UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
or
For the transition period from _____________ to _____________
Commission file number:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of |
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(I.R.S. Employer |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (
(Former name, former address, and former fiscal year, if changed since last report.): N/A
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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The |
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Warrants, to acquire one-half of one share of Common Stock for $11.50 per share |
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CLNNW |
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The Nasdaq Capital Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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 |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The number of shares outstanding of the Registrant’s common stock as of August 10, 2022 was
CLENE INC.
Quarterly Report on Form 10-Q for the Quarter Ended June 30, 2022
i
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements
CLENE INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
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June 30, |
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December 31, |
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2022 |
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2021 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities |
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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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Total current assets |
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Restricted cash |
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Right-of-use assets |
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Property and equipment, net |
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TOTAL ASSETS |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued liabilities |
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Operating lease obligations, current portion |
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Finance lease obligations, current portion |
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Total current liabilities |
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Operating lease obligations, net of current portion |
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Finance lease obligations, net of current portion |
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Notes payable |
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Convertible notes payable |
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Common stock warrant liability |
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Clene Nanomedicine contingent earn-out |
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Initial Stockholders contingent earn-out |
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TOTAL LIABILITIES |
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Commitments and contingencies ) |
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Stockholders’ equity (deficit): |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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( |
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Accumulated other comprehensive income |
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TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) |
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( |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
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$ |
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$ |
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See accompanying notes to the condensed consolidated financial statements.
1
CLENE INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenue: |
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Product revenue |
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$ |
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$ |
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$ |
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$ |
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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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( |
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( |
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( |
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( |
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Other income (expense), net: |
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Interest expense |
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( |
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( |
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( |
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Gain on extinguishment of notes payable |
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Gain on termination of lease |
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Change in fair value of common stock warrant liability |
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Change in fair value of Clene Nanomedicine contingent earn-out |
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( |
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Change in fair value of Initial Stockholders contingent earn-out |
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Australia research and development credit |
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Other income (expense), net |
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( |
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Total other income (expense), net |
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( |
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Net loss before income taxes |
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( |
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( |
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( |
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Income tax benefit |
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Net loss |
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( |
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( |
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( |
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( |
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Other comprehensive loss: |
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Unrealized loss on available-for-sale securities |
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( |
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( |
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Foreign currency translation adjustments |
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( |
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( |
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( |
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( |
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Total other comprehensive loss |
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( |
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( |
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( |
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( |
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Comprehensive loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Net loss per share-- basic and diluted (Note 16) |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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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.
2
CLENE INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(In thousands, except share amounts)
(Unaudited)
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Common Stock |
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Additional |
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Accumulated |
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Accumulated |
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Total |
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Shares |
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Amount |
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Capital |
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Deficit |
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Income (Loss) |
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(Deficit) |
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Balances at December 31, 2021 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Reclassification of common stock warrant liability to equity |
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— |
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— |
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Exercise of stock options |
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Stock-based compensation expense |
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— |
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Unrealized loss on available-for-sale securities |
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— |
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( |
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( |
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Foreign currency translation adjustment |
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— |
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Net loss |
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— |
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( |
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( |
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Balances at March 31, 2022 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Exercise of stock options |
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Stock-based compensation expense |
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— |
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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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— |
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( |
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( |
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Offering costs |
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— |
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( |
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( |
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Foreign currency translation adjustment |
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— |
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( |
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( |
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Net loss |
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— |
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( |
) |
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( |
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Balances at June 30, 2022 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
( |
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Balances at December 31, 2020 |
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( |
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Exercise of stock options |
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Stock-based compensation expense |
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— |
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Foreign currency translation adjustment |
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— |
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Net loss |
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— |
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( |
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( |
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Balances at March 31, 2021 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
( |
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Issuance of common stock upon the private offering |
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Exercise of stock options |
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Stock-based compensation expense |
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— |
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Issuance of common stock upon vesting of restricted stock awards |
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Foreign currency translation adjustment |
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— |
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( |
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( |
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Net loss |
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— |
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( |
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( |
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Balances at June 30, 2021 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
( |
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See accompanying notes to the condensed consolidated financial statements.
3
CLENE INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Six Months Ended June 30, |
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2022 |
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2021 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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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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Change in fair value of common stock warrant liability |
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( |
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( |
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Change in fair value of Clene Nanomedicine contingent earn-out |
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( |
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Change in fair value of Initial Stockholders contingent earn-out |
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( |
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Stock-based compensation expense |
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Gain on extinguishment of notes payable |
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( |
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Gain on termination of lease |
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( |
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Accretion of debt discount |
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Non-cash interest expense |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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( |
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Inventory |
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( |
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Prepaid expenses and other current assets |
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( |
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( |
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Accounts payable |
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Accrued liabilities |
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( |
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Deferred income tax |
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( |
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Operating lease obligations |
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( |
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( |
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Net cash used in operating activities |
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( |
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( |
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Cash flows from investing activities: |
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Purchases of marketable securities |
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( |
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Proceeds from maturity of marketable securities |
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Proceeds from sale of marketable securities |
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Purchases of property and equipment |
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( |
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( |
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Net cash used in investing activities |
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( |
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( |
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Cash flows from financing activities: |
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Proceeds from exercise of stock options |
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Payments of finance lease obligations |
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( |
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( |
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Proceeds from the issuance of notes payable |
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Payments of debt issuance costs |
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( |
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( |
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Payments of notes payable |
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( |
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Proceeds from the private placement |
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Payment of deferred offering costs |
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( |
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( |
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Net cash provided by financing activities |
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Effect of foreign exchange rate changes on cash and restricted cash |
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( |
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( |
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Net increase (decrease) in cash, cash equivalents and restricted cash |
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( |
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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 |
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$ |
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$ |
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Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets |
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Cash and cash equivalents |
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Restricted cash |
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Cash, cash equivalents and restricted cash |
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$ |
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$ |
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See accompanying notes to the condensed consolidated financial statements.
4
CLENE INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)
(In thousands)
(Unaudited)
|
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Six Months Ended June 30, |
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2022 |
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2021 |
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Supplemental disclosure of non-cash investing and financing activities: |
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Lease liability arising from obtaining right-of-use assets, leasehold improvements, and lease incentives |
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$ |
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$ |
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Lease incentive realized |
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$ |
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$ |
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Lease liability settled through termination of lease |
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$ |
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$ |
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Reclassification of common stock warrant liability to permanent equity |
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$ |
|
|
$ |
|
||
Purchases of property and equipment in accounts payable |
|
$ |
|
|
|
|
||
Common stock warrant liability recorded at issuance of notes payable |
|
$ |
|
|
$ |
|
||
Supplemental disclosures: |
|
|
|
|
|
|
||
Cash paid for interest expense |
|
$ |
|
|
$ |
|
||
See accompanying notes to the condensed consolidated financial statements.
5
CLENE INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 1. Nature of the Business
Clene Inc. (the “Company,” “we,” “us,” or similar such references) is a clinical-stage pharmaceutical company pioneering the discovery, development, and commercialization of novel clean-surfaced nanotechnology therapeutics. We have developed an electro-crystal-chemistry drug development platform which enables production of concentrated, stable, highly active, clean-surfaced nanocrystal suspensions. We have multiple drug assets currently in development for applications in neurology, infectious disease, and oncology. Our efforts are currently focused on addressing the high unmet medical needs in two areas: first, those related to central nervous system disorders including Amyotrophic Lateral Sclerosis (“ALS”), Multiple Sclerosis (“MS”), and Parkinson’s Disease (“PD”); and second, those related to COVID-19, a highly infectious viral respiratory disease with serious and sometimes fatal co-morbidities. 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”), a related party (see Note 17).
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 our expenses to increase significantly and to incur additional losses in the future to fund our operations, 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 our expenses relating to regulatory compliance and sales and marketing personnel to increase significantly as we prepare to commence commercialization if we obtain regulatory approval for our drug candidates.
Our management performs strategic reviews of our operating plans and budgets, considering the status of our product development programs, human capital, capital needs and resources, and current capital market conditions. Based on these reviews, our Board of Directors (the “Board”) and management make adjustments to our operating plans and budgets to allocate our projected cash expenditures. Notwithstanding these ongoing adjustments, we project 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, and we must obtain additional financing. Additionally, pursuant to our term loan with Avenue Venture Opportunities Fund, L.P. (“Avenue”), we must maintain unrestricted cash and cash equivalents of at least $
To mitigate our funding needs, we intend to implement plans to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as well as potentially utilizing additional funds available under our term loan with Avenue, subject to certain contingent conditions (see Note 9), as well as our existing at-the-market facility. 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. Depending on the results of our plans, we may need to implement cost-saving initiatives, including potentially delaying or reducing research and development programs and commercialization efforts. As a result, 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.
6
Impact of the COVID-19 Pandemic
The COVID-19 pandemic, which began in December 2019 and has spread worldwide, has caused many governments to implement measures to slow the spread of the COVID-19 outbreak. The COVID-19 pandemic and government measures taken in response have had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred, supply chains have been disrupted, and facilities and production have been suspended. The future progression of the COVID-19 pandemic and its effects on our business and operations remains uncertain. The COVID-19 pandemic may affect our ability to initiate and complete preclinical studies and clinical trials, delay the initiation of future clinical trials, disrupt regulatory activities, or have other adverse effects on our business and operations. In particular, we and our third-party contract research organizations (“CROs”) have faced disruptions that have affected our ability to initiate and complete preclinical studies, caused manufacturing disruptions, and created delays at clinical trial site initiation and clinical trial enrollment, leading to the early conclusion of an ongoing clinical trial. The COVID-19 pandemic has already caused significant disruptions in the financial markets, and may continue to cause such disruptions, which could impact our ability to raise additional funds to support our operations. Moreover, the COVID-19 pandemic has significantly impacted economies worldwide and could result in adverse effects on our business and operations.
We are monitoring the potential impact of the COVID-19 pandemic on our business, financial condition, results of operations, and cash flows. While the COVID-19 pandemic has led to various research restrictions and led to pauses and early conclusion of certain of our clinical trials, these impacts have been temporary and to date we have not experienced material business disruptions or incurred impairment losses in the carrying values of our assets as a result of the COVID-19 pandemic and we are not aware of any specific related event or circumstance that would require us to revise the estimates reflected in these condensed consolidated financial statements. The extent to which the COVID-19 pandemic will directly or indirectly impact our business, financial condition, results of operations, and cash flows, including planned and future clinical trials and research and development costs, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, the actions taken to contain or treat it, and the duration and intensity of the related effects.
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. (“Clene Nanomedicine”), a subsidiary incorporated in Delaware, Clene Australia Pty Ltd (“Clene Australia”), a subsidiary incorporated in Australia, and dOrbital, Inc., a subsidiary incorporated in Delaware, after elimination of all intercompany accounts and transactions. Our wholly-owned subsidiary, Clene Netherlands B.V. was established on April 21, 2021 and has no financial positions or operations to date. 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 six months ended June 30, 2022 and 2021 are unaudited.
Results of operations for the three and six months ended June 30, 2022 and 2021 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 six months ended June 30, 2022 and 2021 should be read in conjunction with the audited consolidated financial statements included in our Annual Report on Form 10-K.
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
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.
7
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 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.
Concentrations of Credit Risk
Financial instruments which potentially subject us to significant concentrations of credit risk consist primarily of cash. Our cash is mainly held in financial institutions. 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 and investments are 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 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 (loss) 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 old 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.
Contingent Earn-Out Liabilities
In connection with the Reverse Recapitalization, certain stockholders are entitled to receive additional shares of Clene Inc. common stock, par value $0.0001 (“Common Stock”) (the “Contingent Earn-outs”) upon us achieving certain milestones (see Note 3).
8
In accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging (“ASC 815”), the Contingent Earn-outs are not indexed to our own stock and therefore are accounted for as a liability at the Reverse Recapitalization date and subsequently remeasured at each reporting date with changes in fair value recorded as a component of other income (expense), net.
Common Stock Warrants
We account for common stock warrants as either equity-classified instruments or liability-classified instruments based on an assessment of the warrant terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of 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, as of each subsequent quarterly period end date while the warrants are outstanding.
Grant Funding
We may submit applications to receive grant funding from governmental and non-governmental entities. Grant funding received that involves no conditions or continuing performance obligations is recognized upon receipt. Grant funding with conditions or obligations is recognized as the conditions or obligations are fulfilled. We have made an accounting policy election to record such unconditional grants, including the Australia research and development credit, as other income in the condensed consolidated statements of operations and comprehensive loss. We recognize the Australia research and development credit in an amount equal to the qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage.
Grant funding with conditions or obligations is recognized in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grants were provided have been met. Any amount received in advance of fulfilling such conditions or obligations is recorded in accrued liabilities on the condensed consolidated balance sheets if the conditions or obligations are expected to be met within the next twelve months. Grant funding recognized on conditional grants is included as a reduction in research and development expenses in the condensed consolidated statements of operations and comprehensive loss as the conditions are tied to our research and development efforts, and as the arrangement between us and the organizations are not part of our ongoing, major, or central operations. We recorded grants as reductions of research and development expenses of $
Foreign Currency Translation and Transactions
Our functional currency is the U.S. dollar. Clene Australia determined its functional currency to be the Australian dollar and Clene Netherlands B.V. determined its functional currency to be the Euro. We use the U.S. dollar as our reporting currency for the condensed consolidated financial statements. The results of our non-U.S. dollar based functional currency operations are translated to U.S. dollars at the average exchange rates during the period. Our assets and liabilities are translated using the current exchange rate as of the balance sheet date and stockholders’ equity is translated using historical rates.
Adjustments resulting from the translation of the condensed consolidated financial statements of our foreign functional currency subsidiaries into U.S. dollars are excluded from the determination of net loss and are accumulated in a separate component of stockholders’ equity.
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 income (loss) in any periods presented were translation of Australian dollar denominated balances of Clene Australia to U.S. dollars for consolidation and unrealized losses on available-for-sale securities.
Segment Information
We have determined that our chief executive officer is the chief operating decision maker (“CODM”). Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the CODM
9
in making decisions regarding resource allocation and assessing performance. We view our operations and manage our business in
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 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.
Stock-based compensation expense is recognized at fair value. 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 the Nasdaq Capital Market (“Nasdaq”) on the date of grant. The fair value of stock awards with market conditions are determined using a Monte Carlo valuation model.
Recently Adopted Accounting Pronouncements
In May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40). The amendments in this update relate to the recognition and measurement of earnings per share for certain modifications or exchanges of equity-classified written call options or warrants. The guidance was effective for our fiscal year and interim periods within our fiscal year beginning after December 15, 2021. The adoption of this guidance did not have an impact on our condensed consolidated financial statements.
Recent Accounting Pronouncements Not Yet Adopted
In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The amendments in this update, among other things, require the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts.
10
Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. As a smaller reporting company, the guidance is effective for our fiscal years beginning after December 15, 2022. We are currently evaluating the expected impact, if any, of the new guidance as a result of this extended deadline of implementation for smaller reporting companies.
In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. The amendments in this update add disclosure requirements for transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy, including disclosure about the nature of the transactions, accounting policy, affected line items on the balance sheet and income statement, amounts applicable to each financial statement line item, and significant terms and conditions of the transactions including commitments and contingencies. The guidance is effective for all entities for financial statements issued for annual periods beginning after December 15, 2021, with early adoption permitted. We are currently evaluating the expected impact, if any, of the new guidance.
Note 3. Reverse Recapitalization with Tottenham and Clene Nanomedicine
On December 30, 2020 (the “Closing Date”), Chelsea Worldwide Inc., our predecessor, consummated the Reverse Recapitalization by and among Clene Nanomedicine, Tottenham Acquisition I Limited (“Tottenham”), Chelsea Worldwide Inc. (“PubCo”), a Delaware corporation and wholly-owned subsidiary of Tottenham, Creative Worldwide Inc. (“Merger Sub”), a Delaware corporation and wholly-owned subsidiary of PubCo, and Fortis Advisors LLC, a Delaware limited liability company as the representative of our stockholders. The Reverse Recapitalization was effected in two steps: (i) Tottenham was reincorporated to the state of Delaware by merging with and into PubCo (the “Reincorporation Merger”); and (ii) promptly following the Reincorporation Merger, Merger Sub was merged with and into Clene Nanomedicine, resulting in Clene Nanomedicine becoming a wholly-owned subsidiary of PubCo (the “Acquisition Merger”). On the Closing Date, PubCo changed its name from Chelsea Worldwide Inc. to Clene Inc. and listed its shares of Common Stock, par value $
We received gross proceeds of $
The transaction was accounted for as a “reverse recapitalization” in accordance with GAAP. Under this method of accounting, Tottenham was treated as the “acquired” company for financial reporting purposes. This determination was primarily based on the fact that subsequent to the Reverse Recapitalization, Clene Nanomedicine’s stockholders have a majority of the voting power of the Company, Clene Nanomedicine comprises all of the ongoing operations of the Company, Clene Nanomedicine comprises a majority of the governing body of the Company, and Clene Nanomedicine’s senior management comprises all of the senior management of the Company. Accordingly, for accounting purposes, this transaction was treated as the equivalent of Clene Nanomedicine issuing shares for the net assets of Tottenham, accompanied by a recapitalization.
Earn-Out Shares
Certain of Clene Nanomedicine’s stockholders are entitled to receive earn-out shares (the “Clene Nanomedicine Contingent Earn-out”) as follows : (i)
Tottenham’s former officers and directors, sponsor, and public stockholders (the “Initial Stockholders”) may be entitled to receive earn-out shares as follows (the “Initial Stockholders Contingent Earn-out”): (i)
11
Milestone 1 is not achieved but Milestone 2 is achieved, the Initial Stockholders will receive an issuance equal to the shares issued upon satisfaction of Milestone 1.
The Contingent Earn-outs shares have been classified as liabilities in the condensed consolidated balance sheets and are remeasured to fair value at each reporting date. We did not achieve Milestone 3 and the
Note 4. Marketable Securities
Available-for-Sale Securities
Available-for-sale securities are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income (loss) until realized. Available-for-sale securities as of June 30, 2022 were as follows:
|
|
June 30, 2022 |
|
|||||||||||||
(in thousands) |
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
||||
Commercial paper |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Municipal debt securities |
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|
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( |
) |
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|
|||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total |
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$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
All available-for-sale securities had a contractual maturity within
Note 5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets as of June 30, 2022 and December 31, 2021 were as follows:
|
|
June 30, |
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December 31, |
|
||
(in thousands) |
|
2022 |
|
|
2021 |
|
||
Australia research and development credit receivable |
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$ |
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|
$ |
|
||
Metals to be used in research and development |
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|
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Other |
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|
|
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|
||
Total prepaid expenses and other current assets |
|
$ |
|
|
$ |
|
||
Note 6. Property and Equipment, Net
Property and equipment, net, as of June 30, 2022 and December 31, 2021 were as follows:
|
|
June 30, |
|
|
December 31, |
|
||
(in thousands) |
|
2022 |
|
|
2021 |
|
||
Lab equipment |
|
$ |
|
|
$ |
|
||
Office equipment |
|
|
|
|
|
|
||
Computer software |
|
|
|
|
|
|
||
Leasehold improvements |
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|
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|
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|
||
Construction in progress |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Less accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Total property and equipment, net |
|
$ |
|
|
$ |
|
||
12
Depreciation expense recorded in research and development expense and general and administrative expense for the three and six months ended June 30, 2022 and 2021 was as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
General and administrative |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
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|
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||||
Total depreciation expense |
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$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Note 7. Accrued Liabilities
Accrued liabilities as of June 30, 2022 and December 31, 2021 were as follows:
|
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June 30, |
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|
December 31, |
|
||
(in thousands) |
|
2022 |
|
|
2021 |
|
||
Accrued compensation and benefits |
|
$ |
|
|
$ |
|
||
Accrued CRO fees |
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|
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Deferred grant funds |
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Other |
|
|
|
|
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|
||
Total accrued liabilities |
|
$ |
|
|
$ |
|
||
Note 8. 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.
Operating Leases
In September 2021, we commenced an operating lease for laboratory space and recorded a right-of-use asset of $
In February 2022, we commenced an operating lease for existing laboratory space and recorded a right-of-use asset of $
Our right-of-use assets pertain to operating leases. As of June 30, 2022 and December 31, 2021, our operating lease obligations had a weighted-average discount rate of
13
Finance Leases
Assets recorded under finance lease obligations and included with property and equipment as of June 30, 2022 and December 31, 2021 were as follows:
|
|
June 30, |
|
|
December 31, |
|
||
(in thousands) |
|
2022 |
|
|
2021 |
|
||
Lab equipment |
|
$ |
|
|
$ |
|
||
Work in process |
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||
Total |
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|
|
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|
||
Less accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Net |
|
$ |
|
|
$ |
|
||
As of June 30, 2022 and December 31, 2021, our finance lease obligations had a weighted-average interest rate of
Maturity Analysis of Leases
The maturity analysis of our finance and operating leases as of June 30, 2022 was as follows:
(in thousands) |
|
Finance |
|
|
Operating |
|
||
2022 (remainder) |
|
$ |
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|
$ |
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||
2023 |
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2024 |
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2025 |
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2026 |
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2027 |
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Thereafter |
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Total undiscounted cash flows |
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|
||
Less amount representing interest/discounting |
|
|
( |
) |
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|
( |
) |
Present value of future lease payments |
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|
||
Less lease obligations, current portion |
|
|
( |
) |
|
|
( |
) |
Lease obligations, long term portion |
|
$ |
|
|
$ |
|
||
We expect that, in the normal course of business, the existing leases will be renewed or replaced by similar leases.
Components of Lease Cost
The components of finance and operating lease costs for the three and six months ended June 30, 2022 and 2021 were as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Finance lease costs: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Amortization |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Interest on lease liabilities |
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|
||||
Operating lease costs |
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Short-term lease costs |
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Variable lease costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total lease costs |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Supplemental Cash Flow Information
|
|
Six Months Ended June 30, |
|
|||||
(in thousands) |
|
2022 |
|
|
2021 |
|
||
Operating cash flows from operating leases |
|
$ |
( |
) |
|
$ |
( |
) |
Operating cash flows from finance leases |
|
$ |
( |
) |
|
$ |
( |
) |
Financing cash flows from finance leases |
|
$ |
( |
) |
|
$ |
( |
) |
14
Note 9. Notes Payable
Our long-term debt, net of original issue discount and unamortized debt issuance costs, as of June 30, 2022 and December 31, 2021 was as follows:
|
|
Stated |
|
|
June 30, |
|
|
December 31, |
|
|||
(in thousands, except interest rates) |
|
Interest Rate |
|
|
2022 |
|
|
2021 |
|
|||
Notes payable: |
|
|
|
|
|
|
|
|
|
|||
Maryland Department of Housing & Community Development |
|
|
% |
|
$ |
|
|
$ |
|
|||
Maryland Department of Housing & Community Development |
|
|
% |
|
|
|
|
|
|
|||
Advance Cecil, Inc. |
|
|
% |
|
|
|
|
|
|
|||
Avenue Venture Opportunities Fund, L.P. |
|
|
% |
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Accrued and unpaid interest |
|
|
|
|
|
|
|
|
|
|||
Less unamortized debt issuance costs and original issue discounts |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
Less convertible notes payable, net of unamortized debt discount and issuance costs |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
Total notes payable |
|
|
|
|
$ |
|
|
$ |
|
|||
Maryland Loans
In February 2019, we entered into a loan agreement (the “2019 MD Loan”) with the Department of Housing and Community Development (“DHCD”), a principal department of the State of Maryland. The agreement provides for a term loan of $
In May 2022, we entered into a loan agreement (the “2022 MD Loan”) with DHCD which provides for a term loan of up to $
Cecil County Loan
In April 2019, we entered into a loan agreement (the “2019 Cecil Loan”) with Advance Cecil Inc., a non-stock corporation formed under the laws of the state of Maryland. The agreement provides for a term loan of $
15
the end of each reporting period. As of June 30, 2022 and December 31, 2021, the note was recorded at principal plus accrued interest in the condensed consolidated balance sheets. We recognized interest expense of $
PPP Loan
In May 2020, we entered into a note payable in the amount of $
Avenue Loan
In May 2021, we entered into a loan agreement (the “2021 Avenue Loan”) with Avenue. The agreement provides for a 42-month term loan of up to $
Pursuant to the agreement, we granted Avenue a warrant to purchase
Avenue has the right, in its discretion, but not the obligation, at any time between May 21, 2022 through May 21, 2024, while the loan is outstanding, to convert up to $
16
and (iii) amortization of debt discount and issuance costs of $
The net proceeds from the issuance of the loan were initially allocated to the warrant at an amount equal to their fair value of $
Future payments under the 2021 Avenue Loan, net of unamortized debt discounts, if Avenue does not exercise the Conversion Feature, and under the 2022 MD Loan, net of unamortized debt discounts, are as follows:
(in thousands) |
|
2021 Avenue Loan |
|
|
2022 MD Loan |
|
||
2022 (remainder) |
|
$ |
|
|
$ |
|
||
2023 |
|
|
|
|
|
|
||
2024 |
|
|
|
|
|
|
||
2025 |
|
|
|
|
|
|
||
2026 |
|
|
|
|
|
|
||
2027 |
|
|
|
|
|
|
||
Thereafter |
|
|
|
|
|
|
||
Subtotal of future principal payments |
|
|
|
|
|
|
||
Accrued and unpaid interest |
|
|
|
|
|
|
||
Less unamortized debt issuance costs and original issue discounts |
|
|
( |
) |
|
|
( |
) |
Total |
|
$ |
|
|
$ |
|
||
Note 10. Common Stock Warrants
As of June 30, 2022 and December 31, 2021, outstanding warrants to purchase shares of Common Stock were as follows:
Date Exercisable |
|
Number of |
|
|
|
|
Exercise Price |
|
|
Exercisable for |
|
Classification |
|
Expiration |
||
December 2020 |
|
|
|
|
(1) |
|
$ |
|
|
|
|
|||||
December 2020 |
|
|
|
|
(2) |
|
$ |
|
|
|
|
|||||
December 2020 |
|
|
|
|
(3) |
|
$ |
|
|
|
|
|||||
May 2021 |
|
|
|
|
(4) |
|
$ |
|
|
|
|
|||||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Note 11. Commitments and Contingencies
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
17
obligations under binding purchase orders and, in certain cases, nominal early termination fees. These commitments are not deemed significant.
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.
As of June 30, 2022 and December 31, 2021, we had commitments under various agreements for capital expenditures totaling $
Note 12. Income Taxes
We have not recorded income tax benefits for the net operating losses incurred during the three and six months ended June 30, 2022 and 2021 or for research and development tax credits or other deferred tax assets due to uncertainty of realizing benefits from these items.
The components of loss before income taxes for the three and six months ended June 30, 2022 and 2021 was as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
United States |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Foreign |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Loss before provision for income taxes |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
We are subject to taxation in the U.S., Australia, Netherlands, and various state jurisdictions. Our tax returns from 2015 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 adjusts 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 13. Benefit Plans
401(k) Plan
Our 401(k) plan is a deferred salary arrangement under Section 401(k) of the Internal Revenue Code. Under the 401(k) plan, participating U.S. employees may defer a portion of their pretax earnings, up to the U.S. Internal Revenue Service annual contribution limit. We match
2020 Stock Plan
The 2020 Stock Plan reserves
2014 Stock Plan
The 2014 Stock Plan is administered by the Board. Stock options granted under the 2014 Stock Plan expire ten years after the grant date. Stock options and restricted stock awards granted to employees, officers, directors, and consultants generally vest over a four-year period. Effective as of the closing of the Reverse Recapitalization, no additional awards may be granted under the 2014 Stock
18
Plan and as a result, if any award granted under the 2014 Stock Plan expires, or is terminated, forfeited, repurchased, cancelled, or tendered by a participant to us to exercise an award, the unissued shares subject to that award will not be available for future awards.
Stock-Based Compensation Expense
Stock-based compensation expense recorded in research and development expense and general and administrative expense for the three and six months ended June 30, 2022 and 2021 was as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
General and administrative |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Stock-based compensation expense by award type for the three and six months ended June 30, 2022 and 2021 was as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Stock options |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Restricted stock awards |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Stock Options
Outstanding stock options and related activity for the six months ended June 30, 2022 was as follows:
(in thousands, except share, per share, and term data) |
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Intrinsic |
|
||||
Outstanding - December 31, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
|
||
Forfeited |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
|
||
Outstanding - June 30, 2022 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested and exercisable - June 30, 2022 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested, exercisable or expected to vest - June 30, 2022 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
As of June 30, 2022 and December 31, 2021, we had approximately $
Stock options are valued using a Black-Scholes option-pricing model. Due to the limited trading history of our Common Stock, the expected volatility is derived from the average historical stock volatilities of several unrelated comparable public companies within our industry, over a period equivalent to the expected term of the stock option grants. The risk-free interest rate for periods within the contractual life of the stock options is based on the U.S. Treasury yield curve in effect on the grant date. The expected dividend is assumed to be zero as we have never paid a dividend and have no plans to do so. The expected term represents the period the stock options are expected to be outstanding. For stock options that are considered to be in the ordinary course, we determine the expected term using the simplified method, which considers the term to be the average of the time-to-vesting and the contractual life of the stock options. For other stock option grants, we estimate the expected term using historical data on employee exercises and post-vesting employment termination behavior, while also considering the contractual life of the award.
19
The assumptions used to calculate the fair value of stock options granted during the six months ended June 30, 2022 and 2021 were as follows:
|
|
Six Months Ended June 30, |
||
|
|
2022 |
|
2021 |
Expected stock price volatility |
|
|
||
Risk-free interest rate |
|
|
||
Expected dividend yield |
|
|
||
Expected term of options |
|
|
||
The weighted-average grant-date fair value of stock options granted during the six months ended June 30, 2022 and 2021 was $
Restricted Stock Awards
Outstanding rights to restricted stock awards and related activity for the six months ended June 30, 2022 was as follows:
|
|
Number of |
|
|
Weighted Average Grant Date Fair Value |
|
||
Unvested balance as of December 31, 2021 |
|
|
|
|
$ |
|
||
Converted to shares of Common Stock upon vesting |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Unvested balance as of June 30, 2022 |
|
|
|
|
$ |
|
||
As of June 30, 2022 and December 31, 2021, there was
Note 14. Fair Value
Cash and cash equivalents are carried at fair value. Financial instruments, including accounts receivable, accounts payable, and accrued expenses are carried at cost, which approximates fair value given their short-term nature. Marketable securities, the Avenue Warrant, and the Contingent Earn-outs are carried at fair value. The 2019 MD Loan and the 2019 Cecil Loan are carried at the greater of principal plus accrued interest or the value of Phantom Shares. The 2021 Avenue Loan, including the convertible notes payable and Conversion Feature, and the 2022 MD Loan are carried at amortized cost, which approximate fair value due to our credit risk and market interest rates.
20
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 June 30, 2022 is as follows:
|
|
June 30, 2022 |
|
|||||||||||||
(in thousands) |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Municipal debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock warrant liability |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clene Nanomedicine contingent earn-out |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Initial Stockholders contingent earn-out |
|
|
|
|
|
|
|
|
|
|
|
|
||||
The fair value hierarchy for financial instruments measured at fair value on a recurring basis as of December 31, 2021 is as follows:
|
|
December 31, 2021 |
|
|||||||||||||
(in thousands) |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Notes payable |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Common stock warrant liability |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clene Nanomedicine contingent earn-out |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Initial Stockholders contingent earn-out |
|
|
|
|
|
|
|
|
|
|
|
|
||||
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 for the six months ended June 30, 2022 were as follows:
(in thousands) |
|
Common Stock Warrant |
|
|
Clene |
|
|
Initial |
|
|||
Balance - December 31, 2021 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Change in fair value |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Reclassification from liability to equity |
|
|
( |
) |
|
|
|
|
|
|
||
Balance - June 30, 2022 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Changes in the fair value of our Level 3 financial instruments for the six months ended June 30, 2021 were as follows:
(in thousands) |
|
Common Stock Warrant |
|
|
Clene |
|
|
Initial |
|
|||
Balance - December 31, 2020 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Initial fair value of instrument |
|
|
|
|
|
|
|
|
|
|||
Change in fair value |
|
|
( |
) |
|
|
|
|
|
|
||
Balance - June 30, 2021 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Valuation of Notes Payable and Convertible Notes Payable
As of June 30, 2022 and December 31, 2021, the carrying value of the 2019 MD Loan was $
As of June 30, 2022, the amortized cost of the 2021 Avenue Loan was $
21
Valuation of Conversion Feature
The Conversion Feature of the convertible notes payable from the 2021 Avenue Loan is carried at amortized cost and did not meet the requirements for separate accounting as a derivative instrument. As of June 30, 2022 and December 31, 2021, the estimated fair value of the Conversion Feature was $
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Expected stock price volatility |
|
|
% |
|
|
% |
||
Risk-free interest rate |
|
|
% |
|
|
% |
||
Expected dividend yield |
|
|
% |
|
|
% |
||
Expected term |
|
|
|
|
||||
Valuation of the Common Stock Warrant Liability
The common stock warrant liability associated with the Avenue Warrant is comprised of the potentially issuable Tranche 2 warrant to purchase an estimated
The estimated fair value was determined using a Black-Scholes option-pricing model. The carrying amount of the liability may fluctuate significantly and actual amounts may be materially different from the liabilities’ estimated value.
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Expected stock price volatility |
|
|
% |
|
|
% |
||
Risk-free interest rate |
|
|
% |
|
|
% |
||
Expected dividend yield |
|
|
% |
|
|
% |
||
Expected term |
|
|
|
|
||||
Probability of drawing Tranche 2 |
|
|
% |
|
|
% |
||
As we did not complete a bona fide round of equity financing by March 31, 2022, the exercise price and underlying shares of the Tranche 1 warrant became fixed and therefore qualified for equity classification. We remeasured the Tranche 1 warrant liability to fair value as of March 31, 2022 and recognized the change in fair value in the condensed consolidated statements of operations and comprehensive loss and the Tranche 1 warrant liability was reclassified to additional paid-in-capital.
Valuation of the Contingent Earn-Outs
The
The estimated fair value of the Contingent Earn-outs is 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.
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Expected stock price volatility |
|
|
% |
|
|
% |
||
Risk-free interest rate |
|
|
% |
|
|
% |
||
Expected dividend yield |
|
|
% |
|
|
% |
||
Expected term |
|
|
|
|
||||
22
Note 15. Common Stock
As of June 30, 2022 and December 31, 2021, 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.
As of June 30, 2022 and December 31, 2021, our Common Stock issued and outstanding was
Private Placements
Prior to the completion of the Reverse Recapitalization, we entered into subscription agreements with various investors (the “2020 PIPE”) for the sale and issuance of
In May 2021, we entered into subscription agreements with various investors (the “2021 PIPE”) for the sale and issuance of
At-the-Market Offering
On April 14, 2022, we entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Canaccord Genuity LLC and Oppenheimer & Co. Inc., as placement agents (the “Placement Agents”). In accordance with the terms of the Distribution Agreement, we may offer and sell shares of Common Stock having an aggregate offering price of up to $
Subject to terms of the Distribution Agreement, the Placement Agents are not required to sell any specific number or dollar amount of Common Stock but will act as our placement agents, using commercially reasonable efforts to sell, on our behalf, all of the Common Stock requested by us to be sold, consistent with the Placement Agents’ normal trading and sales practices, on terms mutually agreed between the Placement Agents and us. The Placement Agents will be entitled to compensation under the terms of the Distribution Agreement at a fixed commission rate of
During the three and six months ended June 30, 2022,
Note 16. Net Loss Per Share
The computation of basic and diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2022 and 2021 was as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands, except share and per share data) |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss attributable to common stockholders |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
23
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 six months ended June 30, 2022 and 2021 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 June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Convertible notes payable (see Note 9) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock warrants (see Note 10) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Options to purchase common stock (see Note 13) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unvested restricted stock awards (see Note 13) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unit purchase option to purchase common stock |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contingent earn-out shares (see Note 3) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Note 17. Related Party Transactions
License and Supply Agreements
In August 2018, we entered into a license agreement and exclusive supply agreement (collectively, the “4Life Agreement”) in conjunction with 4Life’s investment in our Series C preferred stock and warrants. Pursuant to the 4Life Agreement, we granted 4Life an exclusive license to develop, make, manufacture, use, sell, and commercialize certain dietary supplements. The term of the exclusive license is
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Product revenue from related parties |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Royalty revenue from related parties |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenue from related parties |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Note 18. Geographic and Segment Information
Geographic Information
Long-lived assets, which were composed of property and equipment, net by location, as of June 30, 2022 and December 31, 2021, were as follows:
|
|
June 30, |
|
|
December 31, |
|
||
(in thousands) |
|
2022 |
|
|
2021 |
|
||
United States |
|
$ |
|
|
$ |
|
||
Australia |
|
|
|
|
|
|
||
Total property and equipment, net |
|
$ |
|
|
$ |
|
||
24
Segment Information
Our operating segment profit measure is segment loss from operations, which is calculated as revenue less cost of revenue, research and development, and general and administrative expenses.
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Drugs: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenue from external customers |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Depreciation expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Stock compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Supplements: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenue from external customers |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Depreciation expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Stock compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Income (loss) from operations |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Consolidated: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenue from external customers |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Depreciation expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Stock compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
A reconciliation of the total of the reportable segments’ loss from operations to consolidated net loss before income taxes for the three and six months ended June 30, 2022 and 2021 was as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Segment loss from operations |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Total other income (expense), net |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Net loss before income taxes |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Segment assets exclude corporate assets, such as cash, restricted cash, and corporate facilities. Total assets by reportable segment as of June 30, 2022 and December 31, 2021, were as follows:
|
|
June 30, |
|
|
December 31, |
|
||
(in thousands) |
|
2022 |
|
|
2021 |
|
||
Total assets: |
|
|
|
|
|
|
||
Drugs |
|
$ |
|
|
$ |
|
||
Supplements |
|
|
|
|
|
|
||
Corporate |
|
|
|
|
|
|
||
Consolidated |
|
$ |
|
|
$ |
|
||
Additions to long-lived assets were through cash expenditure, accounts payable, and a lease incentive representing an allowance for facility alterations.
|
|
Six Months Ended June 30, |
|
|||||
(in thousands) |
|
2022 |
|
|
2021 |
|
||
Drugs |
|
$ |
|
|
$ |
|
||
Supplements |
|
|
|
|
|
|
||
Corporate |
|
|
|
|
|
|
||
Consolidated |
|
$ |
|
|
$ |
|
||
Note 19. Subsequent Events
On August 5, 2022, we amended and restated a promissory note pursuant to the 2022 MD Loan with DHCD. The amended and restated promissory note clarified the repayment terms of the note (see Note 9 under the heading “Maryland Loans”).
On August 9, 2022, we entered into a second amendment to the 2021 Avenue Loan which permits indebtedness secured by a lien of up to $
25
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 management team’s expectations, hopes, beliefs, intentions, or strategies regarding our future 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 “we,” “us,” the “Company” 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 began in 2013 by innovating 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 human 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 now have multiple drug assets currently in development and/or clinical trials for applications in neurology, infectious disease, and oncology. Our development and clinical efforts are currently focused on addressing the high unmet medical needs in two areas: first, those related to central nervous system disorders including Amyotrophic Lateral Sclerosis (“ALS”), Multiple Sclerosis (“MS”), and Parkinson’s Disease (“PD”); and second, those related to COVID-19, a highly infectious viral respiratory disease with serious and sometimes fatal co-morbidities.
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”), a 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. We incurred a loss from operations of $13.6 million and $13.8 million for the three months ended June 30, 2022 and 2021, respectively; and $26.9 million and $25.5 million for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022 and December 31, 2021, we had an accumulated deficit of $181.2 million and $163.3 million, respectively.
We expect to continue investing in product development and sales and marketing, and we expect to incur additional losses in the future to fund our operations and conduct product research and development. We also 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.
26
Recent Developments of Our Clinical Programs
CNM-Au8®: We have one Phase 2/3 registration clinical trial, the Healey ALS Platform Trial, which is currently ongoing to establish the safety and efficacy of CNM-Au8 in patients with ALS. Based on discussions with the sponsor and review of data from the RESCUE-ALS clinical trial, the secondary and exploratory endpoints for CNM-Au8 (Regimen C) were recently revised in the statistical analysis plan, which has been submitted to the U.S. Food and Drug Administration (“FDA”). Secondary endpoints now include a combined joint-rank score based on survival and change in ALSFRS-R score (combined assessment of function and survival, or CAFS), change in slow vital capacity, and overall survival. Exploratory endpoints include change in hand-held dynamometry measurements, voice pathology measurements, time to clinical events, and biofluid-based pharmacodynamic and metabolic assays. The primary endpoint, change of the slope of the ALSFRS-R score from baseline to week 24, incorporating survival into the statistical model, is unchanged. Topline results are anticipated in the third quarter of 2022, with full unblinded results anticipated in the fourth quarter of 2022. Should the Healey ALS Platform Trial result in a statistically significant treatment benefit that supports the submission of a New Drug Application (“NDA”), we plan to discuss the totality of CNM-Au8 clinical data with the FDA in anticipation of an NDA filing in 2023.
We recently reported positive topline data from our Phase 2 VISIONARY-MS clinical trial which evaluated the efficacy and safety of CNM-Au8 in stable relapsing remitting MS patients. The trial was stopped prematurely due to COVID-19 pandemic operational challenges, limiting enrollment to 73 out of the 150 planned participants. Due to the limited enrollment, the threshold for significance was pre-specified at p=0.10 prior to database lock. The primary analysis was conducted in a modified intent to treat (“mITT”) population, which censored invalid data. The mITT population excluded data from a single site (n=9) with Low Contrast Letter Acuity (“LCLA”) testing execution errors and the timed 25-foot walk data from one subject with a change in mobility assist device. The ITT results were directionally consistent with the mITT results, although the ITT results were not significant. The trial met the primary endpoint of change from baseline in LCLA at 48 weeks compared to placebo. The trial also met the secondary endpoints of mean standardized change from baseline in the modified MS Functional Composite (“mMSFC”) and mMSFC average rank score. CNM-Au8 was well-tolerated, and there were no significant safety findings reported. The open label extension of VISIONARY-MS is ongoing.
We also completed the first dosing cohort of REPAIR-MS, an open-label, investigator blinded Phase 2 clinical trial, and have initiated a second dosing cohort in non-active progressive MS patients which is expected to be complete by the end of 2022. We anticipate launching RESCUE-PD, a Phase 2 clinical trial for the treatment of patients with PD, in the fourth quarter of 2022.
CNM-ZnAg: We have one Phase 2 clinical trial that recently concluded the blinded treatment period. The objective of this study is to investigate the efficacy and safety of CNM-ZnAg for the treatment of COVID-19. As pre-specified in the protocol, due to insufficient hospitalization events in the randomized study population, the primary and secondary endpoints were interchanged. The primary endpoint is now time to substantial alleviation of COVID-19 symptoms up to 28-days, over a continuous period greater than or equal to 48 hours. The key secondary endpoints include (i) time to complete alleviation of COVID-19 symptoms up to 28-days, over a continuous period greater than or equal to 48 hours; and (ii) the proportion of participants who are hospitalized, require hospitalization, or are deceased from baseline to day 28 (the original primary endpoint). Topline results are anticipated in the third quarter of 2022.
27
The chart below reflects the respective stages of our main drug candidates.
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 March 2022, the FDA Peripheral and Central Nervous System Drugs Advisory Committee (“PCNSDAC”) reviewed a New Drug Application (“NDA”) for AMX0035, an investigational drug from Amylyx Pharmaceuticals, Inc., for the treatment of ALS. The PCNSDAC voted 4 (yes) and 6 (no) as to whether the data from a single randomized, controlled trial and the open-label extension study established a conclusion that AMX0035 was effective in the treatment of patients with ALS. The PCNSDAC will reconvene on September 7, 2022 to discuss additional analyses of AMX0035 clinical trial data, and the FDA has extended the review timeline of the NDA, with a Prescription Drug User Fee Act (“PDUFA”) goal date of September 29, 2022. In June 2022, Health Canada conditionally approved AMX0035 for the treatment of ALS.
In May 2022, the FDA approved an orally administered version of edaravone, which has been available since 2017 as an intravenous infusion for the treatment of ALS. Additionally, in July 2022, the FDA accepted an NDA for tofersen, an investigational drug from Biogen Inc., for the treatment of superoxide dismutase 1 (“SOD1”) ALS. The NDA has been granted priority review with a PDUFA goal date of January 25, 2023.
Impact of the COVID-19 Pandemic
The COVID-19 pandemic, which began in December 2019 and has spread worldwide, has caused many governments to implement measures to slow the spread of the COVID-19 outbreak. The COVID-19 pandemic and government measures taken in response have had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred, supply chains have been disrupted, and facilities and production have been suspended. The future progression of the COVID-19 pandemic and its effects on our business and operations remain uncertain. The COVID-19 pandemic may affect our ability to initiate and complete preclinical studies and clinical trials, delay the initiation of future clinical trials, disrupt regulatory activities, or have other adverse effects on our business and operations. In particular, we and our third-party contract research organizations (“CROs”) have faced disruptions that have affected our ability to initiate and complete preclinical studies, caused manufacturing disruptions, and created delays at clinical trial site initiation and clinical trial enrollment, leading to the early conclusion of an ongoing clinical trial. The COVID-19 pandemic has already caused significant disruptions in the financial markets, and may continue to cause such disruptions, which could impact our ability to raise additional funds to support our operations. Moreover, the COVID-19 pandemic has significantly impacted economies worldwide and could result in adverse effects on our business and operations.
We are monitoring the potential impact of the COVID-19 pandemic on our business, financial condition, results of operations, and cash flows. While the COVID-19 pandemic has led to various research restrictions and led to pauses and early conclusion of certain of our clinical trials, these impacts have been temporary and to date we have not experienced material business disruptions or incurred impairment losses in the carrying values of our assets as a result of the COVID-19 pandemic. We are not aware of any specific related
28
event or circumstance that would require us to revise the estimates reflected in our condensed consolidated financial statements. The extent to which the COVID-19 pandemic will directly or indirectly impact our business, financial condition, results of operations, and cash flows, including planned and future clinical trials and research and development costs, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, the actions taken to contain or treat it, and the duration and intensity of the related effects.
Reverse Recapitalization with Tottenham and Clene Nanomedicine
On December 30, 2020 (the “Closing Date”), Chelsea Worldwide Inc., our predecessor, consummated a business combination (the “Reverse Recapitalization”) by and among Clene Nanomedicine, Inc. (“Clene Nanomedicine”), Tottenham Acquisition I Limited (“Tottenham”), Chelsea Worldwide Inc. (“PubCo”), a Delaware corporation and wholly-owned subsidiary of Tottenham, Creative Worldwide Inc. (“Merger Sub”), a Delaware corporation and wholly-owned subsidiary of PubCo, and Fortis Advisors LLC, a Delaware limited liability company as the representative of our stockholders. Prior to the Reverse Recapitalization, Tottenham was incorporated in the British Virgin Islands as a blank check company for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization, or other similar business combination with one or more businesses or entities. Prior to the Reverse Recapitalization, there was not a public market for the shares of Clene Nanomedicine common stock.
The Reverse Recapitalization was effected in two steps: (i) Tottenham was reincorporated to the state of Delaware by merging with and into PubCo; and (ii) Merger Sub was merged with and into Clene Nanomedicine, resulting in Clene Nanomedicine becoming a wholly-owned subsidiary of PubCo. On the Closing Date, PubCo changed its name from Chelsea Worldwide Inc. 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.”
Earn-Out Shares
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. The Contingent Earn-outs have been classified as liabilities in the condensed consolidated balance sheets and were initially measured at fair value on the date of the Reverse Recapitalization and are subsequently remeasured to fair value at each reporting date. The change in fair value of the Contingent Earn-outs has been recorded in the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2022 and 2021.
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 and expanding, with two clinical-stage drug candidates currently being investigated.
Historically, substantially all of our research and development expenses relate to CNM-Au8, our lead asset. Our research and development expenses are affected by the timing and advancement of our existing product pipeline as well as the timing and quantity of new drug programs commenced. Drug candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to per patient clinical trial site fees for larger clinical trials, the costs of opening and monitoring clinical sites, CRO activity, and manufacturing expenses. We anticipate that our research and development expenses will increase significantly due to the increase in clinical trial expenses incurred to develop our drug candidates.
Research and development costs are charged to operations as incurred. Research and development costs include payroll and personnel expenses, including salaries and related benefits and stock-based compensation expense for employees engaged in research and development functions; clinical trial supplies and materials to support our clinical trials; payments to CROs, principal investigators, and clinical trial sites; costs associated with preclinical activities; consulting costs; and allocated overhead, including rent, equipment, utilities, depreciation, insurance, and facilities maintenance costs. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities initially as an asset and then as expenses when the goods have been received or when the service has been performed rather than when the payment is made.
29
Our clinical trial accrual process seeks to account for expenses resulting from obligations under contracts with CROs, consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract 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 trial expenses in the condensed consolidated financial statements by matching the appropriate expenses with the period in which services and efforts are expended. In the event advance payments are made to a CRO, the payments will be recorded as a prepaid asset, which will be expensed over the period of time the contracted services are performed.
General and Administrative Expense
General and administrative expenses consist primarily of payroll and personnel expenses, including salaries and related benefits and stock-based compensation expense; professional fees for legal, accounting, tax, and information technology services; fees for directors’ and officers’ insurance; expenses for business development activities; utilities and facility expenses; travel expenses; rental fees; consulting fees; and other administrative expenses.
We anticipate that our general and administrative expenses will increase in future periods to support increases in our drug development activities and as we build out our commercial capabilities in advance of receiving regulatory approval for the rapidly advancing clinical trials of our drug candidates. These increases 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. We also anticipate increasing legal, compliance, accounting, and investor and public relations expenses associated with being a public company.
Total Other Income (Expense), Net
Total other income (expense), net, consists primarily of (i) changes in the fair value of our (a) common stock warrant liability and (b) Contingent Earn-outs, (ii) interest income and interest expense, (iii) interest income and expense resulting from changes in fair value of our notes payable, (iv) gains and losses on extinguishment of notes payable, (v) gains and losses on termination of leases, and (vi) the Australia research and development credit.
We also received grants issued by non-government entities which require us to comply with conditions attached to the grants. Income from grants is recognized in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grants were provided have been met. We receive tax incentives from the Australian government in the form of cash subsidies for research and development activities related to clinical trial activities conducted by our Australian subsidiary, which are recognized as other income upon compliance with certain conditions.
Results of Operations
Our results of operations for the three and six months ended June 30, 2022 and 2021 were as follows:
|
|
Three Months Ended June 30, |
|
|
Change |
|
|
Six Months Ended June 30, |
|
|
Change |
|
||||||||||||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
Dollars |
|
|
% |
|
|
2022 |
|
|
2021 |
|
|
Dollars |
|
|
% |
|
||||||||
Product revenue |
|
$ |
2 |
|
|
$ |
138 |
|
|
$ |
(136 |
) |
|
|
(99 |
)% |
|
$ |
9 |
|
|
$ |
337 |
|
|
$ |
(328 |
) |
|
|
(97 |
)% |
Royalty revenue |
|
|
33 |
|
|
|
63 |
|
|
|
(30 |
) |
|
|
(48 |
)% |
|
|
56 |
|
|
|
77 |
|
|
|
(21 |
) |
|
|
(27 |
)% |
Total revenue |
|
|
35 |
|
|
|
201 |
|
|
|
(166 |
) |
|
|
(83 |
)% |
|
|
65 |
|
|
|
414 |
|
|
|
(349 |
) |
|
|
(84 |
)% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Cost of revenue |
|
|
— |
|
|
|
555 |
|
|
|
(555 |
) |
|
|
(100 |
)% |
|
|
— |
|
|
|
798 |
|
|
|
(798 |
) |
|
|
(100 |
)% |
Research and development |
|
|
9,166 |
|
|
|
6,472 |
|
|
|
2,694 |
|
|
|
42 |
% |
|
|
17,746 |
|
|
|
12,747 |
|
|
|
4,999 |
|
|
|
39 |
% |
General and administrative |
|
|
4,464 |
|
|
|
6,949 |
|
|
|
(2,485 |
) |
|
|
(36 |
)% |
|
|
9,250 |
|
|
|
12,339 |
|
|
|
(3,089 |
) |
|
|
(25 |
)% |
Total operating expenses |
|
|
13,630 |
|
|
|
13,976 |
|
|
|
(346 |
) |
|
|
(2 |
)% |
|
|
26,996 |
|
|
|
25,884 |
|
|
|
1,112 |
|
|
|
4 |
% |
Loss from operations |
|
|
(13,595 |
) |
|
|
(13,775 |
) |
|
|
180 |
|
|
|
1 |
% |
|
|
(26,931 |
) |
|
|
(25,470 |
) |
|
|
(1,461 |
) |
|
|
(6 |
)% |
Total other income (expense), net |
|
|
9,061 |
|
|
|
10,352 |
|
|
|
(1,291 |
) |
|
|
(12 |
)% |
|
|
9,043 |
|
|
|
(17,781 |
) |
|
|
26,824 |
|
|
|
151 |
% |
Net loss before income taxes |
|
|
(4,534 |
) |
|
|
(3,423 |
) |
|
|
(1,111 |
) |
|
|
(32 |
)% |
|
|
(17,888 |
) |
|
|
(43,251 |
) |
|
|
25,363 |
|
|
|
59 |
% |
Income tax benefit |
|
|
— |
|
|
|
72 |
|
|
|
(72 |
) |
|
|
(100 |
)% |
|
|
— |
|
|
|
144 |
|
|
|
(144 |
) |
|
|
(100 |
)% |
Net loss |
|
$ |
(4,534 |
) |
|
$ |
(3,351 |
) |
|
$ |
(1,183 |
) |
|
|
(35 |
)% |
|
$ |
(17,888 |
) |
|
$ |
(43,107 |
) |
|
$ |
25,219 |
|
|
|
59 |
% |
30
Revenue
Product revenue totaled $2,000 and $0.1 million for the three months ended June 30, 2022 and 2021, respectively; and $9,000 and $0.3 million for the six months ended June 30, 2022 and 2021, respectively, in our Supplements segment related to (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 totaled $33,000 and $63,000 for the three months ended June 30, 2022 and 2021, respectively; and $56,000 and $77,000 for the six months ended June 30, 2022 and 2021, respectively, under an exclusive and royalty-bearing license agreement with 4Life relating to the sale of Gold Factor. For more details on the supply and license agreements, see Note 17 to our condensed consolidated financial statements.
Cost of Revenue
Cost of revenue totaled $0 and $0.6 million for the three months ended June 30, 2022 and 2021, respectively; and $0 and $0.8 million for the six months ended June 30, 2022 and 2021, respectively, relating 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 for the three and six months ended June 30, 2022 and 2021 was as follows:
|
|
Three Months Ended June 30, |
|
|
Change |
|
|
Six Months Ended June 30, |
|
|
Change |
|
||||||||||||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
Dollars |
|
|
% |
|
|
2022 |
|
|
2021 |
|
|
Dollars |
|
|
% |
|
||||||||
CNM-Au8 |
|
$ |
3,028 |
|
|
$ |
2,134 |
|
|
$ |
894 |
|
|
|
42 |
% |
|
$ |
5,833 |
|
|
$ |
4,506 |
|
|
$ |
1,327 |
|
|
|
29 |
% |
CNM-ZnAg |
|
|
484 |
|
|
|
384 |
|
|
|
100 |
|
|
|
26 |
% |
|
|
1,893 |
|
|
|
517 |
|
|
|
1,376 |
|
|
|
266 |
% |
Unallocated |
|
|
2,179 |
|
|
|
884 |
|
|
|
1,295 |
|
|
|
146 |
% |
|
|
3,183 |
|
|
|
1,287 |
|
|
|
1,896 |
|
|
|
147 |
% |
Personnel |
|
|
2,642 |
|
|
|
1,462 |
|
|
|
1,180 |
|
|
|
81 |
% |
|
|
5,260 |
|
|
|
3,434 |
|
|
|
1,826 |
|
|
|
53 |
% |
Stock-based compensation |
|
|
833 |
|
|
|
1,608 |
|
|
|
(775 |
) |
|
|
(48 |
)% |
|
|
1,577 |
|
|
|
3,003 |
|
|
|
(1,426 |
) |
|
|
(47 |
)% |
Total research and development |
|
$ |
9,166 |
|
|
$ |
6,472 |
|
|
$ |
2,694 |
|
|
|
42 |
% |
|
$ |
17,746 |
|
|
$ |
12,747 |
|
|
$ |
4,999 |
|
|
|
39 |
% |
The change in research and development expenses was primarily due to the following:
31
General and Administrative Expense
General and administrative expense for the three and six months ended June 30, 2022 and 2021 was as follows:
|
|
Three Months Ended June 30, |
|
|
Change |
|
|
Six Months Ended June 30, |
|
|
Change |
|
||||||||||||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
Dollars |
|
|
% |
|
|
2022 |
|
|
2021 |
|
|
Dollars |
|
|
% |
|
||||||||
Directors’ and officersʼ insurance |
|
$ |
849 |
|
|
$ |
929 |
|
|
$ |
(80 |
) |
|
|
(9 |
)% |
|
$ |
1,698 |
|
|
$ |
1,903 |
|
|
$ |
(205 |
) |
|
|
(11 |
)% |
Legal |
|
|
149 |
|
|
|
451 |
|
|
|
(302 |
) |
|
|
(67 |
)% |
|
|
327 |
|
|
|
645 |
|
|
|
(318 |
) |
|
|
(49 |
)% |
Finance and accounting |
|
|
273 |
|
|
|
1,115 |
|
|
|
(842 |
) |
|
|
(76 |
)% |
|
|
684 |
|
|
|
2,341 |
|
|
|
(1,657 |
) |
|
|
(71 |
)% |
Public and investor relations |
|
|
139 |
|
|
|
794 |
|
|
|
(655 |
) |
|
|
(82 |
)% |
|
|
469 |
|
|
|
877 |
|
|
|
(408 |
) |
|
|
(47 |
)% |
Personnel |
|
|
1,260 |
|
|
|
823 |
|
|
|
437 |
|
|
|
53 |
% |
|
|
2,441 |
|
|
|
1,629 |
|
|
|
812 |
|
|
|
50 |
% |
Stock-based compensation |
|
|
1,351 |
|
|
|
2,647 |
|
|
|
(1,296 |
) |
|
|
(49 |
)% |
|
|
2,809 |
|
|
|
4,517 |
|
|
|
(1,708 |
) |
|
|
(38 |
)% |
Other |
|
|
443 |
|
|
|
190 |
|
|
|
253 |
|
|
|
133 |
% |
|
|
822 |
|
|
|
427 |
|
|
|
395 |
|
|
|
93 |
% |
Total general and administrative |
|
$ |
4,464 |
|
|
$ |
6,949 |
|
|
$ |
(2,485 |
) |
|
|
(36 |
)% |
|
$ |
9,250 |
|
|
$ |
12,339 |
|
|
$ |
(3,089 |
) |
|
|
(25 |
)% |
The change in general and administrative expense was primarily due to the following:
Total Other Income (Expense), Net
Total other income (expense), net, for the three and six months ended June 30, 2022 and 2021 was as follows:
|
|
Three Months Ended June 30, |
|
|
Change |
|
|
Six Months Ended June 30, |
|
|
Change |
|
||||||||||||||||||||
(in thousands) |
|
2022 |
|
|
2021 |
|
|
Dollars |
|
|
% |
|
|
2022 |
|
|
2021 |
|
|
Dollars |
|
|
% |
|
||||||||
Interest expense |
|
$ |
(751 |
) |
|
$ |
(26 |
) |
|
$ |
(725 |
) |
|
|
(2,788 |
)% |
|
$ |
(1,533 |
) |
|
$ |
(577 |
) |
|
$ |
(956 |
) |
|
|
(166 |
)% |
Gain on extinguishment of notes payable |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
0 |
% |
|
|
— |
|
|
|
647 |
|
|
|
(647 |
) |
|
|
(100 |
)% |
Gain on termination of lease |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
0 |
% |
|
|
420 |
|
|
|
— |
|
|
|
420 |
|
|
|
100 |
% |
Change in fair value of common stock warrant liability |
|
|
20 |
|
|
|
133 |
|
|
|
(113 |
) |
|
|
(85 |
)% |
|
|
2 |
|
|
|
133 |
|
|
|
(131 |
) |
|
|
(98 |
)% |
Change in fair value of Clene Nanomedicine contingent earn-out |
|
|
8,310 |
|
|
|
8,640 |
|
|
|
(330 |
) |
|
|
(4 |
)% |
|
|
8,253 |
|
|
|
(16,970 |
) |
|
|
25,223 |
|
|
|
149 |
% |
Change in fair value of Initial Stockholders contingent earn-out |
|
|
1,066 |
|
|
|
1,232 |
|
|
|
(166 |
) |
|
|
(13 |
)% |
|
|
1,054 |
|
|
|
(1,729 |
) |
|
|
2,783 |
|
|
|
161 |
% |
Australia research and development credit |
|
|
356 |
|
|
|
375 |
|
|
|
(19 |
) |
|
|
(5 |
)% |
|
|
655 |
|
|
|
714 |
|
|
|
(59 |
) |
|
|
(8 |
)% |
Other income (expense), net |
|
|
60 |
|
|
|
(2 |
) |
|
|
62 |
|
|
|
3,100 |
% |
|
|
192 |
|
|
|
1 |
|
|
|
191 |
|
|
|
19,100 |
% |
Total other income (expense), net |
|
$ |
9,061 |
|
|
$ |
10,352 |
|
|
$ |
(1,291 |
) |
|
|
(12 |
)% |
|
$ |
9,043 |
|
|
$ |
(17,781 |
) |
|
$ |
26,824 |
|
|
|
151 |
% |
The change in total other income (expense), net, was primarily due to the following:
32
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% for the three and six months ended June 30, 2022 and 2021. We are also subject to state income tax in Utah and Maryland, at a rate of 4.85% and 8.25%, respectively, for the three and six months ended June 30, 2022 and 2021. As of June 30, 2022 and December 31, 2021, 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 on March 5, 2018 and is subject to corporate income tax at a rate of 25% for the three and six months ended June 30, 2022 and 2021, respectively. Clene Australia income tax benefit totaled $0 and $0.1 million for the three months ended June 30, 2022 and 2021, respectively; and $0 and $0.1 million for the six months ended June 30, 2022 and 2021, respectively. We recorded other income of $0.4 million and $0.4 million for the three months ended June 30, 2022 and 2021, respectively; and $0.7 million and $0.7 million for the six months ended June 30, 2022 and 2021, respectively, for research and development credits pertaining to Clene Australia for the 2022 and 2021 tax years, respectively.
Netherlands
Our wholly-owned subsidiary, Clene Netherlands B.V., was established in the Netherlands on April 21, 2021 and is subject to corporate income tax at a rate of 15% up to €395,000 of taxable income and 25.8% for taxable income in excess of €395,000. Clene Netherlands B.V. had no taxable income or provision for income taxes for the three and six months ended June 30, 2022 and 2021.
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 product research and development. 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 of our resources to the development of our drug candidates. We have financed our operations principally through the following sources:
33
We also receive indirect financial support for the Healey ALS Platform Trial, administered by Massachusetts General Hospital, which is conducting a platform trial of CNM-Au8 alongside other drugs at significantly lower costs than we would otherwise incur if we were to conduct a comparably designed clinical trial at reasonable market rates.
Going Concern
We incurred a loss from operations of $13.6 million and $13.8 million for the three months ended June 30, 2022 and 2021, respectively; and $26.9 million and $25.5 million for the six months ended June 30, 2022 and 2021, respectively. Our accumulated deficit was $181.2 million and $163.3 million as of June 30, 2022 and December 31, 2021, respectively. Our cash, cash equivalents, and marketable securities totaled $26.3 million and $50.3 million as of June 30, 2022 and December 31, 2021, respectively, and net cash used in operating activities was $22.8 million and $17.7 million for the six months ended June 30, 2022 and 2021, 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 our expenses to increase significantly and to incur additional losses in the future to fund our operations, 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 our expenses relating to regulatory compliance and sales and marketing personnel to increase significantly as we prepare to commence commercialization if we obtain regulatory approval for our drug candidates.
Our management performs strategic reviews of our operating plans and budgets, considering the status of our product development programs, human capital, capital needs and resources, and current capital market conditions. Based on these reviews, our Board of Directors and management make adjustments to our operating plans and budgets to allocate our projected cash expenditures. Notwithstanding these ongoing adjustments, we project 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, and we must obtain additional financing. Additionally, pursuant to our term loan with Avenue, we must maintain unrestricted cash and cash equivalents of at least $5.0 million to avoid acceleration of the full balance of the loan. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.
To mitigate our funding needs, we intend to implement plans to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as well as potentially utilizing additional funds available under our term loan with Avenue, subject to certain contingent conditions (see Note 9), as well as our existing at-the-market facility. 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. Depending on the results of our plans, we may need to implement cost-saving initiatives, including potentially delaying or reducing research and development programs and commercialization efforts. As a result, 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.
34
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 $0.1 million and $1.0 million of payments under finance and operating lease obligations, respectively; payment of interest on notes payable totaling $2.3 million; and commitments under various agreements for capital expenditures totaling $3.7 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; capital expenditures related to construction and expansion of our manufacturing facilities; and general and administrative costs to support our drug development and pre-commercial 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 $0.1 million and $8.1 million of payments under finance and operating lease obligations, respectively; and interest and principal repayment of notes payable of $23.9 million.
Use of Funds
Our cash flows for the six months ended June 30, 2022 and 2021 were as follows:
|
|
Six Months Ended June 30, |
|
|||||
(in thousands) |
|
2022 |
|
|
2021 |
|
||
Net cash used in operating activities |
|
$ |
(22,814 |
) |
|
$ |
(17,713 |
) |
Net cash used in investing activities |
|
|
(20,857 |
) |
|
|
(420 |
) |
Net cash provided by financing activities |
|
|
783 |
|
|
|
21,898 |
|
Effect of foreign exchange rate changes on cash |
|
|
(147 |
) |
|
|
(33 |
) |
Net increase (decrease) in cash |
|
$ |
(43,035 |
) |
|
$ |
3,732 |
|
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 $22.8 million for the six months ended June 30, 2022, which resulted from a net loss of $17.9 million, adjusted for non-cash items totaling $4.2 million and a net change in operating assets and liabilities of $0.8 million. Significant non-cash items included (i) depreciation expense of $0.5 million relating to laboratory and office equipment and leasehold improvements; (ii) non-cash lease expense of $0.2 million; (iii) stock-based compensation expense of $4.4 million; (iv) gain on termination of lease of $0.4 million; (v) accretion of debt discount of $0.4 million; (vi) non-cash interest expense of $0.1 million; and (vii) the changes in fair value of the Clene Nanomedicine and Initial Stockholders Contingent Earn-outs of $8.3 million and $1.1 million, respectively. The changes in fair value of these instruments were primarily driven by the decrease of the closing price of our Common Stock on Nasdaq. The net change in operating assets and liabilities was primarily attributable to the following: (a) a decrease in accounts receivable of $49,000 and an increase in accounts payable of $1.5 million due to the timing of vendor invoicing and payments; (b) an increase in inventory of $0.1 million; (c) an increase in prepaid expenses and other current assets of $1.0 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 Australia research and development credit receivable; (d) a decrease in accrued liabilities of $1.0 million primarily due to decreased accrued compensation and benefits; and (e) a decrease in operating lease obligations of $0.2 million.
35
Net cash used in operating activities was $17.7 million for the six months ended June 30, 2021, which resulted from a net loss of $43.1 million, adjusted for non-cash items totaling $26.4 million and a net change in operating assets and liabilities of $1.0 million. Non-cash items primarily consisted of the following: (i) depreciation expense of $0.5 million, (ii) stock-based compensation expense of $7.5 million, (iii) change in fair value of Clene Nanomedicine Contingent Earn-out of $17.0 million, (iv) change in fair value of Initial Stockholders Contingent Earn-out of $1.7 million, (iv) gain on extinguishment of debt of $0.6 million and increase in interest accrued on notes payable and accretion of debt discount of $0.4 million. The net change in operating assets and liabilities was primarily attributable to the following: (a) a decrease in inventory of $0.1 million, (b) an increase in accounts receivable of $48,000, (c) an increase in prepaid expenses and other current assets of $1.5 million due to the increase in Australia research and development credit receivable, metal to be used in research and development, and directors and officers insurance; partially offset by a decrease in CRO prepayments, (d) an increase in accounts payable of $0.6 million, (e) a decrease in operating lease obligations of $0.1 million, (f) an increase in accrued liabilities of $0.1 million due to the timing of vendor invoicing and payments, and (g) a decrease in deferred income tax of $0.1 million.
Investing Activities
Net cash used in investing activities was $20.9 million for the six months ended June 30, 2022, which consisted of (i) purchases of marketable securities of $24.5 million and (ii) purchases of property and equipment of $1.8 million, offset primarily by (iii) proceeds from maturity of marketable securities of $2.5 million and (iv) proceeds from sale of marketable securities of $3.0 million. Net cash used in investing activities was $0.4 million for the six months ended June 30, 2021, which consisted of purchases of property and equipment.
Financing Activities
Net cash provided by financing activities was $0.8 million for the six months ended June 30, 2022, which primarily consisted of (i) proceeds from exercise of stock options of $0.3 million and (ii) proceeds from the issuance of notes payable of $0.7 million, offset primarily by (iii) payments of finance lease obligations of $0.1 million, (iv) payment of debt issuance costs of $30,000, and (v) payment of deferred offering costs of $0.1 million. Net cash provided by financing activities was $21.9 million for the six months ended June 30, 2021, which primarily consisted of (i) proceeds from exercise of stock options of $0.1 million, (ii) proceeds from the issuance of notes payable of $15.0 million offset by payments of debt issuance costs of $0.5 million, and (iii) proceeds from the May 2021 private placement of common stock of $9.3 million, offset primarily by (iv) payments of finance lease obligations of $0.1 million and (v) payments of deferred offering costs of $1.9 million.
Maryland Loans
In February 2019, we entered into a loan agreement (the “2019 MD Loan”) with the Department of Housing and Community Development (“DHCD”), a principal department of the State of Maryland. The agreement provides for a term loan of $0.5 million bearing simple interest at an annual rate of 8.00%. We are subject to affirmative and negative covenants until maturity, including providing information about the Company and our operations; limitations on our ability to retire, repurchase, or redeem our common or preferred stock, options, and warrants other than per the terms of the securities; and limitations on our ability to pay dividends of cash or property. There are no financial covenants associated with the 2019 MD Loan. We are not in violation of any covenants. The 2019 MD Loan established “Phantom Shares” at issuance based on 119,907 shares of Common Stock. Repayment of the full balance is due on February 22, 2034, with the repayment amount and carrying value equal to the greater of the balance of principal plus accrued interest or the value of the Phantom Shares. The value of the Phantom Shares is based on the closing price of our Common Stock on Nasdaq at the end of each reporting period. As of June 30, 2022 and December 31, 2021, the note was recorded at principal plus accrued interest in the condensed consolidated balance sheets.
In May 2022, we entered into a loan agreement (the “2022 MD Loan”) with DHCD which provides for a term loan of up to $3.0 million bearing simple interest at an annual rate of 6.00% for the purchase of certain personal property (the “Assets”) related to the production of pharmaceutical drugs. As of June 30, 2022, we had drawn $0.7 million under the term loan, with the remainder available upon our submission of disbursement requests to purchase the Assets. The 2022 MD Loan matures on July 1, 2027 (the “Maturity Date”). The first twelve payments, commencing on July 1, 2022, are deferred. Immediately thereafter, there shall be eighteen monthly installments of interest-only based on the actual amount advanced under the loan, each up to a maximum amount of $15,000; followed by thirty monthly installments of principal and interest, each in the amount of $33,306, which is due and payable even if the entire loan has not been advanced prior to the date such monthly payment is due and payable, with a balloon payment of all accrued and unpaid interest and principal due on the Maturity Date. We recorded $31,000 of debt issuance costs that are being amortized over the contractual term using the effective interest method. Pursuant to the 2022 MD Loan, DHCD was granted a continuing security interest in the Assets as collateral. Under a priority of liens agreement by and between DHCD and Avenue Venture Opportunities Fund, L.P. (“Avenue”), an existing secured creditor of the Company, DHCD’s continuing security interest in the Assets shall be a first priority lien.
36
Cecil County Loan
In April 2019, we entered into a loan agreement (the “2019 Cecil Loan”) with Advance Cecil Inc., a non-stock corporation formed under the laws of the state of Maryland. The agreement provides for a term loan of $0.1 million bearing simple interest at an annual rate of 8.00%. We are subject to affirmative covenants until maturity, including providing information about the Company and our operations. There are no financial covenants associated with the 2019 Cecil Loan. We are not in violation of any covenants. The 2019 Cecil Loan established “Phantom Shares” at issuance based on 23,981 shares of Common Stock. Repayment of the full balance is due on April 30, 2034, with the repayment amount and carrying value equal to the greater of the balance of principal plus accrued interest or the value of the Phantom Shares. The value of the Phantom Shares is based on the closing price of our Common Stock on Nasdaq at the end of each reporting period. As of June 30, 2022 and December 31, 2021, the note was recorded at principal plus accrued interest in the condensed consolidated balance sheets.
Avenue Loan
In May 2021, we entered into a loan agreement (the “2021 Avenue Loan”) with Avenue. The agreement provides for a 42-month term loan of up to $30.0 million. The first tranche is $20.0 million (“Tranche 1”), of which $15.0 million was funded at close and $5.0 million was funded in September 2021. We incurred issuance costs of $0.6 million of which $46,951 was expensed immediately. The remaining unfunded tranche of $10.0 million (“Tranche 2”) is available until December 31, 2022. Funding of Tranche 2 is subject to (a) our receipt of $5.0 million financing through the state of Maryland; (b) our achievement of a statistically significant result in certain clinical trials (“Performance Milestone 1”); (c) our receipt of net proceeds of at least $30.0 million from the sale and issuance of our equity securities between May 2, 2021 and December 31, 2022; and (d) mutual agreement of us and Avenue. The 2021 Avenue Loan bears interest at a variable rate equal to the sum of (i) the greater of (a) the prime rate or (b) 3.25%, plus (ii) 6.60%. As of June 30, 2022 and December 31, 2021, the interest rate was 11.35% and 9.85%, respectively. Payments are interest-only for the first 12 months and have been extended an additional 12 months (the “First Interest-only Period Extension”) based on our achievement of Performance Milestone 1. Payments may be extended up to 36 months if we (i) achieve the First Interest-only Period Extension and (b) draw from Tranche 2. The loan principal will amortize equally from the end of the interest period to the expiration of the 42-month term on December 1, 2024. On the maturity date, an additional payment equal to 4.25% of the funded loans, currently equal to $0.9 million (the “Final Payment”), is due in addition to the remaining unpaid principal and accrued interest. The Final Payment was recorded as a debt premium and is being amortized over the contractual term using the effective interest method. The Final Payment is related to the loan host and is not bifurcated pursuant to Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging (“ASC 815”). We are subject to affirmative and negative covenants until maturity in the absence of prepayments, including providing information about the Company and our operations; limitation on our ability to retire, repurchase, or redeem our Common Stock, options, and warrants other than per the terms of the securities; and limitations on our ability to pay dividends of cash or property. Also pursuant to the 2021 Avenue Loan, we are required to maintain unrestricted cash and cash equivalents of at least $5.0 million, provided that upon our (i) achievement of Performance Milestone 1, and (ii) receiving of net proceeds of at least $30.0 million from the sale and issuance of our equity securities, we shall no longer be subject to financial covenants. We are not in violation of any covenants. Avenue also has the ability to make all obligations under the 2021 Avenue Loan immediately due and payable upon occurrence of certain events of default or material adverse effects, as outlined in the loan agreement. The 2021 Avenue Loan is collateralized by substantially all of our assets other than intellectual property, including our capital stock and the capital stock of our subsidiaries, in which Avenue is granted a continuing security interest.
Pursuant to the agreement, we granted Avenue a warrant to purchase 115,851 shares of Common Stock (the “Avenue Warrant”) at an exercise price of $8.63 per share. Upon the funding of Tranche 2, the Avenue Warrant shall be adjusted to include an additional estimated 245,832 shares of Common Stock, which is equal to 5% of the principal amount of Tranche 2, divided by the five (5)-day VWAP per share as of the end of trading on the last trading day before the issuance of Tranche 2. We accounted for the Tranche 2 contingently-issuable warrant at inception of the 2021 Avenue Loan in accordance with ASC 815 and the fair value and issuable shares are remeasured at each reporting period.
Avenue has the right, in its discretion, but not the obligation, at any time between May 21, 2022 through May 21, 2024, while the loan is outstanding, to convert up to $5.0 million of principal into Common Stock (the “Conversion Feature”) at a price per share equal to 120% of the Avenue Warrant exercise price. The Conversion Feature is subject to certain minimum price and volume conditions of our Common Stock on Nasdaq. The Conversion Feature did not meet the requirements for separate accounting and is not accounted for as a derivative instrument. The number of shares of Common Stock potentially issuable upon conversion is 482,703 shares. We classified $5.0 million of the 2021 Avenue Loan as convertible notes payable as of June 30, 2022 and December 31, 2021, with unamortized debt discount and issuance costs of $0.3 million and $0.4 million, respectively.
At-the-Market Offering
On April 14, 2022, we entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Canaccord Genuity LLC and Oppenheimer & Co. Inc., as placement agents (the “Placement Agents”). In accordance with the terms of the Distribution
37
Agreement, we may offer and sell shares of Common Stock having an aggregate offering price of up to $50.0 million from time to time through the Placement Agents. The issuance and sale of Common Stock, if any, by us under the Distribution Agreement will be made pursuant to our registration statement on Form S-3 (the “Registration Statement”), which was declared effective by the Securities and Exchange Commission on April 26, 2022 (file number 333-264299), and our prospectus supplement relating to the offering.
Subject to terms of the Distribution Agreement, the Placement Agents are not required to sell any specific number or dollar amount of Common Stock but will act as our placement agents, using commercially reasonable efforts to sell, on our behalf, all of the Common Stock requested by us to be sold, consistent with the Placement Agents’ normal trading and sales practices, on terms mutually agreed between the Placement Agents and us. The Placement Agents will be entitled to compensation under the terms of the Distribution Agreement at a fixed commission rate of 3.0% of the gross proceeds from each issuance and sale of Common Stock, if any.
During the three and six months ended June 30, 2022, no shares of Common Stock were sold under the Distribution Agreement.
Critical Accounting Policies and 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. See Note 2 to our condensed consolidated financial statements for a description of other significant accounting policies.
Contingent Earn-Out Liabilities
In connection with the Reverse Recapitalization, certain stockholders are entitled to the Contingent Earn-outs payments based on achievement of certain milestones. In accordance with ASC 815, we classified the Contingent Earn-outs as liabilities and measured them at fair value on the date of the Reverse Recapitalization. We remeasure the liabilities at each reporting date and record the change in fair value as a component of other income (expense), net, in the condensed consolidated statements of operations and comprehensive loss. We estimate the fair value using a Monte Carlo valuation model, which requires significant judgment. The unobservable inputs include the expected stock price volatility, the risk-free interest rate, and the expected term.
As of June 30, 2022 and December 31, 2021, the unobservable inputs were as follows:
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Expected stock price volatility |
|
|
115.00 |
% |
|
|
105.00 |
% |
Risk-free interest rate |
|
|
3.00 |
% |
|
|
1.10 |
% |
Expected dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
Expected term |
|
3.50 years |
|
|
4.00 years |
|
||
We recorded a gain due to the change in fair value of the Clene Nanomedicine Contingent Earn-out of $8.3 million and $8.6 million for the three months ended June 30, 2022 and 2021, respectively; and a gain of $8.3 million and loss of $17.0 million for the six months ended June 30, 2022 and 2021, respectively. We recorded a gain due to change in fair value of the Initial Stockholders Contingent Earn-out of $1.1 million and $1.2 million for the three months ended June 30, 2022 and 2021, respectively; and a gain of $1.1 million and loss of $1.7 million for the six months ended June 30, 2022 and 2021, respectively.
Convertible Notes
Pursuant to the 2021 Avenue Loan, $5.0 million of the outstanding principal is subject to the Conversion Feature. In accordance with Accounting Standards Update (“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 this portion as convertible notes payable in the condensed consolidated balance sheets and did not bifurcate the Conversion Feature from the host contract. Consequently, we account for the convertible note as a single liability
38
measured at its amortized cost. As of June 30, 2022 and December 31, 2021, the convertible note was carried at $4.7 million and $4.6 million, respectively.
Common Stock Warrant Liability
Pursuant to the 2021 Avenue Loan, we issued the Avenue Warrant. In accordance with ASC 815, we recognized both the issued Tranche 1 warrant and the Tranche 2 warrant issuable pursuant to the potential draw of Tranche 2 as liabilities measured at fair value. As we did not complete a bona fide round of equity financing by March 31, 2022, the exercise price and underlying shares of the Tranche 1 warrant became fixed and therefore qualified for equity classification. We remeasured the Tranche 1 warrant liability to fair value as of March 31, 2022 and recognized the change in fair value in the condensed consolidated statements of operations and comprehensive loss and the Tranche 1 warrant liability was reclassified to additional paid-in-capital. We remeasure the Tranche 2 warrant liability 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.
We estimate the fair value using a Black-Scholes option-pricing model, with a probability weight related to the potential draw of Tranche 2, which requires significant judgment. The unobservable inputs include the expected stock price volatility, risk-free interest rate, expected term, and the probability of drawing Tranche 2. As of June 30, 2022 and December 31, 2021, the unobservable inputs were as follows:
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Expected stock price volatility |
|
|
115.00 |
% |
|
|
105.00 |
% |
Risk-free interest rate |
|
|
3.00 |
% |
|
|
1.20 |
% |
Expected dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
Expected term |
|
3.70 years |
|
|
3.89 – 4.39 years |
|
||
Probability of drawing Tranche 2 |
|
|
45.00 |
% |
|
|
50.00 |
% |
We recorded a change in fair value of the common stock warrant liability of $20,000 and $0.1 million for the three months ended June 30, 2022 and 2021, respectively; and $2,000 and $0.1 million for the six months ended June 30, 2022 and 2021, respectively.
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.
39
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 six months ended June 30, 2022 and 2021, the unobservable inputs were as follows:
|
|
Six Months Ended June 30, |
||
|
|
2022 |
|
2021 |
Expected stock price volatility |
|
89.57% – 93.38% |
|
84.80% – 87.70% |
Risk-free interest rate |
|
1.65% – 3.00% |
|
0.59% – 1.90% |
Expected dividend yield |
|
0.00% |
|
0.00% |
Expected term of options |
|
5.00 – 6.98 years |
|
6.00 years |
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 six months ended June 30, 2022 and 2021.
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 June 30, 2022, 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 June 30, 2022, 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 Securities and Exchange Commission (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, 2021 and 2020, 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:
40
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 weakness. During 2021, we made the following enhancements to our control environment:
Our remediation activities are continuing during 2022. In addition to the above actions, we expect to engage in additional activities, or have completed additional activities, including, but not limited to:
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 weakness 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 June 30, 2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
41
PART II—OTHER INFORMATION
Item 1. Legal Proceedings
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.
Item 1A. Risk 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 2021 Annual Report on Form 10-K which was filed with the SEC on March 11, 2022. There have been no material changes to the risk factors since previously disclosed in the 2021 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
None.
None.
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not Applicable.
Item 5. Other Information
On August 5, 2022, we amended and restated a promissory note (the “Amended Promissory Note”) pursuant to a security agreement, dated May 17, 2022, with the Department of Housing and Community Development, a principal department of the State of Maryland (the “DHCD”). The Amended Promissory Note clarifies that borrowings mature on July 1, 2027 (the “Maturity Date”); the first twelve payments, commencing on July 1, 2022, are deferred; and immediately thereafter there shall be eighteen monthly installments of interest-only based on the actual amount advanced under the loan, each up to a maximum amount of $15,000; followed by thirty monthly installments of principal and interest, each in the amount of $33,306, which is due and payable even if the entire loan has not been advanced prior to the date such monthly payment is due and payable, with a balloon payment of all accrued and unpaid interest and principal due on the Maturity Date.
On August 9, 2022, we entered into a second amendment to loan and security agreement (the “Amended Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (“Avenue”), which permits indebtedness secured by a lien of up to $3.0 million with any unrelated third-party providing equipment financing on terms reasonably acceptable to Avenue.
The foregoing descriptions of the Amended Promissory Note and Amended Loan Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the Amended Promissory Note and Amended Loan Agreement, which are filed herewith as Exhibit 10.5 and Exhibit 10.6 to this Quarterly Report on Form 10-Q and are incorporated herein by reference.
42
Item 6. Exhibits
Exhibit Number |
|
Exhibit Description |
3.1 |
|
|
3.2 |
|
|
10.1 |
|
|
10.2 |
|
|
10.3# |
|
|
10.4 |
|
|
10.5* |
|
|
10.6*## |
|
|
31.1* |
|
|
31.2* |
|
|
32.1** |
|
|
32.2** |
|
|
101.INS |
|
Inline XBRL Instance Document. |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document. |
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document. |
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document. |
101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
* |
Filed herewith. |
** |
Furnished herewith. |
# |
Certain information has been redacted from this Exhibit in accordance with Item 601(a)(6) of Regulation S-K. |
## |
Schedules and similar attachments to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K. We agree to furnish supplementally a copy of such omitted materials to the SEC upon request. |
43
SIGNATURES
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: August 15, 2022 |
By: |
/s/ Robert Etherington |
|
Name: |
Robert Etherington |
|
Title: |
President, Chief Executive Officer and Director |
|
|
|
Dated: August 15, 2022 |
By: |
/s/ Morgan R. Brown |
|
Name: |
Morgan R. Brown |
|
Title: |
Chief Financial Officer |
44
Exhibit 10.5
AMENDED AND RESTATED
PROMISSORY NOTE
$3,000,000 |
North East, Maryland |
|
August 5, 2022 |
FOR VALUE RECEIVED, CLENE NANOMEDICINE, INC., a Delaware corporation (“Borrower”) promises to pay to the order of the DEPARTMENT OF HOUSING AND COMMUNITY DEVELOPMENT, a principal department of the State of Maryland (“DHCD”) the sum of THREE MILLION AND 00/100 Dollars ($3,000,000.00) (the “Loan”), or so much thereof as has been or may be advanced to, or for the account of, the Borrower (the “Principal Sum”), together with interest payable as set forth below.
RECITALS
WHEREAS, the Borrower executed a Promissory Note, dated May 17, 2022 (the “Original Note”) in the original principal sum of Three Million and 00/100 Dollars ($3,000,000) evidencing the Loan from DHCD to the Borrower.
WHEREAS, as of the date of this Amended and Restated Note (the “Note”), the outstanding balance due under the Original Note is $682,096.50.
WHEREAS, the Original Note contained a typographical error in the terms of repayment and the Borrower and DHCD wish to replace the Original Note with this Note.
TERMS
The Loan shall mature on July 1, 2027 (the “Maturity Date”). The first twelve (12) payments for the Loan, commencing on July 1, 2022, and continuing through June 1, 2023, shall be deferred. Immediately thereafter, commencing July 1, 2023 and continuing through December 1, 2024 (the “Interest Only Period”), there shall be eighteen (18) consecutive monthly installments of interest only, in the amount of Fifteen Thousand and 00/100 Dollars ($15,000) due on the first (1st) day of each month. The Fifteen Thousand and 00/100 Dollars ($15,000) installment amount assumes that the entire Loan has been advanced prior to the start of the Interest Only Period. If not, each monthly payment during the Interest Only Period will be calculated based on the actual amount that has been advanced under this Note prior to the date such monthly payment is due and payable. Following the Interest Only Period, there shall be thirty (30) consecutive monthly installments of principal and interest, based on an amortization of ten (10) years, in the amount of Thirty-Three Thousand Three Hundred Six and 15/100 Dollars ($33,306.15). The Thirty-Three Thousand Three Hundred Six and 15/100 Dollars ($33,306.15) installment amount shall be due and payable even if the entire Loan has not been advanced prior to the date such monthly payment is due and payable. Payments shall be due in arrears on the first (1st) day of each month, with a balloon payment of all accrued and unpaid interest and the principal balance of the Loan due and payable on the Maturity Date. Interest will accrue on funds actually advanced from the date of each advance. Interest will be charged on a basis of a 360-day year composed of twelve thirty-day months and applied to actual days elapsed. Each payment required hereunder shall be made when due, even if at that time the full amount of the Loan has not yet been advanced. Any regular scheduled monthly payment that is received by DHCD before the date it is due shall be deemed to have been received on the due date solely for the purpose of calculating interest.
1
2
3
Signature(s) to follow on next page
4
IN WITNESS WHEREOF, the signature(s) and seal(s) of the Borrower are subscribed to this Note as of the day and year written above with the specific intention of creating a document under seal.
WITNESS: |
|
BORROWER: |
||
|
|
|
|
|
|
|
CLENE NANOMEDICINE, INC., a Delaware corporation |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Anna M. Gardner |
|
By: |
/s/ Mark Mortenson |
(SEAL) |
|
|
|
Name: Mark Mortenson |
|
|
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Title: Chief Science Officer |
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Exhibit 10.6
SECOND AMENDMENT TO LOAN AND SECURITY
AGREEMENT
This Second Amendment to Loan and Security Agreement (this “Amendment”) is entered into as of August 9, 2022, by and between AVENUE VENTURE OPPORTUNITIES FUND, L.P., a Delaware limited partnership (“Lender”) and CLENE INC., a Delaware corporation and CLENE NANOMEDICINE, INC., a Delaware corporation (individually and collectively, jointly and severally, “Borrower”).
RECITALS
Borrower and Lender are parties to that certain Loan and Security Agreement dated as of May 21, 2021, as amended by First Amendment to Loan and Security Agreement dated as of June 30, 2021 (and as amended from time to time, the “Agreement”). The parties desire to amend the Agreement in accordance with the terms of this Amendment.
NOW, THEREFORE, the parties agree as follows:
“(l) Indebtedness secured by a lien described in clause (c) of the defined term “Permitted Liens” to be incurred in an additional aggregate original principal amount of up to $6,000,000, of which up to $3,000,000 shall be with the state of Maryland or its associated government associations or departments, and of which up to $3,000,000 may be with any unrelated third party lender providing equipment financing on terms reasonably acceptable to Lender;”
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IN WITNESS WHEREOF, the undersigned have executed this Amendment as of the first date above written.
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BORROWER: |
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CLENE INC. |
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By: |
/s/ Rob Etherington |
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Name: |
Rob Etherington |
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Title: |
President |
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CLENE NANOMEDICINE, INC. |
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By: |
/s/ Rob Etherington |
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Name: |
Rob Etherington |
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Title: |
President |
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LENDER: |
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AVENUE VENTURE OPPORTUNITIES FUND, L.P. |
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By: |
Avenue Venture Opportunities Partners, LLC Its: General Partner |
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By: |
/s/ Sonia Gardner |
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Name: |
Sonia Gardner |
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Title: |
Authorized Signatory |
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ANNEX A
[Omitted pursuant to Regulation S-K, Item 601(a)(5). We agree to furnish supplementally a copy of such omitted materials to the SEC upon request.]
Exhibit 31.1
CERTIFICATION
I, Robert Etherington, certify that:
Date: August 15, 2022
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/s/ Robert Etherington |
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Robert Etherington |
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President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATION
I, Morgan R. Brown, certify that:
Date: August 15, 2022
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/s/ Morgan R. Brown |
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Morgan R. Brown |
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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:
Dated: August 15, 2022
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/s/ Robert Etherington |
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Robert Etherington |
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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:
Dated: August 15, 2022
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/s/ Morgan R. Brown |
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Morgan R. Brown |
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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.