rates during the period. Our assets and liabilities are translated using the current exchange rate as of the balance sheet date and stockholders’ equity is translated using historical rates. Adjustments resulting from the translation of the condensed consolidated financial statements of our foreign functional currency subsidiaries into U.S. dollars are excluded from the determination of net loss and are accumulated in a separate component of stockholders’ equity. We also incur foreign exchange transaction gains and losses for purchases denominated in foreign currencies. Foreign exchange transaction gains and losses are included in other income (expense), net, as incurred.
Comprehensive Loss	Comprehensive income (loss) includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. The only elements of other comprehensive income (loss) in any periods presented were translation of foreign currency denominated balances of Clene Australia and Clene Netherlands to U.S. dollars for consolidation and unrealized gain (loss) on available-for-sale securities.
Segment Information	Segment Information We have determined that our chief executive officer is the chief operating decision maker (“CODM”). Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the CODM in making decisions regarding resource allocation and assessing performance. We view our operations and manage our business in two operating segments, which are our reportable segments: (1) the development and commercialization of novel clean-surfaced nanotechnology therapeutics (“Drugs”), and (2) the development and commercialization of dietary supplements (“Supplements”).
Income Taxes	Income Taxes We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the condensed consolidated financial statements or in our tax returns. Deferred tax assets and liabilities are determined based on the differences between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. We assess the likelihood that our deferred tax assets will be recovered from future taxable income and, to the extent we believe, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. We account for uncertainty in income taxes recognized in the condensed consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the condensed consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, which are considered appropriate as well as the related net interest and penalties.
Stock-Based Compensation	Stock-Based Compensation We account for stock-based compensation arrangements using a fair value-based method for costs related to all share-based payments including stock options and stock awards. Stock-based compensation expense is recorded in research and development and general and administrative expenses based on the classification of the work performed by the grantees. The fair value is recognized over the period during which a grantee is required to provide services in exchange for the option award and service-based stock awards, known as the requisite service period (usually the vesting period), on a straight-line basis. For stock awards with market conditions, the fair value is recognized over the period based on the expected milestone achievement dates as the derived service period (usually the vesting period), on a straight-line basis. For stock awards with performance conditions, the grant-date fair value of these awards is the market price on the applicable grant date, and compensation expense will be recognized when the conditions become probable of being satisfied. We recognize a cumulative true-up adjustment once the conditions become probable of being satisfied as the related service period had been completed in a prior period. Stock-based compensation expense is recognized at fair value. We elect to account for forfeitures as they occur, rather than estimating expected forfeitures. We determine the fair value of each share of Common Stock underlying stock-based awards using a Black-Scholes option pricing model based on the closing price of our Common Stock as reported by the Nasdaq Capital Market (“Nasdaq”) on the date of grant. The fair value of stock awards with market conditions are determined using a Monte Carlo valuation model.
Recently Adopted Accounting Pronouncements	Recently Adopted Accounting Pronouncements In May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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). The amendments in this update relate to the recognition and measurement of earnings per share for certain modifications or exchanges of equity-classified written call options or warrants. The guidance was effective for our fiscal year and interim periods within our fiscal year beginning after December 15, 2021. The adoption of this guidance did not have an impact on our condensed consolidated financial statements.
Recent Accounting Pronouncements Not Yet Adopted	Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The amendments in this update, among other things, require the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. As a smaller reporting company, the guidance is effective for our fiscal years beginning after December 15, 2022. We are currently evaluating the expected impact, if any, of the new guidance as a result of this extended deadline of implementation for smaller reporting companies. In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. The amendments in this update add disclosure requirements for transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy, including disclosure about the nature of the transactions, accounting policy, affected line items in the balance sheet and income statement, amounts applicable to each financial statement line item, and significant terms and conditions of the transactions including commitments and contingencies. The guidance is effective for all entities for financial statements issued for annual periods beginning after December 15, 2021, with early adoption permitted. We are currently evaluating the expected impact, if any, of the new guidance.

Marketable Securities (Tables)

9 Months Ended

Sep. 30, 2022

Marketable Securities [Abstract]

Schedule of Available-for-Sale Securities

Available-for-Sale Securities


	September 30, 2022
(in thousands)	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Commercial paper	$	4,984	$	—	$	(37	)	$	4,947
Corporate debt securities		4,036		—		(17	)		4,019
Total	$	9,020	$	—	$	(54	)	$	8,966

Summary of Proceeds from the Sale and Maturity of Available-for-Sale-Securities

As of December 31, 2021, there were no outstanding available-for-sale securities. Proceeds from the sale and maturity of available-for-sale securities were as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Proceeds from maturity of marketable securities	$	5,500	$	—	$	8,000	$	—
Proceeds from sale of marketable securities	$	4,597		—	$	7,614		—
Total	$	10,097	$	—	$	15,614	$	—

Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2022

Prepaid Expenses And Other Current Assets [Abstract]

Schedule of prepaid expenses and other current assets

Prepaid expenses and other current assets as of September 30, 2022 and December 31, 2021 were as follows:


	September 30,		December 31,
(in thousands)	2022		2021
Australia research and development credit receivable	$	1,598	$	1,564
Metals to be used in research and development		2,493		2,237
Other		998		404
Total prepaid expenses and other current assets	$	5,089	$	4,205

Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment [Abstract]

Schedule of property and equipment, net

Property and equipment, net, as of September 30, 2022 and December 31, 2021 were as follows:


	September 30,			December 31,
(in thousands)	2022			2021
Lab equipment	$	3,410		$	3,327
Office equipment		177			147
Computer software		459			—
Leasehold improvements		3,956			3,943
Construction in progress		6,684			2,052
		14,686			9,469
Less accumulated depreciation		(4,933	)		(4,297	)
Total property and equipment, net	$	9,753		$	5,172

Schedule of depreciation expense

Depreciation expense recorded in research and development expense and general and administrative expense for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
General and administrative	$	67	$	29	$	163	$	86
Research and development		166		206		552		648
Total depreciation expense	$	233	$	235	$	715	$	734

Accrued Liabilities (Tables)

9 Months Ended

Sep. 30, 2022

Disclosure Text Block Supplement [Abstract]

Schedule of accrued liabilities

Accrued liabilities as of September 30, 2022 and December 31, 2021 were as follows:


	September 30,		December 31,
(in thousands)	2022		2021
Accrued compensation and benefits	$	764	$	2,049
Accrued CRO and clinical fees		744		718
Deferred grant funds		520		520
Other		108		323
Total accrued liabilities	$	2,136	$	3,610

Leases (Tables)

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Schedule of finance lease obligations included in property and equipment

Assets recorded under finance lease obligations and included with property and equipment as of September 30, 2022 and December 31, 2021 were as follows:


	September 30,			December 31,
(in thousands)	2022			2021
Lab equipment	$	408		$	408
Work in process		228			228
Total		636			636
Less accumulated depreciation		(305	)		(244	)
Net	$	331		$	392

Schedule of financing and operating lease liability maturities

The maturity analysis of our finance and operating leases as of September 30, 2022 was as follows:


(in thousands)	Finance Leases			Operating Leases
2022 (remainder)	$	37		$	188
2023		96			1,145
2024		27			1,171
2025		—			1,202
2026		—			1,231
2027		—			1,129
Thereafter		—			2,786
Total undiscounted cash flows		160			8,852
Less amount representing interest/discounting		(18	)		(2,674	)
Present value of future lease payments		142			6,178
Less lease obligations, current portion		(97	)		(467	)
Lease obligations, long term portion	$	45		$	5,711

Schedule of finance and operating lease costs

The components of finance and operating lease costs for the three and nine months ended September 30, 2022 and 2021 were as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Finance lease costs:
Amortization	$	20	$	37	$	61	$	110
Interest on lease liabilities		6		6		12		21
Operating lease costs		256		107		695		247
Short-term lease costs		—		98		—		214
Variable lease costs		65		32		238		71
Total lease costs	$	347	$	280	$	1,006	$	663

Schedule of supplemental cash flow information

Supplemental Cash Flow Information


	Nine Months Ended September 30,
(in thousands)	2022			2021
Operating cash flows from operating leases	$	(933	)	$	(533	)
Operating cash flows from finance leases	$	(12	)	$	(21	)
Financing cash flows from finance leases	$	(101	)	$	(117	)

Notes Payable (Tables)

9 Months Ended

Sep. 30, 2022

Debt Disclosure [Abstract]

Schedule of long-term debt, net of original issue discount and unamortized debt issuance costs

Our long-term debt, net of original issue discount and unamortized debt issuance costs, as of September 30, 2022 and December 31, 2021 was as follows:


	Stated			September 30,			December 31,
(in thousands, except interest rates)	Interest Rate			2022			2021
Maryland DHCD (commenced 2019)		8.00	%	$	644		$	614
Maryland DHCD (commenced 2022)		6.00	%		694			—
Advance Cecil, Inc. (commenced 2019)		8.00	%		128			122
Avenue Venture Opportunities Fund, L.P. (commenced 2021)		12.85	%		20,000			20,000
					21,466			20,736
Less unamortized debt issuance costs and original issue discounts					(977	)		(1,654	)
Less convertible notes payable, net of unamortized debt discount and issuance costs					(4,763	)		(4,598	)
Total notes payable				$	15,726		$	14,484

Schedule of future payments under the 2021 Avenue Loan and under the 2022 MD Loan, net of unamortized debt discounts


(in thousands)	2021 Avenue Loan			2022 MD Loan
2022 (remainder)	$	—		$	—
2023		6,667			—
2024		13,333			—
2025		—			369
2026		—			313
2027		—			—
Thereafter		—			—
Subtotal of future principal payments		20,000			682
Accrued and unpaid interest		—			13
Less unamortized debt issuance costs and original issue discounts		(948	)		(29	)
Total	$	19,052		$	666

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

+ References

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+ Details

Common Stock Warrants (Tables)

9 Months Ended

Sep. 30, 2022

Common Stock Warrants Disclosure [Abstract]

Schedule of outstanding warrants to purchase shares of common stock

As of September 30, 2022 and December 31, 2021, outstanding warrants to purchase shares of Common Stock were as follows:


Date Exercisable	Number of Shares Issuable			Exercise Price		Exercisable for	Classification	Expiration
December 2020		2,407,500	(1)	$	11.50	Common Stock	Equity	December 2025
December 2020		24,583	(2)	$	11.50	Common Stock	Equity	December 2025
December 2020		1,929,111	(3)	$	1.97	Common Stock	Equity	April 2023
May 2021		115,851	(4)	$	8.63	Common Stock	Equity	May 2026
Total		4,477,045

(1)

(2)

(3)

(4)

Consists of 115,851 shares of Common Stock underlying the Avenue Warrant. As of September 30, 2022 and December 31, 2021, the warrant had not been exercised.

Income Taxes (Tables)

9 Months Ended

Sep. 30, 2022

Income Tax Disclosure [Abstract]

Schedule of components of income (loss) before income taxes

The components of loss before income taxes for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,						Nine Months Ended September 30,
(in thousands)	2022			2021			2022			2021
United States	$	(9,432	)	$	29,860		$	(25,787	)	$	(11,435	)
Foreign		(1,544	)		(985	)		(3,077	)		(2,941	)
Income (loss) before provision for income taxes	$	(10,976	)	$	28,875		$	(28,864	)	$	(14,376	)

Benefit Plans (Tables)

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

Schedule of stock-based compensation expense

Stock-Based Compensation Expense

Stock-based compensation expense recorded in research and development expense and general and administrative expense for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
General and administrative	$	1,247	$	1,567	$	4,056	$	6,084
Research and development		851		858		2,428		3,861
Total stock-based compensation expense	$	2,098	$	2,425	$	6,484	$	9,945

Stock-based compensation expense by award type for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Stock options	$	2,098	$	1,583	$	6,484	$	3,096
Restricted stock awards		—		842		—		6,849
Total stock-based compensation expense	$	2,098	$	2,425	$	6,484	$	9,945

Schedule of outstanding common stock options and related activity

Outstanding stock options and related activity for the nine months ended September 30, 2022 was as follows:


(in thousands, except share, per share, and term data)	Number of Options			Weighted Average Exercise Price Per Share		Weighted Average Remaining Term (Years)		Intrinsic Value
Outstanding – December 31, 2021		10,395,027			3.35		6.32	$	21,082
Granted		2,865,411			3.01		9.41		—
Exercised		(1,044,448	)		0.27		—		2,641
Forfeited		(42,420	)		5.06		—		—
Outstanding – September 30, 2022		12,173,570		$	3.53		6.75	$	10,225
Vested and exercisable – September 30, 2022		6,529,233		$	2.33		4.81	$	10,120
Vested, exercisable or expected to vest – September 30, 2022		12,173,570		$	3.53		6.75	$	10,225

Schedule of assumptions used to calculate the fair value of stock options

The assumptions used to calculate the fair value of stock options granted during the nine months ended September 30, 2022 and 2021 were as follows:


	Nine Months Ended September 30,
	2022	2021
Expected stock price volatility	89.57% – 98.13%	84.80% – 87.40%
Risk-free interest rate	1.65% – 3.00%	0.59% – 0.94%
Expected dividend yield	0.00%	0.00%
Expected term of options	5.00 – 6.98 years	6.00 years

Schedule of restricted common stock activity

Outstanding rights to restricted stock awards and related activity for the nine months ended September 30, 2022 was as follows:


	Number of Restricted Stock Awards			Weighted Average Grant Date Fair Value
Unvested balance – December 31, 2021		916,603		$	10.00
Converted to shares of Common Stock upon vesting		(145,439	)		—
Forfeited		(2,025	)		9.84
Unvested balance – September 30, 2022		769,139		$	9.84

Fair Value (Tables)

9 Months Ended

Sep. 30, 2022

Fair Value Disclosures [Abstract]

Schedule of Fair Value Hierarchy of Financial Instruments Measured at Fair Value on Recurring Basis

The fair value hierarchy for financial instruments measured at fair value on a recurring basis as of September 30, 2022 is as follows:


	September 30, 2022
(in thousands)	Level 1		Level 2		Level 3		Total
Cash equivalents
Money market funds	$	4,724	$	—	$	—	$	4,724
Marketable securities
Commercial paper		—		4,947		—		4,947
Corporate debt securities		—		4,019		—		4,019
Common stock warrant liability		—		—		18		18
Clene Nanomedicine contingent earn-out liability		—		—		11,438		11,438
Initial Stockholders contingent earn-out liability		—		—		1,468		1,468

The fair value hierarchy for financial instruments measured at fair value on a recurring basis as of December 31, 2021 is as follows:


	December 31, 2021
(in thousands)	Level 1		Level 2		Level 3		Total
Notes payable	$	736	$	—	$	—	$	736
Common stock warrant liability		—		—		474		474
Clene Nanomedicine contingent earn-out liability		—		—		18,100		18,100
Initial Stockholders contingent earn-out liability		—		—		2,317		2,317

Schedule of Unobservable Inputs to Conversion Feature, Warrant Liability, and Contingent Earn-Out Valuation Models

The unobservable inputs to the Black-Scholes option-pricing model were as follows:


	September 30,			December 31,
	2022			2021
Expected stock price volatility		105.00	%		105.00	%
Risk-free interest rate		4.20	%		0.70	%
Expected dividend yield		0.00	%		0.00	%
Expected term	1.64 years			2.39 years

The unobservable inputs to the Black-Scholes option-pricing model were as follows:


	September 30,			December 31,
	2022			2021
Expected stock price volatility		115.00	%		105.00	%
Risk-free interest rate		4.20	%		1.20	%
Expected dividend yield		0.00	%		0.00	%
Expected term	3.47 years			3.89 – 4.39 years
Probability of drawing Tranche 2		5.00	%		50.00	%

The unobservable inputs to the Monte Carlo valuation model were as follows:


	September 30,			December 31,
	2022			2021
Expected stock price volatility		115.00	%		105.00	%
Risk-free interest rate		4.20	%		1.10	%
Expected dividend yield		0.00	%		0.00	%
Expected term	3.25 years			4.00 years

Schedule of Changes in Fair Value of Financial Instruments Related to Level 3 Financial Instruments

Changes in the fair value of our Level 3 financial instruments for the nine months ended September 30, 2022 were as follows:


(in thousands)	Common Stock Warrant Liability			Clene Nanomedicine Contingent Earn-out			Initial Stockholders Contingent Earn-out
Balance – December 31, 2021	$	474		$	18,100		$	2,317
Change in fair value		(151	)		(6,662	)		(849	)
Reclassification from liability to equity		(305	)		—			—
Balance – September 30, 2022	$	18		$	11,438		$	1,468

Changes in the fair value of our Level 3 financial instruments for the nine months ended September 30, 2021 were as follows:


(in thousands)	Common Stock Warrant Liability			Clene Nanomedicine Contingent Earn-out			Initial Stockholders Contingent Earn-out
Balance – December 31, 2020	$	—		$	52,053		$	5,906
Initial fair value of instrument		1,457			—			—
Change in fair value		(547	)		(18,072	)		(1,710	)
Balance – September 30, 2021	$	910		$	33,981		$	4,196

Net Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2022

Earnings Per Share [Abstract]

Schedule of basic and diluted net loss per share

The computation of basic and diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,					Nine Months Ended September 30,
(in thousands, except share and per share data)	2022			2021		2022			2021
Numerator:
Net income (loss) attributable to common stockholders – Basic	$	(10,976	)	$	28,944	$	(28,864	)	$	(14,163	)
Less interest expense on potentially dilutive convertible notes payable	$	—		$	196	$	—		$	—
Net income (loss) attributable to common stockholders – Diluted	$	(10,976	)	$	29,140	$	(28,864	)	$	(14,163	)

Denominator:
Weighted average common shares outstanding – Basic		63,508,928			62,071,754		63,234,757			61,307,699
Weighted average effect of potentially dilutive securities:
Stock options		—			5,791,023		—			—
Common stock warrants		—			1,485,049		—			—
Convertible notes payable		—			482,703		—			—
Restricted stock awards		—			208,105		—			—
Weighted average common shares outstanding – Diluted		63,508,928			70,038,634		63,234,757			61,307,699

Net income (loss) per share attributable to common stockholders
Basic	$	(0.17	)	$	0.47	$	(0.46	)	$	(0.23	)
Diluted	$	(0.17	)	$	0.42	$	(0.46	)	$	(0.23	)

Schedule of securities excluded from computation of diluted net income (loss) per share


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Convertible notes payable (see Note 9)		482,703		—		482,703		482,703
Common stock warrants (see Note 10)		4,477,045		2,547,934		4,477,045		4,594,545
Options to purchase common stock (see Note 13)		12,173,570		2,685,575		12,173,570		9,063,423
Unvested restricted stock awards (see Note 13)		769,139		1,100,050		769,139		1,245,489
Contingent earn-out shares (see Note 3)		6,592,334		9,096,185		6,592,334		9,096,185
Total		24,494,791		15,429,744		24,494,791		24,482,345

Related Party Transactions (Tables)

9 Months Ended

Sep. 30, 2022

Schedule Of Total Revenue

Total revenue under the 4Life Agreement for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Product revenue from related parties	$	127	$	51	$	127	$	376
Royalty revenue from related parties		44		47		100		124
Total revenue from related parties	$	171	$	98	$	227	$	500

Geographic and Segment Information (Tables)

9 Months Ended

Sep. 30, 2022

Segment Reporting [Abstract]

Schedule of property and equipment, net by location

Long-lived assets, which were composed of property and equipment, net by location, as of September 30, 2022 and December 31, 2021, were as follows:


	September 30,		December 31,
(in thousands)	2022		2021
United States	$	9,753	$	5,142
Australia		—		30
Total property and equipment, net	$	9,753	$	5,172

Schedule of Profit and Loss Information by Reportable Segment

Profit and loss information by reportable segment for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended September 30,						Nine Months Ended September 30,
(in thousands)	2022			2021			2022			2021
Drugs:
Revenue from external customers	$	—		$	—		$	—		$	—
Depreciation expense		(222	)		(223	)		(681	)		(700	)
Stock compensation expense		2,098			2,425			6,484			9,945
Loss from operations		(10,073	)		(10,546	)		(37,012	)		(35,632	)
Supplements:
Revenue from external customers	$	174		$	110		$	239		$	524
Depreciation expense		(11	)		(12	)		(34	)		(34	)
Stock compensation expense		—			—			—			—
Income (loss) from operations		268			96			276			(288	)
Consolidated:
Revenue from external customers	$	174		$	110		$	239		$	524
Depreciation expense		(233	)		(235	)		(715	)		(734	)
Stock compensation expense		2,098			2,425			6,484			9,945
Loss from operations		(9,805	)		(10,450	)		(36,736	)		(35,920	)

Schedule of Reconciliation of Operating Loss from Segments to Consolidated Net Loss


	Three Months Ended September 30,						Nine Months Ended September 30,
(in thousands)	2022			2021			2022			2021
Segment loss from operations	$	(9,805	)	$	(10,450	)	$	(36,736	)	$	(35,920	)
Total other income (expense), net		(1,171	)		39,325			7,872			21,544
Net income (loss) before income taxes	$	(10,976	)	$	28,875		$	(28,864	)	$	(14,376	)

Schedule of Reconciliation of Long Lived Assets and Total Assets by Reportable Segment

Segment assets exclude corporate assets, such as cash, restricted cash, and corporate facilities. Total assets by reportable segment as of September 30, 2022 and December 31, 2021, were as follows:


	September 30,		December 31,
(in thousands)	2022		2021
Total assets:
Drugs	$	19,106	$	12,052
Supplements		331		337
Corporate		16,567		50,674
Consolidated	$	36,004	$	63,063

Schedule of Additions to Long-lived Assets

For the nine months ended September 30, 2022 and 2021, total additions were as follows:


	Nine Months Ended September 30,
(in thousands)	2022		2021
Drugs	$	5,296	$	661
Supplements		—		—
Corporate		—		—
Consolidated	$	5,296	$	661

Nature of the Business (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended		3 Months Ended		9 Months Ended
	Oct. 31, 2022	May 31, 2021	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Accounting Policies [Abstract]
Loss from operations			$ (9,805)	$ (10,450)	$ (36,736)	$ (35,920)
Cash, cash equivalents, restricted cash and marketable securities			16,200		16,200		$ 50,300
Accumulated deficit			$ (192,165)		(192,165)		$ (163,301)
Net cash (used in) operating activities					$ (31,295)	$ (25,018)
Common share, par value (in Dollars per share)			$ 0.0001		$ 0.0001		$ 0.0001
Minimum cash balance for loan covenant		$ 5,000
Net cash proceeds from equity offering	$ 10,800

Summary of Significant Accounting Policies (Details)	3 Months Ended		9 Months Ended
Summary of Significant Accounting Policies (Details)	Sep. 30, 2022 USD ($)	Sep. 30, 2021 USD ($)	Sep. 30, 2022 USD ($) Segment	Sep. 30, 2021 USD ($)	Dec. 31, 2021 USD ($)
Summary of Significant Accounting Policies (Details) [Line Items]
Inventory in raw materials	$ 24,000		$ 24,000		$ 26,000
Inventory Finished Goods	14,000		$ 14,000		$ 15,000
Number of operating segments \| Segment			2
Grant funding recognized on conditional grants	$ 0	$ 0	$ 0	$ 200,000
Equipment [Member] \| Minimum [Member]
Summary of Significant Accounting Policies (Details) [Line Items]
Useful lives of asset			3 years
Equipment [Member] \| Maximum [Member]
Summary of Significant Accounting Policies (Details) [Line Items]
Useful lives of asset			5 years
Furniture and Fixtures [Member] \| Minimum [Member]
Summary of Significant Accounting Policies (Details) [Line Items]
Useful lives of asset			3 years
Furniture and Fixtures [Member] \| Maximum [Member]
Summary of Significant Accounting Policies (Details) [Line Items]
Useful lives of asset			7 years

Reverse Recapitalization with Tottenham and Clene Nanomedicine (Details) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended	9 Months Ended
	Dec. 30, 2020	Sep. 30, 2022	Dec. 31, 2021	Dec. 31, 2020
Business Combination, Separately Recognized Transactions [Line Items]
Net Proceeds From Reverse Recapitalization	$ 3.5
Proceeds from reverse recapitalization (in Dollars)	$ 9.4
Shares Issued For Payment of Offering Costs	644,164
Clene nanomedicine contingent earnout milestone1 shares		3,333,333
Clene nanomedicine contingent earnout milestone 1 price (in Dollars per share)		$ 15.00
Clene nanomedicine contingent earnout milestone 2 shares		2,500,000
Clene nanomedicine contingent earnout milestone 2 price (in Dollars per share)		20.00
Clene nanomedicine contingent earnout milestone 3 shares		2,500,000
Total clene nanomedicine contingent earnout shares		8,346,185
Initial Shareholders Contingent Earnout Milestone One Shares		375,000
Initial shareholders contingent earnout milestone 2 shares		375,000
Clene nanomedicine contingent earnout milestone three shares cancelled			2,503,851
Reverse recapitalization [Member]
Business Combination, Separately Recognized Transactions [Line Items]
Offering costs (in Dollars)	$ 5.9
Clene Inc [Member]
Business Combination, Separately Recognized Transactions [Line Items]
Common stock, par value (in Dollars per share)				$ 0.0001

Marketable Securities - Schedule of Available-for-Sale Securities (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Marketable Securities [Line Items]
Amortized cost	$ 9,020
Gross unrealized gains	0
Gross Unrealized losses	(54)
Fair value	8,966	$ 0
Commercial Paper
Marketable Securities [Line Items]
Amortized cost	4,984
Gross unrealized gains	0
Gross Unrealized losses	(37)
Fair value	4,947
Corporate Debt Securities
Marketable Securities [Line Items]
Amortized cost	4,036
Gross unrealized gains	0
Gross Unrealized losses	(17)
Fair value	$ 4,019

Marketable Securities (Details) - USD ($) $ in Thousands	9 Months Ended
Marketable Securities (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Marketable Securities [Abstract]
Available-for-sale securities, maturity period	1 year
Fair value	$ 8,966	$ 0

Marketable Securities - Summary of Proceeds from the Sale and Maturity of Available-for-Sale-Securities (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Marketable Securities [Abstract]
Proceeds from maturity of marketable securities	$ 5,500	$ 0	$ 8,000	$ 0
Proceeds from sale of marketable securities	4,597	0	7,614	0
Total	$ 10,097	$ 0	$ 15,614	$ 0

Prepaid Expenses and Other Current Assets - Schedule of prepaid expenses and other current assets (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Schedule of prepaid expenses and other current assets [Abstract]
Australia research and development credit receivable	$ (1,598)	$ (1,564)
Metals to be used in research and development	2,493	2,237
Other	998	404
Total prepaid expenses and other current assets	$ 5,089	$ 4,205

Property and Equipment, Net - Schedule of property and equipment, net (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Schedule of property and equipment, net [Abstract]
Laboratory equipment	$ 3,410	$ 3,327
Furniture and fixtures	177	147
Computer software	459	0
Leasehold improvements	3,956	3,943
Construction in progress	6,684	2,052
Total property and equipment, gross	14,686	9,469
Less accumulated depreciation	(4,933)	(4,297)
Total property and equipment, net	$ 9,753	$ 5,172

Property and Equipment, Net - Schedule of depreciation expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Property, Plant and Equipment [Line Items]
Depreciation expense	$ 233	$ 235	$ 715	$ 734
General and Administrative [Member]
Property, Plant and Equipment [Line Items]
Depreciation expense	67	29	163	86
Research and Development [Member]
Property, Plant and Equipment [Line Items]
Depreciation expense	$ 166	$ 206	$ 552	$ 648

Accrued Liabilities - Schedule of accrued liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Schedule of accrued liabilities [Abstract]
Accrued compensation and benefits	$ 764	$ 2,049
Accrued CRO and clinical fees	744	718
Deferred grant funds	520	520
Other	108	323
Accrued liabilities	$ 2,136	$ 3,610

Leases (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Leases (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Feb. 28, 2022	Dec. 31, 2021
Leases [Abstract]
Right-of-use assets value		$ 2,400		$ 2,400	$ 2,300
Operating lease liability		2,400		2,400	2,300
Terminated right-of-use asset					600
Terminated Operating Lease Liability					$ 1,000
Gain on termination of lease	$ 0	0	$ 420	0
Lease incentive		$ 1,000		$ 1,000
Lease incentive recorded construction in progress	$ 1,000		$ 1,000			$ 500
Description of lease term			The lease has an initial ten-year term and provides us the right and option to extend or renew for two periods of five years each. In accordance with ASC 842, Leases, the payments to be made in option periods have not been recognized as part of the right-of-use asset or lease liability because we do not assess the exercise of the option to be reasonably certain.
Finance lease obligations weighted-average interest rate	9.60%		9.60%			8.80%
Finance lease weighted-average remaining term	1 year 3 months 18 days		1 year 3 months 18 days			1 year 10 months 24 days
Operating lease obligations weighted average interest rate	9.60%		9.60%			9.60%
Operating lease weighted-average remaining term	7 years 6 months		7 years 6 months			8 years 1 month 6 days

Leases - Schedule of finance lease obligations included in property and equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Schedule Of Finance Lease Obligations Included In Property And Equipment [Abstract]
Lab equipment	$ 408	$ 408
Work in process	228	228
Total	636	636
Less accumulated depreciation	(305)	(244)
Net	$ 331	$ 392

Leases - Schedule of noncancelable finance and operating lease liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Feb. 28, 2022	Dec. 31, 2021	Sep. 30, 2021
Lessee, Lease, Description [Line Items]
Present value of future lease payments		$ 2,300		$ 2,400
Less lease obligations, current portion	$ (467)		$ (347)
Lease obligations, long term portion	5,711		$ 4,370
Finance Leases [Member]
Lessee, Lease, Description [Line Items]
2022 (remainder)	37
2023	96
2024	27
2025	0
2026	0
2027	0
Thereafter	0
Total undiscounted cash flows	160
Less amount representing interest/discounting	(18)
Present value of future lease payments	142
Less lease obligations, current portion	(97)
Lease obligations, long term portion	45
Operating Leases [Member]
Lessee, Lease, Description [Line Items]
2022 (remainder)	188
2023	1,145
2024	1,171
2025	1,202
2026	1,231
2027	1,129
Thereafter	2,786
Total undiscounted cash flows	8,852
Less amount representing interest/discounting	(2,674)
Present value of future lease payments	6,178
Less lease obligations, current portion	(467)
Lease obligations, long term portion	$ 5,711

Leases - Schedule of finance and operating lease costs (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Finance lease costs:
Amortization	$ 20	$ 37	$ 61	$ 110
Interest on lease liabilities	6	6	12	21
Operating lease costs	256	107	695	247
Short-term lease costs	0	98	0	214
Variable lease costs	65	32	238	71
Total lease costs	$ 347	$ 280	$ 1,006	$ 663

Leases - Schedule of supplemental cash flow information (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Sep. 30, 2021
Schedule of supplemental cash flow information [Abstract]
Operating cash flows from operating leases	$ (933)	$ (533)
Operating cash flows from finance leases	(12)	(21)
Financing cash flows from finance leases	$ (101)	$ (117)

Notes Payable - Schedule of long-term debt, net of original issue discount and unamortized debt issuance costs (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Term Loans:
Total term loans	$ 21,466	$ 20,736
Less unamortized debt issuance costs and original issue discounts	(977)	(1,654)
Less convertible notes payable, net of unamortized debt discount and issuance costs	(4,763)	(4,598)
Notes payable	$ 15,726	14,484
Maryland DHCD (commenced 2019) [Member]
Term Loans:
Interest Rate	8.00%
Total term loans	$ 644	614
Maryland DHCD (commenced 2022)
Term Loans:
Interest Rate	6.00%
Total term loans	$ 694	0
Advance Cecil, Inc. (commenced 2019)
Term Loans:
Interest Rate	8.00%
Total term loans	$ 128	122
Avenue Venture Opportunities Fund, L.P. (commenced 2021)
Term Loans:
Interest Rate	12.85%
Total term loans	$ 20,000	$ 20,000

Notes Payable (Details) - USD ($)	1 Months Ended				3 Months Ended		9 Months Ended
Notes Payable (Details) - USD ($)	May 31, 2022	May 31, 2021	Apr. 30, 2019	Feb. 28, 2019	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021	May 31, 2020
Notes Payable (Details) [Line Items]
Debt issuance costs							$ 30,000	$ 534,000
Minimum cash balance for loan covenant		$ 5,000,000.0
2019 MD Loan [Member]
Notes Payable (Details) [Line Items]
Term loan				$ 500,000
Interest rate				8.00%
Phantom shares, description				The 2019 MD Loan established “Phantom Shares” at issuance based on 119,907 shares of Common Stock.
Interest income (expense)						$ 500,000		300,000
Interest expense					$ 10,000		30,000
2019 Cecil Loan [Member]
Notes Payable (Details) [Line Items]
Term loan			$ 100,000
Interest rate			8.00%
Phantom shares, description			The 2019 Cecil Loan established “Phantom Shares” at issuance based on 23,981 shares of Common Stock.
Interest income (expense)						106,000		52,000
Interest expense					$ 2,000		$ 6,000
PPP Note [Member]
Notes Payable (Details) [Line Items]
Note payable										$ 600,000
2021 Avenue Loan [Member] \| Notes Payable [Member]
Notes Payable (Details) [Line Items]
Term loan		30,000,000.0
Interest rate					12.85%		12.85%		9.85%
Interest expense					$ 800,000	600,000	$ 2,300,000	800,000
Accrued debt issuance costs		600,000
Amortization of Debt Issuance Costs		$ 46,951
Conditions for future funding, description		Funding of Tranche 2 is subject to (a) our receipt of $5.0 million financing through the state of Maryland; (b) our achievement of a statistically significant result in certain clinical trials (“Performance Milestone 1”); (c) our receipt of net proceeds of at least $30.0 million from the sale and issuance of our equity securities between May 2, 2021 and December 31, 2022; and (d) mutual agreement of us and Avenue.
Rate of interest, description							The 2021 Avenue Loan bears interest at a variable rate equal to the sum of (i) the greater of (a) the prime rate or (b) 3.25%, plus (ii) 6.60%. As of September 30, 2022 and December 31, 2021, the interest rate was 12.85% and 9.85%, respectively.
Additional payment upon maturity, description							On the maturity date, an additional payment equal to 4.25% of the funded loans, currently equal to $0.9 million (the “Final Payment”), is due in addition to the remaining unpaid principal and accrued interest.
Additional final payment at debt maturity		$ 900,000
Minimum funding from maryland state incentive program		5,000,000.0
Equity offering proceeds required for tranche 2 funding		$ 30,000,000.0
Warrant to purchase shares (in Shares)		115,851
Common stock at an exercise price (in Dollars per share)		$ 8.63
Tranche warrant adjustment description		Upon the funding of Tranche 2, the Avenue Warrant shall be adjusted to include an additional estimated 184,133 shares of Common Stock, which is equal to 5% of the principal amount of Tranche 2, divided by the five (5)-day VWAP per share as of the end of trading on the last trading day before the issuance of Tranche 2.
Convertible note payable					5,000,000.0		$ 5,000,000.0		$ 5,000,000.0
Minimum cash balance for loan covenant		$ 5,000,000.0
Equity offering proceeds required to remove financial covenants		30,000,000.0
Conversion feature							$ 5,000,000.0
Conversion percentage of common stock price for convertible note payable							120.00%
Convertible note issuable shares							482,703
Unamortized debt discount and issuance costs					200,000		$ 200,000		$ 400,000
Amortization of debt discount					100,000	41,000	200,000	64,000
Interest expense					200,000	200,000	600,000	300,000
Coupon interest expense					$ 200,000	$ 100,000	$ 400,000	$ 200,000
Debt Instrument, Interest Rate, Effective Percentage					18.41%	15.46%	18.41%	15.46%
Fair value of warrant		1,500,000
Financing costs		500,000
2021 Avenue Loan [Member] \| Tranche one [Member]
Notes Payable (Details) [Line Items]
First loan amount		20,000,000.0
Funded amount		15,000,000.0
Additional funded amount						$ 5,000,000.0		$ 5,000,000.0
2021 Avenue Loan [Member] \| Tranche Two [Member]
Notes Payable (Details) [Line Items]
Unfunded amount		10,000,000.0
2022 MD Loan Member
Notes Payable (Details) [Line Items]
Term loan	$ 3,000,000.0
Interest rate	6.00%
Interest expense					$ 10,000		$ 12,000
Debt issuance costs	$ 31,000
Monthly installments of principal and interest amount		33,306
Line of Credit Facility, Current Borrowing Capacity					$ 700,000		$ 700,000
2022 MD Loan Member \| Maximum [Member]
Notes Payable (Details) [Line Items]
Installment interest amount		$ 15,000,000

Notes Payable - Schedule of future payments under the 2021 Avenue Loan and under the 2022 MD Loan, net of unamortized debt discounts (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Notes Payable (Details) [Line Items]
Less unamortized debt issuance costs and original issue discounts	$ (977)	$ (1,654)
2021 Avenue Loan [Member]
Notes Payable (Details) [Line Items]
2022 (remainder)	0
2023	6,667
2024	13,333
2025	0
2026	0
2027	0
Thereafter	0
Subtotal of future principal payments	20,000
Accrued and unpaid interest	0
Less unamortized debt issuance costs and original issue discounts	(948)
Total	19,052
2022 MD Loan Member
Notes Payable (Details) [Line Items]
2022 (remainder)	0
2023	0
2024	0
2025	369
2026	313
2027	0
Thereafter	0
Subtotal of future principal payments	682
Accrued and unpaid interest	13
Less unamortized debt issuance costs and original issue discounts	(29)
Total	$ 666

Common Stock Warrants - Schedule of outstanding warrants to purchase shares of common stock (Details) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Class of Warrant or Right [Line Items]
Number of Shares Issuable	4,477,045	4,477,045
December 2020 [Member]
Class of Warrant or Right [Line Items]
Number of Shares Issuable	2,407,500	2,407,500
Exercise Price	$ 11.50	$ 11.50
Exercisable for	Common Stock	Common Stock
Classification	Equity	Equity
Expiration	December 2025	December 2025
December 2020 One [Member]
Class of Warrant or Right [Line Items]
Number of Shares Issuable	24,583	24,583
Exercise Price	$ 11.50	$ 11.50
Exercisable for	Common Stock	Common Stock
Classification	Equity	Equity
Expiration	December 2025	December 2025
December 2020 Two [Member]
Class of Warrant or Right [Line Items]
Number of Shares Issuable	1,929,111	1,929,111
Exercise Price	$ 1.97	$ 1.97
Exercisable for	Common Stock	Common Stock
Classification	Equity	Equity
Expiration	April 2023	April 2023
May 2021 [Member]
Class of Warrant or Right [Line Items]
Number of Shares Issuable	115,851	115,851
Exercise Price	$ 8.63	$ 8.63
Exercisable for	Common Stock	Common Stock
Classification	Equity	Equity
Expiration	May 2026	May 2026

Common Stock Warrants (Details)	9 Months Ended
Common Stock Warrants (Details)	Sep. 30, 2022 $ / shares shares
Common Stock Warrants (Details) [Line Items]
Shares, issued	2,407,500
Warrant redemption price per share \| $ / shares	$ 0.01
Sale of stock, price per share \| $ / shares	$ 16.50
Company warrant redemption right	We may redeem the outstanding warrants, in whole and not in part, at $0.01 per warrant if the last sales price of our Common Stock equals or exceeds $16.50 per share for any twenty trading days within a thirty-trading day period.
Avenue Loan [Member]
Common Stock Warrants (Details) [Line Items]
Shares, issued	115,851
Common Stock Warrants [Member]
Common Stock Warrants (Details) [Line Items]
Shares, issued	1,929,111
Chardan Unit Purchase Option [Member]
Common Stock Warrants (Details) [Line Items]
Shares, issued	24,583

Commitments and Contingencies (Details) - USD ($) $ in Millions	1 Months Ended
	Sep. 30, 2019	Sep. 30, 2022	Dec. 31, 2021
Commitments and contingencies
Grants received for research	$ 0.3
Repayment terms for grant received	Pursuant to a Sponsored Research Agreement with NMSS, if we make future commercial sales of CNM-Au8 for the treatment of MS, we agreed to repay certain amounts based upon the following milestones: (i) 50% of the grant upon the first commercial product sale, (ii) an additional 50% of the grant upon cumulative sales of $10.0 million, (iii) an additional 150% of the grant upon cumulative sales of $50.0 million, and (iv) an additional 200% of the grant upon cumulative sales of $100.0 million, with the maximum repayment equal to 450% of the grant funding if all milestones are achieved. Additionally, if NMSS has not yet received repayments equal in the aggregate to 300% of the grant funding, then upon the closing of any of the following events we will repay 300% of the grant funding, or $1.0 million, less any amounts previously paid by us: (i) sale of all or substantially all of our assets and business, (ii) a public offering that occurs more than twelve months after completion of the biomarker research, (iii) sale of any portion of our assets and business including CNM-Au8 for the treatment of MS, (iv) exclusive licensing of our intellectual property claiming CNM-Au8 for the treatment of MS, and (v) a collaboration with a third-party to develop CNM-Au8 for the treatment of MS
Loss contingency, Management's estimate of the possible range of loss	Management’s estimate of the possible range of loss is between the minimum and maximum repayment amounts, equal to 50% and 450% of the grant funding, or approximately $0.2 million and $1.5 million, respectively. However, it is at least reasonably possible that Management’s estimate of the probability of occurrence of each contingent event and the possible range of loss will change in the near term.
Maximum [Member]
Possible range of contingency loss , amount	$ 1.5
Possible range of contingency loss , percentage	450.00%
Minimum [Member]
Possible range of contingency loss , amount	$ 0.2
Possible range of contingency loss , percentage	50.00%
Manufacturing Facility
Commitments and contingencies		$ 1.7	$ 0.6

Income Taxes - Schedule of components of income (loss) before income taxes (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Schedule of components of income (loss) before income taxes [Abstract]
United States	$ (9,432)	$ 29,860	$ (25,787)	$ (11,435)
Foreign	(1,544)	(985)	(3,077)	(2,941)
Net income (loss) before income taxes	$ (10,976)	$ 28,875	$ (28,864)	$ (14,376)

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8906-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (f)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 940
-SubTopic 20
-Section 25
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=126941158&loc=d3e41242-110953

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(10))
-URI https://asc.fasb.org/extlink&oid=126953954&loc=SL114868664-224227

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(8))
-URI https://asc.fasb.org/extlink&oid=120400993&loc=SL114874131-224263

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 235
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
-URI https://asc.fasb.org/extlink&oid=120399901&loc=d3e537907-122884

Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 31
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8924-108599

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(15))
-URI https://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

+ Details

Benefit Plans (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
Benefit Plans (Details) - USD ($)	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Employer matching contribution, percent of match			100.00%
Maximum annual contributions per employee, percent			3.00%
Maximum annual contributions per employee, amount			$ 4,500
Shares granted	12,173,570		12,173,570		10,395,027
Unrecognized stock-based compensation	$ 18,100,000		$ 18,100,000		$ 18,300,000
Weighted average period			2 years 7 months 13 days		3 years 18 days
Weighted average grant-date fair value of stock options granted			$ 2.24	$ 8.85
Defined Contribution Plan Four Zero One K [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Defined contribution amount	34,000	$ 28,000	$ 200,000	$ 100,000
Restricted Stock Awards RSA [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Restricted stock units shares, description			In connection with the Reverse Recapitalization, the following outstanding and unvested rights to restricted stock awards were granted to various employees and non-employee directors:•454,781 shares which are eligible to vest based on certain market conditions, subject to the holder’s continuous employment through such vesting date. The award complements the Milestone 1 earn-out share entitlement of Clene Nanomedicine stockholders and vests based on the same market condition (see Note 3). The grant-date fair value of these awards, using a Monte Carlo valuation model, was $4.3 million. Based on the outcome of the market condition as of the September 30, 2022 and December 31, 2021 measurement dates, no shares were vested.•341,090 shares which are eligible to vest based on certain market conditions, subject to the holder’s continuous employment through such vesting date. The award complements the Milestone 2 earn-out share entitlement of Clene Nanomedicine stockholders and vests based on the same market condition (see Note 3). The grant-date fair value of these awards, using a Monte Carlo valuation model, was $3.5 million. Based on the outcome of the market condition as of the September 30, 2022 and December 31, 2021 measurement dates, no shares were vested.
Unrecognized compensation cost	$ 0		$ 0		$ 0
2020 Stock Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Shares authorized	12,000,000		12,000,000
Minimum fair market value of option grant, description			The exercise prices, vesting periods, and other restrictions are determined at the discretion of the Board, except that the exercise price per share of stock options may not be less than 100% of the fair market value of the Common Stock on the date of grant.
Shares granted	7,683,138		7,683,138
Shares for future grants	4,316,862		4,316,862

Benefit Plans - Schedule of 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 (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation	$ 2,098	$ 2,425	$ 6,484	$ 9,945
Stock options [Member]
Stock-Based Compensation (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation	2,098	1,583	6,484	3,096
Restricted Stock Awards RSA [Member]
Stock-Based Compensation (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation	0	842	0	6,849
General and Administrative [Member]
Stock-Based Compensation (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation	1,247	1,567	4,056	6,084
Research and Development [Member]
Stock-Based Compensation (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation	$ 851	$ 858	$ 2,428	$ 3,861

Benefit Plans - Schedule of outstanding common stock options and related activity (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Schedule of outstanding common stock options and related activity [Abstract]
Number of Options, Beginning Balance	10,395,027
Number of Options, Granted	2,865,411
Number of Options, Exercised	(1,044,448)
Number of Options, Forfeited	(42,420)
Number of Options, Ending Balance	12,173,570	10,395,027
Number of Options, Vested and exercisable - September 30, 2022	6,529,233
Number of Options, Vested, exercisable and expected to vest - September 30, 2022	12,173,570
Weighted Average Exercise Price Per Share, Beginning Balance	$ 3.35
Weighted Average Exercise Price Per Share, Granted	3.01
Weighted Average Exercise Price Per Share, Exercised	0.27
Weighted Average Exercise Price Per Share, Forfeited	5.06
Weighted Average Exercise Price Per Share, Ending Balance	3.53	$ 3.35
Weighted Average Exercise Price Per Share, Vested and exercisable - June 30, 2022	2.33
Weighted Average Exercise Price Per Share, Vested, exercisable and expected to vest - June 30, 2022	$ 3.53
Weighted Average Remaining Term, Beginning Balance		6 years 3 months 25 days
Weighted Average Remaining Term, Granted	9 years 4 months 28 days
Weighted Average Remaining Term, Ending Balance	6 years 9 months
Weighted Average Remaining Term, Vested and exercisable - June 30, 2022	4 years 9 months 21 days
Weighted Average Remaining Term, Vested, exercisable and expected to vest - June, 2022	6 years 9 months
Intrinsic Value, Beginning Balance	$ 21,082
Intrinsic Value, Granted	0
Intrinsic Value, Exercised	2,641
Intrinsic Value, Forfeited	0
Intrinsic Value, Ending Balance	10,225	$ 21,082
Intrinsic Value, Vested and exercisable - June 30, 2022	10,120
Intrinsic Value, Vested, exercisable and expected to vest - June 30, 2022	$ 10,225

Benefit Plans - Schedule of assumptions used to calculate the fair value of stock options (Details) - Equity Option [Member]	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Schedule of assumptions used to calculate the fair value of stock option awards granted [Line Items]
Expected dividend yield	0.00%	0.00%
Expected term of options		6 years
Minimum [Member]
Schedule of assumptions used to calculate the fair value of stock option awards granted [Line Items]
Expected stock price volatility	89.57%	84.80%
Risk-free interest rate	1.65%	0.59%
Expected term of options	5 years
Maximum [Member]
Schedule of assumptions used to calculate the fair value of stock option awards granted [Line Items]
Expected stock price volatility	98.13%	87.40%
Risk-free interest rate	3.00%	0.94%
Expected term of options	6 years 11 months 23 days

Benefit Plans - Schedule of restricted common stock activity (Details) - Restricted Stock Awards RSA [Member]	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Stock-Based Compensation (Details) - Schedule of restricted common stock activity [Line Items]
Beginning balance, Number of Restricted Stock Awards, Unvested balance \| shares	916,603
Beginning balance, Weighted- Average Grant Date Fair Value, Unvested balance \| $ / shares	$ 10.00
Number of Restricted Stock Awards, Vested \| shares	(145,439)
Weighted- Average Grant Date Fair Value, Vested \| $ / shares	$ 0
Number of Restricted Stock Awards, Forfeited \| shares	(2,025)
Weighted- Average Grant Date Fair Value, Forfeited \| $ / shares	$ 9.84
Ending balance, Number of Restricted Stock Awards, Unvested balance \| shares	769,139
Ending balance, Weighted- Average Grant Date Fair Value, Unvested balance \| $ / shares	$ 9.84

Fair Value (Details) - USD ($) $ in Millions	9 Months Ended	12 Months Ended
Fair Value (Details) - USD ($) $ in Millions	Sep. 30, 2022	Dec. 31, 2021
Fair Value (Details) [Line Items]
Warrants to purchase common stock (in Shares)	2,407,500
Clene nanomedicine contingent earnout milestone three shares cancelled		2,503,851
Clene Nanomedicine Contingent Earn-out [Member]
Fair Value (Details) [Line Items]
Common stock issuable	5,842,334	5,842,334
Initial Shareholders Contingent Earn-out [Member]
Fair Value (Details) [Line Items]
Common stock issuable	750,000	750,000
Series of Individually Immaterial Business Acquisitions [Member]
Fair Value (Details) [Line Items]
Contingent earn-out, description	Clene Nanomedicine and Initial Stockholders Contingent Earn-outs were recorded at fair value at the closing of the Reverse Recapitalization and are remeasured at each reporting period. As of September 30, 2022 and December 31, 2021, Clene Nanomedicine’s common stockholders were entitled to receive up to 5,842,334 shares of Common Stock and the Initial Stockholders were entitled to receive up to 750,000 shares of Common Stock.
Avenue Loan [Member]
Fair Value (Details) [Line Items]
Warrants to purchase common stock (in Shares)	115,851
Two Thousand Twenty One Avenue Loans [Member]
Fair Value (Details) [Line Items]
Fair value amortized cost	$ 19.1	$ 18.3
Notes payable	14.3	13.7
Embedded conversion feature	4.8	4.6
Fair value of conversion feature	$ 0.3	0.8
Warrants to purchase common stock (in Shares)	184,133
Two Thousand Twenty Two MD Loan [Member]
Fair Value (Details) [Line Items]
Fair value amortized cost	$ 0.7
2019 MD Loan [Member]
Fair Value (Details) [Line Items]
Carrying value of notes payable	0.6	0.6
2019 Cecil Loan [Member]
Fair Value (Details) [Line Items]
Carrying value of notes payable	$ 0.1	$ 0.1

Fair Value - Schedule of Fair Value Hierarchy of Financial Instruments Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	$ 8,966	$ 0
Notes payable		736
Common stock warrant liability	18	474
Clene Nanomedicine contingent earn-out liability	11,438	18,100
Initial Shareholders contingent earn-out liability	1,468	2,317
Level 1 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Notes payable		736
Common stock warrant liability	0	0
Clene Nanomedicine contingent earn-out liability	0	0
Initial Shareholders contingent earn-out liability	0	0
Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Notes payable		0
Common stock warrant liability	0	0
Clene Nanomedicine contingent earn-out liability	0	0
Initial Shareholders contingent earn-out liability	0	0
Level 3 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Notes payable		0
Common stock warrant liability	18	474
Clene Nanomedicine contingent earn-out liability	11,438	18,100
Initial Shareholders contingent earn-out liability	1,468	$ 2,317
Corporate Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	4,019
Corporate Debt Securities [Member] \| Level 1 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	0
Corporate Debt Securities [Member] \| Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	4,019
Corporate Debt Securities [Member] \| Level 3 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	0
Commercial Paper [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	4,947
Commercial Paper [Member] \| Level 1 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	0
Commercial Paper [Member] \| Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	4,947
Commercial Paper [Member] \| Level 3 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	0
Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents	4,724
Money Market Funds [Member] \| Level 1 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents	4,724
Money Market Funds [Member] \| Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents	0
Money Market Funds [Member] \| Level 3 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents	$ 0

Fair Value - Schedule of Unobservable Inputs to the Conversion Feature, Warrant Liability, and Contingent Earn-out Valuation Models (Details)	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Contingent Earn-Out Liabilities [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Expected stock price volatility	115.00%	105.00%
Risk-free interest rate	4.20%	1.10%
Expected dividend yield	0.00%	0.00%
Expected term	3 years 3 months	4 years
Convertible Notes Payable [Member] \| Black-Scholes Valuation Model [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Expected stock price volatility	105.00%	105.00%
Risk-free interest rate	4.20%	0.70%
Expected dividend yield	0.00%	0.00%
Expected term	1 year 7 months 20 days	2 years 4 months 20 days
Common Stock Warrant Liability [Member] \| Black-Scholes Valuation Model [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Expected stock price volatility	115.00%	105.00%
Risk-free interest rate	4.20%	1.20%
Expected dividend yield	0.00%	0.00%
Expected term	3 years 5 months 19 days
Probability of drawing Tranche 2	5.00%	50.00%
Common Stock Warrant Liability [Member] \| Black-Scholes Valuation Model [Member] \| Minimum [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Expected term		3 years 10 months 20 days
Common Stock Warrant Liability [Member] \| Black-Scholes Valuation Model [Member] \| Maximum [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Expected term		4 years 4 months 20 days

Fair Value - Schedule of Changes in Fair Value of Financial Instruments Related to Level 3 Financial Instruments (Details) (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Common Stock Warrant Liability [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Beginning balance	$ 474	$ 0
Initial fair value of instrument		1,457
Change in fair value	(151)	(547)
Reclassification From Liability to Equity	(305)
Ending balance	18	910
Clene Nanomedicine Contingent Earn-out [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Beginning balance	18,100	52,053
Initial fair value of instrument		0
Change in fair value	(6,662)	(18,072)
Reclassification From Liability to Equity	0
Ending balance	11,438	33,981
Initial Shareholders Contingent Earn-out [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Beginning balance	2,317	5,906
Initial fair value of instrument		0
Change in fair value	(849)	(1,710)
Reclassification From Liability to Equity	0
Ending balance	$ 1,468	$ 4,196

Common Stock (Details) - USD ($)		1 Months Ended			3 Months Ended	6 Months Ended	9 Months Ended
Common Stock (Details) - USD ($)	Apr. 14, 2022	May 31, 2021	Dec. 31, 2020	Dec. 30, 2020	Sep. 30, 2022	Dec. 20, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Common Stock (Details) [Line Items]
Common stock, shares authorized					150,000,000		150,000,000		150,000,000
Common share, par value (in Dollars per share)					$ 0.0001		$ 0.0001		$ 0.0001
Preferred stock, shares authorized					1,000,000		1,000,000		1,000,000
Preferred stock par value (in Dollars per share)					$ 0.0001		$ 0.0001		$ 0.0001
Net proceeds (in Dollars)							$ 0	$ 9,250,000
Proceeds from exercise of warrants							$ 0	10,000
Common stock, shares issued					63,541,984		63,541,984		62,312,097
Common stock, shares outstanding					63,541,984		63,541,984		62,312,097
Shares issued					2,407,500		2,407,500
Proceeds from at-the-market facility							$ 132,000	$ 0
At The Market Facility [Member]
Common Stock (Details) [Line Items]
Aggregate offering price	$ 50,000,000.0
Fixed commission rate percentage	3.00%
Sale of common stock under the ATM Facility					40,000		40,000
Proceeds from at-the-market facility					$ 100,000		$ 100,000
2020 Private Placements of Equity Securities [Member]
Common Stock (Details) [Line Items]
Shares price (in Dollars per share)			$ 10.00
Net proceeds (in Dollars)			$ 22,200,000
Private placement warrants description				In addition, investors in the 2020 PIPE also received warrants (the “PIPE Warrants”) to purchase a number of shares equal to one-half (1/2) of the number of 2020 PIPE shares, totaling 1,119,750 shares of Common Stock, at $0.01 per share and subject to a 180-day holding period.
Shares issued upon exercise of warrants						1,119,750
Proceeds from exercise of warrants						$ 11,198
Shares issued			2,239,500
2021 Private Placements of Equity Securities [Member]
Common Stock (Details) [Line Items]
Shares price (in Dollars per share)		$ 9.63
Net proceeds (in Dollars)		$ 9,300,000
Common stock, shares issued		960,540

Net Loss Per Share - Schedule of basic and diluted net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Net Income (Loss) Per Share Attributable to Common Shareholders (Details) - Schedule of basic and diluted net loss per share [Line Items]
Net income (loss) attributable to common stockholders - Basic (in Dollars)	$ (10,976)	$ 28,944	$ (28,864)	$ (14,163)
Less interest expense on potentially dilutive convertible notes payable (in Dollars)	0	196	0
Net income (loss) attributable to common stockholders - Diluted (in Dollars)	$ (10,976)	$ 29,140	$ (28,864)	$ (14,163)
Weighted average common shares outstanding, Basic	63,508,928	62,071,754	63,234,757	61,307,699
Stock options	0	5,791,023	0	0
Common stock warrants	0	1,485,049	0	0
Convertible notes payable	0	482,703	0	0
Restricted stock awards	0	208,105	0	0
Weighted average common shares outstanding - Diluted	63,508,928	70,038,634	63,234,757	61,307,699
Net loss per share attributable to common stockholders, Basic	$ (0.17)	$ 0.47	$ (0.46)	$ (0.23)
Net loss per share attributable to common stockholders, Diluted	$ (0.17)	$ 0.42	$ (0.46)	$ (0.23)

Net Loss Per Share - Schedule of securities excluded from computation of diluted net income (loss) per share (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Schedule of securities excluded from computation of diluted net income (loss) per share [Abstract]
Convertible notes payable (see Note 9)	482,703	0	482,703	482,703
Common stock warrants (see Note 10)	4,477,045	2,547,934	4,477,045	4,594,545
Options to purchase common stock (see Note 13)	12,173,570	2,685,575	12,173,570	9,063,423
Unvested restricted stock awards (see Note 13)	769,139	1,100,050	769,139	1,245,489
Contingent earn-out shares (see Note 3)	6,592,334	9,096,185	6,592,334	9,096,185
Total	24,494,791	15,429,744	24,494,791	24,482,345

Related Party Transactions (Details)	1 Months Ended
Related Party Transactions (Details)	Aug. 31, 2018
Related Party Transactions [Abstract]
Exclusive rights intellectual property term	5 years
Related party transaction royalty fee rate for revenues	3.00%

Related Party Transactions - Schedule of Total Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Related Party Transaction [Line Items]
Total revenue from related parties	$ 171	$ 98	$ 227	$ 500
Product revenue
Related Party Transaction [Line Items]
Total revenue from related parties	127	51	127	376
Royalty revenue
Related Party Transaction [Line Items]
Total revenue from related parties	$ 44	$ 47	$ 100	$ 124

- Definition

Amount of revenue, fees and commissions earned from transactions between (a) a parent company and its subsidiaries; (b) subsidiaries of a common parent; (c) an entity and trusts for the benefit of employees, for example, but not limited to, pension and profit-sharing trusts that are managed by or under the trusteeship of the entity's management; (d) an entity and its principal, owners, management, or members of their immediate families; and (e) affiliates.

+ References

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+ Details

Geographic and Segment Information - Schedule of Property and Equipment, Net by Location (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Geographic and Segment Information (Details) - Schedule of property and equipment, net by location [Line Items]
Total property and equipment, net	$ 9,753	$ 5,172
United States [Member]
Geographic and Segment Information (Details) - Schedule of property and equipment, net by location [Line Items]
Total property and equipment, net	9,753	5,142
Australia [Member]
Geographic and Segment Information (Details) - Schedule of property and equipment, net by location [Line Items]
Total property and equipment, net	$ 0	$ 30

Geographic and Segment Information - Schedule of Profit and Loss Information by Reportable Segment (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Segment Reporting Information [Line Items]
Revenue from external customers	$ 174	$ 110	$ 239	$ 524
Depreciation expense	(233)	(235)	(715)	(734)
Stock compensation expense	2,098	2,425	6,484	9,945
Loss from operations	(9,805)	(10,450)	(36,736)	(35,920)
Drugs [Member]
Segment Reporting Information [Line Items]
Revenue from external customers	0	0	0	0
Depreciation expense	(222)	(223)	(681)	(700)
Stock compensation expense	2,098	2,425	6,484	9,945
Loss from operations	(10,073)	(10,546)	(37,012)	(35,632)
Supplements [Member]
Segment Reporting Information [Line Items]
Revenue from external customers	174	110	239	524
Depreciation expense	(11)	(12)	(34)	(34)
Stock compensation expense	0	0	0	0
Loss from operations	$ 268	$ 96	$ 276	$ (288)

- Definition

Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss).

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+ Details

Geographic and Segment Information - Schedule of Reconciliation of Operating Loss from Segments to Consolidated Net Loss (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Segment Reporting [Abstract]
Segment loss from operations	$ (9,805)	$ (10,450)	$ (36,736)	$ (35,920)
Total other income (expense), net	(1,171)	39,325	7,872	21,544
Net income (loss) before income taxes	$ (10,976)	$ 28,875	$ (28,864)	$ (14,376)

- Definition

+ References

+ Details

Geographic and Segment Information - Schedule of Reconciliation of Total Assets by Reportable Segment (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Segment Reporting, Asset Reconciling Item [Line Items]
Total assets	$ 36,004	$ 63,063
Drugs [Member]
Segment Reporting, Asset Reconciling Item [Line Items]
Total assets	19,106	12,052
Supplements [Member]
Segment Reporting, Asset Reconciling Item [Line Items]
Total assets	331	337
Corporate [Member]
Segment Reporting, Asset Reconciling Item [Line Items]
Total assets	$ 16,567	$ 50,674

- Definition

Sum of the carrying amounts as of the balance sheet date of all assets that are recognized. Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events.

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+ Details

Geographic and Segment Information - Schedule of Additions to Long-lived Assets (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Segment Reporting, Asset Reconciling Item [Line Items]
Additions to long-lived assets	$ (5,296)	$ (661)
Drugs [Member]
Segment Reporting, Asset Reconciling Item [Line Items]
Additions to long-lived assets	(5,296)	(661)
Supplements [Member]
Segment Reporting, Asset Reconciling Item [Line Items]
Additions to long-lived assets	0	0
Corporate [Member]
Segment Reporting, Asset Reconciling Item [Line Items]
Additions to long-lived assets	$ 0	$ 0

Subsequent Events (Details) - USD ($)			3 Months Ended	9 Months Ended
Subsequent Events (Details) - USD ($)	Oct. 31, 2022	Oct. 03, 2022	Sep. 30, 2022	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Subsequent Event [Line Items]
Proceeds from at-the-market offering				$ 132,000	$ 0
Common stock, shares issued			63,541,984	63,541,984		62,312,097
At The Market Facility [Member]
Subsequent Event [Line Items]
Sale of common stock under the ATM Facility			40,000	40,000
Proceeds from at-the-market offering			$ 100,000	$ 100,000
Commitment Letter [Member]
Subsequent Event [Line Items]
Borrowing amount			$ 5,000,000.0	$ 5,000,000.0
Subsequent Events [Member]
Subsequent Event [Line Items]
Subsequent events, description		The issuance and sale of Common Stock under the ATM Facility was made pursuant to our registration statement on Form S-3 (file number 333-264299), which was declared effective by the SEC on April 26, 2022, and our prospectus supplement relating to the offering.
Common stock, shares issued	10,723,926
Proceeds Before Expenses	$ 10,800,000
Shares price (in Dollars per share)	$ 1.01
Total offering expense	$ 20,000
Subsequent Events [Member] \| At The Market Facility [Member]
Subsequent Event [Line Items]
Sale of common stock under the ATM Facility		318,769
Proceeds from at-the-market offering		$ 600,000