Clene Inc.

Previous wording

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. 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.*

Current wording

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.*

Previous wording

The planned NDA submission will be supported by NfL biomarker and clinical data from the 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. Supporting data include reductions in plasma NfL associated with longer survival in the open-label extension and additional clinical outcomes. CNM-Au8 has previously received Orphan Drug Designation from the FDA for the treatment of ALS. We plan to initiate our Phase 3 RESTORE-ALS trial during the first quarter of 2027 and serving as the post-approval confirmatory study.

Current wording

We intend to submit our NDA in early fourth quarter of 2026, which will remain a matter of FDA review. The planned NDA submission will be supported by NfL biomarker and clinical data from the 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 plan to initiate a Phase 3 RESTORE-ALS trial during the second quarter of 2027, which will serve as the post-approval confirmatory study.

Previous wording

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 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.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

Our results of operations for the three months ended March 31, 2026 and 2025 were as follows:

Current wording

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

Previous wording

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 months ended March 31, 2026 and 2025, changes in product and royalty revenue was due to the timing of purchases and sales of Zinc Factor and Gold Factor by 4Life under the supply and license agreements.

Current wording

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 six months ended June 30, 2026 and 2025, changes in product and royalty revenue was due to the timing of purchases and sales of Zinc Factor and Gold Factor by 4Life under the supply and license agreements.

Previous wording

Research and development expenses during the three months ended March 31, 2026 and 2025 was as follows:

Current wording

Research and development expenses during the three and six months ended June 30, 2026 and 2025 was as follows:

Previous wording

General and administrative expenses during the three months ended March 31, 2026 and 2025 were as follows:

Current wording

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

Previous wording

Total other income (expense), net, during the three months ended March 31, 2026 and 2025 was as follows:

Current wording

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

Previous wording

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 three months ended March 31, 2026 and 2025. We recorded other income of $36,000 and $24,000 for the three months ended March 31, 2026 and 2025, respectively, for research and development tax credits pertaining to Clene Australia for the 2026 and 2025 tax years, respectively.

Current wording

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 six months ended June 30, 2026 and 2025. We recorded other income of $64,000 and $40,000 for the six months ended June 30, 2026 and 2025, respectively, for research and development tax credits pertaining to Clene Australia for the 2026 and 2025 tax years, respectively.

Previous wording

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 three months ended March 31, 2026 and 2025. Clene Netherlands had no taxable income or provision for income taxes for the three months ended March 31, 2026 and 2025.

Current wording

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 six months ended June 30, 2026 and 2025. Clene Netherlands had no taxable income or provision for income taxes for the six months ended June 30, 2026 and 2025.

Previous wording

We incurred a loss from operations of $2.1 million and $4.1 million for the three months ended March 31, 2026 and 2025, respectively. Our accumulated deficit was $316.4 million and $308.3 million as of March 31, 2026 and December 31, 2025, respectively. Our cash and cash equivalents totaled $5.9 million and $5.2 million as of March 31, 2026 and December 31, 2025, respectively, and net cash used in operating activities was $4.5 million and $5.0 million for the three months ended March 31, 2026 and 2025, respectively.

Current wording

We incurred a loss from operations of $5.3 million and $5.9 million for the three months ended June 30, 2026 and 2025, respectively; and $7.4 million and $9.9 million for the six months ended June 30, 2026 and 2025, respectively. Our accumulated deficit was $329.8 million and $308.3 million as of June 30, 2026 and December 31, 2025, respectively. Our cash and cash equivalents totaled $9.7 million and $5.2 million as of June 30, 2026 and December 31, 2025, respectively, and net cash used in operating activities was $7.1 million and $9.8 million for the six months ended June 30, 2026 and 2025, respectively.

Previous wording

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 months ended March 31, 2026, we raised $6.0 million of gross proceeds from a registered direct offering of equity securities (see Note 13 to the condensed consolidated financial statements), and subsequent to March 31, 2026, we raised $7.0 million of gross proceeds from a registered direct offering of equity securities (see Note 17 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, reducing employee compensation, 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 are issued.

Current wording

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 six months ended June 30, 2026, we raised $7.0 million and $13.0 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, reducing employee compensation, 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.

Previous wording

For at least the next twelve months, our primary capital requirements are to fund our operations, including research and development, personnel, regulatory, and other clinical trial costs related to development of our lead drug candidate, CNM-Au8; general and administrative costs to support our drug development and pre-commercial activities in advance of receiving regulatory approval for our drug candidates; and 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 $2.5 million, and a commitment for capital expenditures totaling $0.2 million related to the construction of our manufacturing facilities. We expect to meet our short-term liquidity requirements primarily through cash on hand. Additional sources of funds include equity financing, debt financing, or other capital sources.

Current wording

For at least the next twelve months, our primary capital requirements are to fund our operations, including research and development, personnel, regulatory, and other clinical trial costs related to development of our lead drug candidate, CNM-Au8; general and administrative costs to support our drug development and pre-commercial activities in advance of receiving regulatory approval for our drug candidates; and 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 $0.7 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. Additional sources of funds include 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.

Previous wording

Beyond the next twelve months, our primary capital requirements are to fund our operations, including research and development, personnel, regulatory, and other clinical trial costs related to development of our lead drug candidate, CNM-Au8; general and administrative costs to support our drug development activities in advance of receiving regulatory approval for our drug candidates; and 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 $3.6 million of payments under operating lease obligations, and interest and principal repayment of notes payable and convertible notes payable of $18.6 million. We expect to meet our long-term liquidity requirements primarily through equity financing, debt financing, or other capital sources.

Current wording

Beyond the next twelve months, our primary capital requirements are to fund our operations, including research and development, personnel, regulatory, and other clinical trial costs related to development of our lead drug candidate, CNM-Au8; general and administrative costs to support our drug development activities in advance of receiving regulatory approval for our drug candidates; and 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 $3.4 million of payments under operating lease obligations, and interest and principal repayment of notes payable and convertible notes payable of $21.2 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.

Previous wording

Our cash flows for the three months ended March 31, 2026 and 2025 were as follows:

Current wording

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

Previous wording

Net cash used in operating activities was $4.5 million for the three months ended March 31, 2026, which resulted from a net loss of $8.1 million, adjusted for non-cash items totaling $7.8 million and a net change in operating assets and liabilities of $4.3 million. Significant non-cash items included: (i) depreciation expense of $0.4 million related to laboratory and office equipment and leasehold improvements, (ii) non-cash lease expense of $0.2 million, (iii) stock-based compensation expense of $1.3 million, (iv) accretion of debt discount of $0.3 million, (v) non-cash interest expense on notes payable of $0.4 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 $1.1 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 payable of $0.4 million due to the timing of vendor invoicing and payments, (ii) an increase in prepaid expenses and other current assets of $3.3 million due to (A) the timing of vendor invoicing and payments, (B) an increase 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 (C) an increase in grants receivable related to ACT-EAP reimbursements, partially offset by (D) a decrease in research and development tax credits receivable due to the timing of refund payments, and (E) a decrease in miscellaneous prepaids and other current assets, (iii) a decrease in accrued liabilities of $1.2 million primarily due to (A) a decrease in accrued compensation and benefits resulting from payments of deferred employee bonuses in cash and equity and 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, and (iv) a decrease in operating lease obligations of $0.2 million.

Current wording

Net cash used in operating activities was $7.1 million for the six months ended June 30, 2026, which resulted from a net loss of $21.5 million, adjusted for non-cash items totaling $17.5 million and a net change in operating assets and liabilities of $3.1 million. Significant non-cash items included: (i) depreciation expense of $0.7 million related to laboratory and office equipment and leasehold improvements, (ii) non-cash lease expense of $0.3 million, (iii) stock-based compensation expense of $2.4 million, (iv) accretion of debt discount of $0.5 million, (v) non-cash interest expense on notes payable of $0.8 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 $5.2 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 $2.6 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 and an increase in accounts payable of $0.3 million due to the timing of vendor invoicing and payments, (ii) an increase in prepaid expenses and other current assets of $1.4 million due to (A) the timing of vendor invoicing and payments, (B) an increase 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, (C) an increase in grants receivable related to ACT-EAP reimbursements, and (D) an increase in prepaid clinical and CRO expenses related to the ACT-EAP, partially offset by (E) a decrease in research and development tax credits receivable due to the timing of refund payments, and (F) a decrease in miscellaneous prepaids and other current assets, (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, (B) a decrease in deferred grants due to satisfaction of grant conditions or performance obligations, and (C) a decrease in other miscellaneous accrued liabilities, partially offset by (D) an increase in accrued CRO and clinical fees related to our ongoing clinical programs, and (iv) a decrease in operating lease obligations of $0.4 million.

Previous wording

Net cash used in operating activities was $5.0 million for the three months ended March 31, 2025, which resulted from a net loss of $0.8 million, adjusted for non-cash items totaling $0.9 million and a net change in operating assets and liabilities of $3.3 million. Significant non-cash items included: (i) depreciation expense of $0.4 million related to laboratory and office equipment and leasehold improvements, (ii) non-cash lease expense of $0.1 million, (iii) stock-based compensation expense of $1.9 million, (iv) accretion of debt discount of $0.2 million, (v) non-cash interest expense on notes payable of $12,000, (vi) a change in fair value of our common stock warrant liabilities of $2.5 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 $1.1 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 $0.2 million due to the timing of vendor invoicing and payments, (ii) a decrease in inventory of $30,000 (iii) an increase in prepaid expenses and other current assets of $0.9 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, (C) an increase in prepaid ACT-EAP expenses, and (D) an increase in research and development tax credits receivable, (iv) a decrease in accrued liabilities of $2.5 million primarily due to (A) a decrease in deferred grants, (B) a decrease in accrued CRO and clinical fees, and (C) a decrease in other miscellaneous accrued liabilities, partially offset by (D) an increase in accrued compensation and benefits, and (v) a decrease in operating lease obligations of $0.2 million.

Current wording

Net cash used in operating activities was $9.8 million for the six months ended June 30, 2025, which resulted from a net loss of $8.2 million, adjusted for non-cash items totaling $2.2 million and a net change in operating assets and liabilities of $3.8 million. Significant non-cash items included: (i) depreciation expense of $0.8 million related to laboratory and office equipment and leasehold improvements, (ii) non-cash lease expense of $0.3 million, (iii) stock-based compensation expense of $3.3 million, (iv) accretion of debt discount of $0.5 million, (v) non-cash interest expense on notes payable of $24,000, (vi) a change in fair value of our common stock warrant liabilities of $2.0 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 $0.7 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) a decrease in accounts receivable of $0.1 million and a decrease in accounts payable of $0.4 million 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) 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 $2.3 million primarily due to (A) a decrease in deferred grants, and (B) a decrease in other miscellaneous accrued liabilities, partially offset by (C) an increase in accrued compensation and benefits, and (iv) a decrease in operating lease obligations of $0.3 million.

Previous wording

We had no net cash provided by or used in investing activities during the three months ended March 31, 2026 and 2025.

Current wording

Net cash used in investing activities for the six months ended June 30, 2026 consisted of purchases of property and equipment of $1,000. We had no net cash provided by or used in investing activities during the six months ended June 30, 2025.

Previous wording

Net cash provided by financing activities was $5.2 million for the three months ended March 31, 2026, which consisted of proceeds from the issuance of common stock and warrants, net of offering costs, of $5.3 million, partially offset by payments of notes payable of $0.1 million. Net cash provided by financing activities was $2.7 million for the three months ended March 31, 2025, which consisted of proceeds from the issuance of common stock of $2.7 million.

Current wording

Net cash provided by financing activities was $11.6 million for the six months ended June 30, 2026, which consisted of proceeds from the issuance of common stock and warrants, net of offering costs, of $11.7 million, partially offset by payments of notes payable of $0.2 million. Net cash provided by financing activities was $4.8 million for the six months ended June 30, 2025, which consisted of proceeds from the issuance of common stock of $5.0 million, partially offset by payments of notes payable of $0.2 million.

Previous wording

In January 2026, pursuant to a placement agency agreement with BTIG, LLC (“BTIG”), we sold 928,333 shares of Common Stock, Series A Warrants to purchase up to 1,114,000 shares of Common Stock, and Series B Warrants to purchase up to 2,599,333 shares of Common Stock. 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 BTIG 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 333-286058), declared effective on April 25, 2025, and a related prospectus supplement. The total fair value of the Common Stock, Series A Warrants, and Series B Warrants sold in the offerings exceeded the offering proceeds by $4.6 million, therefore pursuant to ASC 815, we recognized this amount as a loss on the initial issuance of equity during the three months ended March 31, 2026. The placement agent fees and offering expenses were allocated to the Common Stock, Series A Warrants, and Series B Warrants sold in the offering based on their relative fair values, with the amounts allocated to the liability-classified Series A and Series B Warrants recorded as an expense and the amounts allocated to the Common Stock as a reduction to its initial carrying value.

Current wording

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 BTIG 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 333-286058), declared effective on April 25, 2025 (the “2025 S-3”), and a related prospectus supplement.

Previous wording

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) $9.9 million and $9.3 million for the 2024 SSCP Notes as of March 31, 2026 and December 31, 2025, respectively, and (ii) $1.5 million and $1.4 million for the 2025 SSCP Notes as of March 31, 2026 and December 31, 2025, respectively.

Current wording

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) $10.4 million and $9.3 million for the 2024 SSCP Notes as of June 30, 2026 and December 31, 2025, respectively, and (ii) $1.5 million and $1.4 million for the 2025 SSCP Notes as of June 30, 2026 and December 31, 2025, respectively.

Previous wording

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 loss. The change in fair value of the SSCPN Derivative Liabilities resulted in a gain of $0.7 million and a gain of $1.1 million during the three months ended March 31, 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) dissolution of the Company, or (iii) held to maturity. These estimates require significant judgment. The unobservable valuation inputs were as follows:

Current wording

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 loss. The change in fair value of the SSCPN Derivative Liabilities resulted in a loss of $3.3 million and a loss of $0.4 million during the three months ended June 30, 2026 and 2025, respectively; and a loss of $2.6 million and a gain of $0.7 million during the six months ended June 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:

Previous wording

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 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 $0.1 million and a gain of $0.2 million during the three months ended March 31, 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:

Current wording

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 loss of $0.1 million and a loss of $25,000 during the three months ended June 30, 2026 and 2025, respectively; and a loss of $0.1 million and a gain of $0.1 million during the six months ended June 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:

Previous wording

Pursuant to an underwritten public offering in June 2023, we issued warrants to purchase 2,500,000 shares of Common Stock at $22.00 per share (the “Tranche A Warrants”). The change in fair value of the Tranche A Warrants resulted in a gain of $0.4 million and a gain of $0.6 million during the three months ended March 31, 2026 and 2025, respectively. We estimate 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 require significant judgment. The unobservable valuation inputs were as follows:

Current wording

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 $30,000 during the three months ended June 30, 2025, and a gain of $0.4 million and a gain of $0.6 million during the six months ended June 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:

Previous wording

Pursuant to a registered direct public offering in October 2024, we issued warrants to purchase 1,546,914 shares of 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 $0.7 million and a gain of $1.8 million during the three months ended March 31, 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:

Current wording

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 loss of $1.0 million and a loss of $0.5 million during the three months ended June 30, 2026 and 2025, respectively; and a loss of $0.3 million and a gain of $1.3 million during the six months ended June 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:

Previous wording

Pursuant to a registered direct public offering in January 2026, we issued Series A Warrants to purchase 1,114,000 shares of 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.

Current wording

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.

Previous wording

The change in fair value of the Series A Warrants resulted in a loss of $0.3 million during the three months ended March 31, 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:

Current wording

The change in fair value of the Series A Warrants resulted in a loss of $0.6 million and a loss of $0.9 million during the three and six months ended June 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:

Previous wording

Pursuant to a registered direct public offering in January 2026, we issued Series B Warrants to purchase 2,599,333 shares of 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.

Current wording

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.

Previous wording

The change in fair value of the Series B Warrants resulted in a loss of $1.9 million during the three months ended March 31, 2026. We estimate the fair value using a Monte Carlo simulation with estimates for (i) the probability of the Series B 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:

Current wording

The change in fair value of the Series B Warrants resulted in a loss of $2.4 million and a loss of $4.3 million during the three and six months ended June 30, 2026. We estimate the fair value using a Monte Carlo simulation with estimates for (i) the probability of the Series B 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: