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, 2024
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 |
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, 2024, the registrant had a total of 3,951,767 shares of its common stock, par value $0.001 per share, issued and outstanding.
INDEX
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; |
|
|
|
|
● |
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 distributors’ 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 Consolidated Financial Statements (Unaudited)
Tenon
Medical, Inc.
Condensed
Consolidated Balance Sheets (Unaudited)
(In
thousands, except share data)
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Assets | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 1,968 | | |
$ | 2,428 | |
Accounts receivable, net | |
| 679 | | |
| 518 | |
Inventory | |
| 609 | | |
| 554 | |
Prepaid expenses and other current assets | |
| 831 | | |
| 389 | |
Total current assets | |
| 4,087 | | |
| 3,889 | |
Fixed assets, net | |
| 904 | | |
| 961 | |
Deposits | |
| 51 | | |
| 51 | |
Operating lease right-of-use asset | |
| 525 | | |
| 646 | |
Deferred offering costs | |
| 439 | | |
| 798 | |
TOTAL ASSETS | |
$ | 6,006 | | |
$ | 6,345 | |
| |
| | | |
| | |
Liabilities and Stockholders’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,111 | | |
$ | 433 | |
Accrued expenses | |
| 932 | | |
| 808 | |
Current portion of accrued commissions | |
| 1,089 | | |
| 470 | |
Current portion of operating lease liability | |
| 271 | | |
| 256 | |
Convertible notes payable and accrued interest, net of debt discount of $0 and $77 at June 30, 2024 and December 31, 2023, respectively | |
| — | | |
| 1,173 | |
Total current liabilities | |
| 3,403 | | |
| 3,140 | |
Accrued commissions, net of current portion | |
| 1,481 | | |
| 1,999 | |
Operating lease liability, net of current portion | |
| 290 | | |
| 428 | |
Total liabilities | |
| 5,174 | | |
| 5,567 | |
Commitments and contingencies (Note 8) | |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Series A convertible preferred stock, $0.001 par value; 4,500,000 shares authorized at June 30, 2024 and December 31, 2023; 256,968 and 0 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | |
| 3,300 | | |
| — | |
Common stock, $0.001 par value; 130,000,000 shares authorized at June 30, 2024 and December 31, 2023; 3,780,827 and 2,600,311 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | |
| 4 | | |
| 3 | |
Additional paid-in capital | |
| 60,003 | | |
| 55,894 | |
Accumulated deficit | |
| (62,475 | ) | |
| (55,073 | ) |
Accumulated other comprehensive loss | |
| — | | |
| (46 | ) |
Total stockholders’ equity | |
| 832 | | |
| 778 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 6,006 | | |
$ | 6,345 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
Tenon
Medical, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In
thousands, except per share data)
| |
Three Months Ended
June 30, | | |
Six Months Ended
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue | |
$ | 901 | | |
$ | 743 | | |
$ | 1,620 | | |
$ | 1,176 | |
Cost of sales | |
| 431 | | |
| 549 | | |
| 680 | | |
| 1,029 | |
Gross Profit | |
| 470 | | |
| 194 | | |
| 940 | | |
| 147 | |
| |
| | | |
| | | |
| | | |
| | |
Operating Expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 708 | | |
| 901 | | |
| 1,377 | | |
| 1,735 | |
Sales and marketing | |
| 1,448 | | |
| 1,883 | | |
| 2,829 | | |
| 3,909 | |
General and administrative | |
| 2,186 | | |
| 1,732 | | |
| 4,112 | | |
| 3,711 | |
Total Operating Expenses | |
| 4,342 | | |
| 4,516 | | |
| 8,318 | | |
| 9,355 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from Operations | |
| (3,872 | ) | |
| (4,322 | ) | |
| (7,378 | ) | |
| (9,208 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other Income (Expense) | |
| | | |
| | | |
| | | |
| | |
Gain on investments | |
| 39 | | |
| 37 | | |
| 66 | | |
| 93 | |
Interest expense | |
| — | | |
| — | | |
| (34 | ) | |
| — | |
Other income (expense), net | |
| 7 | | |
| — | | |
| (56 | ) | |
| — | |
Total Other Income (Expense), net | |
| 46 | | |
| 37 | | |
| (24 | ) | |
| 93 | |
Net Loss | |
$ | (3,826 | ) | |
$ | (4,285 | ) | |
$ | (7,402 | ) | |
$ | (9,115 | ) |
Net Loss Per Share of Common Stock | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
$ | (1.02 | ) | |
$ | (3.28 | ) | |
$ | (2.24 | ) | |
$ | (7.50 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-Average Shares of Common Stock Outstanding | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 3,749 | | |
| 1,305 | | |
| 3,301 | | |
| 1,215 | |
| |
| | | |
| | | |
| | | |
| | |
Consolidated Statements of Comprehensive Loss: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (3,826 | ) | |
$ | (4,285 | ) | |
$ | (7,402 | ) | |
$ | (9,115 | ) |
Unrealized gain on investments | |
| — | | |
| 3 | | |
| — | | |
| 16 | |
Foreign currency translation adjustment | |
| — | | |
| 13 | | |
| 46 | | |
| 12 | |
Total comprehensive loss | |
$ | (3,826 | ) | |
$ | (4,269 | ) | |
$ | (7,356 | ) | |
$ | (9,087 | ) |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
Tenon
Medical, Inc.
Condensed
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Unaudited)
(In
thousands, except share data)
Three
months ended June 30, 2024 and 2023:
| |
Series A Convertible Preferred Stock | | |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Total | |
Balance at March 31, 2024 | |
| 256,968 | | |
$ | 3,300 | | |
| 3,726,974 | | |
$ | 4 | | |
$ | 58,969 | | |
$ | (58,649 | ) | |
$ | — | | |
$ | 3,624 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,034 | | |
| — | | |
| — | | |
| 1,034 | |
Release of restricted stock units | |
| — | | |
| — | | |
| 53,853 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Net Loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (3,826 | ) | |
| — | | |
| (3,826 | ) |
Balance at June 30, 2024 | |
| 256,968 | | |
$ | 3,300 | | |
| 3,780,827 | | |
$ | 4 | | |
$ | 60,003 | | |
$ | (62,475 | ) | |
$ | — | | |
$ | 832 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at March 31, 2023 | |
| — | | |
$ | — | | |
| 1,125,128 | | |
$ | 1 | | |
$ | 46,883 | | |
$ | (44,322 | ) | |
$ | (88 | ) | |
$ | 2,474 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,054 | | |
| — | | |
| — | | |
| 1,054 | |
Release of restricted stock units | |
| — | | |
| — | | |
| 37,247 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Issuance of common stock and warrants, net of issuance costs | |
| — | | |
| — | | |
| 1,000,000 | | |
| 1 | | |
| 1,643 | | |
| — | | |
| — | | |
| 1,644 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 16 | | |
| 16 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (4,285 | ) | |
| — | | |
| (4,285 | ) |
Balance at June 30, 2023 | |
| — | | |
$ | — | | |
| 2,162,375 | | |
$ | 2 | | |
$ | 49,580 | | |
$ | (48,607 | ) | |
$ | (72 | ) | |
$ | 903 | |
Six
months ended June 30, 2024 and 2023:
| |
Series A Convertible Preferred Stock | | |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Total | |
Balance at December 31, 2023 | |
| — | | |
$ | — | | |
| 2,600,311 | | |
$ | 3 | | |
$ | 55,894 | | |
$ | (55,073 | ) | |
$ | (46 | ) | |
$ | 778 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| 2,052 | | |
| — | | |
| — | | |
| 2,052 | |
Issuance of common stock, net of issuance costs | |
| — | | |
| — | | |
| 1,123,439 | | |
| 1 | | |
| 1,803 | | |
| — | | |
| — | | |
| 1,804 | |
Issuance of series A convertible preferred stock, net of issuance costs | |
| 256,968 | | |
| 3,300 | | |
| — | | |
| — | | |
| 254 | | |
| — | | |
| — | | |
| 3,554 | |
Release of restricted stock units | |
| — | | |
| — | | |
| 57,077 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 46 | | |
| 46 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (7,402 | ) | |
| — | | |
| (7,402 | ) |
Balance at June 30, 2024 | |
| 256,968 | | |
$ | 3,300 | | |
| 3,780,827 | | |
$ | 4 | | |
$ | 60,003 | | |
$ | (62,475 | ) | |
$ | — | | |
$ | 832 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at December 31, 2022 | |
| — | | |
$ | — | | |
| 1,123,680 | | |
$ | 1 | | |
$ | 45,843 | | |
$ | (39,492 | ) | |
$ | (100 | ) | |
$ | 6,252 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| 2,094 | | |
| — | | |
| — | | |
| 2,094 | |
Release of restricted stock units | |
| — | | |
| — | | |
| 38,695 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Issuance of common stock and warrants, net of issuance costs | |
| — | | |
| — | | |
| 1,000,000 | | |
| 1 | | |
| 1,643 | | |
| — | | |
| — | | |
| 1,644 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 28 | | |
| 12 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (9,115 | ) | |
| — | | |
| (9,115 | ) |
Balance at June 30, 2023 | |
| — | | |
$ | — | | |
| 2,162,375 | | |
$ | 2 | | |
$ | 49,580 | | |
$ | (48,607 | ) | |
$ | (72 | ) | |
$ | 903 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
Tenon
Medical, Inc.
Condensed
Consolidated Statements of Cash Flows (Unaudited)
(In
thousands)
| |
Six Months Ended
June 30, | |
| |
2024 | | |
2023 | |
Cash Flows from Operating Activities | |
| | |
| |
Net loss | |
$ | (7,402 | ) | |
$ | (9,115 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Stock-based compensation expense | |
| 2,052 | | |
| 2,094 | |
Depreciation and amortization | |
| 189 | | |
| 60 | |
Provision for losses on accounts receivable | |
| 46 | | |
| — | |
Amortization of operating right-of-use asset | |
| 121 | | |
| 111 | |
Increase (decrease) in cash resulting from changes in: | |
| | | |
| | |
Accounts receivable | |
| (207 | ) | |
| (373 | ) |
Inventory | |
| (55 | ) | |
| (155 | ) |
Prepaid expenses and other assets | |
| (442 | ) | |
| (325 | ) |
Accounts payable | |
| 678 | | |
| 362 | |
Accrued expenses | |
| 385 | | |
| 698 | |
Operating lease liability | |
| (123 | ) | |
| (109 | ) |
Net cash used in operating activities | |
| (4,758 | ) | |
| (6,752 | ) |
| |
| | | |
| | |
Cash Flows from Investing Activities | |
| | | |
| | |
Sales of short-term investments | |
| — | | |
| 6,503 | |
Purchases of short-term investments | |
| — | | |
| (493 | ) |
Purchases of property and equipment | |
| (119 | ) | |
| (212 | ) |
Net cash (used in) provided by investing activities | |
| (119 | ) | |
| 5,798 | |
| |
| | | |
| | |
Cash Flows from Financing Activities | |
| | | |
| | |
Proceeds from issuance of Series A Convertible Preferred Stock, net | |
| 2,437 | | |
| — | |
Proceeds from issuance of common stock, net | |
| 1,934 | | |
| — | |
Proceeds from issuance of common stock and warrants, net of issuance costs | |
| — | | |
| 4,808 | |
Deferred offering costs | |
| — | | |
| (143 | ) |
Net cash provided by financing activities | |
| 4,371 | | |
| 4,665 | |
| |
| | | |
| | |
Effect of foreign currency translation on cash flow | |
| 46 | | |
| 12 | |
Net (Decrease) Increase in Cash and Cash Equivalents | |
| (460 | ) | |
| 3,723 | |
| |
| | | |
| | |
Cash and Cash Equivalents at Beginning of Period | |
| 2,428 | | |
| 2,129 | |
Cash and Cash Equivalents at End of Period | |
$ | 1,968 | | |
$ | 5,852 | |
| |
| | | |
| | |
Supplemental Disclosures of Cash Flow Information | |
| | | |
| | |
Non-cash investing and financing activities: | |
| | | |
| | |
Preferred stock issued upon conversion of debt and accrued interest | |
$ | 1,186 | | |
| — | |
Reclassification of deferred offering costs to additional paid-in capital | |
$ | 130 | | |
| — | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
Notes to Condensed Consolidated 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 that has developed The Catamaran™ SI Joint Fusion System (“the
Catamaran System”) that offers a novel, less invasive approach to the sacroiliac joint (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 U.S.
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.
Principles of consolidation
The condensed consolidated financial statements
of the Company for the three and six months ended June 30, 2023 and as of December 31, 2023 include the accounts of its wholly-owned subsidiary,
Tenon Technology AG (“TTAG”), a Swiss company. All intercompany balances and transactions have been eliminated in consolidation.
The financial statements of TTAG are prepared for the same reporting period as the parent, using consistent accounting policies in all
material respects. In 2024, TTAG was dissolved and, as such, the financial statements for the three and six months ended June 30, 2024
and as of June 30, 2024 only include the accounts of the Company.
2. Summary of Significant Accounting Principles
Basis of presentation
The accompanying unaudited condensed consolidated
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 consolidated financial statements prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”). The condensed consolidated balance sheet as
of December 31, 2023 has been derived from the Company’s audited consolidated financial statements, which are included
in its Annual Report on Form 10-K filed with the SEC on March 29, 2024.
These unaudited condensed consolidated financial
statements and accompanying notes should be read in conjunction with the Company’s audited consolidated financial statements as
of and for the years ended December 31, 2023 and 2022 included in its Annual Report of Form 10-K filed with the SEC on March 29, 2024.
These condensed consolidated financial statements
have been prepared on the same basis as the Company’s annual consolidated financial statements and, in management’s opinion,
reflect all adjustments, consisting only of normal recurring adjustments, that are necessary for a fair presentation of 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.
The Company’s significant accounting policies
are disclosed in the audited consolidated financial statements as of and for the years ended December 31, 2023 and 2022. There have been
no material changes in the Company’s significant accounting policies during the six months ended June 30, 2024.
Going concern uncertainty and liquidity requirements
The accompanying consolidated financial statements
have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the settlement
of liabilities and commitments in the normal course of business. There is substantial doubt about the Company’s ability to continue
as a going concern for one year after the date that these condensed consolidated 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, 2024 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 consolidated 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. The consolidated financial statements
do not include any adjustments that might result from the outcome of this uncertainty.
Notice from Nasdaq
On May 7, 2024, the Company received a letter
from the Nasdaq Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) stating that for the 30 consecutive
business day period between March 25, 2024 and May 6, 2024, the common stock of the Company had not maintained a minimum closing bid price
of $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid
Price Rule”). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar days, or
until November 4, 2024 (the “Compliance Period”), to regain compliance with the Bid Price Rule.
If the Company does not regain compliance with
the Bid Price Rule by November 4, 2024, the Company may be eligible for an additional 180-day period to regain compliance. To qualify,
the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial
listing standards for The Nasdaq Capital Market, with the exception of the Bid Price Rule, and would need to provide written notice of
its intention to cure the bid price deficiency during the second compliance period, by effecting a reverse stock split, if necessary.
If the Company cannot regain compliance during
the Compliance Period or any subsequently granted compliance period, the common stock of the Company will be subject to delisting. At
that time, the Company may appeal the delisting determination to a Nasdaq hearings panel.
The notice from Nasdaq has no immediate effect
on the listing of the Company’s common stock. The Company is currently evaluating its options for regaining compliance. On December
21, 2023, the Company’s shareholders approved an amendment to its Certificate of Incorporation to provide for a reverse stock split
in a ratio ranging from one for two (1:2) to one for fifty (1:50) at the discretion of the Company’s Board of Directors.
Use of estimates
The preparation of the consolidated financial
statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect certain reported amounts and
disclosures. Accordingly, actual results could differ from those estimates. Significant estimates made by management include, but are
not limited to, realization of deferred tax assets, accrued liabilities, accrued commissions, incremental borrowing rate, obsolescence
of inventory, allowance for credit losses, and stock-based compensation.
Reverse Stock Split
On November 2, 2023, the Company effected a 1-for-10
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 reverse stock split combined every ten shares of our common stock issued and outstanding immediately
prior to effecting the reverse stock split into one share of common stock. No fractional shares were issued in connection with the reverse
stock split. All historical share and per share amounts reflected throughout this document have been adjusted to reflect the reverse stock
split. The authorized number of shares and the par value per share of the Company’s common stock were not affected by the reverse
stock split.
Income Taxes
The Company accounts for income taxes utilizing
ASC 740, “Income Taxes”. ASC 740 requires the measurement of deferred tax assets for deductible temporary differences and
operating loss carry forwards, and of deferred tax liabilities for taxable temporary differences. Measurement of current and deferred
tax liabilities and assets is based on provisions of enacted tax law. The effects of future changes in tax laws or rates are not included
in the measurement. The Company recognizes the amount of taxes payable or refundable for the current year and recognizes deferred tax
liabilities and assets for the expected future tax consequences of events and transactions that have been recognized in the Company’s
financial statements or tax returns. The Company currently has substantial net operating loss carry forwards. The Company has recorded
a 100% valuation allowance against net deferred tax assets due to uncertainty of their ultimate realization. Valuation allowances are
established when necessary to reduce deferred tax assets to the amount expected to be realized.
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 certain potential common stock
equivalents (convertible preferred stock, stock options, and warrants) are converted or exercised. The calculation of diluted net loss
per share excludes potential common stock equivalents if the effect is anti-dilutive. The Company’s weighted average common shares
outstanding for basic and diluted are the same because the effect of the potential common stock equivalents is anti-dilutive.
The Company had the following dilutive common
stock equivalents as of June 30, 2024 and 2023 which were excluded from the calculation because their effect was anti-dilutive:
| |
June 30, 2024 | | |
June 30, 2023 | |
Outstanding restricted stock units | |
| 136,690 | | |
| 93,156 | |
Outstanding stock options | |
| 72,563 | | |
| 96,934 | |
Outstanding warrants | |
| 2,388,068 | | |
| 2,009,600 | |
Common shares convertible from preferred stock | |
| 2,625,016 | | |
| — | |
Total | |
| 5,222,337 | | |
| 2,199,690 | |
Recent
Accounting Pronouncements Not Yet Adopted
In November 2023, the Financial Accounting Standards
Board (the “FASB”) issued Accounting Standards Update No. 2023-07, Segment Reporting (Topic 280): Improvements to
Reportable Segment Disclosures, which increases the disclosures about reportable segments including more detailed information about
a reportable segment’s expenses. This guidance will be effective for the Company for the fiscal year ending December 31, 2024 and
the interim periods thereafter, with early adoption permitted. The guidance will have no effect on the Company’s results of operations
as the changes are disclosure related. The Company has elected not to early adopt.
In December 2023, the FASB issued Accounting Standards
Update 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
will be effective on a prospective basis, with the option to apply it retrospectively, for fiscal years beginning after December 15, 2024.
We are currently evaluating the impact of adopting this new accounting guidance.
3. Fixed Assets, Net
Fixed assets, net, consisted of the following:
| |
June 30, 2024 | | |
December 31, 2023 | |
Construction in progress | |
$ | 718 | | |
$ | 602 | |
Catamaran tray sets | |
| 538 | | |
| 538 | |
IT equipment | |
| 56 | | |
| 56 | |
Leasehold improvements | |
| 15 | | |
| 15 | |
Lab equipment | |
| 14 | | |
| 14 | |
Office furniture | |
| 9 | | |
| 9 | |
Fixed assets, gross | |
| 1,350 | | |
| 1,234 | |
Less: accumulated depreciation | |
| (446 | ) | |
| (273 | ) |
Fixed assets, net | |
$ | 904 | | |
$ | 961 | |
Construction in progress is made up of reusable
components that will become reusable Catamaran Tray Sets. Depreciation expense was approximately $86 and $35 for the three months ended
June 30, 2024 and 2023, respectively. Depreciation expense was approximately $173 and $60 for the six months ended June 30, 2024 and 2023,
respectively.
4. Accrued Expenses
Accrued expenses consisted of the following:
| |
June 30, 2024 | | |
December 31, 2023 | |
Accrued compensation | |
$ | 531 | | |
$ | 334 | |
Other accrued expenses | |
| 401 | | |
| 474 | |
Total accrued expenses | |
$ | 932 | | |
$ | 808 | |
5. Debt
Convertible notes payable
In November 2023, the Company entered into Securities
Purchase Agreements with certain investors (the “Investors”), pursuant to which the Company sold to the Investors a total
of $1,250,000 in secured notes (the “Convertible Notes”) and warrants to purchase 45,000 shares of the Company’s common
stock at an exercise price equal to $1.94 per share.
The Convertible Notes bear an interest rate of
10% per annum with a default rate of 12% per annum and have a maturity date of November 21, 2024. All principal and accrued interest is
payable at maturity. At any time during the term of the Convertible Notes, the principal amount together with all accrued interest thereon
(the “Prepayment Amount”) may be paid in full, but not in part, by the Company. The Prepayment Amount may be paid by the Company
in cash or by the issuance to the Investors of shares of Series A Preferred Stock, if prior to such payment with Series A Preferred Stock
(i) certain stockholder proposals described in the Convertible Notes are approved by the Company’s stockholders; and (ii) the Company
has commitments from investors other than the Investors to purchase shares of Series A Preferred Stock with a stated value of at least
$3,750,000. The Convertible Notes are secured by a first priority security interest in all of the assets of the Company. The warrants
expire five years from the issuance date. The warrants contain a “cashless exercise” feature and contain anti-dilution rights
on subsequent issuances of equity or equity equivalents.
On February 20, 2024, the Investors agreed to
a complete prepayment of the Company’s obligations under the Convertible Notes, including accrued interest, in exchange for 84,729
shares of Series A Preferred Stock and warrants to purchase 157,094 shares of our common stock at $1.2705 per share and the Convertible
Notes were cancelled. See Note 7.
6. 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, 2024 and 2023, respectively, and were $146 and
$146 for the six months ended June 30, 2024 and 2023, respectively.
Supplemental balance sheet information related
to leases was as follows:
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Operating lease right-of-use assets | |
$ | 525 | | |
$ | 646 | |
| |
| | | |
| | |
Operating lease liability, current | |
$ | (271 | ) | |
$ | (256 | ) |
Operating lease liability, noncurrent | |
| (290 | ) | |
| (428 | ) |
Total operating lease liabilities | |
$ | (561 | ) | |
$ | (684 | ) |
Future maturities of operating lease liabilities
as of June 30, 2024 were as follows:
2024 | |
$ | 154 | |
2025 | |
| 310 | |
2026 | |
| 144 | |
Total lease payments | |
| 608 | |
Less: imputed interest | |
| (47 | ) |
Present value of operating lease liabilities | |
$ | 561 | |
Other information:
Cash paid for operating leases for the six months ended June 30, 2024 | | $ | 148 | |
Cash paid for operating leases for the six months ended June 30, 2023 | | $ | 144 | |
Remaining lease term - operating leases (in years) | | | 2.00 | |
Average discount rate - operating leases | | | 8.0 | % |
7. 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.
During the six months ended June 30, 2024, 1,033,592 shares of the Company’s common stock were sold under the program at a weighted-average
price of $1.83 per share with aggregate proceeds, net of issuance costs, of $1,834. No shares were sold under the program during the three
months ended June 30, 2024. As of the date of this report, the Company may not sell additional shares under this program.
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.
During the six months ended June 30, 2024, 89,847
shares of the Company’s common stock were sold under the program at a weighted-average price of $1.113 per share with aggregate
net proceeds of $96. No shares were sold under the program during the three months ended June 30, 2024.
Series A Preferred Stock
On February 20, 2024, the Company entered into
a Securities Purchase Agreement (the “Purchase Agreement”) with certain investors, pursuant to which the Company agreed to
sell, issue and deliver to these investors, in a private placement offering (the “Offering”), a total of 172,239 shares of
the Company’s Series A Preferred Stock and warrants (the “Series A Warrants”) to purchase 258,374 shares of common stock,
par value $0.001 per share, of the Company (“Common Stock”) at an exercise price equal to $1.2705 per share for an aggregate
offering price of $2,605,000.
Additionally, on February 20, 2024, the Investors
agreed to a complete prepayment of the Company’s obligations under the Convertible Notes, including accrued interest, in exchange
for 84,729 shares of Series A Preferred Stock and warrants to purchase 157,094 shares of our common stock at $1.2705 per share and the
Convertible Notes were cancelled. The Series A Warrants are immediately exercisable and expire five years from the date of issuance.
The Series A Preferred Stock is convertible, at
any time, at the option of the holder into shares of Common Stock. Each share of Series A Preferred Stock shall be convertible, at any
time after the date of issuance, at the option of the holder thereof (or, upon a Required Conversion (as defined below), at the option
of the Corporation), into that number of shares of Common Stock determined by dividing the Stated Value (as defined below) for such share
of Series A Preferred Stock by the Conversion Price (as defined below). “Stated Value” means for any share of Series A Preferred
Stock, an amount equal to the product of (x) $15.125 multiplied by (y) the sum of 1 plus the product of (A) 0.06 multiplied by (B) a fraction
equal to the number of days that such share of Series A Preferred Stock has been issued divided by 365. “Conversion Price”
means (i) for the shares of Series A Preferred Stock issued on the Closing Date, $1.5125 and (ii) for each share of Series A Preferred
Stock issued thereafter, an amount equal to the greater of (x) $1.5125 and the average of the VWAPs for the 10 Trading Days prior the
issuance date of such share of Series A Preferred Stock, in each case subject to adjustment as set forth herein. On any date that ten
out of the last 15 daily VWAPs of the Common Stock is 250% higher than the Conversion Price on such date, then the Company will have the
right to require 50% of the Preferred Stock to be converted into shares of Common Stock. Additionally, on and after the time on which
the Company has $2.25 million in revenues in any single financial quarter, the Company will have the right to require 50% of the Preferred
Stock to be converted into shares of Common Stock (a “Required Conversion”). No dividends are payable on the Series A Preferred
Stock. The Series A Preferred Stock will vote together with the Common Stock on all matters other than as required by law; provided however
that any additional shares underlying the Series A Preferred Stock as a result of the anti-dilution provision described below shall not
vote on an “as converted” basis and shall only vote when issued upon conversion. Notwithstanding the foregoing, the vote of
an individual holder of Series A Preferred Stock (and underlying Common Stock) shall be capped at 9.99% (or 4.99% if selected by the holder).
The Conversion Price is subject to anti-dilution
adjustment as the result of any subdivision, combination of shares or recapitalization, stock dividends, stock splits and similar transactions
affecting the Common Stock. In addition, the Series A Preferred Stock will have weighted average anti-dilution protection providing for
adjustment of the Conversion Price in the event of issuance of, or commitments to issue, Common Stock for less than the Conversion Price
then in effect immediately prior to such issue or sale (a “Dilutive Issuance”), subject to customary exceptions; provided
however the anti-dilution for Dilutive Issuances shall not be operative until the stockholders of the Company have approved the terms
of the Series A Preferred Stock. Upon any liquidation or winding up of the Company (a “Liquidation”), the holders of Series
A Preferred Stock will be entitled to receive in preference to any other class or series of the Company’s equity securities the
greater of (i) the Stated Value plus accrued and unpaid dividends and (ii) what would be paid if the Series A Preferred Stock plus accrued
and unpaid dividends had been converted into Common Stock. A consolidation or merger of the Company or sale or transfer of all or substantially
all of its assets, or any transaction which results in the stockholders of the Company owning less than 50% of the equity or voting power
of the surviving entity (excluding the issuance of Common Stock in any financing transaction unless more than 50% of the Company’s
shares are issued to one stockholder or a number of stockholders who act as a one group) shall be deemed a Liquidation (a “Deemed
Liquidation”) with respect to the shares of Series A Preferred Stock of any holder who opts to have such occurrence treated as a
Deemed Liquidation; provided that if the liquidation preference payable on a Deemed Liquidation is less than 110% of the stated value
of the Series A Preferred Stock, the dividend rate on any accrued and unpaid dividends payable with respect to such Deemed Liquidation
will increase to 10%. All liquidation preferences payable in respect of a Deemed Liquidation will be payable in shares of Common Stock
based on the closing price of the Common Stock on the date of such Deemed Liquidation. Consent of the majority of the holders will be
required to (i) amend the Certificate of Incorporation or Bylaws of the Company so as to adversely alter the rights, preferences, privileges
of the Series A Preferred Stock, (ii) create any new class of shares pari passu or senior to the Series A Preferred Stock or increase
or decrease the number of authorized shares of Common Stock or preferred stock, (iii) pay or declare any dividend on Common Stock or other
junior securities, or incur indebtedness in any single transaction in excess of $1 million or (iv) redeem, purchase or otherwise acquire
any share or shares of preferred stock or Common Stock (other than (a) the repurchase of shares of Common Stock pursuant to a written
benefit plan or employment or consulting agreement, or (b) the repurchase of any equity securities in connection with the Company’s
right of first offer with respect to those securities contained in any written agreement with the Company).
Voting rights
The holders of vested shares of common stock are
entitled to vote on any matter submitted to a vote of the stockholders and each such holder is entitled to one vote per share of common
stock held. The holders of Series A and Series B Preferred Stock are entitled to vote together with the common stock as a single class
on any matter submitted to a vote of the stockholders. Holders of Series A and Series B Preferred Stock are entitled to the number of
votes equal to the number of common stock issuable upon conversion of their respective Series A and Series B Preferred Stock at the time
such shares are voted. The holders of a majority of the preferred stock had additional voting rights as specified in the Company’s
Amended and Restated Certificate of Incorporation, as amended.
Equity awards
In 2012, the Board of Directors of the Company
(the “Board”) approved the Tenon Medical, Inc. 2012 Equity Incentive Plan (the “2012 Plan”). The 2012 Plan provides
for the issuance of common stock options, appreciation rights, and other awards to employees, directors, and consultants. Options issued
under the 2012 Plan generally vest over a period of 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.
Option Exchange
On April 8, 2024, the Company issued an offer
to holders of outstanding stock options to purchase an aggregate of 90,987 shares of the Company’s common stock to exchange their
options for a lesser number of new restricted stock units (“RSUs”) to be granted under the 2022 Plan upon the terms and subject
to the conditions set forth in the Offer to Exchange Certain Outstanding Stock Options for Restricted Stock Units (the “Offer to
Exchange”). The Offer to Exchange expired on May 6, 2024. A total of 27 eligible participants participated in the exchange. The
Company accepted for exchange options to purchase an aggregate of 83,391 shares of common stock of the Company. All surrendered options
were cancelled effective as of the expiration of the Option Exchange, and immediately thereafter, in exchange therefor, the Company granted
a total of 41,698 new RSUs under the 2022 Plan. The incremental fair value of the new RSUs that were vested at the issuance date was $32
and was immediately expensed.
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, 2023 | |
| 102,089 | | |
$ | 42.54 | | |
| 76,916 | | |
$ | 69.50 | |
Granted | |
| 66,967 | | |
$ | 0.87 | | |
| 119,351 | | |
$ | 1.00 | |
Released | |
| — | | |
| — | | |
| (57,077 | ) | |
$ | 32.05 | |
Cancelled or forfeited | |
| (96,493 | ) | |
$ | 43.27 | | |
| (2,500 | ) | |
$ | 2.91 | |
Outstanding at June 30, 2024 | |
| 72,563 | | |
$ | 3.12 | | |
| 136,690 | | |
$ | 26,55 | |
The following table sets forth stock-based compensation
expense recognized for the three and six months ended June 30, 2024 and 2023:
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 358 | | |
$ | 378 | | |
$ | 725 | | |
$ | 750 | |
Sales and marketing | |
| 34 | | |
| 58 | | |
| 77 | | |
| 116 | |
General, and administrative | |
| 642 | | |
| 618 | | |
| 1,250 | | |
| 1,228 | |
Total stock-based compensation expense | |
$ | 1,034 | | |
$ | 1,054 | | |
$ | 2,052 | | |
$ | 2,094 | |
At June 30, 2024, there were 54,173 shares available
for issuance under the 2022 Plan.
Warrants
In April 2022, in association with the Company’s
initial public offering, the Company granted to The Benchmark Company, LLC and Valuable Capital Limited warrants to purchase a total of
9,600 shares of the Company’s common stock. The warrants were immediately exercisable at an exercise price of $50.00 per share and
expire on the fifth anniversary of the commencement of sales under the IPO. The fair value of the warrants on the grant date was $27.50
per warrant, which was calculated using a Black-Scholes option valuation model with an expected term of 5.00 years, expected volatility
of 62.55%, dividend yield of 0%, and risk-free interest rate of 2.92%. The Company recorded the fair value of these warrants of $264 as
an issuance cost to additional paid-in capital in 2022.
In June 2023, in connection with a registered
offering of stock, the Company issued warrants to purchase a total of 2,000,000 shares of the Company’s common stock (the “Offering
Warrants”). The Offering Warrants were exercisable upon issuance and will expire five years from the date of issuance. Per the terms
of the Offering Warrants, the exercise price of the Offering Warrants reset on July 16, 2023, to $3.146 per share. The fair value of the
Offering Warrants on the grant date of $3,164, or $1.58 per warrant, was calculated using a Monte-Carlo simulation to estimate the final
exercise price, which is considered a Level 3 fair value measurement, using as inputs; the starting value of $3.00 per share, the Company’s
VWAP on June 16; an assumed daily distribution of returns; a mean daily return of 5.18%; a short-term annual volatility of 100% and a
standard deviation of 6.3%. The model used Black-Scholes to then calculate the estimated fair value of the Offering Warrants, using an
estimated time to maturity of 4.9 years, a risk-free interest rate of 3.99% and a long-term volatility of 60%.
In November 2023, in connection with the issuance
of the Convertible Notes, the Company issued warrants to purchase a total of 45,000 shares of the Company’s common stock at an exercise
price equal to $1.94 per share. The warrants expire five years from the issuance date. The fair value of the warrants on the grant date
was $1.29 per warrant, which was calculated using a Black-Scholes option valuation model with an expected term of 5.00 years, expected
volatility of 68.89%, dividend yield of 0%, and risk-free interest rate of 4.41%. The Company recorded the fair value of these warrants
of approximately $58 as an issuance cost to additional paid-in capital in 2023.
On February 20, 2024, in connection with the Purchase
Agreement, the Company issued the Series A Warrants to purchase a total of 415,468 shares of the Company’s common stock at an exercise
price equal to $1.2705 per share. The Series A Warrants are immediately exercisable and expire five years from the date of issuance. The
fair value of the Series A Warrants on the grant date was $0.61 per warrant, which was calculated using a Black-Scholes option valuation
model with an expected term of 5.00 years, expected volatility of 68.24%, dividend yield of 0%, and risk-free interest rate of 4.3%. The
Company recorded the fair value of these warrants of $254 to additional paid-in capital in 2024.
8. 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 $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 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 consolidated statements of operations and comprehensive
loss and recorded as accrued commissions in the consolidated balance sheets. A reconciliation of the liability under clause (b) and clause
(c) for the six months ended June 31, 2024 is as follows:
Balance at January 1, 2024 | |
$ | 2,377 | |
Amounts paid during 2024 | |
| (252 | ) |
Accretion | |
| 185 | |
Balance at June 30, 2024 | |
$ | 2,310 | |
Per the terms of the Termination Agreement, the
Company ultimately expects to expense $3,600 under clause (b) and clause (c).
Simultaneously with the execution of the Termination
Agreement, the Company entered into a Consulting Agreement dated October 6, 2022, with the Representative (the “Consulting Agreement”).
Under the terms and conditions of the Consulting Agreement, the Representative is tasked with organizing, recruiting, training, and coordinating
the Company’s Clinical Specialist program, Physician Education program and Sales Education program as more specifically described
in the Consulting Agreement.
The term of the Consulting Agreement was from
October 6, 2022, until October 5, 2023, when it terminated in accordance with the terms of the Consulting Agreement. In consideration
for the services to be provided, the Company paid the Representative a base consulting fee of $700 per year, payable in monthly instalments,
along with additional compensation of $62.5 per quarter, if certain sales targets were met, for four quarters; along with any travel and
related out-of-pocket expenses incurred by the Representative in connection with the performance of the services.
Litigation
In the normal course of business, the Company
may possibly be named as a defendant in various lawsuits.
9. Concentrations of Risk
Credit risk
Financial instruments that potentially subject
the Company to concentrations of credit risk consist principally of cash and cash equivalents and accounts receivable.
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.
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 consolidated 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 on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission
on March 29, 2024. 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 on Form 10-K filed with the Securities and Exchange Commission on March 29, 2024, 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, 2024, we had an accumulated deficit of approximately $62.5 million. To date, we have financed our operations primarily
through an initial public offering, 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.
2024 Series A Offering
On February 20, 2024, we entered into a Securities
Purchase Agreement (the “Series A Purchase Agreement”) with certain investors (the “Series A Investors”), pursuant
to which the Company agreed to sell, issue and deliver to the Series A Investors, in a private placement offering (the “Series A
Offering”), a total of 172,239 shares of the Company’s Series A Preferred Stock (the “Series A Preferred Stock”)
and warrants (the “Warrants”) to purchase 258,374 shares of our common stock, par value $0.001 per share, at an exercise price
equal to $1.2705 per share for an aggregate offering price of $2,605,000. Under the Series A Purchase Agreement, each Series A Investor
paid $15.125 for each share of Series A Preferred Stock and along with their shares of Series A Preferred Stock, received Warrants equal
to 15% of the number of shares of our common stock initially underlying such shares of Series A Preferred Stock. In connection with the
offering of the Series A Preferred Stock, the Company exchanged the Notes (as defined below) for 84,729 shares of Series A Preferred Stock
and Series A Warrants to purchase 157,094 shares of our common stock. There are a total of 256,968 shares of Series A Preferred Stock
outstanding as of June 30, 2024.
Reverse Stock Split
On November 2, 2023, the Company effected a 1-for-10
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 reverse stock split combined every ten shares of our common stock issued and outstanding immediately
prior to effecting the reverse stock split into one share of common stock. No fractional shares were issued in connection with the reverse
stock split. All historical share and per share amounts reflected throughout this document have been adjusted to reflect the reverse stock
split. The authorized number of shares and the par value per share of the Company’s common stock were not affected by the reverse
stock split.
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, 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 overhead related to operation personnel
and facility costs, costs of the components of The Catamaran System implants and instruments, 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,
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 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 Securities and Exchange Commission 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. 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, | |
Consolidated Statements of Operations Data: | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue | |
$ | 901 | | |
$ | 743 | | |
$ | 1,620 | | |
$ | 1,176 | |
Cost of goods sold | |
| 431 | | |
| 549 | | |
| 680 | | |
| 1,029 | |
Gross profit | |
| 470 | | |
| 194 | | |
| 940 | | |
| 147 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 708 | | |
| 901 | | |
| 1,377 | | |
| 1,735 | |
Sales and marketing | |
| 1,448 | | |
| 1,883 | | |
| 2,829 | | |
| 3,909 | |
General and administrative | |
| 2,186 | | |
| 1,732 | | |
| 4,112 | | |
| 3,711 | |
Total operating expenses | |
| 4,342 | | |
| 4,516 | | |
| 8,318 | | |
| 9,355 | |
Loss from operations | |
| (3,872 | ) | |
| (4,322 | ) | |
| (7,378 | ) | |
| (9,208 | ) |
Interest and other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
Gain on investments | |
| 39 | | |
| 37 | | |
| 66 | | |
| 93 | |
Interest expense | |
| — | | |
| — | | |
| (34 | ) | |
| — | |
Other income (expense) | |
| 7 | | |
| — | | |
| (56 | ) | |
| — | |
Net loss | |
$ | (3,826 | ) | |
$ | (4,285 | ) | |
$ | (7,402 | ) | |
$ | (9,115 | ) |
The following table sets forth our results of
operations as a percentage of revenue:
| |
Three Months Ended June 30, | | |
Six Months Ended
June 30, | |
Consolidated Statements of Operations Data: | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue | |
| 100 | % | |
| 100 | % | |
| 100 | % | |
| 100 | % |
Cost of goods sold | |
| 48 | | |
| 74 | | |
| 42 | | |
| 88 | |
Gross profit | |
| 52 | | |
| 26 | | |
| 58 | | |
| 12 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 79 | | |
| 121 | | |
| 85 | | |
| 148 | |
Sales and marketing | |
| 161 | | |
| 253 | | |
| 175 | | |
| 332 | |
General and administrative | |
| 243 | | |
| 233 | | |
| 254 | | |
| 316 | |
Total operating expenses | |
| 482 | | |
| 608 | | |
| 513 | | |
| 795 | |
Loss from operations | |
| (430 | ) | |
| (582 | ) | |
| (455 | ) | |
| (783 | ) |
Interest and other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
Gain on investments | |
| 4 | | |
| 5 | | |
| 4 | | |
| 8 | |
Interest expense | |
| — | | |
| — | | |
| (2 | ) | |
| — | |
Other expense | |
| 1 | | |
| — | | |
| (3 | ) | |
| — | |
Net loss | |
| (425 | )% | |
| (577 | )% | |
| (457 | )% | |
| (775 | )% |
Comparison of the Three and Six Months Ended June 30, 2024 and 2023
(in thousands, except percentages)
Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin
| |
Three Months Ended
June 30, | | |
| | |
| |
| |
2024 | | |
2023 | | |
$ Change | | |
% Change | |
Revenue | |
$ | 901 | | |
$ | 743 | | |
$ | 158 | | |
| 21 | % |
Cost of goods sold | |
| 431 | | |
| 549 | | |
| (118 | ) | |
| (21 | )% |
Gross profit | |
$ | 470 | | |
$ | 194 | | |
$ | 276 | | |
| 142 | % |
Gross profit percentage | |
| 52 | % | |
| 26 | % | |
| | | |
| | |
| |
Six Months Ended
June 30, | | |
| | |
| |
| |
2024 | | |
2023 | | |
$ Change | | |
% Change | |
Revenue | |
$ | 1,620 | | |
$ | 1,176 | | |
$ | 444 | | |
| 38 | % |
Cost of goods sold | |
| 680 | | |
| 1,029 | | |
| (349 | ) | |
| (34 | )% |
Gross profit | |
$ | 940 | | |
$ | 147 | | |
$ | 793 | | |
| 539 | % |
Gross profit percentage | |
| 58 | % | |
| 13 | % | |
| | | |
| | |
Revenue. The increase in revenue for
the three and six months ended June 30, 2024 as compared to the same periods in 2023 was primarily due to increases of 7% and 19%, respectively,
in the number of surgical procedures in which the Catamaran System was used.
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, 2024 as compared to the same periods in
2023 was due to increases of 7% and 19%, respectively, in the number of surgical procedures performed. Gross profit and gross margin percentage
for the three and six month periods ended June 30, 2024 as compared to the same periods in 2023 improved due to the absorption of more
production overhead costs into our standard cost, operating leverage created due to lower relative fixed costs and higher revenue associated
with the increase in the number of surgical procedures.
Operating Expenses
| |
Three Months Ended
June 30, | | |
| | |
| |
| |
2024 | | |
2023 | | |
$ Change | | |
% Change | |
Research and development | |
$ | 708 | | |
$ | 901 | | |
$ | (193 | ) | |
| (21 | )% |
Sales and marketing | |
| 1,448 | | |
| 1,883 | | |
| (435 | ) | |
| (23 | )% |
General and administrative | |
| 2,186 | | |
| 1,732 | | |
| 454 | | |
| 26 | % |
Total operating expenses | |
$ | 4,342 | | |
$ | 4,516 | | |
$ | (174 | ) | |
| (4 | )% |
| |
Six Months Ended
June 30, | | |
| | |
| |
| |
2024 | | |
2023 | | |
$ Change | | |
% Change | |
Research and development | |
$ | 1,377 | | |
$ | 1,735 | | |
$ | (358 | ) | |
| (21 | )% |
Sales and marketing | |
| 2,829 | | |
| 3,909 | | |
| (1,080 | ) | |
| (28 | )% |
General and administrative | |
| 4,112 | | |
| 3,711 | | |
| 401 | | |
| 11 | % |
Total operating expenses | |
$ | 8,318 | | |
$ | 9,355 | | |
$ | (1,037 | ) | |
| (11 | )% |
Research and Development Expenses. Research
and development expenses for the three months ended June 30, 2024 decreased as compared to the same period in 2023 primarily due to decreased
professional fees ($141), payroll expenses ($29) and stock-based compensation ($19). Research and development expenses for the six months
ended June 30, 2024 decreased as compared to the same period in 2023 primarily due to decreased professional fees ($279), payroll expenses
($111) and stock-based compensation ($25).
Sales and Marketing Expenses. Sales
and marketing expenses for the three months ended June 30, 2024 decreased as compared to the same period in 2023 primarily due to SpineSource
transition fees in 2023 ($260), decreased payroll and employee expenses ($165) and consulting and professional fees ($102) partially offset
by increased commission expense ($108). Sales and marketing expenses for the six months ended June 30, 2024 decreased as compared to the
same period in 2023 primarily due to SpineSource transition fees in 2023 ($690), decreased payroll and employee expenses ($312) and consulting
and professional fees ($197) partially offset by increased commission expense ($153).
General and Administrative Expenses. General
and administrative expenses for the three months ended June 30, 2024 increased as compared to the same period in 2023 primarily due to
increased legal and professional service fees ($215), insurance costs ($93), bad debt expense ($36) and stock-based compensation ($25).
General and administrative expenses for the six months ended June 30, 2024 increased as compared to the same period in 2023 primarily
due to increased insurance costs ($191), legal and professional service fees ($93), bad debt expense ($46) and stock-based compensation
($22).
Gain on Investments, Interest Expense and
Other Income (Expense), Net
Gain on investments for the six months ended June
30, 2024 decreased approximately $28 as compared to the six months ended June 30, 2023 due to interest on our investments in money market
and corporate debt securities. We did not have significant investments in corporate debt securities during the first six months of 2024.
Interest expense for the six months ended June 30, 2024 related to our convertible debt. Other expense, net was related to foreign exchange
losses on the liquidation of our Swiss subsidiary.
Liquidity and Capital Resources
As of June 30, 2024, we had cash and cash equivalents
of $2.0 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, 2024, we had no outstanding debt.
As of June 30, 2024, we had an accumulated deficit
of $62.5 million and 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 consolidated financial statements were available
to be released. 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.
On February 20, 2024, we entered into the Series A Purchase Agreement
with certain investors, pursuant to which we agreed to sell, issue and deliver to these investors, in a private placement offering, a
total of 172,239 shares of our Series A Preferred Stock and warrants to purchase 258,374 shares of our common stock, par value $0.001
per share, at an exercise price equal to $1.2705 per share for an aggregate offering price of $2,605,000. Additionally, on February 20,
2024, the Series A Investors agreed to a complete prepayment of our obligations under convertible notes (the “Convertible Notes”),
including accrued interest, in exchange for 84,729 shares of Series A Preferred Stock and warrants to purchase 157,094 shares of our common
stock at $1.2705 per share and the Convertible Notes were cancelled. The Series A Warrants are immediately exercisable and expire five
years from the date of issuance. There are a total of 256,968 shares of Series A Preferred Stock outstanding as of May 14, 2024.
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 consolidated
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, | | |
| | |
| |
| |
2024 | | |
2023 | | |
$ Change | | |
% Change | |
Net cash (used in) provided by: | |
| | | |
| | | |
| | | |
| | |
Operating activities | |
$ | (4,758 | ) | |
$ | (6,752 | ) | |
$ | 1,994 | | |
| (30 | )% |
Investing activities | |
| (119 | ) | |
| 5,798 | | |
| (5,917 | ) | |
| (102 | )% |
Financing activities | |
| 4,371 | | |
| 4,665 | | |
| (294 | ) | |
| (6 | )% |
Effect of foreign currency translation on cash flow | |
| 46 | | |
| 12 | | |
| 34 | | |
| 283 | % |
Net (decrease) increase in cash and cash equivalents | |
$ | (460 | ) | |
$ | 3,723 | | |
$ | (4,183 | ) | |
| (112 | )% |
The decrease in net cash used in operating activities
for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023 was primarily attributable to our decreased net
loss of $1.7 million, adjusted for decreases in non-cash stock-based compensation expenses ($42), in addition to increased accounts
payable ($316), partially offset by decreases in accrued expenses ($313).
Cash provided by investing activities for the
six months ended June 30, 2024 consisted primarily purchases of property and equipment ($119). Cash provided by investing activities for
the six months ended June 30, 2023 consisted primarily of the net sales of short-term investments ($6,010) to fund our operations, partially
offset by purchases of property and equipment ($212).
Cash provided by financing activities for the
six months ended June 30, 2024 consisted primarily of net proceeds from the issuance of Series A Convertible Preferred Stock ($2,437)
and from the issuance of common stock ($1,934). Cash provided by financing activities for the six months ended June 30, 2023 consisted
primarily of the $4.8 million, net of relevant expenses, received from our registered offering in June 2023.
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, 2024, there were no significant changes to our existing critical
accounting policies from those disclosed on our Annual Report on Form 10-K.
Off-Balance Sheet Arrangements
As of June 30, 2024, and December 31, 2023, 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 Principal Accounting 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, 2024, we carried out an evaluation, under the supervision
and with the participation of our management, including our Chief Executive Officer and President and Principal Accounting 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 Principal Accounting 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 intend to take 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 control 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, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
The retirement of our Chief Financial Officer and his transition to a CFO Advisor effective July 31, 2024 did not significantly impact
our internal control over financial reporting for the fiscal quarter ended June 30, 2024; however, if we are unable to hire a replacement
in a timely manner, changes in our internal control over financial reporting will be implemented to ensure reasonable controls over financial
reporting for the quarter ending September 30, 2024.
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, there have been 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 29, 2024.
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
On July 23, 2024, our stockholders approved, among other things, the following: (i) the terms of (A) our Series
B Preferred Stock, (B) the warrants to be issued on the issuance date of our Series B Preferred Stock and (C) the amendment to the terms
of our Series A Preferred Stock to decrease the amount of the conversion price thereof, in each case, to comply with Listing Rule 5635(d)
of The Nasdaq Stock Market LLC; and (ii) amendments to the Tenon Medical, Inc. 2022 Equity Incentive Plan to (i) increase the total number
of shares of the Company’s common stock subject to the 2022 Plan by 1,100,000 shares and (ii) permit the issuance of equity awards
to individuals and legal entities.
ITEM 6. EXHIBITS
EXHIBIT INDEX
* |
Filed herewith. |
|
|
** |
Exhibits 32.1 and 32.2 are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing. |
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, 2024 |
/s/ Steven M. Foster |
|
Steven M. Foster |
|
Chief Executive Officer and President, Director
(Principal Executive Officer) |
|
|
Dated: August 13, 2024 |
/s/ Jay D. Hanson |
|
Jay D. Hanson |
|
Director of SEC Reporting and Compliance
(Principal Accounting Officer) |
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1. I have reviewed this Quarterly Report on Form
10-Q of Tenon Medical, Inc.;
2. Based on my knowledge, this report does not
contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements,
and other financial information included in this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer
and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant
and have:
5. The registrant’s other certifying officer
and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
1. I have reviewed this Quarterly Report on Form
10-Q of Tenon Medical, Inc.;
2. Based on my knowledge, this report does not
contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements,
and other financial information included in this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer
and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant
and have:
5. The registrant’s other certifying officer
and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions)
Pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, Steven Foster, the Chief Executive Officer of Tenon Medical, Inc. (the “Company”),
hereby certify, that, to my knowledge:
1. The Quarterly Report on
Form 10-Q for the period ended June 30, 2024 (the “Report”) of the Company fully complies with the requirements of Section
13(a) and 15(d) of the Securities Exchange Act of 1934; and
2. The information contained
in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, Steven Van Dick, the Chief Financial Officer of Tenon Medical, Inc. (the
“Company”), hereby certify, that, to my knowledge:
1. The Quarterly Report on
Form 10-Q for the period ended June 30, 2024 (the “Report”) of the Company fully complies with the requirements of Section
13(a)/15(d) of the Securities Exchange Act of 1934; and
2. The information contained
in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.