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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2024
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ________ to ________
Commission
File Number: 001-36445
![](https://www.sec.gov/Archives/edgar/data/1326706/000149315224032138/form10-q_001.jpg)
NanoVibronix,
Inc
(Exact
name of registrant as specified in its charter)
Delaware |
|
01-0801232 |
(State
or other jurisdiction
of
incorporation or organization) |
|
(I.R.S.
Employer
Identification
Number) |
|
|
|
525
Executive Blvd. Elmsford, New York |
|
10523 |
(Address
of principal executive office) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (914) 233-3004
(Former
name, former address and
former
fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share |
|
NAOV |
|
NASDAQ
Capital Market |
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 and every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant has been required to submit
and post 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 ☒
The
number of shares outstanding of the registrant’s Common Stock as of August 14, 2024 was 2,784,354 shares.
NanoVibronix,
Inc.
Quarter
Ended June 30, 2024
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
ITEM
1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NanoVibronix,
Inc.
Condensed
Consolidated Balance Sheets
(Amounts
in thousands except share and per share data)
| |
(Unaudited) June 30, 2024 | | |
December 31, 2023 | |
ASSETS: | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 2,170 | | |
$ | 3,283 | |
Trade receivables | |
| 489 | | |
| 318 | |
Prepaid expenses and other accounts receivable | |
| 296 | | |
| 154 | |
Inventory | |
| 2,431 | | |
| 2,732 | |
Total current assets | |
| 5,386 | | |
| 6,487 | |
| |
| | | |
| | |
Noncurrent assets: | |
| | | |
| | |
Fixed assets, net | |
| 9 | | |
| 7 | |
Other assets | |
| 1 | | |
| 1 | |
Severance pay fund | |
| 167 | | |
| 174 | |
Operating lease right-of-use assets, net | |
| 133 | | |
| 5 | |
Total non-current assets | |
| 310 | | |
| 187 | |
Total assets | |
$ | 5,696 | | |
$ | 6,674 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY: | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Trade payables | |
$ | 92 | | |
$ | 138 | |
Other accounts payable and accrued expenses | |
| 2,383 | | |
| 2,265 | |
Deferred licensing income, current | |
| 37 | | |
| 46 | |
Operating lease liabilities, current | |
| 44 | | |
| 5 | |
Total current liabilities | |
| 2,556 | | |
| 2,454 | |
| |
| | | |
| | |
Non-current liabilities: | |
| | | |
| | |
Accrued severance pay | |
| 209 | | |
| 217 | |
Deferred licensing income, non-current | |
| 1 | | |
| 15 | |
Operating lease liabilities, non-current | |
| 89 | | |
| - | |
Total liabilities | |
| 2,855 | | |
| 2,686 | |
| |
| | | |
| | |
Commitments and contingencies | |
| - | | |
| | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| - | |
Series C Preferred Stock of $0.001 par value – Authorized: 3,000,000 shares at both June 30, 2024 and December 31, 2023; issued and outstanding: 0 shares at both June 30, 2024 and December 31, 2023, respectively | |
| - | | |
| - | |
| |
| | | |
| | |
Series D Preferred Stock of $0.001 par value – Authorized: 506 shares at both June 30, 2024, and December 31, 2023; issued and outstanding: 0 shares at both June 30, 2024 and December 31, 2023, respectively | |
| - | | |
| - | |
| |
| | | |
| | |
Series E Preferred Stock of $0.001 par value – Authorized: 1,999,494 shares at both June 30, 2024 and December 31, 2023, respectively; issued and outstanding: 0 shares at both June 30, 2024 and December 31, 2023, respectively | |
| - | | |
| - | |
| |
| | | |
| | |
Series F Preferred Stock of $0.01 par value – Authorized: 40,000 and 0 shares at June 30, 2024 and December 31, 2023, respectively; issued and outstanding: 0 shares at both June 30, 2024 and December 31, 2023, respectively | |
| - | | |
| - | |
Preferred
stock value | |
| - | | |
| - | |
| |
| | | |
| | |
Common Stock of $0.001 par value – Authorized: 40,000,000 shares at June 30, 2024 and December 31, 2023, respectively; issued and outstanding: 2,784,353 and 2,046,307 shares at June 30, 2024 and December 31, 2023, respectively | |
| 2 | | |
| 2 | |
Additional paid in capital | |
| 70,284 | | |
| 70,149 | |
Accumulated other comprehensive income | |
| (73 | ) | |
| (67 | ) |
Accumulated deficit | |
| (67,372 | ) | |
| (66,096 | ) |
Total stockholders’ equity | |
| 2,841 | | |
| 3,988 | |
Total liabilities and stockholders’ equity | |
$ | 5,696 | | |
$ | 6,674 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
NanoVibronix,
Inc.
Condensed
Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(Amounts
in thousands except share and per share data)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenues | |
$ | 817 | | |
$ | 294 | | |
$ | 1,738 | | |
$ | 648 | |
Cost of revenues | |
| 389 | | |
| 78 | | |
| 646 | | |
| 197 | |
Gross profit | |
| 428 | | |
| 216 | | |
| 1,092 | | |
| 451 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 187 | | |
| 35 | | |
| 308 | | |
| 90 | |
Selling and marketing | |
| 199 | | |
| 227 | | |
| 364 | | |
| 441 | |
General and administrative | |
| 716 | | |
| 963 | | |
| 1,662 | | |
| 1,984 | |
| |
| | | |
| | | |
| | | |
| | |
Total operating expenses | |
| 1,102 | | |
| 1,225 | | |
| 2,334 | | |
| 2,515 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (674 | ) | |
| (1,009 | ) | |
| (1,242 | ) | |
| (2,064 | ) |
| |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (34 | ) | |
| (33 | ) | |
| (68 | ) | |
| (67 | ) |
Financial expense, net | |
| 24 | | |
| (18 | ) | |
| 45 | | |
| (25 | ) |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Income tax expense | |
| (4 | ) | |
| (13 | ) | |
| (11 | ) | |
| (15 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (688 | ) | |
$ | (1,074 | ) | |
$ | (1,276 | ) | |
$ | (2,171 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss available for holders of Common Stock | |
$ | (0.25 | ) | |
$ | (0.65 | ) | |
$ | (0.48 | ) | |
$ | (1.31 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average Common Stock outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 2,784,353 | | |
| 1,662,330 | | |
| 2,648,088 | | |
| 1,657,313 | |
Comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
Net loss available to common stockholders | |
| (688 | ) | |
| (1,074 | ) | |
| (1,276 | ) | |
| (2,171 | ) |
Change in foreign currency translation adjustments | |
| (3 | ) | |
| (30 | ) | |
| (6 | ) | |
| (37 | ) |
Comprehensive loss available to common stockholders | |
| (691 | ) | |
| (1,104 | ) | |
| (1,282 | ) | |
| (2,208 | ) |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
NanoVibronix,
Inc.
Condensed
Consolidated Statement of Stockholders’ Equity (Unaudited)
(Amounts
in thousands except share and per share data)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Income | | |
Deficit | | |
Equity | |
| |
Series C Preferred Stock | | |
Series D Preferred Stock | | |
Series E Preferred Stock | | |
Series F Preferred Stock | | |
Common Stock | | |
Additional Paid - in | | |
Accumulated Other Comprehensive | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Income | | |
Deficit | | |
Equity | |
Balance, December 31, 2023 | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 2,046,307 | | |
$ | 2 | | |
$ | 70,149 | | |
$ | (67 | ) | |
$ | (66,096 | ) | |
$ | 3,988 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Exercise of options | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 135 | | |
| - | | |
| - | | |
| 135 | |
Currency translation adjustment | |
| - | | |
| - | | |
| | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (6 | ) | |
| - | | |
| (6 | ) |
Issuance of Common stock | |
| - | | |
| - | | |
| | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 738,046 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Other comprehensive loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,276 | ) | |
| (1,276 | ) |
Balance, June 30, 2024 | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 2,784,353 | | |
$ | 2 | | |
| 70,284 | | |
$ | (73 | ) | |
| (67,372 | ) | |
| 2,841 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, December 31, 2022 | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 1,641,146 | | |
| 2 | | |
| 65,634 | | |
| (18 | ) | |
| (62,385 | ) | |
| 3,233 | |
Balance | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 1,641,146 | | |
| 2 | | |
| 65,634 | | |
| (18 | ) | |
| (62,385 | ) | |
| 3,233 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 133 | | |
| - | | |
| - | | |
| 133 | |
Currency translation adjustment | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (37 | ) | |
| - | | |
| (37 | ) |
Exercise of pre-funded warrants | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 5,458 | | |
| - | | |
| 7 | | |
| - | | |
| - | | |
| 7 | |
Exercise of options | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Rounding-up of fractional shares due to reverse stock split | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 15,726 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Other comprehensive loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,171 | ) | |
| (2,171 | ) |
Balance, June 30, 2023 | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 1,662,330 | | |
$ | 2 | | |
$ | 65,774 | | |
$ | (55 | ) | |
$ | (64,556 | ) | |
$ | 1,165 | |
Balance | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 1,662,330 | | |
$ | 2 | | |
$ | 65,774 | | |
$ | (55 | ) | |
$ | (64,556 | ) | |
$ | 1,165 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
NanoVibronix,
Inc.
Condensed
Consolidated Statements of Cash Flows (Unaudited)
(Amounts
in thousands except share and per share data)
| |
2024 | | |
2023 | |
| |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (1,276 | ) | |
$ | (2,171 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 1 | | |
| 1 | |
Stock-based compensation | |
| 107 | | |
| 133 | |
Noncash interest expense | |
| 67 | | |
| 67 | |
Change in fair value of equity investment | |
| - | | |
| - | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Trade receivable | |
| (171 | ) | |
| (62 | ) |
Other accounts receivable and prepaid expenses | |
| (142 | ) | |
| 536 | |
Inventory | |
| 301 | | |
| (939 | ) |
Trade payables | |
| (46 | ) | |
| (33 | ) |
Other accounts payable and accrued expenses | |
| 51 | | |
| 85 | |
Deferred revenue | |
| (23 | ) | |
| (44 | ) |
Accrued severance pay, net | |
| (1 | ) | |
| (2 | ) |
Net cash used in operating activities | |
| (1,132 | ) | |
| (2,429 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Purchases of fixed assets | |
| (3 | ) | |
| (1 | ) |
Net cash used in investing activities | |
| (3 | ) | |
| (1 | ) |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from exercise of options | |
| 28 | | |
| 7 | |
Net cash provided by financing activities | |
| 28 | | |
| 7 | |
| |
| | | |
| | |
Effects of currency translation on cash | |
| (6 | ) | |
| (7 | ) |
| |
| | | |
| | |
Net (decrease) increase in cash | |
| (1,113 | ) | |
| (2,430 | ) |
Cash at beginning of period | |
| 3,283 | | |
| 2,713 | |
| |
| | | |
| | |
Cash at end of period | |
$ | 2,170 | | |
$ | 253 | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Cash paid for interest | |
$ | - | | |
$ | - | |
Cash paid for taxes | |
$ | - | | |
$ | - | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
NanoVibronix,
Inc.
Notes
to Condensed Consolidated Financial Statements (Unaudited)
NOTE
1 – DESCRIPTION OF BUSINESS
NanoVibronix,
Inc. (the “Company”), a Delaware corporation, commenced operations on October 20, 2003 and is a medical device company focusing
on noninvasive biological response-activating devices that target wound healing and pain therapy and can be administered at home without
the assistance of medical professionals.
The
Company’s principal research and development activities are conducted in Israel through its wholly owned subsidiary, NanoVibronix
(Israel 2003) Ltd., a company registered in Israel, which commenced operations in October 2003.
NOTE
2 – GOING CONCERN, LIQUIDITY AND OTHER UNCERTAINTIES
Liquidity
and Going Concern
The
Company’s ability to continue to operate is dependent mainly on its ability to successfully market and sell its products and the
receipt of additional financing until profitability is achieved. During the three and six months ended June 30, 2024, the Company has
incurred losses as well as negative cash outflows from operating activities and expects to incur losses and negative cash outflows from
operating activities through at least fiscal year 2024. Because the Company does not have sufficient resources to fund its operations
for the next twelve months from the date of this filing and there could be a significant arbitration payment due (see Note 10), substantial
doubt exists as to the Company’s ability to continue as a going concern.
The
Company will need to raise additional capital to finance its losses and negative cash flows from operations and may continue to be dependent
on additional capital raising as long as the Company’s products do not reach commercial profitability. If the Company is unable
to obtain additional financing, the development of its product candidates and the Company’s commercial strategy may be impacted
and there could be a material adverse effect on the Company’s business and financial condition. These financial statements do not
include any adjustments that may result from the outcome of this uncertainty.
NOTE
3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of presentation and principles of consolidation
The
unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts
and transactions have been eliminated in consolidation. The Company’s condensed consolidated financial statements have been prepared
in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for the interim
financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the accompanying
unaudited interim consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary
to state fairly the financial position and results of operations of the Company. These condensed consolidated financial statements and
notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended
December 31, 2023, as found in the Company’s Annual Report on Form 10-K, as amended, initially filed with the Securities and Exchange
Commission (the “SEC”) on April 8, 2024.
The
balance sheet for December 31, 2023 was derived from the Company’s audited financial statements for the year ended December 31,
2023. The results of operations for the periods presented are not necessarily indicative of results that could be expected for the entire
fiscal year due to seasonality and other factors. Certain information and footnote disclosures normally included in the consolidated
financial statements in accordance with U.S. GAAP have been omitted in accordance with the rules and regulations of the SEC for interim
reporting.
Use
of estimates
The
preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and
assumptions. The Company believes that the estimates, judgments and assumptions used are reasonable based upon information available
at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of revenue and expenses during
the reporting period. Actual results could differ from those estimates.
Foreign
currency translation
Non-U.S.
dollar denominated transactions and balances have been re-measured to U.S. dollars. All gains and losses from re-measurement of monetary
balance sheet items denominated in non-U.S. dollar currencies are reflected in the statements of operations as other comprehensive income,
as appropriate. The cumulative translation gains for the three months ended June 30, 2024 and 2023 were $6,000 and $37,000, respectively.
Cash
The
Company holds cash in various banking institutions. Such funds are insured by the Federal Deposit Insurance Corporation (“FDIC”)
up to $250,000. Cash balances could exceed insured amounts at any given time. As of June 30, 2024, the company had cash in excess of
the FDIC insured amount totaling $1,487,754.
Trade
receivables
The
Company’s trade receivable balance consists of amounts due from its customers. The Current Expected Credit Losses (“CECL”)
impairment model requires an estimate of expected credit losses, measured over the contractual life of an instrument, which considers
forecasts of future economic conditions in addition to information about past events and current conditions. Based on this model, the
Company considers many factors, including the age of the balance, collection history, and current economic trends. Credit losses are
written off after all collection efforts have ceased. Allowances for credit losses are recorded as a direct reduction from an asset’s
amortized cost basis. Credit losses and recoveries are recorded in selling, general and administrative expenses in the consolidated statements
of operations. Recoveries of financial assets previously written off are recorded when received. Trades receivables were $489,000 as
of June 30, 2024 and are not anticipated to possess substantial credit risk or expected credit losses. Historically, the Company has
not had significant write offs of trade receivables. All sales are nonrefundable. As of June 30, 2024, the change in CECL is $0.
Revenue
recognition
Revenues
from product sales are recognized in accordance with ASC 606 “Revenue Recognition.” Five basic steps must be followed before
revenue can be recognized; (1) identifying the contract(s) with a customer that creates enforceable rights and obligations; (2) identifying
the performance obligations in the contract, such as promising to transfer goods or services to a customer; (3) determining the transaction
price, meaning the amount of consideration in a contract to which an entity expects to be entitled in exchange for transferring promised
goods or services to a customer; (4) allocating the transaction price to the performance obligations in the contract, which requires
the company to allocate the transaction price to each performance obligation on the basis of the relative standalone selling prices of
each distinct good or services promised in the contract; and (5) recognizing revenue when (or as) the entity satisfies a performance
obligation by transferring a promised good or service to a customer. The amount of revenue recognized is the amount allocated to the
satisfied performance obligation.
Revenue
from product sales is recorded at the net sales price, or “transaction price,” which includes estimates of variable consideration
that result from coupons, discounts, distributor fees and processing fees, as well as allowances for returns and government rebates.
The Company constrains revenue by considering factors that could otherwise lead to a probable reversal of revenue. Collectability of
revenue is reasonably assured based on historical evidence of collectability between the Company and its customers.
Revenues
from sales to distributors are recognized at the time the products are delivered to the distributors (“sell-in”). The Company
does not grant rights of return, credits, rebates, price protection, or other privileges on its products to distributors.
Recently
adopted accounting standards
In
June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13,
Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”)
and subsequent amendments to the initial guidance: ASU 2018-19, ASU 2019-04, and ASU 2019-05 (collectively, “Topic 326”).
Topic 326 requires measurement and recognition of expected credit losses for financial assets held. This ASU is effective for interim
and annual reporting periods beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted
ASU 2016-13 as of January 1, 2023, and there was no material impact on its condensed consolidated financial statements upon adoption.
In
November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,
which requires an enhanced disclosure of significant segment expenses on an annual and interim basis. This guidance is effective for
annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption
is permitted. Upon adoption, the guidance should be applied retrospectively to all prior periods presented in the financial statements.
The Company is currently evaluating the impact that adoption of ASU 2023-09 will have on its financial statements.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (ASU 2023-09). ASU
2023-09 requires that an entity, on an annual basis, disclose additional income tax information, primarily related to the rate reconciliation
and income taxes paid. The amendment in the ASU is intended to enhance the transparency and decision usefulness of income tax disclosures.
The ASU’s amendments are effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the
impact that adoption of ASU 2023-09 will have on its financial statements.
NOTE
4 – INVENTORY
Inventory
consists of the following components:
SCHEDULE OF INVENTORY
| |
June 30,
2024 | | |
December 31, 2023 | |
| |
| | |
| |
Raw materials | |
$ | 343,000 | | |
$ | 210,000 | |
Finished goods | |
| 2,088,000 | | |
| 2,522,000 | |
Inventory | |
$ | 2,431,000 | | |
$ | 2,732,000 | |
NOTE
5 – STOCKHOLDERS’ EQUITY
Common
stock
The
common stock, par value $0.001 per share (the “Common Stock”), confers upon the holders the right to receive notice to participate
and vote in general meetings of the Company, the right to receive dividends, if declared, and to participate in the distribution of the
surplus assets and funds of the Company in the event of liquidation, dissolution, or winding up of the Company.
Reverse
stock split
On
February 8, 2023, the Company effected a reverse stock split of its Common Stock at a ratio of 1 post-split share for every 20 pre-split
shares. The Company’s Common Stock begin trading on a split-adjusted basis when the market opened on February 9, 2023 (the “Reverse
Stock Split”).
At
the effective time of the Reverse Stock Split, every 20 shares of the Company’s issued and outstanding Common Stock were converted
automatically into one issued and outstanding share of Common Stock without any change in the par value per share. Stockholders holding
shares through a brokerage account had their shares automatically adjusted to reflect the 1-for-20 Reverse Stock Split. The Reverse Stock
Split affected all stockholders uniformly and did not alter any stockholder’s percentage interest in the Company’s equity,
except to the extent that the Reverse Stock Split resulted in a stockholder owning a fractional share. Any fractional share of a stockholder
resulting from the Reverse Stock Split was rounded up to the nearest whole number of shares. Proportional adjustments were made to the
number of shares of the Company’s Common Stock issuable upon exercise or conversion of the Company’s equity awards, warrants,
and other convertible securities, as well as the applicable exercise or conversion price thereof. On February 16, 2023, the Company rounded
up fractional shares to its nearest whole number of 15,726 shares. On March 31, 2024, the Company rounded up fractional shares to its
nearest whole number of 46 shares.
All
references in this Quarterly Report on Form 10-Q to number of shares, price per share, and weighted average number of shares of Common
Stock outstanding prior to the Reverse Stock Split have been adjusted to reflect the Reverse Stock Split on a retroactive basis, unless
otherwise noted.
Issuance
of Common Stock for cash through private placement
On
August 30, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional
investor for the issuance and sale in a private placement (the “Private Placement”) of 180,000 shares (the “Common
Stock”) of Common Stock, pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 2,726,977 shares of Common Stock,
with an exercise price of $0.0001 per share, A-1 Warrants (the “A-1 Warrants”) to purchase up to 2,906,977 shares of Common
Stock, with an exercise price of $1.47 per share, and A-2 Warrants (the “A-2 Warrants” and together with the A-1 Warrants,
the “Warrants”) to purchase up to 2,906,977 shares of Common Stock with an exercise price of $1.47 per share. The
A-1 Warrants are exercisable immediately upon issuance and expire March 1, 2029. The A-2 Warrants are exercisable immediately upon issuance
and expire October 1, 2024. The combined purchase price for one Common Share and the accompanying Warrants was $1.72, and the combined
purchase price for one Pre-Funded Warrant and the accompanying Warrants was $1.7199.
The
net proceeds to the Company from the Private Placement were approximately $4,215,000, after deducting placement agent fees and expenses
and estimated offering expenses payable by the Company. The Company intends to use the net proceeds received from the Private Placement
for general corporate purposes, including funding of the Company’s development programs, commercial planning, sales and marketing
expenses, potential strategic acquisitions, general and administrative expenses, and working capital.
H.C.
Wainwright & Co., LLC (“Wainwright”) served as the Company’s exclusive placement agent in connection with the Private
Placement, pursuant to that certain engagement letter, dated as of July 5, 2023, between the Company and Wainwright (as amended, the
“Engagement Letter”). As part of Wainwright’s compensation, we issued to Wainwright or its designees warrants (the
“Placement Agent Warrants”) to purchase up to an aggregate of 218,023 shares of Common Stock at an exercise price equal to
$2.15 per share. The Placement Agent Warrants are exercisable immediately upon issuance and expire March 1, 2029.
Stock-based
compensation and Options
During
the three-month and six-month period ended June 30, 2024, 0
employee options were exercised, respectively. During the three and six-month period ended June 30, 2023, 0
and 5,459
employee options were exercised, respectively. During the three month and six month period ended June 30, 2024, no
employee options were granted. During the three and six-month period ended June 30, 2023, no employee options were granted.
The
options granted to employees and board members were recorded at a fair value and vested over ten years. During the three and six-month
period ended June 30, 2024, stock-based compensation expense of $28 and $135 was recorded for options that vested, respectively. During
the three and six-month period ended June 30, 2023, stock-based compensation expense of $66 and $133 was recorded for options that vested,
respectively.
SCHEDULE OF OPTIONS ACTIVITY
| |
Shares Under Options | | |
Weighted Average Exercise Price per Share | | |
Weighted Average Remaining Life (Years) | |
Outstanding – December 31, 2022 | |
| 147,619 | | |
$ | 24.42 | | |
| 7.24 | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| (5,459 | ) | |
| 1.40 | | |
| 0.24 | |
Expired | |
| - | | |
| - | | |
| - | |
Outstanding – March 31, 2023 | |
| 142,160 | | |
$ | 25.31 | | |
| 7.50 | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Outstanding – June 30, 2023 | |
| 142,160 | | |
| 25.31 | | |
| 7.50 | |
| |
| | | |
| | | |
| | |
Outstanding – December 31, 2023 | |
| 112,685 | | |
$ | 13.10 | | |
| 8.41 | |
Granted | |
| 90,000 | | |
| 0.90 | | |
| 9.82 | |
Exercised | |
| - | | |
| - | | |
| - | |
Expired | |
| (36 | ) | |
| 39.2 | | |
| 0.16 | |
Outstanding – March 31, 2024 | |
| 202,650 | | |
$ | 7.67 | | |
| 8.90 | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Outstanding – June 30, 2024 | |
| 202,650 | | |
| 7.67 | | |
| 8.90 | |
Warrants
On
August 30, 2023, the Company granted (a) Pre-Funded Warrants to purchase up to 2,726,977 shares of Common Stock with an exercise price
of $0.0001 per share, (b) A-1 Warrants to purchase up to 2,906,977 shares of Common Stock with an exercise price of $1.47 per share,
and (c) A-2 Warrants to purchase up to 2,906,977 shares of Common Stock with an exercise price of $1.47 per share, for a total of 8,540,931
warrants, in conjunction with the Private Placement disclosed above. The A-1 Warrants and A-2 Warrants are exercisable immediately upon
issuance and expire on March 1, 2029 and October 1, 2024, respectively.
For
the same Private Placement, the Company granted Placement Agent Warrants to Wainwright, or its designees, to purchase up to an aggregate
of 218,023 shares of Common Stock at an exercise price equal to $2.15 per share. The Placement Agent Warrants are exercisable immediately
upon issuance and expire March 1, 2029.
For
the six months ended June 30, 2024 and 2023, there were 0 warrants granted, respectively. For the three months ended June 30, 2024 and
2023, there were 743,000 and 0 warrants exercised and/or cancelled, respectively
SCHEDULE OF WARRANTS ACTIVITY
| |
Warrants | |
Outstanding – December 31, 2022 | |
| 78,252 | |
Granted | |
| - | |
Exercised | |
| - | |
Canceled | |
| - | |
Expired | |
| - | |
Outstanding – June 30, 2023 | |
| 78,252 | |
| |
| | |
Outstanding – December 31, 2023 | |
| 8,633,229 | |
Granted | |
| - | |
Exercised | |
| (738,000 | ) |
Canceled | |
| - | |
Expired | |
| (5,000 | ) |
Outstanding – June 30, 2024 | |
| 7,890,229 | |
NOTE
6 – LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDER
Basic
net loss per share of Common Stock is computed by dividing net loss available to common stockholders by the weighted average number of
shares of Common Stock outstanding during the period. All outstanding stock options and warrants for the six months ended June 30, 2024
and 2023 have been excluded from the calculation of the diluted net loss per share because all such securities are anti-dilutive for
all periods presented.
The
following table summarizes the Company’s securities, in Common Stock equivalents, which have been excluded from the calculation
of dilutive loss per share as their effect would be anti-dilutive:
SUMMARY
OF COMMON STOCK EQUIVALENTS EXCLUDED FROM CALCULATION OF DILUTIVE LOSS PER SHARE
| |
June 30, 2024 | | |
June 30, 2023 | |
Stock Options – employee and non-employee | |
| 202,650 | | |
| 142,160 | |
Warrants | |
| 7,890,229 | | |
| 78,252 | |
Total | |
| 8,092,879 | | |
| 220,412 | |
Anti-dilutive shares | |
| 8,092,879 | | |
| 220,412 | |
NOTE
7 – GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA
The
Company derives revenues from selling its products directly to patients as well as through distributor agreements. The following is a
summary of revenues within geographic areas:
SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
United States | |
$ | 794,000 | | |
$ | 282,000 | | |
$ | 1,698,000 | | |
$ | 592,000 | |
Europe | |
| - | | |
| - | | |
| - | | |
| 19,000 | |
Australia/New Zealand | |
| 8,000 | | |
| - | | |
| 13,000 | | |
| 13,000 | |
Asia | |
| - | | |
| - | | |
| - | | |
| 1,000 | |
Other | |
| 15,000 | | |
| 12,000 | | |
| 27,000 | | |
| 23,000 | |
Total | |
$ | 817,000 | | |
$ | 294,000 | | |
$ | 1,738,000 | | |
$ | 648,000 | |
The
Company’s long-lived assets are all located in Israel.
For
both the three and six months ended June 30, 2024, the Company’s largest customer comprised approximately 52% and 41% of total
revenues in each of the respective periods. During the three and six months ended June 30, 2023, the Company’s two largest customers
comprised approximately 86% of total revenues in each of the respective periods. One of the Company’s largest customers comprised
36% and 86% in each of the respective periods, while the other remaining customer comprised 50% and 0%, respectively.
NOTE
8 – LEASES
The
Company has operating lease agreements with terms up to 2-3 years, including car and office space leases.
The
Company’s weighted-average remaining lease term relating to its operating leases is 2.68 years, with a weighted-average discount
rate of 10%. The discount rate was determined by referencing rates used by companies in the same industry.
The
Company incurred $23,000 and $36,000 of lease expense for its operating leases for the six months ended June 30, 2024 and 2023, respectively.
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating leases as
of June 30, 2024:
SCHEDULE OF LIABILITIES ARISING FROM OPERATING LEASES
| |
| | |
2024 | |
$ | 27 | |
2025 | |
| 57 | |
2026 | |
| 58 | |
Thereafter | |
| 10 | |
Total undiscounted operating lease payments | |
| 152 | |
Less: Imputed interest | |
| 19 | |
Present value of operating lease liabilities | |
$ | 133 | |
NOTE
9 – OTHER ASSETS
On
April 9, 2020, pursuant to a licensing agreement entered into in March 2020, the Company received 10-year warrants to purchase 127,000
shares of Sanuwave Health, Inc. at a price of $0.19 per share. The fair value for warrants received was estimated at the date of grant
and at each reporting period using a Black-Scholes-Merton pricing model with the following underlying assumptions:
SCHEDULE OF WARRANTS ASSUMPTIONS
| |
June 30, 2024 | | |
June 30, 2023 | |
Price at valuation | |
$ | 0.02 | | |
$ | 0.04 | |
Exercise price | |
$ | 0.19 | | |
$ | 0.19 | |
Risk free interest | |
| 4.52 | % | |
| 3.97 | % |
Expected term (in years) | |
| 6 | | |
| 7 | |
Volatility | |
| 196.7 | % | |
| 155.6 | % |
The
Company considers this to be Level 3 inputs which are valued at each reporting period. For the three and six months June 30, 2024, changes
in the fair value of these warrants amounted to $11 and $500, leaving a balance of $2,000 as of June 30, 2024. For the three and six
months ended June 30, 2023, changes in the fair value of these warrants amounted to $(2,000) and $0, respectively, leaving a balance
of $3,000 as of June 30, 2023.
Financial
Instruments Measured at Fair Value on a Recurring Basis
The
fair value accounting standards define fair value as the amount that would be received to sell an asset or paid to transfer a liability
in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants
would use in pricing an asset or liability. Fair value measurements are rated on a three-tier hierarchy as follows:
● |
Level
1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; |
|
|
● |
Level
2 inputs: Inputs, other than quoted prices included in Level 1, that are observable either directly or indirectly; and |
|
|
● |
Level
3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own
assumptions. |
There
were no transfers between Level 3 during the six months ended June 30, 2024, and 2023.
The
following table presents changes in Level 3 asset and liability measured at fair value for the quarters ended June 30, 2024 and 2023:
SCHEDULE OF CHANGES IN LEVEL 3 AND LIABILITY MEASURED AT FAIR VALUE
| |
Asset | |
Balance – December 31, 2022 | |
$ | 3,000 | |
Fair value adjustments – Sanuwave warrants | |
| 2,000 | |
Balance – March 31, 2023 | |
$ | 5,000 | |
Fair Value adjustments – Sanuwave warrants | |
| (2,000 | ) |
Balance – June 30, 2023 | |
| 3,000 | |
| |
| | |
Balance – December 31, 2023 | |
| 1,000 | |
Fair value adjustments – Sanuwave warrants | |
| 1,000 | |
Balance – March 31, 2024 | |
$ | 2,000 | |
Fair Value adjustments – Sanuwave warrants | |
| - | |
Balance – June 30, 2024 | |
| 2,000 | |
The
following table sets forth the Company’s assets and liabilities which are measured at fair value on a recurring basis by level
within the fair value hierarchy:
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
| |
Fair Value Measurements as of June 30, 2024 | |
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
Asset: | |
| | |
| | |
| | |
| |
Other assets | |
$ | - | | |
$ | - | | |
$ | 2,000 | | |
$ | 2,000 | |
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
| |
Fair Value Measurements as of June 30, 2023 | |
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
Asset: | |
| | |
| | |
| | |
| |
Other assets | |
$ | - | | |
$ | - | | |
$ | 3,000 | | |
$ | 3,000 | |
NOTE
10 – COMMITMENTS AND CONTINGENCIES
Pending
litigation
On
February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the
International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging that the Company is in breach
of an Exclusive Distribution Agreement dated March 7, 2019, between Protrade and the Company (the “Exclusive Distribution Agreement”).
Protrade alleges, in part, that the Company has breached the Exclusive Distribution Agreement by discontinuing the manufacture of the
DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims damages estimated at $3 million.
On
March 15, 2022, the arbitrator issued a final award which determined that (i) the Company had the right to terminate the Exclusive Distribution
Agreement; (ii) the Company did not breach the duty of good faith and fair dealing with regard to the Exclusive Distribution Agreement;
and (iii) the Company did not breach any confidentiality obligations to Protrade. Nevertheless, the arbitrator determined that the Company
did not comply with the obligation to supply Protrade with a year’s supply of patches and awarded Protrade $1,500,250, which consists
of $1,432,000 for “lost profits” and $68,250 as reimbursement of arbitration costs, on the grounds that the Company allegedly
failed to supply Protrade with certain patches utilized by users of DV0057 Painshield MD device. The arbitrator based the decision on
the testimony of Protrade’s president who asserted that a user would use in excess of 33 patches per device. The Company believes
that the number of patches per device alleged by Protrade is grossly inflated and that these claims were not properly raised before the
arbitrator. Accordingly, on April 13, 2022, the Company submitted an application for correction of the award which the arbitrator denied
on June 22, 2022.
On
April 5, 2022, Protrade filed a Petition with the Supreme Court of New York, Nassau County seeking to confirm the award. On April 13,
2022, the Company submitted an application to the ICA seeking to correct an error in the award based on the evidence that the Company
only sold 2-3 reusable patches per device contrary to the 33 reusable patches claimed by Protrade. The same arbitrator who issued the
award denied the application.
On
July 22, 2022, the Company filed a cross-motion seeking to vacate the arbitration award on the grounds that the arbitrator exceeded her
authority, that the award was procured by fraud, and that the arbitrator failed to follow procedures established by New York law. In
particular, the Company averred in its motion that Protrade’s witness made false statements in arbitration and that the arbitrator
resolved a claim that was never raised by Protrade and has no factual basis.
On
October 3, 2022, the court issued a decision granting Protrade its petition to confirm the award and denying the cross-motion.
On
November 9, 2022, the Company filed a motion to re-argue and renew its cross-motion to vacate the arbitration decision based on newer
information that was not available during the initial hearing. On the same day, the Company also filed a notice of appeal with the Appellate
Division, Second Department. On March 21, 2023, the court denied the motion to re-argue and renew.
On
July 10, 2023, the Company filed an appeal with the Appellate Division, Second Department. The Company intends to continue to vigorously
pursue its opposition to the award in all appropriate fora.
As
of June 30, 2024 and December 31, 2023, the Company accrued the amount of the arbitration award to Protrade of approximately $2 million
for both periods including interest which is classified in “Other accounts payable and accrued expenses.”
NOTE
11 – RELATED PARTY TRANSACTION
The
firm FisherBroyles LLP is handling the Company’s Protrade litigation and appeals. For the three and six months ended June 30, 2024,
the Company has been billed and paid legal fees from FisherBroyles amounting to $0 and $76,034, respectively, which have been recorded
as part of “General and administrative expenses” in the condensed consolidated statements of operations. As has been previously
disclosed, one of the Company’s board members, Aurora Cassirer, was a partner at FisherBroyles. On January 1, 2024, Ms. Cassirer
left FisherBroyles to become a partner at Pierson Ferdinand. Pierson Ferdinand was paid $6,917 and $20,831 during the three and six months
ended June 30, 2024. Ms. Cassirer does not provide any legal services or legal advice to the Company.
NOTE
12 – SUBSEQUENT EVENTS
The Company has evaluated subsequent events through
August 14, 2024. Based on this evaluation, the Company has determined that there are no material subsequent events that require disclosure
in these financial statements.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis of the results of operations and financial condition of NanoVibronix, Inc. (the “Company”)
as of June 30, 2024 should be read in conjunction with our financial statements and the notes to those financial statements that are
included elsewhere in this Quarterly Report on Form 10-Q. This discussion and analysis should be read in conjunction with the Company’s
audited financial statements and related disclosures as of December 31, 2023 and for the year then ended December 31, 2023, which are
included in the Form 10-K, as amended, initially filed with the Securities and Exchange Commission (“SEC”) on April 8, 2024.
References in this Management’s Discussion and Analysis of Financial Condition and Results of Operations to “us,” “we,”
“our,” and similar terms refer to the Company.
Cautionary
Note Regarding Forward-Looking Statements
This
Quarterly Report on Form 10-Q contains “forward-looking statements,” which include information relating to future events,
future financial performance, financial projections, strategies, expectations, competitive environment, and regulations. Words such as
“may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,”
“expects,” “anticipates,” “future,” “intends,” “plans,” “believes,”
“estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking
statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance
or results will be achieved. Forward-looking statements are based on information we have when those statements are made 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. Important factors that could
cause such differences include, but are not limited to:
|
● |
Our
history of losses and expectation of continued losses. |
|
● |
Global
economic and political instability and conflicts, such as the conflict between Russia and Ukraine, and Israel and Palestine, could
adversely affect our business, financial condition, or results of operations. |
|
● |
Increasing
inflation could adversely affect our business, financial condition, results of operations, or cash flows. |
|
● |
Our
ability to raise funding for, and the timing of, clinical studies and eventual U.S. Food and Drug Administration (“FDA”)
approval of our product candidates. |
|
● |
Our
product candidates may not be developed or commercialized successfully. |
|
● |
Risks
of product liability claims and the availability of insurance. |
|
● |
Our
ability to successfully develop and commercialize our products. |
|
● |
Our
ability to generate internal growth. |
|
● |
Risks
related to computer system failures, cyber-attacks, or deficiencies in our cyber-security. |
|
● |
Our
ability to obtain regulatory approval in foreign jurisdictions. |
|
● |
Uncertainty
regarding the success of our clinical trials for our products in development. |
|
● |
The
price of our securities is volatile with limited trading volume. |
|
● |
Our
ability to regain and maintain compliance with the continued listing requirements of the Nasdaq Capital Market (“Nasdaq”). |
|
● |
Our
ability to maintain effective internal control over financial reporting. |
|
● |
We
are a “smaller reporting company” and have reduced disclosure obligations that may make our stock less attractive to
investors. |
|
● |
Our
intellectual property portfolio and our ability to protect our intellectual property rights. |
|
● |
The
adoption of health policy changes and health care reform. |
|
● |
Lack
of financial resources to adequately support our operations. |
|
● |
Difficulties
in maintaining commercial scale manufacturing capacity and capability. |
The
foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or
risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements.
For a discussion of these and other risks that relate to our business and financial performance, you should carefully review the risks
and uncertainties described under the heading “Item 1A. Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q
and in our Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2023, and those described from time to time
in our future reports filed with the SEC. Moreover, new risks regularly emerge and it is not possible for us to predict or articulate
all risks we face, nor can we assess the impact of all risks on our business, or the extent to which any risk, or combination of risks,
may cause actual results to differ from those contained in any forward-looking statements. All forward-looking statements included in
this Form 10-Q are based on information available to us on the date of this Quarterly Report on Form 10-Q. Except to the extent required
by applicable laws or rules, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result
of new information, future events, or otherwise.
Overview
We
are a medical device company focusing on noninvasive biological response-activating devices that target wound healing and pain therapy
and can be administered at home, without the assistance of medical professionals. Our WoundShield, PainShield and UroShield products
are backed by novel technology which relates to ultrasound delivery through surface acoustic waves. The global wound care device market
totaled approximately $20.8 billion in 2022 and is expected to grow to $27.2 billion by 2027 at a CAGR of 5.4% during 2022-2027 (as reported
by Markets and Markets in June 2022).
Going
Concern
The
Company’s unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates
the realization of assets and the satisfaction of liabilities in the normal course of business. During the six months ended June 30,
2024, the Company’s cash used in operations was $1,113,000 leaving a cash balance of $2,170,000 as of June 30, 2024. Because the
Company does not have sufficient resources to fund its operations for the next twelve months from the date of this filing, management
has substantial doubt about the Company’s ability to continue as a going concern.
Protrade
Proceeding
On
February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the
International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging that we were in breach of
the Exclusive Distribution Agreement. Protrade alleges, in part, that we breached the Exclusive Distribution Agreement by discontinuing
the manufacture of the DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims damages estimated
at $3 million.
On
March 15, 2022, the arbitrator issued a final award, which, determined that (i) we had the right to terminate the Exclusive Distribution
Agreement; (ii) we did not breach the duty of good faith and fair dealing with regard to the Exclusive Distribution Agreement; and (iii)
we did not breach any confidentiality obligations to Protrade. Nevertheless, the arbitrator determined that we did not comply with the
obligation to supply Protrade with a year’s supply of patches and awarded Protrade $1,500,250, which consists of $1,432,000 for
“lost profits” and $68,250 as reimbursement of arbitration costs, on the grounds that we allegedly failed to supply Protrade
with certain patches utilized by users of DV0057 Painshield MD device. The arbitrator based the decision on the testimony of Protrade’s
president who asserted that a user would use in excess of 33 patches per each device. We believe that the number of patches per device
alleged by Protrade is grossly inflated and that these claims were not properly raised before the arbitrator. Accordingly, on April 13,
2022, we submitted an application for the correction of the award which the arbitrator denied on June 22, 2022.
On
April 5, 2022, Protrade filed a Petition with the Supreme Court of New York, Nassau County seeking to confirm the award. On April 13,
2022, we submitted an application to the ICA seeking to correct an error in the award based on the evidence that we only sold 2-3 reusable
patches per device contrary to the 33 reusable patches claimed by Protrade. The same arbitrator who issued the award denied the application.
On
July 22, 2022, we filed a cross-motion seeking to vacate arbitration award on the grounds that the arbitrator exceeded her authority,
that the award was procured by fraud, and that the arbitrator failed to follow procedures established by New York law. In particular,
we averred in our motion that Protrade’s witness made false statements in arbitration and that the arbitrator resolved a claim
that was never raised by Protrade and that has no factual basis.
On
October 3, 2022, the court issued a decision granting Protrade its petition to confirm the award and denying the cross-motion.
On
November 9, 2022, we filed a motion to re-argue and renew its cross-motion to vacate the arbitration decision based on newer information
that was not available during the initial hearing. On the same day, we also filed a notice of appeal with the Appellate Division, Second
Department. On March 21, 2023, the court denied the motion to re-argue and renew.
On
July 10, 2023, we filed an appeal with the Appellate Division, Second Department. We intend to continue to vigorously pursue our opposition
to the award in all appropriate fora.
As
of June 30, 2024 and December 31, 2023, the Company accrued the amount of the arbitration award to Protrade of approximately $2.0 million
for both periods including interest which is classified in “Other accounts payable and accrued expenses.”
Critical
Accounting Estimates
Our
financial statements have been prepared in accordance with U.S. GAAP. The preparation of the consolidated financial statements requires
us to make assumptions, estimates and judgments that affect the reported amounts of assets and liabilities, the disclosures of contingent
assets and liabilities as of the date of the consolidated financial statements, and the reported amounts of revenues and expenses during
the reporting periods. Certain of our more critical accounting policies require the application of significant judgment by management
in selecting the appropriate assumptions for calculating financial estimates. A critical accounting policy is one that is both important
to the portrayal of our financial condition and results of operation and requires management’s most difficult, subjective, or complex
judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Our critical accounting
policies are more fully described in both (i) “Item 7. Management’s Discussion and Analysis of Financial Condition and Results
of Operations” and (ii) Note 3 of the Notes to the Consolidated Financial Statements included in our Annual Report on Form 10-K,
as amended, for the fiscal year ended December 31, 2023. There have not been any material changes to such critical accounting policies
since December 31, 2023.
The
currency of the primary economic environment in which our operations are conducted is the U.S. dollar (“$” or “dollar”).
Accordingly, our functional currency is the dollar.
Results
of Operations
Three
Months Ended June 30, 2024 Compared to Three Months Ended June 30, 2023
Revenues.
For the three months ended June 30, 2024 and 2023, our revenues were approximately $817,000 and $294,000, respectively, an increase of
approximately 178%, or $523,000, between the periods. The increase was mainly attributable to increased sales from our Ultra Pain Products
Inc. (“UPPI”) distributor as well an increase of customers from Veteran Administration facilities or through workman’s
compensation programs, referred to us from three sales representatives to whom we sold our products directly for the three months ended
June 30, 2024, as compared to the three months ended June 30, 2023. Our revenues may fluctuate as we add new customers or when existing
distributors make large purchases of our products during one period and no purchases during another period. Our revenues by quarter may
not be linear or consistent. We do not anticipate that our revenues will be impacted by inflation or changing prices in the foreseeable
future.
For
the three months ended June 30, 2024, the percentage of revenues attributable to our products was: PainShield Plus – 38%,
PainShield MD – 45%, Painshield Plus Monthly Kits – 7% and Painshield MD Monthly Kits – 10%. For the three
months ended June 30, 2023, the percentage of revenues attributable to our products was: PainShield – 100% and UroShield
– 0%.
Gross
Profit. For the three months ended June 30, 2024 and 2023, gross profit was approximately $428,000 and $216,000, respectively, an
increase of approximately 98%, or $212, between the periods. The increase was mainly due to increase in revenues from customers from
Veteran Administration facilities and through workman’s compensation programs who are referred to us from certain sales representatives,
and UPPI in 2024. The decrease in the gross margin percentage for the three months ended June 30, 2024 was due to lowering our wholesale
sales price awarded to customers from Veteran Administration facilities or through workman’s compensation programs who are referred
to us from certain sales representatives, which took place in the second quarter of 2024.
Gross
profit as a percentage of revenues was approximately 52% and 73% for the three months ended June 30, 2024 and 2023, respectively. The
decrease in gross profit as a percentage of revenues is mainly due to the reasons described above.
Research
and Development Expenses. For the three months ended June 30, 2024 and 2023, research and development expenses were approximately
$187,000 and $35,000, respectively, an increase of approximately 434%, or $152,000, between the periods. The increase was mainly due
to product redevelopment costs of $150,000 incurred during 2024.
Research
and development expenses as a percentage of total revenues were approximately 44% and 12% for the three months ended June 30, 2024 and
2023, respectively. This increase was due to higher expenses incurred in 2024 compared to revenue.
Our
research and development expenses consist mainly of payroll expenses to employees involved in research and
development activities, stock-based compensation expenses, expenses related to subcontracting, patents application and registration,
and clinical trial and facilities expenses associated with and allocated to research and development activities.
Selling
and Marketing Expenses. For the three months ended June 30, 2024, and 2023, selling and marketing expenses were approximately $199,000
and $227,000, respectively, a decrease of approximately 12%, or $28,000, between the periods. The decrease was mainly due to reduced
consulting fees and related expenses due to completed wed development project in 2024 and reduce use of targeted sales.
Selling
and marketing expenses as a percentage of total revenues were approximately 24% and 77% for the three months ended June 30, 2024 and
2023, respectively.
Selling
and marketing expenses consist mainly of payroll expenses to direct sales and marketing employees, stock-based compensation expenses,
travel expenses, conventions, advertising and marketing expenses, rent, and facilities expenses associated with and allocated to selling
and marketing activities.
General
and Administrative Expenses. For the three months ended June 30, 2024 and 2023, general and administrative expenses were approximately
$716,000 and $963,000, respectively, a decrease of approximately 88%, or $247,000, between the periods. The decrease was primarily due
to a decrease in legal fees related to securities and litigation matters, as well as accounting fees incurred in 2024, as compared to
2023.
General
and administrative expenses as a percentage of total revenues were approximately 88% and 328% for the three months ended June 30, 2024
and 2023, respectively.
Our
general and administrative expenses consist mainly of payroll expenses for management and administrative employees, stock-based compensation
expenses, accounting, legal, and facilities expenses associated with general and administrative activities and costs associated with
being a publicly traded company.
Interest
expense. For the three months ended June 30, 2024, and 2023, interest expense was $34,000 and $33,000, respectively. This pertains
to the interest on the Company’s judgment liability for both years.
Income
tax expense. For the three months ended June 30, 2024 and 2023, tax expenses were $4,000 and $13,000, respectively. The tax expense
is computed by multiplying income before taxes at our Israeli subsidiary by the appropriate tax rate.
Financial
expense, net. For the three months ended June 30, 2024 and 2023, financial expenses, net was approximately $24,000 and $(19,000), respectively,
an increase of approximately $43,000 between the periods mainly due to the change in fair value of the investment in Sanuwave.
Net
loss. Our net loss decreased by approximately 36%, or $386,000, to approximately $688,000 for the three months ended June 30, 2024
from approximately $1,074,000 in the same period of 2023. The decrease in net loss resulted primarily from the factors described above.
Six
Months Ended June 30, 2024 Compared to Six Months Ended June 30, 2023
Revenues.
For the six months ended June 30, 2024 and 2023, our revenues were approximately $1,738,000 and $648,000 respectively, an increase
of approximately 168%, or $1,090,000 between the periods. The increase was due to increase revenues from customers from Veteran Administration facilities and through workman’s
compensation programs who are referred to us from certain sales representatives, and UPPI in 2024. Our revenues may fluctuate as we add new consumers or when existing distributors or consumers make large purchases of our
products during one period and no purchases during another period. Therefore, any growth or decrease in revenues by quarter may not
be linear or consistent.
For
the six months ended June 30, 2024, the percentage of revenues attributable to our products was: PainShield MD- 51%, PainShield Plus
– 23%, Painshield MD Monthly Kits – 19% and Painshield Plus Monthly Kits – 5% and UroShield – 0%. For the
six months ended June 30, 2023, the percentage of revenues attributable to our products was: PainShield - 95% and UroShield –
5%. For the six months ended June 30, 2024 and 2023, the portion of our revenues that was derived from distributors was 41% and 91%,
respectively.
Gross
Profit. For the six months ended June 30, 2024 and 2023, gross profit was approximately $1,092,000 and $451,000, respectively, an
increase of approximately 142% or $641,000. The increase was mainly due to the increase in revenues in 2024. The decrease in the gross
margin percentage for the six months ended June 30, 2024 was due to lowering our wholesale sales price awarded to customers from Veteran
Administration facilities or through workman’s compensation programs who are referred to us from certain sales representatives,
which took place in the second quarter of 2024.
Gross
profit as a percentage of revenues was approximately 63% and 70% for the six months ended June 30, 2024 and 2023, respectively. The decrease
in gross profit as a percentage resulted primarily from the reasons described above.
Research
and Development Expenses. For the six months ended June 30, 2024 and 2023, research and development expenses were approximately $308,000
and $90,000, respectively, a increase of approximately 242%, or $218,000, between the periods. The increase was due to the addition
of product redevelopment costs of $150,000 and clinical trial costs of $84,000 incurred in 2024.
Our
research and development expenses consist mainly of payroll expenses to employees involved in research and
development activities, stock-based compensation expenses, expenses related to subcontracting, patents application and registration,
clinical trial and facilities expenses associated with and allocated to research and development activities.
Research
and development expenses as a percentage of total revenues were relatively steady totaling approximately 18% and 14% for the six months
ended June 30, 2024 and 2023, respectively.
Selling
and Marketing Expenses. For the six months ended June 30, 2024 and 2023, selling and marketing expenses were approximately
$364,000 and $441,000, respectively, a decrease of approximately 17%, or $77,000, between the periods. The decrease was due to
consulting fees and costs incurred during the six months ended June 30, 2023, related to our website development project which was
completed in 2023.
Selling
and marketing expenses consist mainly of payroll expenses to direct sales and marketing employees, stock-based compensation expenses,
travel expenses, conventions, advertising and marketing expenses, rent and facilities expenses associated with and allocated to selling
and marketing activities.
Selling
and marketing expenses as a percentage of total revenues were relatively steady totaling approximately 21% and 68% for the six months
ended June 30, 2024 and 2023, respectively.
General
and Administrative Expenses. For the six months ended June 30, 2024 and 2023, general and administrative expenses were approximately
$1,662,000 and $1,984,000, respectively, a decrease of approximately 16%, or $322,000, between the periods. The decrease was mainly due
to a decrease of legal fees related to securities and litigation matters, as well as accounting fees incurred during the six months ended
June 30, 2024, as compared to the six months ended June 30, 2023.
Our
general and administrative expenses consist mainly of payroll expenses for management and administrative employees, stock-based compensation
expenses, accounting, legal and facilities expenses associated with general and administrative activities and costs associated with being
a publicly traded company.
General
and administrative expenses as a percentage of total revenues were approximately 96% and 306% for the six months ended June 30, 2024
and 2023, respectively.
Financial
expense, net. For the six months ended June 30, 2024 and 2023, financial expenses, net was approximately $45,000 compared to $(25,000),
respectively, an increase of approximately $70,000 between the periods mainly due to the change in fair value of the investment in Sanuwave.
Interest
expense. For the six months ended June 30, 2024 and 2023, interest expense was $68,000 and $67,000, respectively. This pertains to
the interest on the Company’s judgment liability for the first six months of 2024.
Income
tax expenses. For the six months ended June 30, 2024 and 2023, tax expenses were $11,000 and $15,000, respectively. The tax expense
is computed by multiplying income before taxes at our Israeli subsidiary by the appropriate tax rate.
Net
loss. Our net loss decreased by approximately $895,000, or 41%, to approximately $1,276,000 for the six months ended June 30, 2024
from approximately $2,171,000 in the same period of 2023. The decrease in net loss resulted primarily from the factors described above.
Liquidity
and Capital Resources
General
We
have incurred losses in the amount of approximately $1,276,000 during the six months ended June 30, 2024, as we continue to maintain
significant net operating losses from operations. We also had negative cash flow from operating activities of $1,113,000 for the six
months ended June 30, 2024. We had a cash balance of just over $2,170,000 as of June 30, 2024, and we expect to continue to incur losses
and negative cash flows from operating activities. Due to the continued expected negative cash flow from operations and the potential
arbitration payment, if we are unsuccessful in our appeals, the Company does not have sufficient resources to fund operations for at
least the next twelve months from the date of this filing. As such, there is substantial doubt of our ability to continue as a going
concern.
We
will need to continue to raise additional capital to finance our losses and negative cash flows from operations and may continue to be
dependent on additional capital raising as long as our products do not reach commercial profitability. If we are unable to raise additional
capital, we will need to adjust our business plan and reduce workforce, which could have a material adverse effect on the Company and
its financial position.
During
the six-month period ended June 30, 2024, we met our short-term liquidity requirements from our existing cash reserves and from the sale
of our securities. Our future capital requirements and the adequacy of our available funds will depend on many factors, including our
ability to successfully commercialize our products, our development of future products, competing technological, and market developments.
We expect to continue to incur losses and negative flows from operations. We intend to use the proceeds generated from equity financings,
or strategic alliances with third parties, either alone or in combination with equity financing to meet our short-term liquidity requirements
as well as to advance our long-term plans. There are no assurances that we will be able to raise additional capital, as required, on
terms favorable to us.
As
of June 30, 2024, we do not have a commitment to fund our product redevelopment project for approximately another $1.2 million over the
next four quarters as well as the $2 million owed to Protrade as of June 30, 2024, under the court decision, which we continue to appeal.
Off-Balance
Sheet Commitments and Arrangements
As
of June 30, 2024, we have no off-balance sheet transactions, arrangements, obligations (including contingent obligations), or other relationships
with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial
condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.
Cash
Flows
As
of June 30, 2024, we had cash of approximately $2,170,000, compared to approximately $3,283,000 as of December 31, 2023. The decrease
in cash was primarily due to our net loss of $1,276,000 which primarily consisted of increased revenues and increased gross margins offset
by our operating expenses. We have historically met our cash needs through a combination of issuance of equity, borrowing activities
and sales. Our cash requirements are generally for product development, research, and development cost, marketing and sales activities,
finance and administrative cost, capital expenditures, and general working capital.
Cash
used in our operating activities was approximately $1,132,000 for the six months ended June 30, 2024, compared to $2,429,000 for the
six months ended June 30, 2023.
Cash
used in our investing activities was approximately $3,000 for the six months ended June 30, 2024, compared to $1,000 for the six months
ended June 30, 2023.
Cash
provided by financing activities was approximately $28,000 for the six months ended June 30, 2024, compared to $7,000 for the six months
ended June 30, 2023.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required
under this Item 3.
Item
4. Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s
disclosure controls and procedures as of March 31, 2024, the end of the period covered by this Quarterly Report on Form 10-Q. The term
“disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls
and other procedures of a company that are designed to provide reasonable assurance that information required to be disclosed by the
company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods
specified in the SEC’s rules and forms. Disclosure controls and procedures are also designed to provide reasonable assurance that
such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer,
to allow timely decisions regarding required disclosure. Based on their evaluation, as of the end of the period covered by this Form
10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures (as defined
in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were not effective because of the material weaknesses in our internal control
over financial reporting as described in Item 9A in our Annual Report on Form 10-K, as amended, for the fiscal ended December 31, 2023,
initially filed with the SEC on April 8, 2024.
Remediation
Efforts to Address Material Weakness
With
the oversight of senior management and audit committee of the Board of Directors, we have taken the steps below and we plan to take additional
measures to remediate the underlying causes of the material weakness in our internal control over financial reporting as described in
Item 9A in our Annual Report on Form 10-K, as amended, for the fiscal ended December 31, 2023, initially filed with the SEC on April
8, 2024:
|
● |
We
have been able to remediate the material weakness identified above with respect to the issuance of shares in excess of the number
of authorized shares in 2021 issued in connection with the conversion of shares of our preferred stock and the exercise of certain
warrants and implemented a plan to have adequate controls in place to avoid future issuances in excess of authorized shares. The
Company took steps to remediate the stock issuance material weakness through creating procedures over the approval of any new equity
issuances to ensure that there are no further over-issuances which includes the creation of an equity roll forward master sheet that
must be approved and signed off by senior management before any new equity issuances, including warrants, stock options, and issuances
of any shares of stock. |
|
|
|
|
● |
With
assistance from a finance and accounting third-party service provider, the Company was able to formalize our risk assessment process,
policies, and procedures, implementing revised control activities, controls documentation, and ongoing monitoring activities related
to the internal controls over financial reporting, including testing documentation to provide evidence that our system of internal
controls over financial reporting meets the requirements of the COSO 2013 framework and provide a foundation for the Company to communicate
internal control deficiencies in a timely manner to those parties responsible for taking corrective action. |
|
|
|
|
● |
We
expanded consultations with third-party specialists on complex accounting matters, financial reporting and regulatory filings, and
to create enhanced documentation to support a more precise review process, as well as enhanced monitoring of the review process,
effective enhanced monitoring of the review process, and an effective system of training of use and review of our inventory recording
systems. |
In
addition, under the direction of the audit committee of the Board of Directors, management will continue to review and make necessary
changes to the overall design of the Company’s internal control environment, as well as to refine policies and procedures to improve
the overall effectiveness of internal control over financial reporting of the Company. After all the remediation efforts, not all material
weaknesses may be remediated and others may arise in future periods.
Changes
in Internal Control over Financial Reporting
Other
than described above in Item 4, there has been no change in our internal control over financial reporting that occurred during the last
fiscal quarter to which this report relates that has materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
Part
II - OTHER INFORMATION
Item
1. Legal Proceedings
From
time to time, we may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management
assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the
amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome.
On
February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the
International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging we were in breach of an
Exclusive Distribution Agreement. Protrade alleges, in part, that we breached the Exclusive Distribution Agreement by discontinuing the
manufacture of the DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims damages estimated
at $3 million.
On
March 15, 2022, the arbitrator issued a final award, which, determined that (i) the Company had the right to terminate the Exclusive
Distribution Agreement; (ii) we did not breach the duty of good faith and fair dealing with regard to the Exclusive Distribution Agreement;
and (iii) we did not breach any confidentiality obligations to Protrade. Nevertheless, the arbitrator determined that we did not comply
with the obligation to supply Protrade with a year’s supply of patches, and awarded Protrade $1,500,250, which consists of $1,432,000
for “lost profits” and $68,250 as reimbursement of arbitration costs, on the grounds that we allegedly failed to supply Protrade
with certain patches utilized by users of DV0057 Painshield MD device. The arbitrator based the decision on the testimony of Protrade’s
president who asserted that a user would use in excess of 33 patches per each device. We believe that the number of patches per device
alleged by Protrade is grossly inflated, and that these claims were not properly raised before the arbitrator. Accordingly, on April
13, 2022, we submitted an application for the correction of the award which the arbitrator denied on June 22, 2022.
On
April 5, 2022, Protrade filed a Petition with the Supreme Court of New York Nassau County seeking to confirm the award. On April 13,
2022, we submitted an application to the ICA seeking to correct an error in the award based on the evidence that we only sold 2-3 reusable
patches per device contrary to the 33 reusable patches claimed by Protrade. The same arbitrator who issued the award denied the application.
On
July 22, 2022, we filed a cross-motion seeking to vacate arbitration award on the grounds that the arbitrator exceeded her authority,
that the award was procured by fraud, and that the arbitrator failed to follow procedures established by New York law. In particular,
we averred in our motion that Protrade’s witness made false statements in arbitration, and that the arbitrator resolved a claim
that was never raised by Protrade and that has no factual basis.
On
October 3, 2022, the court issued a decision granting Protrade its petition to confirm the award and denying the cross-motion.
On
November 9, 2022, we filed a motion to re-argue and renew our cross-motion to vacate the arbitration decision based on newer information
that was not available during the initial hearing. On the same day, we also filed a notice of appeal with the Appellate Division, Second
Department. On March 21, 2023, the Court denied the motion to re-argue and renew.
On
July 10, 2023, we filed our appeal with the Appellate Division, Second Department. The appeal was fully submitted on October 30, 2023.
As
of June 30, 2024 and 2023, the Company accrued the amount of the arbitration award to Protrade of approximately $2.0 million for both
periods, including interest which is classified in “Other accounts payable and accrued expenses.”
There
are no other material proceedings in which any of our directors, officers, affiliates, any registered or beneficial stockholder of more
than 5% of our Common Stock, or any associate of any of the foregoing is an adverse party or has a material interest adverse to our interest.
Item
1A. Risk Factors
The
following description of risk factors includes any material changes to, and supersedes the description of, the risk factors addressed
below associated with our business, financial condition and results of operations previously disclosed in “Item 1A. Risk Factors”
of our Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2023, as initially filed with the SEC on April
8, 2024. Our business, financial condition, and operating results can be affected by a number of factors, whether currently known or
unknown, including but not limited to those described below, any one or more of which could, directly or indirectly, cause our actual
financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating
results. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating
results, and stock price.
The
following discussion of risk factors contains forward-looking statements. These risk factors may be important to understanding other
statements in this Form 10-Q. The following information should be read in conjunction with the condensed consolidated financial statements
and related notes in Part I, Item 1, “Financial Statements” and Part I, Item 2, “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” of this Form 10-Q.
We
conduct our operations in Israel Conditions in Israel, including the recent attack by Hamas and other terrorist organizations from the
Gaza Strip and Israel’s war against them, may affect our operations.
Because
we are incorporated under the laws of the state of Israel and our operations are conducted in Israel, our business and operations are
directly affected by economic, political, geopolitical, and military conditions in Israel. Since the establishment of the State of Israel
in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries and terrorist organizations active in
the region. These conflicts have involved missile strikes, hostile infiltrations, and terrorism against civilian targets in various parts
of Israel, which have negatively affected business conditions in Israel.
Most
recently, in October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of
attacks on civilian and military targets. Hamas also launched extensive rocket attacks on the Israeli population and industrial centers
located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. Following the attack, Israel’s
security cabinet declared war against Hamas and a military campaign against the terrorist organization commenced in parallel to their
continued rocket and terror attacks. Moreover, the clash between Israel and Hezbollah in Lebanon, may escalate in the future into a greater
regional conflict, especially in the northern part of Israel where our Israel office is located which stores approximately $1.6 million
worth of our inventory.
Any
hostilities involving Israel, or the interruption or curtailment of trade within Israel or between Israel and its trading partners, or
the ability to ship our products overseas, could adversely affect our operations and results of operations and could make it more difficult
for us to raise capital. Parties with whom we may do business have sometimes declined to travel to Israel during periods of heightened
unrest or tension, forcing us to make alternative arrangements when necessary. The conflict situation in Israel could cause situations
where medical product certifying or auditing bodies could not be able to visit manufacturing facilities of our subcontractors in Israel
in order to review our certifications or clearances, thus possibly leading to temporary suspensions or even cancellations of our product
clearances or certifications. The conflict situation in Israel could also result in parties with whom we have agreements involving performance
in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions
in such agreements.
There
have been travel advisories issued related to travel to Israel, restriction on travel, and delays and disruptions as related to imports
and exports may be imposed in the future. An inability to receive supplies and materials, shortages of materials or difficulties in procuring
our materials, among others, or conversely, our ability to ship products to our US facilities or overseas customers, may adversely impact
our ability to commercialize and manufacture our product candidates and products in a timely manner. This could cause a number of delays
and/or issues for our operations, including delay of the review of our product candidates by regulatory agencies, which in turn would
have a material adverse impact on our ability to commercialize our product candidates.
Additionally,
members of our management and employees are located and reside in Israel. Shelter-in-place and work-from-home measures, government-imposed
restrictions on movement and travel, and other precautions taken to address the ongoing conflict may temporarily disrupt our management
and employees’ ability to effectively perform their daily tasks.
The
IDF, the national military of Israel, is a conscripted military service, subject to certain exceptions. None of our employees are subject
to military service in the IDF and have been called to serve, but many do serve on guard duty in their local communities from time to
time. It is possible that there will be further military reserve duty call-ups in the future, which may affect our business due to a
shortage of skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to respond to a decrease
in labor availability, such as overtime and third-party outsourcing, for example, which may have unintended negative effects and adversely
impact our results of operations, liquidity, or cash flows.
It
is currently not possible to predict the duration or severity of the ongoing conflict or its effects on our business, operations, and
financial conditions. The ongoing conflict is rapidly evolving and developing, and could disrupt our business and operations, interrupt
our sources and availability of supply, and hamper our ability to raise additional funds or sell our securities, among others.
The
Company’s financial statements have been prepared on a going concern basis and do not include adjustments that might be necessary
if the Company is unable to continue as a going concern. Management has substantial doubt about the Company’s ability to continue
as a going concern.
The
Company’s unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates
the realization of assets and the satisfaction of liabilities in the normal course of business. During the three months ended June 30,
2024, the Company’s cash used in operations was $1,113,000 leaving a cash balance of $2,170,000 as of June 30, 2024. Because the Company
does not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management has substantial
doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments
relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should
the Company be unable to continue as a going concern.
The
Company will need to raise additional capital to finance its losses and negative cash flows from operations and may continue to be dependent
on additional capital raising as long as our products do not reach commercial profitability. There are no assurances that the Company
would be able to raise additional capital on terms favorable to it. If the Company is unsuccessful in commercializing its products and
raising capital, it will need to reduce activities, curtail, or cease operations.
If
we fail to comply with the continued listing requirements of Nasdaq, our Common Stock may be delisted and the price of our Common Stock
and our ability to access the capital markets could be negatively impacted.
Our
Common Stock is currently listed for trading on Nasdaq. We must satisfy Nasdaq’s continued listing requirements, including, among
other things, a minimum stockholders’ equity of $2.5 million and a minimum closing bid price of $1.00 per share or risk
delisting, which would have a material adverse effect on our business. A delisting of our Common Stock from Nasdaq could materially reduce
the liquidity of our Common Stock and result in a corresponding material reduction in the price of our Common Stock. In addition, delisting
could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in
the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.
On
April 10, 2024, the Company received a letter from the Listing Qualifications Department of Nasdaq indicating that, based upon the closing
bid price of the Company’s Common Stock for the 30 consecutive business days between February 27, 2024 and April 9, 2024, the Company
did not meet the minimum 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 letter also indicated that the Company will be provided with a compliance period of 180 calendar days, or
until October 7, 2024 (the “Compliance Period”), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).
In
order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s Common Stock must maintain a minimum
closing bid price of $1.00 for at least ten consecutive business days during the Compliance Period. In the event the Company does not
regain compliance by the end of the Compliance Period, the Company may be eligible for additional time to regain compliance. To qualify,
the Company will be required to meet the continued listing requirement for the market value of its publicly held shares and all other
initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written
notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split if necessary.
If the Company meets these requirements, the Company may be granted an additional 180 calendar days to regain compliance; however, if
it appears to Nasdaq that the Company will be unable to cure the deficiency, or if the Company is not otherwise eligible for the additional
cure period, Nasdaq will provide notice that the Company’s Common Stock will be subject to delisting. There can be no assurance
that the Company will be eligible for the additional 180 calendar day compliance period, if applicable, or that the Nasdaq staff would
grant the Company’s request for continued listing subsequent to any delisting notification. In the event of such a notification,
the Company may appeal the Nasdaq staff’s determination to delist its securities.
The
letter has no immediate impact on the listing of the Company’s Common Stock, which will continue to be listed and traded on The
Nasdaq Capital Market, subject to the Company’s compliance with the other listing requirements of The Nasdaq Capital Market.
There
can be no assurance that we will be able to regain and maintain compliance. If we do not regain compliance by the end of the extension
granted by Nasdaq or we fail to satisfy another Nasdaq requirement for continued listing, Nasdaq staff could provide notice that our
Common Stock will become subject to delisting. In such event, Nasdaq rules permit us to appeal the decision to reject its proposed compliance
plan or any delisting determination to a Nasdaq Hearings Panel. Accordingly, there can be no guarantee that we will be able to maintain
our Nasdaq listing.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults Upon Senior Securities
Not
applicable.
Item
4. Mine Safety Disclosures
Not
Applicable.
Item
5. Other Information
None.
Item
6. Exhibits
EXHIBIT
INDEX
* |
Filed
herewith. |
** |
Furnished
herewith. |
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.
|
NANOVIBRONIX,
INC. |
|
|
|
Date:
August 14, 2024 |
By: |
/s/
Brian Murphy |
|
Name: |
Brian
Murphy, Ph.D. |
|
Title:
|
Chief
Executive Officer |
|
|
|
Date:
August 14, 2024 |
By: |
/s/
Stephen Brown |
|
Name:
|
Stephen
Brown |
|
Title:
|
Chief
Financial Officer |
Exhibit
31.1
CERTIFICATIONS
UNDER SECTION 302
I,
Brian Murphy, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of NanoVibronix, Inc. (the “registrant”); |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d) |
disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a) |
all
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b) |
any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 14, 2024 |
|
|
|
/s/
Brian Murphy |
|
Brian
Murphy |
|
Chief
Executive Officer
(Principal
Executive Officer) |
|
Exhibit
31.2
CERTIFICATIONS
UNDER SECTION 302
I,
Stephen Brown, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of NanoVibronix, Inc. (the “registrant”); |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d) |
disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a) |
all
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b) |
any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 14, 2024 |
|
|
|
/s/
Stephen Brown |
|
Stephen
Brown |
|
Chief
Financial Officer |
|
(Principal
Financial and Accounting Officer) |
|
Exhibit
32.1
CERTIFICATION
FURNISHED PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
This
certification is furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350) and accompanies the Quarterly
Report on Form 10-Q (the “Form 10-Q”) for the quarter ended June 30, 2024, of NanoVibronix, Inc. (the “Company”).
I, Brian Murphy, the Chief Executive Officer of the Company, certify that, based on my knowledge:
(1)
The Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations
of the Company as of and for the periods covered in this report.
Date:
August 14, 2024 |
By: |
/s/
Brian Murphy |
|
|
Brian
Murphy |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
Exhibit
32.2
CERTIFICATION
FURNISHED PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
This
certification is furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350) and accompanies the Quarterly
Report on Form 10-Q (the “Form 10-Q”) for the quarter ended June 30, 2024, of NanoVibronix, Inc. (the “Company”).
I, Stephen Brown, the Chief Financial Officer of the Company, certify that, based on my knowledge:
(1)
The Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations
of the Company as of and for the periods covered in this report.
Date:
August 14, 2024 |
By: |
/s/
Stephen Brown |
|
|
Stephen
Brown |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
v3.24.2.u1
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2024 |
Aug. 14, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2024
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-36445
|
|
Entity Registrant Name |
NanoVibronix,
Inc
|
|
Entity Central Index Key |
0001326706
|
|
Entity Tax Identification Number |
01-0801232
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity address, address line one |
525
Executive Blvd
|
|
Entity ddress, city or town |
Elmsford
|
|
Entity address, state or province |
NY
|
|
Entity Address, Postal Zip Code |
10523
|
|
City Area Code |
(914)
|
|
Local Phone Number |
233-3004
|
|
Title of 12(b) Security |
Common
Stock, par value $0.001 per share
|
|
Trading Symbol |
NAOV
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
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|
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v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash |
$ 2,170,000
|
$ 3,283,000
|
Trade receivables |
489,000
|
318,000
|
Prepaid expenses and other accounts receivable |
296,000
|
154,000
|
Inventory |
2,431,000
|
2,732,000
|
Total current assets |
5,386,000
|
6,487,000
|
Noncurrent assets: |
|
|
Fixed assets, net |
9,000
|
7,000
|
Other assets |
1,000
|
1,000
|
Severance pay fund |
167,000
|
174,000
|
Operating lease right-of-use assets, net |
133,000
|
5,000
|
Total non-current assets |
310,000
|
187,000
|
Total assets |
5,696,000
|
6,674,000
|
Current liabilities: |
|
|
Trade payables |
92,000
|
138,000
|
Other accounts payable and accrued expenses |
2,383,000
|
2,265,000
|
Deferred licensing income, current |
37,000
|
46,000
|
Operating lease liabilities, current |
44,000
|
5,000
|
Total current liabilities |
2,556,000
|
2,454,000
|
Non-current liabilities: |
|
|
Accrued severance pay |
209,000
|
217,000
|
Deferred licensing income, non-current |
1,000
|
15,000
|
Operating lease liabilities, non-current |
89,000
|
|
Total liabilities |
2,855,000
|
2,686,000
|
Commitments and contingencies |
|
|
Stockholders’ equity: |
|
|
Common Stock of $0.001 par value – Authorized: 40,000,000 shares at June 30, 2024 and December 31, 2023, respectively; issued and outstanding: 2,784,353 and 2,046,307 shares at June 30, 2024 and December 31, 2023, respectively |
2,000
|
2,000
|
Additional paid in capital |
70,284,000
|
70,149,000
|
Accumulated other comprehensive income |
(73,000)
|
(67,000)
|
Accumulated deficit |
(67,372,000)
|
(66,096,000)
|
Total stockholders’ equity |
2,841,000
|
3,988,000
|
Total liabilities and stockholders’ equity |
5,696,000
|
6,674,000
|
Series C Preferred Stock [Member] |
|
|
Stockholders’ equity: |
|
|
Preferred stock value |
|
|
Series D Preferred Stock [Member] |
|
|
Stockholders’ equity: |
|
|
Preferred stock value |
|
|
Series E Preferred Stock [Member] |
|
|
Stockholders’ equity: |
|
|
Preferred stock value |
|
|
Series F Preferred Stock [Member] |
|
|
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|
|
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|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
40,000,000
|
40,000,000
|
Common stock, shares issued |
2,784,353
|
2,046,307
|
Common stock, shares outstanding |
2,784,353
|
2,046,307
|
Series C Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
3,000,000
|
3,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Series D Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
506
|
506
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Series E Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
1,999,494
|
1,999,494
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Series F Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.01
|
$ 0.01
|
Preferred stock, shares authorized |
40,000
|
0
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
$ 817,000
|
$ 294,000
|
$ 1,738,000
|
$ 648,000
|
Cost of revenues |
389,000
|
78,000
|
646,000
|
197,000
|
Gross profit |
428,000
|
216,000
|
1,092,000
|
451,000
|
Operating expenses: |
|
|
|
|
Research and development |
187,000
|
35,000
|
308,000
|
90,000
|
Selling and marketing |
199,000
|
227,000
|
364,000
|
441,000
|
General and administrative |
716,000
|
963,000
|
1,662,000
|
1,984,000
|
Total operating expenses |
1,102,000
|
1,225,000
|
2,334,000
|
2,515,000
|
Loss from operations |
(674,000)
|
(1,009,000)
|
(1,242,000)
|
(2,064,000)
|
Interest expense |
(34,000)
|
(33,000)
|
(68,000)
|
(67,000)
|
Financial expense, net |
24,000
|
(18,000)
|
45,000
|
(25,000)
|
Loss before taxes on income |
(684,000)
|
(1,061,000)
|
(1,265,000)
|
(2,156,000)
|
Income tax expense |
(4,000)
|
(13,000)
|
(11,000)
|
(15,000)
|
Net loss |
$ (688,000)
|
$ (1,074,000)
|
$ (1,276,000)
|
$ (2,171,000)
|
Basic net loss available for holders of Common Stock |
$ (0.25)
|
$ (0.65)
|
$ (0.48)
|
$ (1.31)
|
Diluted net loss available for holders of Common Stock |
$ (0.25)
|
$ (0.65)
|
$ (0.48)
|
$ (1.31)
|
Weighted average Common Stock outstanding, Basic |
2,784,353
|
1,662,330
|
2,648,088
|
1,657,313
|
Weighted average Common Stock outstanding, Diluted |
2,784,353
|
1,662,330
|
2,648,088
|
1,657,313
|
Comprehensive loss: |
|
|
|
|
Net loss available to common stockholders |
$ (688,000)
|
$ (1,074,000)
|
$ (1,276,000)
|
$ (2,171,000)
|
Change in foreign currency translation adjustments |
(3,000)
|
(30,000)
|
(6,000)
|
(37,000)
|
Comprehensive loss available to common stockholders |
$ (691,000)
|
$ (1,104,000)
|
$ (1,282,000)
|
$ (2,208,000)
|
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v3.24.2.u1
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Preferred Stock [Member]
Series C Preferred Stock [Member]
|
Preferred Stock [Member]
Series D Preferred Stock [Member]
|
Preferred Stock [Member]
Series E Preferred Stock [Member]
|
Preferred Stock [Member]
Series F Preferred Stock [Member]
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
|
|
|
|
$ 2
|
$ 65,634
|
$ (18)
|
$ (62,385)
|
$ 3,233
|
Balance, shares at Dec. 31, 2022 |
|
|
|
|
1,641,146
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
133
|
|
|
133
|
Exercise of options |
|
|
|
|
|
|
|
|
|
Currency translation adjustment |
|
|
|
|
|
|
(37)
|
|
(37)
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
(2,171)
|
(2,171)
|
Exercise of pre-funded warrants |
|
|
|
|
|
$ 7
|
|
|
$ 7
|
Exercise of pre-funded warrants, shares |
|
|
|
|
5,458
|
|
|
|
|
Rounding-up of fractional shares due to reverse stock split |
|
|
|
|
|
|
|
|
|
Rounding-up of fractional shares due to reverse stock split, shares |
|
|
|
|
15,726
|
|
|
|
|
Balance at Jun. 30, 2023 |
|
|
|
|
$ 2
|
$ 65,774
|
$ (55)
|
$ (64,556)
|
$ 1,165
|
Balance, shares at Jun. 30, 2023 |
|
|
|
|
1,662,330
|
|
|
|
|
Balance at Dec. 31, 2023 |
|
|
|
|
$ 2
|
70,149
|
(67)
|
(66,096)
|
3,988
|
Balance, shares at Dec. 31, 2023 |
|
|
|
|
2,046,307
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
Exercise of options |
|
|
|
|
|
135
|
|
|
135
|
Currency translation adjustment |
|
|
|
|
|
|
(6)
|
|
(6)
|
Issuance of Common stock |
|
|
|
|
|
|
|
|
|
Issuance of Common stock, shares |
|
|
|
|
738,046
|
|
|
|
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
(1,276)
|
(1,276)
|
Balance at Jun. 30, 2024 |
|
|
|
|
$ 2
|
$ 70,284
|
$ (73)
|
$ (67,372)
|
$ 2,841
|
Balance, shares at Jun. 30, 2024 |
|
|
|
|
2,784,353
|
|
|
|
|
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (1,276)
|
$ (2,171)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
1
|
1
|
Stock-based compensation |
107
|
133
|
Noncash interest expense |
67
|
67
|
Change in fair value of equity investment |
|
|
Changes in operating assets and liabilities: |
|
|
Trade receivable |
(171)
|
(62)
|
Other accounts receivable and prepaid expenses |
(142)
|
536
|
Inventory |
301
|
(939)
|
Trade payables |
(46)
|
(33)
|
Other accounts payable and accrued expenses |
51
|
85
|
Deferred revenue |
(23)
|
(44)
|
Accrued severance pay, net |
(1)
|
(2)
|
Net cash used in operating activities |
(1,132)
|
(2,429)
|
Cash flows from investing activities: |
|
|
Purchases of fixed assets |
(3)
|
(1)
|
Net cash used in investing activities |
(3)
|
(1)
|
Cash flows from financing activities: |
|
|
Proceeds from exercise of options |
28
|
7
|
Net cash provided by financing activities |
28
|
7
|
Effects of currency translation on cash |
(6)
|
(7)
|
Net (decrease) increase in cash |
(1,113)
|
(2,430)
|
Cash at beginning of period |
3,283
|
2,713
|
Cash at end of period |
2,170
|
253
|
Supplemental disclosures of cash flow information: |
|
|
Cash paid for interest |
|
|
Cash paid for taxes |
|
|
X |
- DefinitionIncrease decrease in accrued severance pay net.
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v3.24.2.u1
DESCRIPTION OF BUSINESS
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
DESCRIPTION OF BUSINESS |
NOTE
1 – DESCRIPTION OF BUSINESS
NanoVibronix,
Inc. (the “Company”), a Delaware corporation, commenced operations on October 20, 2003 and is a medical device company focusing
on noninvasive biological response-activating devices that target wound healing and pain therapy and can be administered at home without
the assistance of medical professionals.
The
Company’s principal research and development activities are conducted in Israel through its wholly owned subsidiary, NanoVibronix
(Israel 2003) Ltd., a company registered in Israel, which commenced operations in October 2003.
|
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v3.24.2.u1
GOING CONCERN, LIQUIDITY AND OTHER UNCERTAINTIES
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
GOING CONCERN, LIQUIDITY AND OTHER UNCERTAINTIES |
NOTE
2 – GOING CONCERN, LIQUIDITY AND OTHER UNCERTAINTIES
Liquidity
and Going Concern
The
Company’s ability to continue to operate is dependent mainly on its ability to successfully market and sell its products and the
receipt of additional financing until profitability is achieved. During the three and six months ended June 30, 2024, the Company has
incurred losses as well as negative cash outflows from operating activities and expects to incur losses and negative cash outflows from
operating activities through at least fiscal year 2024. Because the Company does not have sufficient resources to fund its operations
for the next twelve months from the date of this filing and there could be a significant arbitration payment due (see Note 10), substantial
doubt exists as to the Company’s ability to continue as a going concern.
The
Company will need to raise additional capital to finance its losses and negative cash flows from operations and may continue to be dependent
on additional capital raising as long as the Company’s products do not reach commercial profitability. If the Company is unable
to obtain additional financing, the development of its product candidates and the Company’s commercial strategy may be impacted
and there could be a material adverse effect on the Company’s business and financial condition. These financial statements do not
include any adjustments that may result from the outcome of this uncertainty.
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- DefinitionThe entire disclosure when substantial doubt is raised about the ability to continue as a going concern. Includes, but is not limited to, principal conditions or events that raised substantial doubt about the ability to continue as a going concern, management's evaluation of the significance of those conditions or events in relation to the ability to meet its obligations, and management's plans that alleviated or are intended to mitigate the conditions or events that raise substantial doubt about the ability to continue as a going concern.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
NOTE
3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of presentation and principles of consolidation
The
unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts
and transactions have been eliminated in consolidation. The Company’s condensed consolidated financial statements have been prepared
in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for the interim
financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the accompanying
unaudited interim consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary
to state fairly the financial position and results of operations of the Company. These condensed consolidated financial statements and
notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended
December 31, 2023, as found in the Company’s Annual Report on Form 10-K, as amended, initially filed with the Securities and Exchange
Commission (the “SEC”) on April 8, 2024.
The
balance sheet for December 31, 2023 was derived from the Company’s audited financial statements for the year ended December 31,
2023. The results of operations for the periods presented are not necessarily indicative of results that could be expected for the entire
fiscal year due to seasonality and other factors. Certain information and footnote disclosures normally included in the consolidated
financial statements in accordance with U.S. GAAP have been omitted in accordance with the rules and regulations of the SEC for interim
reporting.
Use
of estimates
The
preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and
assumptions. The Company believes that the estimates, judgments and assumptions used are reasonable based upon information available
at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of revenue and expenses during
the reporting period. Actual results could differ from those estimates.
Foreign
currency translation
Non-U.S.
dollar denominated transactions and balances have been re-measured to U.S. dollars. All gains and losses from re-measurement of monetary
balance sheet items denominated in non-U.S. dollar currencies are reflected in the statements of operations as other comprehensive income,
as appropriate. The cumulative translation gains for the three months ended June 30, 2024 and 2023 were $6,000 and $37,000, respectively.
Cash
The
Company holds cash in various banking institutions. Such funds are insured by the Federal Deposit Insurance Corporation (“FDIC”)
up to $250,000. Cash balances could exceed insured amounts at any given time. As of June 30, 2024, the company had cash in excess of
the FDIC insured amount totaling $1,487,754.
Trade
receivables
The
Company’s trade receivable balance consists of amounts due from its customers. The Current Expected Credit Losses (“CECL”)
impairment model requires an estimate of expected credit losses, measured over the contractual life of an instrument, which considers
forecasts of future economic conditions in addition to information about past events and current conditions. Based on this model, the
Company considers many factors, including the age of the balance, collection history, and current economic trends. Credit losses are
written off after all collection efforts have ceased. Allowances for credit losses are recorded as a direct reduction from an asset’s
amortized cost basis. Credit losses and recoveries are recorded in selling, general and administrative expenses in the consolidated statements
of operations. Recoveries of financial assets previously written off are recorded when received. Trades receivables were $489,000 as
of June 30, 2024 and are not anticipated to possess substantial credit risk or expected credit losses. Historically, the Company has
not had significant write offs of trade receivables. All sales are nonrefundable. As of June 30, 2024, the change in CECL is $0.
Revenue
recognition
Revenues
from product sales are recognized in accordance with ASC 606 “Revenue Recognition.” Five basic steps must be followed before
revenue can be recognized; (1) identifying the contract(s) with a customer that creates enforceable rights and obligations; (2) identifying
the performance obligations in the contract, such as promising to transfer goods or services to a customer; (3) determining the transaction
price, meaning the amount of consideration in a contract to which an entity expects to be entitled in exchange for transferring promised
goods or services to a customer; (4) allocating the transaction price to the performance obligations in the contract, which requires
the company to allocate the transaction price to each performance obligation on the basis of the relative standalone selling prices of
each distinct good or services promised in the contract; and (5) recognizing revenue when (or as) the entity satisfies a performance
obligation by transferring a promised good or service to a customer. The amount of revenue recognized is the amount allocated to the
satisfied performance obligation.
Revenue
from product sales is recorded at the net sales price, or “transaction price,” which includes estimates of variable consideration
that result from coupons, discounts, distributor fees and processing fees, as well as allowances for returns and government rebates.
The Company constrains revenue by considering factors that could otherwise lead to a probable reversal of revenue. Collectability of
revenue is reasonably assured based on historical evidence of collectability between the Company and its customers.
Revenues
from sales to distributors are recognized at the time the products are delivered to the distributors (“sell-in”). The Company
does not grant rights of return, credits, rebates, price protection, or other privileges on its products to distributors.
Recently
adopted accounting standards
In
June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13,
Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”)
and subsequent amendments to the initial guidance: ASU 2018-19, ASU 2019-04, and ASU 2019-05 (collectively, “Topic 326”).
Topic 326 requires measurement and recognition of expected credit losses for financial assets held. This ASU is effective for interim
and annual reporting periods beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted
ASU 2016-13 as of January 1, 2023, and there was no material impact on its condensed consolidated financial statements upon adoption.
In
November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,
which requires an enhanced disclosure of significant segment expenses on an annual and interim basis. This guidance is effective for
annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption
is permitted. Upon adoption, the guidance should be applied retrospectively to all prior periods presented in the financial statements.
The Company is currently evaluating the impact that adoption of ASU 2023-09 will have on its financial statements.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (ASU 2023-09). ASU
2023-09 requires that an entity, on an annual basis, disclose additional income tax information, primarily related to the rate reconciliation
and income taxes paid. The amendment in the ASU is intended to enhance the transparency and decision usefulness of income tax disclosures.
The ASU’s amendments are effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the
impact that adoption of ASU 2023-09 will have on its financial statements.
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v3.24.2.u1
INVENTORY
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
INVENTORY |
NOTE
4 – INVENTORY
Inventory
consists of the following components:
SCHEDULE OF INVENTORY
| |
June 30,
2024 | | |
December 31, 2023 | |
| |
| | |
| |
Raw materials | |
$ | 343,000 | | |
$ | 210,000 | |
Finished goods | |
| 2,088,000 | | |
| 2,522,000 | |
Inventory | |
$ | 2,431,000 | | |
$ | 2,732,000 | |
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v3.24.2.u1
STOCKHOLDERS’ EQUITY
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
STOCKHOLDERS’ EQUITY |
NOTE
5 – STOCKHOLDERS’ EQUITY
Common
stock
The
common stock, par value $0.001 per share (the “Common Stock”), confers upon the holders the right to receive notice to participate
and vote in general meetings of the Company, the right to receive dividends, if declared, and to participate in the distribution of the
surplus assets and funds of the Company in the event of liquidation, dissolution, or winding up of the Company.
Reverse
stock split
On
February 8, 2023, the Company effected a reverse stock split of its Common Stock at a ratio of 1 post-split share for every 20 pre-split
shares. The Company’s Common Stock begin trading on a split-adjusted basis when the market opened on February 9, 2023 (the “Reverse
Stock Split”).
At
the effective time of the Reverse Stock Split, every 20 shares of the Company’s issued and outstanding Common Stock were converted
automatically into one issued and outstanding share of Common Stock without any change in the par value per share. Stockholders holding
shares through a brokerage account had their shares automatically adjusted to reflect the 1-for-20 Reverse Stock Split. The Reverse Stock
Split affected all stockholders uniformly and did not alter any stockholder’s percentage interest in the Company’s equity,
except to the extent that the Reverse Stock Split resulted in a stockholder owning a fractional share. Any fractional share of a stockholder
resulting from the Reverse Stock Split was rounded up to the nearest whole number of shares. Proportional adjustments were made to the
number of shares of the Company’s Common Stock issuable upon exercise or conversion of the Company’s equity awards, warrants,
and other convertible securities, as well as the applicable exercise or conversion price thereof. On February 16, 2023, the Company rounded
up fractional shares to its nearest whole number of 15,726 shares. On March 31, 2024, the Company rounded up fractional shares to its
nearest whole number of 46 shares.
All
references in this Quarterly Report on Form 10-Q to number of shares, price per share, and weighted average number of shares of Common
Stock outstanding prior to the Reverse Stock Split have been adjusted to reflect the Reverse Stock Split on a retroactive basis, unless
otherwise noted.
Issuance
of Common Stock for cash through private placement
On
August 30, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional
investor for the issuance and sale in a private placement (the “Private Placement”) of 180,000 shares (the “Common
Stock”) of Common Stock, pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 2,726,977 shares of Common Stock,
with an exercise price of $0.0001 per share, A-1 Warrants (the “A-1 Warrants”) to purchase up to 2,906,977 shares of Common
Stock, with an exercise price of $1.47 per share, and A-2 Warrants (the “A-2 Warrants” and together with the A-1 Warrants,
the “Warrants”) to purchase up to 2,906,977 shares of Common Stock with an exercise price of $1.47 per share. The
A-1 Warrants are exercisable immediately upon issuance and expire March 1, 2029. The A-2 Warrants are exercisable immediately upon issuance
and expire October 1, 2024. The combined purchase price for one Common Share and the accompanying Warrants was $1.72, and the combined
purchase price for one Pre-Funded Warrant and the accompanying Warrants was $1.7199.
The
net proceeds to the Company from the Private Placement were approximately $4,215,000, after deducting placement agent fees and expenses
and estimated offering expenses payable by the Company. The Company intends to use the net proceeds received from the Private Placement
for general corporate purposes, including funding of the Company’s development programs, commercial planning, sales and marketing
expenses, potential strategic acquisitions, general and administrative expenses, and working capital.
H.C.
Wainwright & Co., LLC (“Wainwright”) served as the Company’s exclusive placement agent in connection with the Private
Placement, pursuant to that certain engagement letter, dated as of July 5, 2023, between the Company and Wainwright (as amended, the
“Engagement Letter”). As part of Wainwright’s compensation, we issued to Wainwright or its designees warrants (the
“Placement Agent Warrants”) to purchase up to an aggregate of 218,023 shares of Common Stock at an exercise price equal to
$2.15 per share. The Placement Agent Warrants are exercisable immediately upon issuance and expire March 1, 2029.
Stock-based
compensation and Options
During
the three-month and six-month period ended June 30, 2024, 0
employee options were exercised, respectively. During the three and six-month period ended June 30, 2023, 0
and 5,459
employee options were exercised, respectively. During the three month and six month period ended June 30, 2024, no
employee options were granted. During the three and six-month period ended June 30, 2023, no employee options were granted.
The
options granted to employees and board members were recorded at a fair value and vested over ten years. During the three and six-month
period ended June 30, 2024, stock-based compensation expense of $28 and $135 was recorded for options that vested, respectively. During
the three and six-month period ended June 30, 2023, stock-based compensation expense of $66 and $133 was recorded for options that vested,
respectively.
SCHEDULE OF OPTIONS ACTIVITY
| |
Shares Under Options | | |
Weighted Average Exercise Price per Share | | |
Weighted Average Remaining Life (Years) | |
Outstanding – December 31, 2022 | |
| 147,619 | | |
$ | 24.42 | | |
| 7.24 | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| (5,459 | ) | |
| 1.40 | | |
| 0.24 | |
Expired | |
| - | | |
| - | | |
| - | |
Outstanding – March 31, 2023 | |
| 142,160 | | |
$ | 25.31 | | |
| 7.50 | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Outstanding – June 30, 2023 | |
| 142,160 | | |
| 25.31 | | |
| 7.50 | |
| |
| | | |
| | | |
| | |
Outstanding – December 31, 2023 | |
| 112,685 | | |
$ | 13.10 | | |
| 8.41 | |
Granted | |
| 90,000 | | |
| 0.90 | | |
| 9.82 | |
Exercised | |
| - | | |
| - | | |
| - | |
Expired | |
| (36 | ) | |
| 39.2 | | |
| 0.16 | |
Outstanding – March 31, 2024 | |
| 202,650 | | |
$ | 7.67 | | |
| 8.90 | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Outstanding – June 30, 2024 | |
| 202,650 | | |
| 7.67 | | |
| 8.90 | |
Warrants
On
August 30, 2023, the Company granted (a) Pre-Funded Warrants to purchase up to 2,726,977 shares of Common Stock with an exercise price
of $0.0001 per share, (b) A-1 Warrants to purchase up to 2,906,977 shares of Common Stock with an exercise price of $1.47 per share,
and (c) A-2 Warrants to purchase up to 2,906,977 shares of Common Stock with an exercise price of $1.47 per share, for a total of 8,540,931
warrants, in conjunction with the Private Placement disclosed above. The A-1 Warrants and A-2 Warrants are exercisable immediately upon
issuance and expire on March 1, 2029 and October 1, 2024, respectively.
For
the same Private Placement, the Company granted Placement Agent Warrants to Wainwright, or its designees, to purchase up to an aggregate
of 218,023 shares of Common Stock at an exercise price equal to $2.15 per share. The Placement Agent Warrants are exercisable immediately
upon issuance and expire March 1, 2029.
For
the six months ended June 30, 2024 and 2023, there were 0 warrants granted, respectively. For the three months ended June 30, 2024 and
2023, there were 743,000 and 0 warrants exercised and/or cancelled, respectively
SCHEDULE OF WARRANTS ACTIVITY
| |
Warrants | |
Outstanding – December 31, 2022 | |
| 78,252 | |
Granted | |
| - | |
Exercised | |
| - | |
Canceled | |
| - | |
Expired | |
| - | |
Outstanding – June 30, 2023 | |
| 78,252 | |
| |
| | |
Outstanding – December 31, 2023 | |
| 8,633,229 | |
Granted | |
| - | |
Exercised | |
| (738,000 | ) |
Canceled | |
| - | |
Expired | |
| (5,000 | ) |
Outstanding – June 30, 2024 | |
| 7,890,229 | |
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v3.24.2.u1
LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDER
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDER |
NOTE
6 – LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDER
Basic
net loss per share of Common Stock is computed by dividing net loss available to common stockholders by the weighted average number of
shares of Common Stock outstanding during the period. All outstanding stock options and warrants for the six months ended June 30, 2024
and 2023 have been excluded from the calculation of the diluted net loss per share because all such securities are anti-dilutive for
all periods presented.
The
following table summarizes the Company’s securities, in Common Stock equivalents, which have been excluded from the calculation
of dilutive loss per share as their effect would be anti-dilutive:
SUMMARY
OF COMMON STOCK EQUIVALENTS EXCLUDED FROM CALCULATION OF DILUTIVE LOSS PER SHARE
| |
June 30, 2024 | | |
June 30, 2023 | |
Stock Options – employee and non-employee | |
| 202,650 | | |
| 142,160 | |
Warrants | |
| 7,890,229 | | |
| 78,252 | |
Total | |
| 8,092,879 | | |
| 220,412 | |
Anti-dilutive shares | |
| 8,092,879 | | |
| 220,412 | |
|
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v3.24.2.u1
GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA
|
6 Months Ended |
Jun. 30, 2024 |
Segment Reporting [Abstract] |
|
GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA |
NOTE
7 – GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA
The
Company derives revenues from selling its products directly to patients as well as through distributor agreements. The following is a
summary of revenues within geographic areas:
SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
United States | |
$ | 794,000 | | |
$ | 282,000 | | |
$ | 1,698,000 | | |
$ | 592,000 | |
Europe | |
| - | | |
| - | | |
| - | | |
| 19,000 | |
Australia/New Zealand | |
| 8,000 | | |
| - | | |
| 13,000 | | |
| 13,000 | |
Asia | |
| - | | |
| - | | |
| - | | |
| 1,000 | |
Other | |
| 15,000 | | |
| 12,000 | | |
| 27,000 | | |
| 23,000 | |
Total | |
$ | 817,000 | | |
$ | 294,000 | | |
$ | 1,738,000 | | |
$ | 648,000 | |
The
Company’s long-lived assets are all located in Israel.
For
both the three and six months ended June 30, 2024, the Company’s largest customer comprised approximately 52% and 41% of total
revenues in each of the respective periods. During the three and six months ended June 30, 2023, the Company’s two largest customers
comprised approximately 86% of total revenues in each of the respective periods. One of the Company’s largest customers comprised
36% and 86% in each of the respective periods, while the other remaining customer comprised 50% and 0%, respectively.
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v3.24.2.u1
LEASES
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
LEASES |
NOTE
8 – LEASES
The
Company has operating lease agreements with terms up to 2-3 years, including car and office space leases.
The
Company’s weighted-average remaining lease term relating to its operating leases is 2.68 years, with a weighted-average discount
rate of 10%. The discount rate was determined by referencing rates used by companies in the same industry.
The
Company incurred $23,000 and $36,000 of lease expense for its operating leases for the six months ended June 30, 2024 and 2023, respectively.
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating leases as
of June 30, 2024:
SCHEDULE OF LIABILITIES ARISING FROM OPERATING LEASES
| |
| | |
2024 | |
$ | 27 | |
2025 | |
| 57 | |
2026 | |
| 58 | |
Thereafter | |
| 10 | |
Total undiscounted operating lease payments | |
| 152 | |
Less: Imputed interest | |
| 19 | |
Present value of operating lease liabilities | |
$ | 133 | |
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v3.24.2.u1
OTHER ASSETS
|
6 Months Ended |
Jun. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
OTHER ASSETS |
NOTE
9 – OTHER ASSETS
On
April 9, 2020, pursuant to a licensing agreement entered into in March 2020, the Company received 10-year warrants to purchase 127,000
shares of Sanuwave Health, Inc. at a price of $0.19 per share. The fair value for warrants received was estimated at the date of grant
and at each reporting period using a Black-Scholes-Merton pricing model with the following underlying assumptions:
SCHEDULE OF WARRANTS ASSUMPTIONS
| |
June 30, 2024 | | |
June 30, 2023 | |
Price at valuation | |
$ | 0.02 | | |
$ | 0.04 | |
Exercise price | |
$ | 0.19 | | |
$ | 0.19 | |
Risk free interest | |
| 4.52 | % | |
| 3.97 | % |
Expected term (in years) | |
| 6 | | |
| 7 | |
Volatility | |
| 196.7 | % | |
| 155.6 | % |
The
Company considers this to be Level 3 inputs which are valued at each reporting period. For the three and six months June 30, 2024, changes
in the fair value of these warrants amounted to $11 and $500, leaving a balance of $2,000 as of June 30, 2024. For the three and six
months ended June 30, 2023, changes in the fair value of these warrants amounted to $(2,000) and $0, respectively, leaving a balance
of $3,000 as of June 30, 2023.
Financial
Instruments Measured at Fair Value on a Recurring Basis
The
fair value accounting standards define fair value as the amount that would be received to sell an asset or paid to transfer a liability
in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants
would use in pricing an asset or liability. Fair value measurements are rated on a three-tier hierarchy as follows:
● |
Level
1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; |
|
|
● |
Level
2 inputs: Inputs, other than quoted prices included in Level 1, that are observable either directly or indirectly; and |
|
|
● |
Level
3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own
assumptions. |
There
were no transfers between Level 3 during the six months ended June 30, 2024, and 2023.
The
following table presents changes in Level 3 asset and liability measured at fair value for the quarters ended June 30, 2024 and 2023:
SCHEDULE OF CHANGES IN LEVEL 3 AND LIABILITY MEASURED AT FAIR VALUE
| |
Asset | |
Balance – December 31, 2022 | |
$ | 3,000 | |
Fair value adjustments – Sanuwave warrants | |
| 2,000 | |
Balance – March 31, 2023 | |
$ | 5,000 | |
Fair Value adjustments – Sanuwave warrants | |
| (2,000 | ) |
Balance – June 30, 2023 | |
| 3,000 | |
| |
| | |
Balance – December 31, 2023 | |
| 1,000 | |
Fair value adjustments – Sanuwave warrants | |
| 1,000 | |
Balance – March 31, 2024 | |
$ | 2,000 | |
Fair Value adjustments – Sanuwave warrants | |
| - | |
Balance – June 30, 2024 | |
| 2,000 | |
The
following table sets forth the Company’s assets and liabilities which are measured at fair value on a recurring basis by level
within the fair value hierarchy:
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
| |
Fair Value Measurements as of June 30, 2024 | |
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
Asset: | |
| | |
| | |
| | |
| |
Other assets | |
$ | - | | |
$ | - | | |
$ | 2,000 | | |
$ | 2,000 | |
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
| |
Fair Value Measurements as of June 30, 2023 | |
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
Asset: | |
| | |
| | |
| | |
| |
Other assets | |
$ | - | | |
$ | - | | |
$ | 3,000 | | |
$ | 3,000 | |
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
NOTE
10 – COMMITMENTS AND CONTINGENCIES
Pending
litigation
On
February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the
International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging that the Company is in breach
of an Exclusive Distribution Agreement dated March 7, 2019, between Protrade and the Company (the “Exclusive Distribution Agreement”).
Protrade alleges, in part, that the Company has breached the Exclusive Distribution Agreement by discontinuing the manufacture of the
DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims damages estimated at $3 million.
On
March 15, 2022, the arbitrator issued a final award which determined that (i) the Company had the right to terminate the Exclusive Distribution
Agreement; (ii) the Company did not breach the duty of good faith and fair dealing with regard to the Exclusive Distribution Agreement;
and (iii) the Company did not breach any confidentiality obligations to Protrade. Nevertheless, the arbitrator determined that the Company
did not comply with the obligation to supply Protrade with a year’s supply of patches and awarded Protrade $1,500,250, which consists
of $1,432,000 for “lost profits” and $68,250 as reimbursement of arbitration costs, on the grounds that the Company allegedly
failed to supply Protrade with certain patches utilized by users of DV0057 Painshield MD device. The arbitrator based the decision on
the testimony of Protrade’s president who asserted that a user would use in excess of 33 patches per device. The Company believes
that the number of patches per device alleged by Protrade is grossly inflated and that these claims were not properly raised before the
arbitrator. Accordingly, on April 13, 2022, the Company submitted an application for correction of the award which the arbitrator denied
on June 22, 2022.
On
April 5, 2022, Protrade filed a Petition with the Supreme Court of New York, Nassau County seeking to confirm the award. On April 13,
2022, the Company submitted an application to the ICA seeking to correct an error in the award based on the evidence that the Company
only sold 2-3 reusable patches per device contrary to the 33 reusable patches claimed by Protrade. The same arbitrator who issued the
award denied the application.
On
July 22, 2022, the Company filed a cross-motion seeking to vacate the arbitration award on the grounds that the arbitrator exceeded her
authority, that the award was procured by fraud, and that the arbitrator failed to follow procedures established by New York law. In
particular, the Company averred in its motion that Protrade’s witness made false statements in arbitration and that the arbitrator
resolved a claim that was never raised by Protrade and has no factual basis.
On
October 3, 2022, the court issued a decision granting Protrade its petition to confirm the award and denying the cross-motion.
On
November 9, 2022, the Company filed a motion to re-argue and renew its cross-motion to vacate the arbitration decision based on newer
information that was not available during the initial hearing. On the same day, the Company also filed a notice of appeal with the Appellate
Division, Second Department. On March 21, 2023, the court denied the motion to re-argue and renew.
On
July 10, 2023, the Company filed an appeal with the Appellate Division, Second Department. The Company intends to continue to vigorously
pursue its opposition to the award in all appropriate fora.
As
of June 30, 2024 and December 31, 2023, the Company accrued the amount of the arbitration award to Protrade of approximately $2 million
for both periods including interest which is classified in “Other accounts payable and accrued expenses.”
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v3.24.2.u1
RELATED PARTY TRANSACTION
|
6 Months Ended |
Jun. 30, 2024 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTION |
NOTE
11 – RELATED PARTY TRANSACTION
The
firm FisherBroyles LLP is handling the Company’s Protrade litigation and appeals. For the three and six months ended June 30, 2024,
the Company has been billed and paid legal fees from FisherBroyles amounting to $0 and $76,034, respectively, which have been recorded
as part of “General and administrative expenses” in the condensed consolidated statements of operations. As has been previously
disclosed, one of the Company’s board members, Aurora Cassirer, was a partner at FisherBroyles. On January 1, 2024, Ms. Cassirer
left FisherBroyles to become a partner at Pierson Ferdinand. Pierson Ferdinand was paid $6,917 and $20,831 during the three and six months
ended June 30, 2024. Ms. Cassirer does not provide any legal services or legal advice to the Company.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.24.2.u1
SUBSEQUENT EVENTS
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
12 – SUBSEQUENT EVENTS
The Company has evaluated subsequent events through
August 14, 2024. Based on this evaluation, the Company has determined that there are no material subsequent events that require disclosure
in these financial statements.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of presentation and principles of consolidation |
Basis
of presentation and principles of consolidation
The
unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts
and transactions have been eliminated in consolidation. The Company’s condensed consolidated financial statements have been prepared
in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for the interim
financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the accompanying
unaudited interim consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary
to state fairly the financial position and results of operations of the Company. These condensed consolidated financial statements and
notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended
December 31, 2023, as found in the Company’s Annual Report on Form 10-K, as amended, initially filed with the Securities and Exchange
Commission (the “SEC”) on April 8, 2024.
The
balance sheet for December 31, 2023 was derived from the Company’s audited financial statements for the year ended December 31,
2023. The results of operations for the periods presented are not necessarily indicative of results that could be expected for the entire
fiscal year due to seasonality and other factors. Certain information and footnote disclosures normally included in the consolidated
financial statements in accordance with U.S. GAAP have been omitted in accordance with the rules and regulations of the SEC for interim
reporting.
|
Use of estimates |
Use
of estimates
The
preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and
assumptions. The Company believes that the estimates, judgments and assumptions used are reasonable based upon information available
at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of revenue and expenses during
the reporting period. Actual results could differ from those estimates.
|
Foreign currency translation |
Foreign
currency translation
Non-U.S.
dollar denominated transactions and balances have been re-measured to U.S. dollars. All gains and losses from re-measurement of monetary
balance sheet items denominated in non-U.S. dollar currencies are reflected in the statements of operations as other comprehensive income,
as appropriate. The cumulative translation gains for the three months ended June 30, 2024 and 2023 were $6,000 and $37,000, respectively.
|
Cash |
Cash
The
Company holds cash in various banking institutions. Such funds are insured by the Federal Deposit Insurance Corporation (“FDIC”)
up to $250,000. Cash balances could exceed insured amounts at any given time. As of June 30, 2024, the company had cash in excess of
the FDIC insured amount totaling $1,487,754.
|
Trade receivables |
Trade
receivables
The
Company’s trade receivable balance consists of amounts due from its customers. The Current Expected Credit Losses (“CECL”)
impairment model requires an estimate of expected credit losses, measured over the contractual life of an instrument, which considers
forecasts of future economic conditions in addition to information about past events and current conditions. Based on this model, the
Company considers many factors, including the age of the balance, collection history, and current economic trends. Credit losses are
written off after all collection efforts have ceased. Allowances for credit losses are recorded as a direct reduction from an asset’s
amortized cost basis. Credit losses and recoveries are recorded in selling, general and administrative expenses in the consolidated statements
of operations. Recoveries of financial assets previously written off are recorded when received. Trades receivables were $489,000 as
of June 30, 2024 and are not anticipated to possess substantial credit risk or expected credit losses. Historically, the Company has
not had significant write offs of trade receivables. All sales are nonrefundable. As of June 30, 2024, the change in CECL is $0.
|
Revenue recognition |
Revenue
recognition
Revenues
from product sales are recognized in accordance with ASC 606 “Revenue Recognition.” Five basic steps must be followed before
revenue can be recognized; (1) identifying the contract(s) with a customer that creates enforceable rights and obligations; (2) identifying
the performance obligations in the contract, such as promising to transfer goods or services to a customer; (3) determining the transaction
price, meaning the amount of consideration in a contract to which an entity expects to be entitled in exchange for transferring promised
goods or services to a customer; (4) allocating the transaction price to the performance obligations in the contract, which requires
the company to allocate the transaction price to each performance obligation on the basis of the relative standalone selling prices of
each distinct good or services promised in the contract; and (5) recognizing revenue when (or as) the entity satisfies a performance
obligation by transferring a promised good or service to a customer. The amount of revenue recognized is the amount allocated to the
satisfied performance obligation.
Revenue
from product sales is recorded at the net sales price, or “transaction price,” which includes estimates of variable consideration
that result from coupons, discounts, distributor fees and processing fees, as well as allowances for returns and government rebates.
The Company constrains revenue by considering factors that could otherwise lead to a probable reversal of revenue. Collectability of
revenue is reasonably assured based on historical evidence of collectability between the Company and its customers.
Revenues
from sales to distributors are recognized at the time the products are delivered to the distributors (“sell-in”). The Company
does not grant rights of return, credits, rebates, price protection, or other privileges on its products to distributors.
|
Recently adopted accounting standards |
Recently
adopted accounting standards
In
June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13,
Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”)
and subsequent amendments to the initial guidance: ASU 2018-19, ASU 2019-04, and ASU 2019-05 (collectively, “Topic 326”).
Topic 326 requires measurement and recognition of expected credit losses for financial assets held. This ASU is effective for interim
and annual reporting periods beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted
ASU 2016-13 as of January 1, 2023, and there was no material impact on its condensed consolidated financial statements upon adoption.
In
November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,
which requires an enhanced disclosure of significant segment expenses on an annual and interim basis. This guidance is effective for
annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption
is permitted. Upon adoption, the guidance should be applied retrospectively to all prior periods presented in the financial statements.
The Company is currently evaluating the impact that adoption of ASU 2023-09 will have on its financial statements.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (ASU 2023-09). ASU
2023-09 requires that an entity, on an annual basis, disclose additional income tax information, primarily related to the rate reconciliation
and income taxes paid. The amendment in the ASU is intended to enhance the transparency and decision usefulness of income tax disclosures.
The ASU’s amendments are effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the
impact that adoption of ASU 2023-09 will have on its financial statements.
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v3.24.2.u1
INVENTORY (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
SCHEDULE OF INVENTORY |
Inventory
consists of the following components:
SCHEDULE OF INVENTORY
| |
June 30,
2024 | | |
December 31, 2023 | |
| |
| | |
| |
Raw materials | |
$ | 343,000 | | |
$ | 210,000 | |
Finished goods | |
| 2,088,000 | | |
| 2,522,000 | |
Inventory | |
$ | 2,431,000 | | |
$ | 2,732,000 | |
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v3.24.2.u1
STOCKHOLDERS’ EQUITY (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
SCHEDULE OF OPTIONS ACTIVITY |
SCHEDULE OF OPTIONS ACTIVITY
| |
Shares Under Options | | |
Weighted Average Exercise Price per Share | | |
Weighted Average Remaining Life (Years) | |
Outstanding – December 31, 2022 | |
| 147,619 | | |
$ | 24.42 | | |
| 7.24 | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| (5,459 | ) | |
| 1.40 | | |
| 0.24 | |
Expired | |
| - | | |
| - | | |
| - | |
Outstanding – March 31, 2023 | |
| 142,160 | | |
$ | 25.31 | | |
| 7.50 | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Outstanding – June 30, 2023 | |
| 142,160 | | |
| 25.31 | | |
| 7.50 | |
| |
| | | |
| | | |
| | |
Outstanding – December 31, 2023 | |
| 112,685 | | |
$ | 13.10 | | |
| 8.41 | |
Granted | |
| 90,000 | | |
| 0.90 | | |
| 9.82 | |
Exercised | |
| - | | |
| - | | |
| - | |
Expired | |
| (36 | ) | |
| 39.2 | | |
| 0.16 | |
Outstanding – March 31, 2024 | |
| 202,650 | | |
$ | 7.67 | | |
| 8.90 | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Outstanding – June 30, 2024 | |
| 202,650 | | |
| 7.67 | | |
| 8.90 | |
|
SCHEDULE OF WARRANTS ACTIVITY |
SCHEDULE OF WARRANTS ACTIVITY
| |
Warrants | |
Outstanding – December 31, 2022 | |
| 78,252 | |
Granted | |
| - | |
Exercised | |
| - | |
Canceled | |
| - | |
Expired | |
| - | |
Outstanding – June 30, 2023 | |
| 78,252 | |
| |
| | |
Outstanding – December 31, 2023 | |
| 8,633,229 | |
Granted | |
| - | |
Exercised | |
| (738,000 | ) |
Canceled | |
| - | |
Expired | |
| (5,000 | ) |
Outstanding – June 30, 2024 | |
| 7,890,229 | |
|
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v3.24.2.u1
LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDER (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
SUMMARY OF COMMON STOCK EQUIVALENTS EXCLUDED FROM CALCULATION OF DILUTIVE LOSS PER SHARE |
The
following table summarizes the Company’s securities, in Common Stock equivalents, which have been excluded from the calculation
of dilutive loss per share as their effect would be anti-dilutive:
SUMMARY
OF COMMON STOCK EQUIVALENTS EXCLUDED FROM CALCULATION OF DILUTIVE LOSS PER SHARE
| |
June 30, 2024 | | |
June 30, 2023 | |
Stock Options – employee and non-employee | |
| 202,650 | | |
| 142,160 | |
Warrants | |
| 7,890,229 | | |
| 78,252 | |
Total | |
| 8,092,879 | | |
| 220,412 | |
Anti-dilutive shares | |
| 8,092,879 | | |
| 220,412 | |
|
X |
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v3.24.2.u1
GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Segment Reporting [Abstract] |
|
SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS |
The
Company derives revenues from selling its products directly to patients as well as through distributor agreements. The following is a
summary of revenues within geographic areas:
SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
United States | |
$ | 794,000 | | |
$ | 282,000 | | |
$ | 1,698,000 | | |
$ | 592,000 | |
Europe | |
| - | | |
| - | | |
| - | | |
| 19,000 | |
Australia/New Zealand | |
| 8,000 | | |
| - | | |
| 13,000 | | |
| 13,000 | |
Asia | |
| - | | |
| - | | |
| - | | |
| 1,000 | |
Other | |
| 15,000 | | |
| 12,000 | | |
| 27,000 | | |
| 23,000 | |
Total | |
$ | 817,000 | | |
$ | 294,000 | | |
$ | 1,738,000 | | |
$ | 648,000 | |
|
X |
- DefinitionTabular disclosure of revenue from external customers by geographic areas attributed to the entity's country of domicile and to foreign countries from which the entity derives revenue.
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v3.24.2.u1
LEASES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
SCHEDULE OF LIABILITIES ARISING FROM OPERATING LEASES |
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating leases as
of June 30, 2024:
SCHEDULE OF LIABILITIES ARISING FROM OPERATING LEASES
| |
| | |
2024 | |
$ | 27 | |
2025 | |
| 57 | |
2026 | |
| 58 | |
Thereafter | |
| 10 | |
Total undiscounted operating lease payments | |
| 152 | |
Less: Imputed interest | |
| 19 | |
Present value of operating lease liabilities | |
$ | 133 | |
|
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v3.24.2.u1
OTHER ASSETS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
SCHEDULE OF WARRANTS ASSUMPTIONS |
SCHEDULE OF WARRANTS ASSUMPTIONS
| |
June 30, 2024 | | |
June 30, 2023 | |
Price at valuation | |
$ | 0.02 | | |
$ | 0.04 | |
Exercise price | |
$ | 0.19 | | |
$ | 0.19 | |
Risk free interest | |
| 4.52 | % | |
| 3.97 | % |
Expected term (in years) | |
| 6 | | |
| 7 | |
Volatility | |
| 196.7 | % | |
| 155.6 | % |
|
SCHEDULE OF CHANGES IN LEVEL 3 AND LIABILITY MEASURED AT FAIR VALUE |
The
following table presents changes in Level 3 asset and liability measured at fair value for the quarters ended June 30, 2024 and 2023:
SCHEDULE OF CHANGES IN LEVEL 3 AND LIABILITY MEASURED AT FAIR VALUE
| |
Asset | |
Balance – December 31, 2022 | |
$ | 3,000 | |
Fair value adjustments – Sanuwave warrants | |
| 2,000 | |
Balance – March 31, 2023 | |
$ | 5,000 | |
Fair Value adjustments – Sanuwave warrants | |
| (2,000 | ) |
Balance – June 30, 2023 | |
| 3,000 | |
| |
| | |
Balance – December 31, 2023 | |
| 1,000 | |
Fair value adjustments – Sanuwave warrants | |
| 1,000 | |
Balance – March 31, 2024 | |
$ | 2,000 | |
Fair Value adjustments – Sanuwave warrants | |
| - | |
Balance – June 30, 2024 | |
| 2,000 | |
|
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE |
The
following table sets forth the Company’s assets and liabilities which are measured at fair value on a recurring basis by level
within the fair value hierarchy:
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
| |
Fair Value Measurements as of June 30, 2024 | |
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
Asset: | |
| | |
| | |
| | |
| |
Other assets | |
$ | - | | |
$ | - | | |
$ | 2,000 | | |
$ | 2,000 | |
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
| |
Fair Value Measurements as of June 30, 2023 | |
| |
Level I | | |
Level II | | |
Level III | | |
Total | |
Asset: | |
| | |
| | |
| | |
| |
Other assets | |
$ | - | | |
$ | - | | |
$ | 3,000 | | |
$ | 3,000 | |
|
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
|
|
|
Cumulative translation gains |
$ 6,000
|
$ 37,000
|
|
|
Cash FDIC, insured amount |
250,000
|
|
$ 250,000
|
|
Cash uninsured amount |
1,487,754
|
|
1,487,754
|
|
Trades receivables |
$ 489,000
|
|
489,000
|
$ 318,000
|
Change in current expected credit losses |
|
|
$ 0
|
|
X |
- DefinitionChange in current expected credit losses.
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v3.24.2.u1
SCHEDULE OF INVENTORY (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Inventory Disclosure [Abstract] |
|
|
Raw materials |
$ 343,000
|
$ 210,000
|
Finished goods |
2,088,000
|
2,522,000
|
Inventory |
$ 2,431,000
|
$ 2,732,000
|
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v3.24.2.u1
SCHEDULE OF OPTIONS ACTIVITY (Details) - Share-Based Payment Arrangement, Option [Member] - $ / shares
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
Options, Outstanding - Beginning balance |
202,650
|
112,685
|
142,160
|
147,619
|
112,685
|
147,619
|
147,619
|
|
Weighted Average Exercise Price per Share, Outstanding - Beginning balance |
$ 7.67
|
$ 13.10
|
$ 25.31
|
$ 24.42
|
$ 13.10
|
$ 24.42
|
$ 24.42
|
|
Weighted Average Remaining Life (Years), Outstanding |
8 years 10 months 24 days
|
8 years 10 months 24 days
|
7 years 6 months
|
7 years 6 months
|
|
|
8 years 4 months 28 days
|
7 years 2 months 26 days
|
Options, Granted |
|
90,000
|
|
|
|
|
|
|
Weighted Average Exercise Price per Share, Granted |
|
$ 0.90
|
|
|
|
|
|
|
Options, Exercised |
|
|
|
(5,459)
|
|
(5,459)
|
|
|
Weighted Average Exercise Price per Share, Exercised |
|
|
|
$ 1.40
|
|
|
|
|
Weighted Average Remaining Life (Years), Exercised |
|
|
|
2 months 26 days
|
|
|
|
|
Options, Expired |
|
(36)
|
|
|
|
|
|
|
Weighted Average Exercise Price per Share, Expired |
|
$ 39.2
|
|
|
|
|
|
|
Options, Outstanding - Ending balance |
202,650
|
202,650
|
142,160
|
142,160
|
202,650
|
142,160
|
112,685
|
147,619
|
Weighted Average Exercise Price per Share, Outstanding - Ending balance |
$ 7.67
|
$ 7.67
|
$ 25.31
|
$ 25.31
|
$ 7.67
|
$ 25.31
|
$ 13.10
|
$ 24.42
|
Weighted Average Remaining Life (Years), Granted |
|
9 years 9 months 25 days
|
|
|
|
|
|
|
Weighted Average Remaining Life (Years), Expired |
|
1 month 28 days
|
|
|
|
|
|
|
X |
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v3.24.2.u1
SCHEDULE OF WARRANTS ACTIVITY (Details) - Placement Agent Warrants [Member] - shares
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Warrants, Outstanding - Beginning balance |
8,633,229
|
78,252
|
Warrants, Granted |
|
|
Warrants, Exercised |
(738,000)
|
|
Warrants, Canceled |
|
|
Warrants, Expired |
(5,000)
|
|
Warrants, Outstanding - Ending Balance |
7,890,229
|
78,252
|
X |
- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.24.2.u1
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)
|
|
|
|
3 Months Ended |
6 Months Ended |
|
|
Aug. 30, 2023 |
Feb. 16, 2023 |
Feb. 08, 2023 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Jul. 05, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, per share |
|
|
|
$ 0.001
|
|
|
|
$ 0.001
|
|
$ 0.001
|
|
Reverse stock split |
|
|
1-for-20 Reverse Stock Split
|
|
|
|
|
|
|
|
|
Fractional shares |
|
15,726
|
|
|
|
|
|
|
|
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of options, exercised |
|
|
|
|
|
|
5,459
|
|
5,459
|
|
|
Number of options granted |
|
|
|
|
90,000
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
|
$ 28,000
|
|
$ 66,000
|
|
$ 135,000
|
$ 133,000
|
|
|
Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Share price |
$ 1.72
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of private placement |
$ 4,215,000
|
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Fractional shares |
|
|
|
|
46
|
|
|
|
15,726
|
|
|
Number of new share issued |
|
|
|
|
|
|
|
738,046
|
|
|
|
Common Stock [Member] | Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of new share issued |
180,000
|
|
|
|
|
|
|
|
|
|
|
Pre-Funded Warrants [Member] | Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of securities called by warrants or rights |
2,726,977
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
$ 0.0001
|
|
|
|
|
|
|
|
|
|
|
A-1 Warrants [Member] | Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of securities called by warrants or rights |
2,906,977
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
$ 1.47
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right expire date |
Mar. 01, 2029
|
|
|
|
|
|
|
|
|
|
|
A-2 Warrants [Member] | Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of securities called by warrants or rights |
2,906,977
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
$ 1.47
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right expire date |
Oct. 01, 2024
|
|
|
|
|
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Warrants, granted |
|
|
|
|
|
|
|
0
|
0
|
|
|
Warrants, exercised |
|
|
|
743,000
|
|
0
|
|
|
|
|
|
Warrant [Member] | Private Placement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of securities called by warrants or rights |
8,540,931
|
|
|
|
|
|
|
|
|
|
|
Warrant [Member] | Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Warrants puchase price per share |
$ 1.7199
|
|
|
|
|
|
|
|
|
|
|
Placement Agent Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Warrants, granted |
|
|
|
|
|
|
|
|
|
|
|
Placement Agent Warrants [Member] | Wainwright [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of securities called by warrants or rights |
|
|
|
|
|
|
|
|
|
|
218,023
|
Class of warrant or right expire date |
|
|
|
|
|
|
|
|
|
|
Mar. 01, 2029
|
Share price |
|
|
|
|
|
|
|
|
|
|
$ 2.15
|
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v3.24.2.u1
SUMMARY OF COMMON STOCK EQUIVALENTS EXCLUDED FROM CALCULATION OF DILUTIVE LOSS PER SHARE (Details) - shares
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive shares |
8,092,879
|
220,412
|
Stock Options - Employee and Non-employee [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive shares |
202,650
|
142,160
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive shares |
7,890,229
|
78,252
|
X |
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v3.24.2.u1
SUMMARY OF REVENUE WITHIN GEOGRAPHIC AREAS (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Total |
$ 817,000
|
$ 294,000
|
$ 1,738,000
|
$ 648,000
|
UNITED STATES |
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Total |
794,000
|
282,000
|
1,698,000
|
592,000
|
Europe [Member] |
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Total |
|
|
|
19,000
|
AUSTRALIA |
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Total |
8,000
|
|
13,000
|
13,000
|
Asia [Member] |
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Total |
|
|
|
1,000
|
Other [Member] |
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Total |
$ 15,000
|
$ 12,000
|
$ 27,000
|
$ 23,000
|
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v3.24.2.u1
GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER DATA (Details Narrative) - Revenue Benchmark [Member] - Customer Concentration Risk [Member]
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Customer [Member] |
|
|
|
|
Revenue, Major Customer [Line Items] |
|
|
|
|
Concentration risk, percentage |
52.00%
|
36.00%
|
41.00%
|
86.00%
|
Two Customers [Member] |
|
|
|
|
Revenue, Major Customer [Line Items] |
|
|
|
|
Concentration risk, percentage |
|
86.00%
|
|
86.00%
|
Other Customer [Member] |
|
|
|
|
Revenue, Major Customer [Line Items] |
|
|
|
|
Concentration risk, percentage |
|
50.00%
|
|
0.00%
|
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v3.24.2.u1
SCHEDULE OF WARRANTS ASSUMPTIONS (Details) - Sanuwave Health, Inc. [Member]
|
Jun. 30, 2024
$ / shares
|
Jun. 30, 2023
$ / shares
|
Price at Valuation [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Warrants and rights outstanding, measurement input |
0.02
|
0.04
|
Measurement Input, Exercise Price [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Warrants and rights outstanding, measurement input |
0.19
|
0.19
|
Measurement Input, Risk Free Interest Rate [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Warrants and rights outstanding, measurement input |
4.52
|
3.97
|
Measurement Input, Expected Term [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Expected term (in years) |
6 years
|
7 years
|
Measurement Input, Price Volatility [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Warrants and rights outstanding, measurement input |
196.7
|
155.6
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SCHEDULE OF CHANGES IN LEVEL 3 AND LIABILITY MEASURED AT FAIR VALUE (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Offsetting Assets [Line Items] |
|
|
|
|
|
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|
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$ (2,000)
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$ 500
|
$ 0
|
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|
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|
|
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|
|
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2,000
|
$ 1,000
|
5,000
|
$ 3,000
|
1,000
|
3,000
|
Fair value adjustments - Sanuwave warrants |
|
1,000
|
(2,000)
|
2,000
|
|
|
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$ 2,000
|
$ 2,000
|
$ 3,000
|
$ 5,000
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$ 3,000
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Jun. 30, 2024 |
Jun. 30, 2023 |
Platform Operator, Crypto Asset [Line Items] |
|
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$ 2
|
$ 3
|
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$ 3
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OTHER ASSETS (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Apr. 09, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
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$ 11
|
$ (2,000)
|
$ 500
|
$ 0
|
|
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$ 2,000
|
$ 3,000
|
$ 2,000
|
$ 3,000
|
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|
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|
|
|
|
Warrants and rights outstanding term |
|
|
|
|
10 years
|
Warrants issued to purchase common stock |
|
|
|
|
127,000
|
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|
|
|
|
$ 0.19
|
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)
|
|
|
6 Months Ended |
12 Months Ended |
Mar. 15, 2022 |
Feb. 26, 2021 |
Jun. 30, 2024 |
Dec. 31, 2023 |
Loss contingency damages sought value |
$ 1,500,250
|
$ 3,000,000
|
|
|
Damages awarded value |
1,432,000
|
|
|
|
Loss contingency damages paid value |
$ 68,250
|
|
|
|
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|
|
|
|
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|
|
$ 2,000,000
|
$ 2,000,000
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NanoVibronix (NASDAQ:NAOV)
過去 株価チャート
から 7 2024 まで 8 2024
NanoVibronix (NASDAQ:NAOV)
過去 株価チャート
から 8 2023 まで 8 2024