Skinvisible, Inc. - 10-Q - June 30, 2024
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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
☐
Transition Report pursuant to 13 or 15(d) of the Securities Exchange Act of 1934
For the transition period from __________ to __________
Commission File Number: 000-25911
Skinvisible, Inc.
(Exact name of Registrant as specified in its charter)
Nevada
88-0344219
(State or other jurisdiction of incorporation or organization)
(IRS Employer Identification No.)
6320 South Sandhill Road , Suite 10 , Las Vegas , NV 89120
(Address of principal executive offices)
702 . 433.7154
(Registrant’s telephone number)
_______________________________________________________________
(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(s)
Name of each exchange on which registered
None
None
None
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
☒
Yes ☐
No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No
☐
Indicate by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, 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
☒
State the number of shares outstanding of each of
the issuer’s classes of common stock, as of the latest practicable date: 4,889,843 common shares as of August 14, 2024.
1
Table of Contents
TABLE OF CONTENTS
Page
PART I – FINANCIAL INFORMATION
Item 1:
Financial Statements
3
Item 2:
Management’s Discussion and Analysis of Financial Condition and Results of Operations
4
Item 3:
Quantitative and Qualitative Disclosures About Market Risk
10
Item 4:
Controls and Procedures
10
PART II – OTHER INFORMATION
Item 1:
Legal Proceedings
11
Item 1A:
Risk Factors
11
Item 2:
Unregistered Sales of Equity Securities and Use of Proceeds
12
Item 3:
Defaults Upon Senior Securities
12
Item 4:
Mine Safety Disclosure
12
Item 5:
Other Information
12
Item 6:
Exhibits
12
2
Table of Contents
PART I - FINANCIAL INFORMATION
Item 1.
Financial Statements
Our consolidated financial statements included in this Form 10-Q
are as follows:
F-1
Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023 (unaudited);
F-2
Consolidated Statements of Operations for the three and six months ended June 30, 2024 and 2023 (unaudited);
F-3
Consolidated Statements of Stockholders’ Equity ( Deficit) for the three and six months ended June 30, 2024 and 2023 (unaudited);
F-4
Consolidated Statements of Cash Flow for the three and six months ended June 30, 2024 and 2023 (unaudited);
F-5
Notes to Consolidated Financial Statements.
These consolidated financial statements have been prepared in accordance
with accounting principles generally accepted in the United States of America for interim financial information and the SEC instructions
to Form 10-Q. In the opinion of management, all adjustments considered necessary for a fair presentation have been included. Operating
results for the interim period ended June 30, 2024 are not necessarily indicative of the results that can be expected for the full year.
3
Table of Contents
SKINVISIBLE,
INC.
CONSOLIDATED
BALANCE SHEETS
(UNAUDITED)
June
30, 2024
December
31, 2023
ASSETS
Current assets
Cash
$ 6,990
$ 888
Accounts
receivable
5,000
5,000
Accounts
receivable - related party
17,592
21,592
Prepaid
expense and other current assets
6,300
7,980
Total
current assets
35,882
35,460
Patents
and trademarks, net
127,176
127,409
Total
assets
$ 163,058
$ 162,869
LIABILITIES AND STOCKHOLDERS'
DEFICIT
Current liabilities
Accounts
payable and accrued liabilities
$ 659,692
$ 438,668
Accrued
interest payable
2,872,609
2,575,595
Loans
from related party
4,200
6,000
Loans
payable
433,600
433,600
Convertible
notes payable, net of unamortized debt discount of $ 25,627 and $ 63,785 , respectively
40,000
40,000
Derivative
liability
13,470
18,544
Total
current liabilities
4,023,571
3,512,407
Convertible
notes payable related party, net of unamortized discount of $ 0 and $ 0
respectively
5,372,403
5,372,403
Convertible
notes payable
348,948
301,102
Total liabilities
9,744,922
9,185,912
Stockholders' deficit
Common stock; $ 0.001 par
value; 200,000,000 shares authorized; 4,889,843 and 4,539,843 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively
4,890
4,540
Additional
paid-in capital
30,387,555
30,352,905
Accumulated
deficit
( 39,974,309 )
( 39,380,488 )
Total
stockholders' deficit
( 9,581,864 )
( 9,023,043 )
Total
liabilities and stockholders' deficit
$ 163,058
$ 162,869
See Accompanying Notes
to Consolidated Financial Statements.
F- 1
Table of Contents
SKINVISIBLE,
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
Three
months ended
Six
months ended
June
30, 2024
June
30, 2023
June
30, 2024
June
30, 2023
Revenues
$ 5,000
$ 5,000
$ 10,000
$ 10,000
Cost of revenues
—
—
—
—
Gross
profit
5,000
5,000
10,000
10,000
Operating expenses
Depreciation
and amortization
4,756
4,840
9,451
9,484
Selling
general and administrative
142,937
112,983
266,426
241,243
Total
operating expenses
147,693
117,823
275,877
250,727
Loss from
operations
( 142,693 )
( 112,823 )
( 265,877 )
( 240,727 )
Other income and (expense)
Gain/(loss)
on settlement of debt
—
—
—
—
Interest
expense
( 166,610 )
( 167,522 )
( 333,018 )
( 1,551,636 )
Gain/(loss)
on change in derivative liability
5,854
4,270
5,074
1,232
Total
other income (expense)
( 160,756 )
( 163,252 )
( 327,944 )
( 1,550,404 )
Net
income (loss)
$ ( 303,449 )
$ ( 276,075 )
$ ( 593,821 )
$ ( 1,791,131 )
Basic
income (loss) per common share
$ ( 0.07 )
$ ( 0.06 )
$ ( 0.13 )
$ ( 0.39 )
Fully
diluted income (loss) per common share
$ ( 0.07 )
$ ( 0.06 )
$ ( 0.13 )
$ ( 0.39 )
Basic
weighted average common shares outstanding
4,539,843
4,539,843
4,539,843
4,539,843
Fully
diluted weighted average common shares
outstanding
4,639,843
4,539,843
4,589,843
4,539,843
See Accompanying Notes
to Consolidated Financial Statements.
F- 2
Table of Contents
SKINVISIBLE,
INC.
CONSOLIDATED
STATEMENT OF STOCKHOLDERS' DEFICIT
(UNAUDITED)
Common Stock
Shares
Amount
Additional Paid-in Capital
Shares payable
Accumulated Deficit
Total Stockholders' Deficit
Balance, December 31, 2023
4,539,843
$ 4,540
$ 30,352,905
$ —
$ ( 39,380,488 )
$ ( 9,023,043 )
Net loss
—
—
—
—
( 290,372 )
( 290,372 )
Balance, March 31, 2024
4,539,843
$ 4,540
$ 30,352,905
$ —
$ ( 39,670,860 )
$ ( 9,313,415 )
Units issued for cash
350,000
$ 350
$ 34,650
$ —
$ —
35,000
Net loss
—
—
—
—
( 303,449 )
( 303,449 )
Balance, June 30, 2024
4,889,843
$ 4,890
$ 30,387,555
$ —
$ ( 39,974,309 )
$ ( 9,581,864 )
Balance,
December 31, 2022
4,539,843
$ 4,540
$ 30,352,905
$ —
$ ( 36,998,048 )
$ ( 6,640,603 )
Net
loss
—
—
—
—
( 1,515,056 )
( 1,515,056 )
Balance, March
31, 2023
4,539,843
$ 4,540
$ 30,352,905
$ —
$ ( 38,513,104 )
$ ( 8,155,659 )
Net
loss
—
—
—
—
( 276,075 )
( 276,075 )
Balance, June 30,
2023
4,539,843
$ 4,540
$ 30,352,905
$ —
$ ( 38,789,179 )
$ ( 8,431,734 )
See Accompanying Notes
to Consolidated Financial Statements.
F- 3
Table of Contents
SKINVISIBLE,
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
Six
months ended
June
30, 2024
June
30, 2023
Cash flows from operating
activities:
Net
loss
$ ( 593,821 )
$ ( 1,791,131 )
Adjustments
to reconcile net loss to net cash
provided (used) by operating activities:
—
Depreciation
and amortization
9,451
9,484
Amortization
of debt discount
25,346
1,253,275
Gain/(loss)
on change in derivative liability
( 5,074 )
( 1,232 )
Changes
in operating assets and liabilities:
Decrease
(Increase) in prepaid assets
1,680
1,605
Decrease
(Increase) in accounts receivable - related party
4,000
—
Increase
(decrease) in accounts payable and accrued liabilities
221,024
178,725
Decrease
in due from related party
—
( 29,111 )
Increase
in accrued interest
297,014
309,889
Net cash
provided used in operating activities
( 40,380 )
( 68,496 )
Cash flows from investing
activities:
Purchase
of intangible assets
( 9,218 )
( 9,334 )
Net cash
used in investing activities
( 9,218 )
( 9,334 )
Cash flows from financing
activities:
Common
stock issued for cash
35,000
—
Payments
on related party loans
( 1,800 )
—
Payments
on convertible notes payable
22,500
—
Net
cash provided by (used in) financing activities
55,700
—
Net change in cash
6,102
( 77,830 )
Cash, beginning of period
888
81,378
Cash, end of period
$ 6,990
$ 3,548
Supplemental disclosure of
cash flow information:
Cash
paid for interest
$ —
$ —
Cash
paid for tax
$ —
$ —
SUPPLEMENTAL DISCLOSURE OF
CASH FLOW INFORMATION:
Non-cash
investing and financing activities:
Accrued
salary settled with Convertible notes payable related party
—
1,152,194
See Accompanying Notes to Consolidated Financial Statements.
F- 4
Table of Contents
SKINVISIBLE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2024
1. DESCRIPTION OF BUSINESS
AND HISTORY
Description of business
Skinvisible,
Inc., (referred to as the “Company”) is focused on the development and manufacture and sales of innovative topical, transdermal
and mucosal polymer-based delivery system technologies and formulations incorporating its patent-pending formula/process for combining
hydrophilic and hydrophobic polymer emulsions. The technologies and formulations have broad industry applications within the pharmaceutical,
over-the-counter, personal skincare and cosmetic arenas. Additionally, the Company’s non-dermatological formulations, offer solutions
for a broad spectrum of markets women’s health, pain management, and others. The Company maintains executive and sales offices in
Las Vegas, Nevada.
History
The Company was incorporated in Nevada
on March 6, 1998 , under the name of Microbial Solutions, Inc. The Company underwent a name change on February 26, 1999, when it changed
its name to Skinvisible, Inc. The Company’s subsidiary’s name of Manloe Labs, Inc. was also changed to Skinvisible Pharmaceuticals,
Inc.
Skinvisible, Inc., together with its subsidiaries,
shall herein be collectively referred to as the “Company.”
2. BASIS
OF PRESENTATION AND GOING CONCERN
Basis of presentation
The accompanying unaudited
interim financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United
States of America for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation
S-X , and should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s most
recent Annual Financial Statements on Form 10-K filed with the SEC on June 30, 2024. In the opinion of management, all adjustments, consisting
of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim
period presented have been reflected herein. The results of operations for the interim period are not necessarily indicative of the results
to be expected for the full year. Notes to the financial statements which would substantially duplicate the disclosures contained in the
audited financial statements for the most recent fiscal period, as reported in the Form 10-K, have been omitted.
The condensed consolidated balance sheet at December
31, 2023 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes
required by generally accepted accounting principles in the U.S. for complete financial statements.
Going
concern
The
accompanying 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. For the six months ended June 30, 2024, the Company had a net loss of $ 593,821 . The
Company has also incurred cumulative net losses of $ 39,974,309 since its inception and requires capital for its contemplated operational
and marketing activities to take place. These factors, among others, raises substantial doubt about the Company’s ability to continue
as a going concern within one year from the date of filing.
Managements plans for the Company are to generate
the necessary funding through licensing of its core products and to seek additional debt and equity funding. However, the Company’s
ability to generate the necessary funds through licensing or raise additional capital through the future issuances of common stock or
debt is unknown. The obtainment of additional financing, the successful development of the Company’s contemplated plan of operations,
and its transition, ultimately, to the attainment of profitable operations are necessary for the Company to continue operations. The consolidated
financial statements of the Company do not include any adjustments that may result from the outcome of these aforementioned uncertainties.
F- 5
Table of Contents
3. SUMMARY OF SIGNIFICANT
POLICIES
This
summary of significant accounting policies of Skinvisible Inc. is presented to assist in understanding the Company’s consolidated
financial statements. The consolidated financial statements and notes are representations of the Company’s management, who
are responsible for their integrity and objectivity. These accounting policies conform to accounting principles generally accepted
in the United States of America and have been consistently applied in the preparation of the consolidated financial statements.
Principles of consolidation
The consolidated
financial statements include the accounts of the Company and its subsidiary Skinvisible Pharmaceuticals Inc. All significant intercompany
balances and transactions have been eliminated.
Use of estimates
The preparation of consolidated
financial statements in conformity with accounting principles generally accepted in the United States of America requires management
to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities
at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates. Significant estimates include estimates used to review the Company’s, impairments
and estimations of long-lived assets, allowances for uncollectible accounts, inventory valuation, and the valuations of non-cash capital
stock issuances. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable
in the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that
are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Cash and cash equivalents
For purposes of the
statement of cash flows, the Company considers all highly liquid investments and short-term instruments with original maturities of three
months or less to be cash equivalents.
Fair Value of financial instruments
The
carrying value of cash, accounts payable and accrued expenses, and debt approximate their fair values because of the short-term nature
of these instruments. Management believes the Company is not exposed to significant interest or credit risks arising from these financial
instruments. The carrying amount of the Company’s convertible debt is also stated at a fair value of $ 5,764,477 since the stated
rate of interest approximates market rates.
Fair value is defined as the exchange price that would
be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or
liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value
maximize the use of observable inputs and minimize the use of unobservable inputs. The Company utilizes a fair value hierarchy based on
three levels of inputs, of which the first two are considered observable and the last unobservable.
•
Level 1 Quoted prices in active markets for identical assets or liabilities. These are typically obtained from real-time quotes for transactions in active exchange markets involving identical assets. The Company uses Level 1 measurements to value the transactions when it issues shares, warrants, options and debt with beneficial conversion features.
•
Level 2 Quoted prices for similar assets and liabilities in active markets; quoted prices included for identical or similar assets and liabilities that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets. These are typically obtained from readily available pricing sources for comparable instruments. The Company did not rely on any Level 2 measurements for any of its transactions in the periods included in these financial statements.
•
Level 3 Unobservable inputs, where there is little or no market activity for the asset or liability. These inputs reflect the reporting entity’s own beliefs about the assumptions that market participants would use in pricing the asset or liability, based on the best information available in the circumstances. The Company did not rely on any Level 3 measurements for any of its transactions in the periods included in these financial statements.
F- 6
Table of Contents
Revenue recognition
We recognize revenue
in accordance with generally accepted accounting principles as outlined in the Financial Accounting Standard Board's (“FASB”)
Accounting Standards Codification (“ASC”) 606, Revenue From Contracts with Customers, which requires that five steps be followed
in evaluating revenue recognition: (i) identify the contract with the customer; (ii) identify the performance obligations in the contract;
(iii) determine the transaction price; (iv) allocate the transaction price; and (v) recognize revenue when or as the entity satisfied
a performance obligation.
Product sales –
Revenues from the sale of products (Invisicare® polymers) are recognized when title to the products are transferred to the customer
and only when no further contingencies or material performance obligations are warranted, and thereby have earned the right to receive
reasonably assured payments for products sold and delivered.
Royalty sales –
We also recognize royalty revenue from licensing our patented product formulations only when earned, with no further contingencies or
material performance obligations are warranted, and thereby have earned the right to receive and retain reasonably assured payments.
Distribution and license
rights sales – We also recognize revenue from distribution and license rights when no further contingencies or material
performance obligations are warranted, and thereby have earned the right to receive and retain reasonably assured payments.
The Company has made an accounting policy election
to exclude from the measurement of the transaction price all taxes assessed by governmental authorities that are collected by the Company
from its customers (sales and use taxes, value added taxes, some excise taxes).
Accounts Receivable
Accounts receivable
is comprised of uncollateralized customer obligations due under normal trade terms requiring payment within 30 days from the invoice date.
The carrying amount of accounts receivable is reviewed periodically for collectability. If management determines that collection is unlikely,
an allowance that reflects management’s best estimate of the amounts that will not be collected is recorded. Management reviews
each accounts receivable balance that exceeds 30 days from the invoice date and, based on an assessment of creditworthiness, estimates
the portion, if any, of the balance that will not be collected. As of March 31, 2024 and December 31, 2023, the Company had not recorded
a reserve for doubtful accounts.
Intangible assets
The Company follows Financial Accounting Standard Board’s (FASB) Codification Topic 350-10 (“ASC 350-10”), “ Intangibles
– Goodwill and Other ”. According to this statement, intangible assets with indefinite lives are no longer subject to amortization,
but rather an annual assessment of impairment by applying a fair-value based test. Under
ASC 350-10, the carrying value of assets are calculated at the lowest level for which there are identifiable cash flows.
Stock-based compensation
The
Company follows the guidelines in FASB Codification Topic ASC 718-10 “ Compensation-Stock Compensation ”, which requires
the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors including employee
stock options and employee stock purchases related to an Employee Stock Purchase Plan based on the estimated fair values.
Earnings (loss) per share
The Company
reports earnings (loss) per share in accordance with FASB Codification Topic ASC 260-10 “ Earnings Per Share ”, Basic
earnings (loss) per share is computed by dividing income (loss) available to common shareholders by the weighted average number of common
shares available. Diluted earnings (loss) per share is computed similar to basic earnings (loss) per share except that the denominator
is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been
issued and if the additional common shares were dilutive. Diluted earnings (loss) per share has not been presented for the three months
ending March 31, 2023, since the effect of the assumed exercise of options and warrants to purchase common shares (common stock equivalents)
would have an anti-dilutive effect. There are 83,156,326 additional shares issuable in connection with outstanding convertible debts as
of June 30, 2024.
F- 7
Table of Contents
Recently issued accounting pronouncements
Management has considered all
recent accounting pronouncements issued. The Company’s management believes that these recent pronouncements will not have a material
effect on the Company’s financial statements.
4. INTANGIBLE AND OTHER
ASSETS
Patents and trademarks and other intangible
assets are capitalized at their historical cost and are amortized over their estimated useful lives. As of June 30, 2024, intangible assets
total $ 126,503 , net of $ 177,169 of accumulated amortization.
Amortization expense for the three months
ended June 30, 2024 and 2023 was $ 9,451 and $ 9,484 , respectively. License and distributor rights were acquired by the Company in January
1999 and provide exclusive use distribution of polymers and polymer based products. The Company has a non-expiring term on the license
and distribution rights. Accordingly, the Company annually assesses this license and distribution rights for impairment and has determined
that no impairment write-down is considered necessary as of June 30, 2024.
5. RELATED PARTY TRANSACTIONS
During the three months ended June 30, 2024
and 2023, the Company repaid net $ 1,800 and $ 0 in advances due to related parties. As of June 30, 2024 and December 31, 2023, the Company
had amounts due from related parties of $ 4,200 and $ 6,000 , respectively.
Convertible Notes Related Party
On January 31, 2023, the Company renegotiated accrued
salaries, vacation, and outstanding convertible notes for its two officers. Under the terms of the agreements, all outstanding notes totaling
$ 4,220,209 , accrued salaries of $ 1,062,000 , accrued vacation of $ 90,193 were converted to promissory notes convertible into common stock
with a warrant feature. The convertible promissory notes are unsecured, due five years from issuance, and bear an interest rate of 10 % .
At the investor’s option until the repayment date, the note may be converted to shares of the Company’s common stock at a
fixed price of $0.10 per share along with warrants to purchase one share for every two shares issued at the exercise price of $0.15 per
share for three years after the conversion date . As of June 30, 2024 and December 31, 2023, the balance of the note was $ 5,372,402 and
$ 5,372,402 , respectively.
6. NOTES PAYABLE
Secured debt offering
During the period from May 22, 2013 and December
31, 2018, the Company entered into a 9 % notes payable to nineteen investors and received proceeds of $ 552,000 . The notes
were due two years from the anniversary date of execution. The Notes are secured by the US Patent rights granted for the Company's
Sunscreen Products: US patent number #8,128,913: "Sunscreen Composition with Enhanced UV-A Absorber Stability and Methods.”
As of June 30, 2024, $ 433,600 of
the outstanding notes payable are past due and in default and have been classified as current notes payable.
F- 8
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7. CONVERTIBLE NOTES
PAYABLE
Convertible Notes Payable consists of the following:
June
30,
December 31,
2024
2023
$ 40,000 face value 9 % secured notes payable to investors, due in 2015. At the investor’s option until the repayment date, the note and related interest may be converted to shares of the Company’s common stock a discount of 90 % of the current share price after the first anniversary of the note. The notes are secured by the accounts receivable of a license agreement the Company has with Womens Choice Pharmaceuticals, LLC on its proprietary prescription product, ProCort®. The notes have reached maturity and are now in default, under the notes default provisions the entire balance is now due upon demand.
40,000
40,000
Original issue discount
—
—
Unamortized debt discount
—
—
Total, net of unamortized discount
40,000
40,000
On June 30, 2019, the Company renegotiated accrued salaries and interest and outstanding convertible notes for a former employee. Under the terms of the agreements, all outstanding notes totaling $ 224,064 , accrued interest of $ 119,278 , accrued salaries of $ 7,260 and accrued vacation of $ 1,473 were converted to a promissory note convertible into common stock with a warrant feature. The convertible promissory note is unsecured, due five years from issuance, and bears an interest rate of 10 % . At the noteholder’s option until the repayment date, the note may be converted to shares of the Company’s common stock at a fixed price of $0.20 per share along with warrants to purchase one share for every two shares issued at the exercise price of $0.30 per share for three years after the conversion date .
The Company has determined the value associated with the beneficial conversion feature in connection with the notes to be $ 152,642 as valued under the intrinsic value method. The aggregate beneficial conversion feature has been accreted and charged to interest expenses in the amount of $ 25,346 and $ 25,346 for the six months ended June 30, 2024 and 2023, respectively.
352,075
352,075
Unamortized debt discount
( 25,627
)
( 50,973 )
Total, net of unamortized discount
326,448
301,102
$ 22,500 face value 10 % secured notes payable to investors, due in 2025. At the investor’s option until the repayment date, the note and related interest may be converted to shares of the Company’s common stock at the rate of $0.075. per share and 150,000 warrants exercisable at $0.10 each for 1 year from grant date .
22,500
—
Total Convertible Notes
$
388,948
$
341,102
Current portion:
388,948
40,000
Total long-term convertible notes
$
—
$
301,102
F- 9
Table of Contents
8. COMMITMENTS AND CONTINGENCIES
License
Agreement
On
October 17, 2019, Skinvisible entered an Exclusive License Agreement with Quoin pursuant to which Skinvisible granted to Quoin a license
to certain patents for the development of products for commercial sale. In exchange for the license, Quoin agreed to pay to Skinvisible
a license fee of $ 1,000,000 and a royalty percentage on all net sales on the licensed products subject to adjustment in certain
situations. The agreement also requires that Quoin make certain milestone payments to Skinvisible upon achieving regulatory approval milestones
for certain drug products.
The
agreement is subject to termination, if among other things, 50 % of the license fee is not paid by December 31, 2019 and if the
full License Fee is not paid by March 31, 2020 . No payments were made by Quoin and the agreement was terminated on December 31, 2019.
Both Parties subsequently determined that they continue to see the value in a partnership and therefore on May 8, 2020 and again on July
31, 2020 the companies agreed to extend the Exclusive License Agreement, as amended under the same terms to expire on September 30, 2020 and
on January 27, 2021 the companies agreed to revise the milestone payments due under the agreement and to extend the agreement indefinitely.
On
June 14, 2021, the Company entered into an amendment to change the terms of the license Fee as shown below.
As
partial consideration for the rights conveyed by Skinvisible under this Agreement, Licensee agrees to pay to Skinvisible a one-time, non-refundable,
non-creditable license issue fee of one million USD dollars ( $ 1,000,000 ).
On
February 3, 2020, we entered into a License Agreement with Ovation Science Inc. pursuant to which Skinvisible granted to Ovation Science
Inc. a license for the manufacture and distribution rights to its hand sanitizer product, DermSafe. In exchange for the license, Ovation
Science Inc. agreed to pay to Skinvisible a royalty percentage on all net sales on the licensed products subject to adjustment in certain
situations plus a license fee payable in year 3 of the agreement if it chooses to continue the license. On June 10, 2020, the agreement
was further amended to provide additional assignment rights for its hand sanitizer products in exchange for $ 100,000 .
9. STOCKHOLDERS’
DEFICIT
The Company is authorized to issue 200,000,000 shares
of $ 0.001 par value common stock. The Company had 4,889,843 and 4,539,843 issued and outstanding shares of common stock as of June 30,
2024 and December 31, 2023, respectively.
During May
2024, the Company sold 350,000 units at $0.10 per unit, where one unit consists of one share of common stock and a warrant (the “Warrant”)
with the right to purchase one-half of one share of Common Stock . The Warrant will be exercisable for a period of 1 year from the date
of issuance at $ 0.20 per share.
10. SUBSEQUENT EVENTS
In accordance with ASC Topic 855-10, the Company has
analyzed its operations subsequent to June 30, 2024 to the date these financial statements were available to be issued and has determined
that it does not have any material subsequent events to disclose in these financial statements.
F- 10
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Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations Forward-Looking Statements
This quarterly report contains forward-looking statements. Forward-looking
statements are projections of events, revenues, income, future economic performance or management’s plans and objectives for our
future operations. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”,
“expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”,
“potential” or “continue” or the negative of these terms or other comparable terminology. These statements are
only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled “Risk
Factors” and the risks set out below, any of which may cause our or our industry’s actual results, levels of activity, performance
or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied
by these forward-looking statements. These risks include, by way of example and not in limitation:
§ the uncertainty of profitability based upon our history of losses;
§ legislative or regulatory changes concerning skincare research and therapies;
§ risks related to failure to obtain adequate financing on a timely basis and on acceptable terms to continue
as going concern;
§ risks related to our operations and uncertainties related to our business plan and business strategy;
§ changes in economic conditions;
§ uncertainty with respect to intellectual property rights, protecting those rights and claims of infringement
of other’s intellectual property;
§ competition; and
§ cybersecurity concerns.
This list is not an exhaustive list of the factors that may affect any
of our forward-looking statements. These and other factors should be considered carefully, including those contained in our Annual Report
on Form 10-K under “Risk Factors” for the year ended December 31, 2023, and readers should not place undue reliance on our
forward-looking statements. Forward looking statements are made based on management’s beliefs, estimates and opinions on the date
the statements are made, and we undertake no obligation to update forward-looking statements if these beliefs, estimates and opinions
or other circumstances should change. Although we believe that the expectations reflected in the forward-looking statements are reasonable,
we cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the
securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to
actual results.
Our financial statements are stated in United States dollars (US$) and
are prepared in accordance with United States Generally Accepted Accounting Principles.
Company Overview
We, through our wholly owned subsidiary Skinvisible
Pharmaceuticals Inc., are a pharmaceutical research and development (“R&D”) company that has developed and patented an
innovative polymer delivery system, Invisicare® and formulated over forty topical skin products, which we out-license globally. We
were incorporated in 1998 and target an estimated $80 billion global skincare and dermatology market and a $30 billion global over-the-counter
market as well as other healthcare / medical and consumer goods markets. The Company is also exploring new opportunities in large medical
markets outside of the dermatology market such as obesity and other potential markets where a topical or transdermal solution would be
a viable alternative.
With the research and development complete on
forty products and numerous patents issued (technology and product patents), we are ready to monetize our investment. Our business model
will continue to be to out-license our patented prescription and over-the-counter (“OTC”) products featuring Invisicare to
established manufacturers and marketers of brands internationally and to maximize profits from the products we have already out-licensed.
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The opportunity for us to license our products
continues to be a viable model as the need for pharmaceutical companies to access external R&D companies for new products due to their
own downsizing or elimination of internal R&D departments. The demand for our products is enhanced due to the granting of key US and
international patents and the completed development of a number of unique products.
Our Flagship Product
Pivotal to our success is our patented polymer
delivery system technology Invisicare. Invisicare is a patented polymer delivery system that enhances the delivery of active ingredients
for topically applied skin care products. Its patented technology has a unique formula and process for combining active ingredients with
a delivery system that extends the duration of time the product remains on the skin and active.
Invisicare is specifically formulated to
carry water insoluble active and certain cationic active ingredients in water-based products without the use of alcohol, silicones, waxes,
or other organic solvents. Products utilizing Invisicare have the proven ability to bond active ingredients to the skin for up to four
hours and longer. They are non-occlusive and allow normal skin respiration and perspiration while moisturizing and protecting against
exposure from a wide variety of environmental irritants.
When topically applied, these formulated products
adhere to the skin's outer layers, forming a protective bond, resisting wash-off, and delivering targeted levels of therapeutic or cosmetic
skincare agents to the skin. They allow enhanced delivery performance for a variety of skincare agents resulting in improved efficacy,
longer duration of action, reduced irritation and lower dosage of active agent required. The "invisible" polymer compositions
wear off as part of the natural exfoliation process of the skin's outer layer cells.
The advantage of products formulated with Invisicare
is (1) Invisicare’s ability to bind active ingredients (the drug) to the skin, forming a protective bond on the skin, for extended
periods of time; (2) Invisicare can deliver targeted levels (high or low) of therapeutic or cosmetic ingredients to the skin in a controlled
release; (3) Invisicare can help to reduce the irritation of some active ingredients due to how it controls the slower release of that
active ingredient; and (4) Invisicare science proves that it provides a protective skin barrier which helps retain the natural moisture
content of the skin, while still allowing it to breathe. These benefits present an excellent opportunity for clear scientific advantages
and marketing messages which resonate with physicians and consumers.
We generate revenue by:
LICENSING : We develop topical prescription
and over-the-counter products enhanced with Invisicare to license to pharmaceutical and consumer goods companies around the world for
an upfront fee and ongoing royalties.
CO-DEVELOPMENT : We assist pharmaceutical
clients in the early development of the most optimal formulation, which they then take forward into clinical testing.
LIFE CYCLE MANAGEMENT : We provide cost-effective
solutions to global pharmaceutical companies by reformulating their products coming off patent with a new Invisicare patent and new product
benefits and line extensions. Pharmaceutical companies are under a lot of pressure to develop innovative strategies to counteract the
revenue loss from their drugs coming off patent.
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License Agreement with
Quoin
On October 17, 2019, we entered an Exclusive
License Agreement with Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin”) pursuant to which we granted Quoin a
license to certain patents for the development of products for commercial sale. In exchange for the license, Quoin paid us a license fee
of one million USD dollars (USD $1,000,000) (the “License Fee”) and will additionally pay a single digit royalty interest
of all net sales on the licensed products subject to adjustment in certain situations. The agreement also requires that Quoin make a milestone
payment of $5 million to us upon achieving the first to occur of either FDA or European Union regulatory approval for one product licensed.
In addition, and upon the successful
approval in the US or European Union, whichever occurs first, Skinvisible is entitled to receive a single digit royalty percentage of
Quoins net sales revenues for any licensed product covered by the patent rights licensed under the License Agreement. Plus, Quoin also
agreed to pay Skinvisible 25% of any revenues they receive as royalties in the event that they sublicense any licensed products to a third
party.
On June 6, 2022, the Company announced that its
licensee Quoin and its product QRX003, was the first Invisicare delivery technology product to receive U.S. FDA Acceptance of Investigational
New Drug Application and that Quoin was actively working towards obtaining necessary FDA and other regulatory approvals for marketing
the product in the United States and other countries.
On February 14, 2024, the Company announced that
there was significant progress in Quoin's clinical trials for product formulations containing Invisicare targeting Netherton Syndrome.
The trials focus on the innovative formulation "QRX003," powered by Skinvisible’s Invisicare® proprietary drug delivery
technology. The updates include:
Positive Initial Data and Clean Safety Profile: The trials have
demonstrated positive initial data and a clean safety profile, leading to the implementation of an optimization plan.
Optimization Plan Implementation: Quoin has increased the size
of both clinical trials significantly and adjusted dosing frequency to twice-daily from once-daily for both trials.
Elimination of Lower Dose: In the blinded trial, a lower dose
has been eliminated based on the positive outcomes observed.
Protocol Amendments: Quoin's press release highlights protocol
amendments aimed at enhancing the data set and potentially expediting regulatory approval.
We believe these protocol amendments could ultimately
result in the generation of a highly compelling data set, which could support regulatory filings and approval for QRX003 as the first
treatment for Netherton Syndrome.
On March 4, 2024,
Quoin announced a further milestone: it received FDA Clearance to recruit teen subjects into both ongoing Netherton Syndrome clinical
studies. We believe this announcement is important as:
Clearance to include teen patients in both Quoin’s open
label and placebo-controlled studies are expected to significantly expand the number of eligible subjects, potentially expedite recruitment
and lead to a more robust data set.
This development represents the first ever inclusion of non-adult
subjects in Netherton Syndrome clinical studies conducted under an open Investigational New Drug Application.
It is believed that the inclusion of this patient population
in Quoin’s studies will be a critical component of the development of a robust data set that could result in regulatory approval
with a broad label as QRX003 is being tested both as monotherapy and in conjunction with off-label treatments.
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License Agreement with Ovation Science
On February 3, 2020, we entered into a License
Agreement with Ovation Science Inc. pursuant to which Skinvisible granted to Ovation Science Inc. a license for the manufacture and distribution
rights to its hand sanitizer product, DermSafe. In exchange for the license, Ovation Science Inc. agreed to pay to Skinvisible a royalty
percentage on all net sales on the licensed products subject to adjustment in certain situations plus a license fee payable in year 3
of the agreement if it chooses to continue the license.
On June 10, 2020, Ovation Science paid us the
fee otherwise due in year 3 and in exchange we extended the term of Ovation Science’s license to 6-years and granted Ovation additional
rights to its hand sanitizer products and assigned Canadian Identification Numbers 02310589 and 02355558, all DermSafe Trademarks, DermSafe
clinical data and the right to patent DermSafe where not currently patented. In exchange for these rights, Ovation Science paid a $100,000
license fee. We completed the required assignments during the year ending December 31, 2020 and recognized $100,000 in revenue.
Patent Applications for Transdermal Delivery
for Obesity and Glucose-Controlling Agents
In May and June of 2024, we filed provisional
patent applications covering formulations that leverage Invisicare for the transdermal administration of obesity drugs and glucose-controlling
agents for diseases such as diabetes. The patents are titled "Transdermal Delivery Composition for Delivery of CB-1 Receptor Antagonists
and/or GLP-1 Receptor Agonists, and Method of Delivery” and “Transdermal Delivery Composition for Delivery of at Least One
Glucose Controlling Agent, and Method of Delivering at Least One Glucose Controlling Agent.”
The patent applications focus on the use of Invisicare
in a transdermal delivery technology designed to incorporate CB-1 receptor antagonists and/or GPL-1 receptor agonists, with drugs known
for their potential in obesity management and for glucose-controlling agents, into a lotion that is applied topically to the skin using
a metered applicator. Studies have demonstrated the superior transdermal penetration and controlled release of other active compounds
using Invisicare's innovative technology, with certain actives exhibiting up to a tenfold increase in transdermal delivery effectiveness.
By utilizing Invisicare, we aim to not only offer patients a convenient and effective alternative to traditional oral or injectable therapies
but to also enhance drug efficacy and potentially significantly reduce side effects as transdermal delivery avoids first-pass metabolism.
Additionally, for long-term treatment of obesity and glucose controlling agents, a transdermal delivery system could feasibly provide
a convenient method for administering maintenance doses for these medications.
We are actively pursuing strategic partnerships
with pharmaceutical and/or biotech companies to facilitate the introduction of the first transdermal obesity therapies to market and to
explore the application of its delivery platform across diverse disease domains.
Results of Operations for the Three and Six Months Ended June 30, 2024
and 2023
Revenues
Our revenue, which we combine
from product sales, royalties on patent licenses and license fees (product development fees), was $5,000 for the three months ended June
30, 2024 and $5,000 for the same period ended June 30, 2023.
Our revenue, which we combine
from product sales, royalties on patent licenses and license fees (product development fees), was $10,000 for the six months ended June
30, 2024.
We hope to generate more
revenues from our licenses with Quoin and Ovation for the rest of 2024. We also plan to enter into commercial arrangements with pharma
and biotech companies to exploit our patent applications that were recently filed, and we hope to generate revenue from these efforts
in the future.
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Gross Profit
We had $0 in cost of revenues for the three and six months ended June 30,
2024, compared with $0 in cost of revenues for the three and six months ended June 30, 2023, so our gross profit was $5,000 and $10,000
for the three and six months ended June 30, 2024, respectively, as compared with gross profit of $5,000 and $10,000 for the three and
six ended June 30, 2023, respectively.
Operating Expenses
Operating expenses increased to $147,693 for the three months
ended June 30, 2024, from $117,823 for the same period ended June 30, 2023.
Operating expenses increased to $275,877 for the six months
ended June 30, 2024, from $250,727 for the same period ended June 30, 2023.
Our operating expenses for all periods consisted mainly of selling, general
and administrative expenses.
Our selling, general and administrative expenses for the six months ended
June 30, 2024, consisted mainly of accrued salaries and wages of $175,885 and audit and accounting of $31.638. In comparison, our selling,
general and administrative expenses for the six months ended June 30, 2023, consisted mainly of accrued salaries and wages of $180,365
and audit and accounting of $25,419.
Other Expenses
We had other expenses of $160,756 for the three months ended June 30, 2024,
as compared with other expenses of $163,252 for the three months ended June 30, 2023.
We had other expenses of $327,944 for the six months ended June 30, 2024,
as compared with other expenses of $1,550,404 for the six months ended June 30, 2023.
Our other expenses for the three and six months ended
June 30, 2024 consisted mainly of interest expense, netted against a gain on settlement of debt and gain on derivative liability changes.
Net Loss
We recorded a net loss of $303,449 for the three months ended June
30, 2024, as compared with a net loss of $276,075 for the three months ended June 30, 2023. We recorded a net loss of $593,821 for the
six months ended June 30, 2024, as compared with a net loss of $1,791,131for the six months ended June 30, 2023.
Liquidity and Capital Resources
Going
concern – The accompanying 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. The Company has incurred cumulative net losses of $39,974,309
since its inception and requires capital for its contemplated operational and marketing activities to take place. The Company’s
ability to generate the necessary funds through licensing of its core products or the ability to raise additional capital through the
future issuances of common stock or debt is unknown. The obtainment of additional financing, the successful development of the Company’s
contemplated plan of operations, and its transition, ultimately, to the attainment of profitable operations are necessary for the Company
to continue operations. These factors, among others, raises substantial doubt about the Company’s ability to continue as a going
concern. The consolidated financial statements of the Company do not include any adjustments that may result from the outcome of these
aforementioned uncertainties.
As of June 30, 2024, we had total current assets
of $35,882 and total assets in the amount of $163,058. Our total current liabilities as of June 30, 2024 were $4,023,571. We had a working
capital deficit of $3,987,689 as of June 30, 2024, compared with a working capital deficit of $3,476,947 as of December 31, 2023.
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Operating activities used $40,380 in cash for
the six months ended June 30, 2024, as compared with $68,496 used for the six months ended June 30, 2023. Our negative operating cash
flows for 2023 and 2024 was largely the result of our net loss for those quarter, mainly offset by changes in operating assets and liabilities
and the amortization of debt discount.
We used cash of $9,218 and $9,334 in investing
activities for the six months ended June 30, 2024 and 2023, respectively, for the purchase of intangible assets.
Cash flow provided from financing activities was
$55,700 for the six months ended June 30, 2024, as compared with no cash flows for financing activities
during the six months ended June 30, 2023.
The features of the debt instruments and payables
concerning our financing activities are detailed in the footnotes to our financial statements.
Based upon our current financial condition,
we do not have sufficient cash to operate our business at the current level for the next twelve months. We intend to fund operations through
increased sales and debt and/or equity financing arrangements, which may be insufficient to fund expenditures or other cash requirements.
We plan to seek additional financing in a private equity offering to secure funding for operations. There can be no assurance that we
will be successful in raising additional capital.
Off Balance Sheet Arrangements
As of June 30, 2024, there were no off-balance sheet arrangements.
Critical Accounting Policies
In December 2001, the SEC requested that all registrants list their most
“critical accounting polices” in the Management Discussion and Analysis. The SEC indicated that a “critical accounting
policy” is one which is both important to the portrayal of a company’s financial condition and results, 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.
Product sales – Revenues from the sale of products (Invisicare®
polymers) are recognized when title to the products are transferred to the customer and only when no further contingencies or material
performance obligations are warranted, and thereby have earned the right to receive reasonably assured payments for products sold and
delivered.
Royalty sales – We also recognize royalty revenue from licensing
our patented product formulations only when earned, with no further contingencies or material performance obligations are warranted, and
thereby have earned the right to receive and retain reasonably assured payments.
Distribution and license rights sales – We also recognize
revenue from distribution and license rights only when earned (and are amortized over a five-year period), with no further contingencies
or material performance obligations are warranted, and thereby have earned the right to receive and retain reasonably assured payments.
Costs of Revenue – Cost of revenue includes raw materials,
component parts, and shipping supplies. Shipping and handling costs is not a significant portion of the cost of revenue.
Accounts Receivable – Accounts receivable is comprised of
uncollateralized customer obligations due under normal trade terms requiring payment within 30 days from the invoice date. The carrying
amount of accounts receivable is reviewed periodically for collectability. If management determines that collection is unlikely, an allowance
that reflects management’s best estimate of the amounts that will not be collected is recorded. Management reviews each accounts
receivable balance that exceeds 30 days from the invoice date and, based on an assessment of creditworthiness, estimates the portion,
if any, of the balance that will not be collected. As of June 30, 2024, we had not recorded a reserve for doubtful accounts.
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Recently Issued Accounting Pronouncements
We do not expect the adoption of recently issued accounting pronouncements
to have a significant impact on our results of operations, financial position or cash flow.
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
A smaller reporting company is not required to provide the information
required by this Item.
Item 4.
Controls and Procedures
Disclosure Controls and Procedures
We carried out an evaluation of the effectiveness of the design and operation
of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of June 30, 2024. This evaluation
was carried out under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer. Based
upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of June 30, 2024, our disclosure controls
and procedures were not effective due to the presence of material weaknesses in internal control over financial reporting.
A material weakness is a deficiency, or a combination of deficiencies,
in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s
annual or interim financial statements will not be prevented or detected on a timely basis. Management has identified the following material
weaknesses which have caused management to conclude that, as of June 30, 2024, our disclosure controls and procedures were not effective:
(i) inadequate segregation of duties and effective risk assessment; and (ii) insufficient written policies and procedures for accounting
and financial reporting with respect to the requirements and application of both US GAAP and SEC guidelines.
Remediation Plan to Address the Material Weaknesses in Internal Control
over Financial Reporting
Our company plans to take steps to enhance and improve the design of our
internal controls over financial reporting. During the period covered by this quarterly report on Form 10-Q, we have not been able to
remediate the material weaknesses identified above. To remediate such weaknesses, we plan to implement the following changes during our
fiscal year ending December 31, 2024: (i) appoint additional qualified personnel to address inadequate segregation of duties and ineffective
risk management; and (ii) adopt sufficient written policies and procedures for accounting and financial reporting. The remediation efforts
set out are largely dependent upon our securing additional financing to cover the costs of implementing the changes required. If we are
unsuccessful in securing such funds, remediation efforts may be adversely affected in a material manner.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting
during the three months ended June 30, 2024 that have materially affected, or are reasonable likely to materially affect, our internal
control over financial reporting.
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PART II – OTHER INFORMATION
Item 1.
Legal Proceedings
We are not a party to any pending legal proceeding. We are not aware of
any pending legal proceeding to which any of our officers, directors, or any beneficial holders of 5% or more of our voting securities
are adverse to us or have a material interest adverse to us.
Item 1A.
Risk Factors
Our business faces many risks, a number of which are described in the section
captioned “Risk Factors” in our Annual Report for the year ended December 31, 2024, filed with the SEC on April 16, 2024.
The risks described in our Annual Report and below may not be the only risks we face. Other risks of which we are not yet aware, or that
we currently believe are not material, may also materially and adversely impact our business operations or financial results. If any of
the events or circumstances described in the risk factors contained in our Annual Report or described below occur, our business, financial
condition or results of operations could be adversely impacted and the value of an investment in our securities could decline. Investors
and prospective investors should consider the risks described in our Annual Report and below, and the information contained in the section
captioned “Warning Concerning Forward-Looking Statements” and elsewhere in this Quarterly Report before deciding whether to
invest in our securities.
Our failure to protect our intellectual property rights may undermine
our competitive position, and external infringements of our intellectual property rights may adversely affect our business.
Our success and ability to compete depends in part on our intellectual
property. We primarily rely on a combination of patent, trademark, trade secret, and copyright laws, as well as confidentiality procedures
and contractual restrictions with our employees, contractors and others to establish and protect our intellectual property rights. However,
confidentiality and license arrangements may be breached by counterparties, and there may not be adequate remedies available to us for
any such breach. Accordingly, we may not be able to effectively protect our intellectual property rights or to enforce our contractual
rights. In addition, our trade secrets may be leaked or otherwise become available to, or be independently discovered by, our competitors.
The steps we take to protect our intellectual property rights may be inadequate or we may be unable to secure intellectual property protection
for some of our properties. Infringement of intellectual property rights continues to pose a serious risk of doing business.
We have filed, and may in the future file, patent applications, such as
the two patent applications we have included in this Quarterly Report. It is possible, however, that these innovations may not be patentable.
In addition, given the cost, effort and risks associated with patent application, we may choose not to seek patent protection for some
innovations. Furthermore, our patent applications may not lead to granted patents, the scope of the protection gained may be insufficient
or an issued patent may be deemed invalid or unenforceable. In addition, we have filed, and may continue to file, applications on certain
of our trademarks, which may not always be approved on a timely basis, or at all. We also cannot guarantee that any of our present or
future patents, trademarks or other intellectual property rights will not lapse or be invalidated, circumvented, challenged, or abandoned.
If we are unable to protect our intellectual property, our competitors
could use our intellectual property to market offerings similar to ours and our ability to compete effectively would be impaired. Moreover,
others may independently develop drug delivery treatments that are competitive to ours or infringe on our intellectual property. The enforcement
of our intellectual property rights depends on our legal actions against these infringers being successful, but we cannot be sure these
actions will be successful, even when our rights have been infringed. In addition, defending our intellectual property rights might entail
significant expense and diversion of management resources. Any of our intellectual property rights may be challenged by others or invalidated
through administrative processes or litigations. We can provide no assurance that we will prevail in such litigations, and, even if we
do prevail, we may not obtain a meaningful relief. Accordingly, despite our efforts, we may be unable to prevent external parties from
infringing or misappropriating our intellectual property. Any intellectual property that we own may not provide us with competitive advantages
or may be successfully challenged by external parties.
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Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
On June 4, 2024, we issued a total of 350,000 units to accredited investors,
where each unit was priced at $0.10 per unit and consists of one share of common stock in the company and a warrant to purchase one-half
of one share of common stock in the company, exercisable for one year from issuance with an exercise price at $0.20 per share.
These securities were issued pursuant
to Section 4(2) of the Securities Act and/or Rule 506 and/or Regulation S promulgated thereunder. The investor represented the intention
to acquire the securities for investment only and not with a view towards distribution. The investor was given adequate information about
us to make an informed investment decision. We did not engage in any general solicitation or advertising. We directed our transfer agent
to issue the stock certificates with the appropriate restrictive legend affixed to the restricted stock.
Item 3.
Defaults upon Senior Securities
None
Item 4.
Mine Safety Disclosures
Not applicable.
Item 5.
Other Information
None
Item 6.
Exhibits
Exhibit Number Description of Exhibit
31.1
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101**
The following materials from the Company’s Quarterly Report on Form 10Q for the quarter ended June 30, 2024 formatted in Extensible Business Reporting Language (XBRL).
**Provided herewith
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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.
Skinvisible, Inc.
Date: August 15, 2024
By: /s/ Terry Howlett
Terry Howlett
Title: Chief Executive Officer, Chief Financial Officer and
Director
13
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.