UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form
10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2025
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM _________
to __________
COMMISSION FILE NUMBER 001-41364
TENON MEDICAL, INC.
(Exact name of registrant as specified in its charter)
Delaware | | 45-5574718 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| | |
104 Cooper Court Los Gatos, CA 95032 | | (408) 649-5760 |
(Address of principal executive offices) (Zip Code) | | (Registrant’s telephone number, including area code) |
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common Stock, par value $0.001 per share | | TNON | | The Nasdaq Stock Market LLC |
Warrants | | TNONW | | The Nasdaq Stock Market LLC |
Indicate by check mark whether the
registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past
90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | Emerging growth company | ☒ |
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act) Yes ☐ No ☒
As of August 13, 2025, the registrant had a total of 8,879,220 shares of its common stock, par value $0.001 per share, issued and outstanding.
INDEX
|
|
Page |
PART I. FINANCIAL INFORMATION |
1 |
Item 1. |
Condensed Financial Statements (unaudited) |
1 |
|
Condensed Balance Sheets |
1 |
|
Condensed Statements of Operations and Comprehensive Loss |
2 |
|
Condensed Statements of Convertible Preferred Stock and Stockholders’ Equity |
3 |
|
Condensed Statements of Cash Flows |
5 |
|
Notes to Condensed Financial Statements |
6 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
15 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
20 |
Item 4. |
Controls and Procedures |
20 |
PART II. OTHER INFORMATION |
21 |
Item 1. |
Legal Proceedings |
21 |
Item 1A. |
Risk Factors |
21 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
21 |
Item 3. |
Defaults Upon Senior Securities |
21 |
Item 4. |
Mine Safety Disclosures |
21 |
Item 5. |
Other Information |
21 |
Item 6. |
Exhibits |
22 |
SIGNATURES |
23 |
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
STATEMENTS
This Quarterly Report on
Form 10-Q contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995,
Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”). We have based these forward-looking statements largely on our current expectations
and projections about future events and financial trends impacting the financial condition of our business. Forward-looking statements
should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or
by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those
statements are made and/or management’s good faith belief as of that time with respect to future events and are subject to risks
and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking
statements.
Forward-looking statements
include all statements that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “may,”
“will,” “should,” “could,” “would,” “expect,” “intend,” “seek,”
“plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,”
“potential,” “might,” “forecast,” “continue,” or the negative of those terms, and similar
expressions and comparable terminology intended to reference future periods. Forward-looking statements include, but are not limited to,
statements about:
|
● |
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; and |
|
● |
Our ability to protect our intellectual property and to develop, maintain and enhance a strong brand. |
Should one or more of these
risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from
those anticipated, believed, estimated, expected, intended or planned.
Factors or events that could
cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee
future results, levels of activity, performance or achievements. Accordingly, the forward-looking statements in this Quarterly Report
on Form 10-Q should not be regarded as representations that the results or conditions described in such statements will occur or that
our objectives and plans will be achieved, and we do not assume any responsibility for the accuracy or completeness of any of these forward-looking
statements.
PART I – FINANCIAL INFORMATION
ITEM 1. Condensed Financial Statements (Unaudited)
Tenon Medical, Inc.
Condensed Balance Sheets (Unaudited)
(In thousands, except share data)
| |
June 30, | | |
December 31, | |
| |
2025 | | |
2024 | |
ASSETS | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 7,846 | | |
$ | 6,535 | |
Accounts receivable, net | |
| 770 | | |
| 863 | |
Inventory, net | |
| 688 | | |
| 606 | |
Prepaid expenses and other current assets | |
| 580 | | |
| 206 | |
Total current assets | |
| 9,884 | | |
| 8,210 | |
Property and equipment, net | |
| 842 | | |
| 752 | |
Deposits | |
| 51 | | |
| 51 | |
Operating lease right-of-use asset | |
| 268 | | |
| 399 | |
Deferred offering costs | |
| 69 | | |
| 431 | |
TOTAL ASSETS | |
$ | 11,114 | | |
$ | 9,843 | |
| |
| | | |
| | |
Liabilities and Stockholders’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 894 | | |
$ | 369 | |
Accrued expenses | |
| 1,108 | | |
| 910 | |
Current portion of accrued commissions | |
| 271 | | |
| 303 | |
Current portion of operating lease liability | |
| 290 | | |
| 287 | |
Total current liabilities | |
| 2,563 | | |
| 1,869 | |
Accrued commissions, net of current portion | |
| 1,838 | | |
| 1,862 | |
Operating lease liability, net of current portion | |
| — | | |
| 141 | |
Total liabilities | |
| 4,401 | | |
| 3,872 | |
Commitments and contingencies (Notes 7 and 9) | |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Series A convertible preferred stock, $0.001 par value; 4,500,000 shares authorized at June 30, 2025 and December 31, 2024; 256,968 shares issued and outstanding at June 30, 2025 and December 31, 2024 | |
| 3,300 | | |
| 3,300 | |
Series B convertible preferred stock, $0.001 par value; 491,222 shares authorized at June 30, 2025 and December 31, 2024; 86,454 shares issued and outstanding at June 30, 2025 and December 31, 2024 | |
| 452 | | |
| 452 | |
Common stock, $0.001 par value; 130,000,000 shares authorized at June 30, 2025 and December 31, 2024; 7,592,217 and 3,138,804 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | |
| 8 | | |
| 3 | |
Additional paid-in capital | |
| 78,084 | | |
| 70,962 | |
Accumulated deficit | |
| (75,131 | ) | |
| (68,746 | ) |
Total stockholders’ equity | |
| 6,713 | | |
| 5,971 | |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | |
$ | 11,114 | | |
$ | 9,843 | |
The accompanying notes are an integral part
of these condensed financial statements.
Tenon Medical, Inc.
Condensed Statements of Operations and Comprehensive
Loss (Unaudited)
(In thousands, except per share data)
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Revenue | |
$ | 564 | | |
$ | 901 | | |
$ | 1,290 | | |
$ | 1,620 | |
Cost of sales | |
| 319 | | |
| 431 | | |
| 722 | | |
| 680 | |
Gross Profit | |
| 245 | | |
| 470 | | |
| 568 | | |
| 940 | |
| |
| | | |
| | | |
| | | |
| | |
Operating Expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 503 | | |
| 708 | | |
| 1,194 | | |
| 1,377 | |
Sales and marketing | |
| 1,119 | | |
| 1,448 | | |
| 2,766 | | |
| 2,829 | |
General and administrative | |
| 1,480 | | |
| 2,186 | | |
| 3,142 | | |
| 4,112 | |
Total Operating Expenses | |
| 3,102 | | |
| 4,342 | | |
| 7,102 | | |
| 8,318 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from Operations | |
| (2,857 | ) | |
| (3,872 | ) | |
| (6,534 | ) | |
| (7,378 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other Income (Expense) | |
| | | |
| | | |
| | | |
| | |
Gain on investments | |
| 88 | | |
| 39 | | |
| 149 | | |
| 66 | |
Interest expense | |
| — | | |
| — | | |
| — | | |
| (34 | ) |
Other income (expense), net | |
| — | | |
| 7 | | |
| — | | |
| (56 | ) |
Total Other Income (Expense), net | |
| 88 | | |
| 46 | | |
| 149 | | |
| (24 | ) |
Net Loss | |
$ | (2,769 | ) | |
$ | (3,826 | ) | |
$ | (6,385 | ) | |
$ | (7,402 | ) |
Net Loss Per Share of Common Stock | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
$ | (0.36 | ) | |
$ | (8.16 | ) | |
$ | (1.14 | ) | |
$ | (17.92 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-Average Shares of Common Stock Outstanding | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 7,591 | | |
| 469 | | |
| 5,605 | | |
| 413 | |
| |
| | | |
| | | |
| | | |
| | |
Consolidated Statements of Comprehensive Loss: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (2,769 | ) | |
$ | (3,826 | ) | |
$ | (6,385 | ) | |
$ | (7,402 | ) |
Foreign currency translation adjustment | |
| — | | |
| — | | |
| — | | |
| 46 | |
Total comprehensive loss | |
$ | (2,769 | ) | |
$ | (3,826 | ) | |
$ | (6,385 | ) | |
$ | (7,356 | ) |
The accompanying notes are an integral part
of these condensed financial statements.
Tenon Medical, Inc.
Condensed Statements of Convertible Preferred
Stock and Stockholders’ Equity (Unaudited)
(In thousands, except share data)
Three months ended June 30, 2025 and 2024:
| |
Series A Convertible Preferred Stock | | |
Series B Convertible Preferred Stock | | |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
Balance at March 31, 2025 | |
| 256,968 | | |
$ | 3,300 | | |
| 86,454 | | |
$ | 452 | | |
| 7,589,965 | | |
$ | 8 | | |
$ | 77,978 | | |
$ | (72,362 | ) | |
$ | 9,376 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 417 | | |
| — | | |
| 417 | |
Release of restricted stock units | |
| — | | |
| — | | |
| — | | |
| — | | |
| 2,252 | | |
| — | | |
| — | | |
| — | | |
| — | |
Deferred financing costs | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (311 | ) | |
| — | | |
| (311 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,769 | ) | |
| (2,769 | ) |
Balance at June 30, 2025 | |
| 256,968 | | |
$ | 3,300 | | |
| 86,454 | | |
$ | 452 | | |
| 7,592,217 | | |
$ | 8 | | |
$ | 78,084 | | |
$ | (75,131 | ) | |
$ | 6,713 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at March 31, 2024 | |
| 256,968 | | |
$ | 3,300 | | |
| — | | |
| — | | |
| 465,872 | | |
| — | | |
| 58,973 | | |
| (58,649 | ) | |
$ | 3,624 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,034 | | |
| — | | |
| 1,034 | |
Release of restricted stock units | |
| — | | |
| — | | |
| — | | |
| — | | |
| 6,732 | | |
| — | | |
| — | | |
| — | | |
| — | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (3,826 | ) | |
| (3,826 | ) |
Balance at June 30, 2024 | |
| 256,968 | | |
$ | 3,300 | | |
| — | | |
$ | — | | |
| 472,604 | | |
$ | — | | |
$ | 60,007 | | |
$ | (62,475 | ) | |
$ | 832 | |
Six months ended June 30, 2025 and 2024:
|
|
Series A Convertible Preferred Stock |
|
|
Series B Convertible Preferred Stock |
|
|
Common Stock |
|
|
Additional Paid-In |
|
|
Accumulated |
|
|
Accumulated Other Comprehensive |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Loss |
|
|
Total |
|
Balance at December 31, 2024 |
|
|
256,968 |
|
|
$ |
3,300 |
|
|
|
86,454 |
|
|
$ |
452 |
|
|
|
3,138,804 |
|
|
$ |
3 |
|
|
$ |
70,962 |
|
|
$ |
(68,746 |
) |
|
$ |
— |
|
|
$ |
5,971 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,289 |
|
|
|
— |
|
|
|
— |
|
|
|
1,289 |
|
Issuance of common stock, pre-funded warrants and warrants under inducement agreement, net of issuance costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,445,700 |
|
|
|
3 |
|
|
|
2,732 |
|
|
|
— |
|
|
|
— |
|
|
|
2,735 |
|
Issuance of common stock, prefunded warrants, and warrants, net of issuance costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,005,000 |
|
|
|
2 |
|
|
|
3,522 |
|
|
|
— |
|
|
|
— |
|
|
|
3,524 |
|
Release of restricted stock units |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,713 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Deferred financing costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(421 |
) |
|
|
— |
|
|
|
— |
|
|
|
(421 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,385 |
) |
|
|
|
|
|
|
(6,385 |
) |
Balance at June 30, 2025 |
|
|
256,968 |
|
|
$ |
3,300 |
|
|
|
86,454 |
|
|
$ |
452 |
|
|
|
7,592,217 |
|
|
$ |
8 |
|
|
$ |
78,084 |
|
|
$ |
(75,131 |
) |
|
$ |
— |
|
|
$ |
6,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2023 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
325,039 |
|
|
|
— |
|
|
|
55,897 |
|
|
|
(55,073 |
) |
|
|
(46 |
) |
|
|
778 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,052 |
|
|
|
|
|
|
|
|
|
|
|
2,052 |
|
Issuance of common stock, net of issuance costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
140,430 |
|
|
|
— |
|
|
|
1,804 |
|
|
|
|
|
|
|
|
|
|
|
1,804 |
|
Issuance of Series A preferred stock and warrants, net of issuance costs |
|
|
256,968 |
|
|
|
3,300 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
254 |
|
|
|
— |
|
|
|
— |
|
|
|
3,554 |
|
Release of restricted stock units |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
7,135 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
46 |
|
|
|
46 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,402 |
) |
|
|
|
|
|
|
(7,402 |
) |
Balance at June 30, 2024 |
|
|
256,968 |
|
|
$ |
3,300 |
|
|
|
— |
|
|
$ |
— |
|
|
|
472,604 |
|
|
$ |
— |
|
|
$ |
60,007 |
|
|
$ |
(62,475 |
) |
|
$ |
— |
|
|
$ |
832 |
|
The accompanying notes are an integral part
of these condensed financial statements.
Tenon Medical, Inc.
Condensed Statements of Cash Flows (Unaudited)
(In thousands)
| |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | |
Cash Flows from Operating Activities | |
| | |
| |
Net loss | |
$ | (6,385 | ) | |
$ | (7,402 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Stock-based compensation expense | |
| 1,289 | | |
| 2,052 | |
Depreciation and amortization | |
| 90 | | |
| 189 | |
Provision for credit losses on accounts receivable | |
| — | | |
| 46 | |
Amortization of operating right-of-use asset | |
| 131 | | |
| 121 | |
Increase (decrease) in cash resulting from changes in: | |
| | | |
| | |
Accounts receivable | |
| 93 | | |
| (207 | ) |
Inventory | |
| (70 | ) | |
| (55 | ) |
Prepaid expenses and other assets | |
| (374 | ) | |
| (442 | ) |
Accounts payable | |
| 525 | | |
| 678 | |
Accrued expenses | |
| 142 | | |
| 385 | |
Operating lease liability | |
| (138 | ) | |
| (123 | ) |
Net cash used in operating activities | |
| (4,697 | ) | |
| (4,758 | ) |
| |
| | | |
| | |
Cash Flows from Investing Activities | |
| | | |
| | |
Purchases of property and equipment | |
| (192 | ) | |
| (119 | ) |
Cash used in investing activities | |
| (192 | ) | |
| (119 | ) |
| |
| | | |
| | |
Cash Flows from Financing Activities | |
| | | |
| | |
Gross proceeds from issuance of common stock, prefunded warrants and warrants | |
| 4,010 | | |
| — | |
Gross proceeds from issuance of common stock, prefunded warrants and warrants under inducement agreement | |
| 3,057 | | |
| — | |
Proceeds from issuance of Series A convertible preferred stock | |
| — | | |
| 2,605 | |
Proceeds from issuance of common stock | |
| — | | |
| 1,990 | |
Offering costs | |
| (867 | ) | |
| (224 | ) |
Net cash provided by financing activities | |
| 6,200 | | |
| 4,371 | |
| |
| | | |
| | |
Effect of foreign currency translation on cash flow | |
| — | | |
| 46 | |
Net Increase (Decrease) in Cash and Cash Equivalents | |
| 1,311 | | |
| (460 | ) |
| |
| | | |
| | |
Cash and Cash Equivalents at Beginning of Period | |
| 6,535 | | |
| 2,428 | |
Cash and Cash Equivalents at End of Period | |
$ | 7,846 | | |
$ | 1,968 | |
| |
| | | |
| | |
Supplemental Disclosures of Cash Flow Information | |
| | | |
| | |
Non-cash investing and financing activities: | |
| | | |
| | |
Warrant modification costs | |
$ | 1,402 | | |
| — | |
Preferred stock issued upon conversion of debt and accrued interest | |
$ | — | | |
| 1,186 | |
Reclassification of deferred offering costs to additional paid-in capital | |
$ | 421 | | |
| 130 | |
The accompanying notes are an integral part
of these condensed financial statements.
Notes to Condensed Financial Statements
(unaudited)
(in thousands, except share and per-share data)
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 dedicated to transforming care for patients with sacroiliac joint (the
“SI Joint”) disorders that has developed The Catamaran™ SI Joint Fusion System (“The Catamaran System”)
that offers a novel, less invasive approach to the SI Joint using a single, robust, titanium implant for treatment of the most common
types of SI Joint disorders that cause lower back pain. The Company received U.S. Food and Drug Administration (“FDA”) clearance
in 2018 for The Catamaran System and is currently focused on the US market. Since the national launch of The Catamaran System in October
2022, the Company is focused on three commercial opportunities: 1) Primary SI Joint procedures, 2) Revision procedures of failed SI Joint
implants and 3) SI Joint fusion adjunct to a spine fusion construct.
2. Summary of Significant Accounting Principles
Basis of presentation
The accompanying unaudited condensed financial
statements have been prepared pursuant to the rules and regulations of the United States Securities and Exchange Commission (the “SEC”).
As permitted under these rules and regulations, the Company has condensed or omitted certain financial information and footnote disclosures
normally included in its annual financial statements prepared in accordance with accounting principles generally accepted in the United
States of America (“U.S. GAAP”). The condensed balance sheet as of December 31, 2024 has been derived
from the Company’s audited financial statements, which are included in its Annual Report on Form 10-K filed with the SEC on
March 26, 2025 (the “Annual Report”).
These condensed financial statements have been
prepared on the same basis as the Company’s annual financial statements and, in management’s opinion, reflect all adjustments,
consisting only of normal recurring adjustments, that are necessary for a fair presentation of its financial information. The 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.
These unaudited condensed financial statements
and accompanying notes should be read in conjunction with the Company’s audited financial statements as of and for the years ended
December 31, 2024 and 2023 included in its Annual Report.
The Company’s significant accounting policies
are disclosed in the Annual Report. There have been no material changes in the Company’s significant accounting policies during
the six months ended June 30, 2025.
Going concern uncertainty and liquidity requirements
The accompanying condensed 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. There is substantial doubt about the Company’s ability to continue
as a going concern for one year after the date that these financial statements are issued.
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 the commercialization of The Catamaran System.
Based on the Company’s expected level of revenues and expenditures, the Company believes that its existing cash and cash equivalents
as of June 30, 2025 will not 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 financial statements. The Company plans to raise the necessary additional capital through one or a combination
of public or private equity offerings, debt financings, and collaborations (see Note 6). The financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Use of estimates
The preparation of the 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,
collectability of accounts receivable, realization of deferred tax assets, accrued liabilities, accrued commissions, incremental borrowing
rate, obsolescence of inventory and stock-based compensation.
Reverse Stock Split
On September 6, 2024, the Company effected a 1-for-8
reverse stock split (the “2024 Reverse Stock Split”) by filing an amendment to the Company’s Amended and Restated Certificate
of Incorporation, as amended, with the Delaware Secretary of State. The 2024 Reverse Stock Split combined every eight shares of our common
stock issued and outstanding immediately prior to effecting the 2024 Reverse Stock Split into one share of common stock. No fractional
shares were issued in connection with the 2024 Reverse Stock Split.
All historical share and per share amounts reflected
throughout this document have been adjusted to reflect the 2024 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 2024 Reverse Stock Split.
Income Taxes
Income taxes are recorded in accordance with Accounting
Standards Codification (“ASC”) 740, Income Taxes, which provides for deferred taxes using an asset and liability approach.
Under this method, the Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences
between the financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in
effect when the differences are expected to reverse. Valuation allowances are provided when necessary to reduce net deferred tax assets
to the amount that is more likely than not to be realized. Based on the available evidence, the Company is unable, at this time, to support
the determination that it is more likely than not that its deferred tax assets will be utilized in the future. Accordingly, the Company
recorded a full valuation allowance as of June 30, 2025 and December 31, 2024. The Company intends to maintain valuation allowances until
sufficient evidence exists to support its reversal. The Company also expects the usage of the net operating loss carryforwards will be
limited based on changes in the Company’s ownership.
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
(restricted stock units, stock options, warrants and convertible preferred stock) 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, 2025 and 2024 which were excluded from the calculation because their effect was anti-dilutive:
|
|
June 30,
2025 |
|
|
June 30,
2024 |
|
Outstanding restricted stock units |
|
|
94,470 |
|
|
|
14,978 |
|
Outstanding stock options |
|
|
13,697 |
|
|
|
11,703 |
|
Outstanding warrants |
|
|
5,956,010 |
|
|
|
262,496 |
|
Common shares convertible from preferred stock |
|
|
1,654,191 |
|
|
|
323,322 |
|
Total |
|
|
7,718,368 |
|
|
|
612,499 |
|
Adoption of New Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (the “FASB”)
issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax
Disclosures, which requires additional tax disclosures about a reporting entity’s effective tax rate reconciliation as well
as information on income taxes paid. This guidance is effective on a prospective basis, with the option to apply it retrospectively, for
fiscal years beginning after December 15, 2025. The adoption of ASU 2023-09 will expand the Company’s income tax disclosures in
its Annual Report on Form 10-K, but will have no impact on reported income tax (benefit) expense or related tax assets or liabilities.
Recent
Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03,
Disaggregation of Income Statement Expenses, which requires additional disclosure of specific types of expenses included in the
expense captions presented on the face of the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective
for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The requirements
will be applied prospectively with the option for retrospective application. Early adoption is permitted. We are currently evaluating
the impact of adopting this new accounting guidance.
3. Property and Equipment, net
Property and equipment, net, consisted of the
following:
| |
June 30,
2025 | | |
December 31,
2024 | |
Catamaran tray sets | |
$ | 880 | | |
$ | 785 | |
Construction in progress | |
| 619 | | |
| 541 | |
IT equipment | |
| 56 | | |
| 56 | |
Leasehold improvements | |
| 15 | | |
| 15 | |
Lab equipment | |
| 21 | | |
| 14 | |
Office furniture | |
| 9 | | |
| 9 | |
Property and equipment, gross | |
| 1,600 | | |
| 1,420 | |
Less: accumulated depreciation | |
| (758 | ) | |
| (668 | ) |
Property and equipment, net | |
$ | 842 | | |
$ | 752 | |
Construction in progress is made up of reusable components that will
become reusable Catamaran tray sets. Depreciation expense was approximately $48 and $86 for the three months ended June 30, 2025 and 2024,
respectively. Depreciation expense was approximately $90 and $173 for the six months ended June 30, 2025 and 2024, respectively.
4. Accrued Expenses
Accrued expenses consisted of the following:
| |
June 30, 2025 | | |
December 31, 2024 | |
Accrued compensation | |
$ | 652 | | |
$ | 416 | |
Accrued professional services fees | |
| 154 | | |
| 271 | |
Other accrued expenses | |
| 302 | | |
| 223 | |
Total accrued expenses | |
$ | 1,108 | | |
$ | 910 | |
5. Leases
In June 2021, the Company entered into a facility
lease agreement for its company headquarters in Los Gatos, California. This non-cancellable operating lease expires in June 2026. Operating
lease costs for the facility lease were $73 and $73 for the three months ended June 30, 2025 and 2024, respectively, and were $146 and
$146 for the six months ended June 30, 2025 and 2024, respectively.
Supplemental balance sheet information related
to leases was as follows:
| |
June 30, | | |
December 31, | |
| |
2025 | | |
2024 | |
Operating lease right-of-use assets | |
$ | 268 | | |
$ | 399 | |
| |
| | | |
| | |
Operating lease liability, current | |
$ | (290 | ) | |
$ | (287 | ) |
Operating lease liability, noncurrent | |
| — | | |
| (141 | ) |
Total operating lease liabilities | |
$ | (290 | ) | |
$ | (428 | ) |
Future maturities of operating lease liabilities
as of June 30, 2025 were as follows:
2025 | |
$ | 158 | |
2026 | |
| 144 | |
Total lease payments | |
| 302 | |
Less: imputed interest | |
| (12 | ) |
Present value of operating lease liabilities | |
$ | 290 | |
Other information:
Cash paid for operating leases for the six months ended June 30, 2025 | | $ | 153 | |
Cash paid for operating leases for the six months ended June 30, 2024 | | $ | 148 | |
Remaining lease term - operating leases (in years) | | | 1.00 | |
Average discount rate - operating leases | | | 8.0 | % |
6. Stockholders’ Equity
The Company’s current Amended and Restated
Certificate of Incorporation dated February 18, 2014 authorizes the issuance of 130,000,000 shares of common stock and 20,000,000 shares
of preferred stock, both with a par value of $0.001 per share. With respect to the preferred stock, 4,500,000 shares are designated Series
A Preferred Stock and 491,222 shares are designated Series B Preferred Stock.
At-the-Market Offering Program
On May 4, 2023, the Company entered into an Equity
Distribution Agreement to establish an at-the-market offering program, under which the Company may sell from time to time, at its option,
shares of its common stock having an aggregate gross sales price of $5.5 million. The Company is required to pay the Sales Agents a commission
of 3% of the gross proceeds from the sale of shares and has also agreed to provide the Sales Agents with customary indemnification rights.
No shares were sold under the program during the three months ended June 30, 2025 and 2024. During the six months ended June 30, 2025
and 2024, 0 and 129,199 shares of the Company’s common stock, respectively, were sold under the program at a weighted-average price
of $0 and $14.63 per share with aggregate proceeds, net of current and deferred issuance costs, of $0 and $1,709, respectively.
Equity Line of Credit
On July 24, 2023, the Company entered into a purchase
agreement (“Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), under which, subject to
specified terms and conditions, the Company may sell to Lincoln Park up to $10 million of shares of common stock from time to time during
the term of the Purchase Agreement. On September 22, 2023 (the “Commencement Date”) and on May 10, 2024, the Company filed
registration statements with the SEC covering the resale of shares of common stock issued to Lincoln Park under the Purchase Agreement.
Beginning on the Commencement Date and for a period
of 24 months thereafter, under the terms and subject to the conditions of the Purchase Agreement, from time to time, at the Company’s
discretion, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up
to $10 million of shares of common stock, subject to certain limitations set forth in the Purchase Agreement. Specifically, from time
to time from and after the Commencement Date, the Company may, at its discretion, direct Lincoln Park to purchase on any single business
day on which the closing price of its common stock on The Nasdaq Capital Market (“Nasdaq”) is equal to or greater than $1.50
up to 10,000 shares of common stock (a “Regular Purchase”); provided, that the Company may direct Lincoln Park to purchase
in a Regular Purchase (i) up to 12,500 shares of common stock, if the closing sale price of its common stock on Nasdaq on such business
day is at least $15.00 per share and (ii) up to 15,000 shares of common stock, if the closing sale price of its common stock on Nasdaq
on such business day is at least $25.00 per share. In no case, however, will Lincoln Park’s commitment with respect to any single
Regular Purchase exceed $500,000; provided, that the parties may mutually agree at any time to increase the maximum number of shares of
common stock the Company may direct Lincoln Park to purchase in any single Regular Purchase to up to 100,000 shares or any number of shares
that shall not exceed 4.99% of the then outstanding shares of common stock. The foregoing share amounts and per share prices will be adjusted
for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring after
the date of the Purchase Agreement with respect to our common stock. The purchase price per share for each such Regular Purchase will
be based on prevailing market prices of the Company’s common stock immediately preceding the time of sale, as determined under the
Purchase Agreement.
No shares were sold under the program during the
three months ended June 30, 2025 and 2024. During the six months ended June 30, 2025 and 2024, 0 and 11,231 shares of the Company’s
common stock were sold under the program, respectively, at a weighted-average price of $0 and $8.90 per share, respectively, with aggregate
net proceeds of $95.
2025 Warrant Inducement
On March 11, 2025, the Company entered into a
warrant exercise inducement offer letter agreement (the “Inducement Letter”) with the holder of the Series A New Warrants
and Series B New Warrants (the “Existing Warrants”), pursuant to which, the holder agreed to exercise the Existing Warrants
at a reduced exercise price of $1.25 per share in consideration for the Company’s agreement to issue (i) new unregistered five-year
warrants (the “Series C-1 Warrants”) to purchase up to an aggregate of 2,445,700 shares of common stock at an exercise price
of $1.25 per share and (ii) new unregistered three-year warrants (the “Series C-2 Warrants,” and together with the Series
C-1 Warrants, the “New Warrants”) to purchase up to an aggregate of 1,222,850 shares of common stock at an exercise price
of $1.25 per share (the “Inducement Transaction”). The New Warrants are not exercisable without approval by the Company’s
stockholders (“Stockholder Approval”), which, pursuant to the Inducement Letter, the Company is required to obtain at a meeting
of stockholders no later than 165 days after the consummation of the Inducement Transaction. The Series C-1 Warrants will be exercisable
five years from the date on which Stockholder Approval is obtained, and the Series C-2 Warrants will be exercisable three years from the
date on which Stockholder Approval is obtained. Pursuant to the Inducement Transaction, the Company received proceeds, net of financial
advisor fees and other transaction expenses, of $2,735.
The Company filed a registration statement on
Form S-1 on April 4, 2025 providing for the resale of the shares of common stock issuable upon the exercise of the New Warrants. The Company
has agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any common stock or common
stock equivalents or file any registration statement or any amendment or supplement to any existing registration statement, subject to
certain exceptions, for a period of 60 calendar days after the effectiveness of the Resale Registration Statement. Furthermore, the Company
is also prohibited from entering into any agreement to issue common stock or common stock equivalents involving a variable rate transaction
(as defined in the Inducement Letter), subject to certain exceptions, for a six-month period commencing on March 12, 2025.
2025 Securities Purchase Agreements
On March 25, 2025, the Company entered into a
securities purchase agreement for the issuance of 733,500 shares of its common stock (or common stock equivalents in lieu thereof) in
a registered direct offering at a purchase price of $2.00 per share. In a concurrent private placement, the Company also agreed to issue
to the same investor warrants to purchase up to 733,500 shares of its common stock at an exercise price of $2.00 per share, which will
be exercisable immediately, and will expire five years following the date of issuance. Pursuant to the agreements, the Company received
proceeds, net of financial advisor fees and other transaction expenses, of $1,234.
Also on March 25, 2025, the Company entered into
a securities purchase agreement for the issuance of 1,271,500 shares of its common stock (or common stock equivalents in lieu thereof)
in a registered direct offering at a purchase price of $2.00 per share. In a concurrent private placement, the Company also agreed to
issue to the same investor warrants to purchase up to 1,271,500 shares of its common stock at an exercise price of $2.00 per share, which
will be exercisable immediately, and will expire five years following the date of issuance. Pursuant to the agreements, the Company received
proceeds, net of financial advisor fees and other transaction expenses, of $2,290.
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 two 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.
A summary of the Company’s stock option
and restricted stock unit activity under its plans is as follows:
| | 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 Unit | |
Outstanding at December 31, 2024 | | | 11,322 | | | $ | 20.79 | | | | 20,224 | | | $ | 99.58 | |
Granted | | | 5,000 | | | $ | 1.11 | | | | 77,150 | | | $ | 1.85 | |
Released | | | — | | | | — | | | | (2,252 | ) | | $ | 615.59 | |
Forfeited | | | (2,625 | ) | | $ | 5.36 | | | | (191 | ) | | $ | 708.80 | |
Outstanding at June 30, 2025 | | | 13,697 | | | $ | 16.56 | | | | 94,470 | | | $ | 3.72 | |
The following table sets forth stock-based compensation
expense recognized for the three and six months ended June 30, 2025 and 2024:
| |
Three months ended
June 30, | | |
Six months ended
June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Research and development | |
$ | 208 | | |
$ | 358 | | |
$ | 557 | | |
$ | 725 | |
Sales and marketing | |
| 27 | | |
| 34 | | |
| 64 | | |
| 77 | |
General, and administrative | |
| 182 | | |
| 642 | | |
| 668 | | |
| 1,250 | |
Total stock-based compensation expense | |
$ | 417 | | |
$ | 1,034 | | |
$ | 1,289 | | |
$ | 2,052 | |
At June 30, 2025, there were 70,387 shares available
for issuance under the 2022 Plan.
Warrants
Series C Warrants
On March 11, 2025, in connection with 2025 Warrant
Inducement, the Company issued new unregistered five-year warrants (the “Series C-1 Warrants”) to purchase up to an aggregate
of 2,445,700 shares of common stock at an exercise price of $1.25 per share and new unregistered three-year warrants (the “Series
C-2 Warrants,” and together with the Series C-1 Warrants, the “Series C Warrants”) to purchase up to an aggregate of
1,222,850 shares of common stock at an exercise price of $1.25 per share. The Series C Warrants are not exercisable without approval by
the Company’s stockholders (“Stockholder Approval”), which the Company is required to obtain at a meeting of stockholders
no later than 165 days after the consummation of the Inducement Transaction. The Series C-1 Warrants will be exercisable five years from
the date on which Stockholder Approval is obtained, and the Series C-2 Warrants will be exercisable three years from the date on which
Stockholder Approval is obtained. Pursuant to the Inducement Transaction, the Company received proceeds, net of financial advisor fees
and other transaction expenses, of $2,735.
The fair value of the Series C-1 Warrants on the
grant date was $0.97 per warrant, which was calculated using a Black-Scholes option valuation model with an expected term of 5.00 years,
expected volatility of 68.40%, dividend yield of 0%, and risk-free interest rate of 4.0%. The fair value of the Series C-2 Warrants on
the grant date was $0.80 per warrant, which was calculated using a Black-Scholes option valuation model with an expected term of 3.00
years, expected volatility of 68.40%, dividend yield of 0%, and risk-free interest rate of 4.0%. The Company recorded the fair value of
these warrants to additional paid-in capital in the first quarter of 2025. The Company recorded the excess of the incremental value of
the modified Series A New Warrants and Series B New Warrants and the fair value of the Series C Warrants over the cash proceeds from the
exercise of the modified Series A New Warrants and Series B New Warrants as equity offering costs. All of the Series C Warrants remain
outstanding as of June 30, 2025.
Series D Warrants
On March 25, 2025, in connection with a securities
purchase agreement, the Company issued warrants to purchase up to 733,500 shares of its common stock at an exercise price of $2.00 per
share (the “Series D Warrants”), which were exercisable upon issuance, and will expire five years following the date of issuance.
The fair value of the Series D Warrants on the grant date was $2.72 per warrant, which was calculated using a Black-Scholes option valuation
model with an expected term of 5.00 years, expected volatility of 68.40%, dividend yield of 0%, and risk-free interest rate of 4.1%. The
Company recorded the fair value of these warrants to additional paid-in capital in the first quarter of 2025. All of the Series D Warrants
remain outstanding as of June 30, 2025.
Series E Warrants
Also on March 25, 2025, in connection with a securities
purchase agreement, the Company issued warrants to purchase up to 1,271,500 shares of its common stock at an exercise price of $2.00 per
share (the “Series E Warrants”), which were exercisable upon issuance, and will expire five years following the date of issuance.
The fair value of the Series E Warrants on the grant date was $2.72 per warrant, which was calculated using a Black-Scholes option valuation
model with an expected term of 5.00 years, expected volatility of 68.40%, dividend yield of 0%, and risk-free interest rate of 4.1%. The
Company recorded the fair value of these warrants to additional paid-in capital in the first quarter of 2025. All of the Series E Warrants
remain outstanding as of June 30, 2025.
7. 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 System in the United States and Puerto Rico. The agreement is for an initial period of
five years, and automatically renews for an additional five years unless written notice is given by either party prior to April 27, 2023.
The agreement provides for a bonus to be paid to the Representative upon an acquisition or IPO. In May 2021, the Company entered into
an Amended and Restated Exclusive Sales Representative Agreement (the “Restated Sales Agreement”). In connection with the
amended agreement, the Company paid $500 cash and issued 53,757 shares of common stock to the Representative, for which the Company recorded
a combined total of approximately $880 as sales and marketing expense. In addition, the Representative 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. In October 2021,
the Company issued 4,445 shares of common stock with a fair value of approximately $333 to the Representative in accordance with the anti-dilution
provision. In April 2022, the Company issued 31,235 shares of common stock to the Representative in accordance with the anti-dilution
provision, fully satisfying the Company’s obligations.
The Restated Sales Agreement restructured the
calculation of the bonus paid to the Representative upon an acquisition, removed the bonus payable upon an IPO, and allows the Company
to terminate the Restated Sales Agreement as long as the bonus paid to the Representative is at least $6,000.
On October 6, 2022, the Company entered into the
Terminating Amended and Restated Exclusive Sales Representative Agreement (the “Termination Agreement”) with the Representative,
which terminated the Restated Sales Agreement. In accordance with the Termination Agreement, (i) the Company paid the Representative $1,000
in cash; and (ii) the Company agreed to pay the Representative (a) $85 per month during the six months after the date of the Termination
Agreement in return for efforts by the Representative to transition operations to the Company, (b) 20% of net sales of the product sold
in the United States and Puerto Rico until December 31, 2023 and (c) after December 31, 2023, 10% of net sales until such time as the
aggregate amount paid to the Representative under this clause (c) and clause (b) above equal $3,600. In the event of an acquisition of
the Company, the Company will pay the Representative $3,600 less previous amounts paid pursuant to clause (b) and clause (c) above. The
Company recorded a charge of $1,000 for the payment to the Representative in the fourth quarter of 2022 and expensed the $85 per month
charges as incurred over the six-month period. For payments under clause (b) and clause (c) above, the Company originally estimated the
fair value of the liability using level 3 hierarchy inputs based on a Monte Carlo simulation of future revenues with a 25% quarterly estimated
standard deviation of growth rates and a 10% probability of dissolution, discounted at an estimated discount rate of 15.4%. Based on the
Company’s fair value analysis, a total of $2,611 was charged to sales and marketing expense in the statements of operations and
comprehensive loss and recorded as accrued commissions in the balance sheets. For subsequent periods, the Company has used a discounted
cash flow model with an estimated discount rate of 15.4% to adjust the liability for actual payments made and updated projections of the
timing of future payments. A reconciliation of the liability under clause (b) and clause (c) for the six months ended June 30, 2025 is
as follows:
Balance at January 1, 2025 | |
$ | 2,101 | |
Amounts paid during 2025 | |
| (140 | ) |
Accretion | |
| 44 | |
Balance at June 30, 2025 | |
$ | 2,005 | |
Per the terms of the Termination Agreement, the
Company ultimately expects to expense $3,600 under clause (b) and clause (c).
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. 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.
8. Reportable Segment
The Company operates in one business segment,
the SI Joint segment. The SI Joint segment derives revenue from the sale of the Catamaran System for treatment of the most common types
of SI Joint disorders that cause lower back pain, which is the Company’s only product. The chief operating decision maker, which
is the Company’s senior executive committee that includes the chief executive officer, the chief financial officer and the chief
technology officer, assesses the performance of the SI Joint segment and decides how to allocate resources based on net income which is
reported in the consolidated statements of operations as net loss. The measure of segment assets is reported on the balance sheet as total
assets.
The chief operating decision maker uses net loss
to evaluate income generated from segment assets in deciding whether to continue investing in the segment. Net loss is used to monitor
budget versus actual results, to prepare operating budgets, and to assess the performance of the segment and in establishing management
compensation. The Company does not have intra-entity sales or transfers.
The following table presents selected financial
information for the Company’s single business segment for the three and six months ended June 30, 2025 and 2024:
| |
Three Months Ended
June 30, | | |
Six Months Ended
June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Revenue | |
$ | 564 | | |
$ | 901 | | |
$ | 1,290 | | |
$ | 1,620 | |
Less: | |
| | | |
| | | |
| | | |
| | |
Cost of sales | |
| 319 | | |
| 431 | | |
| 722 | | |
| 680 | |
Research and development | |
| 503 | | |
| 708 | | |
| 1,194 | | |
| 1,377 | |
Sales and marketing | |
| 1,119 | | |
| 1,448 | | |
| 2,766 | | |
| 2,829 | |
General and administrative | |
| 1,480 | | |
| 2,186 | | |
| 3,142 | | |
| 4,112 | |
Total Other Income (Expense), net | |
| 88 | | |
| 46 | | |
| 149 | | |
| (24 | ) |
Net Loss | |
$ | (2,769 | ) | |
$ | (3,826 | ) | |
$ | (6,385 | ) | |
$ | (7,402 | ) |
9. Subsequent Event
The SImmetry Acquisition
On August 1, 2025 (the
“SI Closing Date”), the Company entered into an asset purchase agreement (the “SI APA”) by and between the Company
and SiVantage, Inc., a Delaware corporation (“SI”), pursuant to which the Company acquired substantially all of the assets
of SI, including the assignment of its intellectual property related to sacropelvic fixation and fusion procedures (the “SI Products”),
and assumed certain of its current liabilities and contract obligations, as set forth in the SI APA (the “SImmetry Acquisition”).
The SImmetry Acquisition closed on the SI Closing Date.
On the SI Closing Date,
SI received, as consideration for the SImmetry Acquisition, the purchase price consisting of: (i) $750,000 in cash; (ii) 710,300 shares
of the Company’s common stock, of which 473,533 are to be held in by the Company for a period of one-year as security to satisfy
any indemnification claims against SI in accordance with the SI APA; (iii) a royalty equal to 15% of the sales of all SI Products during
the one-year period following the SI Closing Date and 10% of the sales of all SI Products during the following four-year period, subject
to a cap of $5.0 million; and (iv) a deferred cash payment of up to a maximum of approximately $1.3 million in the event that the all
of the currently issued and outstanding warrants of the Company are exercised (which deferred cash payment will be made pro rata based
on the actual number of warrants exercised).
In addition, during the
three-year period following the SI Closing Date, the Company will issue SI additional shares of its common stock upon the achievement
of the following milestones:
| ● | upon the Company having $1 million in aggregate sales of the SI Products after the
SI Closing Date, the Company will issue SI an additional 276,228 shares of its common stock; |
| ● | upon the Company achieving $10 million in aggregate sales of the SI Products after
the SI Closing Date, the Company will issue SI an additional 276,228 shares of its common stock; and |
| ● | upon the Company achieving $20 million in aggregate sales of the SI Products after
the SI Closing Date, the Company will issue SI an additional 314,900 shares of its common stock. |
The SIMPL Acquisition
On August 1, 2025, the
Company entered into an asset purchase agreement (the “ SIMPL APA”) by and between the Company and SIMPL Medical, LLC, a Delaware
limited liability (“SIMPL”), pursuant to which the Company acquired substantially all of the assets of SIMPL, including the
assignment of its intellectual property related to posterior sacroiliac implant technology (the “SIMPL Products”), and assumed
certain of its contract obligations, as set forth in the SIMPL APA (the “SIMPL Acquisition”). The SIMPL Acquisition closed
on August 4, 2025.
The aggregate purchase
price for the SIMPL Acquisition payable by the Company is a royalty equal to 30% of the net revenue received by the Company from the sale
of any SIMPL Products during the five-year period following the first commercial sale of any SIMPL Products; provided that in the event
that the aggregate royalty payments made by the Company to SIMPL exceed $20.0 million, then from and after such time, the Company shall
pay SIMPL 20% of the net revenue received by the Company from the sale of any SIMPL Products during the remainder of such five-year period.
The royalty payments noted above shall be paid quarterly by the Company. The Company has the option, subject to certain limitations, to
pay up to 33.3% of any quarterly royalty by the issuance of its shares of common stock, based upon the trailing 10-day VWAP at the end
of any applicable quarter.
The SI APA and the SIMPL APA also include various representations, warranties, covenants and indemnities.
Employment Agreements
In connection with the
SImmetry Acquisition, the Company has executed employment agreements with two former executives of SI, Wyatt Geist (“Geist”),
who has been hired by the Company as Chief Innovation Officer and Nate Grawey (“Grawey”), who has been hired by the Company
as Chief Commercial Officer.
The Employment Agreements
for Geist and Grawey (collectively the “Employment Agreements”), are at-will employment agreements and provide each of Geist
and Grawey with (i) base salary of $290,000; (ii) monthly commissions for sales by the Company above $250,000 as set forth in the Employment
Agreements; (iii) 138,114 shares of restricted stock equal to 1.75% that are subject to vesting as described in the Employment Agreements;
and (iv) other employee benefits applicable to senior executives of the Company.
Accounting
The SImmetry Acquisition, the SIMPL Acquisition and the Employment Agreements are in the process of being evaluated, and management
expects that the transactions will be accounted for as a business combination. The Company is in the process of determining the fair value
of the tangible assets, intangible assets and liabilities acquired, as well as the acquisition purchase price, and will disclose supplemental
pro-forma information in a Current Report on Form 8-K when it is available.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and
analysis of our financial condition and results of operations together with our unaudited condensed financial statements and the notes
to those statements included elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and the
other information set forth in our Annual Report of Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange
Commission on March 26, 2025. In addition to historical financial information, this discussion and analysis contains forward-looking statements
that reflect our plans, estimates and beliefs. You should not place undue reliance on these forward-looking statements, which involve
risks and uncertainties. As a result of many factors, including but not limited to those set forth under “Risk Factors” in
our Annual Report of Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, our actual results may differ materially
from those anticipated in these forward-looking statements. See “Cautionary Statement Regarding Forward-Looking Statements.”
Overview
Tenon Medical, Inc., a medical device company
formed in 2012, has developed a proprietary, U.S. Food and Drug Administration (“FDA”) approved surgical implant-system, which
we call The Catamaran™ SI Joint Fusion System (“The Catamaran System”). The Catamaran System offers a novel, less invasive
inferior-posterior approach to the sacroiliac joint (“SI Joint”) using a single, robust titanium implant to treat SI Joint
dysfunction that often causes severe lower back pain. The system features the Catamaran™ Fixation Device which passes through both
the axial and sagittal planes of the ilium and sacrum, transfixing the SI Joint along its longitudinal axis. Published clinical studies
have shown that 15% to 30% of all chronic lower back pain is associated with the SI Joint.
With an entry similar to the SI Joint injection,
the surgical approach is direct to the joint. The angle and trajectory of the inferior-posterior approach is designed to point away from
critical neural and vascular structures and into the strongest cortical bone. Joined by a patented osteotome bridge, the implant design
consists of two hollow fenestrated pontoons with an open framework to facilitate bony in-growth through the SI Joint. One pontoon fixates
into the ilium and the other into the sacrum. The osteotome is designed to disrupt the articular portion of the joint to help facilitate
a fusion response.
Our initial clinical results indicate that the
Catamaran System implant is promoting fusion across the joint as evidenced by computerized tomography (CT) scans which is the gold standard
widely accepted by the clinical community. We had our national launch of The Catamaran System in October 2022 and are building a sales
and marketing infrastructure to market our product and address the greatly underserved market opportunity that exists.
We believe that the implant design and procedure
we have developed, along with the 2D and 3D protocols for proper implantation will be received well by the clinician community who have
been looking for a next generation device.
We have incurred net losses since our inception in 2012. As of June
30, 2025, we had an accumulated deficit of approximately $75.1 million. To date, we have financed our operations primarily through public
equity offerings, private placements of equity securities, certain debt-related financing arrangements, and sales of our product. We have
devoted substantially all of our resources to research and development, regulatory matters and sales and marketing of our product.
Reverse Stock Split
On September 6, 2024, we effected a 1-for-8 reverse
stock split (the “2024 Reverse Stock Split”) by filing an amendment to our Amended and Restated Certificate of Incorporation,
as amended, with the Delaware Secretary of State. The 2024 Reverse Stock Split combined every eight shares of our common stock issued
and outstanding immediately prior to effecting the 2024 Reverse Stock Split into one share of common stock. No fractional shares were
issued in connection with the 2024 Reverse Stock Split. All historical share and per share amounts reflected throughout this document
have been adjusted to reflect the 2024 Reverse Stock Split. The authorized number of shares and the par value per share of our common
stock were not affected by the 2024 Reverse Stock Split.
Components of Results of Operations
Revenue
We derive substantially all our revenue from sales
of The Catamaran System to a limited number of clinicians. Revenue from sales of The Catamaran System fluctuates based on volume of cases
(procedures performed), discounts, rebates, and the number of implants used for a particular patient. Similar to other orthopedic companies,
our revenue can also fluctuate from quarter to quarter due to a variety of factors, including reimbursement, changes in independent sales
representatives and physician activities.
Cost of Goods Sold, Gross Profit, and Gross
Margin
We utilize contract manufacturers for production of The Catamaran System
implants and Catamaran Tray Sets. Cost of goods sold consists primarily of costs of the components of The Catamaran System implants and
instruments, depreciation of Catamaran tray sets, overhead related to operations personnel and facility costs, quality inspection, packaging,
scrap and inventory obsolescence, as well as distribution-related expenses such as logistics and shipping costs. We anticipate that certain
of our cost of goods sold will increase in absolute dollars as case levels increase.
Our gross margins have been and will continue
to be affected by a variety of factors, including the cost to have our product manufactured for us, pricing pressure from increasing competition,
decisions with regard to the level of overhead we choose to maintain, and the factors described above impacting our revenue.
Operating Expenses
Our operating expenses consist of sales and marketing,
research and development, and general and administrative expenses. Personnel costs are the most significant component of operating expenses
and consist of consulting expenses, salaries, sales commissions and other cash and stock-based compensation related expenses. We expect
operating expenses to increase in absolute dollars as we continue to invest and grow our business.
Sales and Marketing Expenses
Sales and marketing expenses primarily consist
of salaries, commissions, stock-based compensation expense and travel and entertainment expenses of our sales and market personnel along
with commissions paid to our independent distributors. We expect our sales and marketing expenses to increase in absolute dollars with
the increased sales of The Catamaran System resulting in higher commissions and salaries, increased clinician and sales representative
training, and the cost to complete our clinical study to gain wider clinician adoption of The Catamaran System. Our sales and marketing
expenses may fluctuate from period to period due to the timing of sales and marketing activities related to the commercial activity of
our product.
Research and Development Expenses
Our research and development expenses primarily
consist of engineering, product development, regulatory expenses, and consulting services, outside prototyping services, outside research
activities, materials, and other costs associated with the development and refinement of our product. Research and development expenses
also include related personnel and consultants’ compensation and stock-based compensation expense. We expense research and development
costs as they are incurred. We expect research and development expense to increase in absolute dollars as we improve The Catamaran System,
develop new products, add research and development personnel, and undergo clinical activities that may be required for regulatory clearances
of future products.
General and Administrative Expenses
General and administrative expenses primarily
consist of salaries, consultants’ compensation, stock-based compensation expense, and other costs for finance, accounting, legal,
compliance, and administrative matters. We expect our general and administrative expenses to increase in absolute dollars as we add personnel
and information technology infrastructure to support the growth of our business. We also expect to incur additional general and administrative
expenses as a result of operating as a public company, including but not limited to: expenses related to compliance with the rules and
regulations of the SEC and those of The Nasdaq Stock Market LLC on which our securities are traded; additional insurance expenses; investor
relations activities; and other administrative and professional services. While we expect the general and administrative expenses to increase
in absolute dollars, we anticipate that it will decrease as a percentage of revenue over time.
Gain on Investments, Interest Expense and
Other Income (Expense), Net
Gain on investments consists of interest income
and realized gains and losses from the sale of our investments in money market and corporate debt securities. Interest expense is related
to borrowings, when applicable. Other income and expenses have not been significant to date.
Results of Operations
The following table sets forth our results of
operations for the periods presented (in thousands):
| |
Three Months Ended June 30, | | |
Six Months Ended
June 30, | |
Statements of Operations Data: | |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Revenue | |
$ | 564 | | |
$ | 901 | | |
$ | 1,290 | | |
$ | 1,620 | |
Cost of goods sold | |
| 319 | | |
| 431 | | |
| 722 | | |
| 680 | |
Gross profit | |
| 245 | | |
| 470 | | |
| 568 | | |
| 940 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 503 | | |
| 708 | | |
| 1,194 | | |
| 1,377 | |
Sales and marketing | |
| 1,119 | | |
| 1,448 | | |
| 2,766 | | |
| 2,829 | |
General and administrative | |
| 1,480 | | |
| 2,186 | | |
| 3,142 | | |
| 4,112 | |
Total operating expenses | |
| 3,102 | | |
| 4,342 | | |
| 7,102 | | |
| 8,318 | |
Loss from operations | |
| (2,857 | ) | |
| (3,872 | ) | |
| (6,534 | ) | |
| (7,378 | ) |
Interest and other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
Gain on investments | |
| 88 | | |
| 39 | | |
| 149 | | |
| 66 | |
Interest expense | |
| — | | |
| — | | |
| — | | |
| (34 | ) |
Other income (expense) | |
| — | | |
| 7 | | |
| — | | |
| (56 | ) |
Net loss | |
$ | (2,769 | ) | |
$ | (3,826 | ) | |
$ | (6,385 | ) | |
$ | (7,402 | ) |
The following table sets forth our results of
operations as a percentage of revenue:
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
Statements of Operations Data: | |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Revenue | |
| 100 | % | |
| 100 | % | |
| 100 | % | |
| 100 | % |
Cost of goods sold | |
| 57 | | |
| 48 | | |
| 56 | | |
| 42 | |
Gross profit | |
| 43 | | |
| 52 | | |
| 44 | | |
| 58 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 89 | | |
| 79 | | |
| 93 | | |
| 85 | |
Sales and marketing | |
| 198 | | |
| 161 | | |
| 214 | | |
| 175 | |
General and administrative | |
| 262 | | |
| 243 | | |
| 244 | | |
| 254 | |
Total operating expenses | |
| 550 | | |
| 482 | | |
| 551 | | |
| 513 | |
Loss from operations | |
| (507 | ) | |
| (430 | ) | |
| (507 | ) | |
| (455 | ) |
Interest and other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
Gain on investments | |
| 16 | | |
| 4 | | |
| 12 | | |
| 4 | |
Interest expense | |
| — | | |
| — | | |
| — | | |
| (2 | ) |
Other expense | |
| — | | |
| 1 | | |
| — | | |
| (3 | ) |
Net loss | |
| (491 | )% | |
| (425 | )% | |
| (495 | )% | |
| (457 | )% |
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
(in thousands, except percentages)
Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin
| |
Three Months Ended
June 30, | | |
| | |
| |
| |
2025 | | |
2024 | | |
$ Change | | |
% Change | |
Revenue | |
$ | 564 | | |
$ | 901 | | |
$ | (337 | ) | |
| (37 | )% |
Cost of goods sold | |
| 319 | | |
| 431 | | |
| (112 | ) | |
| (26 | )% |
Gross profit | |
$ | 245 | | |
$ | 470 | | |
$ | 225 | | |
| (48 | )% |
Gross profit percentage | |
| 43 | % | |
| 52 | % | |
| | | |
| | |
| |
Six Months Ended
June 30, | | |
| | |
| |
| |
2025 | | |
2024 | | |
$ Change | | |
% Change | |
Revenue | |
$ | 1,290 | | |
$ | 1,620 | | |
$ | (330 | ) | |
| (20 | )% |
Cost of goods sold | |
| 722 | | |
| 680 | | |
| 42 | | |
| 6 | % |
Gross profit | |
$ | 568 | | |
$ | 940 | | |
$ | (372 | ) | |
| (40 | )% |
Gross profit percentage | |
| 44 | % | |
| 58 | % | |
| | | |
| | |
Revenue. The decrease in revenue
for the three and six months ended June 30, 2025 as compared to the same periods in 2024 was primarily due to a decrease in the number
of surgical procedures in which The Catamaran System was used, while implants per procedure remained relatively constant.
Cost of Goods Sold, Gross Profit, and Gross
Margin. The change in cost of goods sold for the three and six months ended June 30, 2025 as compared to the same periods in
2024 was due to the absorption of production overhead costs into our standard cost in 2024 and operating leverage created due to lower
relative fixed costs.
Operating Expenses
| |
Three Months Ended
June 30, | | |
| | |
| |
| |
2025 | | |
2024 | | |
$ Change | | |
% Change | |
Research and development | |
$ | 503 | | |
$ | 708 | | |
$ | (205 | ) | |
| (29 | )% |
Sales and marketing | |
| 1,119 | | |
| 1,448 | | |
| (329 | ) | |
| (23 | )% |
General and administrative | |
| 1,480 | | |
| 2,186 | | |
| (706 | ) | |
| (32 | )% |
Total operating expenses | |
$ | 3,102 | | |
$ | 4,342 | | |
$ | (1,240 | ) | |
| (29 | )% |
| |
Six Months Ended
June 30, | | |
| | |
| |
| |
2025 | | |
2024 | | |
$ Change | | |
% Change | |
Research and development | |
$ | 1,197 | | |
$ | 1,377 | | |
$ | (183 | ) | |
| (13 | )% |
Sales and marketing | |
| 2,766 | | |
| 2,829 | | |
| (63 | ) | |
| (2 | )% |
General and administrative | |
| 3,142 | | |
| 4,112 | | |
| (970 | ) | |
| (24 | )% |
Total operating expenses | |
$ | 7,102 | | |
$ | 8,318 | | |
$ | (1,216 | ) | |
| (15 | )% |
Research and Development Expenses. Research
and development expenses for the three months ended June 30, 2025 decreased as compared to 2024 primarily due to decreased professional
fees ($58) and stock-based compensation ($150), partially offset by increased payroll and employee expenses ($13). Research and development
expenses for the six months ended June 30, 2025 decreased as compared to 2024 primarily due to decreased professional fees ($139) and
stock-based compensation ($168), partially offset by increased payroll and employee expenses ($100).
Sales and Marketing Expenses. Sales
and marketing expenses for the three months ended June 30, 2025 decreased as compared to the same period in 2024 primarily due to decreased
commission expenses ($251), payroll and employee expenses ($58), consulting and professional fees ($34), and stock-based compensation
($7). Sales and marketing expenses for the six months ended June 30, 2025 decreased as compared to the same period in 2024 primarily due
to decreased commission expenses ($148) and stock-based compensation ($13), partially offset by increases in payroll and employee expenses
($58) and professional fees ($11).
General and Administrative Expenses. General and administrative expenses for the three months ended June
30, 2025 decreased as compared to the same period in 2024 primarily due to decreased stock-based compensation ($461), insurance costs
($221) and professional service fees ($26), partially offset by increases in payroll and employee expenses ($31). General and administrative
expenses for the six months ended June 30, 2025 decreased as compared to the same period in 2024 primarily due to decreased stock-based
compensation ($582), insurance costs ($325) and professional service fees ($70), partially offset by increases in payroll and employee
expenses ($86).
Gain on Investments, Interest Expense and
Other Income (Expense), Net
Gain on investments for the three and six months
ended June 30, 2025 increased as compared to the same periods in 2024 due to interest on our increased cash and cash equivalent balances.
Interest expense for the six months ended June 30, 2024 related to our convertible debt. Other income (expense), net in 2024 was related
to foreign exchange losses on the liquidation of our Swiss subsidiary.
Liquidity and Capital Resources
As of June 30, 2025, we had cash and cash equivalents
of $7.8 million. Since inception, we have financed our operations through private placements of preferred stock, debt financing arrangements,
our initial public offering, additional stock offerings and the sale of our products. As of June 30, 2025, we had no outstanding debt.
As of June 30, 2025, we had an accumulated deficit of $75.1 million
and we expect to incur additional losses in the future. We have not achieved positive cash flow from operations to date. Based upon our
current operating plan, our existing cash and cash equivalents will not be sufficient to fund our operating expenses and working capital
requirements through at least the next 12 months from the date these financial statements were filed. We plan to raise the necessary additional
capital through one or a combination of public or private equity offerings, debt financings, and collaborations. We continue to face challenges
and uncertainties and, as a result, our available capital resources may be consumed more rapidly than currently expected due to (a) the
uncertainty of future revenues from The Catamaran System; (b) changes we may make to the business that affect ongoing operating expenses;
(c) changes we may make in our business strategy; (d) regulatory developments affecting our existing products; (e) changes we may make
in our research and development spending plans; and (f) other items affecting our forecasted level of expenditures and use of cash resources.
As we attempt to raise additional capital to fund
our operations, funding may not be available to us on acceptable terms, or at all. If we are unable to obtain adequate financing when
needed, we may have to delay, reduce the scope of or suspend one or more of our sales and marketing efforts, research and development
activities, or other operations. We may seek to raise any necessary additional capital through a combination of public or private equity
offerings, debt financings, and collaborations. If we do raise additional capital through public or private equity offerings, the ownership
interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences
that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants
limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring
dividends. If we are unable to raise capital, we will need to delay, reduce, or terminate planned activities to reduce costs. Doing so
will likely harm our ability to execute our business plans. Due to the uncertainty in our ability to raise capital, management believes
that there is substantial doubt in our ability to continue as a going concern for the next twelve months from the issuance of these condensed
financial statements.
Cash Flows (in thousands, except percentages)
The following table sets forth the primary sources
and uses of cash for each of the periods presented below:
| |
Six Months Ended
June 30, | | |
| | |
| |
| |
2025 | | |
2024 | | |
$ Change | | |
% Change | |
Net cash (used in) provided by: | |
| | |
| | |
| | |
| |
Operating activities | |
$ | (4,697 | ) | |
$ | (4,758 | ) | |
$ | 61 | | |
| (1 | )% |
Investing activities | |
| (192 | ) | |
| (119 | ) | |
| (73 | ) | |
| 61 | % |
Financing activities | |
| 6,200 | | |
| 4,371 | | |
| 1,829 | | |
| 42 | % |
Effect of foreign currency translation on cash flow | |
| — | | |
| 46 | | |
| (46 | ) | |
| (100 | )% |
Net increase (decrease) in cash and cash equivalents | |
$ | 1,311 | | |
$ | (460 | ) | |
$ | 1,771 | | |
| (385 | )% |
The decrease in net cash used in operating activities for the six months
ended June 30, 2025 as compared to the six months ended June 30, 2024 was primarily attributable to our decreased net loss ($1,017), adjusted
for decreases in non-cash stock-based compensation expenses ($763), in addition to decreased accounts payable ($153) and accrued expenses
($243), partially offset by decreases in accounts receivable ($300).
Cash used in investing activities for the six
months ended June 30, 2025 and 2024 consisted of purchases of property and equipment ($192 and $119, respectively).
Cash provided by financing activities for the six months ended June
30, 2025 consisted primarily of proceeds from the issuance of common stock from our securities purchase agreements ($4,010) and proceeds
from the exercise of warrants under the inducement agreement ($3,057), partially offset by offering costs ($867). Cash provided by financing
activities for the six months ended June 30, 2024 consisted primarily of proceeds from the issuance of Series A Convertible Preferred
Stock ($2,605) and from the issuance of common stock ($1,990), partially offset by offering costs ($224).
Critical Accounting Policies, Significant Judgments,
and Use of Estimates
Our management’s discussion and analysis
of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with
U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts
of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as
the reported results of operations during the reporting periods. Our estimates are based on our historical experience and on various other
factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
values of assets and liabilities that are not readily apparent from three other sources. Actual results could differ from these estimates
under different assumptions or conditions. For the six months ended June 30, 2025, there were no significant changes to our existing critical
accounting policies from those disclosed in our Annual Report on Form 10-K.
Off-Balance Sheet Arrangements
As of June 30, 2025, and December 31, 2024, we
did not have any relationships with unconsolidated organizations or financial partnerships, such as structured finance or special purpose
entities that would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually
narrow or limited purposes.
ITEM 3. Quantitative and Qualitative Disclosures
about Market Risk
Not required under Regulation S-K for “smaller
reporting companies.”
ITEM 4. Controls and Procedures. Disclosure
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures
that are designed to provide reasonable assurance that the information required to be disclosed by us in reports that we file or submit
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported
within the time periods specified in the rules and forms promulgated by the Securities and Exchange Commission, and that such information
is accumulated and communicated to our management, including our Chief Executive Officer and President and Chief Financial Officer, as
appropriate to allow timely decisions regarding required disclosure. Because of the inherent limitations to the effectiveness of any system
of disclosure controls and procedures, no evaluation of disclosure controls and procedures can provide absolute assurance that all control
issues and instances of fraud, if any, with a company have been prevented or detected on a timely basis. Even disclosure controls and
procedures determined to be effective can only provide reasonable assurance that their objectives are achieved.
As of June 30, 2025, we carried out an evaluation,
under the supervision and with the participation of our management, including our Chief Executive Officer and President and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e))
pursuant to Rule 13a-15 of the Exchange Act. Based upon that evaluation, our Chief Executive Officer and President and Chief Financial
Officer concluded that our disclosure controls and procedures are not effective at the reasonable assurance level.
Our size has prevented us from being able to employ
sufficient resources to enable us to have an adequate level of supervision and segregation of duties. Therefore, it is difficult to effectively
segregate accounting duties which comprises a material weakness in internal controls. This lack of segregation of duties leads management
to conclude that the Company’s disclosure controls and procedures are not effective to give reasonable assurance that the information
required to be disclosed in reports that the Company files under the Exchange Act is recorded, processed, summarized and reported as and
when required.
To the extent reasonably possible given our limited resources, we are
taking measures to cure the aforementioned weaknesses, including, but not limited to, increasing the capacity of our qualified financial
personnel to ensure that accounting policies and procedures are consistent across the organization and that we have adequate controls
over our Exchange Act reporting disclosures.
Changes in Internal Control over Financial
Reporting
There have been no changes in our internal control
procedures over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during our fiscal quarter ended
June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEDINGS
None.
ITEM 1A. RISK FACTORS
As a smaller reporting company as defined by Rule 12b-2 of the Securities
Exchange Act of 1934, as amended, and in item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations and
therefore are not required to provide the information requested by this item. In any event, during the six months ended June 30, 2025,
there were no material changes in our risk factors as previously disclosed in our Annual Report on Form 10-K filed with the U.S. Securities
and Securities Exchange Commission (“SEC”) on March 26, 2025.
ITEM 2. UNREGISTERED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS
(A) Unregistered Sales of Equity Securities
None.
(B) Use of Proceeds
Not applicable.
(C) Issuer Purchases of Equity Securities
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not Applicable.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
EXHIBIT INDEX
Exhibit Number |
|
Description |
3.1 |
|
Second Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-271648, filed on May 4, 2023) |
3.2 |
|
Bylaws of the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-260931, filed on April 20, 2022) |
3.3 |
|
Certificate of Designations, Rights and Preferences for Series A Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on February 22, 2024) |
3.4 |
|
Amendment to Certificate of Designations, Rights and Preferences for Series A Preferred Stock (incorporated by reference to the Registrant’s Registration Statement No. 333-281531, filed on September 9, 2024) |
3.5 |
|
Certificate of Designations, Rights and Preferences for Series B Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on September 6, 2024) |
4.1 |
|
Form of Representative’s Warrant in connection with the Registrant’s Initial Public Offering (incorporated by reference to the Registrant’s Registration Statement No. 333-260931, filed on April 15, 2022) |
4.2 |
|
Form of publicly traded Warrant issued on June 16, 2023 (Incorporated by reference to exhibit 4.1 the Registrant’s Registration Statement No. 333-272488, filed on June 7, 2023) |
4.3 |
|
Form of Warrant Agency Agreement between the Company and VStock Transfer, LLC (incorporated by reference to exhibit 4.3 to the Registrant’s Registration Statement No. 333-272488, filed on June 7, 2023) |
4.4 |
|
Form of Warrant issued to investors on November 21, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on November 28, 2023) |
4.5 |
|
Form of Warrant issued to investors in the Series A Preferred Stock on February 20, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on February 22, 2024) |
4.6 |
|
Form of Warrant issued to the investors in the Series B Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on September 6, 2024) |
4.7 |
|
Description of Securities of the Registrant (incorporated by reference to the Registrant’s 8-A12B Registration Statement, filed on April 26, 2022) |
4.8 |
|
Form of Series C-1 Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on March 12, 2025) |
4.9 |
|
Form of Series C-2 Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on March 12, 2025) |
10.1## |
|
Employment Agreement dated June 1, 2021 between Steven M. Foster and the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-260931, filed on April 20, 2022) |
10.2## |
|
Employment Agreement dated June 1, 2021 between Richard Ginn and the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-260931, filed on April 20, 2022) |
10.3## |
|
Consulting Agreement dated May 7, 2021 by and between Richard Ferrari and the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-260931, filed on April 20, 2022) |
10.4 |
|
Tennon Medical 2022 Equity Incentive Plan (incorporated by reference to the Registrant’s Registration Statement No. 333-271648, filed on May 4, 2023) |
10.5 |
|
Form of Securities Purchase Agreement between the Registrant and Lincoln Park Capital Fund, LLC (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on July 28, 2023) |
10.6 |
|
Form of Securities Purchase Agreement entered into between the Registrant and investors in the Series A Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on February 22, 2024) |
10.7 |
|
Form of Securities Purchase Agreement entered into between the Registrant and investors in the November 2023 Notes (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on November 28, 2023) |
10.8 |
|
Form of Securities Purchase Agreement entered into between the Registrant and investors in the Series B Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on September 6, 2024) |
10.9 |
|
Form of Inducement Letter, dated March 11, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on March 12, 2025) |
19.1 |
|
Insider Trading Policy (incorporated by reference to the Registrant’s Annual Report on Form 10-K, filed on March 29, 2024) |
21.1 |
|
List of Subsidiaries of the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-281531, filed on September 9, 2024) |
31.1* |
|
Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer and President of Tenon Medical, Inc. |
31.2* |
|
Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer of Tenon Medical, Inc. |
32.1** |
|
Section 1350 Certification of the President and Chief Executive Officer of Tenon Medical, Inc. |
32.2** |
|
Section 1350 Certification of the Chief Financial Officer of Tenon Medical, Inc. |
101.INS* |
|
Inline XBRL Instance Document |
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema Document |
101.CAL* |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF* |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB* |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE* |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
## |
Denotes management compensation plan, agreement or arrangement |
** |
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. |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
TENON MEDICAL, INC. |
|
|
Dated: August 13, 2025 |
/s/ Steven M. Foster |
|
Steven M. Foster |
|
Chief Executive Officer and President, Director |
|
(Principal Executive Officer) |
|
|
Dated: August 13, 2025 |
/s/ Kevin Williamson |
|
Kevin Williamson |
|
Chief Financial Officer |
|
(Principal Financial and Accounting Officer) |
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