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 SEPTEMBER 30,
2025
or
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM _________
to __________
COMMISSION FILE NUMBER 001-41364
TENON MEDICAL,
INC.
(Exact name of registrant as specified in its charter)
Delaware 45-5574718
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
104 Cooper Court
Los Gatos , CA 95032
(408) 649-5760
(Address of principal executive offices) (Zip Code) (Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.001 per share TNON The Nasdaq Stock Market LLC
Warrants TNONW The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☒
If an emerging growth company, indicate by
check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act) Yes ☐ No
☒
As of November 13, 2025, the registrant had a total of 8,605,740 shares
of its common stock, par value $0.001 per share, issued and outstanding.
INDEX
Page
PART I. FINANCIAL INFORMATION
1
Item 1.
Condensed Financial Statements (unaudited)
1
Condensed Balance Sheets
1
Condensed Statements of Operations and Comprehensive Loss
2
Condensed Statements of Convertible Preferred Stock and Stockholders’ Equity
3
Condensed Statements of Cash Flows
5
Notes to Condensed Financial Statements
6
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
17
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
22
Item 4.
Controls and Procedures
23
PART II. OTHER INFORMATION
24
Item 1.
Legal Proceedings
24
Item 1A.
Risk Factors
24
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
24
Item 3.
Defaults Upon Senior Securities
24
Item 4.
Mine Safety Disclosures
24
Item 5.
Other Information
24
Item 6.
Exhibits
25
SIGNATURES
27
i
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
STATEMENTS
This Quarterly Report on
Form 10-Q contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995,
Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”). We have based these forward-looking statements largely on our current expectations
and projections about future events and financial trends impacting the financial condition of our business. Forward-looking statements
should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or
by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those
statements are made and/or management’s good faith belief as of that time with respect to future events and are subject to risks
and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking
statements.
Forward-looking statements
include all statements that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “may,”
“will,” “should,” “could,” “would,” “expect,” “intend,” “seek,”
“plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,”
“potential,” “might,” “forecast,” “continue,” or the negative of those terms, and similar
expressions and comparable terminology intended to reference future periods. Forward-looking statements include, but are not limited to,
statements about:
● Our
ability to effectively operate our business segments;
● Our
ability to manage our research, development, expansion, growth and operating expenses;
● Our
ability to evaluate and measure our business, prospects and performance metrics;
● Our
ability and our national distributor’s ability to compete, directly and indirectly,
and succeed in the highly competitive medical devices industry;
● Our
ability to respond and adapt to changes in technology and customer behavior; and
● Our
ability to protect our intellectual property and to develop, maintain and enhance a strong
brand.
Should one or more of these
risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from
those anticipated, believed, estimated, expected, intended or planned.
Factors or events that could
cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee
future results, levels of activity, performance or achievements. Accordingly, the forward-looking statements in this Quarterly Report
on Form 10-Q should not be regarded as representations that the results or conditions described in such statements will occur or that
our objectives and plans will be achieved, and we do not assume any responsibility for the accuracy or completeness of any of these forward-looking
statements.
ii
PART I – FINANCIAL INFORMATION
ITEM 1. Condensed Financial Statements (Unaudited)
Tenon Medical, Inc.
Condensed Balance Sheets (Unaudited)
(In thousands, except share data)
September 30,
December 31,
2025
2024
ASSETS
Current assets:
Cash and cash equivalents
$ 3,442
$ 6,535
Accounts receivable, net
1,311
863
Inventory, net
1,364
606
Prepaid expenses and other current assets
428
206
Total current assets
6,545
8,210
Property and equipment, net
663
752
Deposits
51
51
Operating lease right-of-use asset
200
399
Deferred offering costs
—
431
Intangible assets, net
500
—
Goodwill (Note 3)
2,407
—
TOTAL ASSETS
$ 10,366
$ 9,843
Liabilities and Stockholders’ EQUITY
Current liabilities:
Accounts payable
$ 625
$ 369
Accrued expenses
1,514
910
Current portion of accrued commissions
686
303
Current portion of operating lease liability
216
287
Total current liabilities
3,041
1,869
Accrued commissions, net of current portion
1,516
1,862
Operating lease liability, net of current portion
—
141
Contingent consideration (Note 3)
1,011
—
Total liabilities
5,568
3,872
Commitments and contingencies (Note 9)
Stockholders’ equity:
Series A convertible preferred stock, $ 0.001 par value; 4,500,000 shares authorized at September 30, 2025 and December 31, 2024; 204,159 and 256,968 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively
2,622
3,300
Series B convertible preferred stock, $ 0.001 par value; 491,222 shares authorized at September 30, 2025 and December 31, 2024; 86,454 shares issued and outstanding at September 30, 2025 and December 31, 2024
452
452
Common stock, $ 0.001 par value; 130,000,000 shares authorized at September 30, 2025 and December 31, 2024; 8,605,508 and 3,138,804 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively
9
3
Additional paid-in capital
80,185
70,962
Accumulated deficit
( 78,470 )
( 68,746 )
Total stockholders’ equity
4,798
5,971
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$ 10,366
$ 9,843
The accompanying notes are an integral part
of these condensed financial statements.
1
Tenon Medical, Inc.
Condensed Statements of Operations and Comprehensive
Loss (Unaudited)
(In thousands, except per share data)
Three Months Ended September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Revenue
$ 1,173
$ 887
$ 2,463
$ 2,507
Cost of sales
400
469
1,122
1,149
Gross Profit
773
418
1,341
1,358
Operating Expenses
Research and development
428
657
1,622
2,034
Sales and marketing
1,538
1,212
4,304
4,041
General and administrative
2,199
1,764
5,341
5,876
Total Operating Expenses
4,165
3,633
11,267
11,951
Loss from Operations
( 3,392 )
( 3,215 )
( 9,926 )
( 10,593 )
Other Income (Expense)
Gain on investments
53
31
202
97
Interest expense
—
—
—
( 34 )
Other expense, net
—
—
—
( 56 )
Total Other Income, net
53
31
202
7
Net Loss
$ ( 3,339 )
$ ( 3,184 )
$ ( 9,724 )
$ ( 10,586 )
Net Loss Per Share of Common Stock
Basic and diluted
$ ( 0.40 )
$ ( 3.63 )
$ ( 1.48 )
$ ( 18.60 )
Weighted-Average Shares of Common Stock Outstanding
Basic and diluted
8,250
877
6,581
569
Consolidated Statements of Comprehensive Loss:
Net loss
$ ( 3,339 )
$ ( 3,184 )
$ ( 9,724 )
$ ( 10,586 )
Foreign currency translation adjustment
—
—
—
46
Total comprehensive loss
$ ( 3,339 )
$ ( 3,184 )
$ ( 9,724 )
$ ( 10,540 )
The accompanying notes are an integral part
of these condensed financial statements.
2
Tenon Medical, Inc.
Condensed Statements of Convertible Preferred
Stock and Stockholders’ Equity (Unaudited)
(In thousands, except share data)
Three months ended September 30, 2025 and 2024:
Series A
Convertible
Preferred Stock
Series B
Convertible
Preferred Stock
Common Stock
Additional
Paid-In
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance at June 30, 2025
256,968
$ 3,300
86,454
$ 452
7,592,217
$ 8
$ 78,084
$ ( 75,131 )
$ 6,713
Stock-based compensation expense
—
—
—
—
—
—
58
—
58
Shares issued for acquisition of assets of SiVantage, Inc.
—
—
—
—
710,300
1
1,365
—
1,366
Issuance of common stock upon conversion of Series A convertible preferred stock
( 52,809 )
( 678 )
—
—
300,005
—
678
—
—
Release of restricted stock units
—
—
—
—
2,986
—
—
—
—
Net loss
—
—
—
—
—
—
—
( 3,339 )
( 3,339 )
Balance at September 30, 2025
204,159
$ 2,622
86,454
$ 452
8,605,508
$ 9
$ 80,185
$ ( 78,470 )
$ 4,798
Balance at June 30, 2024
256,968
$ 3,300
—
—
472,604
—
60,007
( 62,475 )
$ 832
Stock-based compensation expense
—
—
—
—
—
—
910
—
910
Issuance of Series B preferred stock and warrants, net of issuance costs
—
—
86,454
452
—
—
37
—
489
Issuance of common stock, prefunded warrants, and warrants, net of issuance costs
—
—
—
—
55,000
—
3,826
—
3,862
Issuance of common stock upon exercise of prefunded warrants
—
—
—
—
1,167,850
1
( 1 )
—
—
Issuance of common stock and warrants under inducement agreement
—
—
—
—
1,222,850
1
4,305
—
4,306
Issuance of common stock upon exercise of warrants
—
—
—
—
32,266
—
812
—
812
Issuance of common stock, net of issuance cost
—
—
—
—
37,618
—
164
—
164
Issuance of common stock for reverse stock split
—
—
—
—
147,825
1
( 1 )
—
—
Net loss
—
—
—
—
—
—
—
( 3,184 )
( 3,184 )
Balance at September 30, 2024
256,968
$ 3,300
86,454
$ 452
3,136,013
$ 3
$ 70,095
$ ( 65,659 )
$ 8,191
3
Nine months ended September 30, 2025 and 2024:
Series
A
Convertible
Preferred Stock
Series
B
Convertible
Preferred Stock
Common
Stock
Additional
Paid-In
Accumulated
Accumulated
Other
Comprehensive
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Loss
Total
Balance
at December 31, 2024
256,968
$ 3,300
86,454
$ 452
3,138,804
$ 3
$ 70,962
$ ( 68,746 )
$ —
$ 5,971
Stock-based
compensation expense
—
—
—
—
—
—
1,347
—
—
1,347
Issuance
of common stock, pre-funded warrants and warrants under inducement agreement, net of issuance costs
—
—
—
—
2,445,700
3
2,732
—
—
2,735
Issuance
of common stock, prefunded warrants, and warrants, net of issuance costs
—
—
—
—
2,005,000
2
3,522
—
—
3,524
Shares
issued for acquisition of assets of SiVantage, Inc.
—
—
—
—
710,300
1
1,365
—
—
1,366
Issuance
of common stock upon conversion of Series A convertible preferred stock
( 52,809 )
( 678 )
—
—
300,005
678
—
—
—
Release
of restricted stock units
—
—
—
—
5,699
—
—
—
—
—
Deferred
financing costs
—
—
—
—
—
—
( 421 )
—
—
( 421 )
Net
loss
—
—
—
—
—
—
—
( 9,724 )
—
( 9,724 )
Balance
at September 30, 2025
204,159
$ 2,622
86,454
$ 452
8,605,508
$ 9
$ 80,185
$ ( 78,470 )
$ —
$ 4,798
Balance
at December 31, 2023
—
$ —
—
$ —
325,039
$ —
$ 55,897
$ ( 55,073 )
$ ( 46 )
$ 778
Stock-based
compensation expense
—
—
—
—
—
—
2,962
—
—
2,962
Issuance
of Series A preferred stock and warrants, net of issuance costs
256,968
3,300
—
—
—
—
254
—
—
3,554
Issuance
of Series B preferred stock and warrants, net of issuance costs
—
—
86,454
452
—
—
37
—
—
489
Issuance
of common stock, prefunded warrants, and warrants, net of issuance costs
—
—
—
—
55,000
—
3,862
—
—
3,862
Issuance
of common stock upon exercise of prefunded warrants
—
—
—
—
1,167,850
1
( 1 )
—
—
—
Issuance
of common stock and warrants under inducement agreement
—
—
—
—
1,222,850
1
4,305
—
—
4,306
Issuance
of common stock upon exercise of warrants
—
—
—
—
32,266
—
812
—
—
812
Issuance
of common stock, net of issuance costs
—
—
—
—
178,048
—
1,968
—
—
1,968
Release
of restricted stock units
—
—
—
—
7,135
—
—
—
—
—
Issuance
of common stock for reverse stock split
—
—
—
—
147,825
1
( 1 )
—
—
—
Other
comprehensive income
—
—
—
—
—
—
—
—
46
46
Net
loss
—
—
—
—
—
—
—
( 10,586 )
—
( 10,586 )
Balance
at September 30, 2024
256,968
$ 3,300
86,454
$ 452
3,136,013
$ 3
$ 70,095
$ ( 65,659 )
$ —
$ 8,191
The accompanying notes are an integral part
of these condensed financial statements.
4
Tenon Medical, Inc.
Condensed Statements of Cash Flows (Unaudited)
(In thousands)
Nine Months Ended
September 30,
2025
2024
Cash Flows from Operating Activities
Net loss
$ ( 9,724 )
$ ( 10,586 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
1,347
2,962
Depreciation and amortization
167
291
Provision for credit losses on accounts receivable
—
46
Amortization of operating right-of-use asset
199
183
Increase (decrease) in cash resulting from changes in:
Accounts receivable
( 448 )
( 404 )
Inventory
( 554 )
( 53 )
Prepaid expenses and other assets
( 203 )
( 154 )
Accounts payable
266
660
Accrued expenses
641
143
Operating lease liability
( 212 )
( 189 )
Net cash used in operating activities
( 8,521 )
( 7,101 )
Cash Flows from Investing Activities
Purchase of assets from SiVantage, Inc.
( 750 )
—
Purchases of property and equipment
( 81 )
( 223 )
Cash used in investing activities
( 831 )
( 223 )
Cash Flows from Financing Activities
Gross proceeds from issuance of common stock, prefunded warrants and warrants
4,010
4,500
Gross proceeds from issuance of common stock, prefunded warrants and warrants under inducement agreement
3,057
4,647
Gross proceeds from issuance of Series A convertible preferred stock
—
2,605
Gross proceeds from issuance of Series B convertible preferred stock
—
550
Gross proceeds from issuance of common stock
—
2,163
Gross proceeds from issuance of common stock upon exercise of warrants
—
812
Offering costs
( 808 )
( 1,265 )
Net cash provided by financing activities
6,259
14,012
Effect of foreign currency translation on cash flow
—
46
Net (Decrease) Increase in Cash and Cash Equivalents
( 3,093 )
6,734
Cash and Cash Equivalents at Beginning of Period
6,535
2,428
Cash and Cash Equivalents at End of Period
$ 3,442
$ 9,162
Supplemental Disclosures of Cash Flow Information
Non-cash investing and financing activities:
Warrant modification costs
$ 1,402
$ 992
Preferred stock issued upon conversion of debt and accrued interest
$ —
$ 1,186
Reclassification of deferred offering costs to additional paid-in capital
$ 421
$ 238
Common stock issued upon conversion of Series A preferred stock
$ 678
$ —
Common stock issued for purchase of assets from SiVantage, Inc.
$ 1,366
$ —
Contingent consideration for purchase of assets from SiVantage, Inc.
$ 1,011
$ —
The accompanying notes are an integral part
of these condensed financial statements.
5
Notes to Condensed Financial Statements
(unaudited) (in thousands, except share and per-share data)
1. Organization and Business
Nature of operations
Tenon Medical, Inc. (the “Company”) was incorporated in
the State of Delaware on June 19, 2012 and was headquartered in San Ramon, California until June 2021 when it relocated to Los Gatos,
California. The Company is a medical device company dedicated to transforming care for patients with certain sacro-pelvic disorders. The
Company has developed The Catamaran™ SI Joint Fusion System (“The Catamaran System”) that offers a novel, less invasive
approach to the SI Joint using a single, robust, titanium implant for treatment of the most common types of SI Joint disorders that cause
lower back pain. The Company received U.S. Food and Drug Administration (“FDA”) clearance in 2018 for The Catamaran System
and is currently focused on the US market. Since the national launch of The Catamaran System in October 2022, the Company is focused on
three commercial opportunities: 1) Primary SI Joint procedures, 2) Revision procedures of failed SI Joint implants and 3) SI Joint fusion
adjunct to a spine fusion construct. In August 2025, the Company closed the SImmetry Acquisition and the SIMPL Acquisition, as described
in Note 3, purchasing substantially all of the assets of SiVantage, Inc., including the SImmetry SI Joint Fusion System that treats disorders
of the sacroiliac joint (the “SI Joint”) using a single, robust, titanium implant.
2. Summary of Significant Accounting Principles
Basis of presentation
The accompanying unaudited condensed financial
statements have been prepared pursuant to the rules and regulations of the United States Securities and Exchange Commission (the “SEC”).
As permitted under these rules and regulations, the Company has condensed or omitted certain financial information and footnote disclosures
normally included in its annual financial statements prepared in accordance with accounting principles generally accepted in the United
States of America (“U.S. GAAP”). The condensed balance sheet as of December 31, 2024 has been derived
from the Company’s audited financial statements, which are included in its Annual Report on Form 10-K filed with the SEC on
March 26, 2025 (the “Annual Report”).
These condensed financial statements have been
prepared on the same basis as the Company’s annual financial statements and, in management’s opinion, reflect all adjustments,
consisting only of normal recurring adjustments, that are necessary for a fair presentation of its financial information. The interim
period operating results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal
year.
These unaudited condensed financial statements
and accompanying notes should be read in conjunction with the Company’s audited financial statements as of and for the years ended
December 31, 2024 and 2023 included in its Annual Report.
The Company’s significant accounting policies are disclosed in
the Annual Report. Material changes in the Company’s significant accounting policies during the nine months ended September 30,
2025 include accounting for business combinations as described below.
Going concern uncertainty and liquidity requirements
The accompanying condensed financial statements
have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the settlement
of liabilities and commitments in the normal course of business. There is substantial doubt about the Company’s ability to continue
as a going concern for one year after the date that these financial statements are issued.
Since inception, the Company has incurred losses
and negative cash flows from operations. Management expects to incur additional operating losses and negative cash flows from operations
in the foreseeable future as the Company continues its product development programs and the commercialization of The Catamaran System.
Based on the Company’s expected level of revenues and expenditures, the Company believes that its existing cash and cash equivalents
as of September 30, 2025 will not provide sufficient funds to enable it to meet its obligations for a period of at least twelve months
from the date of the filing of these financial statements. The Company plans to raise the necessary additional capital through one or
a combination of public or private equity offerings, debt financings, and collaborations (see Note 11). The financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
6
Use of estimates
The preparation of the financial statements in conformity with U.S.
GAAP requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results
could differ from those estimates. Significant estimates made by management include, but are not limited to, the determination of acquisition
purchase price and the allocation of purchase price to the fair values of assets acquired and liabilities assumed, collectability of accounts
receivable, accrued liabilities, accrued commissions, obsolescence of inventory and stock-based compensation.
Reverse Stock Split
On September 6, 2024, the Company effected a 1-for-8
reverse stock split (the “2024 Reverse Stock Split”) by filing an amendment to the Company’s Amended and Restated Certificate
of Incorporation, as amended, with the Delaware Secretary of State. The 2024 Reverse Stock Split combined every eight shares of our common
stock issued and outstanding immediately prior to effecting the 2024 Reverse Stock Split into one share of common stock. No fractional
shares were issued in connection with the 2024 Reverse Stock Split.
All historical share and per share amounts reflected
throughout this document have been adjusted to reflect the 2024 Reverse Stock Split. The authorized number of shares and the par value
per share of the Company’s common stock were not affected by the 2024 Reverse Stock Split.
Business Combinations
The Company accounts for business combinations
in accordance with Accounting Standards Codification (“ASC”) 805, Business Combinations , which requires that assets
acquired and liabilities assumed be recorded at their respective fair values on the date of acquisition. The fair value of the consideration
paid is assigned to the underlying net assets of the acquired business based on their respective fair values. Any excess of the purchase
price over the estimated fair values of the net assets acquired is recorded to goodwill. Intangible assets acquired are amortized over
the expected life of the asset. Fair value determinations and useful life estimates are based on, among other factors, estimates of expected
future cash flows, estimates of appropriate discount rates, estimated useful lives of the intangible assets acquired and other factors.
Although the Company believes the assumptions and estimates made have been reasonable and appropriate, actual results may vary significantly
from estimated results. The Company’s assumptions and estimates are subject to refinement and, as a result, during the measurement
period, which may be up to one year from the acquisition date, the Company records adjustments to the assets acquired and liabilities
assumed with the corresponding offset to goodwill.
Income Taxes
Income taxes are recorded in accordance with ASC 740, Income Taxes ,
which provides for deferred taxes using an asset and liability approach. Under this method, the Company records deferred tax assets and
liabilities for the expected future tax consequences of temporary differences between the financial statement carrying amounts and the
tax basis of assets and liabilities using enacted tax rates expected to be in effect when the differences are expected to reverse. Valuation
allowances are provided when necessary to reduce net deferred tax assets to the amount that is more likely than not to be realized. Based
on the available evidence, the Company is unable, at this time, to support the determination that it is more likely than not that its
deferred tax assets will be utilized in the future. Accordingly, the Company recorded a full valuation allowance as of September 30, 2025
and December 31, 2024. The Company intends to maintain valuation allowances until sufficient evidence exists to support its reversal.
The Company also expects the usage of the net operating loss carryforwards will be limited based on changes in the Company’s ownership.
Net loss per share
Basic net loss per share is based upon the weighted
average number of common shares outstanding. Diluted net loss per share is based on the assumption that all potential common stock equivalents
(restricted stock units, stock options, warrants and convertible preferred stock) are converted or exercised. The calculation of diluted
net loss per share excludes potential common stock equivalents if the effect is anti-dilutive. The Company’s weighted average common
shares outstanding for basic and diluted are the same because the effect of the potential common stock equivalents is anti-dilutive.
The Company had the following dilutive common
stock equivalents as of September 30, 2025 and 2024 which were excluded from the calculation because their effect was anti-dilutive:
September 30,
2025
September 30,
2024
Outstanding restricted stock units
91,484
16,839
Outstanding stock options
17,697
9,322
Outstanding warrants
5,956,010
2,728,160
Common shares convertible from preferred stock
1,374,328
896,661
Total
7,439,519
3,650,982
Adoption of New Accounting Pronouncements
In November 2023, the Financial Accounting Standards
Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740) –
Improvements to Income Tax Disclosures , which requires additional tax disclosures about a reporting entity’s effective tax
rate reconciliation as well as information on income taxes paid. This guidance is effective on a prospective basis, with the option to
apply it retrospectively, for fiscal years beginning after December 15, 2025. The adoption of ASU 2023-09 will expand the Company’s
income tax disclosures in its Annual Report on Form 10-K, but will have no impact on reported income tax (benefit) expense or related
tax assets or liabilities.
7
Recent
Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03,
Disaggregation of Income Statement Expenses , which requires additional disclosure of specific types of expenses included in the
expense captions presented on the face of the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective
for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The requirements
will be applied prospectively with the option for retrospective application. Early adoption is permitted. We are currently evaluating
the impact of adopting this new accounting guidance.
In July 2025, the FASB issued ASU 2025-05, Financial
Instruments - Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets , which provides
a practical expedient to measure credit losses on current accounts receivable and contract assets. The practical expedient allows companies
to assume that current conditions as of the balance sheet date do not change for the remaining life of the asset. For public companies,
ASU 2025-05 is effective for annual reporting periods beginning after December 15, 2025, and interim reporting periods within those annual
reporting periods. The Company is currently evaluating the impact of adopting this guidance on its condensed financial statements.
3. Acquisition
On August 1, 2025 (the
“SI Closing Date”), the Company entered into an asset purchase agreement (the “SI APA”) with SiVantage, Inc.,
a Delaware corporation (“SI”), pursuant to which the Company acquired substantially all of the assets of SI, including the
assignment of its intellectual property related to sacropelvic fixation and fusion procedures (the “SI Products”), and assumed
certain of its current liabilities and contract obligations, as set forth in the SI APA (the “SImmetry Acquisition”). The
SImmetry Acquisition closed on the SI Closing Date.
On the SI Closing Date,
SI received, as consideration for the SImmetry Acquisition, the purchase price consisting of: (i) $ 750 ,000 in cash; (ii) 710,300 shares
of the Company’s common stock, of which 473,533 are to be held by the Company for a period of one-year as security to satisfy any
indemnification claims against SI in accordance with the SI APA; (iii) a royalty equal to 15 % of the sales of all SI Products during the
one-year period following the SI Closing Date and 10 % of the sales of all SI Products during the following four-year period, subject to
a cap of $ 5.0 million; and (iv) a deferred cash payment of up to a maximum of approximately $ 1.3 million in the event that the all of
the currently issued and outstanding warrants of the Company are exercised (which deferred cash payment will be made pro rata based on
the actual number of warrants exercised).
In addition, during the
three-year period following the SI Closing Date, the Company will issue SI additional shares of its common stock upon the achievement
of the following milestones:
● upon the Company having $ 1 million in aggregate sales of the SI Products after the SI Closing Date, the Company will issue SI an additional 276,228 shares of its common stock;
● upon the Company achieving $ 10 million in aggregate sales of the SI Products after the SI Closing Date, the Company will issue SI an additional 276,228 shares of its common stock; and
● upon the Company achieving $ 20 million in aggregate sales of the SI Products after the SI Closing Date, the Company will issue SI an additional 314,900 shares of its common stock.
On August 1, 2025,
the Company also entered into an asset purchase agreement (the “ SIMPL APA”) with SIMPL Medical, LLC, a Delaware limited
liability (“SIMPL”), pursuant to which the Company acquired substantially all of the assets of SIMPL, including the
assignment of its intellectual property related to posterior sacroiliac implant technology (the “SIMPL Products”), and
assumed certain of its contract obligations, as set forth in the SIMPL APA (the “SIMPL Acquisition”). The SIMPL
Acquisition closed on August 4, 2025.
The aggregate purchase
price for the SIMPL Acquisition payable by the Company is a royalty equal to 30 % of the net revenue received by the Company from the sale
of any SIMPL Products during the five-year period following the first commercial sale of any SIMPL Products; provided that in the event
that the aggregate royalty payments made by the Company to SIMPL exceed $ 20.0 million, then from and after such time, the Company shall
pay SIMPL 20% of the net revenue received by the Company from the sale of any SIMPL Products during the remainder of such five-year period.
The royalty payments noted above shall be paid quarterly by the Company. The Company has the option, subject to certain limitations, to
pay up to 33.3 % of any quarterly royalty by the issuance of its shares of common stock, based upon the trailing 10-day VWAP at the end
of any applicable quarter.
8
SI and SIMPL are under
common control and the acquisitions were conditional upon one another; therefore, the Company determined that they are considered related
businesses and the acquisition of the SI and SIMPL assets was treated as a single business acquisition (the “SI Acquisition”)
in accordance with ASC 805, Business Combinations . The Company further determined that the SI Acquisition does not constitute an
asset acquisition under accounting pronouncements, and instead constitutes a business combination. Thus, the acquisition method was applied
to the acquisition. The Company further determined that the acquisitions met the definition of a business.
Purchase Consideration
The total purchase consideration
was $ 3,127 and consisted of the following:
Component
Amount
Cash paid at closing
$
750
Fair value of common stock issued
1,366
Fair value of contingent consideration
1,011
Total consideration
$
3,127
Identifiable Assets
Acquired and Liabilities Assumed
Description
Fair Value
Prepaid expenses
$ 19
Inventory
61
Property and equipment
131
Intangible assets:
Developed technology
103
Trademarks/trade names
196
Customer relationships
210
Total identifiable assets
720
Goodwill
2,407
Total consideration
$ 3,127
Goodwill arising from
the SI Acquisition is primarily attributable to the assembled workforce, expected synergies, and expansion into new markets.
The allocation of the
purchase price to the assets acquired and liabilities assumed is provisional and based on information available as of the acquisition
date. The Company is in the process of completing its detailed valuation of certain tangible and intangible assets and liabilities. In
addition, given the significant variables involved, the Company is still evaluating the methodologies and key assumptions in determining
the acquisition purchase price. Accordingly, the amounts recognized are subject to change upon completion of the valuation work and subsequent
management analysis, which is expected to be finalized within one year of the acquisition date in accordance with ASC 805.
Intangible Assets
Acquired
Asset
Estimated
Useful Life
in Years
Fair Value
Developed technology
7 - 8
$
103
Trademarks/trade names
10
196
Customer relationships
8
210
Total
$
509
Acquisition-Related
Costs
The Company incurred approximately $ 779 of acquisition-related costs,
including legal, accounting, and valuation fees. These costs are included in general and administrative expenses in the condensed statements
of operations and comprehensive loss.
9
Pro Forma Financial Information
The following unaudited pro forma information presents the combined
results of operations as if the acquisition had occurred on January 1, 2024. The pro forma results include adjustments for amortization
of acquired intangible assets. These pro forma results are presented for informational purposes only and do not purport to represent the
actual results that would have occurred if the acquisition had been completed on the date indicated, nor are they necessarily indicative
of future operating results.
Three Months Ended September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Revenue
$ 1,273
$ 1,103
$ 3,336
$ 3,001
Net loss
$ ( 3,532 )
$ ( 3,631 )
$ ( 10,939 )
$ ( 11,902 )
Basic and diluted net loss per share of common stock
$ ( 0.42 )
$ ( 2.29 )
$ ( 1.55 )
$ ( 9.31 )
4. Property and Equipment, net
Property and equipment, net, consisted of the
following:
September 30,
2025
December 31,
2024
Instrument tray sets
$
890
$
785
Construction in progress
440
541
Lab equipment
79
14
IT equipment
56
56
Leasehold improvements
15
15
Office furniture
9
9
Property and equipment, gross
1,489
1,420
Less: accumulated depreciation
( 826
)
( 668
)
Property and equipment, net
$
663
$
752
Construction in progress is made up of reusable
components that will become instrument tray sets. Depreciation expense was approximately $ 68 and $ 105 for the three months ended September
30, 2025 and 2024, respectively. Depreciation expense was approximately $ 158 and $ 278 for the nine months ended September 30, 2025 and
2024, respectively.
5. Intangible Assets, net
Intangible assets, net relate to developed technology, trademarks/trade
names and customer relationships acquired in the SI Acquisition (Note 3). Intangible assets were valued based on their estimated fair
value on the date of acquisition and are being amortized on a straight-line basis over estimated useful lives of 7 - 8 years for developed
technology, 10 years for trademarks/trade names and 8 years for customer relationships.
Intangible assets as of September 30, 2025 consist
of the following:
Gross Value
Accumulated
Amortization
Net Value
Developed technology
$ 103
$ ( 2 )
$ 101
Trademarks/trade names
196
( 3 )
193
Customer relationships
210
( 4 )
206
Total
$ 509
$ ( 9 )
$ 500
Amortization expense for both the three and nine months ended September
30, 2025 was $ 9 . As of September 30, 2025, there was no impairment of the intangible assets.
10
As of September 30, 2025, future amortization
of amortizable intangible assets is as follows:
As of
September 30,
2025
2025
$ 15
2026
59
2027
59
2028
59
2029
59
Thereafter
249
$ 500
6. Accrued Expenses
Accrued expenses consisted of the following:
September 30,
2025
December 31,
2024
Accrued compensation
$ 682
$ 416
Accrued professional services fees
317
271
Other accrued expenses
515
223
Total accrued expenses
$ 1,514
$ 910
7. Leases
In June 2021, the Company entered into a facility
lease agreement for its 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 September 30, 2025 and 2024, respectively, and were $ 216
and $ 219 for the nine months ended September 30, 2025 and 2024, respectively.
Supplemental balance sheet information related
to leases was as follows:
September 30,
December 31,
2025
2024
Operating lease right-of-use assets
$ 200
$ 399
Operating lease liability, current
$ ( 216 )
$ ( 287 )
Operating lease liability, noncurrent
—
( 141 )
Total operating lease liabilities
$ ( 216 )
$ ( 428 )
Future maturities of operating lease liabilities
as of September 30, 2025 were as follows:
2025
$ 79
2026
144
Total lease payments
223
Less: imputed interest
( 7 )
Present value of operating lease liabilities
$ 216
Other information:
Cash paid for operating leases for the nine months ended September 30, 2025 $ 232
Cash paid for operating leases for the nine months ended September 30, 2024 $ 225
Remaining lease term - operating leases (in years) 0.75
Average discount rate - operating leases 8.0 %
11
8. Stockholders’ Equity
The Company’s current Amended and Restated
Certificate of Incorporation dated February 18, 2014 authorizes the issuance of 130,000,000 shares of common stock and 20,000,000 shares
of preferred stock, both with a par value of $ 0.001 per share. With respect to the preferred stock, 4,500,000 shares are designated Series
A Preferred Stock and 491,222 shares are designated Series B Preferred Stock.
At-the-Market Offering Program
On May 4, 2023, the Company entered into an Equity Distribution Agreement
to establish an at-the-market offering program, under which the Company may sell from time to time, at its option, shares of its common
stock having an aggregate gross sales price of $ 5.5 million. The Company is required to pay the Sales Agents a commission of 3 % of the
gross proceeds from the sale of shares and has also agreed to provide the Sales Agents with customary indemnification rights. No shares
were sold under the program during the three months ended September 30, 2025 and 2024. During the nine months ended September 30, 2025
and 2024, 0 and 129,199 shares of the Company’s common stock, respectively, were sold under the program at a weighted-average price
of $ 0 and $ 14.63 per share with aggregate proceeds, net of current and deferred issuance costs, of $ 0 and $ 1,834 , respectively. Per the
terms of the Equity Distribution Agreement, no shares are available to be issued under the program as of September, 30, 2025.
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 three months ended September 30, 2025 and 2024, 0 and 37,618
shares of the Company’s common stock were sold under the program, respectively, at a weighted average price of $ 0 and $ 4.56 , respectively,
with aggregate net proceeds of $ 164 . During the nine months ended September 30, 2025 and 2024, 0 and 48,849 shares of the Company’s
common stock were sold under the program, respectively, at a weighted-average price of $ 0 and $ 5.56 per share, respectively, with aggregate
net proceeds of $ 260 . The Purchase Agreement terminated in September 2025.
12
2025 Warrant Inducement
On March 11, 2025, the Company entered into a
warrant exercise inducement offer letter agreement (the “Inducement Letter”) with the holder of the Series A New Warrants
and Series B New Warrants (the “Existing Warrants”), pursuant to which, the holder agreed to exercise the Existing Warrants
at a reduced exercise price of $ 1.25 per share in consideration for the Company’s agreement to issue (i) new unregistered five-year
warrants (the “Series C-1 Warrants”) to purchase up to an aggregate of 2,445,700 shares of common stock at an exercise price
of $ 1.25 per share and (ii) new unregistered three-year warrants (the “Series C-2 Warrants,” and together with the Series
C-1 Warrants, the “New Warrants”) to purchase up to an aggregate of 1,222,850 shares of common stock at an exercise price
of $ 1.25 per share (the “Inducement Transaction”). The New Warrants are not exercisable without approval by the Company’s
stockholders (“Stockholder Approval”), which, pursuant to the Inducement Letter, the Company is required to obtain at a meeting
of stockholders no later than 165 days after the consummation of the Inducement Transaction. The Series C-1 Warrants will be exercisable
five years from the date on which Stockholder Approval is obtained, and the Series C-2 Warrants will be exercisable three years from the
date on which Stockholder Approval is obtained. Pursuant to the Inducement Transaction, the Company received proceeds, net of financial
advisor fees and other transaction expenses, of $ 2,735 .
The Company filed a registration statement on
Form S-1 on April 4, 2025 providing for the resale of the shares of common stock issuable upon the exercise of the New Warrants. The Company
has agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any common stock or common
stock equivalents or file any registration statement or any amendment or supplement to any existing registration statement, subject to
certain exceptions, for a period of 60 calendar days after the effectiveness of the Resale Registration Statement. Furthermore, the Company
is also prohibited from entering into any agreement to issue common stock or common stock equivalents involving a variable rate transaction
(as defined in the Inducement Letter), subject to certain exceptions, for a six-month period commencing on March 12, 2025.
2025 Securities Purchase Agreements
On March 25, 2025, the Company entered into a
securities purchase agreement for the issuance of 733,500 shares of its common stock (or common stock equivalents in lieu thereof) in
a registered direct offering at a purchase price of $ 2.00 per share. In a concurrent private placement, the Company also agreed to issue
to the same investor warrants to purchase up to 733,500 shares of its common stock at an exercise price of $ 2.00 per share, which will
be exercisable immediately, and will expire five years following the date of issuance. Pursuant to the agreements, the Company received
proceeds, net of financial advisor fees and other transaction expenses, of $ 1,234 .
Also on March 25, 2025, the Company entered into
a securities purchase agreement for the issuance of 1,271,500 shares of its common stock (or common stock equivalents in lieu thereof)
in a registered direct offering at a purchase price of $ 2.00 per share. In a concurrent private placement, the Company also agreed to
issue to the same investor warrants to purchase up to 1,271,500 shares of its common stock at an exercise price of $ 2.00 per share, which
will be exercisable immediately, and will expire five years following the date of issuance. Pursuant to the agreements, the Company received
proceeds, net of financial advisor fees and other transaction expenses, of $ 2,290 .
Equity Awards
In 2012, the Board of Directors of the Company
(the “Board”) approved the Tenon Medical, Inc. 2012 Equity Incentive Plan (the “2012 Plan”). The 2012 Plan provides
for the issuance of common stock options, appreciation rights, and other awards to employees, directors, and consultants. Options issued
under the 2012 Plan generally vest over a period of two to four years and have a 10-year expiration date. In April 2021, the Board increased
the number of shares of common stock reserved for issuance under the 2012 Plan to 662,516 . In July 2021, the Board increased the number
of shares of common stock reserved for issuance under the 2012 Plan to 737,516 . In August 2021, the Board increased the number of shares
of common stock reserved for issuance under the 2012 Plan from 737,516 shares to 799,266 shares and approved the form of a 2022 Equity
Incentive Plan.
On January 10, 2022 and February 2, 2022, the
Board and stockholders, respectively, of the Company approved the Tenon Medical, Inc. 2022 Equity Incentive Plan (the “2022 Plan”),
which was effective on April 25, 2022. The number of shares of common stock that may be subject to awards and sold under the 2022 Plan
is equal to 1,600,000 . Automatic annual increases in number of shares available for issuance under the 2022 Plan is equal to the least
of (a) 1,100,000 shares, (b) 4 % of the total number of shares of all classes of common stock outstanding on the last day of the immediately
preceding fiscal year, or (c) such number determined by the 2022 Plan administrator no later than the last day of the immediately preceding
fiscal year. Annual increases will continue until the tenth anniversary of the earlier of the Board or stockholder approval of the 2022
Plan, which is January 10, 2032. Upon the effective date of the 2022 Plan, the Board terminated the 2012 Plan such that no new equity
awards will be issued by the 2012 Plan.
13
A summary of the Company’s stock option
and restricted stock unit activity under its plans is as follows:
Number of
Shares
Subject to Outstanding
Stock Options
Weighted
Average
Exercise
Price per
Share
Number of
Outstanding
Restricted Stock
Units
Weighted
Average Grant
Date Fair
Value per
Unit
Outstanding at December 31, 2024
11,322
$ 20.79
20,224
$ 99.58
Granted
9,000
$ 1.22
77,150
$ 1.85
Released
—
—
( 5,699 )
$ 295.70
Forfeited
( 2,625 )
$ 5.36
( 191 )
$ 708.80
Outstanding at September 30, 2025
17,697
$ 13.12
91,484
$ 3.67
The following table sets forth stock-based compensation
expense recognized for the three and nine months ended September 30, 2025 and 2024:
Three months ended
September 30,
Nine months ended
September 30,
2025
2024
2025
2024
Research and development
$ 16
$ 355
$ 573
$ 1,080
Sales and marketing
26
31
90
108
General, and administrative
16
524
684
1,774
Total stock-based compensation expense
$ 58
$ 910
$ 1,347
$ 2,962
At September 30, 2025, there were 75,386 shares
available for issuance under the 2022 Plan.
Warrants
Series C Warrants
On March 11, 2025, in connection with 2025 Warrant
Inducement, the Company issued new unregistered five-year warrants (the “Series C-1 Warrants”) to purchase up to an aggregate
of 2,445,700 shares of common stock at an exercise price of $ 1.25 per share and new unregistered three-year warrants (the “Series
C-2 Warrants,” and together with the Series C-1 Warrants, the “Series C Warrants”) to purchase up to an aggregate of
1,222,850 shares of common stock at an exercise price of $ 1.25 per share. The Series C Warrants are not exercisable without approval by
the Company’s stockholders (“Stockholder Approval”), which the Company is required to obtain at a meeting of stockholders
no later than 165 days after the consummation of the Inducement Transaction. The Series C-1 Warrants will be exercisable five years from
the date on which Stockholder Approval is obtained, and the Series C-2 Warrants will be exercisable three years from the date on which
Stockholder Approval is obtained. Pursuant to the Inducement Transaction, the Company received proceeds, net of financial advisor fees
and other transaction expenses, of $ 2,735 .
The fair value of the Series C-1 Warrants on the
grant date was $ 0.97 per warrant, which was calculated using a Black-Scholes option valuation model with an expected term of 5.00 years,
expected volatility of 68.40 %, dividend yield of 0 %, and risk-free interest rate of 4.0 %. The fair value of the Series C-2 Warrants on
the grant date was $ 0.80 per warrant, which was calculated using a Black-Scholes option valuation model with an expected term of 3.00
years, expected volatility of 68.40 %, dividend yield of 0 %, and risk-free interest rate of 4.0 %. The Company recorded the fair value of
these warrants to additional paid-in capital in the first quarter of 2025. The Company recorded the excess of the incremental value of
the modified Series A New Warrants and Series B New Warrants and the fair value of the Series C Warrants over the cash proceeds from the
exercise of the modified Series A New Warrants and Series B New Warrants as equity offering costs. All of the Series C Warrants remain
outstanding as of September 30, 2025.
Series D Warrants
On March 25, 2025, in connection with a securities
purchase agreement, the Company issued warrants to purchase up to 733,500 shares of its common stock at an exercise price of $ 2.00 per
share (the “Series D Warrants”), which were exercisable upon issuance, and will expire five years following the date of issuance.
The fair value of the Series D Warrants on the grant date was $ 2.72 per warrant, which was calculated using a Black-Scholes option valuation
model with an expected term of 5.00 years, expected volatility of 68.40 %, dividend yield of 0 %, and risk-free interest rate of 4.1 %. The
Company recorded the fair value of these warrants to additional paid-in capital in the first quarter of 2025. All of the Series D Warrants
remain outstanding as of September 30, 2025.
14
Series E Warrants
Also on March 25, 2025, in connection with a securities
purchase agreement, the Company issued warrants to purchase up to 1,271,500 shares of its common stock at an exercise price of $ 2.00 per
share (the “Series E Warrants”), which were exercisable upon issuance, and will expire five years following the date of issuance.
The fair value of the Series E Warrants on the grant date was $ 2.72 per warrant, which was calculated using a Black-Scholes option valuation
model with an expected term of 5.00 years, expected volatility of 68.40 %, dividend yield of 0 %, and risk-free interest rate of 4.1 %. The
Company recorded the fair value of these warrants to additional paid-in capital in the first quarter of 2025. All of the Series E Warrants
remain outstanding as of September 30, 2025.
9. Commitments and Contingencies
Sales Representative Agreement
In April 2020, the Company entered into an Exclusive
Sales Representative Agreement, under which the counterparty to the agreement (the “Representative”) received exclusive rights
to market, promote, and distribute The Catamaran System in the United States and Puerto Rico. The agreement is for an initial period of
five years , and automatically renews for an additional five years unless written notice is given by either party prior to April 27, 2023.
The agreement provides for a bonus to be paid to the Representative upon an acquisition or IPO. In May 2021, the Company entered into
an Amended and Restated Exclusive Sales Representative Agreement (the “Restated Sales Agreement”). In connection with the
amended agreement, the Company paid $ 500 cash and issued 53,757 shares of common stock to the Representative, for which the Company recorded
a combined total of approximately $ 880 as sales and marketing expense. In addition, the Representative received anti-dilution protections
to maintain ownership of 3.0 % of the fully diluted equity of the Company through the date of an initial public offering. In October 2021,
the Company issued 4,445 shares of common stock with a fair value of approximately $ 333 to the Representative in accordance with the anti-dilution
provision. In April 2022, the Company issued 31,235 shares of common stock to the Representative in accordance with the anti-dilution
provision, fully satisfying the Company’s obligations.
The Restated Sales Agreement restructured the
calculation of the bonus paid to the Representative upon an acquisition, removed the bonus payable upon an IPO, and allows the Company
to terminate the Restated Sales Agreement as long as the bonus paid to the Representative is at least $ 6,000 .
On October 6, 2022, the Company entered into the
Terminating Amended and Restated Exclusive Sales Representative Agreement (the “Termination Agreement”) with the Representative,
which terminated the Restated Sales Agreement. In accordance with the Termination Agreement, (i) the Company paid the Representative $1,000
in cash; and (ii) the Company agreed to pay the Representative (a) $85 per month during the six months after the date of the Termination
Agreement in return for efforts by the Representative to transition operations to the Company, (b) 20% of net sales of the product sold
in the United States and Puerto Rico until December 31, 2023 and (c) after December 31, 2023, 10% of net sales until such time as the
aggregate amount paid to the Representative under this clause (c) and clause (b) above equal $3,600. In the event of an acquisition of
the Company, the Company will pay the Representative $3,600 less previous amounts paid pursuant to clause (b) and clause (c) above. The
Company recorded a charge of $1,000 for the payment to the Representative in the fourth quarter of 2022 and expensed the $85 per month
charges as incurred over the six-month period. For payments under clause (b) and clause (c) above, the Company originally estimated the
fair value of the liability using level 3 hierarchy inputs based on a Monte Carlo simulation of future revenues with a 25% quarterly estimated
standard deviation of growth rates and a 10% probability of dissolution, discounted at an estimated discount rate of 15.4%. Based on the
Company’s fair value analysis, a total of $2,611 was charged to sales and marketing expense in the statements of operations and
comprehensive loss and recorded as accrued commissions in the balance sheets. For subsequent periods, the Company has used a discounted
cash flow model with an estimated discount rate of 15.4% to adjust the liability for actual payments made and updated projections of the
timing of future payments. A reconciliation of the liability under clause (b) and clause (c) for the nine months ended September 30, 2025
is as follows:
Balance at January 1, 2025
$ 2,101
Amounts paid during 2025
( 226 )
Accretion
118
Balance at September 30, 2025
$ 1,993
15
Per the terms of the Termination Agreement, the
Company ultimately expects to expense $ 3,600 under clause (b) and clause (c).
Credit risk
Financial instruments that potentially subject
the Company to concentrations of credit risk consist principally of cash and cash equivalents.
The Company maintains cash balances at financial
institutions located in California. Accounts at the U.S. financial institutions are secured by the Federal Deposit Insurance Corporation.
At times, balances may exceed federally insured limits. The Company has not experienced any losses in such accounts. Management believes
that the Company is not exposed to any significant credit risk with respect to its cash and cash equivalents.
The Company grants unsecured credit to its customers
based on an evaluation of the customer’s financial condition and a cash deposit is generally not required. Management believes its
credit policies do not result in significant adverse risk and historically has not experienced significant credit-related losses.
10. Reportable Segment
The Company operates in one reportable business segment: the SI Joint
segment. The SI Joint segment derives revenue from the sale of the Catamaran System and the SImmetry SI Joint Fusion System for treatment
of the most common types of SI Joint disorders that cause lower back pain. The chief operating decision maker, which is the Company’s
senior executive committee that includes the chief executive officer, the chief financial officer and the chief technology officer, assesses
the performance of the SI Joint segment and decides how to allocate resources based on net income which is reported in the consolidated
statements of operations and comprehensive loss as net loss. The measure of segment assets is reported on the balance sheet as total assets.
The chief operating decision maker uses net loss
to evaluate income generated from segment assets in deciding whether to continue investing in the segment. Net loss is used to monitor
budget versus actual results, to prepare operating budgets, and to assess the performance of the segment and in establishing management
compensation. The Company does not have intra-entity sales or transfers.
The following table presents selected financial
information for the Company’s single business segment for the three and nine months ended September 30, 2025 and 2024:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Revenue
$ 1,173
$ 887
$ 2,463
$ 2,507
Less:
Cost of sales
400
469
1,122
1,149
Research and development
428
657
1,622
2,034
Sales and marketing
1,538
1,212
4,304
4,041
General and administrative
2,199
1,764
5,341
5,876
Total Other (Income) Expense, net
( 53 )
( 31 )
( 202 )
( 7 )
Net Loss
$ ( 3,339 )
$ ( 3,184 )
$ ( 9,724 )
$ ( 10,586 )
11. Subsequent Event
On November 11, 2025, the Company announced the pricing of an at-the-market
private investment in public equity (the “PIPE”) financing with several accredited investors for total gross proceeds of $ 2,850,000 .
Under the terms of securities purchase agreements, dated November 10, 2025 between the Company and the applicable investors, the Company
will issue an aggregate of 2,217,904 shares of common stock (the “Issued Shares”) and warrants (the “PIPE Warrants”)
to purchase 2,217,904 shares of common stock at a combined offering price of $ 1.285 per share of common stock and warrant to purchase
one share of common stock. The PIPE Warrants have a strike price of $ 1.16 per share, with an expiration date of 3 years from the date
of issuance. The Issued Shares and the shares underlying PIPE Warrants will be entitled to customary resale registration rights. The closing
of the PIPE is subject to customary closing conditions for financing of this nature. The PIPE is expected to close on November 14, 2025.
16
ITEM 2. MANAGEMENT’S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and
analysis of our financial condition and results of operations together with our unaudited condensed financial statements and the notes
to those statements included elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and the
other information set forth in our Annual Report of Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange
Commission on March 26, 2025. In addition to historical financial information, this discussion and analysis contains forward-looking statements
that reflect our plans, estimates and beliefs. You should not place undue reliance on these forward-looking statements, which involve
risks and uncertainties. As a result of many factors, including but not limited to those set forth under “Risk Factors” in
our Annual Report of Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, our actual results may differ materially
from those anticipated in these forward-looking statements. See “Cautionary Statement Regarding Forward-Looking Statements.”
Overview
Tenon Medical, Inc., a medical device company formed in 2012, has developed
a proprietary, U.S. Food and Drug Administration (“FDA”) approved surgical implant-system, which we call The Catamaran™
SI Joint Fusion System (“The Catamaran System”). The Catamaran System offers a novel, less invasive inferior-posterior approach
to the sacroiliac joint (“SI Joint”) using a single, robust titanium implant to treat SI Joint dysfunction that often causes
severe lower back pain. The system features the Catamaran™ Fixation Device which passes through both the axial and sagittal planes
of the ilium and sacrum, transfixing the SI Joint along its longitudinal axis. In August 2025, the Company purchased substantially all
of the assets of SiVantage, Inc., including the SImmetry SI Joint Fusion System that treats disorders of the SI Joint using a single,
robust, titanium implant.
We have incurred net losses since our inception
in 2012. As of September 30, 2025, we had an accumulated deficit of approximately $78.5 million. To date, we have financed our operations
primarily through public equity offerings, private placements of equity securities, certain debt-related financing arrangements, and sales
of our product. We have devoted substantially all of our resources to research and development, regulatory matters and sales and marketing
of our product.
Reverse Stock Split
On September 6, 2024, we effected a 1-for-8 reverse
stock split (the “2024 Reverse Stock Split”) by filing an amendment to our Amended and Restated Certificate of Incorporation,
as amended, with the Delaware Secretary of State. The 2024 Reverse Stock Split combined every eight shares of our common stock issued
and outstanding immediately prior to effecting the 2024 Reverse Stock Split into one share of common stock. No fractional shares were
issued in connection with the 2024 Reverse Stock Split. All historical share and per share amounts reflected throughout this document
have been adjusted to reflect the 2024 Reverse Stock Split. The authorized number of shares and the par value per share of our common
stock were not affected by the 2024 Reverse Stock Split.
Components of Results of Operations
Revenue
We derive substantially all our revenue from sales of The Catamaran
System and, since August 2025, the SImmetry SI Joint Fusion System. Revenue from sales of The Catamaran System and the SImmetry SI Joint
Fusion System fluctuates based on volume of cases (procedures performed), discounts, rebates, and the number of implants used for a particular
patient. Similar to other orthopedic companies, our revenue can also fluctuate from quarter to quarter due to a variety of factors, including
reimbursement, changes in independent sales representatives and physician activities.
Cost of Goods Sold, Gross Profit, and Gross
Margin
We utilize contract manufacturers for production
of The Catamaran System implants, SImmetry implants and the instrument tray sets. Cost of goods sold consists primarily of costs of the
components of the implants and instruments, depreciation of instrument tray sets, overhead related to operations personnel and facility
costs, quality inspection, packaging, scrap and inventory obsolescence, as well as distribution-related expenses such as logistics and
shipping costs. We anticipate that certain of our cost of goods sold will increase in absolute dollars as case levels increase.
Our gross margins have been and will continue to be affected by a variety
of factors, including the cost to have our product manufactured for us, pricing pressure from increasing competition, decisions with regard
to the level of overhead we choose to maintain, sales volumes to absorb fixed production costs, and the factors described above impacting
our revenue.
17
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 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 our products. Our sales and marketing expenses may fluctuate from period
to period due to the timing of sales and marketing activities related to the commercial activity of our product.
Research and Development Expenses
Our research and development expenses primarily
consist of engineering, product development, regulatory expenses, and consulting services, outside prototyping services, outside research
activities, materials, and other costs associated with the development and refinement of our product. Research and development expenses
also include related personnel and consultants’ compensation and stock-based compensation expense. We expense research and development
costs as they are incurred. We expect research and development expense to increase in absolute dollars as we improve our existing products,
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 continue to incur expenses as a result of operating as a public
company, including but not limited to: expenses related to compliance with the rules and regulations of the SEC and those of The Nasdaq
Stock Market LLC on which our securities are traded; additional insurance expenses; investor relations activities; and other administrative
and professional services. We also may incur acquisition-related expenses at the discretion of management and the Board of Directors.
While we expect the general and administrative expenses to increase in absolute dollars, we anticipate that it will decrease as a percentage
of revenue over time.
Gain on Investments, Interest Expense and
Other Income (Expense), Net
Gain on investments consists of interest income
and realized gains and losses from the sale of our investments in money market and corporate debt securities. Interest expense is related
to borrowings, when applicable. Other income and expenses have not been significant to date.
18
Results of Operations
The following table sets forth our results of
operations for the periods presented (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
Statements of Operations Data:
2025
2024
2025
2024
Revenue
$ 1,173
$ 887
$ 2,463
$ 2,507
Cost of goods sold
400
469
1,122
1,149
Gross profit
773
418
1,341
1,358
Operating expenses:
Research and development
428
657
1,622
2,034
Sales and marketing
1,538
1,212
4,304
4,041
General and administrative
2,199
1,764
5,341
5,876
Total operating expenses
4,165
3,633
11,267
11,951
Loss from operations
(3,392 )
(3,215 )
(9,926 )
(10,593 )
Interest and other income (expense), net:
Gain on investments
53
31
202
97
Interest expense
—
—
—
(34 )
Other expense, net
—
—
—
(56 )
Net loss
$ (3,339 )
$ (3,184 )
$ (9,724 )
$ (10,586 )
The following table sets forth our results of
operations as a percentage of revenue:
Three Months Ended
September 30,
Nine Months Ended
September 30,
Statements of Operations Data:
2025
2024
2025
2024
Revenue
100 %
100 %
100 %
100 %
Cost of goods sold
34
53
46
46
Gross profit
66
47
54
54
Operating expenses:
Research and development
36
74
66
81
Sales and marketing
131
137
175
161
General and administrative
187
199
217
234
Total operating expenses
355
410
457
477
Loss from operations
(289 )
(362 )
(403 )
(423 )
Interest and other income (expense), net:
Gain on investments
5
3
8
4
Interest expense
—
—
—
(1 )
Other expense
—
—
—
(2 )
Net loss
(285 )%
(359 )%
(395 )%
(422 )%
19
Comparison of the Three and Nine Months Ended September 30, 2025
and 2024 (in thousands, except percentages)
Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin
Three Months Ended
September 30,
2025
2024
$ Change
% Change
Revenue
$ 1,173
$ 887
$ 286
32 %
Cost of goods sold
400
469
(69 )
(15 )%
Gross profit
$ 773
$ 418
$ 355
(85 )%
Gross profit percentage
66 %
47 %
Nine Months Ended
September 30,
2025
2024
$ Change
% Change
Revenue
$ 2,463
$ 2,507
$ (44 )
(2 )%
Cost of goods sold
1,122
1,149
(27 )
(2 )%
Gross profit
$ 1,341
$ 1,358
$ (17 )
(1 )%
Gross profit percentage
54 %
54 %
Revenue. The changes in revenue for
the three and nine months ended September 30, 2025 as compared to the same periods in 2024 was primarily due to changes in the number
of surgical procedures in which The Catamaran System was used and the addition of sales of the SImmetry SI Joint Fusion System, while
implants per procedure remained relatively constant.
Cost of Goods Sold, Gross Profit, and Gross
Margin . The change in cost of goods sold for the three and nine months ended September 30, 2025 as compared to the same periods
in 2024 was due to the absorption of production overhead costs into our standard cost in 2024 and operating leverage created due to lower
relative fixed costs. The gross margin for the three months ended September 30, 2025 benefitted from increased sales volumes that reduced
per unit fixed production costs.
Operating Expenses
Three Months Ended
September 30,
2025
2024
$ Change
% Change
Research and development
$ 428
$ 657
$ (229 )
(35 )%
Sales and marketing
1,538
1,212
326
27 %
General and administrative
2,199
1,764
435
25 %
Total operating expenses
$ 4,165
$ 3,633
$ 532
15 %
Nine Months Ended
September 30,
2025
2024
$ Change
% Change
Research and development
$ 1,622
$ 2,034
$ (412 )
(20 )%
Sales and marketing
4,304
4,041
263
7 %
General and administrative
5,341
5,876
(535 )
(9 )%
Total operating expenses
$ 11,267
$ 11,951
$ (684 )
(6 )%
Research and Development Expenses . Research
and development expenses for the three months ended September 30, 2025 decreased as compared to 2024 primarily due to decreased stock-based
compensation ($339) and payroll and employee expenses ($46), partially offset by increased professional fees ($106). Research and development
expenses for the nine months ended September 30, 2025 decreased as compared to 2024 primarily due to decreased stock-based compensation
($507) and professional fees ($32), partially offset by increased payroll and employee expenses ($54).
Sales and Marketing Expenses . Sales
and marketing expenses for the three months ended September 30, 2025 increased as compared to the same period in 2024 primarily due to
increased commission expenses ($410) and consulting and professional fees ($38), partially offset by decreases in payroll and employee
expenses ($84), and stock-based compensation ($5). Sales and marketing expenses for the nine months ended September 30, 2025 increased
as compared to the same period in 2024 primarily due to increased commission expenses ($262) and professional fees ($45), partially offset
by decreases in payroll and employee expenses ($27) and stock-based compensation ($18).
20
General and Administrative Expenses . General
and administrative expenses for the three months ended September 30, 2025 increased as compared to the same period in 2024 primarily
due to acquisition expenses ($779) and increases in professional service fees ($190) and payroll and employee expenses ($135), partially
offset by decreased stock-based compensation ($508) and insurance costs ($146). General and administrative expenses for the nine months
ended September 30, 2025 decreased as compared to the same period in 2024 primarily due to decreased stock-based compensation ($1,090)
and insurance costs ($471), partially offset by acquisition expenses ($779) and increases in employee expenses ($221) and professional
service fees ($96).
Gain on Investments, Interest Expense and
Other Income (Expense), Net
Gain on investments for the three and nine months
ended September 30, 2025 increased as compared to the same periods in 2024 due to interest on our increased cash and cash equivalent balances.
Interest expense for the nine months ended September 30, 2024 related to our convertible debt. Other income (expense), net in 2024 was
related to foreign exchange losses on the liquidation of our Swiss subsidiary.
Liquidity and Capital Resources
As of September 30, 2025, we had cash and cash
equivalents of $3.4 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 September 30, 2025,
we had no outstanding debt. As of September 30, 2025, we had an accumulated deficit of $78.5 million, and we expect to incur additional
losses in the future. We have not achieved positive cash flow from operations to date.
Based upon our current operating plan, our existing cash and cash equivalents
will not be sufficient to fund our operating expenses and working capital requirements through at least the next 12 months from the date
these financial statements were filed. We plan to raise the necessary additional capital through one or a combination of public or private
equity offerings, debt financings, and collaborations. We continue to face challenges and uncertainties and, as a result, our available
capital resources may be consumed more rapidly than currently expected due to (a) the uncertainty of future revenues; (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 November 11, 2025, we announced the pricing of an at-the-market private investment in public equity (the “PIPE”)
financing with several accredited investors for total gross proceeds of $2,850,000. Under the terms of securities purchase agreements,
dated November 10, 2025 between us and the applicable investors, we will issue an aggregate of 2,217,904 shares of common stock (the “Issued
Shares”) and warrants (the “PIPE Warrants”) to purchase 2,217,904 shares of common stock at a combined offering price
of $1.285 per share of common stock and warrant to purchase one share of common stock. The PIPE Warrants have a strike price of $1.16
per share, with an expiration date of 3 years from the date of issuance. The Issued Shares and the shares underlying PIPE Warrants will
be entitled to customary resale registration rights. The closing of the PIPE is subject to customary closing conditions for financing
of this nature. The PIPE is expected to close on November 14, 2025.
As we attempt to raise additional capital to fund
our operations, funding may not be available to us on acceptable terms, or at all. If we are unable to obtain adequate financing when
needed, we may have to delay, reduce the scope of or suspend one or more of our sales and marketing efforts, research and development
activities, or other operations. We may seek to raise any necessary additional capital through a combination of public or private equity
offerings, debt financings, and collaborations. If we do raise additional capital through public or private equity offerings, the ownership
interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences
that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants
limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring
dividends. If we are unable to raise capital, we will need to delay, reduce, or terminate planned activities to reduce costs. Doing so
will likely harm our ability to execute our business plans. Due to the uncertainty in our ability to raise capital, management believes
that there is substantial doubt in our ability to continue as a going concern for the next twelve months from the issuance of these condensed
financial statements.
Cash Flows (in thousands, except percentages)
The following table sets forth the primary sources
and uses of cash for each of the periods presented below:
Nine Months Ended
September 30,
2025
2024
$ Change
% Change
Net cash (used in) provided by:
Operating activities
$ (8,521 )
$ (7,101 )
$ 1,361
(19 )%
Investing activities
(831 )
(223 )
(608 )
273 %
Financing activities
6,259
14,012
(7,812 )
(56 )%
Effect of foreign currency translation on cash flow
—
46
(46 )
(100 )%
Net increase (decrease) in cash and cash equivalents
$ (3,039 )
$ 6,734
$ (9,827 )
(385 )%
21
The decrease in net cash used in operating activities for the nine
months ended September 30, 2025 as compared to the nine months ended September 30, 2024 was primarily attributable to our decreased net
loss ($862), adjusted for decreases in non-cash stock-based compensation expenses ($1,615), in addition to increased inventory levels
($501) and decreased accounts payable ($394), partially offset by increases in accrued expenses ($498).
Cash used in investing activities for the nine
months ended September 30, 2025 consisted of the cash payment for the SI Acquisition ($750) and purchases of property and equipment ($81).
Cash used in investing activities for the nine months ended September 30, 2024 consisted of purchases of property and equipment ($223).
Cash provided by financing activities for the nine months ended September
30, 2025 consisted primarily of gross proceeds from the issuance of common stock from our securities purchase agreements ($4,010) and
from the exercise of warrants under the inducement agreement ($3,057), net of total cash offering costs ($867). Cash provided by financing
activities for the nine months ended September 30, 2024 consisted primarily of gross proceeds from the issuance of common stock and warrants
($4,500), the exercise of warrants under the inducement agreement ($4,647), the issuance of Series A Convertible Preferred Stock ($2,605)
and Series B Convertible Preferred Stock ($550) and from issuances of common stock ($2,163), net of total cash offering costs ($1,265).
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 nine months ended September 30, 2025, the only significant change to our existing critical accounting policies from
those disclosed in our Annual Report on Form 10-K was related to accounting for business combinations, as described below.
Business Combinations
We account for business combinations in accordance with Accounting Standards Codification 805, Business Combinations ,
which requires that assets acquired and liabilities assumed be recorded at their respective fair values on the date of acquisition. The
fair value of the consideration paid is assigned to the underlying net assets of the acquired business based on their respective fair
values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded to goodwill. Intangible
assets acquired are amortized over the expected life of the asset. Fair value determinations and useful life estimates are based on,
among other factors, estimates of expected future cash flows, estimates of appropriate discount rates, estimated useful lives of the
intangible assets acquired and other factors. Although we believe the assumptions and estimates we have made have been reasonable and
appropriate, actual results may vary significantly from estimated results. Our assumptions and estimates are subject to refinement and,
as a result, during the measurement period, which may be up to one year from the acquisition date, We record adjustments to the assets
acquired and liabilities assumed with the corresponding offset to goodwill.
Off-Balance Sheet Arrangements
As of September 30, 2025, and December 31, 2024,
we did not have any relationships with unconsolidated organizations or financial partnerships, such as structured finance or special
purpose entities that would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually
narrow or limited purposes.
ITEM 3. Quantitative and Qualitative Disclosures
about Market Risk
Not required under Regulation S-K for “smaller
reporting companies.”
22
ITEM 4. Controls and Procedures. Disclosure
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures
that are designed to provide reasonable assurance that the information required to be disclosed by us in reports that we file or submit
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported
within the time periods specified in the rules and forms promulgated by the Securities and Exchange Commission, and that such information
is accumulated and communicated to our management, including our Chief Executive Officer and President and Chief Financial Officer, as
appropriate to allow timely decisions regarding required disclosure. Because of the inherent limitations to the effectiveness of any system
of disclosure controls and procedures, no evaluation of disclosure controls and procedures can provide absolute assurance that all control
issues and instances of fraud, if any, with a company have been prevented or detected on a timely basis. Even disclosure controls and
procedures determined to be effective can only provide reasonable assurance that their objectives are achieved.
As of September 30, 2025, we carried out an evaluation,
under the supervision and with the participation of our management, including our Chief Executive Officer and President and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e))
pursuant to Rule 13a-15 of the Exchange Act. Based upon that evaluation, our Chief Executive Officer and President and Chief Financial
Officer concluded that our disclosure controls and procedures are not effective at the reasonable assurance level.
Our size has prevented us from being able to employ
sufficient resources to enable us to have an adequate level of supervision and segregation of duties. Therefore, it is difficult to effectively
segregate accounting duties which comprises a material weakness in internal controls. This lack of segregation of duties leads management
to conclude that the Company’s disclosure controls and procedures are not effective to give reasonable assurance that the information
required to be disclosed in reports that the Company files under the Exchange Act is recorded, processed, summarized and reported as and
when required.
To the extent reasonably possible given our limited
resources, we are taking measures to cure the aforementioned weaknesses, including, but not limited to, increasing the capacity of our
qualified financial personnel to ensure that accounting policies and procedures are consistent across the organization and that we have
adequate controls over our Exchange Act reporting disclosures.
On August 1, 2025, we completed the SImmetry
Acquisition and the SIMPL Acquisition (together, the “SI Acquisition”), which were accounted for as a business combination
pursuant to ASC 805. Given the recent date of the acquisition and as integration activities are on-going, management did not include
these businesses in its quarterly disclosure controls and procedures assessment as of September 30, 2025.
Changes in Internal Control over Financial
Reporting
During the quarter ended September 30, 2025, we established adequate controls designed to provide reasonable
assurance regarding the financial reporting for transactions related to the SI Acquisition. Other than changes related to the acquired
businesses, 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 September 30, 2025 that have materially affected, or are reasonably likely
to materially affect, our internal control over financial reporting.
23
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 required by this item.
ITEM 2. UNREGISTERED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS
(A) Unregistered Sales of Equity Securities
None.
(B) Use of Proceeds
Not applicable.
(C) Issuer Purchases of Equity Securities
None.
ITEM 3. DEFAULTS UPON SENIOR
SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not Applicable.
ITEM 5. OTHER INFORMATION
None .
24
ITEM 6. EXHIBITS
EXHIBIT INDEX
Exhibit
Number
Description
3.1
Second Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-271648, filed on May 4, 2023)
3.2
Certificate of Correction to Second Amended and Restated Certificate of Incorporation of the Registrant, filed on October 25, 2023 (incorporated by reference to Registrant’s Registration Statement No. 333-290808, filed on October 10, 2025)
3.3
Amendment to Certificate of Incorporation Certificate of Amendment of Second Amended and Restated Certificate of Incorporation of the Registrant, filed on November 1, 2023 (incorporated by reference to Registrant’s Current Report on Form 8-K, filed on November 7, 2023)
3.4
Amendment to Certificate of Incorporation Certificate of Amendment of Second Amended and Restated Certificate of Incorporation of the Registrant, filed on September 4, 2024 (incorporated by reference to Registrant’s Registration Statement No. 333-290808, filed on October 10, 2025)
3.5
Bylaws of the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-260931, filed on April 20, 2022)
3.6
Certificate of Designations, Rights and Preferences for Series A Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on February 22, 2024)
3.7
Amendment to Certificate of Designations, Rights and Preferences for Series A Preferred Stock (incorporated by reference to the Registrant’s Registration Statement No. 333-281531, filed on September 9, 2024)
3.8
Certificate of Designations, Rights and Preferences for Series B Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on September 6, 2024)
4.1
Form of Representative’s Warrant in connection with the Registrant’s Initial Public Offering (incorporated by reference to the Registrant’s Registration Statement No. 333-260931, filed on April 15, 2022)
4.2
Form of publicly traded Warrant issued on June 16, 2023 (Incorporated by reference to exhibit 4.1 the Registrant’s Registration Statement No. 333-272488, filed on June 7, 2023)
4.3
Form of Warrant Agency Agreement between the Company and VStock Transfer, LLC (incorporated by reference to exhibit 4.3 to the Registrant’s Registration Statement No. 333-272488, filed on June 7, 2023)
4.4
Form of Warrant issued to investors on November 21, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on November 28, 2023)
4.5
Form of Warrant issued to investors in the Series A Preferred Stock on February 20, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on February 22, 2024)
4.6
Form of Warrant issued to the investors in the Series B Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on September 6, 2024)
4.7
Description of Securities of the Registrant (incorporated by reference to the Registrant’s 8-A12B Registration Statement, filed on April 26, 2022)
4.8
Form of Series C-1 Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on March 12, 2025)
4.9
Form of Series C-2 Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on March 12, 2025)
10.1##
Employment Agreement dated June 1, 2021 between Steven M. Foster and the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-260931, filed on April 20, 2022)
10.2##
Employment Agreement dated June 1, 2021 between Richard Ginn and the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-260931, filed on April 20, 2022)
10.3##
Consulting Agreement dated May 7, 2021 by and between Richard Ferrari and the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-260931, filed on April 20, 2022)
10.4
Tennon Medical 2022 Equity Incentive Plan (incorporated by reference to the Registrant’s Registration Statement No. 333-271648, filed on May 4, 2023)
10.5
Amendment to Tenon Medical, Inc. 2022 Equity Incentive Plan, dated as of September 18, 2025 (incorporated by reference to Registrant’s Registration Statement No. 333-290808, filed on October 10, 2025)
25
10.6
Form of Securities Purchase Agreement between the Registrant and Lincoln Park Capital Fund, LLC (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on July 28, 2023)
10.7
Form of Securities Purchase Agreement entered into between the Registrant and investors in the Series A Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on February 22, 2024)
10.8
Form of Securities Purchase Agreement entered into between the Registrant and investors in the November 2023 Notes (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on November 28, 2023)
10.9
Form of Securities Purchase Agreement entered into between the Registrant and investors in the Series B Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on September 6, 2024)
10.10
Form of Inducement Letter, dated March 11, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on March 12, 2025)
19.1
Insider Trading Policy (incorporated by reference to the Registrant’s Annual Report on Form 10-K, filed on March 29, 2024)
21.1
List of Subsidiaries of the Registrant (incorporated by reference to the Registrant’s Registration Statement No. 333-281531, filed on September 9, 2024)
31.1*
Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer and President of Tenon Medical, Inc.
31.2*
Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer of Tenon Medical, Inc.
32.1**
Section 1350 Certification of the President and Chief Executive Officer of Tenon Medical, Inc.
32.2**
Section 1350 Certification of the Chief Financial Officer of Tenon Medical, Inc.
101.INS*
Inline XBRL Instance Document
101.SCH*
Inline XBRL Taxonomy Extension Schema Document
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
##
Denotes management compensation plan, agreement or arrangement
*
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.
26
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: November 13, 2025
/s/ Steven M. Foster
Steven M. Foster
Chief Executive Officer and President, Director
(Principal Executive Officer)
Dated: November 13, 2025
/s/ Kevin Williamson
Kevin Williamson
Chief Financial Officer
(Principal Financial and Accounting Officer)
27
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.