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Represents 120,375 shares of Common Stock underlying warrants to purchase one-fortieth (1/40) of one share of Common Stock, issued during Tottenham’s initial public offering. We may redeem the outstanding warrants at $0.01 per warrant if the last sales price of our Common Stock equals or exceeds $330.00 per share for any 20 trading days within a 30-trading day period. As of September 30, 2025 and December 31, 2024, no warrants had been exercised. Represents 2,500,000 shares of Common Stock underlying the Tranche A Warrants to purchase one share of Common Stock, issued in our June 2023 public equity offering. The Tranche A Warrants expire on the earlier of (i) sixty (60) days following the date of our public announcement that an NDA for CNM-Au8 has been accepted by the FDA, or (ii) June 16, 2026. As of September 30, 2025 and December 31, 2024, no warrants had been exercised. Represents 2,500,000 shares of Common Stock underlying the Tranche B Warrants to purchase one share of Common Stock, issued in our June 2023 public equity offering. The Tranche B Warrants expire on the earlier of (i) sixty (60) days following the date of our public announcement that an NDA for CNM-Au8 has been approved by the FDA, or (ii) June 16, 2030. As of September 30, 2025 and December 31, 2024, no warrants had been exercised. Represents consolidated total other income (expense), net, as reported on the consolidated statements of operations and comprehensive loss. Represents the unobservable inputs to the valuation of the SSCPN Derivative Liabilities related to: (i) the 2024 SSCP Notes immediately following the 2024 SSCPN Amendment, and (ii) the 2025 SSCP Notes at issuance. Represents 424,358 shares of Common Stock underlying the 2024 Pre-Funded Warrants to purchase one share of Common Stock, issued in our October 2024 public equity offering. As of September 30, 2025 and December 31, 2024, 17,626 pre-funded warrants had been exercised for nominal proceeds. Represents the unobservable inputs to the valuation of the SSCPN Derivative Liabilities related to the 2024 SSCP Notes only. Represents 1,546,914 shares of Common Stock underlying the 2024 Common Warrants to purchase one share of Common Stock, issued in our October 2024 public equity offering. As of September 30, 2025 and December 31, 2024, no warrants had been exercised. Represents the unobservable inputs to the valuation of the SSCPN Derivative Liabilities related to the 2024 SSCP Notes immediately preceding the 2024 SSCPN Amendment. Includes expenses for travel, meals, dues, subscriptions, continuing education, and other miscellaneous expenses. 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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _____________ to _____________

Commission file number: 001-39834

CLENE INC.

(Exact name of registrant as specified in its charter)

Delaware		85-2828339
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

6550 South Millrock Drive, Suite G50

Salt Lake City, Utah

84121

(Address of principal executive offices)

(Zip Code)

(801) 676-9695

(Registrant’s telephone number, including area code)

N/A

(Former name, former address, and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value	CLNN	The Nasdaq Capital Market
Warrants, to acquire one-fortieth of one share of Common Stock for $230.00 per share	CLNNW	The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The number of shares outstanding of the Registrant’s common stock as of November 10, 2025 was 10,333,980.

Table of Contents

CLENE INC.

Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2025

PART I—FINANCIAL INFORMATION			1
	Item 1.	Financial Statements (Unaudited)	1
		Condensed Consolidated Balance Sheets	1
		Condensed Consolidated Statements of Operations and Comprehensive Loss	2
		Condensed Consolidated Statements of Stockholders’ Equity (Deficit)	3
		Condensed Consolidated Statements of Cash Flows	4
		Notes to Condensed Consolidated Financial Statements	5
	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	29
	Item 3.	Quantitative and Qualitative Disclosures About Market Risk	44
	Item 4.	Controls and Procedures	44

PART II—OTHER INFORMATION			46
	Item 1.	Legal Proceedings	46
	Item 1A.	Risk Factors	46
	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	46
	Item 3.	Defaults Upon Senior Securities	46
	Item 4.	Mine Safety Disclosures	46
	Item 5.	Other Information	46
	Item 6.	Exhibits	47

Table of Contents

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements

CLENE INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

(Unaudited)

	*September 30,*			*December 31,*
	*2025*			*2024*
ASSETS
Current assets:
Cash and cash equivalents	$	7,925		$	12,155
Accounts receivable		—			64
Inventory		61			68
Prepaid expenses and other current assets		4,687			3,870
Total current assets		12,673			16,157
Restricted cash		58			58
Operating lease right-of-use assets		3,225			3,643
Property and equipment, net		6,355			7,479
TOTAL ASSETS	$	22,311		$	27,337

LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable	$	1,369		$	1,240
Accrued liabilities		4,894			7,766
Operating lease obligations, current portion		783			926
Notes payable, current portion		690			359
Convertible notes payable, current portion		570			—
Total current liabilities		8,306			10,291
Operating lease obligations, net of current portion		3,484			4,132
Notes payable, net of current portion		4,567			4,610
Convertible notes payable		11,218			10,816
Common stock warrant liabilities		4,274			4,541
Derivative liabilities		2,819			1,804
TOTAL LIABILITIES		34,668			36,194
Commitments and contingencies (Note 9)
Stockholders’ deficit:
Common stock, $0.0001 par value: 600,000,000 shares authorized; 10,219,946 and 8,089,565 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively		1			1
Additional paid-in capital		286,562			273,194
Accumulated deficit		(299,070	)		(282,123	)
Accumulated other comprehensive income		150			71
TOTAL STOCKHOLDERS’ DEFICIT		(12,357	)		(8,857	)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	22,311		$	27,337

See accompanying notes to the condensed consolidated financial statements.

Table of Contents

CLENE INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

(Unaudited)

	*Three Months Ended September 30,*						*Nine Months Ended September 30,*
	*2025*			*2024*			*2025*			*2024*
Revenue:
Product revenue	$	—		$	65		$	65		$	173
Royalty revenue		15			22			58			78
Total revenue		15			87			123			251
Operating expenses:
Cost of revenue		—			18			20			52
Research and development		3,513			4,471			8,508			14,490
General and administrative		2,150			3,413			7,183			10,147
Total operating expenses		5,663			7,902			15,711			24,689
Loss from operations		(5,648	)		(7,815	)		(15,588	)		(24,438	)
Other income (expense), net:
Interest income		40			127			183			755
Interest expense		(649	)		(1,022	)		(1,936	)		(3,548	)
Change in fair value of common stock warrant liabilities		(1,728	)		697			267			956
Change in fair value of derivative liabilities		(797	)		—			(89	)		—
Change in fair value of Clene Nanomedicine contingent earn-out liability		—			—			—			75
Change in fair value of Initial Stockholders contingent earn-out liability		—			—			—			10
Research and development tax credits and unrestricted grants		5			27			216			339
Total other income (expense), net		(3,129	)		(171	)		(1,359	)		(1,413	)
Net loss before income taxes		(8,777	)		(7,986	)		(16,947	)		(25,851	)
Income tax expense		—			—			—			—
Net loss	$	(8,777	)	$	(7,986	)	$	(16,947	)	$	(25,851	)

Other comprehensive income:
Unrealized loss on available-for-sale securities	$	—		$	1		$	—		$	(1	)
Foreign currency translation adjustments		1			52			79			25
Total other comprehensive income		1			53			79			24
Comprehensive loss	$	(8,776	)	$	(7,933	)	$	(16,868	)	$	(25,827	)

Net loss per share – basic and diluted	$	(0.85	)	$	(1.22	)	$	(1.77	)	$	(4.00	)
Weighted average common shares used to compute basic and diluted net loss per share		10,284,674			6,557,839			9,549,661			6,467,771

See accompanying notes to the condensed consolidated financial statements.

Table of Contents

CLENE INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

(In thousands, except share amounts)

(Unaudited

	*Common Stock*				*Additional Paid-In Capital*		*Accumulated Deficit*			*Accumulated Other Comprehensive Income (Loss)*			*Total Stockholders’ Equity (Deficit)*
	*Shares*		*Amount*		*Additional Paid-In Capital*		*Accumulated Deficit*			*Accumulated Other Comprehensive Income (Loss)*			*Total Stockholders’ Equity (Deficit)*
Balances at December 31, 2024		8,089,565	$	1	$	273,194	$	(282,123	)	$	71		$	(8,857	)
Issuance of common stock		578,205		—		2,673		—			—			2,673
Stock-based compensation expense		—		—		1,947		—			—			1,947
Foreign currency translation adjustment		—		—		—		—			15			15
Net loss		—		—		—		(751	)		—			(751	)
Balances at March 31, 2025		8,667,770	$	1	$	277,814	$	(282,874	)	$	86		$	(4,973	)
Issuance of common stock		794,301		—		2,412		—			—			2,412
Stock-based compensation expense		—		—		1,367		—			—			1,367
Foreign currency translation adjustment		—		—		—		—			63			63
Net loss		—		—		—		(7,419	)		—			(7,419	)
Balances at June 30, 2025		9,462,071	$	1	$	281,593	$	(290,293	)	$	149		$	(8,550	)
Issuance of common stock		757,875		—		3,266		—			—			3,266
Stock-based compensation expense		—		—		1,703		—			—			1,703
Foreign currency translation adjustment		—		—		—		—			1			1
Net loss		—		—		—		(8,777	)		—			(8,777	)
Balances at September 30, 2025		10,219,946	$	1	$	286,562	$	(299,070	)	$	150		$	(12,357	)

Balances at December 31, 2023		6,421,084		1		255,913		(242,723	)		199			13,390
Stock-based compensation expense		—		—		2,013		—			—			2,013
Issuance of common stock upon vesting of restricted stock awards		543		—		—		—			—			—
Unrealized loss on available-for-sale securities		—		—		—		—			(4	)		(4	)
Foreign currency translation adjustment		—		—		—		—			(55	)		(55	)
Net loss		—		—		—		(11,080	)		—			(11,080	)
Balances at March 31, 2024		6,421,627	$	1	$	257,926	$	(253,803	)	$	140		$	4,264
Exercise of stock options		12,001		—		36		—			—			36
Stock-based compensation expense		—		—		1,951		—			—			1,951
Unrealized gain on available-for-sale securities		—		—		—		—			2			2
Foreign currency translation adjustment		—		—		—		—			28			28
Net loss		—		—		—		(6,785	)		—			(6,785	)
Balances at June 30, 2024		6,433,628	$	1	$	259,913	$	(260,588	)	$	170		$	(504	)
Issuance of common stock		394,453		—		2,036		—			—			2,036
Exercise of stock options		29,089		—		88								88
Stock-based compensation expense		—		—		2,188		—			—			2,188
Unrealized gain on available-for-sale securities		—		—		—		—			1			1
Foreign currency translation adjustment		—		—		—		—			52			52
Net loss		—		—		—		(7,986	)		—			(7,986	)
Balances at September 30, 2024		6,857,170	$	1	$	264,225	$	(268,574	)	$	223		$	(4,125	)

See accompanying notes to the condensed consolidated financial statements.

Table of Contents

CLENE INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

	*Nine Months Ended September 30,*
	*2025*			*2024*
Cash flows from operating activities:
Net loss	$	(16,947	)	$	(25,851	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		1,135			1,240
Non-cash lease expense		418			394
Issuance of common stock as payment of outstanding indebtedness		8			—
Change in fair value of common stock warrant liabilities		(267	)		(956	)
Change in fair value of derivative liabilities		89			—
Change in fair value of Clene Nanomedicine contingent earn-out liability		—			(75	)
Change in fair value of Initial Stockholders contingent earn-out liability		—			(10	)
Stock-based compensation expense		5,017			6,152
Accretion of debt discount		740			1,184
Non-cash interest income on marketable securities		—			(153	)
Non-cash interest expense on notes payable		240			40
Changes in operating assets and liabilities:
Accounts receivable		64			143
Inventory		7			(91	)
Prepaid expenses and other current assets		(817	)		(1,185	)
Accounts payable		129			174
Accrued liabilities		(2,772	)		2,945
Operating lease obligations		(791	)		(412	)
Net cash used in operating activities		(13,747	)		(16,461	)
Cash flows from investing activities:
Purchases of marketable securities		—			(6,168	)
Proceeds from maturities of marketable securities		—			12,500
Purchases of property and equipment		(11	)		(14	)
Net cash provided by (used in) investing activities		(11	)		6,318
Cash flows from financing activities:
Proceeds from exercise of stock options		—			124
Proceeds from issuance of common stock, net of offering costs		8,243			2,036
Proceeds from share subscriptions payable		—			3,810
Proceeds from the issuance of debt and derivative liabilities		1,500			—
Payments of notes payable		(295	)		(10,000	)
Payments of finance lease obligations		—			(27	)
Net cash provided by (used in) financing activities		9,448			(4,057	)
Effect of foreign exchange rate changes on cash and restricted cash		80			24
Net decrease in cash, cash equivalents and restricted cash		(4,230	)		(14,176	)
Cash, cash equivalents and restricted cash – beginning of period		12,213			28,879
Cash, cash equivalents and restricted cash – end of period	$	7,983		$	14,703

Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets:
Cash and cash equivalents	$	7,925		$	14,645
Restricted cash		58			58
Cash, cash equivalents and restricted cash	$	7,983		$	14,703

Supplemental disclosure of non-cash investing and financing activities:
Issuance of common stock as payment of outstanding indebtedness	$	108		$	—
Derivative liability recorded upon debt modification	$	687		$	67
Derivative liability recorded upon debt issuance	$	239		$	—
Deferred transaction costs in accrued liabilities and other current assets	$	—		$	68
Supplemental cash flow information:
Cash paid for interest expense	$	956		$	2,324

See accompanying notes to the condensed consolidated financial statements.

Table of Contents

CLENE INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

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 that enables production of concentrated, stable, highly active, clean-surfaced nanocrystal suspensions. We have multiple drug assets currently in development for applications primarily in neurology. Our efforts are currently focused on addressing the high unmet medical needs in central nervous system disorders including amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”), and Parkinson’s disease (“PD”). 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”), an international supplier of health supplements, stockholder, and related party (see Note 15).

We became a public company on December 30, 2020 (the “Closing Date”) when we completed a reverse recapitalization (the “Reverse Recapitalization”) with Tottenham Acquisition I Limited (“Tottenham”), Tottenham’s wholly-owned subsidiary, Chelsea Worldwide Inc., and Creative Worldwide Inc., a wholly-owned subsidiary of Chelsea Worldwide Inc. On the Closing Date, Chelsea Worldwide Inc. changed its name to Clene Inc. and listed its shares of common stock, par value $0.0001 per share (“Common Stock”) on the Nasdaq Capital Market (“Nasdaq”) under the symbol “CLNN.”

Going Concern

We incurred a loss from operations of $5.6 million and $7.8 million for the three months ended September 30, 2025 and 2024, respectively; and $15.6 million and $24.4 million for the nine months ended September 30, 2025 and 2024, respectively. Our accumulated deficit was $299.1 million and $282.1 million as of September 30, 2025 and December 31, 2024, respectively. Our cash and cash equivalents totaled $7.9 million and $12.2 million as of September 30, 2025 and December 31, 2024, respectively, and net cash used in operating activities was $13.7 million and $16.5 million for the nine months ended September 30, 2025 and 2024, 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. We expect 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 unless we obtain additional financing. Additionally, pursuant to our senior secured convertible promissory notes issued in December 2024 (the “2024 SSCP Notes”), we are required to maintain unrestricted cash and cash equivalents of at least $2.0 million to avoid acceleration of the full balance of the 2024 SSCP Notes (see Note 8). These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as well as utilizing our existing at-the-market facility and equity purchase agreement and potential proceeds from the exercise of outstanding warrants and stock options. 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. During the three and nine months ended September 30, 2025, we generated $3.3 million and $8.4 million, respectively, of gross proceeds from our equity distribution agreement and $1.5 million from the issuance of senior secured convertible promissory notes (see Note 8). Subsequent to September 30, 2025, we generated $1.2 million of gross proceeds from our equity distribution agreement. We have implemented cost-saving initiatives, including delaying and reducing certain research and development programs and commercialization efforts, reducing employee compensation, 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.

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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.

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., 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, 2025 and 2024 are unaudited.

Results of operations for the three and nine months ended September 30, 2025 and 2024 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, 2025 and 2024 should be read in conjunction with the audited consolidated financial statements included in our Annual Report on Form 10-K.

Reverse Stock Split

Effective July 11, 2024 (the “Effective Date”), we filed a Certificate of Amendment to our Fourth Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware, to effect a 1-for-20 reverse stock split (the “Reverse Stock Split”) of our Common Stock. Beginning with the opening of trading on the Effective Date, our Common Stock began trading on Nasdaq on a split-adjusted basis under the same symbol, “CLNN.” As a result of the Reverse Stock Split, every 20 shares of our Common Stock issued and outstanding were automatically combined and converted into 1 validly issued, fully paid and non-assessable share of Common Stock. In lieu of any fractional shares, stockholders received an amount in cash (without interest) equal to: (i) the number of shares of Common Stock held by such stockholder before the Reverse Stock Split that would otherwise have been exchanged for such fractional shares multiplied by (ii) the closing price of our Common Stock on Nasdaq on the trading day immediately preceding the Effective Date.

The Reverse Stock Split did not reduce the total number of authorized shares of Common Stock or preferred stock, par value $0.0001 per share (“Preferred Stock”), or change the par values of the Company’s Common Stock or Preferred Stock. All outstanding stock options, warrants, rights to restricted stock awards, convertible debt, and contingent earn-out shares entitling their holders to purchase or receive shares of Common Stock were adjusted as a result of the Reverse Stock Split, in accordance with the terms of each such security. In addition, the number of shares reserved for issuance pursuant to our Amended 2020 Stock Plan was also appropriately adjusted. All historical share and per share data for the periods presented in these condensed consolidated financial statements, including for periods ending prior to July 11, 2024, has been adjusted to reflect the 1-for-20 Reverse Stock Split on a retroactive basis as if the Reverse Stock Split occurred as of the earliest period presented. As a result of the Reverse Stock Split, approximately $12,000 of par value was reclassified from Common Stock to Additional Paid-In Capital.

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.

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Risks and Uncertainties

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 contract research organizations (“CROs”) and clinical vendors 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. 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.

Concentrations of Credit Risk

Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash. Our cash is held in financial institutions and 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 is classified as current and noncurrent on 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.

Inventory

Inventory is stated at historic cost on a first-in first-out basis. Our inventory consisted of $24,000 in raw materials and $37,000 in finished goods as of September 30, 2025, and $53,000 in raw material and $15,000 in finished goods as of December 31, 2024. Inventory relates to our dietary supplement products.

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 to 5 years for laboratory equipment, 3 to 7 years for furniture and fixtures, and 2 to 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 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.

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Debt

When debt is issued and a derivative is required to be separated (e.g., bifurcated conversion option) or another separate freestanding financial instrument (e.g., warrant) is issued, costs and fees incurred are allocated to the instruments issued (or bifurcated) in proportion to the allocation of proceeds. When some portions of the costs and fees relate to a bifurcated derivative or freestanding financial instrument that is being subsequently measured at fair value, those allocated costs are expensed immediately. Debt discounts, debt premiums, and debt issuance costs related to debt are recorded as deductions that net against the principal value of the debt and are amortized to interest expense over the contractual term of the debt using the effective interest method.

In accordance with ASC 470-20, Debt with Conversion and Other Options, when we issue debt with warrants, we treat the warrants as a debt discount, recorded as a contra-liability against the debt, and amortize the balance over the life of the underlying debt as interest expense in the condensed consolidated statements of operations and comprehensive loss. The offset to the contra-liability is recorded as additional paid-in capital in the condensed consolidated balance sheets if the warrants are not treated as a derivative or liability under ASC 480, Distinguishing Liabilities from Equity (“ASC 480”). Otherwise, the offset to the contra-liability is recorded as a warrant liability in the condensed consolidated balance sheets and is subject to re-measurement to fair value at each balance sheet date, with any changes in fair value recognized in the condensed consolidated statements of operations and comprehensive loss. If the debt is retired early, the associated debt discount is then recognized immediately as interest expense in the condensed consolidated statements of operations and comprehensive loss.

Convertible Debt

In accordance with ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, when we issue notes with conversion features, we evaluate if the conversion feature is freestanding or embedded. If the conversion feature is embedded, we do not separate the conversion feature from the host contract for convertible notes that are not required to be accounted for as derivatives, or that do not result in substantial premiums accounted for as paid-in-capital. Consequently, we account for a convertible note as a single liability measured at its amortized cost as long as no other features require separation and recognition as derivatives. If the conversion feature is freestanding, or is embedded and meets the requirements to be separated, we account for the conversion feature as a derivative under ASC 815, Derivatives and Hedging (“ASC 815”). We record the derivative instrument at fair value at inception, and subsequently re-measure to fair value at each reporting period and immediately prior to the extinguishment of the derivative instrument, with any changes recorded in the condensed consolidated statements of operations and comprehensive loss.

Leases

At inception of a contract, we determine if a contract meets the definition of a lease. We determine if the contract conveys the right to control the use of an identified asset for a period of time. We assess throughout the period of use whether we have both of the following: (i) the right to obtain substantially all the economic benefits from use of the identified asset, and (ii) the right to direct the use of the identified asset. This determination is reassessed if the terms of the contract are changed. Leases are classified as operating or finance leases based on the terms of the lease agreement and certain characteristics of the identified asset. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments less any lease incentives received. At the lease commencement date, the discount rate implicit in the lease is used to discount the lease liability if readily determinable. If not readily determinable or leases do not contain an implicit rate, our incremental borrowing rate is used as the discount rate. Our policy is to not record leases with an original term of twelve months or less within the condensed consolidated balance sheets and we recognize lease expense for these short-term leases on a straight-line basis over the lease term.

Certain lease agreements may require us to pay additional amounts for taxes, insurance, maintenance, and other expenses, which are generally referred to as non-lease components. Such variable non-lease components are treated as variable lease payments and recognized in the period in which the obligation for these payments is incurred. Variable lease components and variable non-lease components are not measured as part of the right-of-use asset and liability. Only when lease components and their associated non-lease components are fixed are they accounted for as a single lease component and are recognized as part of a right-of-use asset and liability. Total contract consideration is allocated to the fixed lease and non-lease component. This policy election applies consistently to all asset classes under lease agreements.

Leases may contain clauses for renewal at our option. Payments to be made in option periods are recognized as part of the right-of-use lease assets and lease liabilities when it is reasonably certain that the option to extend the lease will be exercised, or is not at our option. We determine whether the reasonably certain threshold is met by considering contract-, asset-, market-, and entity-based factors. Operating lease expense, which is recognized on a straight-line basis over the lease term, and the amortization of finance lease right-of-use assets, which are included in property and equipment and depreciated, are included in research and development or general and administrative expenses consistent with the leased assets’ primary use. Accretion on the liabilities for finance leases is included in interest expense.

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Contingent Earn-Out Liabilities

In connection with the Reverse Recapitalization, certain Clene Nanomedicine stockholders are entitled to receive additional shares of Common Stock (the “Clene Nanomedicine Contingent Earn-out”) as follows: (i) 166,928 shares if (a) the volume-weighted average price (“VWAP”) of our Common Stock equals or exceeds $300.00 (the “Milestone 1 Price”) in any twenty trading days within a thirty trading day period within three years 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) 125,200 shares if (a) the VWAP of our Common Stock equals or exceeds $400.00 (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 Reverse Recapitalization (the requirements in (a) and (b) collectively, “Milestone 2”). If Milestone 1 is not achieved but Milestone 2 is achieved, the Clene Nanomedicine stockholders will receive additional shares equal to Milestone 1. Tottenham’s former officers, directors, sponsor, and public stockholders (the “Initial Stockholders”) are entitled to receive earn-out shares (the “Initial Stockholders Contingent Earn-out,” and collectively with the Clene Nanomedicine Contingent Earn-out, the “Contingent Earn-outs”) as follows: (i) 18,750 shares upon the achievement of Milestone 1; and (ii) 18,750 shares upon achievement of Milestone 2. Milestone 1 was not achieved but if Milestone 2 is achieved, the Initial Stockholders will receive additional shares equal to Milestone 1.

In accordance with ASC 815, the Contingent Earn-outs are not indexed to our own stock and therefore were accounted for as a liability at the Reverse Recapitalization date and are subsequently remeasured to fair value at each reporting date with changes recorded as a component of other income (expense), net. As of September 30, 2025 and December 31, 2024, the Contingent Earn-outs had no value as determined using a Monte Carlo valuation model in order to simulate the future path of our stock price over the earn-out periods.

Common Stock Warrants

We account for common stock warrants as either equity- or liability-classified instruments based on an assessment of the warrant terms. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all 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, at each reporting 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 (“IAS 20”). We recognize grant funding without conditions or continuing performance obligations, including certain research and development tax credits, as other income in the condensed consolidated statements of operations and comprehensive loss. We accrue certain research and development tax credits receivable in other current assets (see Note 4) 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 loss. After submission of our tax returns, we receive a cash refund of certain research and development tax credits and relieve the receivable.

We recognize grant funding with conditions or continuing performance obligations as a reduction in research and development or general and administrative expenses 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 (see Note 6) if the conditions or performance obligations are expected to be met within the next twelve months. We recognized grant funding as a reduction of research and development expenses totaling $2.3 million and $1.3 million during the three months ended September 30, 2025 and 2024, respectively; and $8.5 million and $3.3 million during the nine months ended September 30, 2025 and 2024, respectively. We recognized grant funding as a reduction of general and administrative expenses totaling $0.1 million and $41,000 during the three months ended September 30, 2025 and 2024, respectively; and $0.4 million and $0.1 million during the nine months ended September 30, 2025 and 2024, respectively.

In October 2023 we were awarded a grant (“the NIH Grant”) in collaboration with Columbia University, the prime awardee, and Synapticure, a neurology specialty health clinic, from the National Institutes of Health (“NIH”). The NIH Grant was awarded pursuant to the Accelerating Access to Critical Therapies for ALS Act to support up to a four-year Expanded Access Program (the “ACT-EAP”) for CNM-Au8^® treatment of ALS. The NIH Grant totaled $45.1 million and subawards to us may total up to $30.9 million in aggregate and may extend to August 31, 2027. Subawards are awarded annually and subaward funds are paid to us as reimbursement for expenditures to support the ACT-EAP. Subawards for the first and second year of the ACT-EAP totaled $7.3 million and $8.0 million, respectively. We recognized grant revenue totaling $2.2 million and $1.2 million during the three months ended September 30, 2025 and 2024, respectively; and $8.6 million and $3.0 million during the nine months ended September 30, 2025 and 2024, respectively, which we recognized as a reduction of research and development and general and administrative expenses.

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Foreign Currency Translation and Transactions

Our functional and reporting currency is the U.S. dollar (“USD”). Clene Australia and Clene Netherlands determined their functional currencies to be the Australian dollar and Euro, respectively. The results of our foreign currency operations are translated into USD at the average exchange rates during the period, assets and liabilities are translated using the exchange rate as of the balance sheet date, and stockholders’ deficit is translated using historical rates. Adjustments from the translation of the results of our foreign currency operations are excluded from net loss and are accumulated in a separate component of stockholders’ deficit. 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 loss includes net loss as well as other changes in stockholders’ deficit that result from transactions and economic events other than those with stockholders. The only elements of other comprehensive loss in any periods presented were the translation of foreign currency denominated balances of Clene Australia and Clene Netherlands to USD for consolidation and the unrealized loss on available-for-sale securities.

Net Loss Per Share Attributable to Common Stockholders

Basic net loss per share attributable to common stockholders is calculated using our weighted-average outstanding common shares. Shares issuable for little or no cash consideration, such as pre-funded warrants, shall be considered outstanding common shares upon the satisfaction of any contingent conditions or when there are no contingent conditions. Diluted net loss per share attributable to common stockholders is calculated using our weighted-average outstanding common shares including the dilutive effect of securities as determined under the treasury stock method, except for the dilutive effect of convertible notes payable, which is calculated under the if-converted method, even if the embedded conversion option is out-of-the-money. In periods in which we report a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.

Segment Information

We report segment information based on ASC 280 Segment Reporting (“ASC 280”), which defines operating segments as components of a company that engage in activities from which it may recognize revenues and incur expenses, and for which operating results are regularly reviewed by the entity’s chief operating decision maker (“CODM”) to make decisions regarding resource allocation and assess performance, and for which discrete financial information is available. We determined that the Company is a single operating and reportable segment (“Products”) focused on treating central nervous system disorders through discovery, development, and commercialization of our novel CSN therapeutics. Our chief executive officer acts as the CODM and allocates resources and assesses performance at a consolidated level. Segment information is further described in Note 16.

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 basis 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.

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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. We generally grant stock options with a four-year requisite service period. Certain stock options may vest based upon performance conditions instead of service conditions, such as the achievement of regulatory milestones or financial performance measures. For the grant-date fair value, we estimate the expected term of stock options with performance conditions based upon the nature of the conditions. If the expected term is not estimable and the achievement of performance conditions is not probable, we use the contractual term as the expected term. We elect to account for forfeitures as they occur, rather than estimating expected forfeitures. We determine the fair value of stock option awards using a Black-Scholes option pricing model based on the closing price of our Common Stock as reported by Nasdaq on the date of grant. The fair value of stock awards with market conditions are determined using a Monte Carlo valuation model.

Recent Accounting Pronouncements Not Yet Adopted

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). ASU 2023-09 requires, among other things, that public entities on an annual basis disclose specific categories of the tax rate reconciliation, provide additional information for reconciling items that meet a quantitative threshold, and disclose income taxes paid disaggregated by jurisdiction. The guidance is effective for annual periods beginning after December 15, 2024. We are currently evaluating the impact of ASU 2023-09.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”). ASU 2024-03 requires that public entities disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. In January 2025, the FASB clarified the effective date of ASU 2024-03 with the issuance of ASU 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date (“ASU 2025-01”). The guidance is effective for annual periods beginning after December 15, 2026, and interim periods within annual periods beginning after December 15, 2027, with early adoption permitted. We are currently evaluating the impact of ASU 2024-03.

In September 2025, the FASB issued ASU 2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40) (“ASU 2025-06”). ASU 2025-06 requires that entities start capitalizing software costs when funding is authorized and committed and it is probable that the project will be completed and the software will be used to perform its intended function. The guidance is effective for annual periods beginning after December 15, 2027, and interim periods within those annual periods, with early adoption permitted. We are currently evaluating the impact of ASU 2025-06.

Note 3. Cash and Cash Equivalents

Cash and cash equivalents as of September 30, 2025 were as follows:

	*September 30, 2025*
(in thousands)	*Amortized Cost*		*Gross Unrealized Gains*		*Gross Unrealized Losses*		*Fair Value*
Cash equivalents (contractual maturity within 90 days):
Money market funds	$	4,672	$	—	$	—	$	4,672
Total cash equivalents		4,672		—		—		4,672
Cash		3,253		—		—		3,253
Total cash and cash equivalents	$	7,925	$	—	$	—	$	7,925

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Cash and cash equivalents as of December 31, 2024 were as follows:

	*December 31, 2024*
(in thousands)	*Amortized Cost*		*Gross Unrealized Gains*		*Gross Unrealized Losses*		*Fair Value*
Cash equivalents (contractual maturity within 90 days):
Money market funds	$	7,002	$	—	$	—	$	7,002
Total cash equivalents		7,002		—		—		7,002
Cash		5,153		—		—		5,153
Total cash and cash equivalents	$	12,155	$	—	$	—	$	12,155

Note 4. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets as of September 30, 2025 and December 31, 2024 were as follows:

	*September 30,*		*December 31,*
(in thousands)	*2025*		*2024*
Metals to be used in research and development	$	2,702	$	1,849
Prepaid clinical and CRO expenses		1,133		1,557
Research and development tax credits receivable		550		327
Other		302		137
Total prepaid expenses and other current assets	$	4,687	$	3,870

Note 5. Property and Equipment, Net

Property and equipment, net, as of September 30, 2025 and December 31, 2024 were as follows:

	*September 30,*			*December 31,*
(in thousands)	*2025*			*2024*
Lab equipment	$	3,438		$	3,437
Office equipment		178			178
Computer software		459			459
Leasehold improvements		9,983			9,983
Construction in progress		1,298			1,298
		15,356			15,355
Less accumulated depreciation		(9,001	)		(7,876	)
Total property and equipment, net	$	6,355		$	7,479

Depreciation expense recorded in research and development expense and general and administrative expense during the three and nine months ended September 30, 2025 and 2024 was as follows:

	*Three Months Ended September 30,*				*Nine Months Ended September 30,*
(in thousands)	*2025*		*2024*		*2025*		*2024*
General and administrative	$	28	$	67	$	123	$	200
Research and development		337		339		1,012		1,040
Total depreciation expense	$	365	$	406	$	1,135	$	1,240

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Note 6. Accrued Liabilities

Accrued liabilities as of September 30, 2025 and December 31, 2024 were as follows:

	*September 30,*		*December 31,*
(in thousands)	*2025*		*2024*
Accrued compensation and benefits	$	4,070	$	4,079
Deferred grants		542		2,665
Accrued CRO and clinical fees		247		771
Other		35		251
Total accrued liabilities	$	4,894	$	7,766

Note 7. Leases

We lease laboratory and office space and certain laboratory equipment under non-cancellable operating 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. We expect that, in the normal course of business, the existing leases will be renewed or replaced by similar leases.

We have leases for three real estate properties: (i) a laboratory and manufacturing facility lease that commenced in September 2021 with a ten-year term and an option to extend for two five-year periods, (ii) a laboratory and manufacturing facility lease that commenced in February 2022 with a seven-year term and an option to extend for two five-year periods, and (iii) our corporate office lease that commenced in April 2020 for seven years with an option to extend for five years. We did not recognize the payments to be made in the option periods as part of the right-of-use asset or lease liability because the exercise of the option is not reasonably certain.

As of September 30, 2025 and December 31, 2024, our operating lease obligations had a weighted-average discount rate of 9.6% and 9.6%, respectively, and a weighted-average remaining term of 4.8 years and 5.5 years, respectively.

Maturity Analysis of Lease Obligations

The maturity analysis of our operating lease obligations as of September 30, 2025 was as follows:

(in thousands)	*Operating Leases*
2025 (remainder)	$	236
2026		1,236
2027		1,133
2028		1,093
2029		649
2030		623
Thereafter		422
Total minimum lease payments		5,392
Less amount representing interest/discounting		(1,125	)
Present value of minimum lease payments		4,267
Less lease obligations, current portion		(783	)
Lease obligations, net of current portion	$	3,484

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Components of Lease Cost

The components of lease costs for the three and nine months ended September 30, 2025 and 2024 were as follows:

	*Three Months Ended September 30,*				*Nine Months Ended September 30,*
(in thousands)	*2025*		*2024*		*2025*		*2024*
Finance lease amortization	$	—	$	12	$	—	$	57
Operating lease costs		254		255		762		764
Short-term lease costs		—		—		2		2
Variable lease costs		79		88		240		217
Total lease costs	$	333	$	355	$	1,004	$	1,040

Supplemental Cash Flow Information

	*Nine Months Ended September 30,*
(in thousands)	*2025*			*2024*
Operating cash flows from operating leases	$	(1,004	)	$	(983	)
Financing cash flows from finance leases	$	—		$	(27	)

Note 8. Notes Payable and Convertible Notes Payable

Our notes payable and convertible notes payable as of September 30, 2025 and December 31, 2024 were as follows:

	*Stated*			*September 30,*			*December 31,*
(in thousands, except interest rates)	*Interest Rate*			*2025*			*2024*
Notes payable:
Advance Cecil, Inc. (commenced April 2019)		8.00	%	$	152		$	146
Maryland DHCD (commenced February 2019)		8.00	%		764			734
Maryland DHCD (commenced May 2022)		6.00	%		825			1,083
Senior Secured Promissory Notes (commenced December 2024)		12.00	%		3,569			3,537
Senior Secured Promissory Notes (commenced August 2025)		12.00	%		549			—
					5,859			5,500
Unamortized discount and debt issuance costs					(602	)		(531	)
Less notes payable, current portion, net of unamortized discount and debt issuance costs					(690	)		(359	)
Notes payable, net of current portion				$	4,567		$	4,610

Convertible notes payable:
Maryland DHCD (commenced December 2022)		6.00	%	$	5,312		$	5,312
Senior Secured Convertible Promissory Notes (commenced December 2024)		12.00	%		6,629			6,500
Senior Secured Convertible Promissory Notes (commenced August 2025)		12.00	%		975			—
					12,916			11,812
Unamortized discount and debt issuance costs					(1,128	)		(996	)
Less convertible notes payable, current portion, net of unamortized discount and debt issuance costs					(570	)		—
Convertible notes payable				$	11,218		$	10,816

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Our interest expense on notes payable and convertible notes payable for the three and nine months ended September 30, 2025 and 2024 was as follows:

	*Three Months Ended September 30,*				*Nine Months Ended September 30,*
(in thousands)	*2025*		*2024*		*2025*		*2024*
Interest expense on notes payable:
Coupon interest	$	137	$	543	$	395	$	1,835
Amortization of debt discount and issuance costs		88		399		259		1,035
Total interest expense on notes payable		225		942		654		2,870

Interest expense on convertible notes payable:
Coupon interest		261		77		801		529
Amortization of debt discount and issuance costs		163		3		481		149
Total interest expense on convertible notes payable		424		80		1,282		678

Total interest expense on notes payable and convertible notes payable	$	649	$	1,022	$	1,936	$	3,548

Maryland Loans

In April 2019, we entered into a term loan agreement (the “2019 Cecil Loan”) with Advance Cecil Inc., a non-stock corporation formed under the laws of the State of Maryland, for $0.1 million bearing simple interest at an annual rate of 8.00%. The 2019 Cecil Loan established “Phantom Shares” based on 1,199 shares of Common Stock. The 2019 Cecil Loan matures in full on April 30, 2034, with the repayment amount equal to the greater of (i) principal plus accrued interest or (ii) the Phantom Shares multiplied by the closing price of our Common Stock on Nasdaq on the trading day prior to the maturity date. As of September 30, 2025 and December 31, 2024, the 2019 Cecil Loan was recorded at principal plus accrued interest as it was greater than the value of the Phantom Shares.

In February 2019, we entered into a term loan agreement (the “2019 MD Loan”) with the Department of Housing and Community Development (“DHCD”), a principal department of the State of Maryland, for $0.5 million bearing simple interest at an annual rate of 8.00%. We are subject to covenants until maturity, including limitations on our ability to retire, repurchase, or redeem our stock, options, and warrants other than per the terms of the securities; and limitations on our ability to pay dividends. We are not in violation of any covenants. The 2019 MD Loan established “Phantom Shares” based on 5,995 shares of Common Stock. The 2019 MD Loan matures in full on February 22, 2034, with the repayment amount equal to the greater of (i) principal plus accrued interest or (ii) the Phantom Shares multiplied by the closing price of our Common Stock on Nasdaq on the trading day prior to the maturity date. As of September 30, 2025 and December 31, 2024, the 2019 MD Loan was recorded at principal plus accrued interest as it was greater than the value of the Phantom Shares.

In May 2022, we entered into a term loan agreement (the “2022 MD Loan”) with DHCD for up to $3.0 million bearing simple interest at an annual rate of 6.00% for the purchase of certain manufacturing equipment (the “Assets”). We drew a total of $1.0 million and our ability to draw the remaining $2.0 million expired in May 2024. The first 12 payments, commencing July 1, 2022, are deferred, followed by 18 monthly installments of interest-only based on the outstanding principal, each up to $15,000 maximum; followed by monthly installments of principal and interest in the amount of $33,306, payable for the lesser of 30 months or until the principal and accrued and unpaid interest is fully repaid, with a balloon payment of all remaining principal and unpaid interest due on the maturity date of July 1, 2027. As of September 30, 2025 and December 31, 2024, the balance of accrued and unpaid interest was $50,000 and $50,000, respectively, and is recorded as part of the carrying amount of the loan. We recorded debt issuance costs of $31,000 as a debt discount.

In December 2022, we entered into a term loan agreement (the “2022 DHCD Loan”) with DHCD for $5.0 million bearing simple interest at an annual rate of 6.00%. The first 12 payments, commencing January 1, 2023, are deferred, followed by 48 monthly installments of interest-only, with a balloon payment of all principal and unpaid interest due on the maturity date of January 1, 2028. As of September 30, 2025 and December 31, 2024, the balance of accrued and unpaid interest was $0.3 million and $0.3 million, respectively, and is recorded as part of the carrying amount of the loan. We recorded debt issuance costs of $0.1 million as a debt discount. At any time after December 8, 2023, DHCD may, in its sole discretion, convert up to $5.0 million of principal into Common Stock in increments of $1.0 million, at a price equal to the greater of: (i) 97% of the 30-day trailing VWAP of our Common Stock; or (ii) $80.00 per share (the “DHCD Conversion Feature”). The DHCD Conversion Feature did not meet the requirements for derivative accounting. The effective interest rate is 5.99%.

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Avenue Loan

In May 2021, we entered into a term loan agreement (the “2021 Avenue Loan”) with Avenue Venture Opportunities Fund, L.P. (“Avenue”) for up to $30.0 million, bearing interest at a variable rate equal to (i) the greater of (a) the prime rate or (b) 3.25%, plus (ii) 6.60%. We borrowed $15.0 million in May 2021 plus $5.0 million in September 2021 (“Tranche 1”), and the remaining $10.0 million (“Tranche 2”) was not drawn and expired. At inception, we incurred $0.8 million of debt issuance costs of which $47,000 related to liability-classified warrants was expensed immediately and the remainder was recorded as a debt discount. Payments were interest-only for the first 12 months and the interest-only period was extended for (i) 12 months due to our achievement of certain clinical trial milestones, plus (ii) an additional 12 months (through June 30, 2024), pursuant to an amendment in June 2023 (the “Second Amendment”), due to our receipt of at least $35.0 million from the sale and issuance of Common Stock in a public offering in June 2023 (“Equity Milestone 1”). Following the interest-only period, from July 2024 to September 2024, we made equal monthly principal installments of $3.3 million plus interest at the variable rate then in effect.

On September 30, 2024, we entered into an amendment (the “Third Amendment”) that (i) reduced the October 2024 principal installment from $3.3 million to $2.0 million, plus interest at the applicable variable rate, (ii) reduced the November 2024 and December 2024 principal installments from $3.3 million to $0.5 million each, plus interest at the applicable variable rate, and (iii) delayed the maturity date of the loan from December 1, 2024 to April 1, 2025. However, we repaid the 2021 Avenue Loan in full on December 20, 2024 (the “Termination Date”) with the proceeds from the 2024 SSCP Notes (discussed below). The total repayment amount was approximately $7.9 million and included (i) the total outstanding balance of principal and accrued interest, (ii) a final payment of 4.25% of funded principal, equal to $0.9 million (the “Final Payment”), which was previously recorded as a debt premium at the inception of the 2021 Avenue Loan, and (iii) an early termination fee of 1% of the balance of outstanding principal. We recorded a loss on extinguishment of $0.2 million during the year ended December 31, 2024.

Avenue had the right to convert up to $5.0 million of principal into Common Stock (the “Avenue Conversion Feature”), which expired in May 2024 and was not exercised. During the nine months ended September 30, 2024, the effective interest rate was 17.52%.

At the inception of the 2021 Avenue Loan, we issued a warrant to Avenue to purchase Common Stock (the “2021 Avenue Warrant”). A portion of the net proceeds at issuance of the 2021 Avenue Loan were allocated to the 2021 Avenue Warrant in an amount equal to its fair value of $1.5 million and were recorded as a debt discount. Pursuant to the Second Amendment, the 2021 Avenue Warrant was cancelled and a new warrant to purchase 150,000 shares of Common Stock was issued (the “2023 Avenue Warrant”). At issuance, the 2023 Avenue Warrant was recorded as a liability and debt discount in amount equal to its fair value of $0.7 million. The Second Amendment, including the revised terms, cancellation of the 2021 Avenue Warrant, and issuance of the 2023 Avenue Warrant was accounted for as a debt modification. Additionally, pursuant to the Third Amendment, the exercise price of the 2023 Avenue Warrant was reduced from $16.00 per share to $4.6014 per share, with the resulting change in fair value of $0.1 million recorded as a debt discount. The Third Amendment was accounted for as a debt modification that also met the requirements as a troubled debt restructuring under ASC 470, Debt (“ASC 470”), with no restructuring gain required to be recognized as the future cash payments were greater than its carrying amount of the 2021 Avenue Loan.

Senior Secured Convertible Promissory Notes

In December 2024, we entered into a note purchase agreement pursuant to which we sold the 2024 SSCP Notes in a principal amount totaling $10.0 million and bearing interest at an annual rate of 12.00%, which we amended in August 2025 (the “2024 SSCPN Amendment”). The 2024 SSCP Notes were sold to related parties, including: (i) an entity controlled by a member of our board of directors, (ii) 4Life, and (iii) an entity controlled by the chairman of 4Life who is also a board member of a subsidiary of Clene. We first used the 2024 SSCP Note proceeds to satisfy our obligations under the 2021 Avenue Loan. Pursuant to the 2024 SSCPN Amendment, the maturity date of the 2024 SSCP Notes was extended to the earlier of (i) February 13, 2027 or (ii) upon a change in control transaction. Payments were interest-only for the first 12 months, and, pursuant to the 2024 SSCPN Amendment, interest will be capitalized monthly and added to the balance of the 2024 SSCP Notes beginning in August 2025. Pursuant to the 2024 SSCPN Amendment, monthly payments totaling $1.0 million per month will commence in September 2026 and continue until the maturity date and will be applied pro rata to principal and any accrued interest. We recorded debt issuance costs of $1.5 million as a debt discount at the issuance date and an additional $0.7 million at the date of the 2024 SSCPN Amendment. As of September 30, 2025 and December 31, 2024, the balance of accrued and unpaid interest was $0.2 million and $37,000, respectively, and is recorded as part of the carrying amount of the 2024 SSCP Notes. The 2024 SSCPN Amendment was accounted for as a troubled debt restructuring under ASC 470, with no restructuring gain required to be recognized as the future cash payments were greater than the carrying amount of the 2024 SSCP Notes.

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In August 2025, we entered into a note purchase agreement pursuant to which we sold senior secured convertible promissory notes (the “2025 SSCP Notes,” and together with the 2024 SSCP Notes, the “SSCP Notes”) in a principal amount totaling $1.5 million and bearing interest at an annual rate of 12.00%. The 2025 SSCP Notes mature on the earlier of (i) February 13, 2027 or (ii) upon a change in control transaction. Interest will be capitalized monthly and added to the balance of the 2025 SSCP Notes. Monthly payments totaling $150,000 per month will commence in September 2026 and continue until the maturity date and will be applied pro rata to principal and any accrued interest. We recorded debt issuance costs of $0.2 million as a debt discount. As of September 30, 2025, the balance of accrued and unpaid interest was $24,000 and is recorded as part of the carrying amount of the notes.

We are subject to covenants until maturity, including a requirement to maintain unrestricted cash and cash equivalents of at least $2.0 million pursuant to the 2024 SSCP Notes. We are not in violation of any covenants. If certain events of default occur and are continuing, the holders of a majority of the outstanding principal balance may accelerate all obligations under the SSCP Notes, plus a penalty equal to 10% of all outstanding principal and accrued and unpaid interest (the “SSCPN Default Feature”). The SSCP Notes are collateralized by substantially all our tangible and intangible property and rights (the “Collateral”). During the continuance of an event of default, if the Collateral is sold or otherwise disposed of and the proceeds thereof are insufficient to satisfy our obligations under the SSCP Notes, we shall be liable for any deficiency, together with additional interest thereon at the rate of 10% per annum (the “SSCPN Collateral Deficiency Fee”). We account for the SSCPN Collateral Deficiency Fee as a contingent liability (see Note 9).

The holders of SSCP Notes may, in their sole discretion, convert up to (i) 65% of the outstanding balance of principal and accrued interest of the 2024 SSCP Notes into the number of shares of our Common Stock equal to the amount to be converted divided by (A) $5.668 for principal or (B) $4.44 for accrued interest, and (ii) 65% of the outstanding principal balance of the 2025 SSCP Notes into the number of shares of our Common Stock equal to the amount to be converted divided by $4.44 (the “SSCPN Conversion Feature”). Notwithstanding, in the event a holder declines to convert its pro rata share, the remaining holders may convert additional amounts, provided that no aggregate converted amount exceeds (i) 65% of the outstanding balance of principal and accrued interest for the 2024 SSCP Notes or (ii) $975,000 for the 2025 SSCP Notes. In the event of a change in control or any bankruptcy, liquidation, or other restructuring process, the holders may, at their option, (i) convert up to 65% of outstanding balance of principal and accrued interest for the 2024 SSCP Notes and up to 65% of the outstanding principal for the 2025 SSCP Notes into Common Stock, (ii) receive a cash payment equal to 115% of the outstanding balance of principal and accrued interest for the 2024 SSCP Notes and 115% of the outstanding principal for the 2025 SSCP Notes, or (iii) any combination thereof, prior to such monetization event, before any security or claim junior to the SSCP Notes shall receive any proceeds from such monetization event (the “SSCPN Redemption Feature,” collectively with the SSCPN Conversion Feature and SSCPN Default Feature, the “SSCPN Derivative Liabilities”). The SSCPN Derivative Liabilities met the requirements to be separated as derivative instruments and measured at fair value (see Note 12). The issuance date fair value of the SSCPN Derivative Liabilities was (i) $1.4 million for the 2024 SSCP Notes and (ii) $0.2 million for the 2025 SSCP Notes and was recorded as a debt discount. During the three and nine months ended September 30, 2025, the effective interest rate of the 2024 SSCP Notes was 24.17%. During the three and nine months ended September 30, 2025, the effective interest rate of the 2025 SSCP Notes was 24.65%.

We are required to file and maintain an effective registration statement covering the resale of the shares underlying the SSCPN Conversion Feature or we shall pay the holders a penalty equal to 2% of the face value of the 2024 SSCP Notes or 2025 SSCP Notes, as applicable, upon the occurrence of any such failure and for each 30-day period during which such failure is continuing (the “SSCPN Registration Fee”). The aggregate penalty will in no event exceed 10% of the face value of the 2024 SSCP Notes or the 2025 SSCP Notes, as applicable. We account for the SSCPN Registration Fee as a registration payment arrangement to be evaluated as a contingent liability (see Note 9).

Debt Maturities

Future debt payments, net of unamortized discounts and debt issuance costs, without giving effect to any potential future exercise of equity conversion features, are as follows:

(in thousands)	2019 MD Loan		2019 Cecil Loan		2022 MD Loan			2022 DHCD Loan			2024 SSCP Notes			2025 SSCP Notes			Total
2025 (remainder)	$	—	$	—	$	89		$	—		$	—		$	—		$	89
2026		—		—		369			—			3,449			519			4,337
2027		—		—		317			—			6,551			981			7,849
2028		—		—		—			5,000			—			—			5,000
2029		—		—		—			—			—			—			—
2030		—		—		—			—			—			—			—
Thereafter		500		100		—			—			—			—			600
Total debt principal payments		500		100		775			5,000			10,000			1,500			17,875
Accrued and unpaid interest		264		52		50			312			198			24			900
Unamortized discount and debt issuance costs		—		—		(11	)		(29	)		(1,461	)		(229	)		(1,730	)
Future debt payments, net	$	764	$	152	$	814		$	5,283		$	8,737		$	1,295		$	17,045

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Note 9. 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, 2025 and December 31, 2024, we had commitments under various agreements for capital expenditures totaling $0.3 million and $0.2 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.

We received two grants from the National Multiple Sclerosis Society (“NMSS”): (i) $0.3 million in September 2019 (the “2019 Grant”) for our VISIONARY-MS clinical trial, and (ii) $0.7 million in May 2023 (the “2023 Grant”) for our REPAIR-MS clinical trial. Pursuant to the grants, if we make future commercial sales of CNM-Au8 for MS, we will repay: (i) 50% of the grants upon the first commercial sale, (ii) an additional 50% of the grants upon cumulative sales of $10.0 million, (iii) an additional 150% of the grants upon cumulative sales of $50.0 million, and (iv) an additional 200% of the grants upon cumulative sales of $100.0 million, with a maximum repayment of 450% of the grants if all milestones are achieved. If NMSS has not yet received aggregate repayments equal to 300% of the 2019 Grant or 150% of the 2023 Grant, then the following events will trigger repayment of 300% of the 2019 Grant, or $1.0 million, and 150% of the 2023 Grant, or $1.0 million, less any amounts previously paid: (i) sale of all or substantially all of our assets and business, (ii) sale of any portion of our assets and business including CNM-Au8 for MS treatment, (iii) exclusive licensing of our intellectual property claiming CNM-Au8 for MS treatment, (iv) a collaboration with a third-party to develop CNM-Au8 for MS treatment (2019 Grant only), or (v) licensing of our commercialization rights to CNM-Au8 for MS treatment (2023 Grant only). As of September 30, 2025, we have not met any of the above milestones. We account for these provisions in accordance with ASC 450, Contingencies. We assessed the likelihood of each event as less than probable and therefore no contingent liability is recognized. Our estimate of the possible range of loss is between the minimum and maximum repayment amounts, equal to 50% and 450% of each grant, or approximately $0.2 million and $1.5 million for the 2019 Grant, respectively; and approximately $0.3 million and $3.0 million for the 2023 Grant, respectively. However, it is at least reasonably possible that our estimate of the likelihood of each contingent event and the possible range of loss will change in the near term.

We account for the SSCPN Collateral Deficiency Fee and SSCPN Registration Fee (see Note 8) as contingent liabilities that were not probable as of September 30, 2025, and therefore no contingent liabilities were recorded. Our estimate of the possible range of loss for the SSCPN Registration Fee is between $0.2 million, which is equal to the loss upon initial failure to register the SSCPN Conversion Feature underlying shares, and $1.2 million, which is equal to the contractually-limited maximum loss upon continued failure to register the SSCPN Conversion Feature underlying shares. We are not able to estimate a possible range of loss for the SSCPN Collateral Deficiency Fee. It is at least reasonably possible that our estimate of the likelihood of each contingent event and the possible range of loss will change in the near term.

Note 10. Income Taxes

The components of loss before income taxes for the three and nine months ended September 30, 2025 and 2024 were as follows:

	*Three Months Ended September 30,*						*Nine Months Ended September 30,*
(in thousands)	*2025*			*2024*			*2025*			*2024*
United States	$	(8,758	)	$	(7,940	)	$	(16,840	)	$	(25,720	)
Foreign		(19	)		(46	)		(107	)		(131	)
Net loss before income taxes	$	(8,777	)	$	(7,986	)	$	(16,947	)	$	(25,851	)

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We are subject to taxation in the U.S., Australia, Netherlands, and various state jurisdictions. Our tax returns from 2018 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 adjust 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.

Note 11. Benefit Plans

401(k) Plan

Our 401(k) plan is a deferred salary arrangement under Section 401(k) of the Internal Revenue Code. 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 $33,000 and $34,000 during the three months ended September 30, 2025 and 2024, respectively; and $0.1 million and $0.1 million during the nine months ended September 30, 2025 and 2024, respectively.

Stock Compensation Plans

The Clene Nanomedicine, Inc. 2014 Stock Plan (the “2014 Plan”) was adopted in July 2014. Effective as of the closing of the Reverse Recapitalization, no additional awards may be granted under the 2014 Plan. As of September 30, 2025, a total of 152,955 stock options remained outstanding under the 2014 Plan.

The Clene Inc. 2020 Amended Stock Plan (the “2020 Plan”) was adopted in December 2020 and amended in May 2023, May 2024, and May 2025. Currently, 3,220,000 shares of Common Stock are reserved for issuance thereunder. As of September 30, 2025, a total of 2,581,696 stock options and other stock awards had been granted under the 2020 Plan, and 638,304 shares remained available for future grant.

Stock-Based Compensation Expense

Stock-based compensation expense recorded in research and development expense and general and administrative expense during the three and nine months ended September 30, 2025 and 2024 was as follows:

	*Three Months Ended September 30,*				*Nine Months Ended September 30,*
(in thousands)	*2025*		*2024*		*2025*		*2024*
General and administrative	$	949	$	1,126	$	2,717	$	3,310
Research and development		754		1,062		2,300		2,842
Total stock-based compensation expense	$	1,703	$	2,188	$	5,017	$	6,152

Stock-based compensation expense by award type during the three and nine months ended September 30, 2025 and 2024 was as follows:

	*Three Months Ended September 30,*					*Nine Months Ended September 30,*
(in thousands)	*2025*		*2024*			*2025*			*2024*
Stock options	$	1,703	$	2,194		$	5,146		$	6,147
Stock awards		—		(6	)		(129	)		5
Total stock-based compensation expense	$	1,703	$	2,188		$	5,017		$	6,152

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Stock Options

Outstanding stock options and related activity during the nine months ended September 30, 2025 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, 2024		1,944,252		$	27.90		8.24	$	59
Granted		753,992			4.81		9.70		—
Forfeited		(12,115	)		31.35		—		—
Expired		(4,595	)		14.01		—		—
Outstanding – September 30, 2025		2,681,534		$	21.42		8.13	$	1,149
Vested and exercisable – September 30, 2025		1,299,261		$	35.33		7.24	$	569
Vested, exercisable or expected to vest – September 30, 2025		2,681,534		$	21.42		8.13	$	1,149

As of September 30, 2025 and December 31, 2024, we had approximately $5.9 million and $8.3 million, respectively, of unrecognized stock-based compensation costs related to unvested stock options that is expected to be recognized over a weighted-average period of 1.62 years and 1.70 years, respectively. Our unrecognized stock-based compensation cost excludes $2.8 million of stock options that vest based on performance conditions that we assessed as less than probable as of September 30, 2025 and December 31, 2024.

The weighted-average grant-date fair value of stock options granted during the nine months ended September 30, 2025 and 2024 was $3.79 and $6.09, respectively. The assumptions used to calculate the fair value of stock options granted during the nine months ended September 30, 2025 and 2024 were as follows:

	Nine Months Ended September 30,
	2025			2024
Expected stock price volatility		96.77% – 110.25	%		97.78% – 111.49	%
Risk-free interest rate		3.67% – 4.24	%		3.62% – 4.58	%
Expected dividend yield		0.00	%		0.00	%
Expected term of options (in years)		5.00 – 6.25			5.00 – 10.00

Stock Awards

Stock awards include rights to restricted stock awards with market-based vesting conditions and restricted stock units with service-based vesting conditions. Outstanding stock awards and related activity during the nine months ended September 30, 2025 was as follows:

	*Number of Stock Awards*			*Weighted Average Grant Date Fair Value*
Unvested balance – December 31, 2024		37,441		$	196.84
Forfeited		(663	)		193.93
Unvested balance – September 30, 2025		36,778		$	193.93

As of September 30, 2025 and December 31, 2024, we had no unrecognized stock-based compensation cost related to unvested stock awards.

Note 12. 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. Our remaining fair value measures are discussed below.

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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, 2025 was as follows:

	*September 30, 2025*
(in thousands)	*Level 1*		*Level 2*		*Level 3*		*Total*
Cash equivalents:
Money market funds	$	4,672	$	—	$	—	$	4,672
Common stock warrant liabilities		—		—		4,274		4,274
Derivative liabilities		—		—		2,819		2,819

The fair value hierarchy for financial instruments measured at fair value on a recurring basis as of December 31, 2024 was as follows:

	*December 31, 2024*
(in thousands)	*Level 1*		*Level 2*		*Level 3*		*Total*
Cash equivalents:
Money market funds	$	7,002	$	—	$	—	$	7,002
Common stock warrant liabilities		—		—		4,541		4,541
Derivative liabilities		—		—		1,804		1,804

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 during the nine months ended September 30, 2025 were as follows:

(in thousands)	*Common Stock Warrant Liabilities*			*Derivative Liabilities*
Balance – December 31, 2024	$	4,541		$	1,804
Initial fair value of instruments issued		—			239
Change in fair value		(267	)		89
Change in fair value pursuant to the 2024 SSCPN Amendment, recorded as a debt discount		—			687
Balance – September 30, 2025	$	4,274		$	2,819

Changes in the fair value of our Level 3 financial instruments during the nine months ended September 30, 2024 were as follows:

(in thousands)	*Common Stock Warrant Liabilities*			*Clene Nanomedicine Contingent Earn-out*			*Initial Stockholders Contingent Earn-out*
Balance – December 31, 2023	$	1,481		$	75		$	10
Change in fair value		(956	)		(75	)		(10	)
Change in 2023 Avenue Warrant fair value pursuant to the Third Amendment, recorded as a debt discount		67			—			—
Balance – September 30, 2024	$	592		$	—		$	—

Valuation of Notes Payable and Convertible Notes Payable

Our notes payable and convertible notes payable are categorized within Level 3 of the fair value hierarchy. The 2019 MD Loan and 2019 Cecil Loan are carried at the greater of principal plus accrued interest or the value of the Phantom Shares (see Note 8), which approximates fair value. The 2022 MD Loan, 2022 DHCD Loan, and 2025 SSCP Notes are carried at amortized cost, which approximates fair value due to our credit risk and market interest rates.

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The 2024 SSCP Notes are carried at their amortized cost of $8.7 million and $8.6 million as of September 30, 2025 and December 31, 2024, respectively. As of December 31, 2024, amortized cost approximated fair value but as of September 30, 2025, amortized cost did not approximate fair value and the fair value of the 2024 SSCP Notes, excluding the SSCPN Derivative Liabilities pertaining to the 2024 SSCP Notes, was approximately $7.7 million. The SSCPN Derivative Liabilities met the requirements to be separated from the SSCP Notes as derivative instruments measured at fair value. We estimate the fair value of the SSCP Notes with and without the SSCPN Derivative Liabilities and calculate the difference as the implied fair value of the SSCPN Derivative Liabilities. The valuation model consists of a discounted cash flow model and a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) a change of control transaction, (ii) dissolution of the Company, or (iii) another outcome outside of (i)-(ii). These estimates require significant judgment. The carrying amount may fluctuate significantly and the actual settlement amount may be materially different from the estimated fair value. The unobservable valuation inputs were as follows:

	September 30,			August 13,			August 13,			December 31,
	2025			2025⁽¹⁾			2025⁽²⁾			2024⁽³⁾
Expected stock price volatility		100.70	%		96.30	%		89.20	%		101.50	%
Discount rate		15.00	%		21.00	%		21.00	%		12.00	%
Risk-free interest rate		3.70% – 3.80	%		3.80% – 4.10	%		3.90% – 4.10	%		4.20	%
Expected dividend yield		0.00	%		0.00	%		0.00	%		0.00	%
Expected term (in years)		0.50 – 1.37			0.47 – 1.50			0.44 – 0.85			0.50 – 1.47
Probability of change of control		20.00	%		20.00	%		20.00	%		10.00	%
Probability of dissolution		45.00	%		45.00	%		45.00	%		45.00	%
Probability of other outcome		35.00	%		35.00	%		35.00	%		45.00	%

(1)	Represents the unobservable inputs to the valuation of the SSCPN Derivative Liabilities related to: (i) the 2024 SSCP Notes immediately following the 2024 SSCPN Amendment, and (ii) the 2025 SSCP Notes at issuance.

(2)	Represents the unobservable inputs to the valuation of the SSCPN Derivative Liabilities related to the 2024 SSCP Notes immediately preceding the 2024 SSCPN Amendment.

(3)	Represents the unobservable inputs to the valuation of the SSCPN Derivative Liabilities related to the 2024 SSCP Notes only.

Valuation of the Common Stock Warrant Liabilities

The 2023 Avenue Warrant, as amended, is classified as a liability and carried at fair value. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) settlement of the instrument upon a change of control transaction, (ii) dissolution of the Company, or (iii) another outcome outside of (i)-(ii). These estimates require significant judgment. The carrying amount may fluctuate significantly and the actual settlement amount may be materially different from the estimated fair value. The unobservable valuation inputs were as follows:

	September 30,			December 31,
	2025			2024
Expected stock price volatility		96.10% – 110.10	%		100.20% – 101.40	%
Risk-free interest rate		3.60% – 3.80	%		4.20% – 4.30	%
Expected dividend yield		0.00	%		0.00	%
Expected term (in years)		0.50 – 2.75			0.75 – 3.50
Probability of change of control		20.00	%		10.00	%
Probability of dissolution		45.00	%		45.00	%
Probability of other outcome		35.00	%		45.00	%

The Tranche A Warrants are classified as a liability and carried at fair value. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) acceptance of a new drug application (“NDA”) by the U.S. Food and Drug Administration (“FDA”) for CNM-Au8, (ii) settlement upon a fundamental transaction, (iii) dissolution of the Company, and (iv) another outcome outside of (i)-(iii). These estimates require significant judgment. The carrying amount may fluctuate significantly and the actual settlement amount may be materially different from the estimated fair value. The unobservable valuation inputs were as follows:

	September 30,			December 31,
	2025			2024
Expected stock price volatility		98.40% – 100.40	%		97.80% – 101.90	%
Risk-free interest rate		3.80% – 4.10	%		4.20	%
Expected dividend yield		0.00	%		0.00	%
Expected term (in years)		0.21 – 0.71			0.71 – 1.46
Probability of NDA acceptance		20.00	%		20.00	%
Probability of fundamental transaction		20.00	%		10.00	%
Probability of dissolution		45.00	%		45.00	%
Probability of other outcome		15.00	%		25.00	%

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The 2024 Common Warrants are classified as a liability and carried at fair value. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) dissolution of the Company and (ii) another outcome outside of dissolution. These estimates require significant judgment. The carrying amount may fluctuate significantly and the actual settlement amount may be materially different from the estimated fair value. The unobservable valuation inputs were as follows:

	*September 30,*			*December 31,*
	*2025*			*2024*
Expected stock price volatility		100.00	%		107.50	%
Risk-free interest rate		3.70	%		4.40	%
Expected dividend yield		0.00	%		0.00	%
Expected term (in years)		4.00			4.75
Probability of dissolution		45.00	%		45.00	%
Probability of other outcome		55.00	%		55.00	%

Note 13. Capital Stock

As of September 30, 2025 and December 31, 2024, our amended and restated certificate of incorporation authorized us to issue 600,000,000 shares of Common Stock, par value $0.0001 per share; and 1,000,000 shares of Preferred Stock, par value $0.0001 per share. As of September 30, 2025 and December 31, 2024, we had 10,219,946 and 8,089,565 shares of Common Stock issued and outstanding, respectively, and no shares of Preferred Stock issued or outstanding.

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.

Common Stock Warrants

We have issued the following outstanding warrants and pre-funded warrants to purchase shares of Common Stock:

						*Number of Shares Issuable*
						*September 30,*		*December 31,*
Date Exercisable	*Exercise Price*		*Expiration*		*Classification*	*2025*		*2024*
December 2020	$	230.00	December 2025	(1)	Equity		120,375		120,375
December 2020	$	230.00	December 2025	(2)	Equity		1,229		1,229
June 2023	$	4.6014	June 2028	(3)	Liability		150,000		150,000
June 2023	$	22.00	June 2026	(4)	Liability		2,500,000		2,500,000
June 2023	$	30.00	June 2030	(5)	Equity		2,500,000		2,500,000
October 2024	$	0.001	None	(6)	Equity		424,358		424,358
October 2024	$	4.82	October 2029	(7)	Liability		1,546,914		1,546,914
Total shares							7,242,876		7,242,876

(1)

Represents 120,375 shares of Common Stock underlying warrants to purchase one-fortieth (1/40) of one share of Common Stock, issued during Tottenham’s initial public offering. We may redeem the outstanding warrants at $0.01 per warrant if the last sales price of our Common Stock equals or exceeds $330.00 per share for any 20 trading days within a 30-trading day period. As of September 30, 2025 and December 31, 2024, no warrants had been exercised.

(2)

Represents 1,229 shares of Common Stock underlying warrants to purchase one-fortieth (1/40) of one share of Common Stock, issued to the financial advisor and lead underwriter of Tottenham’s initial public offering upon their exercise of a unit purchase option in July 2021. As of September 30, 2025 and December 31, 2024, no warrants had been exercised.

(3)	Represents 150,000 shares of Common Stock underlying the 2023 Avenue Warrant, issued pursuant to the Second Amendment (see Note 8). As of September 30, 2025 and December 31, 2024, the warrant had not been exercised.

(4)

Represents 2,500,000 shares of Common Stock underlying the Tranche A Warrants to purchase one share of Common Stock, issued in our June 2023 public equity offering. The Tranche A Warrants expire on the earlier of (i) sixty (60) days following the date of our public announcement that an NDA for CNM-Au8 has been accepted by the FDA, or (ii) June 16, 2026. As of September 30, 2025 and December 31, 2024, no warrants had been exercised.

(5)

Represents 2,500,000 shares of Common Stock underlying the Tranche B Warrants to purchase one share of Common Stock, issued in our June 2023 public equity offering. The Tranche B Warrants expire on the earlier of (i) sixty (60) days following the date of our public announcement that an NDA for CNM-Au8 has been approved by the FDA, or (ii) June 16, 2030. As of September 30, 2025 and December 31, 2024, no warrants had been exercised.

(6)	Represents 424,358 shares of Common Stock underlying the 2024 Pre-Funded Warrants to purchase one share of Common Stock, issued in our October 2024 public equity offering. As of September 30, 2025 and December 31, 2024, 17,626 pre-funded warrants had been exercised for nominal proceeds.

(7)	Represents 1,546,914 shares of Common Stock underlying the 2024 Common Warrants to purchase one share of Common Stock, issued in our October 2024 public equity offering. As of September 30, 2025 and December 31, 2024, no warrants had been exercised.

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Public Offerings

In October 2024, pursuant to a placement agency agreement with Canaccord Genuity LLC (“Canaccord”), we sold 725,000 shares of Common Stock and pre-funded warrants to purchase up to 17,626 shares of Common Stock (the “2024 Pre-Funded Warrants”). The aggregate gross proceeds were approximately $3.5 million, excluding the proceeds, of any, from the exercise of the pre-funded warrants and before deducting placement agent fees and expenses and other expenses payable by us. We paid Canaccord a placement agent fee of 6.00% of the aggregate gross proceeds of the offering. The offering was made pursuant to our registration statement on Form S-3 (file number 333-264299), declared effective on April 26, 2022, and a related prospectus supplement. Additionally, in separate, concurrent private placements, we also sold 379,930 shares of Common Stock, 2024 Pre-Funded Warrants to purchase up to 424,358 shares of Common Stock, and warrants to purchase up to 1,546,914 shares of Common Stock (the “2024 Common Warrants”). The aggregate gross proceeds from the private placements were approximately $3.8 million, of which $1.3 million was contributed by certain of our directors, executive officers and their affiliated entities, and excludes the proceeds, if any, from the exercise of the 2024 Pre-Funded Warrants and 2024 Common Warrants. The 2024 Pre-Funded Warrants were exercisable immediately at a price of $0.001 per share and expire when exercised in full. The 2024 Common Warrants were exercisable immediately at a price of $4.82 per share and expire five years from issuance. The total fair value of the Common Stock, 2024 Pre-Funded Warrants, and 2024 Common Warrants sold in the offerings exceeded the offering proceeds by $2.1 million, therefore pursuant to ASC 815, we recognized this amount as a loss on the initial issuance of equity during the year ended December 31, 2024. The placement agent fees and offering expenses were allocated to the Common Stock, 2024 Pre-Funded Warrants, and 2024 Common Warrants sold in the offering based on their relative fair values, with the amount allocated to the liability-classified 2024 Common Warrants recorded as an expense and the amounts allocated to the Common Stock and 2024 Pre-Funded Warrants as a reduction to their initial carrying values.

Common Stock Sales Agreement

In April 2022, we entered into an equity distribution agreement (the “2022 ATM Agreement”), which we amended in December 2022. In April 2025, we entered into an equity distribution agreement (the “2025 ATM Agreement,” and collectively with the 2022 ATM Agreement, the “ATM Agreements”). Canaccord acts as placement agent under the ATM Agreements and we may offer and sell shares of Common Stock from time to time through Canaccord. The issuance and sale of Common Stock by us under the 2022 ATM Agreement was made pursuant to our registration statement on Form S-3 (file number 333-264299), declared effective by the SEC on April 26, 2022, and a related prospectus supplement, which expired on April 26, 2025. The issuance and sale of Common Stock by us under the 2025 ATM Agreement was made pursuant to our registration statement on Form S-3 (file number 333-286058), declared effective by the SEC on April 25, 2025, and a related prospectus supplement.

Pursuant to the ATM Agreements, Canaccord is not required to sell any specific number or dollar amount of Common Stock but will act as our placement agent to sell, on our behalf, all of the Common Stock requested by us to be sold, consistent with Canaccord’s normal trading and sales practices, on terms mutually agreed between Canaccord and us, for a fixed commission from each sale of Common Stock, if any. During the three and nine months ended September 30, 2025, we sold 757,875 and 2,095,070 shares of Common Stock, respectively, generated gross proceeds of $3.3 million and $8.4 million, respectively, and paid commissions of $0.1 million and $0.1 million, respectively. During the three and nine months ended September 30, 2024, we sold 394,453 shares of Common Stock, generated gross proceeds of $2.1 million, and paid commissions of $0.1 million.

Common Stock Purchase Agreement

On March 3, 2023, we entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $25.0 million of shares of Common Stock at our sole discretion and subject to certain daily limitations based on our prior day purchase history and the volume and closing price of our Common Stock on Nasdaq, from time to time over a 36-month period commencing on March 7, 2023. The issuance and sale of Common Stock under the Purchase Agreement is made pursuant to our registration statement on Form S-3 (file number 333-264299), declared effective by the SEC on April 26, 2022. On June 16, 2023, we suspended and terminated the prospectus supplement related to the offering with respect to the unsold shares of Common Stock issuable pursuant to the Purchase Agreement. We will not make any further sales of our securities pursuant to the Purchase Agreement, unless and until a new prospectus supplement is filed. Other than the termination of the prospectus supplement related to the offering with respect to future sales by us, the Purchase Agreement remains in full force and effect.

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On the date of the Purchase Agreement, we issued 16,633 shares of Common Stock (the “Initial Commitment Shares”) to Lincoln Park as an initial fee for its commitment under the Purchase Agreement. We recorded the fair value of the Initial Commitment Shares on the date of issuance in other income (expense), net. We may further issue up to 8,317 additional shares of Common Stock (the “Additional Commitment Shares,” and, together with the Initial Commitment Shares, the “Commitment Shares”) on a pro rata basis upon each purchase by Lincoln Park under the Purchase Agreement. Under applicable Nasdaq listing rules, the total number of shares of Common Stock that we may sell to Lincoln Park is limited to 765,506 shares (including the Commitment Shares), representing 19.99% of the outstanding shares of our Common Stock immediately prior to the execution of the Purchase Agreement, unless we (i) first obtain stockholder approval in accordance with applicable Nasdaq listing rules or (ii) the average price paid by Lincoln Park for all shares of Common Stock issued by us under the Purchase Agreement is equal to or greater than $24.8080. The Purchase Agreement prohibits us from directing Lincoln Park to purchase any shares of Common Stock that would result in Lincoln Park having beneficial ownership of greater than 4.99% of our outstanding Common Stock, which Lincoln Park may, in its sole discretion, increase up to 9.99% of our outstanding Common Stock by delivering written notice thereof to us, which shall not be effective until the 61st day after such written notice is delivered to us. We may terminate the Purchase Agreement at any time, for any reason and without any payment or liability to us, by giving Lincoln Park a termination notice with effect one business date after the notice has been received by Lincoln Park.

We evaluated the Purchase Agreement under ASC 815-40 Derivatives and Hedging—Contracts on an Entity's Own Equity as it represents the right to require Lincoln Park to purchase shares of Common Stock in the future, similar to a put option. We concluded it represents a freestanding derivative instrument that does not qualify for equity classification and therefore requires fair value accounting. We analyzed the terms of the contract and concluded the derivative instrument has no value as of September 30, 2025 and December 31, 2024. We did not effect any sales during the periods presented herein.

Note 14. 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, 2025 and 2024 was as follows:

	*Three Months Ended September 30,*						*Nine Months Ended September 30,*
(in thousands, except share and per share data)	*2025*			*2024*			*2025*			*2024*
Numerator:
Net loss attributable to common stockholders	$	(8,777	)	$	(7,986	)	$	(16,947	)	$	(25,851	)
Denominator:
Weighted average common shares outstanding		10,284,674			6,557,839			9,549,661			6,467,771
Net loss per share attributable to common stockholders – basic and diluted	$	(0.85	)	$	(1.22	)	$	(1.77	)	$	(4.00	)

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, 2025 and 2024 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,*
	*2025*		*2024*		*2025*		*2024*
Convertible notes payable (see Note 8)		1,457,849		62,500		1,457,849		62,500
Common stock warrants (see Note 13)		6,818,518		5,271,604		6,818,518		5,271,604
Options to purchase common stock (see Note 11)		2,681,534		1,896,044		2,681,534		1,896,044
Unvested restricted stock awards (see Note 11)		36,778		37,441		36,778		37,441
Contingent earn-out shares (see Note 2)		329,628		329,628		329,628		329,628
Total shares excluded from diluted net loss per share		11,324,307		7,597,217		11,324,307		7,597,217

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Note 15. Related Party Transactions

Supply and License Agreements

In August 2018, we entered into an exclusive supply agreement (the “Supply Agreement”) and license agreement (the “License Agreement”) in conjunction with 4Life’s investment in the Series C preferred stock and warrants of our predecessor. On April 25, 2024, we entered into an amendment to the Supply Agreement and License Agreement (the “Amended 4Life Agreements”). The Amended 4Life Agreements contain the following terms:

●

Supply Agreement. We granted 4Life, or its affiliates and mutually-agreed upon manufacturing vendors (the “Buyer Purchasing Parties”) an exclusive right to purchase certain of our dietary supplement and non-pharmaceutical products (the “Licensed Products”), and we shall exclusively sell the Licensed Products to the Buyer Purchasing Parties. The purchase price of Licensed Products shall be equal to our cost plus 20%. 4Life must sell certain amounts of Licensed Products for the calendar years beginning in 2024 and extending through 2033 (the “Minimum Sales Commitment”), with Minimum Sales Commitments for years subsequent to 2033, if applicable, to be negotiated between the Company and 4Life. The Company may permanently convert 4Life’s exclusive rights to purchase Licensed Products to non-exclusive rights if: (i) 4Life fails to achieve the Minimum Sales Commitment for any two consecutive years, and (ii) 4Life fails to pay additional royalty fees to maintain exclusivity (as set forth under “License Agreement” below) (the “Exclusivity Provision”).

●

License Agreement. We granted 4Life an exclusive, royalty bearing license to use, sell, and commercialize the Licensed Products. On a quarterly basis, 4Life shall pay us a royalty rate of 3% of incremental sales of Licensed Products, which is equal to the lesser of (a) the increase in net sales for the quarter over a base period quarter as determined in the License Agreement, or (b) net sales. If 4Life fails to meet the Exclusivity Provision, 4Life may continue to maintain exclusivity by paying us the difference between (a) the royalty fee that would otherwise have been earned by us if 4Life had met the Minimum Sales Commitment and (b) actual royalties paid to us. However, notwithstanding any other provisions of the License Agreement, on or after January 1, 2027, we shall be permitted to sell Licensed Products through third party retail outlets or via our own websites. The term of the License Agreement will continue until December 31, 2033, unless earlier terminated pursuant to the License Agreement or Supply Agreement. The Amended 4Life Agreements will be renewable for additional five-year terms upon mutual agreement of the parties.

We currently provide, on a non-exclusive basis, an aqueous zinc-silver ion dietary (mineral) supplement to 4Life, which is sold under the trade name Zinc Factor™, and an aqueous gold dietary (mineral) supplement of very low-concentration gold nanoparticles, that is sold by 4Life, on an exclusive basis, under the trade name Gold Factor™ and is subject to royalties. Total revenue under the Supply and License Agreements during the three and nine months ended September 30, 2025 and 2024 was as follows:

	*Three Months Ended September 30,*				*Nine Months Ended September 30,*
(in thousands)	*2025*		*2024*		*2025*		*2024*
Product revenue from related parties	$	—	$	64	$	63	$	171
Royalty revenue from related parties		15		22		58		78
Total revenue from related parties	$	15	$	86	$	121	$	249

Note 16. Geographic and Segment Information

Geographic Information

All of our long-lived assets, composed of property and equipment, net by location, were held in the U.S. as of September 30, 2025 and December 31, 2024. All of our revenues from external customers were generated in the U.S. during the three and nine months ended September 30, 2025 and 2024.

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Segment Information

Our Products segment measures of profit and loss is consolidated loss from operations, and its measure of total assets is consolidated total assets. Our CODM uses loss from operations predominantly in the annual budget and forecasting process to monitor variances in budget versus actual results along with consolidated total assets to determine resource allocation. Segment revenues from external customers, significant segment non-cash items, and other significant segment expense categories included within the measure of profit and loss and provided to our CODM were all based on their consolidated amounts. During the three and nine months ended September 30, 2025 and 2024, these items were as follows:

	*Three Months Ended September 30,*						*Nine Months Ended September 30,*
(in thousands)	*2025*			*2024*			*2025*			*2024*
Segment revenue from external customers	$	15		$	87		$	123		$	251
Segment operating expenses:
Cost of revenue		—			18			20			52
Research and development:
CNM-Au8:
Amyotrophic lateral sclerosis		1,775			694			4,586			2,074
Multiple sclerosis		41			178			230			339
Parkinsonʼs disease		—			—			—			2
Regulatory activities		75			168			335			630
General/pre-clinical/non-clinical		(108	)		(35	)		(26	)		293
CNM-ZnAg		—			4			—			17
Facilities		436			411			1,241			1,193
Depreciation		337			339			1,012			1,040
Manufacturing		363			226			633			887
Research		1			46			8			362
Equipment		30			39			58			103
Maintenance		53			47			117			84
Information technology		68			43			187			109
Personnel		1,945			2,516			6,205			7,725
Stock-based compensation		754			1,062			2,300			2,842
Grant revenue as a reduction of research and development expense		(2,270	)		(1,283	)		(8,495	)		(3,285	)
Other segment items ‒ Research and development⁽¹⁾		13			16			117			75
General and administrative:
Insurance		182			188			544			561
Legal		70			290			393			649
Finance and accounting		270			192			800			565
Public and investor relations		63			156			293			589
Facilities		29			28			90			91
Depreciation		28			67			123			200
Information technology		27			79			123			245
Personnel		569			1,000			2,189			3,140
Stock-based compensation		949			1,126			2,717			3,310
Grant revenue as a reduction of general and administrative expense		(130	)		(41	)		(358	)		(147	)
Other segment items ‒ General and administrative⁽²⁾		93			328			269			944
Segment loss from operations		(5,648	)		(7,815	)		(15,588	)		(24,438	)

Reconciliation of segment loss from operations:
Adjustments and reconciling items		—			—			—			—
Consolidated loss from operations	$	(5,648	)	$	(7,815	)	$	(15,588	)	$	(24,438	)

(1)	Includes expenses for travel, meals, dues, subscriptions, continuing education, and other miscellaneous expenses.

(2)	Includes expenses for travel, meals, dues, subscriptions, continuing education, lobbying, banking fees, postage, and other office and miscellaneous expenses.

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Our revenues during the three and nine months ended September 30, 2025 and 2024 were predominantly with a single customer, 4Life, through our License and Supply Agreements (see Note 15). A reconciliation of the total of the Products segment loss from operations to consolidated net loss before income taxes for the three and nine months ended September 30, 2025 and 2024 was as follows:

	*Three Months Ended September 30,*						*Nine Months Ended September 30,*
(in thousands)	*2025*			*2024*			*2025*			*2024*
Segment loss from operations	$	(5,648	)	$	(7,815	)	$	(15,588	)	$	(24,438	)
Total other income (expense), net⁽¹⁾		(3,129	)		(171	)		(1,359	)		(1,413	)
Net loss before income taxes	$	(8,777	)	$	(7,986	)	$	(16,947	)	$	(25,851	)

(1)	Represents consolidated total other income (expense), net, as reported on the consolidated statements of operations and comprehensive loss.

Products segment assets exclude corporate assets, such as cash, restricted cash, and corporate facilities. Total assets as of September 30, 2025 and December 31, 2024 were as follows:

	*September 30,*		*December 31,*
(in thousands)	*2025*		*2024*
Total assets:
Products	$	14,256	$	15,001
Corporate		8,055		12,336
Consolidated	$	22,311	$	27,337

Additions to long-lived assets during the nine months ended September 30, 2025 and 2024 were as follows:

	*Nine Months Ended September 30,*
(in thousands)	*2025*		*2024*
Products	$	11	$	14
Corporate		—		—
Consolidated	$	11	$	14

Note 17. Subsequent Events

Common Stock Sales Agreement

Subsequent to September 30, 2025, we sold 114,034 shares of Common Stock, generated gross proceeds of $1.2 million, and paid commissions of $18,000 under our 2025 ATM Agreement.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements reflecting our or our management team’s expectations, hopes, beliefs, intentions, strategies, estimates, and assumptions concerning events and financial trends that may affect our future financial condition or results of operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Actual results and the timing of events may differ materially from those contained in these forward-looking statements due to a number of factors, including those discussed in the section titled “Risk Factors” in our Annual Report on Form 10-K. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws. Unless the context otherwise requires, for purposes of this section, the terms the “Company,” “we,” “us,” or “our” are intended to mean the business and operations of Clene Inc. and its consolidated subsidiaries.

Business Overview

We are a clinical-stage pharmaceutical company pioneering the discovery, development, and commercialization of novel clean-surfaced nanotechnology (“CSN^®”) therapeutics. CSN^® therapeutics are comprised of atoms of transition elements that, when assembled in nanocrystal form, possess unusually high, unique catalytic activities not present in those same elements in bulk form. These catalytic activities drive, support, and maintain beneficial metabolic and energetic cellular reactions within diseased, stressed, and damaged cells.

Our patent-protected, proprietary position affords us the potential to develop a broad and deep pipeline of novel CSN therapeutics to address a range of diseases with high impact on human health. We innovated an electro-crystal-chemistry drug development platform that draws from advances in nanotechnology, plasma and quantum physics, material science, and biochemistry. Our platform process results in nanocrystals with faceted structures and surfaces that are free of the chemical surface modifications that accompany other production methods. Many traditional methods of nanoparticle synthesis involve the unavoidable deposition of potentially toxic organic residues and stabilizing surfactants on the particle surfaces. Synthesizing stable nanocrystals that are both nontoxic and highly catalytic has overcome this significant hurdle in harnessing transition metal catalytic activity for therapeutic use. Our clean-surfaced nanocrystals exhibit catalytic activities many-fold higher than other commercially available nanoparticles, produced using various techniques, that we have comparatively evaluated.

Our development and clinical efforts are dedicated to revolutionizing the treatment of neurodegenerative diseases to restore and protect neuronal health and function. Our nanotherapeutics target cellular energy impairments that are common to many diseases and we are currently focused on addressing the high unmet medical needs in central nervous system disorders including amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”), and Parkinson’s disease (“PD”). We currently have no drugs approved for commercial sale and have not generated any revenue from drug sales. We have never been profitable and have incurred operating losses in each year since inception. We generate revenue from sales of dietary supplements through our wholly owned subsidiary, dOrbital, Inc., or through an exclusive license with 4Life Research LLC (“4Life”), an international supplier of health supplements, stockholder, and related party. We anticipate these revenues to be small compared to our operating expenses and to the revenue we expect to generate from potential future sales of our drug candidates, for which we are currently conducting clinical trials.

Reverse Recapitalization

Clene Nanomedicine, Inc. (“Clene Nanomedicine”) became a public company on December 30, 2020 (the “Closing Date”) when it completed a reverse recapitalization (the “Reverse Recapitalization”) with Tottenham Acquisition I Limited (“Tottenham”), and with Tottenham’s wholly-owned subsidiary and our predecessor, Chelsea Worldwide Inc., and Creative Worldwide Inc., a wholly-owned subsidiary of Chelsea Worldwide Inc. On the Closing Date, Chelsea Worldwide Inc. changed its name to Clene Inc. and listed its shares of common stock, par value $0.0001 per share (“Common Stock”) on the Nasdaq Capital Market (“Nasdaq”) under the symbol “CLNN.”

In connection with the Reverse Recapitalization, certain of Clene Nanomedicine’s common stockholders are entitled to receive earn-out payments (the “Clene Nanomedicine Contingent Earn-out”), and Tottenham’s former officers and directors and Norwich Investment Limited (collectively, the “Initial Stockholders”) are entitled to receive earn-out payments (the “Initial Stockholders Contingent Earn-out,” and both collectively the “Contingent Earn-outs”) based on achieving certain milestones.

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Reverse Stock Split

Effective July 11, 2024 (the “Effective Date”), we filed a Certificate of Amendment to our Fourth Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware, to effect a 1-for-20 reverse stock split (the “Reverse Stock Split”) of our Common Stock. Beginning with the opening of trading on the Effective Date, our Common Stock began trading on Nasdaq on a split-adjusted basis under the same symbol, “CLNN.” As a result of the Reverse Stock Split, every 20 shares of our Common Stock issued and outstanding were automatically combined and converted into 1 validly issued, fully paid and non-assessable share of Common Stock. In lieu of any fractional shares, stockholders received an amount in cash (without interest) equal to: (i) the number of shares of Common Stock held by such stockholder before the Reverse Stock Split that would otherwise have been exchanged for such fractional shares multiplied by (ii) the closing price of our Common Stock on Nasdaq on the trading day immediately preceding the Effective Date.

The Reverse Stock Split did not reduce the total number of authorized shares of Common Stock or preferred stock, par value $0.0001 per share (“Preferred Stock”), or change the par values of the Company’s Common Stock or Preferred Stock. All outstanding stock options, warrants, rights to restricted stock awards, convertible debt, and contingent earn-out shares entitling their holders to purchase or receive shares of Common Stock were adjusted as a result of the Reverse Stock Split, in accordance with the terms of each such security. In addition, the number of shares reserved for issuance pursuant to our Amended 2020 Stock Plan was also appropriately adjusted. All historical share and per share data for the periods presented in our condensed consolidated financial statements, including for periods ending prior to July 11, 2024, has been adjusted to reflect the 1-for-20 Reverse Stock Split on a retroactive basis as if the Reverse Stock Split occurred as of the earliest period presented.

Recent Developments of Our Clinical Programs

Amyotrophic Lateral Sclerosis

In December 2024, we announced that we received written guidance from the Division of Neurology 1 (“DN1”) of the U.S. Food and Drug Administration (“FDA”) regarding a potential accelerated approval pathway for CNM-Au8^® in ALS. As announced previously in September 2024, we were initially advised that the data presented in our briefing package for CNM-Au8 was not adequate to support an NDA submission under the accelerated approval pathway. However, following our November 2024 meeting with DN1 and presentation of additional data and analyses, the FDA provided guidance on meeting the regulatory standard for substantial evidence of effectiveness supporting accelerated approval. The FDA recommended three potential paths that could be leveraged to increase the persuasiveness of our data, including the effect of CNM-Au8 on neurofilament light (“NfL”) decline. We intend to follow the FDA’s recommendation to provide data from the HEALEY ALS Platform Trial and our ongoing National Institutes of Health (“NIH”)-sponsored Expanded Access Program (“EAP”) and believe we can address the FDA’s requests. The additional data collection and analyses to support NDA submission is planned to be completed shortly, as summarized below:

●

ACT-EAP NfL biomarker analyses—Provide supportive evidence of NfL declines in participants from our ongoing NIH-sponsored compassionate-use EAP (the “ACT-EAP”). We met with the FDA in the second quarter of 2025 to review our statistical analysis plan for the NfL biomarker analyses, during which the FDA provided constructive feedback on our proposed analyses methodology. NfL change will be analyzed following nine months of treatment (primary NfL analysis) and after six months of treatment (supportive NfL analysis), including several prespecified sub-group analyses. These analyses are planned to provide supportive data of the NfL change demonstrated in the HEALEY ALS Platform Trial double-blind period following six months of treatment with CNM-Au8.

●

Placebo NfL biomarker analyses—Provide an analysis of change from baseline in NfL for original placebo subjects that switched to CNM-Au8 in the open-label extension (“OLE”) of the HEALEY ALS Platform Trial with baseline based on the time the placebo participants initiated treatment with CNM-Au8.

○

Survival pharmacometric modeling—Provide evidence of the magnitude of NfL change and other related disease-specific biomarkers that are associated with clinical survival benefit and clinical outcomes in ALS patients.

●

Additional ALS-specific biomarkers—Provide analyses of additional ALS disease-specific biomarkers to support the effects of CNM-Au8 for treatment of ALS.

The FDA noted that whether NfL or other related disease-specific biomarkers can serve as a reasonably likely surrogate endpoint for the effects of CNM-Au8 in ALS and whether the magnitude of change observed on NfL or other related disease-specific biomarkers in patients treated with CNM-Au8 can reasonably likely predict clinical benefit for ALS would be a matter of review. We recently had a Type C meeting with the FDA to review the long-term survival benefit from CNM-Au8 30 mg treatment compared to concurrently randomized controls from another HEALEY ALS Platform Trial Regimen. The FDA recommended using the evidence of CNM-Au8 30 mg treatment effects on long-term survival as supportive evidence for the clinical meaningfulness of observed NfL or other disease-specific biomarker changes. We plan to continue dialogue with the FDA including presenting additional long-term survival data and biomarker changes with the goal of filing an NDA under an accelerated approval pathway. In addition, the FDA recommended that we conduct further survival analyses comparing Regimen C to other regimens in the HEALEY ALS Platform Trial to strengthen the inference of a survival benefit. Assuming the data from one or more of the FDA potential paths is positive, we plan to submit an NDA in the first quarter of 2026 under an accelerated approval pathway. We also plan to request a Type C meeting with the FDA to review data from these additional biomarker analyses and anticipate this meeting will occur in the first quarter of 2026. Finally, we plan to commence a confirmatory Phase 3 trial, RESTORE-ALS, in the first half of 2026, contingent on funding. The trial is designed to investigate the effects of CNM-Au8 on improved survival (primary endpoint) and delayed time to ALS clinical worsening events (secondary efficacy endpoint).

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Multiple Sclerosis

In September 2025, we announced combined results for REPAIR-MS, an open-label, investigator blinded Phase 2 clinical trial in relapsing MS and non-active progressive MS patients, including the results of the recently-completed second dosing cohort. The primary endpoint was the change in brain NAD+/NADH ratio—a measure of energetic capacity—from baseline to week 12. Participants analyzed for the primary efficacy outcome (all evaluable with post-baseline scans at the week 12 visit) included REPAIR-MS Cohort 1 (relapsing MS, n=11), REPAIR-MS Cohort 2 (non-active progressive MS, n=15), and REPAIR-PD (n=13) in prespecified analyses across the overall population (total n=39). Key findings included:

●

The mean NAD+/NADH ratio in the brain was significantly increased following 12 weeks of treatment with CNM-Au8 in the full REPAIR population (+0.449 units, 95% CI: 0.093 to 0.805, p=0.0148; percent change: 8.65%, 95% CI: 2.6% to 14.7%, p=0.0006).

●

The change in REPAIR-MS participants alone demonstrated consistent increases in the NAD+/NADH ratio to week 12 (+0.480 units, 95% CI: -0.018 to 0.979, p=0.058; percent change: +9.49%, 95% CI: 1.14% to 17.85%, p=0.0275), a measure of how efficiently the brain makes energy.

●

Secondary endpoints: the change in the percent fraction of brain NAD+ and NADH similarly demonstrated statistically significant increases in NAD+ and decreases in NADH for both the full REPAIR population (p=0.0058) and REPAIR-MS (p=0.0232), respectively.

Striking relationships between MS disease activity and brain energy metabolic indices were present at the pre-treatment baseline visit.

●

The Expanded Disability Status Scale (“EDSS”), a global measure of MS disease severity, was significantly associated with the baseline deficits in the NAD+/NADH ratio (Pearson Correlation: ρ=-0.429, p=0.0127).

●

Baseline measures of working memory and cognitive processing speed, measured by the Symbol Digit Modalities Test, were significantly associated with average brain ATP levels (peak signal area average for α-ATP, β-ATP, γ-ATP; Pearson Correlation: ρ=0.542, p=0.0009).

●

Baseline measures of upper extremity function, measured by the 9-Hole Peg Test time (total time across hands), was also significantly associated with average brain ATP levels (peak signal area average for α-ATP, β-ATP, γ-ATP; Pearson Correlation: ρ=-0.513, p=0.0032).

Collectively, these data reinforce the insight that bioenergetic failure in the brain is a key contributor to neurodegeneration and disease progression in MS. By improving brain energy metabolism, CNM-Au8 may help slow progression of disability.

We met with the FDA in a Type B end of Phase 2 meeting during the third quarter of 2025 to review results from the Phase 2 VISIONARY-MS trial and discuss a planned Phase 3 study focusing on cognition improvement as an adjunct to standard-of-care MS therapies, addressing a critical unmet medical need for people struggling with MS. The FDA aligned with Clene acknowledging the limitations of the EDSS and expressed openness to considering other potential primary endpoints, including cognition, to evaluate broader treatment effects. We plan to work closely with regulatory health authorities from the FDA, European Medicines Agency and other international regulatory bodies, MS experts, and patient representatives to determine the proper path to advance CNM-Au8 into Phase 3 and potential future approval.

Parkinson’s Disease

In September 2025, we announced preclinical data showing that CNM-Au8 improved key measures of cellular health in a novel dopaminergic neuron model of PD. The study used skin cells from 8 sporadic PD (“sPD”) patients, 14 familial PD (“fPD”) patients—13 with LRRK2 gene mutations and 1 with a PARK gene mutation—and 13 healthy individuals. The skin cells were directly converted into dopaminergic neurons, the brain cells essential for movement and the most vulnerable to degeneration in PD. This innovative method retains age-related characteristics from PD patient donors, enabling researchers to study disease processes as they occur in aged disease-relevant neurons. Key findings included:

●

Improved mitochondrial health in familial PD—CNM-Au8 increased mitochondrial health (membrane potential) and mitochondrial volume, while reducing harmful reactive oxygen species (“ROS”) in fPD neurons.

●

Reduced inflammation in sporadic PD—CNM-Au8 lowered levels of senescence-related inflammatory proteins, including CD40 and CXCL10, in sPD neurons, helping to reduce neuroinflammation that exacerbates PD progression.

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●

Restored cellular metabolism—CNM-Au8 dose-dependently increased the NAD+/NADH ratio, a measure of cellular energy metabolism. Further, CNM-Au8 corrected the intracellular levels of 36% of metabolites in fPD neurons and 17% in sPD neurons, particularly in the tricarboxylic acid (“TCA”) cycle for energy production and in nucleotide metabolism (e.g., xanthine, inosine) demonstrated by semi-targeted metabolomic analyses.

●

Normalized dysregulated gene expression—CNM-Au8 treatment of PD neurons resulted in a reversal of the global disease-associated gene expression profiles in both sPD and fPD dopaminergic neurons, normalizing the expression of the majority of all top up- and down-regulated PD differentially expressed gene transcripts to near-control levels.

●

Favorable safety profile—CNM-Au8 did not demonstrate evidence of toxicity toward the PD dopaminergic cells at all tested doses, a finding consistent with the clinical observation that CNM-Au8 treatment in humans has over 1,000 patient-years of exposure data in ALS and MS without significant safety concerns.

The chart below reflects the growing body of evidence for CSN therapeutics from our completed and ongoing clinical programs.

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Financial Overview

Our financial condition, results of operations, and the period-to-period comparability of our financial results are principally affected by the following factors:

Research and Development Expense

The discovery and development of novel drug candidates requires a significant investment of resources over a prolonged period of time, and a core part of our strategy is to continue making sustained investments in this area. As a result of this commitment, our pipeline of drug candidates has been advancing, with substantially all our research and development expenses relating to our lead asset, CNM-Au8.

Our research and development expenses are affected by the scope and advancement of our existing product pipeline and the commencement of new drug programs. Drug candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to costs and fees for per patient clinical trial sites for larger clinical trials, opening and monitoring clinical sites, contract research organization (“CRO”) activity, and manufacturing. We anticipate that our research and development expenses will increase in future years if and when we advance our assets into Phase 3. Additionally, if we are able to file an NDA with the FDA under an accelerated approval pathway or subsequent to future Phase 3 clinical development activities, if any, we anticipate that our research and development expenses related to regulatory activities would increase in advance of receiving regulatory approval.

Research and development costs consist primarily of payroll and personnel expenses for salaries, benefits, and stock-based compensation; supplies, materials, and manufacturing expenses to support our clinical trials; payments to CROs, principal investigators, and clinical trial sites; costs of preclinical and nonclinical activities; consulting costs; and allocated overhead costs, including rent, equipment, utilities, depreciation, insurance, maintenance, and information technology. Research and development costs are charged to operations as incurred, and nonrefundable advance payments related to future research and development activities are initially recorded as assets and are expensed when we receive the related goods or services. Grant funding is recognized as a reduction in research and development costs.

Our clinical trial accrual process seeks to account for expenses resulting from obligations under contracts with CROs, consultants, and clinical sites in connection with conducting clinical trials. The financial terms of these contracts vary and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts. We reflect the appropriate clinical trial expenses in the condensed consolidated financial statements by matching the appropriate expenses with the period in which services are performed. In the event advance payments are made to CROs, the payments are recorded as prepaid assets and expensed over the period in which services are performed.

General and Administrative Expense

General and administrative expenses consist primarily of payroll and personnel expenses for salaries, benefits, and stock-based compensation; fees for legal, finance, accounting, tax, and information technology services; insurance costs; expenses for public and investor relations; rent, utilities, depreciation, and other costs related to our facilities.

We anticipate that our general and administrative expenses in future periods will be contingent upon our discussions with the FDA. If we are able to file an NDA with the FDA under an accelerated approval pathway, we anticipate our general and administrative expenses would increase in future periods to support increases in our drug development activities and as we build our commercial capabilities in advance of receiving regulatory approval. This potential increase will likely include increased headcount, increased stock-based compensation expenses, expanded infrastructure including certain sales and marketing activities performed ahead of regulatory approval, and increased insurance expenses. If we are unable to file an NDA with the FDA under an accelerated approval pathway, we would need to continue investing in clinical research activities and we anticipate our general and administrative expenses would decrease in future periods as we decrease commercial manufacturing expansion projects, including at our Elkton, Maryland facility, and as we implement cost-saving initiatives, such as a reduction in compensation, a hiring freeze, and elimination of certain staff positions.

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Total Other Income (Expense), Net

Total other income (expense), net, consists primarily of (i) interest income and interest expense, (ii) changes in the fair value of our common stock warrant liabilities and derivative liabilities, and (iii) research and development tax credits, unrestricted grants, and conditional grants for which applicable conditions have been met.

Results of Operations

Our results of operations for the three and nine months ended September 30, 2025 and 2024 were as follows:

	Three Months Ended September 30,									Nine Months Ended September 30,
(in thousands)	2025			2024			Change			2025			2024			Change
Revenue:
Product revenue	$	—		$	65			*		$	65		$	173			(62	)%
Royalty revenue		15			22			(32	)%		58			78			(26	)%
Total revenue		15			87			(83	)%		123			251			(51	)%
Operating expenses:
Cost of revenue		—			18			*			20			52			(62	)%
Research and development		3,513			4,471			(21	)%		8,508			14,490			(41	)%
General and administrative		2,150			3,413			(37	)%		7,183			10,147			(29	)%
Total operating expenses		5,663			7,902			(28	)%		15,711			24,689			(36	)%
Loss from operations		(5,648	)		(7,815	)		(28	)%		(15,588	)		(24,438	)		(36	)%
Total other income (expense), net		(3,129	)		(171	)		1,730	%		(1,359	)		(1,413	)		(4	)%
Net loss	$	(8,777	)	$	(7,986	)		10	%	$	(16,947	)	$	(25,851	)		(34	)%

Revenue

Product revenue relates to our dietary supplement products and consists of (i) sales of an aqueous zinc-silver ion dietary (mineral) supplement sold by our wholly-owned subsidiary, dOrbital, Inc., under the trade name “rMetx™ ZnAg Immune Boost,” or under a supply agreement with 4Life under the trade name “Zinc Factor™,” and (ii) sales of KHC46, an aqueous gold dietary (mineral) supplement of very low-concentration, sold under a supply agreement with 4Life under the trade name “Gold Factor™.” Royalty revenue relates to our dietary supplement products and consists of proceeds under an exclusive and royalty-bearing license agreement with 4Life relating to the sale of Gold Factor. During the three and nine months ended September 30, 2025 and 2024, changes in product and royalty revenues were due to the timing of purchases and sales of Zinc Factor and Gold Factor by 4Life under the supply and license agreements.

Cost of Revenue

Cost of revenue relates to production and distribution costs for the sales of Gold Factor, Zinc Factor, and rMetx dietary supplements.

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Research and Development Expense

Research and development expense during the three and nine months ended September 30, 2025 and 2024 was as follows:

	Three Months Ended September 30,									Nine Months Ended September 30,
(in thousands)	2025			2024			Change			2025			2024			Change
CNM-Au8:
Amyotrophic lateral sclerosis	$	1,775		$	694			156	%	$	4,586		$	2,074			121	%
Multiple sclerosis		41			178			(77	)%		230			339			(32	)%
Parkinsonʼs disease		—			—			*			—			2			*
Regulatory activities		75			168			(55	)%		335			630			(47	)%
General/pre-clinical/non-clinical		(108	)		(35	)		209	%		(26	)		293			*
CNM-ZnAg		—			4			*			—			17			*
Unallocated:
Facilities		436			411			6	%		1,241			1,193			4	%
Depreciation		337			339			(1	)%		1,012			1,040			(3	)%
Manufacturing		363			226			61	%		633			887			(29	)%
Research		1			46			(98	)%		8			362			(98	)%
Equipment		30			39			(23	)%		58			103			(44	)%
Maintenance		53			47			13	%		117			84			39	%
Information technology		68			43			58	%		187			109			72	%
Other		13			16			(19	)%		117			75			56	%
Personnel		1,945			2,516			(23	)%		6,205			7,725			(20	)%
Stock-based compensation		754			1,062			(29	)%		2,300			2,842			(19	)%
Grant revenue as a reduction of research and development expense		(2,270	)		(1,283	)		77	%		(8,495	)		(3,285	)		159	%
Total research and development	$	3,513		$	4,471			(21	)%	$	8,508		$	14,490			(41	)%

*	Not meaningful.

The change in research and development expenses was primarily due to the following:

(i)

an increase in expenses related to our lead drug candidate, CNM-Au8, primarily due to (A) an increase in expenses related to our ALS clinical programs, including our ACT-EAP due to higher enrollment in the EAP, and an increase in expenses for planning activities for our RESTORE-ALS clinical trial; partially offset by a decrease in expenses related to the HEALEY ALS Platform Trial due to the previous completion of the blinded and open-label extension portions of the trial and a decrease in expenses related to our two other ongoing EAPs with Massachusetts General Hospital, (B) a decrease in expenses related to our MS clinical programs primarily due to a decrease in expenses related to our REPAIR-MS clinical trial due to the conclusion of the second dosing cohort, partially offset by an increase in expenses for our MS EAP which began enrollment in September 2024, (C) a decrease in expenses for regulatory activities primarily driven by lower expenses related to our ongoing FDA discussions and NDA submission-related activities, and (D) a decrease in pre-clinical, non-clinical, and other general CNM-Au8-related expenses primarily due to the renegotiation of a vendor contract upon completion;

(ii)

an increase in unallocated expenses during the three months ended September 30, 2025, primarily due to: (A) an increase in manufacturing expenses to support higher enrollment in our ongoing and expanded EAPs, and (B) a decrease in expenses related to general research activities; and a decrease in unallocated expenses during the nine months ended September 30, 2025, primarily due to: (A) a decrease in manufacturing expenses due to the conclusion of various clinical programs, partially offset by increased manufacturing expenses to support higher enrollment in our ongoing and expanded EAPs, and (B) a decrease in expenses for general research activities with external vendors and consultants, partially offset by (C) an increase in information technology-related expenses;

(iii)

a decrease in personnel expenses, primarily due to cost-saving initiatives and a decrease in expenses for manufacturing personnel due to the conclusion of various clinical programs;

(iv)

a decrease in stock-based compensation expense, primarily due to the timing of award grants, vesting, and forfeitures for research and development personnel; and

(v)

an increase in grant revenue, recorded as a reduction to research and development expense, due to an increase in enrollment and study operations in the ACT-EAP which resulted in higher reimbursable expenses, partially offset by a decrease in grant revenue related to our REPAIR-MS clinical trial due to the conclusion of the second dosing cohort.

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General and Administrative Expense

General and administrative expense during the three and nine months ended September 30, 2025 and 2024 was as follows:

	Three Months Ended September 30,							Nine Months Ended September 30,
(in thousands)	2025		2024		Change			2025		2024		Change
Insurance	$	182	$	188		(3	)%	$	544	$	561		(3	)%
Legal		70		290		(76	)%		393		649		(39	)%
Finance and accounting		270		192		41	%		800		565		42	%
Public and investor relations		63		156		(60	)%

Clene Inc. 10-Q