Clene Inc 10-Q for FY2024 Q3
Clene Inc. (CLNN)
About this 10-Q
Clene Inc filed this 10-Q on November 13, 2024, covering the quarter ended September 30, 2024 (FY2024 Q3).
Headline figures
Quarter ended September 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $87K
- down 19.4% from $108K a year earlier
- Net loss
- $7.99M
- compared with a net loss of $2.42M a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
or
For the transition period from _____________ to _____________
Commission file number:
CLENE INC.
(Exact name of registrant as specified in its charter)
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| (State or other jurisdiction of | (I.R.S. Employer |
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| (Address of principal executive offices) | (Zip Code) |
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(Registrant’s telephone number, including area code)
| N/A |
(Former name, former address, and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| | | The | ||
| | | The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| | ☒ | Smaller reporting company | |
| Emerging growth company | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The number of shares outstanding of the Registrant’s common stock as of November 11, 2024 was
Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2024
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Marketable securities | ||||||||
| Accounts receivable | ||||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Restricted cash | ||||||||
| Operating lease right-of-use assets | ||||||||
| Property and equipment, net | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued liabilities | ||||||||
| Share subscriptions payable | ||||||||
| Operating lease obligations, current portion | ||||||||
| Finance lease obligations, current portion | ||||||||
| Notes payable, current portion | ||||||||
| Convertible notes payable, current portion | ||||||||
| Total current liabilities | ||||||||
| Operating lease obligations, net of current portion | ||||||||
| Notes payable, net of current portion | ||||||||
| Convertible notes payable, net of current portion | ||||||||
| Common stock warrant liabilities | ||||||||
| Clene Nanomedicine contingent earn-out liability | ||||||||
| Initial Stockholders contingent earn-out liability | ||||||||
| TOTAL LIABILITIES | ||||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, $ par value: and shares authorized at September 30, 2024 and December 31, 2023, respectively; and shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Accumulated other comprehensive income | ||||||||
| TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) | ( | ) | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | $ | $ | ||||||
See accompanying notes to the condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended September 30, |
Nine Months Ended September 30, |
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| 2024 |
2023 |
2024 |
2023 |
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| Revenue: |
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| Product revenue |
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| Royalty revenue |
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| Total revenue |
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| Operating expenses: |
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| Cost of revenue |
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| Research and development |
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| General and administrative |
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| Total operating expenses |
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| Loss from operations |
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| Other income (expense), net: |
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| Interest income |
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| Interest expense |
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| Commitment share expense |
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| Issuance costs for common stock warrant liabilities |
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| Loss on initial issuance of equity |
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| Change in fair value of common stock warrant liabilities |
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| Change in fair value of Clene Nanomedicine contingent earn-out liability |
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| Change in fair value of Initial Stockholders contingent earn-out liability |
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| Research and development tax credits and unrestricted grants |
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| Other income, net |
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| Total other income (expense), net |
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| Net loss before income taxes |
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| Income tax expense |
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| Net loss |
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| Other comprehensive income (loss): |
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| Unrealized gain (loss) on available-for-sale securities |
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| Foreign currency translation adjustments |
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| Total other comprehensive income (loss) |
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| Comprehensive loss |
$ | ( |
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| Net loss per share – basic and diluted |
$ | ( |
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| Weighted average common shares used to compute basic and diluted net loss per share |
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See accompanying notes to the condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(In thousands, except share amounts)
(Unaudited
| Common Stock |
Additional Paid-In Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Income (Loss) |
Total Stockholders’ Equity (Deficit) |
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| Shares |
Amount |
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| Balances at December 31, 2023 |
$ | $ | $ | ( |
) | $ | $ | |||||||||||||||||
| Stock-based compensation expense |
— | |||||||||||||||||||||||
| Issuance of common stock upon vesting of restricted stock awards |
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| Unrealized loss on available-for-sale securities |
— | ( |
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| Foreign currency translation adjustment |
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| Net loss |
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| Balances at March 31, 2024 |
$ | $ | $ | ( |
) | $ | $ | |||||||||||||||||
| Exercise of stock options |
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| Stock-based compensation expense |
— | |||||||||||||||||||||||
| Unrealized gain on available-for-sale securities |
— | |||||||||||||||||||||||
| Foreign currency translation adjustment |
— | |||||||||||||||||||||||
| Net loss |
— | ( |
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| Balances at June 30, 2024 |
$ | $ | $ | ( |
) | $ | $ | ( |
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| Issuance of common stock |
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| Exercise of stock options |
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| Stock-based compensation expense |
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| Unrealized gain on available-for-sale securities |
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| Foreign currency translation adjustment |
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| Net loss |
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| Balances at September 30, 2024 |
$ | $ | $ | ( |
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| Balances at December 31, 2022 |
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| Issuance of common stock |
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| Stock-based compensation expense |
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| Unrealized gain on available-for-sale securities |
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| Foreign currency translation adjustment |
— | |||||||||||||||||||||||
| Net loss |
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| Balances at March 31, 2023 |
$ | $ | $ | ( |
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| Issuance of common stock |
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| Issuance of equity-classified warrants |
— | |||||||||||||||||||||||
| Stock-based compensation expense |
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| Issuance of common stock upon vesting of restricted stock awards |
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| Unrealized gain on available-for-sale securities |
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| Foreign currency translation adjustment |
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| Net loss |
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| Balances at June 30, 2023 |
$ | $ | $ | ( |
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| Common stock issuance costs |
— | ( |
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| Stock-based compensation expense |
— | |||||||||||||||||||||||
| Issuance of common stock upon vesting of restricted stock awards |
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| Unrealized loss on available-for-sale securities |
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| Foreign currency translation adjustment |
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| Net loss |
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| Balances at September 30, 2023 |
$ | $ | $ | ( |
) | $ | $ | |||||||||||||||||
See accompanying notes to the condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| Nine Months Ended September 30, |
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| 2024 |
2023 |
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| Cash flows from operating activities: |
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| Net loss |
$ | ( |
) | $ | ( |
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| Adjustments to reconcile net loss to net cash used in operating activities: |
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| Depreciation |
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| Non-cash lease expense |
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| Commitment share expense |
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| Issuance costs for common stock warrant liabilities |
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| Loss on initial issuance of equity |
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| Change in fair value of common stock warrant liabilities |
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| Change in fair value of Clene Nanomedicine contingent earn-out liability |
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| Change in fair value of Initial Stockholders contingent earn-out liability |
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| Stock-based compensation expense |
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| Accretion of debt discount |
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| Non-cash interest income on marketable securities |
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| Non-cash interest expense on notes payable |
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| Changes in operating assets and liabilities: |
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| Accounts receivable |
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| Inventory |
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| Prepaid expenses and other current assets |
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| Accounts payable |
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| Accrued liabilities |
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| Operating lease obligations |
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| Net cash used in operating activities |
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| Cash flows from investing activities: |
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| Purchases of marketable securities |
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| Proceeds from maturities of marketable securities |
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| Purchases of property and equipment |
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| Net cash provided by investing activities |
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| Cash flows from financing activities: |
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| Proceeds from exercise of stock options |
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| Proceeds from issuance of common stock and warrants, net of offering costs |
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| Proceeds from share subscriptions payable |
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| Payments of finance lease obligations |
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| Proceeds from the issuance of notes payable |
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| Payments of notes payable |
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| Payments of notes payable modification fees |
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| Net cash provided by (used in) financing activities |
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| Effect of foreign exchange rate changes on cash and restricted cash |
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| Net increase (decrease) in cash, cash equivalents and restricted cash |
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| Cash, cash equivalents and restricted cash – beginning of period |
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| Cash, cash equivalents and restricted cash – end of period |
$ | $ | ||||||
| Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets |
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| Cash and cash equivalents |
$ | $ | ||||||
| Restricted cash |
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| Cash, cash equivalents and restricted cash |
$ | $ | ||||||
| Supplemental disclosure of non-cash investing and financing activities: |
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| Common stock warrant liability recorded upon debt modification |
$ | $ | ||||||
| Common stock warrant liability recorded upon public stock offering |
$ | $ | ||||||
| Deferred transaction costs in accrued liabilities and other current assets |
$ | $ | ||||||
| Supplemental cash flow information: |
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| Cash paid for interest expense |
$ | $ | ||||||
See accompanying notes to the condensed consolidated financial statements.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 1. Nature of the Business
Clene Inc. (the “Company,” “we,” “us,” or similar such references) is a clinical-stage pharmaceutical company pioneering the discovery, development, and commercialization of novel clean-surfaced nanotechnology therapeutics. We have developed an electro-crystal-chemistry drug development platform which enables production of concentrated, stable, highly active, clean-surfaced nanocrystal suspensions. We have multiple drug assets currently in development for applications primarily in neurology. Our efforts are currently focused on addressing the high unmet medical needs in central nervous system disorders including amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”), and Parkinson’s disease (“PD”). Our patented electro-crystal-chemistry manufacturing platform further enables us to develop very low concentration dietary supplements to advance the health and well-being of broad populations. These dietary supplements can vary greatly and include nanocrystals of varying composition, shapes and sizes as well as ionic solutions with diverse metallic constituents. Dietary supplements are marketed and distributed through our wholly owned subsidiary, dOrbital, Inc., or through an exclusive license with 4Life Research LLC (“4Life”), an international supplier of health supplements, stockholder, and related party (see Note 15).
Clene Nanomedicine, Inc. (“Clene Nanomedicine”) became a public company on December 30, 2020 (the “Closing Date”) when it completed a reverse recapitalization (the “Reverse Recapitalization”) with Tottenham Acquisition I Limited (“Tottenham”), Tottenham’s wholly-owned subsidiary and our predecessor, Chelsea Worldwide Inc., and Creative Worldwide Inc., a wholly-owned subsidiary of Chelsea Worldwide Inc. On the Closing Date, Chelsea Worldwide Inc. changed its name to Clene Inc. and listed its shares of common stock, par value $
Going Concern
We incurred a loss from operations of $
We have incurred significant losses and negative cash flows from operations since our inception. We have not generated significant revenues since our inception, and we do not anticipate generating significant revenues unless we successfully complete development and obtain regulatory approval for commercialization of a drug candidate. We expect to incur additional losses in the future, particularly as we advance the development of our clinical-stage drug candidates, continue research and development of our preclinical drug candidates, and initiate additional clinical trials of, and seek regulatory approval for, these and other future drug candidates. We expect that within the next twelve months, we will not have sufficient cash and other resources on hand to sustain our current operations or meet our obligations as they become due unless we obtain additional financing. Additionally, pursuant to our term loan with Avenue Venture Opportunities Fund, L.P. (“Avenue”), we are required to maintain unrestricted cash and cash equivalents of at least $
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, equity purchase agreement, and potential proceeds from the exercise of outstanding warrants and stock options. These plans are subject to market conditions and reliance on third parties, and there is no assurance that effective implementation of our plans will result in the necessary funding to continue current operations. During the three months ended September 30, 2024, we generated $
The accompanying condensed consolidated financial statements have been prepared assuming we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. As a result, the accompanying condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amounts and classification of liabilities that may result should we be unable to continue as a going concern.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements include the accounts of Clene Inc. and our wholly-owned subsidiaries, Clene Nanomedicine, Inc., a subsidiary incorporated in Delaware, Clene Australia Pty Ltd (“Clene Australia”), a subsidiary incorporated in Australia, Clene Netherlands B.V. (“Clene Netherlands”), a subsidiary incorporated in the Netherlands, and dOrbital, Inc., a subsidiary incorporated in Delaware, after elimination of all intercompany accounts and transactions. We have prepared the accompanying condensed consolidated financial statements in accordance with United States (“U.S.”) Generally Accepted Accounting Principles (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. The condensed consolidated financial statements have been prepared on the same basis as our audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation. The financial data and other information disclosed in the condensed consolidated financial statements and related notes for the three and nine months ended September 30, 2024 and 2023 are unaudited.
Results of operations for the three and nine months ended September 30, 2024 and 2023 are not necessarily indicative of the results for the entire fiscal year or any other period. The condensed consolidated financial statements for the three and nine months ended September 30, 2024 and 2023 should be read in conjunction with the audited consolidated financial statements included in our Annual Report on Form 10-K.
Reverse Stock Split
Effective July 11, 2024 (the “Effective Date”), we filed a Certificate of Amendment to our Fourth Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware, to effect a 1-for-
The Reverse Stock Split did not reduce the total number of authorized shares of Common Stock or preferred stock, par value $
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and disclosure of contingent assets and liabilities, and the reported amounts of expenses. We base our estimates on historical experience and various other assumptions that we believe to be reasonable. Actual results may differ from those estimates or assumptions. Estimates are periodically reviewed in light of changes in circumstances, facts, and experience, and any changes in estimates will be recorded in future periods as they develop.
Risks and Uncertainties
We are subject to certain risks and uncertainties and believe that changes in any of the following areas could have a material adverse effect on future financial condition, results of operations, or cash flows: ability to obtain additional financing; regulatory approval and market acceptance of, and reimbursement for, product candidates; performance of third-party contract research organizations (“CROs”) and manufacturers upon which we rely; protection of our intellectual property; litigation or claims against us based on intellectual property, patent, product, regulatory, or other factors; and our ability to attract and retain employees necessary to support our growth. The product candidates we develop require approvals from regulatory agencies prior to commercial sales. There can be no assurance that our current and future product candidates will receive the necessary approvals or be commercially successful. If we are denied approval or approval is delayed, it will have a material adverse impact on our business and our condensed consolidated financial statements.
Concentrations of Credit Risk
Financial instruments which potentially subject us to significant concentrations of credit risk consist primarily of cash. Our cash is held in financial institutions and amounts on deposit may at times exceed federally insured limits. We have not experienced any losses on our deposits of cash and do not believe that we are subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
Cash and Cash Equivalents
We consider all short-term investments with original maturities of 90 days or less when purchased to be cash equivalents.
Restricted Cash
We classify cash as restricted when it is unavailable for withdrawal or use in our general operating activities. Restricted cash is classified as current and noncurrent on the condensed consolidated balance sheets based on the nature of the restriction. Our restricted cash balance includes contractually restricted deposits related to our corporate credit card.
Marketable Securities
Marketable securities are investments with original maturities of more than 90 days when purchased. We do not invest in securities with original maturities of more than one year. Marketable debt securities are considered available-for-sale, and are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income until realized. Realized gains and losses are included in other income (expense), net, on the basis of specific identification. The cost of marketable securities is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in other income (expense), net.
Inventory
Inventory is stated at historic cost on a first-in first-out basis. Our inventory consisted of $
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Property and equipment consist of laboratory and office equipment, computer software, and leasehold improvements. Depreciation is calculated using the straight-line method over the estimated economic useful lives of the assets, which are
We capitalize costs to obtain or develop computer software for internal use, including development costs incurred during the software development stage and costs to obtain software for access and conversion of historical data. We also capitalize costs to modify, upgrade, or enhance existing internal-use software that result in additional functionality. We expense costs incurred during the preliminary project stage, training costs, data conversion costs, and maintenance costs.
Debt
When debt is issued and a derivative is required to be separated (e.g., bifurcated conversion option) or another separate freestanding financial instrument (e.g., warrant) is issued, costs and fees incurred are allocated to the instruments issued (or bifurcated) in proportion to the allocation of proceeds. When some portions of the costs and fees relate to a bifurcated derivative or freestanding financial instrument that is being subsequently measured at fair value, those allocated costs are expensed immediately. Debt discounts, debt premiums, and debt issuance costs related to debt are recorded as deductions that net against the principal value of the debt and are amortized to interest expense over the contractual term of the debt using the effective interest method.
In accordance with ASC 470-20, Debt with Conversion and Other Options, when we issue debt with warrants, we treat the warrants as a debt discount, recorded as a contra-liability against the debt, and amortize the balance over the life of the underlying debt as interest expense in the condensed consolidated statements of operations and comprehensive loss. The offset to the contra-liability is recorded as additional paid-in capital in the condensed consolidated balance sheets if the warrants are not treated as a derivative or liability under ASC 480, Distinguishing Liabilities from Equity (“ASC 480”). Otherwise, the offset to the contra-liability is recorded as a warrant liability in the condensed consolidated balance sheets and is subject to re-measurement to fair value at each balance sheet date, with any changes in fair value recognized in the condensed consolidated statements of operations and comprehensive loss. If the debt is retired early, the associated debt discount is then recognized immediately as interest expense in the condensed consolidated statements of operations and comprehensive loss.
Convertible Debt
In accordance with ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, when we issue notes with conversion features, we evaluate if the conversion feature is freestanding or embedded. If the conversion feature is embedded, we do not separate the conversion feature from the host contract for convertible notes that are not required to be accounted for as derivatives, or that do not result in substantial premiums accounted for as paid-in-capital. Consequently, we account for a convertible note as a single liability measured at its amortized cost as long as no other features require separation and recognition as derivatives. If the conversion feature is freestanding, or is embedded and meets the requirements to be separated, we account for the conversion feature as a derivative under ASC 815, Derivatives and Hedging (“ASC 815”). We record the derivative instrument at fair value at inception, and subsequently re-measure to fair value at each reporting period and immediately prior to the extinguishment of the derivative instrument, with any changes recorded in the condensed consolidated statements of operations and comprehensive loss.
Leases
At inception of a contract, we determine if a contract meets the definition of a lease. We determine if the contract conveys the right to control the use of an identified asset for a period of time. We assess throughout the period of use whether we have both of the following: (i) the right to obtain substantially all the economic benefits from use of the identified asset, and (ii) the right to direct the use of the identified asset. This determination is reassessed if the terms of the contract are changed. Leases are classified as operating or finance leases based on the terms of the lease agreement and certain characteristics of the identified asset. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments less any lease incentives received. At the lease commencement date, the discount rate implicit in the lease is used to discount the lease liability if readily determinable. If not readily determinable or leases do not contain an implicit rate, our incremental borrowing rate is used as the discount rate. Our policy is to not record leases with an original term of twelve months or less within the condensed consolidated balance sheets and we recognize lease expense for these short-term leases on a straight-line basis over the lease term.
Certain lease agreements may require us to pay additional amounts for taxes, insurance, maintenance, and other expenses, which are generally referred to as non-lease components. Such variable non-lease components are treated as variable lease payments and recognized in the period in which the obligation for these payments is incurred. Variable lease components and variable non-lease components are not measured as part of the right-of-use asset and liability. Only when lease components and their associated non-lease components are fixed are they accounted for as a single lease component and are recognized as part of a right-of-use asset and liability. Total contract consideration is allocated to the fixed lease and non-lease component. This policy election applies consistently to all asset classes under lease agreements.
Leases may contain clauses for renewal at our option. Payments to be made in option periods are recognized as part of the right-of-use lease assets and lease liabilities when it is reasonably certain that the option to extend the lease will be exercised, or is not at our option. We determine whether the reasonably certain threshold is met by considering contract-, asset-, market-, and entity-based factors. Operating lease expense, which is recognized on a straight-line basis over the lease term, and the amortization of finance lease right-of-use assets, which are included in property and equipment and depreciated, are included in research and development or general and administrative expenses consistent with the leased assets’ primary use. Accretion on the liabilities for finance leases is included in interest expense.
Contingent Earn-Out Liabilities
In connection with the Reverse Recapitalization, certain Clene Nanomedicine stockholders are entitled to receive additional shares of Common Stock (the “Clene Nanomedicine Contingent Earn-out”) as follows: (i)
In accordance with ASC 815, the Contingent Earn-outs are not indexed to our own stock and therefore were accounted for as a liability at the Reverse Recapitalization date and are subsequently remeasured to fair value at each reporting date with changes recorded as a component of other income (expense), net.
Common Stock Warrants
We account for common stock warrants as either equity- or liability-classified instruments based on an assessment of the warrant terms. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all the requirements for equity classification under ASC 815, including whether the warrants are indexed to our Common Stock, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and, for liability-classified warrants, at each reporting period end date while the warrants are outstanding.
Grant Funding
We may submit applications to receive grant funding from governmental and non-governmental entities. We account for grants by analogizing to the grant accounting model under IAS 20, Accounting for Government Grants and Disclosure of Government Assistance (“IAS 20”). We recognize grant funding without conditions or continuing performance obligations, including certain research and development tax credits, as other income in the condensed consolidated statements of operations and comprehensive loss. We accrue certain research and development tax credits receivable in other current assets (see Note 4) in an amount equal to the qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage and we recognize other income in the condensed consolidated statements of operations and comprehensive loss. After submission of our tax returns, we receive a cash refund of certain research and development tax credits and relieve the receivable.
We recognize grant funding with conditions or continuing performance obligations as a reduction in research and development expenses in the period during which the related qualifying expenses are incurred and as the conditions or performance obligations are fulfilled. Any amount received in advance of fulfilling such conditions or performance obligations is recorded in accrued liabilities (see Note 6) if the conditions or performance obligations are expected to be met within the next twelve months. We recognized grant funding as a reduction of research and development expenses of $
In October 2023 we were awarded a grant (“the NIH Grant”) in collaboration with Columbia University, the prime awardee, and Synapticure, a neurology specialty health clinic, from the National Institute of Health (“NIH”). The NIH Grant was awarded pursuant to the Accelerating Access to Critical Therapies for ALS Act to support up to a four-year Expanded Access Program (the “ACT-EAP”) for CNM-Au8 treatment of ALS. The NIH Grant totaled $
Foreign Currency Translation and Transactions
Our functional and reporting currency is the U.S. dollar (“USD”). Clene Australia and Clene Netherlands determined their functional currencies to be the Australian dollar and Euro, respectively. The results of our foreign currency operations are translated into USD at the average exchange rates during the period, assets and liabilities are translated using the exchange rate as of the balance sheet date, and stockholders’ equity (deficit) is translated using historical rates. Adjustments from the translation of the results of our foreign currency operations are excluded from net loss and are accumulated in a separate component of stockholders’ equity (deficit). We also incur foreign exchange transaction gains and losses for purchases denominated in foreign currencies. Foreign exchange transaction gains and losses are included in other income (expense), net, as incurred.
Comprehensive Loss
Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. The only elements of other comprehensive loss in any periods presented were the translation of foreign currency denominated balances of Clene Australia and Clene Netherlands to USD for consolidation and our unrealized gain (loss) on available-for-sale securities.
Segment Information
We report segment information based on ASC 280 Segment Reporting (“ASC 280”), which defines operating segments as components of a company that engage in activities from which it may recognize revenues and incur expenses, and for which operating results are regularly reviewed by the entity’s chief operating decision maker (“CODM”) to make decisions regarding resource allocation and assess performance, and for which discrete financial information is available. Effective in the fourth quarter of 2023, we revised our internal reporting processes to better align with our strategic priorities due to the immateriality of our dietary supplement operations. As a result and in accordance with ASC 280, we determined that the Company is a single operating and reportable segment. Our chief executive officer is the CODM and allocates resources and assesses performance at a consolidated level. Prior to the fourth quarter of 2023, we operated as two operating and reportable segments related to our development and commercialization of drugs and dietary supplements. The change did not require any prior period information to be recast.
Income Taxes
We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the condensed consolidated financial statements or in our tax returns. Deferred tax assets and liabilities are determined based on the differences between the financial statement basis and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. We assess the likelihood that our deferred tax assets will be recovered from future taxable income and, to the extent we believe, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies.
We account for uncertainty in income taxes recognized in the condensed consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the condensed consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, which are considered appropriate as well as the related net interest and penalties.
Stock-Based Compensation
We account for stock-based compensation arrangements using a fair value-based method for costs related to all share-based payments including stock options and stock awards. Stock-based compensation expense is recorded in research and development and general and administrative expenses based on the classification of the work performed by the grantees. The fair value is recognized over the period during which a grantee is required to provide services in exchange for the option award and service-based stock awards, known as the requisite service period (usually the vesting period), on a straight-line basis. For stock awards with market conditions, the fair value is recognized over the period based on the expected milestone achievement dates as the derived service period (usually the vesting period), on a straight-line basis. For stock awards with performance conditions, the grant-date fair value of these awards is the market price on the applicable grant date, and compensation expense will be recognized when the conditions become probable of being satisfied. We recognize a cumulative true-up adjustment once the conditions become probable of being satisfied as the related service period had been completed in a prior period. We generally grant stock options with a four-year requisite service period. Certain stock options may vest based upon performance conditions instead of service conditions, such as the achievement of regulatory milestones or financial performance measures. For the grant-date fair value, we estimate the expected term of stock options with performance conditions based upon the nature of the conditions. If the expected term is not estimable and the achievement of performance conditions is not probable, we use the contractual term as the expected term. We elect to account for forfeitures as they occur, rather than estimating expected forfeitures. We determine the fair value of each share of Common Stock underlying stock-based awards using a Black-Scholes option pricing model based on the closing price of our Common Stock as reported by Nasdaq on the date of grant. The fair value of stock awards with market conditions are determined using a Monte Carlo valuation model.
Recent Accounting Pronouncements Not Yet Adopted
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”). ASU 2023-07 requires, among other things, that public entities with a single reportable segment provide all the disclosures required by ASC 280 and ASU 2023-07, and that public entities provide all annual disclosures about a reportable segment’s profit or loss and assets currently required in interim periods. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. We are currently evaluating the impact of ASU 2023-07.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). ASU 2023-09 requires, among other things, that public entities on an annual basis disclose specific categories of the tax rate reconciliation, provide additional information for reconciling items that meet a quantitative threshold, and disclose income taxes paid disaggregated by jurisdiction. The guidance is effective for annual periods beginning after December 15, 2024. We are currently evaluating the impact of ASU 2023-09.
Note 3. Cash, Cash Equivalents, and Marketable Securities
Available-for-Sale Securities
Available-for-sale securities as of September 30, 2024 were as follows:
| September 30, 2024 | ||||||||||||||||
| (in thousands) | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||
| Cash equivalents (contractual maturity within 90 days): | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total cash equivalents | ||||||||||||||||
| Cash | ||||||||||||||||
| Total cash and cash equivalents | $ | $ | $ | $ | ||||||||||||
Available-for-sale securities as of December 31, 2023 were as follows:
| December 31, 2023 | ||||||||||||||||
| (in thousands) | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||
| Cash equivalents (contractual maturity within 90 days): | ||||||||||||||||
| U.S. Treasury securities | $ | $ | $ | $ | ||||||||||||
| Money market funds | ||||||||||||||||
| Total cash equivalents | ||||||||||||||||
| Cash | ||||||||||||||||
| Total cash and cash equivalents | $ | $ | $ | $ | ||||||||||||
| Marketable securities (contractual maturity greater than 90 days but less than 1 year): | ||||||||||||||||
| U.S. Treasury securities | $ | $ | $ | $ | ||||||||||||
| Total marketable securities | $ | $ | $ | $ | ||||||||||||
We had no realized gains or losses from the sale of available-for-sale securities during the three and nine months ended September 30, 2024 and 2023. As of September 30, 2024 and December 31, 2023, we did have any allowance for credit losses or impairments of available-for-sale securities.
Note 4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets as of September 30, 2024 and December 31, 2023 were as follows:
| September 30, |
December 31, |
|||||||
| (in thousands) |
2024 |
2023 |
||||||
| Prepaid clinical and CRO expenses |
$ | $ | ||||||
| Metals to be used in research and development |
||||||||
| Research and development tax credits receivable |
||||||||
| Other |
||||||||
| Total prepaid expenses and other current assets |
$ | $ | ||||||
Note 5. Property and Equipment, Net
Property and equipment, net, as of September 30, 2024 and December 31, 2023 were as follows:
| September 30, |
December 31, |
|||||||
| (in thousands) |
2024 |
2023 |
||||||
| Lab equipment |
$ | $ | ||||||
| Office equipment |
||||||||
| Computer software |
||||||||
| Leasehold improvements |
||||||||
| Construction in progress |
||||||||
| Less accumulated depreciation |
( |
) | ( |
) | ||||
| Total property and equipment, net |
$ | $ | ||||||
Depreciation expense recorded in research and development expense and general and administrative expense during the three and nine months ended September 30, 2024 and 2023 was as follows:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| (in thousands) |
2024 |
2023 |
2024 |
2023 |
||||||||||||
| General and administrative |
$ | $ | $ | $ | ||||||||||||
| Research and development |
||||||||||||||||
| Total depreciation expense |
$ | $ | $ | $ | ||||||||||||
Note 6. Accrued Liabilities
Accrued liabilities as of September 30, 2024 and December 31, 2023 were as follows:
| September 30, |
December 31, |
|||||||
| (in thousands) |
2024 |
2023 |
||||||
| Accrued compensation and benefits |
$ | $ | ||||||
| Deferred grants |
||||||||
| Accrued CRO and clinical fees |
||||||||
| Other |
||||||||
| Total accrued liabilities |
$ | $ | ||||||
Note 7. Leases
We lease laboratory and office space and certain laboratory equipment under non-cancellable operating and finance leases. The carrying value of our right-of-use lease assets is substantially concentrated in our real estate leases, while the volume of lease agreements is primarily concentrated in equipment leases. We expect that, in the normal course of business, the existing leases will be renewed or replaced by similar leases.
Operating Leases
Operating leases primarily consist of real estate leases for office and laboratory space. We have
As of September 30, 2024 and December 31, 2023, our operating lease obligations had a weighted-average discount rate of
Finance Leases
We did not have any finance lease obligations as of September 30, 2024. Assets recorded under finance lease obligations and included within property and equipment as of December 31, 2023 were as follows:
| December 31, | ||||
| (in thousands) | 2023 | |||
| Lab equipment | $ | |||
| Less accumulated depreciation | ( | ) | ||
| Net | $ | |||
As of December 31, 2023, our finance lease obligations had a weighted-average interest rate of
Maturity Analysis of Lease Obligations
The maturity analysis of our operating lease obligations as of September 30, 2024 was as follows:
| (in thousands) | Operating Leases | |||
| 2024 (remainder) | $ | |||
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| Thereafter | ||||
| Total minimum lease payments | ||||
| Less amount representing interest/discounting | ( | ) | ||
| Present value of minimum lease payments | ||||
| Less lease obligations, current portion | ( | ) | ||
| Lease obligations, net of current portion | $ | |||
Components of Lease Cost
The components of finance and operating lease costs for the three and nine months ended September 30, 2024 and 2023 were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Finance lease costs: | ||||||||||||||||
| Amortization | $ | $ | $ | $ | ||||||||||||
| Interest on lease liabilities | ||||||||||||||||
| Operating lease costs | ||||||||||||||||
| Short-term lease costs | ||||||||||||||||
| Variable lease costs | ||||||||||||||||
| Total lease costs | $ | $ | $ | $ | ||||||||||||
Supplemental Cash Flow Information
| Nine Months Ended September 30, | ||||||||
| (in thousands) | 2024 | 2023 | ||||||
| Operating cash flows from operating leases | $ | ( | ) | $ | ( | ) | ||
| Operating cash flows from finance leases | $ | $ | ( | ) | ||||
| Financing cash flows from finance leases | $ | ( | ) | $ | ( | ) | ||
Note 8. Notes Payable and Convertible Notes Payable
Our notes payable and convertible notes payable as of September 30, 2024 and December 31, 2023 was as follows:
| Stated | September 30, | December 31, | ||||||||||
| (in thousands, except interest rates) | Interest Rate | 2024 | 2023 | |||||||||
| Notes payable | ||||||||||||
| Advance Cecil, Inc. (commenced April 2019) | % | $ | $ | |||||||||
| Maryland DHCD (commenced February 2019) | % | |||||||||||
| Maryland DHCD (commenced May 2022) | % | |||||||||||
| Avenue Venture Opportunities Fund, L.P. (commenced May 2021) | % | |||||||||||
| Unamortized premium (discount) and debt issuance costs | ( | ) | ||||||||||
| Less notes payable, current portion, net of unamortized discount and debt issuance costs | ( | ) | ( | ) | ||||||||
| Notes payable, net of current portion | $ | $ | ||||||||||
| Convertible notes payable | ||||||||||||
| Avenue Venture Opportunities Fund, L.P. (commenced May 2021) | % | $ | $ | |||||||||
| Maryland DHCD (commenced December 2022) | % | |||||||||||
| Unamortized discount and debt issuance costs | ( | ) | ( | ) | ||||||||
| Less convertible notes payable, current portion, net of unamortized discount and debt issuance costs | ( | ) | ||||||||||
| Convertible notes payable, net of current portion | $ | $ | ||||||||||
Maryland Loans
In February 2019, we entered into a term loan agreement (the “2019 MD Loan”) with the Department of Housing and Community Development (“DHCD”), a principal department of the State of Maryland, for $
In April 2019, we entered into a term loan agreement (the “2019 Cecil Loan”) with Advance Cecil Inc., a non-stock corporation formed under the laws of the State of Maryland, for $
In May 2022, we entered into a term loan agreement (the “2022 MD Loan”) with DHCD for up to $
In December 2022, we entered into a term loan agreement (the “2022 DHCD Loan”) with DHCD for $
Avenue Loan
In May 2021, we entered into a term loan agreement (the “2021 Avenue Loan”) with Avenue for up to $
The Third Amendment provided for a contingent interest-only period from November 1, 2024 through December 31, 2024 (the “Second Interest-only Period”) if we had received gross proceeds of at least $
Avenue had the right to convert up to $
We are subject to covenants until maturity, including limitations on our ability to retire, repurchase, or redeem our stock, options, and warrants other than per the terms of the securities; limitations on our ability to pay dividends; and we are required to maintain unrestricted cash and cash equivalents of at least $
At the inception of the 2021 Avenue Loan, we issued a warrant to Avenue to purchase Common Stock (the “2021 Avenue Warrant”). A portion of the net proceeds at issuance of the 2021 Avenue Loan were allocated to the 2021 Avenue Warrant in an amount equal to its fair value of $
Debt Maturities
Future debt payments, net of unamortized discounts and debt issuance costs, and without giving effect to any potential future exercise of conversion features, are as follows:
| (in thousands) | 2019 MD Loan | 2019 Cecil Loan | 2021 Avenue Loan | 2022 MD Loan | 2022 DHCD Loan | |||||||||||||||
| 2024 (remainder) | $ | $ | $ | $ | $ | |||||||||||||||
| 2025 | ||||||||||||||||||||
| 2026 | ||||||||||||||||||||
| 2027 | ||||||||||||||||||||
| 2028 | ||||||||||||||||||||
| 2029 | ||||||||||||||||||||
| Thereafter | ||||||||||||||||||||
| Total debt principal payments | ||||||||||||||||||||
| Accrued and unpaid interest | ||||||||||||||||||||
| Unamortized premium (discount) and debt issuance costs | ( | ) | ( | ) | ||||||||||||||||
| Future debt payments, net | $ | $ | $ | $ | $ | |||||||||||||||
Note 9. Commitments and Contingencies
Commitments
We enter into agreements in the normal course of business with CROs for clinical trials and with vendors for preclinical studies and other services and products for operating purposes, which are cancelable at any time by us, subject to payment of our remaining obligations under binding purchase orders and, in certain cases, nominal early termination fees. These commitments are not deemed significant.
As of September 30, 2024 and December 31, 2023, we had commitments under various agreements for capital expenditures totaling $
Contingencies
From time to time, we may have certain contingent legal liabilities that arise in the ordinary course of business activities. We accrue a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. We are not aware of any current material pending legal matters or claims.
We received the following grants from the National Multiple Sclerosis Society (“NMSS”): (i) $
Note 10. Income Taxes
The components of loss before income taxes for the three and nine months ended September 30, 2024 and 2023 were as follows:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| (in thousands) |
2024 |
2023 |
2024 |
2023 |
||||||||||||
| United States |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| Foreign |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Net loss before income taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
We are subject to taxation in the U.S., Australia, Netherlands, and various state jurisdictions. Our tax returns from 2017 to present are subject to examination by the U.S. and state authorities due to the carry forward of unutilized net operating losses and research and development credits. There are currently no pending examinations. We compute our quarterly income tax provision by using a forecasted annual effective tax rate and adjust for any discrete items arising during the quarter. The primary difference between the effective tax rate and the federal statutory tax rate relates to the full valuation allowance on our net operating losses and other deferred tax assets.
Note 11. Benefit Plans
401(k) Plan
Our 401(k) plan is a deferred salary arrangement under Section 401(k) of the Internal Revenue Code. We match
Stock Compensation Plans
The Clene Nanomedicine, Inc. 2014 Stock Plan (the “2014 Plan”) was adopted in July 2014. Effective as of the closing of the Reverse Recapitalization, no additional awards may be granted under the 2014 Plan. As of September 30, 2024,
The Clene Inc. 2020 Amended Stock Plan (the “2020 Plan”) was adopted in December 2020 and amended in May 2023 and May 2024. Currently,
Stock-Based Compensation Expense
Stock-based compensation expense recorded in research and development expense and general and administrative expense during the three and nine months ended September 30, 2024 and 2023 was as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| General and administrative | $ | $ | $ | $ | ||||||||||||
| Research and development | ||||||||||||||||
| Total stock-based compensation expense | $ | $ | $ | $ | ||||||||||||
Stock-based compensation expense by award type during the three and nine months ended September 30, 2024 and 2023 was as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Stock options | $ | $ | $ | $ | ||||||||||||
| Stock awards | ( | ) | ||||||||||||||
| Total stock-based compensation expense | $ | $ | $ | $ | ||||||||||||
Stock Options
Outstanding stock options and related activity during the nine months ended September 30, 2024 was as follows:
| (in thousands, except share, per share, and term data) | Number of Options | Weighted Average Exercise Price Per Share | Weighted Average Remaining Term (Years) | Intrinsic Value | ||||||||||||
| Outstanding – December 31, 2023 | $ | $ | ||||||||||||||
| Granted | — | |||||||||||||||
| Exercised | ( | ) | — | |||||||||||||
| Forfeited | ( | ) | — | — | ||||||||||||
| Expired | ( | ) | — | — | ||||||||||||
| Outstanding – September 30, 2024 | $ | $ | ||||||||||||||
| Vested and exercisable – September 30, 2024 | $ | $ | ||||||||||||||
| Vested, exercisable or expected to vest – September 30, 2024 | $ | $ | ||||||||||||||
As of September 30, 2024 and December 31, 2023, we had approximately $
The weighted-average grant-date fair value of stock options granted during the nine months ended September 30, 2024 and 2023 was $
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Expected stock price volatility | % | % | ||||||
| Risk-free interest rate | % | % | ||||||
| Expected dividend yield | % | % | ||||||
| Expected term of options (in years) | ||||||||
Stock Awards
Stock awards include rights to restricted stock awards with market-based vesting conditions and restricted stock units with service-based vesting conditions. Outstanding stock awards and related activity during the nine months ended September 30, 2024 was as follows:
| Number of Stock Awards | Weighted Average Grant Date Fair Value | |||||||
| Unvested balance – December 31, 2023 | $ | |||||||
| Converted to shares of Common Stock upon vesting | ( | ) | ||||||
| Forfeited | ( | ) | ||||||
| Unvested balance – September 30, 2024 | $ | |||||||
As of September 30, 2024, we had unrecognized stock-based compensation cost related to non-vested stock awards. As of December 31, 2023, we had approximately $
Note 12. Fair Value
Cash, cash equivalents, and marketable securities are carried at fair value. Financial instruments, including accounts receivable, accounts payable, and accrued expenses are carried at cost, which approximates fair value given their short-term nature. Our remaining fair value measures are discussed below.
Financial Instruments with Fair Value Measurements on a Recurring Basis
The fair value hierarchy for financial instruments measured at fair value on a recurring basis as of September 30, 2024 is as follows, excluding the Contingent Earn-outs due to their nominal fair value:
| September 30, 2024 | ||||||||||||||||
| (in thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
| Cash equivalents: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Common stock warrant liabilities | ||||||||||||||||
The fair value hierarchy for financial instruments measured at fair value on a recurring basis as of December 31, 2023 is as follows:
| December 31, 2023 | ||||||||||||||||
| (in thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
| Cash equivalents: | ||||||||||||||||
| U.S. Treasury securities | $ | $ | $ | $ | ||||||||||||
| Money market funds | ||||||||||||||||
| Marketable securities: | ||||||||||||||||
| U.S. Treasury securities | ||||||||||||||||
| Common stock warrant liabilities | ||||||||||||||||
| Clene Nanomedicine contingent earn-out liability | ||||||||||||||||
| Initial Stockholders contingent earn-out liability | ||||||||||||||||
There were no transfers between Level 1, Level 2, or Level 3 during any of the periods above.
Changes in the fair value of our Level 3 financial instruments during the nine months ended September 30, 2024 were as follows:
| (in thousands) | Common Stock Warrant Liabilities | Clene Nanomedicine Contingent Earn-out | Initial Stockholders Contingent Earn-out | |||||||||
| Balance – December 31, 2023 | $ | $ | $ | |||||||||
| Change in fair value | ( | ) | ( | ) | ( | ) | ||||||
| Change in 2023 Avenue Warrant fair value pursuant to the Third Amendment recorded as a debt discount | ||||||||||||
| Balance – September 30, 2024 | $ | $ | $ | |||||||||
Changes in the fair value of our Level 3 financial instruments during the nine months ended September 30, 2023 were as follows:
| (in thousands) | Common Stock Warrant Liabilities | Clene Nanomedicine Contingent Earn-out | Initial Stockholders Contingent Earn-out | |||||||||
| Balance – December 31, 2022 | $ | $ | $ | |||||||||
| Initial fair value of instruments | ||||||||||||
| Change in fair value | ( | ) | ( | ) | ( | ) | ||||||
| Balance – September 30, 2023 | $ | $ | $ | |||||||||
Valuation of Notes Payable and Convertible Notes Payable
The 2019 MD Loan and the 2019 Cecil Loan are carried at the greater of principal plus accrued interest or the value of the Phantom Shares (see Note 8), which approximates fair value. The 2021 Avenue Loan, the 2022 MD Loan, and the 2022 DHCD Loan are carried at amortized cost, which approximates fair value due to our credit risk and market interest rates. Our notes payable and convertible notes payable are categorized within Level 3 of the fair value hierarchy.
Valuation of the Common Stock Warrant Liabilities
The 2023 Avenue Warrant, as amended, is classified as a liability and carried at fair value. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) settlement of the instrument upon a change of control transaction, (ii) dissolution of the Company, or (iii) another outcome outside of (i)-(ii). These estimates require significant judgment. The carrying amount may fluctuate significantly and the actual settlement amount may be materially different from the estimated fair value. The unobservable inputs to the Black-Scholes option pricing model were as follows:
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Expected stock price volatility | % | % | ||||||
| Risk-free interest rate | % | % | ||||||
| Expected dividend yield | % | % | ||||||
| Expected term (in years) | ||||||||
| Probability of change of control | % | % | ||||||
| Probability of dissolution | % | % | ||||||
| Probability of other outcome | % | % | ||||||
The Tranche A Warrants are classified as a liability and carried at fair value (the Tranche B Warrants qualified for equity classification at issuance). We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) acceptance of an NDA by the FDA for CNM-Au8, (ii) settlement upon a fundamental transaction, (iii) dissolution of the Company, and (iv) another outcome outside of (i)-(iii). These estimates require significant judgment. The carrying amount may fluctuate significantly and the actual settlement amount may be materially different from the estimated fair value. The unobservable inputs to the Black-Scholes option pricing model were as follows:
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Expected stock price volatility | % | % | ||||||
| Risk-free interest rate | % | % | ||||||
| Expected dividend yield | % | % | ||||||
| Expected term (in years) | ||||||||
| Probability of NDA acceptance | % | % | ||||||
| Probability of fundamental transaction | % | % | ||||||
| Probability of dissolution | % | % | ||||||
| Probability of other outcome | % | % | ||||||
Valuation of the Contingent Earn-Out Liabilities
The Contingent Earn-outs are carried at fair value, which is nominal, as determined using a Monte Carlo valuation model in order to simulate the future path of our stock price over the earn-out periods. The carrying amount of the liabilities may fluctuate significantly and actual amounts paid may be materially different from the liabilities’ estimated value. The unobservable inputs to the Monte Carlo valuation model were as follows:
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Expected stock price volatility | % | % | ||||||
| Risk-free interest rate | % | % | ||||||
| Expected dividend yield | % | % | ||||||
| Expected term (in years) | ||||||||
Note 13. Capital Stock
As of September 30, 2024 and December 31, 2023, our amended and restated certificate of incorporation authorized us to issue
Our common stockholders are entitled to one vote per share and to notice of any stockholders’ meeting. Voting, dividend, and liquidation rights of the holders of Common Stock are subject to the prior rights of holders of all classes of stock and are qualified by the rights, powers, preferences, and privileges of the holders of Preferred Stock. No distributions shall be made with respect to Common Stock until all declared dividends to Preferred Stock have been paid or set aside for payment. Common Stock is not redeemable at the option of the holder.
Common Stock Warrants
We have issued the following outstanding warrants to purchase shares of Common Stock:
| Number of Shares Issuable | |||||||||||||||||||
| September 30, | December 31, | ||||||||||||||||||
| Date Exercisable | Exercise Price | Expiration | Classification | 2024 | 2023 | ||||||||||||||
| December 2020 | $ | December 2025 | (1) | Equity | |||||||||||||||
| December 2020 | $ | December 2025 | (2) | Equity | |||||||||||||||
| June 2023 | $ | (3) | June 2028 | (4) | Liability | ||||||||||||||
| June 2023 | $ | June 2026 | (5) | Liability | |||||||||||||||
| June 2023 | $ | June 2030 | (6) | Equity | |||||||||||||||
| Total shares | |||||||||||||||||||
| (1) | Represents |
| (2) | Represents |
| (3) | As of December 31, 2023, the exercise price was $ |
| (4) | Represents |
| (5) | Represents |
| (6) | Represents |
Public Offerings
In June 2023, we sold
Common Stock Sales Agreement
In April 2022, we entered into the ATM Agreement, which we amended in December 2022. Canaccord acts as placement agent and we may offer and sell shares of Common Stock from time to time through Canaccord. The issuance and sale of Common Stock by us under the ATM Agreement is made pursuant to our registration statement on Form S-3 (file number 333-264299), which was declared effective by the SEC on April 26, 2022. On September 30, 2024, we notified Canaccord that we were suspending the prospectus supplement related to the ATM Agreement. We will not make any sales of our common stock pursuant to the ATM Agreement, unless and until a new prospectus supplement is filed. Other than the termination of the prospectus supplement related to the ATM Agreement, the ATM Agreement remains in full force and effect.
Pursuant to the ATM Agreement, Canaccord is required to sell any specific number or dollar amount of Common Stock but will act as our placement agent to sell, on our behalf, all of the Common Stock requested by us to be sold, consistent with Canaccord’s normal trading and sales practices, on terms mutually agreed between Canaccord and us. Canaccord is entitled to compensation at a fixed commission rate of
Common Stock Purchase Agreement
On March 3, 2023, we entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $
Pursuant to the Purchase Agreement, we may direct Lincoln Park to purchase up to
On the date of the Purchase Agreement, we issued
We evaluated the Purchase Agreement under ASC 815-40 Derivatives and Hedging—Contracts on an Entity's Own Equity as it represents the right to require Lincoln Park to purchase shares of Common Stock in the future, similar to a put option. We concluded it represents a freestanding derivative instrument that does not qualify for equity classification and therefore requires fair value accounting. We analyzed the terms of the contract and concluded the derivative instrument has value as of September 30, 2024 and December 31, 2023. During the nine months ended September 30, 2023, we sold
Note 14. Net Loss Per Share
The computation of basic and diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2024 and 2023 was as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands, except share and per share data) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Numerator: | ||||||||||||||||
| Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Denominator: | ||||||||||||||||
| Weighted average common shares outstanding | ||||||||||||||||
| Net loss per share attributable to common stockholders – basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
The following shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2024 and 2023 because they were antidilutive, out-of-the-money, or the issuance of such shares is contingent upon certain conditions which were not satisfied by the end of the period:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Convertible notes payable (see Note 8) | | | | | ||||||||||||
| Common stock warrants (see Note 13) | | | | | ||||||||||||
| Options to purchase common stock (see Note 11) | | | | | ||||||||||||
| Unvested restricted stock awards (see Note 11) | | | | | ||||||||||||
| Contingent earn-out shares (see Note 2) | | | | | ||||||||||||
| Total shares excluded from diluted net loss per share | | | | | ||||||||||||
Note 15. Related Party Transactions
License and Supply Agreements
In August 2018, we entered into a license agreement (the “License Agreement”) and exclusive supply agreement (the “Supply Agreement”) in conjunction with 4Life’s investment in the Series C preferred stock and warrants of our predecessor. On April 25, 2024, we entered into an amendment to the License Agreement and Supply Agreement (the “Amended 4Life Agreements”). The Amended 4Life Agreements contain the following terms:
| ● | Supply Agreement. We granted 4Life, or its affiliates and mutually-agreed upon manufacturing vendors (the “Buyer Purchasing Parties”) an exclusive right to purchase certain of our dietary supplement and non-pharmaceutical products (the “Licensed Products”), and we shall exclusively sell the Licensed Products to the Buyer Purchasing Parties. The purchase price of Licensed Products shall be equal to our cost plus |
| ● | License Agreement. We granted 4Life an exclusive, royalty bearing license to use, sell, and commercialize the Licensed Products. On a quarterly basis, 4Life shall pay us a royalty rate of |
We currently provide an aqueous zinc-silver ion dietary (mineral) supplement to 4Life, which is sold by 4Life under the tradename Zinc Factor™; and an aqueous gold dietary (mineral) supplement of very low-concentration gold nanoparticles, which is sold by 4Life under the tradename Gold Factor™. Total revenue under the License and Supply Agreements during the three and nine months ended September 30, 2024 and 2023 was as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Product revenue from related parties | $ | $ | $ | $ | ||||||||||||
| Royalty revenue from related parties | ||||||||||||||||
| Total revenue from related parties | $ | $ | $ | $ | ||||||||||||
Note 16. Subsequent Events
On October 1, 2024, we closed a registered direct offering (the “Offering”) pursuant to a placement agency agreement with Canaccord, pursuant to which Canaccord acted as our exclusive placement agent in connection with the offer and sale of
Additionally, in separate, concurrent Private Placements, we also sold
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements reflecting our or our management team’s expectations, hopes, beliefs, intentions, strategies, estimates, and assumptions concerning events and financial trends that may affect our future financial condition or results of operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Actual results and the timing of events may differ materially from those contained in these forward-looking statements due to a number of factors, including those discussed in the section titled “Risk Factors” in our Annual Report on Form 10-K. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws. Unless the context otherwise requires, for purposes of this section, the terms the “Company,” “we,” “us,” or “our” are intended to mean the business and operations of Clene Inc. and its consolidated subsidiaries.
Business Overview
We are a clinical-stage pharmaceutical company pioneering the discovery, development, and commercialization of novel clean-surfaced nanotechnology (“CSN®”) therapeutics. CSN® therapeutics are comprised of atoms of transition elements that, when assembled in nanocrystal form, possess unusually high, unique catalytic activities not present in those same elements in bulk form. These catalytic activities drive, support, and maintain beneficial metabolic and energetic cellular reactions within diseased, stressed, and damaged cells.
Our patent-protected, proprietary position affords us the potential to develop a broad and deep pipeline of novel CSN therapeutics to address a range of diseases with high impact on human health. We innovated an electro-crystal-chemistry drug development platform that draws from advances in nanotechnology, plasma and quantum physics, material science, and biochemistry. Our platform process results in nanocrystals with faceted structures and surfaces that are free of the chemical surface modifications that accompany other production methods. Many traditional methods of nanoparticle synthesis involve the unavoidable deposition of potentially toxic organic residues and stabilizing surfactants on the particle surfaces. Synthesizing stable nanocrystals that are both nontoxic and highly catalytic has overcome this significant hurdle in harnessing transition metal catalytic activity for therapeutic use. Our clean-surfaced nanocrystals exhibit catalytic activities many-fold higher than multiple other commercially available nanoparticles, produced using various techniques, that we have comparatively evaluated.
We have multiple drug assets currently in development and/or clinical trials for applications primarily in neurology. Our development and clinical efforts are currently focused on addressing the high unmet medical needs in central nervous system disorders including amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”), and Parkinson’s disease (“PD”). We currently have no drugs approved for commercial sale and have not generated any revenue from drug sales. We have never been profitable and have incurred operating losses in each year since inception. We generate revenue from sales of dietary supplements through our wholly owned subsidiary, dOrbital, Inc., or through an exclusive license with 4Life Research LLC (“4Life”), an international supplier of health supplements, stockholder, and related party. We anticipate these revenues to be small compared to our operating expenses and to the revenue we expect to generate from potential future sales of our drug candidates, for which we are currently conducting clinical trials.
Reverse Recapitalization
Clene Nanomedicine, Inc. (“Clene Nanomedicine”) became a public company on December 30, 2020 (the “Closing Date”) when it completed a reverse recapitalization (the “Reverse Recapitalization”) with Tottenham Acquisition I Limited (“Tottenham”), and with Tottenham’s wholly-owned subsidiary and our predecessor, Chelsea Worldwide Inc., and Creative Worldwide Inc., a wholly-owned subsidiary of Chelsea Worldwide Inc. On the Closing Date, Chelsea Worldwide Inc. changed its name to Clene Inc. and listed its shares of common stock, par value $0.0001 per share (“Common Stock”) on the Nasdaq Capital Market (“Nasdaq”) under the symbol “CLNN.”
In connection with the Reverse Recapitalization, certain of Clene Nanomedicine’s common stockholders are entitled to receive earn-out payments (the “Clene Nanomedicine Contingent Earn-out”), and Tottenham’s former officers and directors and Norwich Investment Limited (collectively, the “Initial Stockholders”) are entitled to receive earn-out payments (the “Initial Stockholders Contingent Earn-out,” and both collectively the “Contingent Earn-outs”) based on achieving certain milestones.
Reverse Stock Split
Effective July 11, 2024 (the “Effective Date”), we filed a Certificate of Amendment to our Fourth Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware, to effect a 1-for-20 reverse stock split (the “Reverse Stock Split”) of our Common Stock. Beginning with the opening of trading on the Effective Date, our Common Stock began trading on Nasdaq on a split-adjusted basis under the same symbol, “CLNN.” As a result of the Reverse Stock Split, every 20 shares of our Common Stock issued and outstanding were automatically combined and converted into 1 validly issued, fully paid and non-assessable share of Common Stock. In lieu of any fractional shares, stockholders received an amount in cash (without interest) equal to: (i) the number of shares of Common Stock held by such stockholder before the Reverse Stock Split that would otherwise have been exchanged for such fractional shares multiplied by (ii) the closing price of our Common Stock on Nasdaq on the trading day immediately preceding the Effective Date.
The Reverse Stock Split did not reduce the total number of authorized shares of Common Stock or preferred stock, par value $0.0001 per share (“Preferred Stock”), or change the par values of the Company’s Common Stock or Preferred Stock. All outstanding stock options, warrants, rights to restricted stock awards, convertible debt, and contingent earn-out shares entitling their holders to purchase or receive shares of Common Stock were adjusted as a result of the Reverse Stock Split, in accordance with the terms of each such security. In addition, the number of shares reserved for issuance pursuant to our Amended 2020 Stock Plan was also appropriately adjusted. All historical share and per share data for the periods presented in our condensed consolidated financial statements, including for periods ending prior to July 11, 2024, has been adjusted to reflect the 1-for-20 Reverse Stock Split on a retroactive basis as if the Reverse Stock Split occurred as of the earliest period presented.
Recent Developments of Our Clinical Programs
Amyotrophic Lateral Sclerosis
On November 1, 2024, we met with the FDA in a Type C meeting that we previously announced on September 16, 2024 and are awaiting minutes from that meeting. We are also planning to execute an international confirmatory Phase 3 trial of CNM-Au8 30 mg, RESTORE-ALS, and expect to initiate the trial in the second quarter of 2025, contingent upon the outcome of the Type C meeting and funding. We announced the following planned design of RESTORE-ALS at the 2024 Annual Northeast ALS Consortium (“NEALS”) Meeting on October 23, 2024:
| ● |
Objective: to investigate the effects of CNM-Au8 on survival and delayed clinical worsening events in ALS. |
| ● |
Participant criteria: ALS diagnosis per Gold Coast criteria; symptom onset within 36 months of the screening visit; ≥ 60% predicted vital capacity; TRICALS risk score of -2.5 to -6.5; screening biofluid (plasma) neurofilament light ≥ 45 pg/mL; stable background treatment (e.g. riluzone, edaravone, both). |
| ● |
Locations: North America, Europe, Australia, and Asia/Pacific. |
| ● |
Enrollment: approximately 561 randomized participants, 2:1 treatment allocation with approximately n = 374 active CNM-Au8 30 mg and n = 187 placebo. |
| ● |
Duration: double-blind treatment period until 190 events accrue, with open-label extension continued until study is terminated or study drug is approved. |
| ● |
Primary endpoint: delayed time to death (all-cause mortality); assumed hazard ratio of 0.625; one-sided alpha of < 0.025; power = 87% with 190 events. |
| ● |
Secondary endpoints: (i) time to death or death equivalent (“PAV”), (ii) composite ALS clinical worsening hierarchy, (iii) joint-rank of time to death or PAV and ALSSQOL-SF change to week 72, (iv) joint-rank of time to death or PAV and ALSFRS-R change to week 72, (v) joint-rank of time to death or PAV and ROADs change to week 72, (vi) joint-rank of time to death or PAV and SVC percent change to week 72. |
| ● |
Statistical model: covariate adjusted cox proportional hazard. |
We plan to continue working closely with regulatory health authorities from the FDA, European Medicines Agency, ALS experts, and patient representatives to determine the proper path to support potential approval.
Multiple Sclerosis
We have initiated a second dosing cohort of REPAIR-MS, an open-label, investigator blinded Phase 2 clinical trial in non-active progressive MS patients. We anticipate enrollment concluding by the end of 2024 with topline results available by mid-2025. We plan to work closely with regulatory health authorities from the FDA and EMA, MS experts, and patient representatives to determine the proper path to advance CNM-Au8 into Phase 3 and potential future approval. We expect to meet with the FDA in an end of Phase 2 meeting in the first half of 2025.
The chart below reflects the growing body of evidence for CSN therapeutics from our completed and ongoing clinical programs.
Recent Competition Update
Despite the great need for an effective disease-modifying treatment for ALS and significant research efforts by the pharmaceutical industry to meet this need, there have been limited clinical successes and no curative therapies approved to date. In April 2023, the FDA granted accelerated approval to tofersen, branded as Qalsody, a drug from Biogen Inc. for the treatment of SOD1-ALS, a rare genetic form of ALS. In May 2024, the European Commission granted marketing authorization under exceptional circumstances for Qalsody in the European Union. Additionally, sodium phenylbutyrate and taurursodiol, a drug from Amylyx Pharmaceuticals, Inc. which previously received approval from the FDA and conditional approval from Health Canada based on the results of a Phase 2 trial, was voluntarily withdrawn from the market in the U.S. and Canada following the negative outcome of a Phase 3 clinical trial.
Financial Overview
Our financial condition, results of operations, and the period-to-period comparability of our financial results are principally affected by the following factors:
Research and Development Expense
The discovery and development of novel drug candidates require a significant investment of resources over a prolonged period of time, and a core part of our strategy is to continue making sustained investments in this area. As a result of this commitment, our pipeline of drug candidates has been advancing, with substantially all our research and development expenses relating to CNM-Au8, our lead asset, with the remainder spent on our CNM-ZnAg asset.
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 decrease throughout 2024 as we complete our Phase 2 clinical trials and will increase in future years if and when we advance our assets into Phase 3. Additionally, if we are able to file an NDA with the FDA under an accelerated approval pathway or subsequent to future Phase 3 clinical development activities, if any, we anticipate that our research and development expenses related to regulatory activities would increase in advance of receiving regulatory approval.
Research and development costs consist primarily of payroll and personnel expenses for salaries, benefits, and stock-based compensation; supplies and materials expenses to support our clinical trials; payments to CROs, principal investigators, and clinical trial sites; costs of preclinical activities; consulting costs; and allocated overhead costs, including rent, equipment, utilities, depreciation, insurance, and facilities maintenance. 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.
Our clinical trial accrual process seeks to account for expenses resulting from obligations under contracts with CROs, consultants, and clinical sites in connection with conducting clinical trials. The financial terms of these contracts vary and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts. We reflect the appropriate clinical trial expenses in the condensed consolidated financial statements by matching the appropriate expenses with the period in which services are performed. In the event advance payments are made to CROs, the payments are recorded as prepaid assets and expensed over the period in which services are performed.
General and Administrative Expense
General and administrative expenses consist primarily of payroll and personnel expenses for salaries, benefits, and stock-based compensation; fees for legal, accounting, tax, and information technology services; fees for directors’ and officers’ insurance; expenses for business development activities and investor and public relations; rent, utilities, and facility costs; travel costs; and consulting fees.
We anticipate that our general and administrative expenses in future periods will be contingent upon our discussions with the FDA. If we are able to file an NDA with the FDA under an accelerated 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 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 pathway, we would need to continue investing in clinical research activities and we anticipate our general and administrative expenses would decrease in future periods as we decrease commercial expansion projects, including at our Elkton, Maryland facility, and as we implement cost-saving initiatives, such as a reduction in compensation, a hiring freeze, and elimination of certain staff positions.
Total Other Income (Expense), Net
Total other income (expense), net, consists primarily of (i) interest income and interest expense, (ii) commitment share expense from shares of Common Stock issued as a commitment fee, (iii) issuance costs for common stock warrant liabilities, (iv) a loss on initial issuance of equity from the fair value in excess of proceeds from a public equity offering, (v) changes in the fair value of our common stock warrant liabilities and Contingent Earn-outs, (vi) research and development tax credits, unrestricted grants, and conditional grants for which applicable conditions have been met, and (vii) realized gains and losses on foreign currency transactions and other miscellaneous income and expense items.
Results of Operations
Our results of operations for the three and nine months ended September 30, 2024 and 2023 were as follows:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||||||
| (in thousands) |
2024 |
2023 |
Change |
2024 |
2023 |
Change |
||||||||||||||||||
| Revenue: |
||||||||||||||||||||||||
| Product revenue |
$ | 65 | $ | 65 | 0 | % | $ | 173 | $ | 355 | (51 | )% | ||||||||||||
| Royalty revenue |
22 | 43 | (49 | )% | 78 | 129 | (40 | )% | ||||||||||||||||
| Total revenue |
87 | 108 | (19 | )% | 251 | 484 | (48 | )% | ||||||||||||||||
| Operating expenses: |
||||||||||||||||||||||||
| Cost of revenue |
18 | 12 | 50 | % | 52 | 83 | (37 | )% | ||||||||||||||||
| Research and development |
4,471 | 5,972 | (25 | )% | 14,490 | 19,982 | (27 | )% | ||||||||||||||||
| General and administrative |
3,413 | 3,666 | (7 | )% | 10,147 | 11,029 | (8 | )% | ||||||||||||||||
| Total operating expenses |
7,902 | 9,650 | (18 | )% | 24,689 | 31,094 | (21 | )% | ||||||||||||||||
| Loss from operations |
(7,815 | ) | (9,542 | ) | (18 | )% | (24,438 | ) | (30,610 | ) | (20 | )% | ||||||||||||
| Total other income (expense), net |
(171 | ) | 7,124 | * | (1,413 | ) | (8,721 | ) | (84 | )% | ||||||||||||||
| Net loss |
$ | (7,986 | ) | $ | (2,418 | ) | 230 | % | $ | (25,851 | ) | $ | (39,331 | ) | (34 | )% | ||||||||
Revenue
Product revenue relates to our dietary supplement products and consists of (i) sales of an aqueous zinc-silver ion dietary (mineral) supplement sold by our wholly-owned subsidiary, dOrbital, Inc., under the trade name “rMetx™ ZnAg Immune Boost,” or under a supply agreement with 4Life under the trade name “Zinc Factor™,” and (ii) sales of KHC46, an aqueous gold dietary (mineral) supplement of very low concentration, sold under a supply agreement with 4Life under the trade name “Gold Factor™.” Royalty revenue relates to our dietary supplement products and consists of proceeds under an exclusive and royalty-bearing license agreement with 4Life relating to the sale of Gold Factor. During the three and nine months ended September 30, 2024 and 2023, changes in product and royalty revenues were due to the timing of purchases of Zinc Factor and Gold Factor by 4Life under the supply and license agreements.
Cost of Revenue
Cost of revenue relates to production and distribution costs for the sales of Gold Factor, Zinc Factor, and rMetx dietary supplements.
Research and Development Expense
Research and development expense during the three and nine months ended September 30, 2024 and 2023 was as follows:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||||||
| (in thousands) |
2024 |
2023 |
Change |
2024 |
2023 |
Change |
||||||||||||||||||
| CNM-Au8 |
$ | (278 | ) | $ | 1,207 | * | $ | 53 | $ | 5,172 | (99 | )% | ||||||||||||
| CNM-ZnAg |
4 | (284 | ) | * | 17 | 645 | (97 | )% | ||||||||||||||||
| Unallocated |
1,167 | 1,702 | (31 | )% | 3,853 | 4,082 | (6 | )% | ||||||||||||||||
| Personnel |
2,516 | 2,262 | 11 | % | 7,725 | 6,901 | 12 | % | ||||||||||||||||
| Stock-based compensation |
1,062 | 1,085 | (2 | )% | 2,842 | 3,182 | (11 | )% | ||||||||||||||||
| Total research and development |
$ | 4,471 | $ | 5,972 | (25 | )% | $ | 14,490 | $ | 19,982 | (27 | )% | ||||||||||||
| * |
Not meaningful. |
The change in research and development expenses was primarily due to the following:
| (i) |
a decrease in expenses related to our lead drug candidate, CNM-Au8, primarily due to: (i) reimbursements for expenses incurred during the period from September 25, 2023 to August 31, 2024 for our ongoing ALS expanded access program (“EAP”) funded by a National Institute of Health grant (the “ACT-EAP”) which were received during the three and nine months ended September 30, 2024 and recorded as an offset to research and development expense, (ii) a decrease in expenses in the HEALEY ALS Platform Trial, RESCUE-ALS, REPAIR-MS, and VISIONARY-MS clinical trials due to the previous completion of the blinded period of each trial, (iii) a decrease in expenses for the VISIONARY-MS LTE due to its completion, and (iv) a decrease in non-clinical and pre-clinical activities; partially offset by an increase in expenses related to: (A) our two ALS EAPs with Massachusetts General Hospital due to increased enrollment and expansion of one EAP, (B) our REPAIR-MS EAP, (C) planning activities for our RESTORE-ALS clinical trial, and (D) increased regulatory activities; |
| (ii) |
a decrease in expenses related to CNM-ZnAg, primarily due to completion of the clinical trial for treatment of COVID-19 in late 2022 with expenses continuing through 2023; |
| (iii) |
a decrease in unallocated expenses, primarily due to a decrease in expenses related to research, manufacturing, equipment, materials, facilities, and depreciation. |
| (iv) |
an increase in personnel expenses, primarily due to an increase in compensation expense related to the ACT-EAP and our regulatory activities; and |
| (v) |
a decrease in stock-based compensation expense, primarily due to the timing of award grants, vesting, and forfeitures for research and development personnel. |
General and Administrative Expense
General and administrative expense during the three and nine months ended September 30, 2024 and 2023 was as follows:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||||||
| (in thousands) |
2024 |
2023 |
Change |
2024 |
2023 |
Change |
||||||||||||||||||
| Directors’ and officersʼ insurance |
$ | 188 | $ | 398 | (53 | )% | $ | 561 | $ | 1,195 | (53 | )% | ||||||||||||
| Legal |
290 | 35 | 729 | % | 649 | 296 | 119 | % | ||||||||||||||||
| Finance and accounting |
192 | 489 | (61 | )% | 565 | 1,207 | (53 | )% | ||||||||||||||||
| Public and investor relations |
156 | 94 | 66 | % | 589 | 362 | 63 | % | ||||||||||||||||
| Personnel |
1,000 | 1,011 | (1 | )% | 3,140 | 3,184 | (1 | )% | ||||||||||||||||
| Stock-based compensation |
1,126 | 1,311 | (14 | )% | 3,310 | 3,888 | (15 | )% | ||||||||||||||||
| Other |
461 | 328 | 41 | % | 1,333 | 897 | 49 | % | ||||||||||||||||
| Total general and administrative |
$ | 3,413 | $ | 3,666 | (7 | )% | $ | 10,147 | $ | 11,029 | (8 | )% | ||||||||||||
The change in general and administrative expense was primarily due to the following:
| (i) |
a decrease in directors’ and officers’ insurance fees; |
| (ii) |
an increase in legal fees, primarily due to an increase in legal fees related to regulatory activities, the ACT-EAP, and intellectual property; partially offset by a decrease in legal fees related to financing and fundraising; |
| (iii) |
a decrease in finance and accounting fees, primarily due to a decrease in fees from consultants, advisors, and other financial vendors; partially offset by increased tax and audit fees; |
| (iv) |
an increase in fees related to our public and investor relations efforts; |
| (v) |
a decrease in stock-based compensation expense, primarily due to the timing of award grants, vesting, and forfeitures for general and administrative personnel; and |
| (vi) |
an increase in other expenses, primarily due to an increase in expenses related to lobbying activities and office and professional expenses; partially offset by a decrease in expenses related to supplies and equipment, property and casualty insurance, information technology, facilities, and travel. |
Total Other Income (Expense), Net
Total other income (expense), net, during the three and nine months ended September 30, 2024 and 2023 was as follows:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||||||
| (in thousands) |
2024 |
2023 |
Change |
2024 |
2023 |
Change |
||||||||||||||||||
| Interest income |
$ | 127 | $ | 546 | (77 | )% | $ | 755 | $ | 931 | (19 | )% | ||||||||||||
| Interest expense |
(1,022 | ) | (1,188 | ) | (14 | )% | (3,548 | ) | (3,358 | ) | 6 | % | ||||||||||||
| Commitment share expense |
— | — | * | — | (402 | ) | * | |||||||||||||||||
| Issuance costs for common stock warrant liabilities |
— | — | * | — | (333 | ) | * | |||||||||||||||||
| Loss on initial issuance of equity |
— | — | * | — | (14,840 | ) | * | |||||||||||||||||
| Change in fair value of common stock warrant liabilities |
697 | 6,341 | (89 | )% | 956 | 5,958 | (84 | )% | ||||||||||||||||
| Change in fair value of Clene Nanomedicine contingent earn-out liability |
— | 1,004 | * | 75 | 2,114 | (96 | )% | |||||||||||||||||
| Change in fair value of Initial Stockholders contingent earn-out liability |
— | 129 | * | 10 | 272 | (96 | )% | |||||||||||||||||
| Research and development tax credits and unrestricted grants |
27 | 247 | (89 | )% | 339 | 902 | (62 | )% | ||||||||||||||||
| Other income, net |
— | 45 | * | — | 35 | * | ||||||||||||||||||
| Total other income (expense), net |
$ | (171 | ) | $ | 7,124 | * | $ | (1,413 | ) | $ | (8,721 | ) | (84 | )% | ||||||||||
| * |
Not meaningful. |
The change in total other income (expense), net, was primarily due to the following:
| (i) |
a decrease in interest income primarily due to lower average balances of cash, cash equivalents, and marketable securities in 2024; |
| (ii) |
a decrease in interest expense during the three months ended September 30, 2024 primarily due to declining balances of notes payable following principal repayments and a decrease in non-cash interest expense on notes payable, partially offset by increased amortization of debt discounts and issuances costs on notes payable; and an increase in interest expense during the nine months ended September 30, 2024 primarily due to increasing variable interest rates on our notes payable and increased amortization of debt discounts and issuance costs on notes payable, partially offset by a decrease in non-cash interest expense on notes payable; |
| (iii) |
commitment share expense, due to the shares of Common Stock issued to Lincoln Park Capital Fund, LLC (“Lincoln Park”), as an initial fee for Lincoln Park’s commitment to purchase shares of Common Stock under a purchase agreement with the Company during the nine months ended September 30, 2023; |
| (iv) |
issuance costs from a public equity offering allocated to liability-classified warrants during the nine months ended September 30, 2023; |
| (v) |
a loss on initial issuance of equity from the fair value in excess of proceeds from a public equity offering during the nine months ended September 30, 2023; |
| (vi) |
a gain from a change in fair value of the common stock warrant liability due to the 2023 Avenue Warrant and Tranche A Warrants during the three and nine months ended September 30, 2024. The changes in fair value were due to the change in price of our Common Stock on Nasdaq and updates in the valuation model assumptions (see “Critical Accounting Estimates”); |
| (vii) |
a gain from a change in fair value of the Clene Nanomedicine Contingent Earn-out liability and Initial Stockholders Contingent Earn-out liability during the three and nine months ended September 30, 2024. The changes were due to the price of our Common Stock on Nasdaq and updates in the valuation model assumptions (see “Critical Accounting Estimates”); and |
| (viii) |
a decrease in research and development tax credits and unrestricted grants due to changes in the amount of qualifying research and development expenses incurred. |
Taxation
United States
We are incorporated in the state of Delaware and subject to statutory U.S. federal corporate income tax at a rate of 21.00%. We are also subject to state income tax in Maryland at a rate of 8.25%, and in Utah at a rate of 4.55% and 4.65% for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024 and December 31, 2023, we recorded a full valuation allowance against our net deferred tax assets due to the uncertainty as to whether such assets will be realized resulting from our three-year cumulative loss position and the uncertainty surrounding our ability to generate pre-tax income in the foreseeable future.
Australia
Our wholly-owned subsidiary, Clene Australia Pty Ltd (“Clene Australia”), was established in Australia in March 2018 and is subject to corporate income tax at a rate of 30.00%. Clene Australia had no taxable income or provision for income taxes for the nine months ended September 30, 2024 and 2023. We recorded other income of $0.1 million and $0.9 million for the nine months ended September 30, 2024 and 2023, respectively, for research and development tax credits pertaining to Clene Australia for the 2024 and 2023 tax years, respectively.
Netherlands
Our wholly-owned subsidiary, Clene Netherlands B.V. (“Clene Netherlands”), was established in the Netherlands in April 2021 and is subject to corporate income tax at a rate of 19.00% up to €200,000 of taxable income and 25.80% for taxable income in excess of €200,000. Clene Netherlands had no taxable income or provision for income taxes for the nine months ended September 30, 2024 and 2023.
Liquidity and Capital Resources
Sources of Capital
We have incurred significant losses and negative cash flows from operations since our inception. We expect to incur additional losses in the future to fund our operations and conduct research and development of our drug candidates. We recognize the need to raise additional capital to fully implement our business plan. The long-term continuation of our business plan is dependent upon the generation of sufficient revenues from our products to offset expenses and capital expenditures. In the event that we do not generate sufficient revenues and are unable to obtain funding, we will be forced to delay, reduce, or eliminate some or all of our research and development programs, product portfolio expansion, commercialization efforts, or capital expenditures, which could adversely affect our business prospects, ability to meet long-term liquidity needs, or we may be unable to continue operations.
Since our inception, we have dedicated substantially all our resources to the development of our drug candidates. We have financed our operations principally through the following sources:
| ● | gross proceeds of $177.2 million from equity financing, including sales of common stock, preferred stock, warrants to purchase common stock; |
| ● | gross proceeds of $32.3 million from borrowings under convertible promissory notes; |
| ● | gross proceeds of $27.3 million from borrowings under notes payable and convertible notes payable; |
| ● | gross proceeds of $9.4 million from the Reverse Recapitalization; |
| ● | gross proceeds of $10.1 million from refundable research and development tax credits; |
| ● | gross proceeds of $7.6 million from grants from various organizations; and |
| ● | gross proceeds of $1.1 million from stock option and warrant exercises. |
We also received indirect financial support for the HEALEY ALS Platform Trial, administered by Massachusetts General Hospital, which conducted a platform trial for the treatment of ALS with certain drug candidates, including CNM-Au8, at significantly lower costs than we would have otherwise incurred if we had conducted a comparably designed clinical trial at reasonable market rates.
Going Concern
We incurred a loss from operations of $7.8 million and $9.5 million for the three months ended September 30, 2024 and 2023, respectively; and $24.4 million and $30.6 million for the nine months ended September 30, 2024 and 2023, respectively. Our accumulated deficit was $268.6 million and $242.7 million as of September 30, 2024 and December 31, 2023, respectively. Our cash, cash equivalents, and marketable securities totaled $14.6 million and $35.0 million as of September 30, 2024 and December 31, 2023, respectively, and net cash used in operating activities was $16.5 million and $23.0 million for the nine months ended September 30, 2024 and 2023, respectively.
We have incurred significant losses and negative cash flows from operations since our inception. We have not generated significant revenues since our inception, and we do not anticipate generating significant revenues unless we successfully complete development and obtain regulatory approval for commercialization of a drug candidate. We expect to incur additional losses in the future, particularly as we advance the development of our clinical-stage drug candidates, continue research and development of our preclinical drug candidates, and initiate additional clinical trials of, and seek regulatory approval for, these and other future drug candidates. We expect that within the next twelve months, we will not have sufficient cash and other resources on hand to sustain our current operations or meet our obligations as they become due unless we obtain additional financing. Additionally, pursuant to our term loan with Avenue Venture Opportunities Fund, L.P. (“Avenue”), we are required to maintain unrestricted cash and cash equivalents of at least $5.0 million to avoid acceleration of the full balance of the loan (see Note 8 to the condensed consolidated financial statements). These conditions raise substantial doubt about the Company’s ability to continue as a going concern.
To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as well as utilizing our existing at-the-market facility and equity purchase agreement and potential proceeds from the exercise of outstanding warrants and stock options. These plans are subject to market conditions and reliance on third parties, and there is no assurance that effective implementation of our plans will result in the necessary funding to continue current operations. During the three months ended September 30, 2024, we generated $2.1 million of gross proceeds from our equity distribution agreement (the “ATM Agreement”) and subsequent to September 30, 2024, we raised $3.5 million from a registered direct offering of equity securities and an additional $3.8 million that we received as of September 30, 2024 from separate, concurrent private placements of equity securities that closed on October 1, 2024. We have implemented cost-saving initiatives, including delaying and reducing certain research and development programs and commercialization efforts and elimination of certain staff positions. We have concluded that our plans do not alleviate the substantial doubt about our ability to continue as a going concern beyond one year from the date the condensed consolidated financial statements are issued.
The accompanying condensed consolidated financial statements have been prepared assuming we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. As a result, the accompanying condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amounts and classification of liabilities that may result should we be unable to continue as a going concern.
Short-Term Material Cash Requirements
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; and general and administrative costs to support our drug development and pre-commercial activities in advance of receiving regulatory approval for our drug candidates. Firm commitments for funds include approximately $1.1 million of payments under operating lease obligations; payment of principal and interest on notes payable totaling $11.0 million; and commitments under various agreements 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.
We enter into agreements in the normal course of business with CROs for clinical trials and with vendors for preclinical studies and other services and products for operating purposes, which are cancelable at any time by us, subject to payment of our remaining obligations under binding purchase orders and, in certain cases, nominal early termination fees. These commitments are not deemed significant.
Long-Term Material Cash Requirements
Beyond the next twelve months, our primary capital requirements are to fund our operations, including research and development, personnel, regulatory, and other clinical trial costs related to development of our lead drug candidate, CNM-Au8; and general and administrative costs to support our drug development activities in advance of receiving regulatory approval for our drug candidates. Additional funds may be spent to initiate new clinical trials, at our discretion. Known obligations beyond the next twelve months include $5.5 million of payments under operating lease obligations, and interest and principal repayment of notes payable of $7.7 million. We expect to meet our long-term liquidity requirements primarily through equity financing, debt financing, or other capital sources.
Use of Funds
Our cash flows for the nine months ended September 30, 2024 and 2023 were as follows:
| Nine Months Ended September 30, |
||||||||
| (in thousands) |
2024 |
2023 |
||||||
| Net cash used in operating activities |
$ | (16,461 | ) | $ | (22,999 | ) | ||
| Net cash provided by investing activities |
6,318 | 4,713 | ||||||
| Net cash provided by (used in) financing activities |
(4,057 | ) | 42,181 | |||||
| Effect of foreign exchange rate changes on cash |
24 | (114 | ) | |||||
| Net increase (decrease) in cash, cash equivalents and restricted cash |
$ | (14,176 | ) | $ | 23,781 | |||
Our primary use of cash in all periods presented was to fund our research and development, regulatory and other clinical trial costs, and general corporate expenditures.
Operating Activities
Net cash used in operating activities was $16.5 million for the nine months ended September 30, 2024, which resulted from a net loss of $25.9 million, adjusted for non-cash items totaling $7.8 million and a net change in operating assets and liabilities of $1.6 million. Significant non-cash items included: (i) depreciation expense of $1.2 million for laboratory and office equipment and leasehold improvements; (ii) non-cash lease expense of $0.4 million; (iii) stock-based compensation expense of $6.2 million; (iv) accretion of debt discount of $1.2 million; (v) non-cash interest expense of $40,000; (vi) non-cash interest income on marketable securities of $0.2 million; (vii) a change in fair value of common stock warrant liabilities of $1.0 million due to changes in the price of our Common Stock on Nasdaq and changes in valuation model inputs; and (viii) a change in fair value of the Clene Nanomedicine and Initial Stockholders Contingent Earn-outs of $0.1 million and $10,000, respectively, due to changes in the price of our Common Stock on Nasdaq and changes in valuation model inputs. The net change in operating assets and liabilities was primarily attributable to: (a) 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; (b) an increase in prepaid expenses and other current assets of $1.2 million due to the timing of vendor invoicing and payments, the timing of receipt of metals to be used in research and development, and an increase in prepaid ACT-EAP expenses, partially offset by a decrease in research and development tax credits receivable; (c) an increase in accrued liabilities of $2.9 million primarily due to increased accrued compensation and benefits, increased deferred grants, and an increase in accrued CRO and clinical fees; and (d) a decrease in operating lease obligations of $0.4 million.
Net cash used in operating activities was $23.0 million for the nine months ended September 30, 2023, which resulted from a net loss of $39.3 million, adjusted for non-cash items totaling $17.0 million and a net change in operating assets and liabilities of $0.7 million. Significant non-cash items included: (i) depreciation expense of $1.3 million for laboratory and office equipment and leasehold improvements; (ii) non-cash lease expense of $0.3 million; (iii) commitment share expense of $0.4 million for shares of Common Stock issued to Lincoln Park as an initial fee for their commitment to purchase shares of our Common Stock under a purchase agreement; (iv) issuance costs of $0.3 million for liability-classified warrants issued in a public equity offering; (v) a loss on initial issuance of equity of $14.8 million from the fair value in excess of proceeds from a public equity offering; (vi) stock-based compensation expense of $7.1 million; (vii) accretion of debt discount of $0.8 million; (viii) non-cash interest expense of $0.3 million; (ix) a change in fair value of the Clene Nanomedicine and Initial Stockholders Contingent Earn-outs of $2.1 million and $0.3 million, respectively, due to the decrease in price of our Common Stock on Nasdaq and changes in valuation model inputs; and (x) a change in fair value of common stock warrant liabilities of $6.0 million due to the increase in price of our Common Stock on Nasdaq and changes in valuation model inputs. The net change in operating assets and liabilities was primarily attributable to: (a) a decrease in accounts receivable of $0.1 million and a decrease in accounts payable of $1.1 million due to the timing of vendor invoicing and payments; (b) an increase in inventory of $0.1 million; (c) a decrease in prepaid expenses and other current assets of $1.5 million due to the timing of vendor invoicing and payments, the timing of receipt of metals to be used in research and development, and a decrease in research and development tax credits receivable; (d) a decrease in accrued liabilities of $0.7 million primarily due to decreased accrued compensation and benefits and CRO and clinical fees; and (e) a decrease in operating lease obligations of $0.4 million.
Investing Activities
Net cash provided by investing activities was $6.3 million for the nine months ended September 30, 2024, which consisted of proceeds from maturities of marketable securities of $12.5 million, partially offset by purchases of marketable securities of $6.2 million and purchases of property and equipment of $14,000. Net cash provided by investing activities was $4.7 million for the nine months ended September 30, 2023, which consisted of proceeds from maturity of marketable securities of $5.0 million, partially offset by purchases of property and equipment of $0.3 million.
Financing Activities
Net cash used in financing activities was $4.1 million for the nine months ended September 30, 2024, which consisted of proceeds from the exercise of stock options of $0.1 million, proceeds from the issuance of common stock of $2.0 million, and proceeds from share subscriptions receivable of $3.8 million due to receipt of investor subscriptions from a registered direct offering in advance of the closing date of October 1, 2024; partially offset by payments of finance lease obligations of $27,000 and payments of notes payable principal of $10.0 million related to our loan with Avenue. Net cash provided by financing activities was $42.2 million for the nine months ended September 30, 2023, which consisted of proceeds from issuance of common stock and warrants, net of offering costs, of $42.1 million, and proceeds from the issuance of notes payable of $0.4 million; partially offset by payments of notes payable modification fees of $0.2 million and payments of finance lease obligations of $0.1 million.
Public Offering
In June 2023, we sold 2,500,000 units at a sale price of $16.00 per unit pursuant to an underwriting agreement with Canaccord Genuity LLC (“Canaccord”). Each unit consisted of (i) one share of Common Stock, (ii) one warrant to purchase one share of Common Stock at an exercise price of $22.00 per share (the “Tranche A Warrants”), and (iii) one warrant to purchase one share of Common Stock at an exercise price of $30.00 per share (the “Tranche B Warrants”). The aggregate gross proceeds were $40.0 million, excluding the proceeds, if any, from the exercise of the Tranche A and Tranche B Warrants, and we paid underwriting discounts and commissions of $2.4 million and offering expenses of $0.2 million. The offering was made pursuant to our registration statement on Form S-3 (file number 333-264299), declared effective by the Securities and Exchange Commission (“SEC”) on April 26, 2022, a related registration statement pursuant to Rule 462(b) (file number 333-272692), filed with the SEC and effective on June 16, 2023, and a related prospectus supplement.
Common Stock Sales Agreement
During the three and nine months ended September 30, 2024, we sold 394,453 and 394,453 shares of Common Stock, respectively, under the ATM Agreement with Canaccord, generated gross proceeds of $2.1 million and $2.1 million, respectively, and paid commissions of $0.1 million and $0.1 million, respectively. During the three and nine months ended September 30, 2023, we sold 0 and 144,755 shares of Common Stock, respectively; generated gross proceeds of $0 and $4.5 million, respectively; and paid commissions of $0 and $0.1 million, respectively. The sale of Common Stock under the ATM Agreement was made pursuant to our registration statement on Form S-3 (file number 333-264299), declared effective by the SEC on April 26, 2022, and a related prospectus supplement. On September 30, 2024, we notified Canaccord that we were suspending the prospectus supplement related to the ATM Agreement. We will not make any sales of our common stock pursuant to the ATM Agreement, unless and until a new prospectus supplement is filed. Other than the termination of the prospectus supplement related to the ATM Agreement, the ATM Agreement remains in full force and effect.
Common Stock Purchase Agreement
During the nine months ended September 30, 2023, we sold 20,000 shares of Common Stock under our purchase agreement (the “Purchase Agreement”) with Lincoln Park, issued 145 Additional Commitment Shares, and generated proceeds of $0.4 million. We did not effect any sales during any of the other periods presented herein. The sale of Common Stock under the Purchase Agreement was made pursuant to our registration statement on Form S-3 (file number 333-264299), declared effective by the SEC on April 26, 2022, and a related prospectus supplement. On June 16, 2023, we suspended and terminated the prospectus supplement related to the Purchase Agreement with respect to the unsold shares of Common Stock issuable pursuant to the Purchase Agreement. We will not make any further sales of our securities pursuant to the Purchase Agreement, unless and until a new prospectus supplement is filed. Other than the termination of the prospectus supplement related to the Purchase Agreement with respect to future sales by us, the Purchase Agreement remains in full force and effect.
Critical Accounting Estimates
Our discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. Generally Accepted Accounting Principles. The preparation of these condensed consolidated financial statements requires us to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, revenues, costs, and expenses. We evaluate our estimates and judgments on an ongoing basis, and our actual results may differ from these estimates. We base our estimates on historical experience, known trends and events, contractual milestones, and other various factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
We consider the following estimates to be critical as they involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition and results of operations.
Convertible Notes
In accordance with ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, we classified a portion of the 2021 Avenue Loan as convertible notes payable in the condensed consolidated balance sheets as of December 31, 2023 and did not separate the conversion option from the host contract as it did not meet the requirements for accounting as a derivative instrument. As of September 30, 2024, the conversion option has expired. We accounted for the convertible note as a single liability measured at its amortized cost as December 31, 2023 with a carrying value of $4.9 million.
We classified the 2022 DHCD Loan as convertible notes payable in the condensed consolidated balance sheets and did not separate the conversion option from the host contract as it did not meet the requirements for accounting as a derivative instrument. We account for the convertible note as a single liability measured at its amortized cost. As of September 30, 2024 and December 31, 2023, the convertible note was carried at $5.3 million and $5.3 million, respectively.
Common Stock Warrant Liabilities
Pursuant to amendments to the 2021 Avenue Loan in June 2023 and September 2024, we issued a warrant to purchase 150,000 shares of Common Stock at $4.6014 per share (the “2023 Avenue Warrant”). In accordance with ASC 815, we recognized the 2023 Avenue Warrant as a derivative liability measured at fair value and remeasure the 2023 Avenue Warrant 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 2023 Avenue Warrant resulted in a gain of $0.1 million and a gain of $0.4 million during the three months ended September 30, 2024 and 2023, respectively; and a gain of $39,000 and a gain of $0.3 million during the nine months ended September 30, 2024 and 2023, respectively. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) settlement of the instrument upon a change of control transaction, (ii) dissolution of the Company, or (iii) another outcome outside of (i)-(ii). These estimates require significant judgment. As of September 30, 2024 and December 31, 2023, the unobservable inputs were as follows:
| September 30, |
December 31, |
|||||||
| 2024 |
2023 |
|||||||
| Expected stock price volatility |
108.40% –114.80 | % | 105.00% –110.00 | % | ||||
| Risk-free interest rate |
3.60% –4.50 | % | 3.88% –5.03 | % | ||||
| Expected dividend yield |
0.00 | % | 0.00 | % | ||||
| Expected term (in years) |
0.41 –3.75 | 0.75 –4.50 | ||||||
| Probability of change of control |
10.00 | % | 25.00 | % | ||||
| Probability of dissolution |
55.00 | % | 50.00 | % | ||||
| Probability of other outcome |
35.00 | % | 25.00 | % | ||||
Pursuant to an underwritten public offering in June 2023, we issued the Tranche A Warrants to purchase 2,500,000 shares of Common Stock at $22.00 per share. In accordance with ASC 815, we recognized the Tranche A 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. The change in fair value of the Tranche A Warrants resulted in a gain of $0.6 million and a gain of $5.9 million during the three months ended September 30, 2024 and 2023, respectively; and a gain of $0.9 million and a gain of $5.6 million during the nine months ended September 30, 2024 and 2023, respectively. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) FDA acceptance of an NDA for CNM-Au8, (ii) settlement upon a fundamental transaction, (iii) dissolution of the Company, and (iv) another outcome outside of (i)-(iii). These estimates require significant judgment. As of September 30, 2024 and December 31, 2023, the unobservable inputs were as follows:
| September 30, |
December 31, |
|||||||
| 2024 |
2023 |
|||||||
| Expected stock price volatility |
97.70% –109.50 | % | 100.00% –110.00 | % | ||||
| Risk-free interest rate |
3.80% –4.30 | % | 4.13% –4.74 | % | ||||
| Expected dividend yield |
0.00 | % | 0.00 | % | ||||
| Expected term (in years) |
0.58 –1.71 | 1.08 –2.46 | ||||||
| Probability of NDA acceptance |
20.00 | % | 20.00 | % | ||||
| Probability of fundamental transaction |
10.00 | % | 25.00 | % | ||||
| Probability of dissolution |
55.00 | % | 50.00 | % | ||||
| Probability of other outcome |
15.00 | % | 5.00 | % | ||||
Income Taxes
We account for uncertainty in income taxes by applying a two-step process to determine the amount of tax benefit to be recognized in the condensed consolidated financial statements. First, the tax position is evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. Additionally, we assess the likelihood that our deferred tax assets will be recovered from future taxable income and, to the extent we believe, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The estimation of these factors requires significant judgment. Based on our evaluation of these factors, we have not recorded income tax benefits for the net operating losses or for research and development tax credits or other deferred tax assets due to uncertainty of realizing benefits from these items.
Stock-Based Compensation
We account for stock-based compensation arrangements using a fair value-based method for costs related to all share-based payments including stock options and stock awards. The fair value is recognized over the period during which a grantee was required to provide services in exchange for the option award and service-based stock awards, known as the requisite service period (usually the vesting period), on a straight-line basis. For stock awards with market conditions, the fair value is recognized over the period based on the expected milestone achievement dates as the derived service period (usually the vesting period), on a straight-line basis. For stock awards with performance conditions, the grant-date fair value of these awards is the market price on the applicable grant date, and compensation expense will be recognized when the conditions become probable of being satisfied. We will recognize a cumulative true-up adjustment once the conditions become probable of being satisfied as the related service period had been completed in a prior period. We elect to account for forfeitures as they occur, rather than estimating expected forfeitures.
We estimate the fair value of stock options using a Black-Scholes option-pricing model, which requires significant judgment. The unobservable inputs include the expected price volatility, risk-free interest rate, expected dividend yield, and expected term. For the nine months ended September 30, 2024 and 2023, the unobservable inputs were as follows:
| Nine Months Ended September 30, |
||||||||
| 2024 |
2023 |
|||||||
| Expected stock price volatility |
97.78% –111.49 | % | 96.22% –103.24 | % | ||||
| Risk-free interest rate |
3.62% –4.58 | % | 3.26% –4.41 | % | ||||
| Expected dividend yield |
0.00 | % | 0.00 | % | ||||
| Expected term of options (in years) |
5.00 –10.00 | 5.00 –6.43 | ||||||
We estimate the fair value of restricted stock awards using a Monte Carlo valuation model to simulate the achievement of certain stock price milestones. The unobservable inputs include the expected stock price volatility, risk-free interest rate, and expected term. No restricted stock awards were granted during the nine months ended September 30, 2024 and 2023.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a smaller reporting company, we are not required to provide information required by this Item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of September 30, 2024, as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”). As a result of this evaluation, our principal executive officer and principal financial officer have concluded that, as of September 30, 2024, our disclosure controls and procedures were not effective due to the material weaknesses in internal control over financial reporting described below. Notwithstanding the identified material weaknesses, management, including our principal executive officer and principal financial officer, believes the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q fairly represent, in all material respects, our financial condition, results of operations and cash flows as of and for the periods presented in accordance with United States Generally Accepted Accounting Principles.
Disclosure controls and procedures are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Material Weaknesses in Internal Control over Financial Reporting
In connection with the audit of our financial statements as of and for the years ended December 31, 2023 and 2022, our management identified material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. The material weaknesses identified relate to the fact that we did not design or maintain an effective control environment commensurate with our financial reporting requirements. This deficiency in our control environment contributed to the following additional material weaknesses related to control activities and information and communication within our internal control over financial reporting:
| ● | we did not design and maintain controls over the preparation and review of reconciliations and the review and segregation of duties over manual journal entries, including controls over the completeness and accuracy of information; and |
| ● | we did not design and maintain information technology (“IT”) general controls for IT systems that are relevant to the preparation of the financial statements. Specifically, we did not design and maintain: (a) user access controls to ensure appropriate segregation of duties and that adequately restrict user and privileged access to financial applications, programs, and data to our appropriate personnel; (b) program change management controls to ensure that IT program and data changes affecting financial IT applications and underlying accounting records are identified, tested, authorized, and implemented appropriately; (c) computer operations controls to ensure that data backups are authorized and monitored; and (d) testing and approval controls for program development to ensure that new software development is aligned with business and IT requirements. |
Each of the control deficiencies described above could result in a misstatement of one or more account balances or disclosures that would result in a material misstatement to the annual or interim consolidated financial statements that would not be prevented or detected. Accordingly, our management has determined that each of the control deficiencies described above constitute material weaknesses.
Material Weakness Remediation
Management continues to be actively engaged and committed to taking the steps necessary to remediate the control deficiencies that constituted the above material weaknesses. During 2023, we made the following enhancements to our control environment:
| ● | we have continued to strengthen the experience of our internal accounting team through refinement of our processes and internal controls over financial reporting and our IT and technical accounting resources; and |
| ● | until we have sufficient technical accounting resources, we have engaged external consultants to provide support and to assist us in our evaluation of more complex applications of GAAP. |
Our remediation activities are continuing during 2024. In addition to the above actions, we expect to engage in additional activities, or have completed additional activities, including, but not limited to:
| ● | adding more technical accounting resources to enhance our control environment; and |
| ● | until we have sufficient technical accounting resources, engaging external consultants to provide support and to assist us in our evaluation of more complex applications of GAAP. |
We continue to enhance corporate oversight over process-level controls and structures to ensure that there is appropriate assignment of authority, responsibility, and accountability to enable remediation of our material weaknesses. We believe that our remediation plan will be sufficient to remediate the identified material weaknesses and strengthen our internal control over financial reporting. As we continue to evaluate, and work to improve, our internal control over financial reporting, management may determine that additional measures to address control deficiencies or modifications to the remediation plan are necessary.
Changes in Internal Control over Financial Reporting
Other than changes described under “—Material Weakness Remediation,” there were no changes in our internal control over financial reporting during the quarter ended September 30, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
We are not currently a party to any material pending legal proceedings. From time to time, we may, however, be involved in legal proceedings in the ordinary course of business. We cannot predict the outcome of any such legal proceedings, and despite the potential outcomes, the existence thereof may have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Our business, financial condition, and results of operations can be affected by a number of factors, whether currently known or unknown, including, but not limited to, those described in Part I, Item 1A, Risk Factors of our 2023 Annual Report on Form 10-K, which was filed with the SEC on March 13, 2024. There have been no material changes to the risk factors since previously disclosed in the 2023 Annual Report on Form 10-K. Any one or more of these factors could, directly or indirectly, cause our actual financial condition and results of operations to vary materially from past, or from anticipated future, financial condition and results of operations. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, results of operations, and stock price.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
| (a) |
Recent Sales of Unregistered Securities |
None.
| (b) |
Use of Proceeds |
None.
| (c) |
Purchases of Equity Securities by the Issuer and Affiliated Purchasers |
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not Applicable.
During the three months ended September 30, 2024, of our officers or directors adopted or terminated any “Rule 10b5-1 trading arrangement” or any “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.
| * |
Filed herewith. |
| ** |
Furnished herewith. |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| CLENE INC. |
||
| Dated: November 13, 2024 |
By: |
/s/ Robert Etherington |
| Name: |
Robert Etherington |
|
| Title: |
President, Chief Executive Officer and Director |
|
| Dated: November 13, 2024 |
By: |
/s/ Morgan R. Brown |
| Name: |
Morgan R. Brown |
|
| Title: |
Chief Financial Officer |
|
Exhibit 31.1
CERTIFICATION
I, Robert Etherington, certify that:
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of Clene Inc.; |
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
(c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
(d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 13, 2024
|
/s/ Robert Etherington |
|
|
Robert Etherington |
|
|
President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATION
I, Morgan R. Brown, certify that:
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of Clene Inc.; |
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
(c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
(d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 13, 2024
|
/s/ Morgan R. Brown |
|
|
Morgan R. Brown |
|
|
Chief Financial Officer |
Exhibit 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Robert Etherington, President and Chief Executive Officer of Clene Inc. (the “Company”), hereby certifies that, to the best of his knowledge:
|
1. |
The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and |
|
2. |
The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Dated: November 13, 2024
|
/s/ Robert Etherington |
|
|
Robert Etherington |
|
|
President and Chief Executive Officer |
A signed original of this written statement required by Section 906 of 18 U.S.C. § 1350 has been provided to the Company, and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
Exhibit 32.2
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Morgan R. Brown, Chief Financial Officer of Clene Inc. (the “Company”), hereby certifies that, to the best of his knowledge:
|
1. |
The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024, to which this Certification is attached as Exhibit 32.2 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and |
|
2. |
The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Dated: November 13, 2024
|
/s/ Morgan R. Brown |
|
|
Morgan R. Brown |
|
|
Chief Financial Officer |
A signed original of this written statement required by Section 906 of 18 U.S.C. § 1350 has been provided to the Company, and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.