Clene Inc.

Previous 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.

Current wording

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.

Previous wording

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

Current wording

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.

Previous wording

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

Current wording

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.

Previous wording

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

Current wording

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.

Previous wording

We anticipate that our general and administrative expenses in future periods will be contingent upon our regulatory pathway with the FDA. If we are able to file an NDA with the FDA under an accelerated approval pathway, we anticipate our general and administrative expenses would increase in future periods to support increases in our drug development activities and as we build our commercial capabilities in advance of receiving regulatory approval. This potential increase will likely include increased headcount, increased stock-based compensation expenses, expanded infrastructure including certain sales and marketing activities performed ahead of regulatory approval, and increased insurance expenses. If we are unable to file an NDA with the FDA under an accelerated approval pathway, 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.

Current wording

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.

Previous wording

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

Current wording

Our results of operations for the three and nine months ended September 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 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.

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 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.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

Total other income (expense), net, during the three and nine months ended September 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 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.

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 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.

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 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.

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 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.

Previous 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.

Current wording

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.

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 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.

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 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.

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 $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.

Current wording

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.

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 $3.4 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.

Current wording

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.

Previous wording

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

Current wording

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

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous 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.

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 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.

Previous wording

In May 2026, pursuant to an underwriting agreement with Canaccord Genuity LLC, 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.

Current wording

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.

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) $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.

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) $10.9 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.

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 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:

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 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:

Previous wording

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 loss.

Current wording

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).

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 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:

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 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:

Previous 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:

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 $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:

Previous 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:

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 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:

Previous 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:

Current wording

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:

Previous 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:

Current wording

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: