Quarterly Report for Quarter Ending September 30, 2026 (Form 10-Q)

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 unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report. 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, materials 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, debt holder, and related party. We anticipate this revenue 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.

Recent Developments of Our Clinical Programs

Amyotrophic Lateral Sclerosis

In October 2026, we submitted a new drug application ("NDA") to the U.S. Food and Drug Administration ("FDA") seeking accelerated approval of CNM-Au8^® for the treatment of ALS. The NDA submission is supported by neurofilament light chain ("NfL") biomarker data and clinical outcomes from our Phase 2 HEALEY ALS Platform Trial and its open-label extension, as well as the Phase 2 RESCUE-ALS Trial, and the National Institutes of Health-sponsored expanded access protocol for CNM-Au8. We expect a response from the FDA before the end of 2026 regarding whether it will accept and review our NDA based on the existing regulatory framework. We plan to initiate a Phase 3 RESTORE-ALS trial during the second quarter of 2027, which will serve as the post-approval confirmatory study.

Multiple Sclerosis

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 the Company acknowledging the limitations of the Expanded Disability Status Scale, a global measure of MS disease severity, 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. We also believe that once CNM-Au8 receives regulatory approval in another indication, licensing opportunities for the MS indication will improve.

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

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 Expenses

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 the FDA accepts our NDA for review 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, 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 Expenses

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; and 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 regulatory pathway with the FDA. If the FDA accepts our NDA for review 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 the FDA does not accept our NDA for review, or if our NDA is not approved, 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.

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, (iii) research and development tax credits, unrestricted grants, and conditional grants for which applicable conditions have been met, (iv) issuance costs for common stock warrant liabilities, and (v) losses on initial issuances of equity if the fair value exceeds the proceeds from public equity offerings.

Results of Operations

Our results of operations for the three and nine months ended September 30, 2026 and 2025 were as follows:

		Three Months Ended September 30,												Nine Months Ended September 30,
(in thousands)		2026				2025				Change				2026				2025				Change
Revenue:
Product revenue		$	43			$	-				*			$	118			$	65				82	%
Royalty revenue			13				15				(13	)%			43				58				(26	)%
Total revenue			56				15				273	%			161				123				31	%
Operating expenses:
Cost of revenue			16				-				*				52				20				160	%
Research and development			4,447				3,513				27	%			8,247				8,508				(3	)%
General and administrative			1,940				2,150				(10	)%			5,617				7,183				(22	)%
Total operating expenses			6,403				5,663				13	%			13,916				15,711				(11	)%
Loss from operations			(6,347	)			(5,648	)			12	%			(13,755	)			(15,588	)			(12	)%
Total other income (expense), net			10,262				(3,129	)			*				(3,845	)			(1,359	)			183	%
Net income (loss)		$	3,915			$	(8,777	)			*			$	(17,600	)		$	(16,947	)			4	%

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, 2026 and 2025, changes in product and royalty revenue 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 related to production and distribution costs for the sales of Gold Factor, Zinc Factor, and rMetx dietary supplements.

Research and Development Expenses

Research and development expenses during the three and nine months ended September 30, 2026 and 2025 were as follows:

		Three Months Ended September 30,												Nine Months Ended September 30,
(in thousands)		2026				2025				Change				2026				2025				Change
CNM-Au8:
Amyotrophic lateral sclerosis		$	1,509			$	1,775				(15	)%		$	3,045			$	4,586				(34	)%
Multiple sclerosis			45				41				10	%			152				230				(34	)%
Regulatory activities			483				75				544	%			1,050				335				213	%
General/preclinical/nonclinical			17				(108	)			*				138				(26	)			*
Unallocated:
Facilities			423				436				(3	)%			1,207				1,241				(3	)%
Depreciation			333				337				(1	)%			1,007				1,012				(0	)%
Manufacturing			776				363				114	%			931				633				47	%
Research			3				1				200	%			13				8				63	%
Equipment			40				30				33	%			124				58				114	%
Maintenance			69				53				30	%			118				117				1	%
Information technology			102				68				50	%			245				187				31	%
Other			29				13				123	%			62				117				(47	)%
Personnel			2,201				1,945				13	%			6,412				6,205				3	%
Stock-based compensation			524				754				(31	)%			1,764				2,300				(23	)%
Grant revenue as a reduction of research and development expense			(2,107	)			(2,270	)			(7	)%			(8,021	)			(8,495	)			(6	)%
Total research and development		$	4,447			$	3,513				27	%		$	8,247			$	8,508				(3	)%

*

Not meaningful.

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

(i)

a decrease in expenses related to our lead drug candidate, CNM-Au8, primarily due to (A) a decrease in expenses related to our ALS clinical programs, including a decrease in expenses related to our two ongoing expanded access programs ("EAPs") with Massachusetts General Hospital and our ongoing National Institutes of Health-sponsored compassionate-use EAP (the "ACT-EAP") and a decrease in expenses for planning activities for our RESTORE-ALS clinical trial; (B) a decrease in expenses related to our MS clinical programs during the nine months ended September 30, 2026, primarily due to a decrease in expenses for our REPAIR-MS clinical trial due to conclusion of the second cohort, partially offset by an increase in expenses for our ongoing MS EAP; partially offset by (C) an increase in expenses for regulatory activities, primarily due to our NDA submission-related activities; and (D) an increase in pre-clinical, non-clinical, and other general CNM-Au8-related expenses;

(ii)

an increase in unallocated expenses, primarily due to (A) an increase in manufacturing expenses primarily due to use of gold lots purchased at higher commodity prices to manufacture CNM-Au8, (B) an increase in equipment expenses primarily due to an increase in equipment service contracts, and (C) an increase in information technology expenses primarily related to software licenses, subscriptions, and managed services, partially offset by (D) a decrease in other miscellaneous expenses during the nine months ended September 30, 2026;

(iii)

an increase in personnel expenses, primarily due to non-executive employee salary increases, higher expenses related to our regulatory and NDA submission-related activities, and reinstatement of employee compensation that was previously reduced as part of our cost-saving initiatives;

(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)

a decrease in grant revenue, which is recorded as a reduction to research and development expense, due to a decrease in reimbursable research and development expenses in the ACT-EAP.

General and Administrative Expenses

General and administrative expenses during the three and nine months ended September 30, 2026 and 2025 were as follows:

		Three Months Ended September 30,												Nine Months Ended September 30,
(in thousands)		2026				2025				Change				2026				2025				Change
Insurance		$	158			$	182				(13	)%		$	486			$	544				(11	)%
Legal			37				70				(47	)%			232				393				(41	)%
Finance and accounting			226				270				(16	)%			714				800				(11	)%
Public and investor relations			80				63				27	%			282				293				(4	)%
Facilities			31				29				7	%			94				90				4	%
Depreciation			16				28				(43	)%			50				123				(59	)%
Information technology			38				27				41	%			100				123				(19	)%
Personnel			837				569				47	%			2,254				2,189				3	%
Stock-based compensation			555				949				(42	)%			1,667				2,717				(39	)%
Grant revenue as a reduction of general and administrative expense			(116	)			(130	)			(11	)%			(445	)			(358	)			24	%
Other			78				93				(16	)%			183				269				(32	)%
Total general and administrative		$	1,940			$	2,150				(10	)%		$	5,617			$	7,183				(22	)%

The change in general and administrative expenses was primarily due to the following:

(i)

a decrease in insurance expenses, primarily due to a decrease in fees for clinical trial, product liability, property, casualty, and directors' and officers' insurance;

(ii)

a decrease in legal fees, primarily due to a decrease in legal fees related to financing and fundraising, intellectual property, public company compliance, and other general corporate legal fees;

(iii)

a decrease in finance and accounting expenses, primarily due to a decrease in audit and tax fees and fees for consultants, advisors, and other financial vendors;

(iv)

a decrease in depreciation expense due to certain assets reaching the end of their depreciable life;

(v)

an increase in personnel expenses, primarily due to non-executive employee salary increases and reinstatement of employee compensation that was previously reduced as part of our cost-saving initiatives;

(vi)

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

(vii)

an increase in grant revenue during the nine months ended September 30, 2026, which is recorded as a reduction to general and administrative expense, due to an increase in reimbursable general and administrative expenses in the ACT-EAP; and

(viii)

a decrease in other expenses related to lobbying activities and other miscellaneous expenses.

Total Other Income (Expense), Net

Total other income (expense), net, during the three and nine months ended September 30, 2026 and 2025 was as follows:

		Three Months Ended September 30,												Nine Months Ended September 30,
(in thousands)		2026				2025				Change				2026				2025				Change
Interest income		$	50			$	40				25	%		$	152			$	183				(17	)%
Interest expense			(665	)			(649	)			2	%			(2,151	)			(1,936	)			11	%
Issuance costs for common stock warrant liabilities			-				-				*				(393	)			-				*
Loss on initial issuance of equity			-				-				*				(4,582	)			-				*
Change in fair value of common stock warrant liabilities			7,493				(1,728	)			*				2,301				267				762	%
Change in fair value of derivative liabilities			3,368				(797	)			*				748				(89	)			*
Research and development tax credits and unrestricted grants			16				5				220	%			80				216				(63	)%
Total other income (expense), net		$	10,262			$	(3,129	)			*			$	(3,845	)		$	(1,359	)			183	%

*

Not meaningful.

The change in total other income (expense), net, was primarily due to the following:

(i)

an increase in interest expense primarily due to the senior secured convertible promissory notes issued in August 2025;

(ii)

issuance costs from a public equity offering allocated to liability-classified warrants during the nine months ended September 30, 2026;

(iii)

a loss on initial issuance of equity from the fair value in excess of proceeds from a public equity offering during the nine months ended September 30, 2026;

(iv)

a gain from the changes in fair value of common stock warrant liabilities during the three and nine months ended September 30, 2026 and the nine months ended September 30, 2025, and a loss during the three months ended September 30, 2025. The changes in fair value were due to changes in price of our common stock and updates in valuation model assumptions (see "Critical Accounting Estimates");

(v)

a gain from the change in fair value of the derivative liabilities separated from our senior secured convertible promissory notes during the three and nine months ended September 30, 2026, and a loss during the three and nine months ended September 30, 2025. The changes in fair value were due to changes in price of our common stock and updates in valuation model assumptions (see "Critical Accounting Estimates"); and

(vi)

a decrease in research and development tax credits and unrestricted grants during the nine months ended September 30, 2026, due to the receipt of Maryland tax credits during the nine months ended September 30, 2025, that were not received during the nine months ended September 30, 2026.

Taxation

United States

We are incorporated in the state of Delaware and subject to statutory U.S. federal corporate income tax at a rate of 21.00%. We are also subject to state income tax in Maryland at a rate of 8.25%, and in Utah at a rate of 4.50%. As of September 30, 2026 and December 31, 2025, we recorded a full valuation allowance against our net deferred tax assets due to the uncertainty as to whether such assets will be realized resulting from our three-year cumulative loss position and the uncertainty surrounding our ability to generate pre-tax income in the foreseeable future.

Australia

Our wholly-owned subsidiary, Clene Australia Pty Ltd ("Clene Australia"), was established in Australia in March 2018 and is subject to corporate income tax at a rate of 30.00%. Clene Australia had no taxable income or provision for income taxes for the nine months ended September 30, 2026 and 2025. We recorded other income of $80,000 and $45,000 for the nine months ended September 30, 2026 and 2025, respectively, for research and development tax credits pertaining to Clene Australia for the 2026 and 2025 tax years, respectively.

Netherlands

Our wholly-owned subsidiary, Clene Netherlands B.V. ("Clene Netherlands"), was established in the Netherlands in April 2021 and is subject to corporate income tax at a rate of 19.00% up to €200,000 of taxable income and 25.80% for taxable income in excess of €200,000 for the nine months ended September 30, 2026 and 2025. Clene Netherlands had no taxable income or provision for income taxes for the nine months ended September 30, 2026 and 2025.

Liquidity and Capital Resources

Sources of Capital

We have incurred significant losses and negative cash flows from operations since our inception. We expect to incur additional losses in the future to fund our operations and conduct research and development of our drug candidates. We recognize the need to raise additional capital to fully implement our business plan. The long-term continuation of our business plan is dependent upon the generation of sufficient revenue from our products to offset expenses and capital expenditures. In the event that we do not generate sufficient revenue and are unable to obtain funding, we will be forced to delay, reduce, or eliminate some or all of our research and development programs, product portfolio expansion, commercialization efforts, or capital expenditures, which could adversely affect our business prospects, ability to meet long-term liquidity needs, or we may be unable to continue operations.

Since our inception, we have dedicated substantially all our resources to the development of our drug candidates. We have financed our operations principally through the following sources:

●

gross proceeds of $214.4 million from equity financing, including sales of common stock, preferred stock, common stock warrants, and pre-funded common stock warrants;

●

gross proceeds of $71.1 million from borrowings under notes payable, convertible notes payable, and convertible promissory notes;

●

gross proceeds of $9.4 million from our reverse recapitalization whereby we became a public company;

●

gross proceeds of $10.2 million from refundable research and development tax credits;

●

gross proceeds of $22.0 million from grants from various organizations; and

●

gross proceeds of $1.1 million from stock option and warrant exercises.

We also received indirect financial support for the HEALEY ALS Platform Trial, administered by Massachusetts General Hospital, which conducted an ALS platform trial of CNM-Au8 alongside multiple other drug candidates, at significantly lower costs than we would have otherwise incurred if we had conducted a comparably designed clinical trial at reasonable market rates.

Going Concern

We incurred a loss from operations of $6.3 million and $5.6 million for the three months ended September 30, 2026 and 2025, respectively; and $13.8 million and $15.6 million for the nine months ended September 30, 2026 and 2025, respectively. Our accumulated deficit was $325.9 million and $308.3 million as of September 30, 2026 and December 31, 2025, respectively. Our cash and cash equivalents totaled $9.9 million and $5.2 million as of September 30, 2026 and December 31, 2025, respectively, and net cash used in operating activities was $11.7 million and $13.7 million for the nine months ended September 30, 2026 and 2025, respectively.

We have incurred significant losses and negative cash flows from operations since our inception. We have not generated significant revenue since our inception, and we do not anticipate generating significant revenue 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 to the condensed consolidated financial statements). 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 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, 2026, we sold 216,161 shares of our common stock, generated gross proceeds of $1.0 million, and paid commissions of $15,000 pursuant to our at-the-market offering program; and during the three and nine months ended September 30, 2026, we raised $4.0 million and $17.0 million, respectively, of gross proceeds from registered direct offerings of equity securities (see Note 13 to the condensed consolidated financial statements). While we have implemented cost-saving initiatives, including delaying and reducing certain research and development programs and commercialization efforts and eliminating 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 contained in this report are issued.

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

Short-Term Material Cash Requirements

For at least the next twelve months, our primary capital requirements are to fund our operations, including (i) research and development costs for personnel, ongoing and potential future clinical studies, regulatory activities, pre-commercial activities in advance of receiving regulatory approval for our drug candidates, costs for commercial activities if our NDA is approved by the FDA, and other costs related to the development of our lead drug candidate, CNM-Au8; (ii) general and administrative costs to support our drug development and commercialization efforts; and (iii) principal and interest payments on our notes payable and convertible notes payable. Firm commitments for funds include approximately $1.1 million of payments under operating lease obligations, payment of principal and interest on notes payable and convertible notes payable totaling $15.4 million, and a commitment for capital expenditures totaling $1.6 million related to the construction of our manufacturing facilities. We expect to meet our short-term liquidity requirements primarily through cash on hand plus equity financing, debt financing, or other capital sources. However, there can be no assurance that we will be able to secure such financing on favorable terms, or at all.

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.

Long-Term Material Cash Requirements

Beyond the next twelve months, our primary capital requirements are to fund our operations, including (i) research and development costs for personnel, ongoing and potential future clinical studies, regulatory activities, pre-commercial activities in advance of receiving regulatory approval for our drug candidates, costs for commercial activities if our NDA is approved by the FDA, and other costs related to the development of our lead drug candidate, CNM-Au8; (ii) general and administrative costs to support our drug development and commercialization efforts; and (iii) principal and interest payments on our notes payable and convertible notes payable. Additional funds may be spent to initiate new clinical trials, at our discretion. Known obligations beyond the next twelve months include $3.1 million of payments under operating lease obligations, and interest and principal repayment of notes payable and convertible notes payable of $6.4 million. We expect to meet our long-term liquidity requirements primarily through equity financing, debt financing, or other capital sources. However, there can be no assurance that we will be able to secure such financing on favorable terms, or at all.

Use of Funds

Our cash flows for the nine months ended September 30, 2026 and 2025 were as follows:

		Nine Months Ended September 30,
(in thousands)		2026				2025
Net cash used in operating activities		$	(11,733	)		$	(13,747	)
Net cash used in investing activities			(52	)			(11	)
Net cash provided by financing activities			16,428				9,448
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash			55				80
Net increase (decrease) in cash, cash equivalents and restricted cash		$	4,698			$	(4,230	)

Our primary use of cash in all periods presented was to fund our research and development, regulatory and other clinical trial costs, and general corporate expenditures.

Operating Activities

Net cash used in operating activities was $11.7 million for the nine months ended September 30, 2026, which resulted from a net loss of $17.6 million, adjusted for non-cash items totaling $8.8 million and a net change in operating assets and liabilities of $2.9 million. Significant non-cash items included: (i) depreciation expense of $1.1 million related to laboratory and office equipment and leasehold improvements, (ii) non-cash lease expense of $0.5 million, (iii) stock-based compensation expense of $3.4 million, (iv) accretion of debt discount of $0.7 million, (v) non-cash interest expense on notes payable of $1.2 million, (vi) issuance costs for common stock warrant liabilities of $0.4 million, (vii) a loss on initial issuance of equity from the fair value in excess of proceeds from a public equity offering of $4.6 million, (viii) a change in fair value of our common stock warrant liabilities of $2.3 million due to changes in the price of our common stock and changes in valuation model inputs, and (ix) a change in fair value of our derivative liabilities of $0.7 million due to changes in the price of our common stock and changes in valuation model inputs. The net change in operating assets and liabilities was primarily attributable to: (i) an increase in accounts receivable of $43,000 due to the timing of sales and customer payments and a decrease in accounts payable of $30,000 due to the timing of vendor invoicing and payments, (ii) an increase in prepaid expenses and other current assets of $0.8 million due to (A) the timing of vendor invoicing and payments, (B) an increase in grants receivable related to ACT-EAP reimbursements, (C) an increase in prepaid clinical and CRO expenses related to the ACT-EAP, and (D) an increase in miscellaneous prepaids and other current assets, partially offset by (E) a decrease in metals to be used in research and development due to the timing of invoicing, payments, and deliveries from our supplier, and changes in the commodity price of gold during reprocessing by our supplier compared to the original purchase price, and (F) a decrease in research and development tax credits receivable due to the timing of refund payments, (iii) a decrease in accrued liabilities of $1.4 million primarily due to (A) a decrease in accrued compensation and benefits resulting from payments of deferred employee bonuses in cash and equity and (B) a decrease in deferred grants due to satisfaction of grant conditions or performance obligations, partially offset by (C) an increase in other miscellaneous accrued liabilities primarily due to accrued CRO and clinical fees related to our ongoing clinical programs, and (iv) a decrease in operating lease obligations of $0.7 million.

Net cash used in operating activities was $13.7 million for the nine months ended September 30, 2025, which resulted from a net loss of $16.9 million, adjusted for non-cash items totaling $7.4 million and a net change in operating assets and liabilities of $4.2 million. Significant non-cash items included: (i) depreciation expense of $1.1 million related to laboratory and office equipment and leasehold improvements, (ii) non-cash lease expense of $0.4 million, (iii) stock-based compensation expense of $5.0 million, (iv) accretion of debt discount of $0.7 million, (v) non-cash interest expense on notes payable of $0.2 million, (vi) a change in fair value of our common stock warrant liabilities of $0.3 million due to changes in the price of our common stock and changes in valuation model inputs, and (vii) a change in fair value of the our derivative liabilities of $0.1 million due to changes in the price of our common stock and changes in valuation model inputs. The net change in operating assets and liabilities was primarily attributable to: (i) a decrease in accounts receivable of $0.1 million and an increase in accounts payable of $0.1 million due to the timing of invoicing and payments, (ii) an increase in prepaid expenses and other current assets of $0.8 million due to (A) the timing of vendor invoicing and payments, (B) the timing of receipt of metals to be used in research and development, and (C) an increase in research and development tax credits receivable, partially offset by (D) a decrease in prepaid clinical and CRO expenses related to the ACT-EAP, (iii) a decrease in accrued liabilities of $2.8 million primarily due to (I) a decrease in deferred grants, (II) a decrease in accrued CRO and clinical fees, and (III) a decrease in other miscellaneous accrued liabilities, and (iv) a decrease in operating lease obligations of $0.8 million.

Investing Activities

Net cash used in investing activities for the nine months ended September 30, 2026 and 2025 consisted of purchases of property and equipment of $52,000 and $11,000, respectively.

Financing Activities

Net cash provided by financing activities was $16.4 million for the nine months ended September 30, 2026, which consisted of proceeds from the issuance of common stock and warrants, net of offering costs, of $16.7 million, partially offset by payments of notes payable of $0.3 million. Net cash provided by financing activities was $9.4 million for the nine months ended September 30, 2025, which consisted of proceeds from the issuance of common stock of $8.2 million and proceeds from the issuance of debt and derivative instruments of $1.5 million, partially offset by payments of notes payable of $0.3 million.

Public Offerings

In January 2026, pursuant to a placement agency agreement with BTIG, LLC ("BTIG"), we sold 928,333 shares of our common stock, warrants to purchase up to 1,114,000 shares of our common stock (the "Series A Warrants"), and warrants to purchase up to 2,599,333 shares of our common stock (the "Series B Warrants"). The aggregate gross proceeds were approximately $6.0 million, of which $0.3 million was contributed by certain of our directors and their affiliated entities, excluding the proceeds, of any, from the exercise of the Series A Warrants and Series B Warrants and before deducting placement agent fees and expenses and other expenses payable by us. We paid placement agent fees of $0.4 million and other offering expenses of $0.3 million. The offering was made pursuant to our registration statement on Form S-3 (file number 333-286058), declared effective on April 25, 2025 (the "2025 S-3"), and a related prospectus supplement.

In May 2026, pursuant to an underwriting agreement with Canaccord Genuity LLC ("Canaccord"), we sold 1,000,000 shares of our common stock at an offering price of $7.00 per share. The aggregate gross proceeds were $7.0 million. We paid underwriting discounts and commissions of $0.5 million and other offering expenses of $0.1 million. The offering was made pursuant to our 2025 S-3 and a prospectus supplement related to the offering.

In September 2026, we sold 1,219,513 shares of our common stock at an offering price of $3.28 per share. The aggregate gross proceeds were $4.0 million, of which $2.1 million was contributed by certain of our directors and officers. We completed the offering without a placement agent, underwriter, broker, or dealer, and we paid an insignificant amount of offering expenses. The offering was made pursuant to our 2025 S-3 and a prospectus supplement related to the offering.

During the three and nine months ended September 30, 2026, we sold 216,161 shares of our common stock under our at-the-market offering program (the "ATM") with Canaccord, generated gross proceeds of $1.0 million, and paid commissions of $15,000. During the three and nine months ended September 30, 2025, we sold 757,875 and 2,095,070 shares of our common stock, respectively, generated gross proceeds of $3.3 million and $8.4 million, respectively, and paid commissions of $50,000 and $0.1 million, respectively. The issuance and sale of common stock by us under the ATM through April 25, 2025 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, which expired on April 26, 2025, with all subsequent sales made pursuant to the 2025 S-3 and a related prospectus supplement.

Critical Accounting Estimates

Our discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. Generally Accepted Accounting Principles. The preparation of these condensed consolidated financial statements requires us to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, revenues, costs, and expenses. We evaluate our estimates and judgments on an ongoing basis, and our actual results may differ from these estimates. We base our estimates on historical experience, known trends and events, contractual milestones, and other various factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

We consider the following estimates to be critical as they involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition and results of operations.

Convertible Notes

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, we classified the 2022 DHCD Loan as convertible notes payable in the condensed consolidated balance sheets and did not separate the conversion option from the host contract as it did not meet the requirements for accounting as a derivative instrument. We account for the convertible note as a single liability measured at its amortized cost as of September 30, 2026 and December 31, 2025, with a carrying value of $5.3 million and $5.3 million, respectively.

We classified a portion of the senior secured convertible promissory notes (the "SSCP Notes") as convertible notes payable in the consolidated balance sheets and separated three features from the host contract as derivative instruments measured at fair value: (i) the conversion option (the "SSCPN Conversion Feature"), (ii) the redemption option upon a change of control or any bankruptcy, liquidation, or other restructuring process consisting of a cash payment equal to 115% of the outstanding principal (the "SSCPN Redemption Feature"), and (iii) the acceleration option plus a penalty equal to 10% of all outstanding principal and accrued and unpaid interest upon the occurrence and continuation of certain events of default (the "SSCPN Default Feature," collectively with the SSCPN Conversion Feature and SSCPN Redemption Feature, the "SSCPN Derivative Liabilities"). We accounted for the remainder of the SSCP Notes as liabilities measured at their amortized cost, with carrying values of (i) $10.9 million and $9.3 million for the 2024 SSCP Notes as of September 30, 2026 and December 31, 2025, respectively, and (ii) $1.6 million and $1.4 million for the 2025 SSCP Notes as of September 30, 2026 and December 31, 2025, respectively.

We remeasure the SSCPN Derivative Liabilities at each reporting date and record the change in fair value as a component of other income (expense), net in the condensed consolidated statements of operations and comprehensive income (loss). The change in fair value of the SSCPN Derivative Liabilities resulted in a gain of $3.4 million and a loss of $0.8 million during the three months ended September 30, 2026 and 2025, respectively; and a gain of $0.7 million and a loss of $0.1 million during the nine months ended September 30, 2026 and 2025, respectively. 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 (i) a change of control transaction, (ii) default of the Company, or (iii) held to maturity. These estimates require significant judgment. The unobservable valuation inputs were as follows:

		September 30,				May 18,				May 18,				May 11,				May 11,				December 31,
		2026				2026(1)				2026(2)				2026(3)				2026(4)				2025
Expected stock price volatility			93.40	%			113.30	%			120.50	%			112.60	%			120.40	%			107.30	%
Discount rate			23.00	%			20.00	%			20.00	%			20.00	%			20.00	%			19.00	%
Risk-free interest rate			4.50	%			3.90	%			3.70% - 3.80	%			3.80	%			3.70% - 3.80	%			3.50% - 3.60	%
Expected dividend yield			0.00	%			0.00	%			0.00	%			0.00	%			0.00	%			0.00	%
Expected term (in years)			0.29 - 0.87				0.41 - 1.24				0.32 - 0.74				0.43 - 1.26				0.34 - 0.76				0.38 - 1.12
Probability of change of control			30.00	%			30.00	%			5.00	%			30.00	%			5.00	%			20.00	%
Probability of default			5.00	%			5.00	%			5.00	%			5.00	%			5.00	%			35.00	%
Probability of held to maturity			65.00	%			65.00	%			90.00	%			65.00	%			90.00	%			45.00	%

(1)

Represents the unobservable inputs to the valuation of the SSCPN Derivative Liabilities related to the 2025 SSCP Notes immediately following an amendment in May 2026.

(2)

Represents the unobservable inputs to the valuation of the SSCPN Derivative Liabilities related to the 2025 SSCP Notes immediately preceding an amendment in May 2026.

(3)

Represents the unobservable inputs to the valuation of the SSCPN Derivative Liabilities related to the 2024 SSCP Notes immediately following an amendment in May 2026.

(4)

Represents the unobservable inputs to the valuation of the SSCPN Derivative Liabilities related to the 2024 SSCP Notes immediately preceding an amendment in May 2026.

Common Stock Warrant Liabilities

In accordance with ASC 815, we recognized the below common stock warrants as derivative liabilities measured at fair value and will remeasure them at each reporting date and record the change in fair value as a component of other income (expense), net, in the condensed consolidated statements of operations and comprehensive income (loss).

Pursuant to a loan with Avenue Venture Opportunities Fund, L.P. ("Avenue"), which we repaid in 2024, we issued a warrant to purchase 150,000 shares of our common stock at $4.6014 per share (the "2023 Avenue Warrant"). The change in fair value of the 2023 Avenue Warrant resulted in a gain of $0.2 million and a loss of $0.1 million during the three months ended September 30, 2026 and 2025, respectively; and a gain of $0.1 million and a gain of $4,000 during the nine months ended September 30, 2026 and 2025, respectively. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of (i) settlement of the instrument upon a change of control transaction, (ii) dissolution of the Company, or (iii) held to expiration. These estimates require significant judgment. The unobservable valuation inputs were as follows:

Pursuant to an underwritten public offering in June 2023, we issued warrants to purchase 2,500,000 shares of our common stock at $22.00 per share (the "Tranche A Warrants"). The Tranche A Warrants expired unexercised in June 2026. The change in fair value prior to the expiration of the Tranche A Warrants resulted in a loss of $0.1 million during the three months ended September 30, 2025, and a gain of $0.4 million and a gain of $0.5 million during the nine months ended September 30, 2026 and 2025, respectively. We estimated the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of (i) acceptance of an NDA by the FDA for CNM-Au8, (ii) settlement upon a fundamental transaction, (iii) dissolution of the Company, and (iv) held to expiration. These estimates required significant judgment. The unobservable valuation inputs were as follows:

		December 31,
		2025
Expected stock price volatility			124.00	%
Risk-free interest rate			3.60	%
Expected dividend yield			0.00	%
Expected term (in years)			0.46
Probability of NDA acceptance before warrant expiration			0.00	%
Probability of fundamental transaction before warrant expiration			0.00	%
Probability of dissolution before warrant expiration			35.00	%
Probability of held to expiration			65.00	%

Pursuant to a registered direct public offering in October 2024, we issued warrants to purchase 1,546,914 shares of our common stock at $4.82 per share (the "2024 Common Warrants"). The change in fair value of the 2024 Common Warrants resulted in a gain of $1.9 million and a loss of $1.5 million during the three months ended September 30, 2026 and 2025, respectively; and a gain of $1.6 million and a loss of $0.2 million during the nine months ended September 30, 2026 and 2025, respectively. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of (i) dissolution of the Company and (ii) held to maturity. These estimates require significant judgment. The unobservable valuation inputs were as follows:

		September 30,				December 31,
		2026				2025
Expected stock price volatility			104.20	%			104.30	%
Risk-free interest rate			5.00	%			3.60	%
Expected dividend yield			0.00	%			0.00	%
Expected term (in years)			3.00				3.75
Probability of dissolution			30.00	%			35.00	%
Probability of held to expiration			70.00	%			65.00	%

Pursuant to a registered direct public offering in January 2026, we issued Series A Warrants to purchase 1,114,000 shares of our common stock at $6.00 per share. The exercise price of the Series A Warrants will increase to $7.00 per share if (i) the Series A Warrant is exercised prior to our public announcement of the FDA's posted action date under the Prescription Drug User Fee Act for our NDA for CNM-Au8 (the "Series A Trigger Announcement"), or (ii) the volume weighted average price ("VWAP") of our common stock equals or exceeds $10.00 on the Series A Price Measurement Date, as defined below. The "Series A Price Measurement Date" means (A) the trading day on which the Series A Trigger Announcement is made, if such announcement is made prior to 9:00 a.m. (New York City time) on such trading day, or (B) the first trading day immediately following the day on which the Series A Trigger Announcement is made, if such announcement is made at or after 9:01 a.m. (New York City time) on a trading day or on a day that is not a trading day.

The change in fair value of the Series A Warrants resulted in a gain of $1.1 million and a gain of $0.3 million during the three and nine months ended September 30, 2026. We estimate the fair value using a Monte Carlo simulation with estimates for (i) the probability of the Series A Trigger Announcement, (ii) the expected stock price increase if the Series A Trigger Announcement occurs, and (iii) the expected stock price decrease if the Series A Trigger Announcement does not occur. These estimates require significant judgment. The unobservable valuation inputs were as follows:

		September 30,				January 13,
		2026				2026
Expected stock price volatility			101.30	%			107.30	%
Risk-free interest rate			4.93	%			3.68	%
Expected term (in years)			0.25 - 2.29				0.46 - 3.00
Probability of Series A Trigger Announcement			50.00	%			35.00	%
Expected stock price increase if Series A Trigger Announcement occurs			35.00	%			35.00	%
Expected stock price decrease if Series A Trigger Announcement does not occur			85.00	%			85.00	%

Pursuant to a registered direct public offering in January 2026, we issued Series B Warrants to purchase 2,599,333 shares of our common stock at $6.00 per share. The exercise price of the Series B Warrants will increase to (i) $10.00 per share if the VWAP of our common stock equals or exceeds $20.00 on the Series B Price Measurement Date, or (ii) $12.50 per share if (A) the VWAP of our common stock equals or exceeds $25.00 on the Series B Price Measurement Date, or (B) the Series B Warrant is exercised prior to our public announcement of receipt of written approval from the FDA of our NDA for CNM-Au8 in ALS, which announcement shall be made promptly after receipt of such approval (the "Series B Trigger Announcement"). The "Series B Price Measurement Date" means (A) the trading day on which the Series B Trigger Announcement is made, if such announcement is made prior to 9:00 a.m. (New York City time) on such trading day, or (B) the first trading day immediately following the day on which the Series B Trigger Announcement is made, if such announcement is made at or after 9:01 a.m. (New York City time) on a trading day or on a day that is not a trading day.

The change in fair value of the Series B Warrants resulted in a gain of $4.2 million and a loss of $0.1 million during the three and nine months ended September 30, 2026. We estimate the fair value using a Monte Carlo simulation with estimates for (i) the probability of the Series B Trigger Announcement (ii) the expected stock price increase if the Series B Trigger Announcement occurs, and (iii) the expected stock price decrease if the Series B Trigger Announcement does not occur. These estimates require significant judgment. The unobservable valuation inputs were as follows:

		September 30,				January 13,
		2026				2026
Expected stock price volatility			101.30	%			107.30	%
Risk-free interest rate			4.93	%			3.68	%
Expected term (in years)			0.75 - 4.29				0.96 - 5.00
Probability of Series B Trigger Announcement			35.00	%			24.00	%
Expected stock price increase if Series B Trigger Announcement occurs			100.00	%			100.00	%
Expected stock price decrease if Series B Trigger Announcement does not occur			95.00	%			95.00	%

Income Taxes

We record uncertain tax positions in accordance with ASC 740, Income Taxes, on the basis of a two-step process to (i) determine whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position, and (ii) for those tax positions that meet the more-likely-than-not recognition threshold, we recognize the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. We recognize deferred tax assets to the extent we believe these assets are more likely than not to be realized. In making such a determination, we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and recent results of operations. If we determine that we would be able to realize any deferred tax assets in the future in excess of their net recorded amount, we would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The estimation of these factors requires significant judgment. Based on our evaluation of these factors, we have not recorded income tax benefits for the net operating losses or for research and development tax credits or other deferred tax assets due to uncertainty of realizing benefits from these items.

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. The fair value is recognized over the period during which a grantee was 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 will 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 elect to account for forfeitures as they occur, rather than estimating expected forfeitures.

We estimate the fair value of stock options using a Black-Scholes option-pricing model, which requires significant judgment. The unobservable valuation inputs were as follows: