QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM | to |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | ||
( | |||
(Address of principal executive offices) (Zip Code) | (Registrant’s telephone number, including area code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Large accelerated filer | ¨ | Accelerated filer | ¨ |
x | Smaller reporting company | ||
Emerging growth company |
Page | ||
1 | ||
· | Our ability to effectively operate our business segments; |
· | Our ability to manage our research, development, expansion, growth and operating expenses; |
· | Our ability to evaluate and measure our business, prospects and performance metrics; |
· | Our ability and our national distributor’s ability to compete, directly and indirectly, and succeed in the highly competitive medical devices industry; |
· | Our ability to respond and adapt to changes in technology and customer behavior; |
· | Our ability to protect our intellectual property and to develop, maintain and enhance a strong brand; and |
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June 30, |
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December31, |
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||
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2022 |
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|
2021 |
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||
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(Unaudited) |
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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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$ |
|
|
Short-term investments |
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|
Accounts receivable |
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Inventory |
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Prepaid expenses |
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Total current assets |
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Fixed assets, net |
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Deposits |
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Operating lease right-of-use asset |
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|
Deferred offering costs |
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|
|
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|
TOTAL ASSETS |
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$ |
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$ |
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|
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|
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|
Liabilities, Convertible Preferred Stock, and Stockholders’ EQUITY (DEFICIT) |
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Current liabilities: |
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|
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|
Accounts payable |
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$ |
|
|
|
$ |
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|
Accrued expenses |
|
|
|
|
|
|
|
|
Current portion of operating lease liability |
|
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|
|
|
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|
Convertible notes payable and accrued interest, net of debt discount of $ |
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|
|
|
|
Convertible notes payable and accrued interest due to related parties, net of debt discount of $ |
|
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|
Total current liabilities |
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|
Operating lease liability, net of current portion |
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Total liabilities |
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|
Commitments and contingencies (Notes 6 and 9) |
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Convertible preferred stock: |
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|
|
Series A convertible preferred stock, $ |
|
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|
|
|
|
|
|
Series B convertible preferred stock, $ |
|
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|
|
|
|
|
Stockholders’ equity (deficit): |
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|
|
|
|
|
|
Common stock, $ |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
|
|
|
|
|
|
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Accumulated other comprehensive income (loss) |
|
|
( |
) |
|
|
( |
) |
Total stockholders’ equity (deficit) |
|
|
|
|
|
( |
) |
|
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT) |
|
$ |
|
|
|
$ |
|
|
1 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenue | $ | $ | $ | $ | ||||||||||||
Cost of sales | ||||||||||||||||
Gross (Loss) Profit | ( | ) | ( | ) | ||||||||||||
Operating Expenses | ||||||||||||||||
Research and development | ||||||||||||||||
Sales and marketing | ||||||||||||||||
General and administrative | ||||||||||||||||
Total Operating Expenses | ||||||||||||||||
Loss from Operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
Other Income (Expense) | ||||||||||||||||
Gain on investments | ||||||||||||||||
Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
Other income (expense) | ( | ) | ||||||||||||||
Total Other Expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
Net Loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
Loss attributable to non-controlling interest | — | ( | ) | ( | ) | |||||||||||
Net Loss Attributable to Tenon Medical, Inc. | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
Net Loss Attributable to Tenon Medical, Inc. Per Share of Common Stock | ||||||||||||||||
Basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
Weighted-Average Shares of Common Stock Outstanding | ||||||||||||||||
Basic and diluted | ||||||||||||||||
Consolidated Statements of Comprehensive Loss: | ||||||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
Unrealized loss on investments | ( | ) | ( | ) | ||||||||||||
Foreign currency translation adjustment | ( | ) | ( | ) | ||||||||||||
Total Comprehensive Loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
Comprehensive loss attributable to non-controlling interest | ( | ) | ( | ) | ||||||||||||
Total comprehensive loss attributable to Tenon Medical, Inc. | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) |
2 |
Series A Convertible Preferred Stock |
|
|
Series B Convertible Preferred Stock |
|
|
Common Stock |
|
|
Additional Paid-In Capital |
|
|
Accumulated Deficit |
|
|
Accumulated Other Comprehensive Income |
|
|
Non- Controlling Interest |
|
|
|
|
||||||||||||||||||||||
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Total |
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|||||||||||||||||||||||||
Balance at March 31, 2022 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
( |
) |
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Issuance of common stock and warrants, net of issuance costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued upon conversion of Series A preferred stock |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued upon conversion of Series B preferred stock |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued upon conversion of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued for services |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Balance at June 30, 2022 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
Balance at March 31, 2021 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
( |
) |
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued for services |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at June 30, 2021 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
( |
) |
3 |
Series A Convertible Preferred Stock |
|
|
Series B Convertible Preferred Stock |
|
|
Common Stock |
|
|
Additional Paid-In Capital |
|
|
Accumulated Deficit |
|
|
Accumulated Other Comprehensive Income |
|
|
Non- Controlling Interest |
|
|
|
|
||||||||||||||||||||||
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Total |
|
|||||||||||||||||||||||||
Balance at December 31, 2021 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
( |
) |
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Issuance of common stock and warrants, net of issuance costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued upon conversion of Series A preferred stock |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued upon conversion of Series B preferred stock |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
— |
|
|
|
1,272 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,272 |
|
Common stock issued upon conversion of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued for services |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Balance at June 30, 2022 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
Balance at December 31, 2020 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
( |
) |
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued for services |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at June 30, 2021 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
( |
) |
4 |
|
|
Six Months Ended June 30, |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Cash Flows from Operating Activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Non-cash interest expense |
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
Common stock issued for services |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
|
|
|
|
|
|
Amortization of operating right-of-use asset |
|
|
|
|
|
|
|
|
Increase (decrease) in cash resulting from changes in: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
|
|
|
|
|
Inventory |
|
|
( |
) |
|
|
|
|
Prepaid expenses and other assets |
|
|
( |
) |
|
|
( |
) |
Accounts payable |
|
|
( |
) |
|
|
|
|
Accrued expenses |
|
|
|
|
|
|
|
|
Operating lease liability |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|||
Cash Flows from Investing Activities |
|
|
|
|
|
|
|
|
Sales of short-term investments |
|
|
|
|
|
|
|
|
Purchases of short-term investments |
|
|
( |
) |
|
|
|
|
Purchases of property and equipment |
|
|
( |
) |
|
|
|
|
Net cash used in investing activities |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities |
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance costs |
|
|
|
|
|
|
|
|
Proceeds from issuance of convertible notes payable |
|
|
|
|
|
|
|
|
Repayment of notes payable |
|
|
|
|
|
|
( |
) |
Debt issuance costs |
|
|
|
|
|
|
( |
) |
Deferred offering costs |
|
|
|
|
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of foreign currency translation on cash flow |
|
|
( |
) |
|
|
( |
) |
Net Increase in Cash and Cash Equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and Cash Equivalents at Beginning of Period |
|
|
|
|
|
|
|
|
Cash and Cash Equivalents at End of Period |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosures of Cash Flow Information |
|
|
|
|
|
|
|
|
Cash paid during the year for: |
|
|
|
|
|
|
|
|
Interest |
|
$ |
|
|
|
$ |
|
|
Income taxes |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Non-cash investment and financing activities: |
|
|
|
|
|
|
|
|
Common stock issued upon conversion of preferred stock |
|
$ |
|
|
|
$ |
|
|
Common stock issued upon conversion of debt |
|
$ |
|
|
|
$ |
|
|
Right-of-use assets obtained in exchange for lease liability |
|
$ |
|
|
|
$ |
|
|
Conversion of trade payable to law firm to note payable |
|
$ |
|
|
|
$ |
|
|
5 |
6 |
June 30, 2022 |
|
|
June 30, 2021 |
|
||||
Outstanding restricted stock units |
|
|
|
|
|
|
|
|
Outstanding stock options |
|
|
|
|
|
|
|
|
Outstanding warrants |
|
|
|
|
|
|
|
|
Common shares convertible from notes payable |
|
|
|
|
|
|
|
|
Common shares convertible from preferred stock |
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
7 |
|
|
Level 2 |
|
|
Corporate debt securities: |
|
|
|
|
June 30, 2022 |
|
$ |
|
|
December 31, 2021 |
|
$ |
|
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
||||
Corporate debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2022 |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
December 31, 2021 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
June 30, 2022 |
|
|
December 31,2021 |
|
||||||
Reusable Product |
|
$ |
|
|
|
$ |
|
|
||||
IT Equipment |
|
|
|
|
|
|
|
|
||||
Lab Equipment |
|
|
|
|
|
|
|
|
||||
Office Furniture |
|
|
|
|
|
|
|
|
||||
Fixed assets, gross |
|
|
|
|
|
|
|
|
||||
Less: accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
||||
Fixed assets, net |
|
$ |
|
|
|
$ |
|
|
|
|
June 30, 2022 |
|
|
December 31, 2021 |
|
||
Accrued compensation |
|
$ |
|
|
|
$ |
|
|
Accrued commissions |
|
|
|
|
|
|
|
|
Other accrued expenses |
|
|
|
|
|
|
|
|
Total accrued expenses |
|
$ |
|
|
|
$ |
|
|
8 |
9 |
10 |
June 30, | December 31, | |||||||
2022 | 2021 | |||||||
Operating lease right-of-use assets | $ | $ | ||||||
Operating lease liability, current | $ | ( | ) | $ | ( | ) | ||
Operating lease liability, noncurrent | ( | ) | ( | ) | ||||
Total operating lease liabilities | $ | ( | ) | $ | ( | ) |
2022 | $ | |||
2023 | ||||
2024 | ||||
2025 | ||||
2026 | ||||
Total lease payments | ||||
Less: imputed interest | ( | ) | ||
Present value of operating lease liabilities | $ |
Cash paid for operating leases for the six months ended June 30, 2022 | $ | |||
Cash paid for operating leases for the six months ended June 30, 2021 | $ | |||
Remaining lease term - operating leases (in years) | ||||
Average discount rate - operating leases | % |
11 |
12 |
13 |
Number of Shares Subject to Outstanding Stock Options | Weighted Average Exercise Price Per Share | Number of Outstanding Restricted Stock Units | Weighted- average Grant Date Fair Value per Share | |||||||||||||
Outstanding at December 31, 2021 | $ | $ | ||||||||||||||
Granted | $ | $ | ||||||||||||||
Forfeited | $ | $ | ||||||||||||||
Outstanding at June 30, 2022 | $ | $ |
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Research and development | $ | $ | $ | $ | ||||||||||||
Sales and marketing | ||||||||||||||||
General, and administrative | ||||||||||||||||
Total stock-based compensation expense | $ | $ | $ | $ |
14 |
15 |
16 |
17 |
18 |
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
Consolidated Statements of Operations Data: |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Revenue |
|
$ |
135 |
|
|
$ |
22 |
|
|
$ |
206 |
|
|
$ |
37 |
|
Cost of goods sold |
|
|
271 |
|
|
|
9 |
|
|
|
546 |
|
|
|
20 |
|
Gross (loss) profit |
|
|
(136 |
) |
|
|
13 |
|
|
|
(340 |
) |
|
|
17 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
657 |
|
|
|
237 |
|
|
|
1,219 |
|
|
|
324 |
|
Sales and marketing |
|
|
1,943 |
|
|
|
913 |
|
|
|
2,219 |
|
|
|
917 |
|
General and administrative |
|
|
2,720 |
|
|
|
476 |
|
|
|
3,757 |
|
|
|
578 |
|
Total operating expenses |
|
|
5,320 |
|
|
|
1,626 |
|
|
|
7,195 |
|
|
|
1,819 |
|
Loss from operations |
|
|
(5,456 |
) |
|
|
(1,613 |
) |
|
|
(7,535 |
) |
|
|
(1,802 |
) |
Interest and other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on investments |
|
|
35 |
|
|
|
— |
|
|
|
36 |
|
|
|
— |
|
Interest expense |
|
|
(88 |
) |
|
|
(62 |
) |
|
|
(362 |
) |
|
|
(73 |
) |
Other income (expense) |
|
|
21 |
|
|
|
— |
|
|
|
20 |
|
|
|
(1 |
) |
Net loss |
|
|
(5,488 |
) |
|
|
(1,675 |
) |
|
|
(7,841 |
) |
|
|
(1,876 |
) |
Loss attributable to non-controlling interest |
|
|
— |
|
|
|
(10 |
) |
|
|
— |
|
|
|
(11 |
) |
Net loss attributable to Tenon Medical, Inc. |
|
$ |
(5,488 |
) |
|
$ |
(1,665 |
) |
|
$ |
(7,841 |
) |
|
$ |
(1,865 |
) |
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
Consolidated Statements of Operations Data: |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Revenue |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
Cost of goods sold |
|
|
201 |
|
|
|
41 |
|
|
|
265 |
|
|
|
54 |
|
Gross profit |
|
|
(101 |
) |
|
|
59 |
|
|
|
(165 |
) |
|
|
46 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
487 |
|
|
|
1,077 |
|
|
|
592 |
|
|
|
876 |
|
Sales and marketing |
|
|
1,439 |
|
|
|
4,150 |
|
|
|
1,077 |
|
|
|
2,478 |
|
General and administrative |
|
|
2,015 |
|
|
|
2,164 |
|
|
|
1,824 |
|
|
|
1,562 |
|
Total operating expenses |
|
|
3,941 |
|
|
|
7,391 |
|
|
|
3,493 |
|
|
|
4,916 |
|
Loss from operations |
|
|
(4,041 |
) |
|
|
(7,332 |
) |
|
|
(3,658 |
) |
|
|
4,870 |
|
Interest and other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on investments |
|
|
26 |
|
|
|
— |
|
|
|
17 |
|
|
|
— |
|
Interest expense |
|
|
(65 |
) |
|
|
(282 |
) |
|
|
(176 |
) |
|
|
(197 |
) |
Other expense |
|
|
16 |
|
|
|
— |
|
|
|
10 |
|
|
|
(3 |
) |
Net loss |
|
|
(4,065 |
) |
|
|
(7,614 |
) |
|
|
(3,806 |
) |
|
|
(5,070 |
) |
Loss attributable to non-controlling interest |
|
|
— |
|
|
|
(45 |
) |
|
|
— |
|
|
|
(30 |
) |
Net loss attributable to Tenon Medical, Inc. |
|
|
(4,065 |
)% |
|
|
(7,568 |
)% |
|
|
(3,806 |
)% |
|
|
(5,041 |
)% |
|
|
Three Months Ended June 30, |
|
|
|
|
|
|
|
|||||||
|
|
2022 |
|
|
2021 |
|
|
$ Change |
|
|
% Change |
|
||||
Revenue |
|
$ |
135 |
|
|
$ |
22 |
|
|
$ |
113 |
|
|
|
514 |
% |
Cost of goods sold |
|
|
271 |
|
|
|
9 |
|
|
|
262 |
|
|
|
2,911 |
% |
Gross (loss) profit |
|
$ |
(136 |
) |
|
$ |
13 |
|
|
$ |
(149 |
) |
|
|
(1,146 |
)% |
Gross (loss) profit percentage |
|
|
(101 |
)% |
|
|
59 |
% |
|
|
|
|
|
|
|
|
19 |
|
|
Six Months Ended June 30, |
|
|
|
|
|
|
|
|||||||
|
|
2022 |
|
|
2021 |
|
|
$ Change |
|
|
% Change |
|
||||
Revenue |
|
$ |
206 |
|
|
$ |
37 |
|
|
$ |
169 |
|
|
|
457 |
% |
Cost of goods sold |
|
|
546 |
|
|
|
20 |
|
|
|
526 |
|
|
|
2,630 |
% |
Gross (loss) profit |
|
$ |
(340 |
) |
|
$ |
17 |
|
|
$ |
(357 |
) |
|
|
(2,100 |
)% |
Gross (loss) profit percentage |
|
|
(165 |
)% |
|
|
46 |
% |
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
|
|
|
|
|||||||
|
|
2022 |
|
|
2021 |
|
|
$ Change |
|
|
% Change |
|
||||
Research and development |
|
$ |
657 |
|
|
$ |
237 |
|
|
$ |
420 |
|
|
|
177 |
% |
Sales and marketing |
|
|
1,943 |
|
|
|
913 |
|
|
|
1,030 |
|
|
|
113 |
% |
General and administrative |
|
|
2,720 |
|
|
|
476 |
|
|
|
2,244 |
|
|
|
471 |
% |
Total operating expenses |
|
$ |
5,320 |
|
|
$ |
1,626 |
|
|
$ |
1,682 |
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
|
|
|
|
|||||||
|
|
2022 |
|
|
2021 |
|
|
$ Change |
|
|
% Change |
|
||||
Research and development |
|
$ |
1,219 |
|
|
$ |
324 |
|
|
$ |
895 |
|
|
|
276 |
% |
Sales and marketing |
|
|
2,219 |
|
|
|
917 |
|
|
|
1,302 |
|
|
|
142 |
% |
General and administrative |
|
|
3,757 |
|
|
|
578 |
|
|
|
3,179 |
|
|
|
550 |
% |
Total operating expenses |
|
$ |
7,195 |
|
|
$ |
1,819 |
|
|
$ |
5,376 |
|
|
|
|
|
20 |
|
|
Payments Due By Period (In thousands) |
|
|||||||||||||||||
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
More than |
|
|||||
|
|
Total |
|
|
1 year |
|
|
1-3 years |
|
|
4-5 years |
|
|
5 years |
|
|||||
Operating leases |
|
$ |
1,192 |
|
|
$ |
144 |
|
|
$ |
594 |
|
|
$ |
454 |
|
|
$ |
— |
|
Purchase obligations |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Total |
|
$ |
1,192 |
|
|
$ |
144 |
|
|
$ |
594 |
|
|
$ |
454 |
|
|
$ |
— |
|
21 |
|
|
Six Months Ended June 30, |
|
|
|
|
|
|
|
|||||||
|
|
2022 |
|
|
2021 |
|
|
$ Change |
|
|
% Change |
|
||||
Net cash (used in) provided by: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
(5,227 |
) |
|
$ |
(1,191 |
) |
|
$ |
(4,036 |
) |
|
|
339 |
% |
Investing activities |
|
|
(3,906 |
) |
|
|
— |
|
|
|
(3,906 |
) |
|
|
N/A |
|
Financing activities |
|
|
14,139 |
|
|
|
7,862 |
|
|
|
6,277 |
|
|
|
80 |
% |
Effect of foreign currency translation on cash flow |
|
|
(48 |
) |
|
|
(4 |
) |
|
|
(44 |
) |
|
|
1,100 |
% |
Net increase in cash and cash equivalents |
|
$ |
4,958 |
|
|
$ |
6,667 |
|
|
$ |
(1,709 |
) |
|
|
(26 |
)% |
22 |
23 |
24 |
Exhibit Number |
|
Description |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
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 |
25 |
101.PRE*** |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
# |
Incorporated by reference to the same exhibit number in the Company’s Registration Statement No. 333-260931, filed with the Securities and Exchange Commission on April 20, 2022. |
* |
Filed herewith |
** |
Exhibits 32.1 and 32.2 are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing. |
*** |
Pursuant to Rule 406T of Regulation S-T, the interactive data files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, and otherwise are not subject to liability under those sections. |
26 |
|
TENON MEDICAL, INC. |
|
|
Dated: August 12, 2022 |
/s/ Steven M. Foster |
|
Steven M. Foster |
|
Chief Executive Officer and President, Director (Principal Executive Officer) |
|
|
Dated: August 12, 2022 |
/s/ Steven Van Dick |
|
Steven Van Dick |
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
27 |
EXHIBIT 31.1
CERTIFICATION OF PRINCIPAL EXECTUIVE OFFICER
PURSUANT TO RULE 13a-14(a)/15d-14(a), AS ADOPTED
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Steven Foster, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Tenon Medical, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: August 12, 2022 | By: | /s/ Steven Foster | |
Name: | Steven Foster | ||
Title: | Chief Executive Officer and President | ||
(Principal Executive Officer) |
EXHIBIT 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO RULE 13a-14(a)/15d-14(a), AS ADOPTED
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Steven Van Dick, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Tenon Medical, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: August 12, 2022 | By: | /s/ Steven Van Dick | |
Name: | Steven Van Dick | ||
Title: | Chief Financial Officer | ||
(Principal Financial Officer) | |||
(Principal Accounting Officer) |
EXHIBIT 32.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, Steven Foster, the Chief Executive Officer and President of Tenon Medical, Inc. (the “Company”), hereby certify, that, to my knowledge:
1. The Quarterly Report on Form 10-Q for the period ended June 30, 2022 (the “Report”) of the Company fully complies with the requirements of Section 13(a) and 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 12, 2022 | By: | /s/ Steven Foster | |
Name: | Steven Foster | ||
Title: | Chief Executive Officer and President | ||
(Principal Executive Officer) |
EXHIBIT 32.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, Steven Van Dick, the Chief Financial Officer of Tenon Medical, Inc. (the “Company”), hereby certify, that, to my knowledge:
1. The Quarterly Report on Form 10-Q for the period ended June 30, 2022 (the “Report”) of the Company fully complies with the requirements of Section 13(a)/15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 12, 2022 | By: | /s/ Steven Van Dick | |
Name: | Steven Van Dick | ||
Title: | Chief Financial Officer | ||
(Principal Financial Officer) | |||
(Principal Accounting Officer) |
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
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Debt discount | $ 0 | $ 31 |
Debt discount related to related parties | $ 0 | $ 2 |
Common stock par or stated value per share | $ 0.001 | $ 0.001 |
Common stock shares authorized | 130,000,000 | 10,487,904 |
Common stock shares issued | 11,236,801 | 989,954 |
Common stock shares outstanding | 11,236,801 | 989,954 |
Series A Convertible Preferred Stock [Member] | ||
Temporary equity par or stated value per share | $ 0.001 | $ 0.001 |
Temporary equity shares authorized | 4,500,000 | 2,805,839 |
Temporary equity shares issued | 0 | 2,550,763 |
Temporary equity shares outstanding | 0 | 2,550,763 |
Series B Convertible Preferred Stock [Member] | ||
Temporary equity par or stated value per share | $ 0.001 | $ 0.001 |
Temporary equity shares authorized | 491,222 | 491,222 |
Temporary equity shares issued | 0 | 491,222 |
Temporary equity shares outstanding | 0 | 491,222 |
Organization and Business |
6 Months Ended |
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Jun. 30, 2022 | |
Organization And Business Disclosure [Abstract] | |
Organization and Business | 1. Organization and Business Nature of operations Tenon Medical, Inc. (the “Company”), was incorporated in the State of Delaware on June 19, 2012 and was headquartered in San Ramon, California until June 2021 when it relocated to Los Gatos, California. The Company is a medical device company that has developed a novel inferior-posterior approach to sacroiliac joint fusion for treatment of the most common types of sacroiliac joint disorders that cause lower back pain. The Company received U.S. Food and Drug Administration (“FDA”) clearance in 2018 for its primary product, The Catamaran TM SI Joint Fusion System (“The Catamaran System”). The Company is in the early stages of its commercial launch with its primary focus being on the US market.Basis of consolidation The consolidated financial statements of the Company include the accounts of the Company and its wholly-owned subsidiary, Tenon Technology AG (“TTAG”), a Swiss company. TTAG was a majority-owned subsidiary until October 28, 2021, at which date the Company acquired the remaining non-controlling interest of TTAG (see Note 8). All intercompany balances and transactions have been eliminated in consolidation. |
Summary of Significant Accounting Principles |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Principles | 2. Summary of Significant Accounting Principles Basis of presentation We have prepared the accompanying unaudited condensed consolidated financial statements pursuant to the rules and regulations of the SEC. As permitted under these rules and regulations, we have condensed or omitted certain financial information and footnote disclosures we normally include in our annual consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The unaudited condensed consolidated balance sheet as of December 31, 2021 has been derived from our audited consolidated financial statements, which are included in our amended Registration Statement on Form S-1 filed with the SEC on April 20, 2022 (our “amended Registration Statement”). These condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and, in management’s opinion, reflect all adjustments consisting only of normal recurring adjustments that are necessary for a fair presentation of our financial information. Our interim period operating results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year. The financial statements of the subsidiary are prepared for the same reporting period as the parent, using consistent accounting policies in all material respects. The amount of consolidated net loss attributable to the Company and ownership interests in TTAG held by parties other than the Company are both presented on the face of the Consolidated Statements of Operations. Given that TTAG is a wholly-owned subsidiary as of June 30, 2022, this separate presentation has been discontinued for the three and six months then ended. Further, given that the Company purchased the non-controlling interest in TTAG as of October 28, 2021, the amount of consolidated net loss attributable to the Company and the non-controlling interest are both presented on the face of the Consolidated Statements of Operations and Comprehensive Loss. These unaudited condensed consolidated financial statements and accompanying notes should be read in conjunction with the Company’s audited consolidated financial statements as of and for the years ended December 31, 2021 and 2020 included in our amended Registration Statement. The Company’s significant accounting policies are disclosed in the audited consolidated financial statements as of and for the years ended December 31, 2021 and 2020 included in our amended Registration Statement. There have been no material changes in the Company’s significant accounting policies during the six months ended June 30, 2022. Going concern uncertainty and liquidity requirements The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. Since inception, the Company has incurred losses and negative cash flows from operations. Management expects to incur additional operating losses and negative cash flows from operations in the foreseeable future as the Company continues its product development programs and starts the commercial launch of The Catamaran System. On April 29, 2022, the Company closed an initial public offering (the “IPO”) of its common stock for proceeds of $13,765, net of issuance costs. Based on the Company’s current level of expenditures, the Company believes that its existing cash and cash equivalents and short-term investments as of June 30, 2022 will provide sufficient funds to enable it to meet its obligations for a period of at least twelve months from the date of the filing of these consolidated financial statements. Use of estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ from those estimates. Significant estimates made by management include, but are not limited to, realization of deferred tax assets, accrued liabilities, obsolescence of inventory, stock-based compensation and the fair value of the Company’s common stock and preferred stock. Income Taxes The Company accounts for income taxes utilizing ASC 740, “Income Taxes”. ASC 740 requires the measurement of deferred tax assets for deductible temporary differences and operating loss carry forwards, and of deferred tax liabilities for taxable temporary differences. Measurement of current and deferred tax liabilities and assets is based on provisions of enacted tax law. The effects of future changes in tax laws or rates are not included in the measurement. The Company recognizes the amount of taxes payable or refundable for the current year and recognizes deferred tax liabilities and assets for the expected future tax consequences of events and transactions that have been recognized in the Company’s financial statements or tax returns. The Company currently has substantial net operating loss carry forwards. The Company has recorded a 100% valuation allowance against net deferred tax assets due to uncertainty of their ultimate realization. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Impact of COVID-19 In March 2020, the World Health Organization declared the coronavirus (“COVID-19”) outbreak to be a pandemic. During the years ended December 31, 2021 and 2020, the Company’s financial results were not significantly affected by the COVID-19 outbreak. The Company has considered all information available as of the date of issuance of these consolidated financial statements and the Company is not aware of any specific events or circumstances that would require an update to its estimates or judgments, or a revision to the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information becomes available. The extent to which the COVID-19 outbreak affects the Company’s future financial results and operations will depend on future developments which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the outbreak, and current or future domestic and international actions to contain and treat it. Net loss per share Basic net loss per share is based upon the weighted-average number of common shares outstanding. Diluted net loss per share is based on the assumption that all potential common stock equivalents (convertible preferred stock, stock options, and warrants) are converted or exercised. The calculation of diluted net loss per share excludes potential common stock equivalents if the effect is anti-dilutive. The Company’s weighted-average common shares outstanding for basic and diluted are the same because the effect of the potential common stock equivalents is anti-dilutive. The Company had the following dilutive common stock equivalents as of June 30, 2022 and 2021 which were excluded from the calculation because their effect was anti-dilutive.
Recent Accounting Pronouncements There have been no accounting pronouncements or changes in accounting pronouncements in the six months ended June 30, 2022 that are significant or potentially significant to the Company. |
Investments |
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Investments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments | 3. Investments The following table sets forth by level, within the fair value hierarchy, the Company’s investments at fair value as of June 30, 2022 and December 31, 2021:
Cost and fair value of available-for-sale investments as of June 30, 2022 and December 31, 2021 are as follows:
All of the investments with gross unrealized losses have been in a continuous loss position for less than 12 months. During the three and six months ended June 30, 2022 and 2021, the Company did not recognize any significant other-than-temporary impairment losses because the Company does not intend to sell the investments before recovery of their amortized cost bases. During the three and six months ended June 30, 2022, there were net gains of approximately $35 and $36, respectively, included in the Company’s net loss. During the three and six months ended June 30, 2021, there were no such gains included in the Company’s net loss. Accrued interest as of June 30, 2022 and December 31, 2021 was approximately $9 and $18, respectively, and is included in prepaid expenses in the Company’s consolidated balance sheet. |
Fixed Assets |
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Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fixed Assets | 4. Fixed Assets Fixed assets, net, consisted of the following:
Depreciation expense was approximately $19 and $0 for the three months ended June 30, 2022 and 2021, respectively. Depreciation expense was approximately $29 and $0 for the six months ended June 30, 2022 and 2021, respectively. |
Accrued Expenses |
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Accrued Expenses | 5. Accrued Expenses Accrued expenses consisted of the following:
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Debt |
6 Months Ended |
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Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | 6. Debt Convertible notes payable – parent company During 2015, the Company issued a $53 convertible promissory note to a consultant that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon a preferred stock financing of at least $500, at a conversion price equal to 90% of the price per share paid by the other cash purchasers in the future financing. In June 2019, the note and its accrued interest to date was replaced by a $68 convertible promissory note that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon a preferred stock financing of at least $1,000, at a conversion price equal to 90% of the price per share paid by the other cash purchasers in the future financing. The note had a maturity date of June 12, 2021. In May 2021, the note was again replaced by a $68 convertible promissory note with a maturity date of May 7, 2022 that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon an IPO or a capital stock financing of at least $5,000. The conversion price was equal to 80% of the IPO price or $1.9565 per share in the event of a capital stock financing of at least $5,000. Accrued interest at June 30, 2022 and December 31, 2021 totaled approximately $0 and $14, respectively. During 2016, the Company issued a $118 convertible promissory note to a vendor that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon a preferred stock financing of at least $500, at a conversion price equal to 90% of the price per share paid by the other cash purchasers in the future financing. The note had a maturity date of January 1, 2019 and remained unpaid during 2019 and 2020. In April 2021, the note was replaced by a $118 convertible promissory note with a maturity date of April 30, 2022 that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon an IPO or a capital stock financing of at least $5,000. The conversion price was equal to 80% of the IPO price or $1.9565 per share in the event of a capital stock financing of at least $5,000. Accrued interest at June 30, 2022 and December 31, 2021 totaled approximately $0 and $56, respectively. In October 2019, the Company issued a $70 convertible promissory note to the Company’s former Chief Executive Officer that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon a preferred stock financing of at least $500, at a conversion price equal to 80% of the price per share paid by the other cash purchasers in the future financing. The note had a maturity date of October 12, 2022. In April 2021, the note was replaced by a $70 convertible promissory note with a maturity date of April 30, 2022 that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon an IPO or a capital stock financing of at least $5,000. The conversion price was equal to 70% of the IPO price or $1.9565 per share in the event of a capital stock financing of at least $5,000. Accrued interest at June 30, 2022 and December 31, 2021 totaled approximately $0 and $12, respectively. In October 2019, the Company issued a $50 convertible promissory note to an investor that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon a preferred stock financing of at least $500, at a conversion price equal to 80% of the price per share paid by the other cash purchasers in the future financing. The note had a maturity date of October 21, 2022. In May 2021, the note was replaced by a $50 convertible promissory note with a maturity date of May 3, 2022 that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon an IPO or a capital stock financing of at least $5,000. The conversion price was equal to 70% of the IPO price or $1.9565 per share in the event of a capital stock financing of at least $5,000. Accrued interest at June 30, 2022 and December 31, 2021 totaled approximately $0 and $9, respectively. In November 2020, the Company issued a $200 convertible promissory note to the same investor that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon a preferred stock financing of at least $2,000, at a conversion price equal to 80% of the price per share paid by the other cash purchasers in the future financing. The note had a maturity date of November 16, 2022. In May 2021, the note was replaced by a $200 convertible promissory note with a maturity date of May 3, 2022 that, along with accrued interest at an annual rate of 8.0%, was automatically convertible upon an IPO or a capital stock financing of at least $5,000. The conversion price was equal to 70% of the IPO price or 70% of the price per share paid by the other cash purchasers in the future financing. Accrued interest at June 30, 2022 and December 31, 2021 was approximately $0 and $18, respectively. In January 2021, the Company issued a promissory note of $131 to a law firm. The note bore interest at 3.0% per annum and had a maturity date of the earlier of July 27, 2021, the closing of a debt or equity financing, or the closing of a change in control transaction. The interest rate was to increase to 5.0% if all principal and interest had not been paid by the maturity date. The Company repaid this note and accrued interest in May 2021. In April 2021, the Company issued two convertible promissory notes of $40 and $170 to the vendor described in the second paragraph above that, along with accrued interest at an annual rate of 8.0%, were automatically convertible upon an IPO or a capital stock financing of at least $5,000. The conversion price was equal to 70% of the IPO price or 70% of the price per share paid by the other cash purchasers in the future financing. Accrued interest at June 30, 2022 and December 31, 2021 totaled approximately $0 and $11, respectively. From May through July 2021, in multiple rounds of closings the Company issued convertible promissory notes to multiple investors for aggregate proceeds of approximately $12,177, with maturity dates twelve months from the issuance dates. Of this amount, $620 of notes were issued to related officers, directors, and their family members, and a $50 note was issued to the Chief Executive Officer of the Representative described in Note 9. The notes, along with accrued interest at an annual rate of 8.0%, were automatically convertible upon an IPO, a capital stock financing of at least $5,000, or a change of control transaction. The conversion price upon an IPO or a capital stock financing was equal to the lesser of 70% of the price per share paid by the other cash purchasers, or the price per share at a Company valuation of $22,500. The Company recorded debt issuance costs of approximately $71 as a discount on the convertible notes payable balance. Accrued interest at June 30, 2022 and December 31, 2021 was approximately $0 and $527, respectively. On April 29, 2022, as a result of the completion of the IPO and as required under the terms of the convertible notes payable described above, the Company converted the entirety of the outstanding principal and accrued interest of the outstanding convertible notes payable to 3,955,415 shares of the Company’s common stock at the conversion price detailed above and issued the common stock to the noteholders, fully satisfying the Company’s obligations. Convertible notes payable – subsidiary In June 2021, the Company’s subsidiary issued a convertible promissory note for approximately $107 to TTAG’s minority shareholder. This note, along with accrued interest at an annual rate of 8.0%, could be applied to future TTAG capital increases. The Company purchased this note and accrued interest of approximately $114 in October 2021 from TTAG’s minority shareholder. |
Leases |
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Leases | 7. Leases In June 2021, the Company entered into a facility lease agreement for its company headquarters in Los Gatos, California. This non-cancelable operating lease expires in June 2026. The Company includes options that are reasonably certain to be exercised as part of the determination of lease terms. The Company may negotiate termination clauses in anticipation of any changes in market conditions, but generally these termination options are not exercised. Residual value guarantees are generally not included within operating leases. In addition to base rent payments, leases may require the Company to pay directly for taxes and other non-lease components, such as insurance, maintenance, and other operating expenses, which may be dependent on usage or vary month-to-month. Non-lease components were considered and determined not to be material. The Company determined if an arrangement is a lease at inception of the contract in accordance with guidance detailed in the new standard and performed the lease classification test as of the lease commencement date. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease’s commencement date based on the present value of lease payments over the lease term. When a lease did not provide an implicit rate, the Company used its estimated incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. Operating lease costs for the facility lease were $73 and $12 for the three months ended June 30, 2022 and 2021, respectively, and were $146 and $12 for the six months ended June 30, 2022 and 2021, respectively. Lease costs are included in general and administrative expenses in the consolidated statements of operations and comprehensive loss. Supplemental balance sheet information related to leases was as follows:
Future maturities of operating lease liabilities as of June 30, 2022 were as follows:
Other information:
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Stockholders' Equity | 8. Stockholders’ Equity The Amended and Restated Certificate of Incorporation dated February 18, 2014 authorized the issuance of 3,937,550 shares of common stock and 2,099,525 shares of preferred stock, with a par value of $0.001 per share. During April 2021 the Company increased the number of authorized shares to 7,000,000 shares of common stock and 2,460,802 shares of preferred stock, and increased the number of authorized shares of Series A Convertible Preferred Stock (“Series A Preferred Stock”) to 1,798,905. During October 2021 the Company increased the number of authorized shares to 10,487,904 shares of common stock and 3,297,061 shares of preferred stock. During February 2022, the Company increased the number of authorized shares to 130,000,000 shares of common stock and 20,000,000 shares of preferred stock. Reverse Stock Split On April 6, 2022, the Company effected a 1:2 reverse stock split (the “Reverse Stock Split”) by filing an amendment to the Company’s Amended and Restated Certificate Incorporation, as amended, with the Delaware Secretary of State. The Reverse Stock Split combined every two shares of our common stock issued and outstanding immediately prior to effecting the Reverse Stock Split into one share of common stock. Similarly, shares of Series A and Series B Preferred Stock became convertible into common stock at a conversion rate of one-to-0.5, subject to adjustments for stock dividends, splits, combinations, and similar events. No fractional shares were issued in connection with the Reverse Stock Split. All historical and per share amounts reflected throughout this document have been adjusted to reflect the Reverse Stock Split. The authorized number of shares and the par value per share of the Company’s common stock were not affected by the Reverse Stock Split. Initial Public Offering On April 26, 2022, the Company’s Registration Statement relating to the IPO was declared effective by the SEC. The IPO consisted of 3,200,000 shares of common stock, par value $0.001 per share at a public offering price of $5.00 per share. Pursuant to the Underwriting Agreement dated April 26, 2022, between the Company, The Benchmark Company, LLC (“Benchmark”) and Valuable Capital Limited (together with Benchmark, the “Underwriters”), the Company granted the Underwriters warrants to purchase a total of 96,000 shares of the Company’s common stock at an exercise price of $5.00 per share. The warrants expire on the fifth anniversary of the commencement of sales under the IPO. On April 27, 2022, the shares of the Company’s common stock began trading on the Nasdaq Capital Market LLC under the symbol “TNON.”
On April 29, 2022, the IPO closed, and the Company received approximately $13.8 million in net proceeds from the IPO after deducting the underwriting discount and commission and other estimated IPO expenses payable by the Company. As a result of the completion of the IPO and as required under the terms of the convertible notes payable described in Note 6, the Company converted the entirety of the related outstanding principal and accrued interest to 3,955,415 shares of the Company’s common stock at the conversion price detailed in Note 6 and issued the common stock to the noteholders, fully satisfying the Company’s obligations. On April 29, 2022, as result of the completion of the IPO, the Company converted all shares of Series A and Series B Preferred Stock to 2,693,342 shares of the Company’s common stock at the conversion rate detailed below and issued the common stock to the preferred stockholders, fully satisfying the Company’s obligations. This includes 1,172,346 shares issued to TTAG’s minority shareholder in accordance with the anti-dilution protection provisions of the Exchange Agreement. Concurrent with the completion of the IPO and in accordance with the Amended and Restated Exclusive Sales Representative Agreement executed in May 2021, the counterparty to the agreement received anti-dilution protections to maintain ownership of 3.0% of the fully diluted equity of the Company through the date of an initial public offering and was issued 312,351 shares of the Company’s common stock to the Representative, fully satisfying the Company’s obligations. Also, as a result of the completion of the IPO, the Company issued 85,739 shares of its common stock to a consultant. The value of these shares issued at the IPO price of $5.00 per share was charged to operating expenses in the Company’s financial statements. Preferred Stock On October 28, 2021, the Company entered into an Agreement (the “Exchange Agreement”) with TTAG’s minority shareholder. Pursuant to the Exchange Agreement, TTAG’s minority shareholder agreed to exchange 574,033 shares of Series A Convertible Preferred Stock issued by TTAG, representing its entire ownership interest in TTAG, for the Company’s Series A Preferred Stock, representing a 24% ownership interest in the Company’s fully-diluted capital, which includes the pro forma conversion of all outstanding convertible preferred stock and promissory notes, options, and warrants. Pursuant to the terms of the Exchange Agreement, the Company issued TTAG’s minority shareholder 2,550,763 shares of Series A Preferred Stock. These shares were subject to anti-dilution protection to maintain TTAG’s minority shareholder’s 24% ownership interest in the Company, excluding any shares issued by the Company in an IPO or a qualified offering of at least $5,000 at a per share price of at least $3.3737. Upon conversion of the Company’s convertible notes payable as described in Note 6, the Company issued 1,172,346 shares of its common stock to TTAG’s minority shareholder. In accordance with ASC 810-10-45-23, the Company did not recognize any gain or loss in the consolidated statements of operations and comprehensive loss in conjunction with the Exchange Agreement. The carrying value of the non-controlling interest in TTAG was reduced to zero, and the value of the Company’s investment in TTAG increased accordingly. The shares of Series A Preferred Stock issued were recorded at fair value. The difference between the increase in the Company’s investment and the fair value of the Series A Preferred Stock issued was recorded as a decrease in Additional Paid in Capital (“APIC”). The resulting negative APIC was then reclassified to accumulated deficit. In a series of closings from 2012 through 2015, the Company issued an aggregate of 491,222 shares of Series B Convertible Preferred Stock (“Series B Preferred Stock”) at $2.795 per share for proceeds of $1,272, net of stock issuance costs. The Company classified the convertible preferred stock outside of total stockholders’ deficit because, in the event of certain deemed liquidation events that are not solely within the control of the Company, the shares would become redeemable at the option of the holders. The Company did not adjust the carrying values of the convertible preferred stock to the deemed liquidation values of such shares since a liquidation event was not probable of occurring. Conversion At the option of the holder, shares of Series A and Series B Preferred Stock were convertible into common stock at a conversion rate of one-to-0.5, subject to adjustments for stock dividends, splits, combinations, and similar events. Automatic conversion will occur in the event of a firmly underwritten public offering of common stock of the Company at a price of at least $4.00 per share, subject to appropriate adjustments for stock dividends, splits, combinations, and similar events, and with total gross proceeds to the Company of at least $15,000, before deduction of underwriters’ commissions and expenses. As noted above, the Series A and Series B Preferred Stock were converted to common stock at the time of the Company’s IPO. Redemption The shares of the Series A and Series B Preferred Stock were redeemable only upon acquisition or liquidation of the Company. Liquidation preference With respect to any distributions in connection with a liquidation, dissolution or winding up of the Company, or in connection with the sale of voting control of all or substantially all of the assets of the Company, by way of merger, acquisition, consolidation or similar transaction, prior to any distribution to common stockholders, the holders of Series A and Series B Preferred Stock were entitled to receive $1.526 and $4.981 per share, respectively, plus any declared but unpaid dividends, adjusted to reflect any dividends previously paid. If, upon the occurrence of such event, the assets and funds distributed among the holders of Series A and Series B Preferred Stock shall be insufficient to permit the payment to such holders of the full liquidation preference amounts, the entire assets and funds of the Company legally available shall be distributed ratably among the preferred stockholders in proportion to the preferential amount to which each holder is entitled. After payment of the liquidation preferences, the holders of common stock are entitled to receive the remaining assets of the Company available for distribution to its stockholders pro rata based on the number of shares of common stock held by each holder. Voting rights The holders of vested shares of common stock shall be entitled to vote on any matter submitted to a vote of the stockholders and each such holder shall be entitled to one vote per share of common stock held. The holders of Series A and Series B Preferred Stock were entitled to vote together with the common stock as a single class on any matter submitted to a vote of the stockholders. Holders of Series A and Series B Preferred Stock were entitled to the number of votes equal to the number of common stock issuable upon conversion of their respective Series A and Series B Preferred Stock at the time such shares are voted. The holders of a majority of the preferred stock had additional voting rights as specified in the Company’s Amended and Restated Certificate of Incorporation, as amended. Equity awards In 2012, the Board of Directors of the Company (the “Board”) approved the Tenon Medical, Inc. 2012 Equity Incentive Plan (the “2012 Plan”). The 2012 Plan provides for the issuance of common stock options, appreciation rights, and other awards to employees, directors, and consultants. Options issued under the 2012 Plan generally vest over a period of to four years and have a 10-year expiration date. In April 2021, the Board increased the number of shares of common stock reserved for issuance under the 2012 Plan to 662,516. In July 2021, the Board increased the number of shares of common stock reserved for issuance under the 2012 Plan to 737,516. In August 2021, the Board increased the number of shares of common stock reserved for issuance under the 2012 Plan from 737,516 shares to 799,266 shares and approved the form of a 2022 Equity Incentive Plan.On January 10, 2022 and February 2, 2022, the Board and stockholders, respectively, of the Company approved the Tenon Medical, Inc. 2022 Equity Incentive Plan (the “2022 Plan”), which was effective on April 25, 2022. The number of shares of common stock that may be subject to awards and sold under the 2022 Plan is equal to 1,600,000. Automatic annual increases in number of shares available for issuance under the 2022 Plan is equal to the least of (a) 1,100,000 shares, (b) 4% of the total number of shares of all classes of common stock outstanding on the last day of the immediately preceding fiscal year, or (c) such number determined by the 2022 Plan administrator no later than the last day of the immediately preceding fiscal year. Annual increases will continue until the tenth anniversary of the earlier of the Board or stockholder approval of the 2022 Plan, which is January 10, 2032. Upon the effective date of the 2022 Plan, the Board terminated the 2012 Plan such that no new equity awards will be issued by the 2012 Plan. The Company adopted the fair value recognition provisions in accordance with authoritative guidance related to equity-based payments. Compensation expense in 2022 and 2021 includes the portion of awards vested in the periods for all equity-based awards granted, based on the grant date fair value estimated using a Black-Scholes option valuation model, consistent with authoritative guidance. A summary of the Company’s share option and restricted stock unit activity under its plans is as follows:
The following table sets forth stock-based compensation expense recognized for the three and six months ended June 30, 2022 and 2021:
At June 30, 2022, there were 482,470 shares available for issuance under the 2022 Plan. Warrants During 2020, the Company issued warrants to purchase 25,000 shares of common stock to a consultant. The warrants, which are equity-classified, are immediately exercisable at an exercise price of $5.20 per share. The fair value of the warrants on the grant date was $2.30 per warrant, which was calculated based on the following weighted-average assumptions, using a Black-Scholes option valuation model: expected term of 5.00 years; expected volatility of 51.88%; dividend yield of 0%, and risk-free interest rate of 0.30%. The Company recorded deferred offering costs of approximately $58 associated with these warrants during 2020. In April 2022, as noted above, the Company granted the Underwriters warrants to purchase a total of 96,000 shares of the Company’s common stock. The warrants are immediately exercisable at an exercise price of $5.00 per share and expire on the fifth anniversary of the commencement of sales under the IPO. The fair value of the warrants on the grant date was $2.75 per warrant, which was calculated based on the following weighted-average assumptions, using a Black-Scholes option valuation model: expected term of 5.00 years; expected volatility of 62.55%; dividend yield of 0%, and risk-free interest rate of 2.92%. The Company recorded the fair value of these warrants of approximately $264 as an issuance cost to additional paid-in capital in 2022. As the IPO issuance costs were also recorded to additional paid-in capital, the net impact was $0. |
Commitments and Contingencies |
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Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Sales Representative Agreement In April 2020, the Company entered into an Exclusive Sales Representative Agreement, under which the counterparty to the agreement (the “Representative”) received exclusive rights to market, promote, and distribute The Catamaran In June 2021, the Company issued a $50 convertible note payable to the Chief Executive Officer of the Representative, as part of the convertible debt offering described in Note 6. Litigation In the normal course of business, the Company may possibly be named as a defendant in various lawsuits. On September 2, 2021, Khalid Mentak, a former director and Chief Executive Officer of the Company filed an arbitration claim with the American Arbitration Association (“AAA”) against the Company, asserting damages in excess of $3,000, plus attorneys’ fees and other costs, for alleged unpaid wages, defamation, and other claims. The services provided by Mr. Mentak were governed by a Consulting Agreement between the Company and Key Medical Technologies, Inc (“Key Medical”), a company which Mr. Mentak served as Chief Executive Officer. The AAA proceeding was also initiated pursuant to the arbitration provision in the Consulting Agreement. The parties selected an arbitrator and the Company filed a motion to dismiss the proceeding as currently pled because the proper parties should be Key Medical and the Company, and not Mr. Mentak as an individual. The arbitrator ruled that Mr. Mentak was the real-party-in-interest and denied the motion, without prejudice to any arguments on the merits of the underlying claims. On March 1, 2022, Mr. Mentak filed a more detailed Statement of Claims, which the Company responded to on March 16, 2022. The Company also filed a cross-complaint for declaratory relief seeking to establish its rights and obligations under the Consulting Agreement with respect to the claimant and Key Medical, which was formally named a defendant in the cross complaint. The claimant objected to the cross-complaint as unnecessary. On July 21, 2022, the Company entered into a Settlement Agreement and General Release of All Claims (the “Settlement Agreement”) with Key Medical and Mr. Mentak to settle all claims and counterclaims. Pursuant to the Settlement Agreement, the Company has agreed to pay Key Medical the total sum of $1,200. The Company recorded an additional charge of $574 in the second quarter of 2022 for this settlement. The full settlement amount was fully accrued as of June 30, 2022. |
Concentrations of Risk |
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Risks and Uncertainties [Abstract] | |
Concentrations of Risk | 10. Concentrations of Risk Credit risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash balances at financial institutions located in California and Switzerland. Accounts at the U.S. financial institutions are secured by the Federal Deposit Insurance Corporation. At times, balances may exceed federally insured limits. The Company has not experienced any losses in such accounts. Management believes that the Company is not exposed to any significant credit risk with respect to its cash and cash equivalents. The Company grants unsecured credit to its customers based on an evaluation of the customer’s financial condition and a cash deposit is generally not required. Management believes its credit policies do not result in significant adverse risk and historically has not experienced significant credit-related losses. Currency risk The Company’s subsidiary, Tenon Technology AG, realizes a portion of its expenses in Swiss francs. Consequently, certain assets and liabilities are exposed to foreign currency fluctuations. At June 30, 2022 and December 31, 2021, approximately $14 and $21, respectively, of the Company’s net monetary assets were denominated in Swiss francs. The Company has not entered into any hedging transactions to reduce the exposure to currency risk. |
Related Party Transactions |
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Related Party Transactions [Abstract] | |
Related Party Transactions | 11. Related Party Transactions During 2018 through 2020, the Company’s subsidiary issued convertible promissory notes to TTAG’s minority shareholder. In November 2020, these notes payable and accrued interest were converted into TTAG shares. In June 2021, the Company’s subsidiary issued a convertible promissory note for approximately $107 to TTAG’s minority shareholder. The Company purchased this note and accrued interest of $114 in October 2021 from TTAG’s minority shareholder. See Note 6. The Company had a consulting agreement with a company owned by the former Chief Executive Officer of the Company. Under this consulting agreement, the Chief Executive Officer was to provide services from 2015 through June 1, 2021. Total payments under the consulting agreement of $600 are to be paid as follows: (a) $300 paid upon closing of financing round of at least $5,000, followed by twelve monthly payments of $25 per month; (b) $300 paid upon achieving at least $3,000 of annual revenue and a financing round of less than $5,000; or (c) the entire $ 600 payable immediately upon an acquisition of the Company. During the three months ended June 30, 2022 and 2021, the Company recorded consulting expense of $574 and $8, respectively, related to this agreement. During the six months ended June 30, 2022 and 2021, the Company recorded expense of $574 and $25, respectively, related to this agreement. As of June 30, 2022 and December 31, 2021, approximately $1,200 and $600, respectively, owed to this party was included in accrued expenses with respect of these services. See Note 9.During 2021, the Company issued convertible promissory notes totaling $620 to officers, directors, and their family members. See Note 6. In addition, a note was issued to the Chief Executive Officer of the Representative described in Note 9. On October 28, 2021, the Company entered into an agreement with TTAG’s minority shareholder. See Note 8. Pursuant to the terms of the Exchange Agreement, the Company purchased the convertible note and accrued interest between TTAG and Zuhlke Ventures AG (“ZVAG”), TTAG’s minority shareholder, in the amount of approximately $114. On December 31, 2021, the Company and TTAG entered into the IP Sale and Purchase Agreement, whereby TTAG transferred certain patents and trademarks to the Company. In connection with this transfer, the Company issued an unsecured promissory note to TTAG in the amount of $818 which eliminates in consolidation. |
Subsequent Events |
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Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent Events On July 21, 2022, the Company entered into the Settlement Agreement with Key Medical and Mr. Mentak to settle all claims and counterclaims related to Mr. Mentak’s claims against the Company. See Note 9. Pursuant to the Settlement Agreement, the Company has agreed to pay Key Medical the total sum of $1,200. The Company recorded an additional charge of $574 in the second quarter of 2022 for this settlement. The full settlement amount was fully accrued as of June 30, 2022. |
Summary of Significant Accounting Principles (Policies) |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basis of presentation | Basis of presentation We have prepared the accompanying unaudited condensed consolidated financial statements pursuant to the rules and regulations of the SEC. As permitted under these rules and regulations, we have condensed or omitted certain financial information and footnote disclosures we normally include in our annual consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The unaudited condensed consolidated balance sheet as of December 31, 2021 has been derived from our audited consolidated financial statements, which are included in our amended Registration Statement on Form S-1 filed with the SEC on April 20, 2022 (our “amended Registration Statement”). These condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and, in management’s opinion, reflect all adjustments consisting only of normal recurring adjustments that are necessary for a fair presentation of our financial information. Our interim period operating results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year. The financial statements of the subsidiary are prepared for the same reporting period as the parent, using consistent accounting policies in all material respects. The amount of consolidated net loss attributable to the Company and ownership interests in TTAG held by parties other than the Company are both presented on the face of the Consolidated Statements of Operations. Given that TTAG is a wholly-owned subsidiary as of June 30, 2022, this separate presentation has been discontinued for the three and six months then ended. Further, given that the Company purchased the non-controlling interest in TTAG as of October 28, 2021, the amount of consolidated net loss attributable to the Company and the non-controlling interest are both presented on the face of the Consolidated Statements of Operations and Comprehensive Loss. These unaudited condensed consolidated financial statements and accompanying notes should be read in conjunction with the Company’s audited consolidated financial statements as of and for the years ended December 31, 2021 and 2020 included in our amended Registration Statement. The Company’s significant accounting policies are disclosed in the audited consolidated financial statements as of and for the years ended December 31, 2021 and 2020 included in our amended Registration Statement. There have been no material changes in the Company’s significant accounting policies during the six months ended June 30, 2022. |
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Going concern uncertainty and liquidity requirements | Going concern uncertainty and liquidity requirements The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. Since inception, the Company has incurred losses and negative cash flows from operations. Management expects to incur additional operating losses and negative cash flows from operations in the foreseeable future as the Company continues its product development programs and starts the commercial launch of The Catamaran System. On April 29, 2022, the Company closed an initial public offering (the “IPO”) of its common stock for proceeds of $13,765, net of issuance costs. Based on the Company’s current level of expenditures, the Company believes that its existing cash and cash equivalents and short-term investments as of June 30, 2022 will provide sufficient funds to enable it to meet its obligations for a period of at least twelve months from the date of the filing of these consolidated financial statements. |
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Use of estimates | Use of estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ from those estimates. Significant estimates made by management include, but are not limited to, realization of deferred tax assets, accrued liabilities, obsolescence of inventory, stock-based compensation and the fair value of the Company’s common stock and preferred stock. |
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Income Taxes | Income Taxes The Company accounts for income taxes utilizing ASC 740, “Income Taxes”. ASC 740 requires the measurement of deferred tax assets for deductible temporary differences and operating loss carry forwards, and of deferred tax liabilities for taxable temporary differences. Measurement of current and deferred tax liabilities and assets is based on provisions of enacted tax law. The effects of future changes in tax laws or rates are not included in the measurement. The Company recognizes the amount of taxes payable or refundable for the current year and recognizes deferred tax liabilities and assets for the expected future tax consequences of events and transactions that have been recognized in the Company’s financial statements or tax returns. The Company currently has substantial net operating loss carry forwards. The Company has recorded a 100% valuation allowance against net deferred tax assets due to uncertainty of their ultimate realization. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. |
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Impact of COVID-19 | Impact of COVID-19 In March 2020, the World Health Organization declared the coronavirus (“COVID-19”) outbreak to be a pandemic. During the years ended December 31, 2021 and 2020, the Company’s financial results were not significantly affected by the COVID-19 outbreak. The Company has considered all information available as of the date of issuance of these consolidated financial statements and the Company is not aware of any specific events or circumstances that would require an update to its estimates or judgments, or a revision to the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information becomes available. The extent to which the COVID-19 outbreak affects the Company’s future financial results and operations will depend on future developments which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the outbreak, and current or future domestic and international actions to contain and treat it. |
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Net loss per share | Net loss per share Basic net loss per share is based upon the weighted-average number of common shares outstanding. Diluted net loss per share is based on the assumption that all potential common stock equivalents (convertible preferred stock, stock options, and warrants) are converted or exercised. The calculation of diluted net loss per share excludes potential common stock equivalents if the effect is anti-dilutive. The Company’s weighted-average common shares outstanding for basic and diluted are the same because the effect of the potential common stock equivalents is anti-dilutive. The Company had the following dilutive common stock equivalents as of June 30, 2022 and 2021 which were excluded from the calculation because their effect was anti-dilutive.
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Recent Accounting Pronouncements | Recent Accounting Pronouncements There have been no accounting pronouncements or changes in accounting pronouncements in the six months ended June 30, 2022 that are significant or potentially significant to the Company. |
Summary of Significant Accounting Principles (Tables) |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Securities Excluded Due To Anti Dilutive Effect | The Company had the following dilutive common stock equivalents as of June 30, 2022 and 2021 which were excluded from the calculation because their effect was anti-dilutive.
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Investments (Tables) |
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Schedule of Investments At Fair Value in Fair Value Hierarchy Level | The following table sets forth by level, within the fair value hierarchy, the Company’s investments at fair value as of June 30, 2022 and December 31, 2021:
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Schedule of Cost And Fair Value of Available For Sale Investments | Cost and fair value of available-for-sale investments as of June 30, 2022 and December 31, 2021 are as follows:
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Fixed Assets (Tables) |
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Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Fixed Assets | Fixed assets, net, consisted of the following:
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Accrued Expenses (Tables) |
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Schedule of Accrued Expenses | Accrued expenses consisted of the following:
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Leases (Tables) |
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Summary of Supplemental Balance Sheet Information Related To Leases | Supplemental balance sheet information related to leases was as follows:
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Summary of Future Maturities of Operating Lease Liabilities | Future maturities of operating lease liabilities as of June 30, 2022 were as follows:
Other information:
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Stockholders' Equity (Tables) |
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Share Based Compensation Arrangements By Share Based Payment Award | A summary of the Company’s share option and restricted stock unit activity under its plans is as follows:
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Summary of Employee Service Share Based Compensation Allocation of Recognized Period Costs | The following table sets forth stock-based compensation expense recognized for the three and six months ended June 30, 2022 and 2021:
|
Summary of Significant Accounting Principles - Additional Information (Detail) - USD ($) $ in Thousands |
6 Months Ended | ||
---|---|---|---|
Apr. 29, 2022 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Accounting Policies [Abstract] | |||
Percentage of valuation allowance in deferred tax assets | 100.00% | ||
Proceeds from Issuance of Common Stock | $ 13,765 | $ 14,139 | $ 0 |
Investments - Schedule of Investments At Fair Value in Fair Value Hierarchy Level (Detail) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, Fair Value Disclosure | $ 8,141 | $ 4,404 |
Investments - Schedule of Cost And Fair Value of Available For Sale Investments (Detail) - Corporate Debt Securities [Member] - USD ($) $ in Thousands |
6 Months Ended | 12 Months Ended |
---|---|---|
Jun. 30, 2022 |
Dec. 31, 2021 |
|
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 8,168 | $ 4,404 |
Unrealized Gains | 1 | 0 |
Unrealized Losses | (28) | 0 |
Fair Value | $ 8,141 | $ 4,404 |
Investments - Additional Information (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
Dec. 31, 2021 |
|
Other than temporary impairment losses | $ 27 | $ 0 | $ 27 | $ 0 | |
Net gain on investments | 35 | $ 0 | 36 | $ 0 | |
Prepaid Expenses and Other Current Assets [Member] | |||||
Accrued interest | $ 9 | $ 9 | $ 18 |
Fixed Assets - Summary of Fixed Assets and Equipment Net (Detail) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Fixed Assets [Line Items] | ||
Fixed Assets, gross | $ 272 | $ 103 |
Less: accumulated depreciation | (31) | (2) |
Fixed Assets, net | 241 | 101 |
Reusable Product [Member] | ||
Fixed Assets [Line Items] | ||
Fixed Assets, gross | 211 | 77 |
IT Equipment [Member] | ||
Fixed Assets [Line Items] | ||
Fixed Assets, gross | 38 | 17 |
Lab Equipment [Member] | ||
Fixed Assets [Line Items] | ||
Fixed Assets, gross | 14 | 0 |
Office Equipment [Member] | ||
Fixed Assets [Line Items] | ||
Fixed Assets, gross | $ 9 | $ 9 |
Fixed Assets - Additional Information (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Property, Plant and Equipment [Abstract] | ||||
Depreciation | $ 19 | $ 0 | $ 29 | $ 0 |
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 1,441 | $ 846 |
Accrued commissions | 20 | 14 |
Other accrued expenses | 196 | 228 |
Total accrued expenses | $ 1,657 | $ 1,088 |
Leases - Summary of Supplemental Balance Sheet Information Related to Leases (Detail) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Lessee Disclosure [Abstract] | ||
Operating lease right-of-use assets | $ 981 | $ 1,084 |
Operating lease liability, current | (234) | (202) |
Operating lease liability, noncurrent | (782) | (911) |
Total operating lease liabilities | $ (1,016) | $ (1,113) |
Leases - Summary of Future Maturities of Operating Lease Liabilities (Detail) - USD ($) $ in Thousands |
6 Months Ended | ||
---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Dec. 31, 2021 |
|
Lessee Disclosure [Abstract] | |||
2022 | $ 144 | ||
2023 | 293 | ||
2024 | 301 | ||
2025 | 310 | ||
2026 | 144 | ||
Total lease payments | 1,192 | ||
Less: imputed interest | (176) | ||
Present value of operating lease liabilities | 1,016 | $ 1,113 | |
Cash paid for operating leases | $ 140 | $ 23 | |
Remaining lease term - operating leases (in years) | 4 years | ||
Average discount rate - operating leases | 8.00% |
Leases - Additional Information (Detail) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Lessee, Operating lease, Expiration, Month and Year | 2026-06 | ||||
General and Administrative Expense [Member] | |||||
Operating lease costs | $ 73 | $ 12 | $ 146 | $ 12 |
Stockholders' Equity - Summary of Employee Service Share Based Compensation Allocation of Recognized Period Costs (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based Payment Arrangement, Expense | $ 552 | $ 61 | $ 721 | $ 65 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based Payment Arrangement, Expense | 178 | 13 | 207 | 13 |
Sales and marketing | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based Payment Arrangement, Expense | 12 | 4 | 24 | 8 |
General, and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based Payment Arrangement, Expense | $ 362 | $ 44 | $ 490 | $ 44 |
Concentrations of Risk - Additional Information (Detail) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Switzerland, Francs [Member] | Net Assets, Geographic Area [Member] | ||
Concentration Risk [Line Items] | ||
Net assets | $ 14 | $ 21 |
Subsequent Events - Additional Information (Detail) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Jul. 21, 2022 |
Jun. 30, 2022 |
|
Subsequent Event [Line Items] | ||
Litigation Settlement, Expense | $ 574 | |
Subsequent Event [Member] | Key Medical [Member] | ||
Subsequent Event [Line Items] | ||
Litigation Settlement | $ 1,200 |
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