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,
2023
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 to purchase shares of Common Stock, par value $0.001 per share 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 14, 2023, the registrant had a total of 2,471,046 shares
of its common stock, par value $0.001 per share, issued and outstanding.
INDEX
Page
PART I. FINANCIAL INFORMATION
Item 1.
Condensed Consolidated Financial Statements (unaudited)
1
Condensed Consolidated Balance Sheets
1
Condensed Consolidated Statements of Operations and Comprehensive Loss
2
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity
3
Condensed Consolidated Statements of Cash Flows
4
Notes to Condensed Consolidated Financial Statements
5
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
15
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
20
Item 4.
Controls and Procedures
21
PART II. OTHER INFORMATION
Item 1.
Legal Proceedings
22
Item 1A.
Risk Factors
22
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
22
Item 3.
Defaults Upon Senior Securities
22
Item 4.
Mine Safety Disclosures
22
Item 5.
Other Information
23
Item 6.
Exhibits
24
SIGNATURES
25
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;
●
Our ability to protect our intellectual property and to develop, maintain and enhance a strong brand; and
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 Consolidated Financial Statements
Tenon Medical, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share data)
September 30,
December 31,
2023
2022
(Unaudited)
Assets
Current assets:
Cash and cash equivalents
$ 3,371
$ 2,129
Short-term investments
—
6,441
Accounts receivable
773
228
Inventory
474
415
Prepaid expenses
345
134
Total current assets
4,963
9,347
Fixed assets, net
956
793
Deposits
51
51
Operating lease right-of-use asset
704
873
Deferred offering costs
644
25
TOTAL ASSETS
$ 7,318
$ 11,089
Liabilities and Stockholders’ EQUITY
Current liabilities:
Accounts payable
$ 763
$ 550
Accrued expenses
571
717
Current portion of accrued commissions
1,502
1,035
Current portion of operating lease liability
249
228
Total current liabilities
3,085
2,530
Accrued commissions, net of current portion
1,222
1,624
Operating lease liability, net of current portion
494
683
Total liabilities
4,801
4,837
Commitments and contingencies (Note 8)
Stockholders’ equity:
Common stock, $ 0.001 par value; 130,000,000 shares authorized at September 30, 2023 and December 31, 2022; 2,471,014 and 1,123,680 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively
2
1
Additional paid-in capital
54,556
45,843
Accumulated deficit
( 51,939 )
( 39,492 )
Accumulated other comprehensive loss
( 102 )
( 100 )
Total stockholders’ equity
2,517
6,252
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 7,318
$ 11,089
The accompanying notes are an integral part
of these condensed consolidated financial statements.
1
Tenon Medical, Inc.
Condensed Consolidated Statements of Operations
and Comprehensive Loss (Unaudited)
(In thousands, except per share data)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
Revenue
$ 944
$ 208
$ 2,120
$ 414
Cost of sales
409
302
1,438
848
Gross (Loss) Profit
535
( 94 )
682
( 434 )
Operating Expenses
Research and development
737
797
2,472
2,016
Sales and marketing
1,527
645
5,436
2,864
General and administrative
1,649
1,726
5,360
5,483
Total Operating Expenses
3,913
3,168
13,268
10,363
Loss from Operations
( 3,378 )
( 3,262 )
( 12,586 )
( 10,797 )
Other Income (Expense)
Gain on investments
50
72
143
108
Interest expense
( 4 )
—
( 4 )
( 362 )
Other income (expense), net
—
19
—
39
Total Other Income (Expense), net
46
91
139
( 215 )
Net Loss
$ ( 3,332 )
$ ( 3,171 )
$ ( 12,447 )
$ ( 11,012 )
Net Loss Per Share of Common Stock
Basic and diluted
$ ( 1.46 )
$ ( 2.82 )
$ ( 7.91 )
$ ( 15.91 )
Weighted-Average Shares of Common Stock Outstanding
Basic and diluted
2,276
1,124
1,573
692
Consolidated Statements of Comprehensive Loss:
Net loss
$ ( 3,332 )
$ ( 3,171 )
$ ( 12,447 )
$ ( 11,012 )
Unrealized gain (loss) on investments
—
( 10 )
16
( 37 )
Foreign currency translation adjustment
( 30 )
( 19 )
( 18 )
( 40 )
Total comprehensive loss
$ ( 3,362 )
$ ( 3,200 )
$ ( 12,449 )
$ ( 11,089 )
The accompanying notes are an integral part
of these condensed consolidated financial statements.
2
Tenon Medical, Inc.
Condensed Consolidated Statements of Convertible
Preferred Stock and Stockholders’ Equity
(Unaudited)
(In thousands, except share data)
Three Months Ended September 30, 2023 and 2022:
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 June 30, 2023
—
$ —
—
$ —
2,162,377
$ 2
$ 49,580
$ ( 48,607 )
$ ( 72 )
$ 903
Stock-based
compensation expense
—
—
—
—
—
—
1,070
—
—
1,070
Release
of restricted stock units
—
—
—
—
5,124
—
—
—
—
—
Issuance
of common stock, net of issuance costs
—
—
—
—
204,604
—
453
—
—
453
Common
stock issued for services
—
—
—
—
98,909
—
289
—
—
289
Reclassification
of warrant liability to equity
—
—
—
—
—
—
3,164
—
—
3,164
Other
comprehensive income
—
—
—
—
—
—
—
—
( 30 )
( 30 )
Net
loss
—
—
—
—
—
—
—
( 3,332 )
—
( 3,332 )
Balance
at September 30, 2023
—
$ —
—
$ —
2,471,014
$ 2
$ 54,556
$ ( 51,939 )
$ ( 102 )
$ 2,517
Balance
at June 30, 2022
—
$ —
—
$ —
1,123,680
$ 1
$ 43,667
$ ( 28,416 )
$ ( 139 )
$ 15,113
Stock-based
compensation expense
—
—
—
—
—
—
1,034
—
—
1,034
Other
comprehensive income
—
—
—
—
—
—
—
—
( 29 )
( 29 )
Net
loss
—
—
—
—
—
—
—
( 3,171 )
—
( 3,171 )
Balance
at September 30, 2022
—
$ —
—
$ —
1,123,680
$ 1
$ 44,701
$ ( 31,587 )
$ ( 168 )
$ 12,947
Nine
months ended September 30, 2023 and 2022:
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, 2022
—
$ —
—
$ —
1,123,680
$ 1
$ 45,843
$ ( 39,492 )
$ ( 100 )
$ 6,252
Stock-based
compensation expense
—
—
—
—
—
—
3,164
—
—
3,164
Release
of restricted stock units
—
—
—
—
43,821
—
—
—
—
—
Issuance
of common stock and warrants, net of issuance costs
—
—
—
—
1,000,000
1
1,643
—
—
1,643
Reclassification
of warrant liability to equity
3,164
3,164
Issuance
of common stock, net of issuance costs
—
—
—
—
204,604
—
453
—
—
453
Common
stock issued for services
—
—
—
—
98,909
—
289
—
—
289
Other
comprehensive income
—
—
—
—
—
—
—
—
( 2 )
( 2 )
Net
loss
—
—
—
—
—
—
—
( 12,447 )
—
( 12,447 )
Balance
at September 30, 2023
—
$ —
—
$ —
2,471,014
$ 2
$ 54,556
$ ( 51,939 )
$ ( 102 )
$ 2,517
Balance
at December 31, 2021
2,550,763
$ 12,367
491,222
$ 1,272
98,995
$ —
$ 114
$ ( 20,575 )
$ ( 91 )
$ ( 20,552 )
Stock-based
compensation expense
—
—
—
—
—
—
1,755
—
—
1,755
Issuance
of common stock and warrants, net of issuance costs
—
—
—
—
320,000
—
13,765
—
—
13,765
Common
stock issued upon conversion of Series A preferred stock
( 2,550,763 )
( 12,367 )
—
—
244,773
—
12,367
12,367
Common
stock issued upon conversion of Series B preferred stock
—
—
( 491,222 )
( 1,272 )
24,561
—
1,272
1,272
Common
stock issued upon conversion of debt
—
—
—
—
395,542
1
13,867
—
—
13,868
Common
stock issued for services
—
—
—
—
39,809
—
1,561
—
—
1,561
Other
comprehensive income
—
—
—
—
—
—
—
—
( 77 )
( 77 )
Net
loss
—
—
—
—
—
—
—
( 11,012 )
—
( 11,012 )
Balance
at September 30, 2022
—
$ —
—
$ —
1,123,680
$ 1
$ 44,701
$ ( 31,587 )
$ ( 168 )
$ 12,947
The accompanying notes are an integral part
of these condensed consolidated financial statements.
3
Tenon Medical, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
Nine Months Ended
September 30,
2023
2022
Cash Flows from Operating Activities
Net loss
$ ( 12,447 )
$ ( 11,012 )
Adjustments to reconcile net loss to net cash used in operating activities:
Unrealized loss on investments
—
( 37 )
Non-cash interest expense
—
362
Stock-based compensation expense
3,164
1,755
Common stock issued for services
—
1,561
Depreciation and amortization
106
53
Amortization of operating right-of-use asset
169
157
Increase (decrease) in cash resulting from changes in:
Accounts receivable
( 545 )
( 68 )
Inventory
( 59 )
( 622 )
Prepaid expenses and other assets
( 257 )
( 100 )
Accounts payable
213
( 56 )
Accrued expenses
( 81 )
( 485 )
Operating lease liability
( 168 )
( 148 )
Net cash used in operating activities
( 9,905 )
( 8,640 )
Cash Flows from Investing Activities
Sales and maturities of short-term investments
6,996
4,404
Purchases of short-term investments
( 493 )
( 9,381 )
Purchases of fixed assets
( 269 )
( 246 )
Net cash provided by (used in) investing activities
6,234
( 5,223 )
Cash Flows from Financing Activities
Proceeds from issuance of common stock and warrants, net of issuance costs
4,808
14,139
Proceeds from issuance of common stock, net of issuance costs
453
—
Deferred offering costs
( 330 )
—
Net cash provided by financing activities
4,931
14,139
Effect of foreign currency translation on cash flow
( 18 )
( 40 )
Net Increase in Cash and Cash Equivalents
1,242
236
Cash and Cash Equivalents at Beginning of Period
2,129
2,917
Cash and Cash Equivalents at End of Period
$ 3,371
$ 3,153
Supplemental Disclosures of Cash Flow Information
Non-cash investment and financing activities:
Common stock issued upon conversion of preferred stock
$ —
$ 13,639
Common stock issued upon conversion of debt
$ —
$ 13,868
The accompanying notes are an integral part
of these condensed consolidated financial statements.
4
Notes to Condensed Consolidated Financial Statements
(unaudited)(in thousands, except share and per-share data)
1. Organization and Business
Nature of operations
Tenon Medical, Inc. (the “Company”),
was incorporated in the State of Delaware on June 19, 2012 and was headquartered in San Ramon, California until June 2021 when it relocated
to Los Gatos, California. The Company is a medical device company that has developed The Catamaran™ SI Joint Fusion System (“The
Catamaran System”) that offers a novel, less invasive approach to the sacroiliac joint (the “SI Joint”) using a single,
robust, titanium implant for treatment of the most common types of SI Joint disorders that cause lower back pain. The Company received
U.S. Food and Drug Administration (“FDA”) clearance in 2018 for The Catamaran System and is currently focused on the US market.
Principles of consolidation
The condensed consolidated financial statements
of the Company include the accounts of the Company and its wholly-owned subsidiary, Tenon Technology AG (“TTAG”), a Swiss
company. All intercompany balances and transactions have been eliminated in consolidation. The financial statements of TTAG are prepared
for the same reporting period as the parent, using consistent accounting policies in all material respects.
2. Summary of Significant Accounting Principles
Basis of presentation
The accompanying unaudited condensed consolidated
financial statements have been prepared pursuant to the rules and regulations of the United States Securities and Exchange Commission
(the “SEC”). As permitted under these rules and regulations, the Company has condensed or omitted certain financial information
and footnote disclosures normally included in its annual consolidated financial statements prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”). The condensed consolidated balance sheet as of December
31, 2022 has been derived from the Company’s audited consolidated financial statements, which are included in its Annual Report
on Form 10-K filed with the SEC on March 10, 2023.
These condensed consolidated financial statements
have been prepared on the same basis as the Company’s annual consolidated financial statements and, in management’s opinion,
reflect all adjustments, consisting only of normal recurring adjustments, that are necessary for a fair presentation of its financial
information. The interim period operating results do not necessarily indicate the results that may be expected for any other interim period
or for the full fiscal year.
These unaudited condensed consolidated financial
statements and accompanying notes should be read in conjunction with the Company’s audited consolidated financial statements as
of and for the years ended December 31, 2022 and 2021 included in its Annual Report on Form 10-K filed with the SEC on March 10, 2023.
The Company’s significant accounting policies
are disclosed in the audited consolidated financial statements as of and for the years ended December 31, 2022 and 2021. There have been
no material changes in the Company’s significant accounting policies during the nine months ended September 30, 2023.
Going concern uncertainty and liquidity requirements
The accompanying consolidated financial statements
have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the settlement
of liabilities and commitments in the normal course of business. There is substantial doubt about the Company’s ability to continue
as a going concern for one year after the date that these 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 current level of revenues and expenditures, the Company believes that its existing cash and cash equivalents
and short-term investments as of September 30, 2023 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 condensed consolidated financial statements. The Company plans to raise
the necessary additional capital through one or a combination of public or private equity offerings, debt financings, and collaborations.
The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
5
Notices from Nasdaq
On July 20, 2023, the Company received a letter
from the Nasdaq Listing Qualifications Staff of Nasdaq therein stating that for the 30 consecutive business day period between June 6,
2023 through July 19, 2023, the common stock of the Company had not maintained a minimum closing bid price of $ 1.00 per share required
for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). Pursuant
to Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar days, or until January 16, 2024 (the
“Compliance Period”), to regain compliance with the Bid Price Rule.
To regain compliance, the closing bid price of
the Company’s common stock must meet or exceed $ 1.00 per share for a minimum of 10 consecutive trading days, unless extended by
Nasdaq under Nasdaq Rule 5810(c)(3)(H), prior to January 16, 2024.
If the Company does not regain compliance with
the Bid Price Rule by January 16, 2024, the Company may be eligible for an additional 180-day period to regain compliance. To qualify,
the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial
listing standards for The Nasdaq Capital Market, with the exception of the Bid Price Rule, and would need to provide written notice of
its intention to cure the bid price deficiency during the second compliance period, by effecting a reverse stock split, if necessary.
On September 13, 2023, the Company’s shareholders
approved a plan to effect a reverse stock split of the Company’s common stock in a ratio ranging from 1-for-2 and 1-for-10, as determined
by the Company’s Board of Directors, in its discretion. On November 2, 2023, the Company effected a 1-for-10 reverse stock split
as further explained below.
On May 17, 2023, the Company received a written
notice from Nasdaq notifying the Company that it is no longer in compliance with Nasdaq Rule 5550(b)(1), the minimum stockholders’
equity requirement of $ 2,500,000 for continued listing on The Nasdaq Capital Market (the “Minimum Equity Requirement”).
On June 16, 2023, the Company consummated a public
offering (the “Public Offering”) of 1,000,000 units, each unit consisting of one share of the Company’s common stock
and two warrants, each to purchase one share of the Company’s common stock in which it received net proceeds of $ 4,866,000 . As of
July 14, 2023, the Company believes it is in compliance with the Minimum Equity Requirement as a result of the Public Offering.
Nasdaq will continue to monitor the Company’s
ongoing compliance with the Minimum Equity Requirement and, if at the time of its next periodic report the Company does not evidence compliance,
it may be subject to delisting.
Use of estimates
The preparation of the consolidated financial
statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect certain reported amounts and
disclosures. Accordingly, actual results could differ from those estimates. Significant estimates made by management include, but are
not limited to, realization of deferred tax assets, accrued liabilities, accrued commissions, incremental borrowing rate, obsolescence
of inventory, stock-based compensation and the fair value of investments, inventory and of the Company’s common stock.
Reverse Stock Splits
On April 6, 2022, the Company effected a 1-for-2
reverse stock split (the “2022 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 2022 Reverse Stock Split combined every two shares of our common
stock issued and outstanding immediately prior to effecting the 2022 Reverse Stock Split into one share of common stock. Similarly, shares
of Series A and Series B Preferred Stock became convertible into common stock at a conversion rate of one-to-0.5, subject to adjustments
for stock dividends, splits, combinations, and similar events. No fractional shares were issued in connection with the 2022 Reverse Stock
Split.
6
On November 2, 2023, the Company effected a 1-for-10
reverse stock split (the “2023 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 2023 Reverse Stock Split combined every ten shares of our common
stock issued and outstanding immediately prior to effecting the 2023 Reverse Stock Split into one share of common stock. No fractional
shares were issued in connection with the 2023 Reverse Stock Split. All historical share and per share amounts reflected throughout this
document have been adjusted to reflect the 2022 Reverse Stock Split and the 2023 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 2022 Reverse Stock Split or the 2023 Reverse
Stock Split.
Income Taxes
The Company accounts for income taxes utilizing
ASC 740, “Income Taxes”. ASC 740 requires the measurement of deferred tax assets for deductible temporary differences and
operating loss carry forwards, and of deferred tax liabilities for taxable temporary differences. Measurement of current and deferred
tax liabilities and assets is based on provisions of enacted tax law. The effects of future changes in tax laws or rates are not included
in the measurement. The Company recognizes the amount of taxes payable or refundable for the current year and recognizes deferred tax
liabilities and assets for the expected future tax consequences of events and transactions that have been recognized in the Company’s
financial statements or tax returns. The Company currently has substantial net operating loss carry forwards. The Company has recorded
a 100 % valuation allowance against net deferred tax assets due to uncertainty of their ultimate realization. Valuation allowances are
established when necessary to reduce deferred tax assets to the amount expected to be realized.
Net loss per share
Basic net loss per share is based upon the weighted
average number of common shares outstanding. Diluted net loss per share is based on the assumption that all potential common stock equivalents
(convertible preferred stock, stock options, and warrants) are converted or exercised. The calculation of diluted net loss per share excludes
potential common stock equivalents if the effect is anti-dilutive. The Company’s weighted average common shares outstanding for
basic and diluted are the same because the effect of the potential common stock equivalents is anti-dilutive.
The Company had the following dilutive common
stock equivalents as of September 30, 2023 and 2022 which were excluded from the calculation because their effect was anti-dilutive:
September 30,
2023
2022
Outstanding restricted stock units
95,407
131,853
Outstanding stock options
99,834
84,134
Outstanding warrants
2,009,600
12,100
Total
2,204,841
228,087
Recent
Accounting Pronouncements Adopted
In June
2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-13, “Financial Instruments-Credit Losses
(Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). This standard requires an impairment
model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses.
Under the new guidance, each reporting entity estimates an allowance for expected credit losses, which is intended to result in more
timely recognition of losses. The new standard applies to trade receivables arising from revenue transactions such as contract assets
and accounts receivable. When trade receivables are recorded, they become subject to the CECL model and estimates of expected credit losses
on trade receivables over their contractual life will be recorded at inception based on historical information, current conditions, and
reasonable and supportable forecasts. The Company adopted ASU 2016-13 as of January 1, 2023. The adoption had no material impact
on its results of operations or on its condensed consolidated financial statements.
7
Recent
Accounting Pronouncements Not Yet Adopted
There have been no accounting pronouncements or
changes in accounting pronouncements in the nine months ended September 30, 2023 that are significant or potentially significant to the
Company.
3. Investments
The following table sets forth by level, within
the fair value hierarchy, the Company’s investments at fair value as of September 30, 2023 and December 31, 2022:
Level 2
Corporate debt securities:
September 30, 2023
$ —
December 31, 2022
$ 6,441
Cost and fair value of available-for-sale investments
as of September 30, 2023 and December 31, 2022 are as follows:
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair
Value
Corporate debt securities:
September 30, 2023
$ —
$ —
$ —
$ —
December 31, 2022
$ 6,457
$ —
$ ( 16 )
$ 6,441
All of the investments with gross unrealized losses
have been in a continuous loss position for less than 12 months.
During the three and nine months ended September
30, 2023 and 2022, the Company did not recognize any significant other-than-temporary impairment losses because the Company does not intend
to sell the investments before recovery of their amortized cost bases.
During the three and nine months ended September
30, 2023, there were net gains of approximately $ 51 and $ 144 , respectively, included in the Company’s net loss. During the three
and nine months ended September 30, 2022, there were net gains of approximately $ 72 and $ 108 , respectively, included in the Company’s
net loss. Accrued interest as of September 30, 2023 and December 31, 2022 was approximately $ 0 and $ 13 , respectively, and is included
in prepaid expenses in the Company’s condensed consolidated balance sheets.
4. Fixed Assets, Net
Fixed assets, net, consisted of the following:
September 30,
2023
December 31,
2022
Catamaran tray sets
$ 538
$ 193
Construction in progress
510
601
IT equipment
56
56
Leasehold improvements
15
—
Lab equipment
14
14
Office furniture
9
9
Fixed assets, gross
1,142
873
Less: accumulated depreciation
( 186 )
( 80 )
Fixed assets, net
$ 956
$ 793
Construction in progress is made up of reusable
components that will become Catamaran Tray Sets. Depreciation expense was approximately $ 46 and $ 24 for the three months ended September
30, 2023 and 2022, respectively. Depreciation expense was approximately $ 106 and $ 53 for the nine months ended September 30, 2023 and
2022, respectively.
8
5. Accrued Expenses
Accrued expenses consisted of the following:
September 30,
2023
December 31,
2022
Accrued compensation
$ 306
$ 452
Other accrued expenses
265
265
Total accrued expenses
$ 571
$ 717
6. Leases
In June 2021, the Company entered into a facility
lease agreement for its company headquarters in Los Gatos, California. This non-cancellable operating lease expires in June 2026. The
Company includes options that are reasonably certain to be exercised as part of the determination of lease terms. The Company may negotiate
termination clauses in anticipation of any changes in market conditions, but generally these termination options are not exercised. Residual
value guarantees are generally not included within operating leases. In addition to base rent payments, leases may require the Company
to pay directly for taxes and other non-lease components, such as insurance, maintenance, and other operating expenses, which
may be dependent on usage or vary month-to-month. Non-lease components were considered and determined not to be material. The Company
determined if an arrangement is a lease at inception of the contract and performed the lease classification test as of the lease commencement
date. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent
the obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the
lease’s commencement date based on the present value of lease payments over the lease term. When a lease did not provide an implicit
rate, the Company used its estimated incremental borrowing rate based on the information available at the commencement date in determining
the present value of future payments.
Operating lease costs for the facility lease were
$ 73 and $ 73 for the three months ended September 30, 2023 and 2022, respectively, and were $ 219 and $ 219 for the nine months ended September
30, 2023 and 2022, respectively. Lease costs are included in general and administrative expenses in the condensed consolidated statements
of operations and comprehensive loss.
Supplemental balance sheet information related
to leases was as follows:
September 30,
December 31,
2023
2022
Operating lease right-of-use assets
$ 704
$ 873
Operating lease liability, current
$ ( 249 )
$ ( 228 )
Operating lease liability, noncurrent
( 494 )
( 683 )
Total operating lease liabilities
$ ( 743 )
$ ( 911 )
Future maturities of operating lease liabilities
as of September 30, 2023 were as follows:
2023
$ 75
2024
301
2025
310
2026
144
Total lease payments
830
Less: imputed interest
( 87 )
Present value of operating lease liabilities
$ 743
Other information:
Cash paid for operating leases for the nine months ended September 30, 2023
$ 218
Cash paid for operating leases for the nine months ended September 30, 2022
$ 212
Remaining lease term - operating leases (in years)
2.75
Average discount rate - operating leases
8.0 %
9
7. Stockholders’ Equity
The Company’s current Amended and Restated
Certificate of Incorporation dated February 18, 2014 authorizes the issuance of 130,000,000 shares of common stock and 20,000,000 shares
of preferred stock, 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. As of September 30, 2023 and December 31, 2022, there were
no shares of Series A Preferred stock or Series B Preferred Stock issued and outstanding.
Initial Public Offering
On April 26, 2022, the Company’s Registration
Statement relating to the IPO was declared effective by the SEC. The IPO consisted of 320,000 shares of common stock, par value $ 0.001
per share at a public offering price of $ 50.00 per share. Pursuant to the Underwriting Agreement dated April 26, 2022, between the Company,
The Benchmark Company, LLC (“Benchmark”) and Valuable Capital Limited (together with Benchmark, the “Underwriters”),
the Company granted the Underwriters warrants to purchase a total of 9,600 shares of the Company’s common stock at an exercise price
of $ 50.00 per share. The warrants expire on the fifth anniversary of the commencement of sales under the IPO. On April 27, 2022, the shares
of the Company’s common stock began trading on the Nasdaq Capital Market LLC under the symbol “TNON.”
On April 29, 2022, the IPO closed, and the Company
received approximately $ 13.8 million in net proceeds from the IPO after deducting the underwriting discount and commission and other estimated
IPO expenses payable by the Company. As a result of the completion of the IPO, the Company converted the entirety of the outstanding principal
and accrued interest of the convertible notes payable to 395,542 shares of the Company’s common stock.
On April 29, 2022, as result of the completion
of the IPO, the Company converted all shares of Series A and Series B Preferred Stock to 269,334 shares of the Company’s common
stock at the conversion rate detailed below and issued the common stock to the preferred stockholders.
Concurrent with the completion of the IPO and
in accordance with the Amended and Restated Exclusive Sales Representative Agreement executed in May 2021, the counterparty to the agreement
received anti-dilution protections to maintain ownership of 3.0 % of the fully diluted equity of the Company through the date of an initial
public offering and was issued 31,235 shares of the Company’s common stock to the Representative, fully satisfying the Company’s
obligations. Also, as a result of the completion of the IPO, the Company issued 8,574 shares of its common stock to a consultant. The
value of these shares issued at the IPO price of $ 50.00 per share was charged to operating expenses in the Company’s consolidated
financial statements.
Registered Offering
On June 16, 2023, the Company closed the Registered
Offering of a total of 1,000,000 units (the “Units”) for proceeds, net of issuance costs, of $ 4,808 , with each Unit consisting
of (i) one share of the Company’s common stock, and (ii) two warrants, each warrant to purchase one share of the Company’s
common stock at an exercise price equal to $ 5.60 per share (the “Offering Warrants”). The Offering Warrants were exercisable
upon issuance and will expire five years from the date of issuance. Per the terms of the Offering Warrants, the exercise price reset subsequent
to quarter end on July 16, 2023 to $ 3.146 per share.
At-the-Market Offering Program
On May 4, 2023, the Company entered into an Equity
Distribution Agreement to establish an at-the-market offering program, under which the Company may sell from time to time, at its option,
shares of its common stock having an aggregate gross sales price of $ 5.5 million. The Company is required to pay the Sales Agents a commission
of 3 % of the gross proceeds from the sale of shares and has also agreed to provide the Sales Agents with customary indemnification rights.
During the three and nine months ended September 30, 2023, 204,604 shares of the Company’s common stock were sold under the program
at a weighted-average price of $ 2.28 per share with aggregate net proceeds of $ 452 .
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”), the Company filed a registration statement
with the Securities and Exchange Commission (the “SEC”), covering the resale of shares of common stock issued to Lincoln Park
under the Purchase Agreement.
10
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.
Voting rights
The holders of vested shares of common stock are
entitled to vote on any matter submitted to a vote of the stockholders and each such holder is entitled to one vote per share of common
stock held. The holders of Series A and Series B Preferred Stock were entitled to vote together with the common stock as a single class
on any matter submitted to a vote of the stockholders. Holders of Series A and Series B Preferred Stock were entitled to the number of
votes equal to the number of common stock issuable upon conversion of their respective Series A and Series B Preferred Stock at the time
such shares are voted. The holders of a majority of the preferred stock had additional voting rights as specified in the Company’s
Amended and Restated Certificate of Incorporation, as amended.
Equity awards
In 2012, the Board of Directors of the Company
(the “Board”) approved the Tenon Medical, Inc. 2012 Equity Incentive Plan (the “2012 Plan”). The 2012 Plan provided
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.
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 initial number of shares of common stock subject to awards and sold under the 2022 Plan was
160,000. The 2022 Plan calls for automatic annual increases in the number of shares available for issuance equal to the least of (a) 110,000
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.
Compensation expense for the three and nine months
ended September 30, 2023 and 2022 includes the portion of awards vested in the periods for all equity-based awards granted, based on the
grant date fair value estimated using a Black-Scholes option valuation model.
11
A summary of the Company’s stock option
and restricted stock unit activity under its plans is as follows:
Stock Options
Restricted Stock Units
Number of
Shares Subject
to Outstanding
Stock Options
Weighted
Average
Exercise
Price per
Share
Number of
Outstanding
Restricted Stock
Units
Weighted
Average Grant
Date Fair
Value per
Share
Outstanding at December 31, 2022
89,884
$ 47.42
131,853
$ 79.29
Granted
12,050
$ 15.62
7,500
2.91
Released
—
—
( 43,946 )
$ 79.29
Canceled/Forfeited
( 2,100 )
$ 35.53
—
—
Outstanding at September 30, 2023
99,834
$ 43.83
95,407
$ 73.28
The following table sets forth stock-based compensation
expense recognized for the three and nine months ended September 30, 2023 and 2022:
Three months ended
September 30,
Nine months ended
September 30,
2023
2022
2023
2022
Research and development
$ 380
$ 374
$ 1,130
$ 581
Sales and marketing
55
37
171
61
General, and administrative
635
623
1,863
1,113
Total stock-based compensation expense
$ 1,070
$ 1,034
$ 3,164
$ 721
At September 30, 2023, there were 38,500 shares
available for issuance under the 2022 Plan.
Warrants
In April 2022, as noted above, the Company granted
the Underwriters warrants to purchase a total of 9,600 shares of the Company’s common stock. The warrants are immediately exercisable
at an exercise price of $ 50.00 per share and expire on the fifth anniversary of the commencement of sales under the IPO. The fair value
of the warrants on the grant date was $ 27.50 per warrant, which was calculated based on the following weighted average assumptions, using
a Black-Scholes option valuation model: expected term of 5.00 years; expected volatility of 62.55 %; dividend yield of 0 %; and risk-free
interest rate of 2.92 %. The Company recorded the fair value of these warrants of approximately $ 264 as an issuance cost to additional
paid-in capital in 2022. As the IPO issuance costs were also recorded to additional paid-in capital, the net impact was $ 0 .
In June 2023, as noted above, in connection with
the Registered Offering, the Company issued Offering Warrants to purchase a total of 2,000,000 shares of the Company’s common stock.
The Offering Warrants were exercisable upon issuance at an exercise price of $ 5.60 per share and will expire five years from the date
of issuance. Per the terms of the Offering Warrants, the exercise price of the Offering Warrants reset on July 16, 2023, to a price equal
to the greater of (i) $ 2.80 per share and (ii) 100 % of the last VWAP (as defined in the Warrants) on July 14, 2023, which was $ 3.146 per
share. The fair value of the Offering Warrants on the grant date was approximately $ 3,164 , or $ 1.58 per warrant, which was calculated
using a Monte-Carlo simulation to estimate the final exercise price, which is considered a Level 3 fair value measurement, using as inputs;
the starting value of $ 3.00 per share, the Company’s VWAP on June 16; an assumed daily distribution of returns; a mean daily return
of 5.18 %; a short-term annual volatility of 100 % and a standard deviation of 6.3 %. The model used Black-Scholes to then calculate the
estimated fair value of the Offering Warrants, using an estimated time to maturity of 4.9 years, a risk-free interest rate of 3.99 % and
a long-term volatility of 60 %. Based on the accounting guidance under ASC 815, the Company determined that the Offering Warrants did not
meet the criteria for classification as equity as of June 30, 2023. Accordingly, the Company classified the fair value of the Offering
Warrants as a liability. As of July 16, 2023, with the resolution of the reset value, the Company has determined that the Offering Warrants
do meet the criteria for classification as equity and the fair value of the Offering Warrants has been reclassified to additional paid-in
capital on the Company’s consolidated balance sheet as of that date.
12
8. Commitments and Contingencies
Sales Representative Agreement
In April 2020, the Company entered into an Exclusive
Sales Representative Agreement, under which the counterparty to the agreement (the “Representative”) received exclusive rights
to market, promote, and distribute The Catamaran System in the United States and Puerto Rico. The agreement is for an initial period of
five years , and automatically renews for an additional five years unless written notice is given by either party prior to April 27, 2023.
The agreement provides for a bonus to be paid to the Representative upon an acquisition or IPO. In May 2021, the Company entered into
an Amended and Restated Exclusive Sales Representative Agreement (the “Restated Sales Agreement”). In connection with the
amended agreement, the Company paid $ 500 cash and issued 53,757 shares of common stock to the Representative, for which the Company recorded
a combined total of 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 is expensing the $ 85 per charges
as incurred over the six-month period. For payments under clause (b) and clause (c) above, the Company estimated the fair value of the
liability using level 3 hierarchy inputs based on a Monte Carlo simulation of future revenues with a 25 % quarterly estimated standard
deviation of growth rates and a 10 % probability of dissolution, discounted at an estimated discount rate of 15.4 %. Based on the Company’s
fair value analysis, a total of $ 2,611 was charged to sales and marketing expense in the consolidated statements of operations and comprehensive
loss and recorded as accrued commissions in the consolidated balance sheets. A reconciliation of the liability under clause (b) and clause
(c) for the nine months ended September 30, 2023 is as follows:
2023
Balance at December 31, 2022
$ 2,560
Amounts paid during 2023
( 406 )
Accretion
381
Balance at September 30, 2023
$ 2,535
Per the terms of the Termination Agreement, the
Company ultimately expects to expense $ 3,600 under clause (b) and clause (c).
Simultaneously with the execution of the Termination
Agreement, the Company entered into a Consulting Agreement dated October 6, 2022, with the Representative (the “Consulting Agreement”).
Under the terms and conditions of the Consulting Agreement, the Representative is tasked with organizing, recruiting, training, and coordinating
the Company’s Clinical Specialist program, Physician Education program and Sales Education program as more specifically described
in the Consulting Agreement.
The term of the Consulting Agreement is from October
6, 2022, until October 05, 2023, unless extended by mutual agreement of the parties in writing for additional one-year terms, or terminated
in accordance with the terms of the Consulting Agreement. In consideration for the services to be provided, the Company shall pay the
Representative a base consulting fee of $ 700 per year, payable in monthly instalments, along with additional compensation of up to $ 62.5
per quarter, if certain sales targets are met, for four quarters; along with any travel and related out-of-pocket expenses incurred by
the Representative in connection with the performance of the services.
13
Litigation
In the normal course of business, the Company
may possibly be named as a defendant in various lawsuits.
9. Concentrations of Risk
Credit risk
Financial instruments that potentially subject
the Company to concentrations of credit risk consist principally of cash and cash equivalents.
The Company maintains cash balances at financial
institutions located in California and Switzerland. Accounts at the U.S. financial institutions are secured by the Federal Deposit Insurance
Corporation. At times, balances may exceed federally insured limits. The Company has not experienced any losses in such accounts. Management
believes that the Company is not exposed to any significant credit risk with respect to its cash and cash equivalents.
The Company grants unsecured credit to its customers
based on an evaluation of the customer’s financial condition and a cash deposit is generally not required. Management believes its
credit policies do not result in significant adverse risk and historically has not experienced significant credit-related losses.
Currency risk
The Company’s subsidiary, Tenon Technology
AG, realizes a portion of its expenses in Swiss francs. Consequently, certain assets and liabilities are exposed to foreign currency fluctuations.
At September 30, 2023 and December 31, 2022, approximately $ 687 and $ 8 , respectively, of the Company’s net monetary assets were
denominated in Swiss francs. The Company has not entered into any hedging transactions to reduce the exposure to currency risk.
10. Subsequent Events
On November 2, 2023, the Company effected the
2023 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 2023 Reverse Stock Split combined every ten shares of our common stock issued and outstanding
immediately prior to effecting the 2023 Reverse Stock Split into one share of common stock. No fractional shares were issued in connection
with the 2023 Reverse Stock Split. All historical and per share amounts reflected throughout this document have been adjusted to reflect
the 2022 Reverse Stock Split and the 2023 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 2022 Reverse Stock Split or the 2023 Reverse Stock Split.
14
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis is intended
as a review of significant factors affecting our financial condition and results of operations for the periods indicated. The discussion
should be read in conjunction with our unaudited condensed consolidated financial statements and the related notes included elsewhere
in this Quarterly Report on Form 10-Q and the audited financial statements and the other information set forth in the Registration Statement.
In addition to historical information, the following Management’s Discussion and Analysis of Financial Condition and Results of
Operations contains forward-looking statements that involve risks and uncertainties. Our actual results could differ significantly from
those anticipated in these forward-looking statements as a result of certain factors discussed herein and any other periodic reports filed
and to be filed with the SEC.
Overview
Tenon Medical, Inc., a medical device company
formed in 2012, has developed a proprietary, U.S. Food and Drug Administration (“FDA”) approved surgical implant-system, which
we call The Catamaran™ SI Joint Fusion System (“The Catamaran System”). The Catamaran System offers a novel, less invasive
inferior-posterior approach to the sacroiliac joint (“SI Joint”) using a single, robust titanium implant to treat SI Joint
dysfunction that often causes severe lower back pain. The system features the Catamaran™ Fixation Device which passes through both
the axial and sagittal planes of the ilium and sacrum, transfixing the SI Joint along its longitudinal axis. Published clinical studies
have shown that 15% to 30% of all chronic lower back pain is associated with the SI Joint.
With an entry similar to the SI Joint injection,
the surgical approach is direct to the joint. The angle and trajectory of the inferior-posterior approach is designed to point away from
critical neural and vascular structures and into the strongest cortical bone. Joined by a patented osteotome bridge, the implant design
consists of two hollow fenestrated pontoons with an open framework to facilitate bony in-growth through the SI Joint. One pontoon fixates
into the ilium and the other into the sacrum. The osteotome is designed to disrupt the articular portion of the joint to help facilitate
a fusion response.
Our initial clinical results indicate that The
Catamaran System implant is promoting fusion across the joint as evidenced by computerized tomography (CT) scans which is the gold standard
widely accepted by the clinical community. We had our national launch of The Catamaran System in October 2022 and are building a sales
and marketing infrastructure to market our product and address the greatly underserved market opportunity that exists.
We believe that the implant design and procedure
we have developed, along with the 2D and 3D protocols for proper implantation will be received well by the clinician community who have
been looking for a next generation device.
We have incurred net losses since our inception
in 2012. As of September 30, 2023, we had an accumulated deficit of approximately $51.9 million. To date, we have financed our operations
primarily through an initial public offering, private placements of equity securities, certain debt-related financing arrangements, and
sales of our product. We have devoted substantially all of our resources to research and development, regulatory matters and sales and
marketing of our product.
Components of Results of Operations
Revenue
We derive substantially all our revenue from sales
of The Catamaran System to a limited number of clinicians. Revenue from sales of The Catamaran System fluctuates based on volume of cases
(procedures performed), discounts, and the number of implants used for a particular patient. Similar to other orthopedic companies, our
revenue can also fluctuate from quarter to quarter due to a variety of factors, including reimbursement, changes in independent sales
representatives and physician activities.
Cost of Goods Sold, Gross Profit, and Gross
Margin
We utilize contract manufacturers for production
of The Catamaran System implants and Catamaran Tray Sets. Cost of goods sold consists primarily of costs of the components of The Catamaran
System implants and instruments, quality inspection, packaging, scrap and inventory obsolescence, as well as distribution-related expenses
such as logistics and shipping costs. We anticipate that our cost of goods sold will increase in absolute dollars as case levels increase.
15
Our gross margins have been and will continue
to be affected by a variety of factors, including the cost to have our product manufactured for us, pricing pressure from increasing competition,
and the factors described above impacting our revenue.
Operating Expenses
Our operating expenses consist of sales and marketing,
research and development, and general and administrative expenses. Personnel costs are the most significant component of operating expenses
and consist of consulting expenses, salaries, sales commissions and other cash and stock-based compensation related expenses. We expect
operating expenses to increase in absolute dollars as we continue to invest and grow our business.
Sales and Marketing Expenses
Sales and marketing expenses primarily consist
of independent sales representative training and commissions in addition to salaries and stock-based compensation expense. Starting in
May 2021, commissions to our national distributor have been based on a percentage of sales and we anticipate that these commissions will
make up a significant portion of our sales and marketing expenses. We expect our sales and marketing expenses to increase in absolute
dollars with the commercial launch of The Catamaran System resulting in higher commissions and salaries, increased clinician and sales
representative training, and the start of clinical studies to gain wider clinician adoption of The Catamaran System. Our sales and marketing
expenses may fluctuate from period to period due to timing of sales and marketing activities related to the commercial launch 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 development of our product. Research and development expenses also include related
personnel and consultants’ compensation and stock-based compensation expense. We expense research and development costs as they
are incurred. We expect research and development expense to increase in absolute dollars as we improve The Catamaran System, develop new
products, add research and development personnel, and undergo clinical activities that may be required for regulatory clearances of future
products.
General and Administrative Expenses
General and administrative expenses primarily
consist of salaries, consultants’ compensation, stock-based compensation expense, and other costs for finance, accounting, legal,
compliance, and administrative matters. We expect our general and administrative expenses to increase in absolute dollars as we add personnel
and information technology infrastructure to support the growth of our business. We also expect to incur additional general and administrative
expenses as a result of operating as a public company, including but not limited to: expenses related to compliance with the rules and
regulations of the SEC and those of The Nasdaq Stock Market LLC on which our securities are traded; additional insurance expenses; investor
relations activities; and other administrative and professional services. While we expect the general and administrative expenses to increase
in absolute dollars, we anticipate that it will decrease as a percentage of revenue over time.
Gain (Loss) on Investments, Interest Expense
and Other Income (Expense), Net
Gain (loss) 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 and includes deemed interest derived from the beneficial conversion prices of notes payable. Other income and
expenses have not been significant to date.
16
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,
Consolidated Statements of Operations Data:
2023
2022
2023
2022
Revenue
$ 944
$ 208
$ 2,120
$ 414
Cost of goods sold
409
302
1,438
848
Gross (loss) profit
535
(94 )
682
(434 )
Operating expenses:
Research and development
737
797
2,472
2,016
Sales and marketing
1,527
645
5,436
2,864
General and administrative
1,649
1,726
5,360
5,483
Total operating expenses
3.913
3,168
13,268
10,363
Loss from operations
(3,378 )
(3,262 )
(12,586 )
(10,797 )
Interest and other income (expense), net:
Gain on investments
50
72
143
108
Interest expense
(4 )
—
(4 )
(362 )
Other income (expense)
—
19
—
39
Net loss
$ (3,332 )
$ (3,171 )
$ (12,447 )
$ (11,012 )
The following table sets forth our results of
operations as a percentage of revenue:
Three Months Ended
September 30,
Nine Months Ended
September 30,
Consolidated Statements of Operations Data:
2023
2022
2023
2022
Revenue
100 %
100 %
100 %
100 %
Cost of goods sold
43
145
68
205
Gross profit
57
(45 )
32
(105 )
Operating expenses:
Research and development
78
383
117
487
Sales and marketing
162
310
256
692
General and administrative
175
830
253
1,324
Total operating expenses
415
1,523
626
2,503
Loss from operations
(358 )
(1,568 )
(594 )
(2,608
Interest and other income (expense), net:
Gain on investments
5
35
7
26
Interest expense
—
—
—
(87 )
Other expense
—
9
—
9
Net loss
(353 )%
(1,525 )%
(587 )%
(2,660 )%
Comparison of the Three and Nine Months Ended September 30, 2023
and 2022 (in thousands, except percentages)
Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin
Three Months Ended
September 30,
2023
2022
$ Change
% Change
Revenue
$ 944
$ 208
$ 736
354 %
Cost of goods sold
409
302
107
35 %
Gross (loss) profit
$ 535
$ (94 )
$ 629
(669 )%
Gross (loss) profit percentage
57 %
(45 )%
Nine Months Ended
September 30,
2023
2022
$ Change
% Change
Revenue
$ 2,120
$ 414
$ 1,706
412 %
Cost of goods sold
1,438
848
590
70 %
Gross (loss) profit
$ 682
$ (434 )
$ 1,116
(257 )%
Gross (loss) profit percentage
32 %
(105 )%
17
Revenue. The increase in revenue for
the three and nine months ended September 30, 2023 as compared to the same periods in 2022 was primarily due to increases of 329% and
404%, respectively, in the number of surgical procedures in which The Catamaran System was used.
Cost of Goods Sold, Gross Profit, and Gross
Margin. The increase in cost of goods sold for the three and nine months ended September 30, 2023 as compared to the same periods
in 2022 was due to increases of 329% and 404%, respectively, in the number of surgical procedures performed. Gross loss and gross margin
percentage improved due to higher revenue associated with the increase in the number of surgical procedures.
Operating Expenses
Three Months Ended September 30,
2023
2022
$ Change
% Change
Research and development
$ 737
$ 797
$ (60 )
(8 )%
Sales and marketing
1,527
645
882
137 %
General and administrative
1,649
1,726
(77 )
(4 )%
Total operating expenses
$ 3,613
$ 3,168
$ (745 )
24 %
Nine Months Ended September 30,
2023
2022
$ Change
% Change
Research and development
$ 2,472
$ 2,016
$ 456
23 %
Sales and marketing
5,436
2,864
2,572
90 %
General and administrative
5,360
5,483
(123 )
(2 )%
Total operating expenses
$ 13,268
$ 10,363
$ 2,905
30 %
Research and Development Expenses . Research
and development expenses for the three months ended September 30, 2023 decreased as compared to the same period in 2022 primarily due
to decreased professional fees ($64), partially offset by increased payroll expenses ($15).
Research and development expenses for the nine
months ended September 30, 2023 increased as compared to the same period in 2022 primarily due to increased stock-based compensation ($549)
and payroll expenses ($101), partially offset by decreased professional fees ($36).
Sales and Marketing Expenses. Sales
and marketing expenses for the three months ended September 30, 2023 increased as compared to the same period in 2022 primarily due to
increased payroll expenses ($641), SpineSource transition expenses ($203), sales commissions ($75), and stock-based compensation ($18),
partially offset by decreased consulting and professional fees ($54). The increase in payroll and payroll related expenses is primarily
due to the increased number of sales and marketing employees as we build out our sales function.
Sales and marketing expenses for the nine months
ended September 30, 2023 increased as compared to the same period in 2022 primarily due to increased payroll expenses ($1,965), SpineSource
transition expenses ($893), sales commissions ($684) and stock-based compensation ($110), partially offset by decreased consulting and
professional fees ($1,198). The increase in payroll and payroll related expenses is primarily due to the increased number of sales and
marketing employees as we build out our sales function.
General and Administrative Expenses . General
and administrative expenses for the three months ended September 30, 2023 decreased as compared to the same period in 2022 primarily due
to decreased professional service fees ($91) and payroll expenses ($22) partially offset by increased stock-based compensation ($12).
General and administrative expenses for the nine
months ended September 30, 2023 decreased as compared to the same period in 2022 primarily due to a legal settlement accrual in 2022 ($574)
and decreased professional service fees ($603), partially offset by increased stock-based compensation ($738) and payroll expenses ($223).
Gain (Loss) on Investments, Interest Expense
and Other Income (Expense), Net
Gain on investments for the three months ended
September 30, 2023 decreased $22 as compared to the three months ended September 30, 2022. Gain on investments for the nine months ended
September 30, 2023 increased $35 as compared to the nine months ended September 30, 2022 due to interest on our investments in money market
and corporate debt securities. We had no significant interest expense for the three and nine months ended September 30, 2023 and interest
expense for the nine months ended September 30, 2022 of $362 related to our convertible debt.
18
Liquidity and Capital Resources; Going Concern
As of September 30, 2023, we had cash and cash
equivalents and short-term investments of approximately $3.4 million. Since inception, we have financed our operations through private
placements of preferred stock, debt financing arrangements, our initial public offering, a subsequent public offering, issuance of stock
under our Equity Distribution Agreement and the sale of our products. As of September 30, 2023, we had no outstanding debt.
As of September 30, 2023, we had an accumulated
deficit of approximately $51.9 million and expect to incur additional losses in the future. We have not achieved positive cash flow from
operations to date and don’t expect to in the near future. Based upon our current operating plan, our existing cash and cash equivalents
will not be sufficient to fund our operating expenses and working capital requirements through at least the next 12 months from the date
these consolidated financial statements were available to be released. We plan to raise the necessary additional capital through one or
a combination of public or private equity offerings, debt financings, and collaborations. We continue to face challenges and uncertainties
and, as a result, our available capital resources may be consumed more rapidly than currently expected due to (a) the uncertainty of future
revenues from The Catamaran System; (b) changes we may make to the business that affect ongoing operating expenses; (c) changes we may
make in our business strategy; (d) regulatory developments affecting our existing products; (e) changes we may make in our research and
development spending plans; and (f) other items affecting our forecasted level of expenditures and use of cash resources.
As we attempt to raise additional capital to fund
our operations, funding may not be available to us on acceptable terms, or at all. If we are unable to obtain adequate financing when
needed, we may have to delay, reduce the scope of or suspend one or more of our sales and marketing efforts, research and development
activities, or other operations. We may seek to raise any necessary additional capital through a combination of public or private equity
offerings, debt financings, and collaborations. If we do raise additional capital through public or private equity offerings, the ownership
interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences
that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants
limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring
dividends. If we are unable to raise capital, we will need to delay, reduce, or terminate planned activities to reduce costs. Doing so
will likely harm our ability to execute our business plans. Due to the uncertainty in our ability to raise capital, management believes
that there is substantial doubt in our ability to continue as a going concern for the next twelve months from the issuance of these consolidated
financial statements.
We plan to use our cash within the twelve months
from September 30, 2023 and beyond for working capital and research and development.
Contractual Obligations
The following table summarizes our contractual obligations as of September
30, 2023:
Payments Due By Period
(In thousands)
Less than
More than
Total
1 year
1-3 years
4-5 years
5 years
Operating leases
$ 830
$ 75
$ 611
$ 144
$ —
Purchase obligations
—
—
—
—
—
Total
$ 830
$ 75
$ 611
$ 144
$ —
Obligations under Terminated Sales Representative
Agreement : On October 6, 2022, we entered into the Terminating Amended and Restated Exclusive Sales Representative Agreement (the
“Termination Agreement”). In accordance with the Termination Agreement, (i) we paid the Representative $1,000 in cash; and
(ii) we 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 us, (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, we will pay the Representative $3,600 less previous
amounts paid pursuant to clause (b) and clause (c) above. The timing of the payments under clause (b) and (c) is variable depending on
the timing of our sales.
19
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,
2023
2022
$ Change
% Change
Net cash (used in) provided by:
Operating activities
$ (9,905 )
$ (8,640 )
$ (1,265 )
15 %
Investing activities
6,234
(5,223 )
11,457
(219 )%
Financing activities
4,931
14,139
(9,208 )
(65 )%
Effect of foreign currency translation on cash flow
(18 )
(40 )
22
(55 )%
Net increase in cash and cash equivalents
$ 1,242
$ 236
$ (1,006 )
(426 )%
The increase in net cash used in operating activities
for the nine months ended September 30, 2023 as compared to the nine months ended September 30, 2022 was primarily attributable to our
increased net loss of $1.8 million, adjusted for increases in non-cash stock-based compensation expenses ($1,409) and a decrease in common
stock issued for services (1,561), in addition to increases in accounts receivable ($477) and prepaid expenses ($157).
Cash provided by investing activities for the
nine months ended September 30, 2023 consisted primarily of the net sales of short-term investments of approximately $6.5 million to use
to fund our operations, partially offset by purchases of property and equipment of $0.3 million. Cash used in investing activities for
the nine months ended September 30, 2022 consisted primarily of the net purchases of short-term investments of $5.0 million and purchases
of property and equipment of $0.2 million.
Cash provided by financing activities for the
nine months ended September 30, 2023 consisted primarily of the $5.3 million, net of relevant expenses, received from our offerings of
stock in 2023. Cash provided by financing activities for the nine months ended September 30, 2022 consisted of the $14.1 million cash
received from our initial public offering in April 2022, net of relevant expenses.
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, 2023, there were no significant changes
to our existing critical accounting policies from those disclosed on our Annual Report on Form 10-K.
Off-Balance Sheet Arrangements
As of September 30, 2023, and December 31, 2022,
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.”
20
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 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, 2023, we carried out an evaluation,
under the supervision and with the participation of our management, including our Chief Executive Officer 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 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 intend to take measures to cure the aforementioned weaknesses, including, but not limited to, increasing the capacity of
our qualified financial personnel to ensure that accounting policies and procedures are consistent across the organization and that we
have adequate control over our Exchange Act reporting disclosures.
Changes in Internal Control over Financial
Reporting
There have been no changes in our internal control
procedures over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the nine months ended September
30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
21
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEDINGS
ITEM 1A. RISK FACTORS
As a smaller reporting company as defined by Rule
12b-2 of the Securities Exchange Act of 1934, as amended, and in item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting
obligations and therefore are not required to provide the information requested by this item. In any event, there have been no material
changes in our risk factors as previously disclosed in our Annual Report on Form 10-K filed with the U.S. Securities and Securities Exchange
Commission (“SEC”) on March 10, 2023.
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.
22
ITEM 5. OTHER INFORMATION
On September 13, 2023, the Company held its Annual
Meeting of Stockholders. The following are the matters acted upon at the Annual Meeting and the final voting results on each matter.
PROPOSAL 1 — ELECTION OF DIRECTORS
Nominees
For
Withhold
Broker Non-Vote
Richard Ferrari
6,844,269
328,273
5,310,919
Steven M. Foster
6,426,657
745,885
5,310,919
Richard Ginn
6,348,738
823,804
5,310,919
Frank Fischer
6,825,908
346,634
5,310,919
Stephen H. Hochschuler, M.D.
6,620,809
551,733
5,310,919
Ivan Howard
6,745,304
427,238
5,310,919
Robert K. Weigle
6,634,717
537,825
5,310,919
PROPOSAL 2 — TO APPROVE, FOR PURPOSES
OF COMPLYING WITH NASDAQ LISTING RULE 5635(D), THE ISSUANCE OF SHARES OF OUR COMMON STOCK, PAR VALUE $0.001 PER SHARE, PURSUANT TO THE
EQUITY LINE OF CREDIT ISSUED IN 2023
For
Against
Abstain
Broker Non-Vote
6,897,552
237,961
37,029
5,310,919
PROPOSAL 3 — TO APPROVE AN AMENDMENT
TO OUR CERTIFICATE OF INCORPORATION TO EFFECT A REVERSE STOCK SPLIT OF OUR COMMON STOCK AT A REVERSE STOCK SPLIT RATIO RANGING FROM 1:2
TO 1:10, INCLUSIVE, AS DETERMINED BY THE BOARD IN ITS SOLE DISCRETION
For
Against
Abstain
Broker Non-Vote
11,254,895
1,223,008
5,557
12,483,460
PROPOSAL 4 — RATIFICATION OF THE SELECTION
OF ARMANINO LLP AS OUR INDEPENDENT AUDITORS FOR THE FISCAL YEAR ENDING DECEMBER 31, 2023
For
Against
Abstain
Broker Non-Vote
12,322,481
101,752
59,228
12,483,461
PROPOSAL 5: — APPROVAL OF THE ADJOURNMENT
OF THE ANNUAL MEETING, IF NECESSARY OR APPROPRIATE, TO SOLICIT ADDITIONAL PROXIES
For
Against
Abstain
Broker Non-Vote
11,671,040
735,987
76,432
12,483,459
23
ITEM 6. EXHIBITS
EXHIBIT INDEX
Exhibit
Number
Description
3.1#
Second Amended and Restated Certificate of Incorporation of the Registrant.
3.2#
Bylaws of the Registrant.
4.1##
Form of Warrant.
4.2#
Form of Pre-funded Warrant.
4.3#
Form of Warrant Agency Agreement.
4.4##
Form of Securities Purchase Agreement
10.1#
Employment Agreement dated June 1, 2021 between Steven M. Foster and the Registrant.
10.2#
Employment Agreement dated June 1, 2021 between Richard Ginn and the Registrant.
10.3#
Consulting Agreement dated May 7, 2021 by and between Richard Ferrari and the Registrant.
10.4#
Employment Agreement dated June 1, 2021 between Steven Van Dick and the Registrant.
10.5#
Tenon Medical 2022 Equity Incentive Plan.
10.6###
Purchase Agreement dated as of July 24, 2023, by and between Tenon Medical, Inc. and Lincoln Park Capital Fund, LLC
10.7###
Registration Rights Agreement dated as of July 24, 2023, by and between Tenon Medical, Inc. and Lincoln Park Capital Fund, LLC
21.1#
List of Subsidiaries of the Registrant.
31.1*
Rule 13a-14(a)/15d-14(a) Certification of the President and Chief Executive Officer 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)
# Incorporated by reference to the same exhibit number in the
Company’s Registration Statement No. 333-260931, filed with the Securities and Exchange Commission on June 7, 2023.
##
Incorporated by reference to the same exhibit number in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2023 as amended by the Form 8-K/A filed with the Securities and Exchange Commission on July 18, 2023.
###
Incorporated by reference to the same exhibit number in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 28, 2023.
*
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.
24
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 14, 2023
/s/ Steven M. Foster
Steven M. Foster
Chief Executive Officer and President, Director
(Principal Executive Officer)
Dated: November 14, 2023
/s/ Steven Van Dick
Steven Van Dick
Chief Financial Officer
(Principal Financial and Accounting Officer)
25
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.