UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR
THE QUARTERLY PERIOD ENDED June 30, 2020
[
] 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: 000-54554
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
(Exact
Name of Registrant as Specified in Its Charter)
Nevada
|
|
45-1226465
|
(State
or Other Jurisdiction of
Incorporation or Organization)
|
|
(I.R.S. Employer
Identification No.)
|
4093 Oceanside Boulevard, Suite B
|
Oceanside, California 92056
|
(Address of principal executive offices, including zip code)
|
(760) 295-7208
|
(Registrant’s telephone number, including area code)
|
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 [X] No [ ]
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if any, every
Interactive Data File required to be submitted and posted 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 and post such files). Yes [X] 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
|
[ ]
|
Non-Accelerated
Filer
|
[X]
|
Accelerated Filer
|
[ ]
|
Smaller reporting
company
|
[X]
|
|
|
Emerging growth
company
|
[ ]
|
Indicate by check
mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes [ ] No [X]
As of August 19,
2020, the Registrant had 1,987,355,997 outstanding shares of Common
Stock with a par value of $0.001 per share.
1
IMPORTANT PREFATORY NOTE
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements contained in this report and the information
incorporated by reference herein may contain “forward-looking
statements” (as such term is defined in Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended). These statements,
which involve risks and uncertainties, reflect our current
expectations, intentions, or strategies regarding our possible
future results of operations, performance, and achievements.
Forward-looking statements include, without limitation: statements
regarding future products or product development; statements
regarding future selling, general and administrative costs and
research and development spending; statements regarding our product
development strategy; and statements regarding future financial
performance, results of operations, capital expenditures and
sufficiency of capital resources to fund our operating
requirements. These forward-looking statements are made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995 and applicable rules of the Securities and
Exchange Commission and common law.
These
forward-looking statements may be identified in this report and the
information incorporated by reference by words such as
“anticipate”, “believe”, “could”, “estimate”, “expect”, “intend”,
“plan”, “predict”, “project”, “should” and similar terms and
expressions, including references to assumptions and strategies.
These statements reflect our current beliefs and are based on
information currently available to us. Accordingly, these
statements are subject to certain risks, uncertainties, and
contingencies, which could cause our actual results, performance,
or achievements to differ materially from those expressed in, or
implied by, such statements.
The
following factors are among those that may cause actual results to
differ materially from our forward-looking statements:
·Need
for additional capital;
·Limited
operating history in our new business model;
·Limited
experience introducing new products;
·Our
ability to successfully expand our operations and manage our future
growth;
·Difficulty
in managing our growth and expansion;
·Dilutive
effects of any raising of additional capital;
·The
deterioration of global economic conditions and the decline of
consumer confidence and spending;
·Material
weaknesses reported in our internal control over financial
reporting;
·Our
ability to protect intellectual property rights and the value of
our products;
·The
potential for product liability claims against us;
·Our
dependence on third party manufacturers to manufacture our
products;
·Our
common stock is currently classified as a penny
stock;
·Our
stock price may experience future volatility;
·The
illiquidity of our common stock; and
·Substantial
sales of shares of our common stock.
·Other
factors not specifically described above, including the other
risks, uncertainties, and contingencies described under
“Description of Business”, “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” in Items 1 and 7 of our Annual Report on Form 10-K for
the year ended December 31, 2018.
2
When
considering these forward-looking statements, you should keep in
mind the cautionary statements in this report and the documents
incorporated by reference. We have no obligation and do not
undertake to update or revise any such forward-looking statements
to reflect events or circumstances after the date of this
report.
Actual results may vary materially from those in such
forward-looking statements as a result of various factors. No
assurance can be given that the risk factors described in this
Quarterly Report on Form 10-Q are all of the factors that could
cause actual results to vary materially from the forward-looking
statements. References in this Quarterly Report on Form 10-Q to the
“Company,” “TSOI,” “we,” “our,” and “us” refer to Therapeutic
Solutions International, Inc.
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
INDEX
PART 1. Financial Information
|
PAGE
|
Item 1. Financial
Statements (Unaudited)
|
4
|
Condensed Consolidated Balance Sheets as of June 30, 2020 and
December 31, 2019
|
4
|
Condensed Consolidated Statements of Operations for the three and
six months ended June 30, 2020 and 2019
|
5
|
Condensed Consolidated Statement of Changes in Shareholders’
Deficit for the Period from January 1, 2020 to June 30, 2020 and
January 1, 2019 to June 30, 2019
|
6
|
Condensed Consolidated Statements of Cash Flows for the six months
ended June 30, 2020 and 2019
|
7
|
Notes to Condensed Consolidated Financial Statements
|
8
|
|
|
Item 2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
16
|
Item 3. Quantitative
and Qualitative Disclosures about Market Risk
|
23
|
Item 4. Controls and
Procedures
|
23
|
|
|
PART II. Other Information
|
|
Item 1. Legal
Proceedings
|
25
|
Item 1A. Risk
Factors
|
25
|
Item 2. Unregistered
Sales of Equity Securities and Use of Proceeds
|
25
|
Item 3. Defaults upon
Senior Securities
|
26
|
Item 4. Mine Safety
Disclosures
|
26
|
Item 5. Other
Information
|
26
|
Item 6. Exhibits
|
26
|
Signatures
|
27
|
3
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
|
|
June
30,
2020
|
|
December
31,
2019
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash
and cash equivalents
|
$
|
31,741
|
$
|
26,410
|
Restricted cash
|
|
10,202
|
|
10,187
|
Accounts receivable
|
|
4,233
|
|
2,904
|
Inventory
|
|
3,838
|
|
5,180
|
Prepaid
expenses and other current assets
|
|
74,325
|
|
89,379
|
Right-of-use asset
|
|
65,384
|
|
5,619
|
Total
current assets
|
|
189,723
|
|
139,679
|
|
|
|
|
|
Property and equipment, net
|
|
5,383
|
|
-
|
Other
assets
|
|
151,580
|
|
171,322
|
|
|
|
|
|
Total
assets
|
$
|
346,686
|
$
|
311,001
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' DEFICIT
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
$
|
329,400
|
$
|
324,936
|
Accounts payable-related parties
|
|
7,222
|
|
12,715
|
Accrued
expenses and other current liabilities
|
|
512,624
|
|
505,072
|
Lease
liability
|
|
20,240
|
|
5,619
|
Convertible notes payable, net of discount of $82,800 and $105,525,
at
June
30, 2020 and December 31, 2019, respectively
|
|
21,200
|
|
38,475
|
Notes
payable-related parties, net
|
|
954,611
|
|
937,528
|
Derivative liabilities
|
|
187,968
|
|
521,700
|
Total
current liabilities
|
|
2,033,265
|
|
2,346,045
|
|
|
|
|
|
LONG
TERM LIABILITIES
|
|
|
|
|
Notes
payable, net of current portion
|
|
7,145
|
|
-
|
Lease
liability, net of current portion
|
|
45,144
|
|
-
|
TOTAL
LIABILITIES
|
|
2,085,554
|
|
2,346,045
|
|
|
|
|
|
Commitments and contingencies
|
|
-
|
|
-
|
|
|
|
|
|
Shareholders' Deficit:
|
|
|
|
|
Preferred stock, $ 0.001 par value; 5,000,000 shares authorized
|
|
-
|
|
-
|
Common
stock, $ 0.001 par value; 2,500,000,000 shares authorized;
1,947,438,492 and 1,614,627,811 shares issued and outstanding
at
June
30, 2020 and December 31, 2019, respectively.
|
|
1,947,439
|
|
1,614,628
|
Additional paid-in capital
|
|
6,003,461
|
|
5,183,228
|
Accumulated deficit
|
|
(9,689,768)
|
|
(8,832,900)
|
Total
shareholders' deficit
|
|
(1,738,868)
|
|
(2,035,044)
|
|
|
|
|
|
Total
liabilities and shareholders' deficit
|
$
|
346,686
|
$
|
311,001
|
|
|
|
|
|
See
accompanying notes to condensed consolidated financial
statements.
4
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
For the
Three
Months
Ended
June
30,
2020
|
|
For the
Three
Months
Ended
June
30,
2019
|
|
For the
Six
Months
Ended
June
30,
2020
|
|
For the
Six
Months
Ended
June
30,
2019
|
Net
sales
|
$
|
14,021
|
$
|
8,931
|
$
|
33,535
|
$
|
11,395
|
Cost of
goods sold
|
|
2,463
|
|
1,036
|
|
5,953
|
|
1,182
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
|
11,558
|
|
7,895
|
|
27,582
|
|
10,213
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
General and administrative
|
|
18,722
|
|
20,138
|
|
34,203
|
|
33,621
|
Salaries, wages, and related costs
|
|
55,243
|
|
98,982
|
|
108,413
|
|
205,388
|
Officer’s director’s compensation
|
|
151,500
|
|
-
|
|
151,500
|
|
225,000
|
Consulting fees
|
|
34,041
|
|
50,966
|
|
71,260
|
|
84,351
|
Legal
and professional fees
|
|
94,428
|
|
25,809
|
|
127,008
|
|
82,443
|
Research and development
|
|
329,772
|
|
6,232
|
|
329,772
|
|
6,232
|
Total operating
expenses
|
|
683,756
|
|
202,127
|
|
822,156
|
|
637,035
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
(672,198)
|
|
(194,232)
|
|
(794,574)
|
|
(626,822)
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
Loss
on derivatives liabilities
|
|
(82,493)
|
|
(19,133)
|
|
(103,248)
|
|
(227,060)
|
Change in fair value of derivative liabilities
|
|
(18,126)
|
|
88,020
|
|
218,276
|
|
440,891
|
Interest expense
|
|
(94,987)
|
|
(102,675)
|
|
(156,122)
|
|
(190,175)
|
Other
income
|
|
(21,200)
|
|
-
|
|
(21,200)
|
|
-
|
Total other income
(expense)
|
|
(216,806)
|
|
(33,788)
|
|
(62,294)
|
|
23,656
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
(889,004)
|
$
|
(228,020)
|
$
|
(856,868)
|
$
|
(603,166)
|
|
|
|
|
|
|
|
|
|
Net
loss per share – basic and diluted
|
$
|
(0.00)
|
$
|
(0.00)
|
$
|
(0.00)
|
$
|
(0.00)
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding –
basic
and diluted
|
|
1,723,008,195
|
|
1,144,167,799
|
|
1,672,290,253
|
|
1,117,620,490
|
|
|
|
|
|
|
|
|
|
See
accompanying notes to condensed consolidated financial
statements.
5
Therapeutic Solutions
International, Inc.
Condensed Consolidated Statements of Changes in Shareholders'
Deficit
(Unaudited)
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Additional
Paid-in Capital
|
|
Accumulated
Deficit
|
|
Total
Stockholders' Deficit
|
December
31, 2018
|
|
1,011,063,182
|
$
|
1,011,063
|
$
|
4,314,047
|
$
|
(7,135,578)
|
$
|
(1,810,468)
|
Common
stock issued for services
|
|
70,000,000
|
|
70,000
|
|
229,000
|
|
-
|
|
299,000
|
Common
stock issued upon conversion of
convertible notes payable
|
|
105,980,405
|
|
105,980
|
|
340,606
|
|
-
|
|
446,586
|
Common
stock issued for a license
|
|
95,970,000
|
|
95,970
|
|
57,582
|
|
-
|
|
153,552
|
Common
stock issued
|
|
12,000,000
|
|
12,000
|
|
6,000
|
|
-
|
|
18,000
|
Beneficial conversion feature on note payable
|
|
-
|
|
-
|
|
12,500
|
|
-
|
|
12,500
|
Net
loss
|
|
-
|
|
-
|
|
-
|
|
(603,166)
|
|
(603,166)
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2019
|
|
1,295,013,587
|
$
|
1,295,013
|
$
|
4,959,735
|
$
|
(7,738,744)
|
$
|
(1,483,996)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Total
Stockholders'
Deficit
|
March
31, 2019
|
|
1,101,102,071
|
$
|
1,101,102
|
$
|
4,709,028
|
$
|
(7,510,724)
|
$
|
(1,700,594)
|
Common
stock issued for services
|
|
15,000,000
|
|
15,000
|
|
9,000
|
|
-
|
|
24,000
|
Common
stock issued upon conversion of
convertible notes payable
|
|
70,941,516
|
|
70,941
|
|
165,625
|
|
-
|
|
236,566
|
Common
stock issued for a license
|
|
95,970,000
|
|
95,970
|
|
57,582
|
|
-
|
|
153,552
|
Common
stock issued
|
|
12,000,000
|
|
12,000
|
|
6,000
|
|
-
|
|
18,000
|
Beneficial conversion feature on note payable
|
|
-
|
|
-
|
|
12,500
|
|
-
|
|
12,500
|
Net
loss
|
|
-
|
|
-
|
|
-
|
|
(228,020)
|
|
(228,020)
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2019
|
|
1,295,013,587
|
$
|
1,295,013
|
$
|
4,959,735
|
$
|
(7,738,744)
|
$
|
(1,483,996)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Total
Stockholders'
Deficit
|
December
31, 2019
|
|
1,614,627,811
|
$
|
1,614,628
|
$
|
5,183,228
|
$
|
(8,832,900)
|
$
|
(2,035,044)
|
Common
stock issued for services
|
|
156,000,000
|
|
156,000
|
|
413,700
|
|
-
|
|
569,700
|
Common
stock issued for salaries
|
|
18,181,818
|
|
18,182
|
|
41,818
|
|
-
|
|
60,000
|
Common
stock issued for cash
|
|
16,179,309
|
|
16,179
|
|
40,821
|
|
-
|
|
57,000
|
Common
stock issued for conversion of convertible notes,
accrued interest and derivative liabilities
|
|
142,449,554
|
|
142,450
|
|
10,190
|
|
-
|
|
152,640
|
Relief
of derivative liabilities
|
|
-
|
|
-
|
|
313,704
|
|
-
|
|
313,704
|
Net
loss
|
|
-
|
|
-
|
|
-
|
|
(856,868)
|
|
(856,868)
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2020
|
|
1,947,438,492
|
$
|
1,947,439
|
$
|
6,003,461
|
$
|
(9,689,768)
|
$
|
(1,760,686)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Total
Stockholders'
Deficit
|
March
31, 2020
|
|
1,656,544,032
|
$
|
1,656,544
|
$
|
5,206,268
|
$
|
(8,800,764)
|
$
|
(1,937,952)
|
Common
stock issued for services
|
|
156,000,000
|
|
156,000
|
|
413,700
|
|
-
|
|
569,700
|
Common
stock issued for salaries
|
|
18,181,818
|
|
18,182
|
|
41,818
|
|
-
|
|
60,000
|
Common
stock issued for cash
|
|
16,179,309
|
|
16,179
|
|
40,821
|
|
-
|
|
57,000
|
Common
stock issued for conversion of convertible notes,
accrued interest and derivative liabilities
|
|
100,533,333
|
|
100,534
|
|
20,106
|
|
-
|
|
120,640
|
Relief
of derivative liabilities
|
|
-
|
|
-
|
|
280,748
|
|
-
|
|
280,748
|
Net
loss
|
|
-
|
|
-
|
|
-
|
|
(889,004)
|
|
(889,004)
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2020
|
|
1,947,438,492
|
$
|
1,947,439
|
$
|
6,003,461
|
$
|
(9,689,768)
|
$
|
(1,760,686)
|
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes to condensed consolidated financial
statements.
6
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
For
the Six
Months Ended
June
30,
2020
|
|
For
the Six
Months Ended
June
30,
2019
|
Cash flows from
operating activities
|
|
|
|
|
Net income (loss)
|
$
|
(856,868)
|
$
|
(603,166)
|
Adjustments to
reconcile net income (loss) to net cash used in operating
activities:
|
|
|
|
|
Stock-based
compensation to consultants
|
|
100,200
|
|
74,000
|
Stock-based
compensation to related parties
|
|
529,500
|
|
225,000
|
Loss on derivative
liabilities
|
|
103,248
|
|
227,060
|
Change in fair value
of derivatives liabilities
|
|
(218,276)
|
|
(440,891)
|
Amortization of debt
discount
|
|
131,663
|
|
157,902
|
Patent
amortization
|
|
3,296
|
|
-
|
Depreciation
|
|
65
|
|
-
|
Changes in operating
assets and liabilities:
|
|
|
|
|
Accounts
receivable
|
|
(1,329)
|
|
(1,475)
|
Inventory
|
|
1,342
|
|
-
|
Prepaid expenses and
other current assets
|
|
31,500
|
|
1,100
|
Right-of-use asset
|
|
(59,765)
|
|
(22,116)
|
Accounts payable
|
|
4,665
|
|
1,658
|
Accounts payable -
related parties
|
|
(5,493)
|
|
-
|
Accrued expenses and
other current liabilities
|
|
22,199
|
|
186,504
|
Lease liability
|
|
59,764
|
|
22,116
|
Net cash used in
operating activities
|
|
(154,489)
|
|
(172,308)
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
|
|
Purchases of property
and equipment
|
|
(5,448)
|
|
-
|
Net cash used in
investing activities
|
|
(5,448)
|
|
-
|
|
|
|
|
|
Cash flows from
financing activities
|
|
|
|
|
Payments on notes
payable to related party
|
|
(1,196)
|
|
(1,505)
|
Proceeds from notes
payable to related party
|
|
-
|
|
25,000
|
Proceeds from
convertible notes payable
|
|
95,000
|
|
115,000
|
Proceeds from notes
payable
|
|
14,479
|
|
-
|
Proceeds from sale of
common stock
|
|
57,000
|
|
18,000
|
Net cash provided
by financing activities
|
|
165,283
|
|
156,495
|
|
|
|
|
|
Net decrease in cash,
cash equivalents and restricted cash
|
|
5,346
|
|
(15,813)
|
Cash, cash equivalents
and restricted cash at beginning of period
|
|
36,597
|
|
32,570
|
Cash, cash equivalents
and restricted cash at end of period
|
$
|
41,943
|
$
|
16,757
|
|
|
|
|
|
Supplemental cash
flow information:
|
|
|
|
|
Cash paid for
interest
|
$
|
1,250
|
$
|
1,980
|
Cash paid for income
taxes
|
$
|
-
|
$
|
-
|
|
|
|
|
|
Non-cash investing
and financing transactions:
|
|
|
|
|
Original issuance
discount on convertible notes payable
|
$
|
9,000
|
$
|
12,000
|
Debt discount recorded
in connection with derivative liability
|
$
|
95,000
|
$
|
115,000
|
Common stock issued in
conversion of convertible notes payable and interest
|
$
|
466,344
|
$
|
446,586
|
Beneficial conversion
feature on convertible note
|
$
|
-
|
$
|
12,500
|
Common stock issued in
payment of license agreement
|
$
|
-
|
$
|
153,552
|
Formalization of
accrued salary into related party note
|
$
|
-
|
$
|
-
|
Accrued interest added
to principal
|
$
|
13,341
|
$
|
-
|
|
|
|
|
|
Reconciliation of
cash, cash equivalents and restricted cash to the consolidated
balance sheets:
|
|
|
|
|
Cash and cash
equivalents
|
$
|
31,741
|
$
|
6,585
|
Restricted cash
|
|
10,202
|
|
10,172
|
Total cash, cash
equivalents, and restricted cash shown in the
|
|
|
|
|
consolidated
statements of cash flows:
|
$
|
41,943
|
$
|
16,757
|
|
|
|
|
|
See
accompanying notes to condensed consolidated financial
statements.
7
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
Note 1 – Organization and Business Description
Therapeutic Solutions International, Inc. (“TSOI” or the “Company”)
was organized August 6, 2007 under the name Friendly Auto Dealers,
Inc., under the laws of the State of Nevada. In the first quarter
of 2011, the Company changed its name from Friendly Auto Dealers,
Inc. to Therapeutic Solutions International, Inc., and acquired
Splint Decisions, Inc., a California corporation.
Currently, the Company is focused on immune modulation for the
treatment of several specific diseases. Immune modulation refers to
the ability to upregulate (make more active) or downregulate (make
less active) one’s immune system.
Activating one’s immune system is now an accepted method to cure
certain cancers, reduce recovery time from viral or bacterial
infections and to prevent illness. Additionally, inhibiting one’s
immune system is vital for reducing inflammation, autoimmune
disorders, and allergic reactions.
TSI is developing a range of
immune-modulatory agents to target certain cancers and diseases,
and for daily health.
Nutraceutical Division – TSOI has been producing high
quality nutraceuticals. Our most recent product, QuadraMune™, is a
blend of four powerful anti-inflammatory, antioxidant, compounds.
Those four ingredients are pterostilbene, epigallocatechingallate,
sulforaphane, and thymoquinone.
Cellular Division – TSOI recently obtained exclusive
rights to a patented adult stem cell for development of
therapeutics in the areas of chronic traumatic encephalopathy (CTE)
and traumatic brain injury (TBI).
The
stem cell licensed, termed “JadiCell” is unique in that it
possesses features of mesenchymal stem cells, however, outperforms
these cells in terms of a) enhanced growth factor production; b)
augmented ability to secrete exosomes; and c) superior angiogenic
and neurogenic ability.
Chronic Traumatic Encephalopathy (CTE) is caused by repetitive
concussive/sub-concussive hits to the head sustained over a period
of years and is often found in football players. The condition is
characterized by memory loss, impulsive/erratic behavior, impaired
judgment, aggression, depression, and dementia. In many patients
with CTE, it is anatomically characterized by brain atrophy,
reduced mass of frontal and temporal cortices, and medial temporal
lobe. TSOI has previously filed several patents in the area of CTE
based on modulating the brain microenvironment to enhance
receptivity of regenerative cells such as stem cells.
The
Company announced recently submission of a publication providing
preclinical data which supports repositioning of its Cancer
Immunotherapy StemVacs™ as a candidate for treatment of COVID-19.
StemVacs™ is based on activating universal donor immune system
cells called dendritic cells in a manner so that upon injection
they reprogram the body’s “Natural Killer” cells.
Natural killer cells are the most potent cell type in the body in
terms of killing viruses. Unfortunately, natural killer cells also
produce chemicals called cytokines which at high concentrations can
be lethal. The current data suggests that StemVacs™ can activate
natural killer cells while at the same time suppressing lung
inflammation. This dual mechanism of action makes StemVacs™ a
promising candidate for treatment of coronavirus.
Management does not expect existing cash as of June 30, 2020 to be
sufficient to fund the Company’s operations for at least twelve
months from the issuance date of these financial statements. These
financial statements have been prepared on a going concern basis
which assumes the Company will continue to realize its assets and
discharge its liabilities in the normal course of business. As of
June 30, 2020, the Company has incurred losses totaling $9.7
million since inception, has not yet generated material revenue
from operations, and will require additional funds to maintain its
operations. These factors raise substantial doubt regarding the
Company’s ability to continue as a going concern within one year
after the consolidated financial statements are issued. The
Company’s ability to continue as a going concern is dependent upon
its ability to generate future profitable operations and obtain the
necessary financing to meet its obligations and repay its
liabilities arising from normal business operations when they
become due. The Company intends to finance operating costs over the
next twelve months through its existing financial resources and we
may also raise additional capital through equity offerings, debt
financings, collaborations and/or licensing arrangements. If
adequate funds are not available on acceptable terms, we may be
required to delay, reduce the scope of, or curtail, our operations.
The accompanying consolidated financial statements do not include
any adjustments to the recoverability and classification of
recorded asset amounts.
8
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
Note 2 – Summary of Significant Accounting
Policies
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements
of the Company have been prepared in accordance with U.S. generally
accepted accounting principles (GAAP) for interim financial
information and with the instructions to Form 10-Q and Article 8 of
the Securities and Exchange Commission (SEC) Regulation S-X, and
should be read in conjunction with the audited financial statements
and notes thereto for the year ended December 31, 2019, included in
the Company’s Annual Report on Form 10-K filed with the SEC on May
21, 2020. The accompanying unaudited condensed consolidated
financial statements include the accounts of TSOI and its
subsidiaries. All significant inter-company transactions and
balances have been eliminated in consolidation. The unaudited
condensed consolidated financial statements contain all normal
recurring accruals and adjustments that, in the opinion of
management, are necessary to present fairly the balances and
results for the interim period included herein. The results of
operations for the three and six months ended June 30, 2020 and
2019 are not necessarily indicative of the results to be expected
for the full year or any future interim periods. The accompanying
condensed consolidated balance sheet at December 31, 2019 has been
derived from the audited consolidated balance sheet at December 31,
2019, contained in the above referenced Form 10-K.
Principles of Consolidation
The
accompanying consolidated financial statements include the accounts
of Therapeutic Solutions International, Inc. and its subsidiaries.
All significant intercompany balances and transactions have been
eliminated in consolidation.
Revenue Recognition
The
Company recognizes revenue in accordance with ASC 606, “Revenue
from Contracts with Customers” (“ASC 606”). In accordance with ASC
606, the Company applies the following methodology to recognize
revenue:
1)Identify
the contract with a customer.
2)Identify
the performance obligations in the contract.
3)Determine
the transaction price.
4)Allocate
the transaction price to the performance obligations in the
contract.
5)Recognize
revenue when (or as) the entity satisfies a performance
obligation.
ASC 606 provides that sales revenue is
recognized when control of the promised goods or services is
transferred to customers at an amount that reflects the
consideration to which the entity expects to be entitled to in
exchange for those goods or services. The Company generally
satisfies performance obligations upon shipment of the product or
service to the customer. This is consistent with the time in which
the customer obtains control of the product or service.
Cash
and Cash Equivalents
The
Company considers all highly liquid instruments with maturity of
three months or less at the time of issuance to be cash
equivalents.
Derivative Liabilities
A
derivative is an instrument whose value is “derived” from an
underlying instrument or index such as a future, forward, swap,
option contract, or other financial instrument with similar
characteristics, including certain derivative instruments embedded
in other contracts and for hedging activities.
As a
matter of policy, the Company does not invest in separable
financial derivatives or engage in hedging transactions. However,
the Company entered into certain debt financing transactions in
fiscal 2020 and 2019 as disclosed in Note 5, containing certain
conversion features that have resulted in the instruments being
deemed derivatives. We evaluate such derivative instruments to
properly classify such instruments within equity or as
9
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
Note 2 – Summary of Significant Accounting Policies
(Continued)
liabilities in our financial statements. Our policy is to settle
instruments indexed to our common shares on a first-in-first-out
basis.
The
classification of a derivative instrument is reassessed at each
reporting date. If the classification changes as a result of events
during a reporting period, the instrument is reclassified as of the
date of the event that caused the reclassification. There is no
limit on the number of times a contract may be reclassified.
Instruments classified as derivative liabilities are remeasured
using the Black-Scholes model at each reporting period (or upon
reclassification) and the change in fair value is recorded on our
consolidated statement of operations. We recorded derivative
liabilities of $187,968 and $521,700 at June 30, 2020 and December
31, 2019, respectively.
Fair
Value of Financial Instruments
The
Company’s financial instruments consist of cash and cash
equivalents, prepaids, convertible notes, and payables. The
carrying amount of cash and cash equivalents and payables
approximates fair value because of the short-term nature of these
items.
Fair
value is an exit price, representing the amount that would be
received from the sale of an asset or paid to transfer a liability
in an orderly transaction between market participants. As such,
fair value is a market-based measurement that should be determined
based on assumptions that market participants would use in pricing
an asset or liability. Fair value measurements are required to be
disclosed by level within the following fair value hierarchy:
Level
1 – Inputs are unadjusted, quoted prices in active markets for
identical assets or liabilities at the measurement date.
Level
2 – Inputs (other than quoted prices included in Level 1) are
either directly or indirectly observable for the asset or liability
through correlation with market data at the measurement date and
for the duration of the instrument’s anticipated life.
Level
3 – Inputs lack observable market data to corroborate
management’s estimate of what market participants would use in
pricing the asset or liability at the measurement date.
Consideration is given to the risk inherent in the valuation
technique and the risk inherent in the inputs to the model.
When
determining fair value, whenever possible the Company uses
observable market data, and relies on unobservable inputs only when
observable market data is not available. As of June 30, 2020, the
Company has level 3 fair value calculations on derivative
liabilities. The table below reflects the results of our Level 3
fair value calculations:
The
following is the change in derivative liability for the six months
ended June 30, 2020:
Balance- December 31,
2019
|
$
|
521,700
|
Issuance of new
derivative liabilities
|
|
198,248
|
Conversions to
paid-in capital
|
|
(313,704)
|
Change in fair market
value of derivative liabilities
|
|
(218,276)
|
Balance- June 30,
2020
|
$
|
187,968
|
Use
of Estimates
The
preparation of the 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 and
disclosure of contingent assets and liabilities at the date of the
balance sheet and the reported amounts of revenues and expenses
during the reporting period. Estimates were made relating to
valuation allowances, impairment of assets, share-based
compensation expense and accruals. Actual results could differ
materially from those estimates.
10
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
Note 2 – Summary of Significant Accounting Policies
(Continued)
Net
Income (Loss) Per Share
Basic
income (loss) per share is computed by dividing net income (loss)
available to common stockholders by the weighted average number of
common shares outstanding during the period of computation. Diluted
income (loss) per share is computed similar to basic income (loss)
per share except that the denominator is increased to include the
number of additional common shares that would have been outstanding
if potential common shares had been issued, if such additional
common shares were dilutive. In periods in which a net loss is
incurred, basic and diluted loss per share are the same, and
additional potential common shares are excluded as their effect
would be antidilutive.
For
the periods ended June 30, 2020 and 2019, a total of 47,358,833 and
876,393,993, respectively, potential common shares, consisting of
shares underlying outstanding convertible notes payable were
excluded as their inclusion would be antidilutive due to the net
loss during the period.
Property and Equipment
Property and equipment are recorded at cost, less accumulated
depreciation. Expenditures for major additions and improvements are
capitalized and minor replacements, maintenance, and repairs are
charged to expense as incurred. When property and equipment are
retired or otherwise disposed of, the cost and accumulated
depreciation are removed from the accounts and any resulting gain
or loss is included in the results of operations for the respective
period. Depreciation is calculated using the straight-line method
over the term of the agreement. Depreciation expense for the six
months ended June 30, 2020 and 2019 was $65 and $0,
respectively.
Intangible Assets
Intangible assets consisted primarily of intellectual properties
such as proprietary nutraceutical formulations. Intellectual assets
are capitalized in accordance with ASC Topic 350 “Intangibles
– Goodwill and Other.” Intangible assets with finite lives are
amortized over their respective estimated lives and reviewed for
impairment whenever events or other changes in circumstances
indicate that the carrying amount may not be recoverable.
Amortization expense for the six months ended June 30, 2020 and
2019 was $3,296 and $0, respectively.
Long-lived Assets
In
accordance with ASC 360, Property, Plant and Equipment, the
carrying value of intangible assets and other long-lived assets is
reviewed on a regular basis for the existence of facts or
circumstances that may suggest impairment. The Company recognizes
impairment when the sum of the expected undiscounted future cash
flows is less than the carrying amount of the asset. Impairment
losses, if any, are measured as the excess of the carrying amount
of the asset over its estimated fair value.
Research and Development
Research and Development costs are expensed as incurred. Research
and Development expenses were $329,772 and $6,232 for the six
months ended June 30, 2020 and 2019, respectively.
Income Taxes
The
Company accounts for income taxes under ASC 740 "Income Taxes,"
which codified SFAS 109, "Accounting for Income Taxes" and FIN 48
“Accounting for Uncertainty in Income Taxes – an
Interpretation of FASB Statement No. 109.” Under the asset and
liability method of ASC 740, deferred tax assets and liabilities
are recognized for the future tax consequences attributable to
differences between the financial statements carrying amounts of
existing assets and liabilities and their respective tax bases.
Deferred tax assets and liabilities are measured using enacted tax
rates expected to apply to taxable income in the years in which
those temporary differences are expected to be recovered or
settled. Under ASC 740, the effect on deferred tax assets and
liabilities of a change in tax rates is recognized in income in the
period the enactment occurs. A valuation allowance is provided for
certain deferred tax assets if it is more likely than not that the
Company will not realize tax assets through future operations.
11
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
Note 2 – Summary of Significant Accounting Policies
(Continued)
Stock-Based
Compensation
Compensation expense
for stock issued to employees is determined as the fair value of
consideration or services received or the fair value of the equity
instruments issued, whichever is more reliably measured. The
Financial Accounting Standards Board (FASB) issued ASU 2018-07 to
expand the scope of Topic 718 to include share-based payments
issued to nonemployees.
Leases
In
February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The
new standard requires lessees to recognize most leases on their
balance sheets as lease liabilities with corresponding right-of-use
assets and eliminates certain real estate-specific provisions. The
Company recorded a Right-of-use asset of $65,384 and a Lease
Liability of $65,384 as of June 30, 2020.
Recent Accounting Pronouncements
In
December 2019, the FASB issued guidance that simplifies the
accounting for income taxes by removing certain exceptions in
existing guidance and improves consistency in application by
clarifying and amending existing guidance. This guidance is
effective for annual periods beginning after December 15, 2020, and
interim periods within those annual periods, where the transition
method varies depending upon the specific amendment. Early adoption
is permitted, including adoption in any interim period. An entity
that elects to early adopt the amendments in an interim period
should reflect any adjustments as of the beginning of the annual
period that includes that interim period, and all amendments must
be adopted in the same period. The Company has reviewed the
provisions of the new standard, but it is not expected to have a
significant impact on the Company.
In
January 2020, the FASB issued Accounting Standards Update (“ASU”)
No. 2020-01, "Investments-Equity Securities (Topic 321),
Investments-Equity Method and Joint Ventures (Topic 323), and
Derivatives and Hedging (Topic 815): Clarifying the Interactions
between Topic 321, Topic 323, and Topic 815", which clarifies the
interaction of the accounting for equity securities under Topic 321
and investments accounted for under the equity method of accounting
under Topic 323, and the accounting for certain forward contracts
and purchased options accounted for under Topic 815. This guidance
is effective for the Company for fiscal years beginning after
December 15, 2020, including interim periods within those fiscal
years. Early adoption is permitted. The Company has reviewed the
provisions of the new standard, but it is not expected to have a
significant impact on the Company.
Note 3 - Restricted Cash
Included in cash and non-cash equivalents is a $10,000 certificate
of deposit with an annual interest rate of 0.6%. This certificate
matures on June 17, 2021 and is used as collateral for a Company
credit card, pursuant to a security agreement dated June 20,
2011.
Note 4 – Property and
Equipment
Fixed
assets consisted of the following:
|
|
June 30,
2020
|
|
December 31,
2019
|
Computer hardware
|
$
|
10,747
|
$
|
10,747
|
Office furniture and
equipment
|
|
9,087
|
|
3,639
|
Shipping and other
equipment
|
|
1,575
|
|
1,575
|
Total
|
|
21,409
|
|
15,961
|
Accumulated
depreciation
|
|
(16,026)
|
|
(15,961)
|
Property and
equipment, net
|
$
|
5,383
|
$
|
-
|
Depreciation expense for the six months ended June 30, 2020 and
2019 was $65 and $0, respectively.
12
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
Note 5 – Other Assets
Other
assets consist of the following:
|
|
June 30,
2020
|
|
December 31,
2019
|
Prepaid
consulting
|
$
|
3,792
|
$
|
20,238
|
Deposit
|
|
4,123
|
|
4,123
|
Licenses, net
|
|
143,665
|
|
146,961
|
Total
|
$
|
151,580
|
$
|
171,322
|
Prepaid consulting agreements are for one to two years and are
expensed monthly over the term of the agreement. The net licenses
amount consists of the following:
|
|
June 30,
2020
|
|
December 31,
2019
|
License
|
$
|
153.552
|
$
|
153,552
|
Accumulated
amortization
|
|
(9,887)
|
|
(6,591)
|
Licenses, net
|
$
|
143,665
|
$
|
146,961
|
Note 6 - Notes Payable-Related Party
At
June 30, 2020 and December 31, 2019, the Company has unsecured
interest-bearing demand notes outstanding to certain officers and
directors amounting to $954,611 and $937,528, respectively.
Interest accrued on these notes during the six months ended June
30, 2020 and 2019 was $13,341 and $7,936, respectively. Of
these, $251,000 are convertible into common stock at prices ranging
from $0.004 and $0.005.
Note 7 – Convertible Notes Payable
On
February 4, 2020, April 27, 2020, and June 5, 2020, the Company
entered into one $33,000, one $28,000, and one $43,000 convertible
promissory notes with a third party for which the proceeds were
used for operations. The Company received net proceeds of $95,000,
and a $9,000 original issuance discount was recorded. The
convertible promissory notes incur interest at 12% per annum and
mature on dates ranging from February 3, 2021 to June 5, 2021. The
convertible promissory notes are convertible to shares of the
Company's common stock 180 days after issuance. The conversion
price per share is equal to 61% of the average of the three (3)
lowest trading prices of the Company's common stock during the
fifteen (15) trading days immediately preceding the applicable
conversion date. The trading price is defined within the agreement
as the closing bid price on the applicable trading market. The
Company has the option to prepay the convertible notes in the first
180 days from closing subject to prepayment penalties ranging from
120% to 145% of principal balance plus interest, depending upon the
date of prepayment. The convertible promissory notes include
various default provisions for which the default interest rate
increases to 22% per annum with the outstanding principal and
accrued interest increasing by 150%. The Company was required to
reserve at June 30, 2020 a total of 600,463,381 common shares in
connection with these promissory notes.
Derivative
liabilities
These
convertible promissory notes are convertible into a variable number
of shares of common stock for which there is not a floor to the
number of common stock shares we might be required to issue. Based
on the requirements of ASC 815 Derivatives and Hedging, the
conversion feature represented an embedded derivative that is
required to be bifurcated and accounted for as a separate
derivative liability. The derivative liability is originally
recorded at its estimated fair value and is required to be revalued
at each conversion event and reporting period. Changes in the
derivative liability fair value are reported in operating results
each reporting period. The company uses the Black-Scholes option
pricing model for the valuation of its derivative liabilities as
further discussed below. There are no material differences between
using the Black-Scholes option pricing model for these estimates as
compared to the Binomial Lattice model.
13
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
Note 7 – Convertible Notes Payable (Continued)
For
the three notes issued during the six months ended June 30, 2020,
the Company valued the conversion features on the date of issuance
resulting in initial liabilities totaling $198,248. Since the fair
value of the derivative was in excess of the proceeds received, a
full discount to convertible notes payable and a day one loss on
derivative liabilities of $103,248 was recorded during the six
months ended June 30, 2020. The Company valued the conversion
feature using the Black-Scholes option pricing model with the
following assumptions: conversion prices ranging from $0.0008 to
$0.0012, the closing stock price of the Company's common stock on
the dates of valuation ranging from $0.0023 to $0.0033, an expected
dividend yield of 0%, expected volatilities ranging from 239%-255%,
risk-free interest rate ranging from 0.17% to 1.48%, and an
expected term of one year.
At
December 31, 2019, the Company had existing derivative liabilities
of $521,700 related to three convertible notes totaling $144,000.
During the six months ended June 30, 2020, these convertible notes
plus their accrued interest were fully converted into 142,449,554
shares of common stock. At each conversion date, the Company
recalculated the value of the derivative liability associated with
the convertible note recording a gain (loss) in connection with the
change in fair market value. In addition, the pro-rata portion of
the derivative liability as compared to the portion of the
convertible note converted was reclassed to additional paid-in
capital. During the six months ended June 30, 2020, the Company
recorded $313,704 to additional paid-in capital. The derivative
liabilities were revalued using the Black-Scholes option pricing
model with the following assumptions: conversion prices ranging
from $0.00055 to $0.0012, the closing stock price of the Company's
common stock on the dates of valuation ranging from $0.001 to
$0.010, an expected dividend yield of 0%, expected volatility
ranging from 197% to 305%, risk-free interest rates ranging from
0.13% to 0.89%, and expected terms ranging from 0.07 to 0.49
years.
On
June 30, 2020, the derivative liabilities on the remaining three
convertible notes were revalued at $187,968 resulting in a gain of
$218,276 for the six months ended June 30, 2020 related to the
change in fair value of the derivative liabilities. The derivative
liabilities were revalued using the Black-Scholes option pricing
model with the following assumptions: exercise price of $0.0076,
the closing stock price of the Company's common stock on the date
of valuation of $0.0022, an expected dividend yield of 0%, expected
volatility ranging from 256% to 300%, risk-free interest rate of
0.16%, and an expected term ranging from 0.60 to 0.93 years.
The
Company amortizes the discounts over the term of the convertible
promissory notes using the straight-line method which is similar to
the effective interest method. During the six months ended June 30,
2020 and 2019, the Company amortized $126,724 and $157,902 to
interest expense, respectively. As of June 30, 2020, discounts of
$82,500 remained for which will be amortized through June 4,
2021.
Note 8 – Equity
Our
authorized capital stock consists of an aggregate of 2,505,000,000
shares, comprised of 2,500,000,000 shares of common stock, par
value $0.001 per share, and 5,000,000 shares of preferred stock,
which may be issued in various series from time to time and the
rights, preferences, privileges and restrictions of which shall be
established by our board of directors. As of June 30, 2020, we have
1,947,438,492 shares of common stock and no preferred shares issued
and outstanding.
On March 2, 2020, we issued
8,333,333 shares of common stock for the partial conversion of
$10,000 for a convertible note dated August 28, 2019.
On
March 12, 2020, we issued 11,764,706 shares of common stock for the
partial conversion of $10,000 for convertible note dated August 28,
2019.
On
March 26, 2020, we issued 21,818,182 shares of common stock for the
partial conversion of $12,000 for convertible note dated August 28,
2019.
14
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
Note 8 – Equity (Continued)
On
May 29, 2020, we issued 10,000,000 shares of common stock for the
partial conversion of $12,000 for convertible note dated August 28,
2019.
On
June 2, 2020, we issued 12,500,000 shares of common stock for the
partial conversion of $15,000 for convertible note dated August 28,
2019.
On
June 3, 2020, we issued 19,733,333 shares of common stock for the
partial conversion of $23,680 for convertible note dated August 28,
2019.
On
June 4, 2020, we issued 24,733,333 shares of common stock for the
complete conversion of $29,680 for convertible note dated October
30, 2019.
On
June 4, 2020, we issued 5,000,000 shares of common stock, valued at
$0.0023 per share, for consulting services.
On June 4,
2020 we issued 70,000,000 shares of common stock, valued at $0.023
each to three officers and one director of the Company under a
Restricted Stock Award.
On
June 8, 2020, we issued 10,000,000 shares of common stock, valued
at $0.0033 per share, for consulting services.
On
June 9, 2020, the Company settled an accrual of wages with Timothy
G. Dixon with a convertible note payable of $60,000 with interest
at 5% per annum. On June 9, 2020, we issued 18,181,818 shares of
common stock for the complete conversion of $60,000 for convertible
note dated June 9, 2020.
On
June 11, 2020 we issued 40,000,000 shares of common stock, valued
at $0.0046 each to three officers and one director of the Company
under a Restricted Stock Award.
On
June 15, 2020 we issued 3,000,000 shares of common stock, valued at
$0.0017 each to one officer and one director of the Company under a
Restricted Stock Award.
On
June 15, 2020, we issued 10,000,000 shares of common stock, valued
at $0.0023 per share, to the medical officer for consulting
services.
On
June 16, 2020, we issued 33,566,667 shares of common stock for the
complete conversion of $40,280 for convertible note dated December
12, 2019.
On
June 22, 2020, we issued 13,634,482 shares of common stock, valued
at $0.005 per share, for an investment in the Company’s Private
Placement.
On
June 22, 2020, we issued 8,000,000 shares of common stock, valued
at $0.0029 per share, for financing fees dated January 24,
2020.
On
June 25, 2020, we issued 10,000,000 shares of common stock, valued
at $0.0083 per share, to the medical officer for consulting
services.
On
June 29, 2020, we issued 344,827 shares of common stock, valued at
$0.0029 per share, for an investment in the Company’s Private
Placement.
On
June 29, 2020, we issued 2,200,000 shares of common stock, valued
at $0.005 per share, for an investment in the Company’s Private
Placement.
15
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
Note 9– Subsequent Events
On
July 7, 2020, we issued 2,000,000 shares of common stock, valued at
$0.0035 per share, for an investment in the Company’s Private
Placement.
On
July 14, 2020, we issued 4,000,000 shares of common stock, valued
at $0.005 per share, for an investment in the Company’s Private
Placement.
On
July 17, 2020 we issued 7,500,000 shares of common stock, valued at
$0.0064 each to two officers, and one director of the Company under
a Restricted Stock Award.
On
July 17, 2020, we issued 2,000,000 shares of common stock, valued
at $0.0064 per share, for consulting services.
On
July 23, 2020, we issued 3,448,275 shares of common stock, valued
at $0.0029 per share, for an investment in the Company’s Private
Placement.
On
July 31, 2020 we issued 12,000,000 shares of common stock, valued
at .0077 each to three officers, and one director of the Company
under a Restricted Stock Award.
On
August 4, 2020, we issued 8,969,230 shares of common stock for the
complete conversion of $34,980 for convertible note dated February
4, 2020.
In
accordance with ASC 855, the Company has analyzed its operations
subsequent to June 30, 2020 through the date these financial
statements were issued, and has determined that it does not have
any other material subsequent events to disclose in these financial
statements.
Note 10 – Commitments and Contingencies
Effective May 1, 2017, the Company entered into a fourth amendment
to a Lease Agreement for property located in Oceanside, CA. On
March 1, 2020, the Company entered into a fifth amendment to the
lease agreement for property located in Oceanside, CA. The
amendment extends the expiration date to April 20, 2023 with
escalating monthly payments ranging from $2,024 to $2,153. The
lease consists of approximately 1,700 square feet. Total rent
expense for the six months.
Future minimum lease payments as of June 30, 2020 are as
follows:
For the quarter
ending June 30,
|
|
|
|
|
|
2021
|
$
|
18,871
|
2022
|
|
25,572
|
2023
|
|
6,459
|
16
Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
The following discussion and analysis contains forward-looking
statements within the meaning of the federal securities laws. The
safe harbor provided in section 27A of the Securities Act of 1933
and section 21E of the Securities Exchange Act of 1934 (“statutory
safe harbors”) shall apply to forward-looking information provided
pursuant to the statements made in this filing by the Company. We
urge you to carefully review our description and examples of
forward-looking statements included in the section entitled
“Cautionary Note Regarding Forward-Looking Statements” at the
beginning of this report. Forward-looking statements speak only as
of the date of this report and we undertake no obligation to
publicly update any forward-looking statements to reflect new
information, events or circumstances after the date of this report.
Actual events or results may differ materially from such
statements. In evaluating such statements, we urge you to
specifically consider various factors identified in this report,
any of which could cause actual results to differ materially from
those indicated by such forward-looking statements. The following
discussion and analysis should be read in conjunction with the
accompanying financial statements and related notes, as well as the
Financial Statements and related notes in our Annual Report on Form
10-K for the fiscal year ended December 31, 2019 and the risk
factors discussed therein.
General
Our
principal executive office is located at 4093 Oceanside Blvd.,
Suite B, Oceanside, California 92056, our telephone number is (760)
295-7208 and our website is www.therapeuticsolutionsint.com. The
reference to our website does not constitute incorporation by
reference of the information contained on our website.
We
file our quarterly and annual reports with the Securities and
Exchange Commission (SEC), which the public may view and copy at
the SEC’s Public Reference Room at 100 F Street, N.E. Washington
D.C. 20549, on official business days during the hours of 10 a.m.
to 3 p.m. The public may obtain information on the operation of the
SEC’s Public Reference Room by calling the SEC at 1–800–SEC–0330.
The SEC also maintains an Internet site, the address of which is
www.sec.gov, which contains reports, proxy and information
statements, and other information regarding issuers which file
electronically with the SEC. The periodic and current reports that
we file with the SEC can also be obtained from us free of charge by
directing a request to Therapeutic Solutions International, Inc.,
4093 Oceanside Blvd, Suite B, Oceanside, California 92056, Attn:
Corporate Secretary.
DESCRIPTION OF BUSINESS
CURRENT BUSINESS DESCRIPTION
Currently, the Company is focused on immune modulation for the
treatment of several specific diseases. Immune modulation refers to
the ability to upregulate (make more active) or downregulate (make
less active) one’s immune system.
Activating one’s immune system is now an accepted method to treat
certain cancers, reduce recovery time from viral or bacterial
infections and to prevent illness. Additionally, inhibiting one’s
immune system is vital for reducing inflammation, autoimmune
disorders and allergic reactions.
TSOI
is developing a range of immune-modulatory agents to target certain
cancers, fight disease, and for daily health.
TSI
is developing a range of immune-modulatory agents to target certain
cancers and diseases, and for daily health.
Nutraceutical Division – TSOI has been producing high
quality nutraceuticals. Our most recent product, QuadraMune™, is a
blend of four powerful anti-inflammatory, antioxidant, compounds.
Those four ingredients are pterostilbene, epigallocatechingallate,
sulforaphane, and thymoquinone.
Cellular Division – TSOI recently obtained exclusive
rights to a patented adult stem cell for development of
therapeutics in the areas of chronic traumatic encephalopathy (CTE)
and traumatic brain injury (TBI).
The
stem cell licensed, termed “JadiCell” is unique in that it
possesses features of mesenchymal stem cells, however, outperforms
these cells in terms of a) enhanced growth factor production; b)
augmented ability to secrete exosomes; and c) superior angiogenic
and neurogenic ability.
Chronic Traumatic Encephalopathy (CTE) is caused by repetitive
concussive/sub-concussive hits to the head sustained over a period
of years and is often found in football players. The condition is
characterized by memory loss, impulsive/erratic behavior, impaired
judgment, aggression, depression, and dementia. In many patients
with CTE, it is anatomically characterized by brain atrophy,
reduced mass of frontal and temporal cortices, and medial temporal
lobe. TSOI has previously filed several patents in the area of CTE
based on modulating the brain microenvironment to enhance
receptivity of regenerative cells such as stem cells.
17
The
Company announced recently submission of a publication providing
preclinical data which supports repositioning of its Cancer
Immunotherapy StemVacs™ as a candidate for treatment of COVID-19.
StemVacs™ is based on activating universal donor immune system
cells called dendritic cells in a manner so that upon injection
they reprogram the body’s “Natural Killer” cells.
Natural killer cells are the most potent cell type in the body in
terms of killing viruses. Unfortunately, natural killer cells also
produce chemicals called cytokines which at high concentrations can
be lethal. The current data suggests that StemVacs™ can activate
natural killer cells while at the same time suppressing lung
inflammation. This dual mechanism of action makes StemVacs™ a
promising candidate for treatment of coronavirus.
SandBox Dental Labs, Inc. – is a wholly-owned
subsidiary of TSOI consisting of a future dental laboratory to
manufacture and fill prescriptions from dentists who will use our
proprietary Sleep Appliance to treat their patients with mild to
moderate obstructive sleep apnea. The Company needs to seek
regulatory approval for its device to treat sleep apnea. As of June
30, 2020, formal operations have not commenced.
Nutraceutical Division (TSOI)
ProJuvenol® is a patented, (US No.:
9,682,047) and powerful synergistic blend of complex anti-aging
ingredients in capsules.
NanoStilbeneÔ is an easily absorbed nanoemulsion
of nanoparticle pterostilbene derived from the ‘047 patent.
DermalStilbene is a topical form of pterostilbene
delivered via spray application onto skin, derived from the ‘047
patent.
IsoStilbene an
injectable formulation of pterostilbene is available by
prescription only, derived from the ‘047 patent.
NeuroStilbeneÔ is an intranasal form of
pterostilbene delivered via spray application inside the nostril,
derived from the ‘047 patent.
NanoPlus is a blend of NanoStilbene and NanoCannabidiol
which are an easily absorbed Nanoparticles formulation of
Pterostilbene and Cannabidiol.
NanoCannabidiol is an easily absorbed Nanoparticle
formulation of Cannabidiol Isolate in the range of 75-90
nanometers. This product is built on the same nano platform as
NanoStilbene and is delivered at a concentration of 200mg per
milliliter.
NanoPSA is a
blend of NanoStilbene™ and Broccoli Sprout Extract (BSE)
providing 74mg of BSE and 125mg of our patented NanoStilbene, a
proprietary formulation of nanoparticle
pterostilbene.
NLRP3 Trifecta is a
two-product combo and consists of one bottle of NanoPSA and
one bottle of GTE-50 green tea extract.
QuadraMuneÔ
is a synergistic blend of
pterostilbene, sulforaphane, epigallocatechingallate, and
thymoquinone.
Patents:
TSOI
filed a patent in July 2015 covering the use of its
ProJuvenol® product, as well as various
pterostilbene compositions, for use in augmenting efficacy of
existing immuno-oncology drugs that are currently on the market.
The patent is based on the ability of pterostilbene, one of the
major ingredients of ProJuvenol®, to reduce oxidative
stress produced by cancer cells, which in turn protects the immune
system from cancer mediated immune suppression. That patent, U.S.
No.: 9,682,047 was granted on 6-20-2017.
In
addition, on April 28, 2016, the Company filed a patent application
covering the use of ProJuvenol© and its active
ingredient pterostilbene for augmentation of stem cell activity.
Diseases such as diabetes, cardiovascular disease, and
neurodegenerative diseases are characterized by deficient stem cell
activity. The patent covers the stimulation of stem cells that
already exist in the patient’s body, as well as stem cells that are
administered therapeutically. Studies have shown that patients who
have higher levels of endogenous stem cell activity have reduced
cardiovascular disease risk and undergo accelerated neurological
recovery after stroke as compared to patients with lower numbers of
such stem cells.
On
October 16, 2017, the Company filed a patent application titled
"Synergistic Inhibition of Glioma Using Pterostilbene and Analogues
Thereof" which was developed to utilize the ability of the immune
system to augment the possibility of increasing overall survival of
glioma patients after treatment with conventional therapies. Our
data suggests that when pterostilbene is combined with brain cancer
therapeutics such as Gefitinib, Sertraline, or Temozolomide, the
prognosis is vastly improved.
18
On
August 13, 2018, the Company filed a patent application titled
“Enhancement of Ozone
Therapy using Pterostilbene” showing pterostilbene potently augments
killing of breast cancer, prostate cancer, and ovarian cancer cells
by ozone therapy. The data obtained is an extension of ongoing work
at the Company seeking to identify means of enhancing the effects
of pterostilbene administration for treatment of a variety of
cancers, as well as enhancing the efficacy of existing cancer
therapies.
On
September 17, 2018, the Company filed a patent application titled
“Pterostilbene and Compositions Thereof for Prevention and
Treatment of Chronic Traumatic Encephalopathy” with new data
demonstrating the ability of its NeuroStilbene intranasal
formulation of pterostilbene to successfully prevent the
development of brain injury in an animal model of Chronic Traumatic
Encephalopathy aka CTE.
On
September 25, 2018, the Company filed a patent application titled
“Pterostilbene and Formulations Thereof for Treatment of
Pathological Immune Activation” covering novel clinical data using
its NanoStilbene™ formulation to reduce inflammatory cytokine
production in cancer patients.
On
September 9, 2019, the Company filed a patent application titled
“Pterostilbene and Formulations Thereof for Protection of
Hematopoiesis from Chemotherapy and Radiation” covering the ability
of NanoStilbene™ and its active ingredient, pterostilbene, at
accelerating recovery of blood cells after treatment with
chemotherapy.
On
November 4, 2019, the Company filed a patent application titled
“Cellular, Organ, and Whole-Body Rejuvenation Utilizing Cord Blood
Plasma and Pterostilbene” suggesting that pterostilbene, the active
ingredient in commercially available NanoStilbene™, augments the
ability of cord blood plasma to suppress biological properties
associated with aging.
On
May 4, 2020, the Company filed a patent application titled
“Nutraceuticals for the Prevention, Inhibition and Treatment of
SARS-Cov-2 and Associated COVID-19” developed to address issues of
susceptibility, inflammation, and viral immunity, for COVID-19
patients.
On
May 11, 2020, the Company filed a patent application titled
“Treatment of COVID-19 Lung Injury Using Umbilical Cord Plasma
Based Compositions” covers new data in which combinations of
pterostilbene and other compounds with cord blood are shown to be
capable of suppressing lung inflammation associated with COVID-19
in an animal model.
On
June 11, 2020, the Company filed a patent application titled
“Nutraceuticals for Reducing Myeloid Suppressor Cells” showing
QuadraMuneä reduces the number and
activity of immune inhibitory cells termed “myeloid suppressor
cells.”
On
June 15, 2020, the Company filed a patent application titled
“Nutraceuticals for Suppressing Indolamine 2,3 Deoxygenase” from
new data showing QuadraMune™ significantly inhibited inflammation
associated with memory impairment, as well as reduced levels of
kynurenine. Elevation of kynurenine is associated with activation
of indolamine 2,3 deoxygenase, an enzyme associated with
inflammation and depression.
On
June 22, 2020, the Company filed a patent application titled
“Treatment of SARS-CoV-2 with Dendritic Cells for Innate and/or
Adaptive Immunity” with new data showing its clinical-stage cancer
immunotherapeutic product StemVacs™ appears to reduce innate immune
induced inflammation in lungs while stimulating immune cells known
to possess antiviral properties. StemVacs™ is a cell-based drug
comprised of dendritic cells activated in a proprietary manner
which when administered stimulates a type of immune system cell
termed “natural killer” or NK cells. Numerous studies have shown
that NK cells are involved in protecting the body from cancer and
from viruses. The FDA has allowed for clinical trials of COVID-19
patients using an NK cell-based drug termed CYNK-001.
On
June 30, 2020, the Company filed a patent application titled
“Augmentation of Natural Killer Cell Activity and Induction of
Cytotoxic Immunity Using Leukocyte Lysate Activated Allogeneic
Dendritic Cells: StemVacs™” which describes the process of
preparing allogeneic dendritic cells utilizing a leukocyte lysate
based approach. These data support development of StemVacs for
conditions that would benefit from NK activation such as cancer and
COVID-19.
On
July 13, 2020, the Company filed a patent application titled
“Prevention of Pathological Coagulation in COVID-19 and other
Inflammatory Conditions” with new data showing that the ingredients
of QuadraMune™ suppress expression of an inflammation stimulated
molecule which is known to induce coagulation of blood. Inhibition
of this coagulation-promoting molecule, called Tissue Factor, was
synergistic with all four ingredients of QuadraMune™ when combined.
Tissue Factor is known to be associated with COVID-19 disease, and
is the culprit for clotting associated conditions such as deep vein
thrombosis and atherothrombosis.
19
On
July 22, 2020, the Company filed a patent application titled
“Additive and/or Synergistic Combinations of Metformin with
Nutraceuticals for the Prevention, Inhibition and Treatment of
SARS-Cov-2 and Associated COVID-19” showing potent synergy between
QuadraMune™ and the antidiabetic drug metformin in treating
COVID-19 associated lung damage models. It was discovered that the
ability of QuadraMune™ to protect the lungs from inflammation that
resembles coronavirus-induced pathology is markedly amplified by
concurrent administration of metformin. At a mechanistic level, it
was shown that metformin increased the ability of QuadraMune™ to a)
increase the number of “healing macrophages” (“M2” macrophages); b)
augment production of anti-inflammatory and regenerative proteins;
and c) suppress production of pathological inflammatory
proteins.
On
July 28, 2020, the Company filed a patent application titled
“Neuroprotection and Neuroregeneration by Pterostilbene and
Compositions Thereof” with new data demonstrating that the
blueberry derived compound pterostilbene possesses numerous brain
protective and potentially brain regenerative activities. The data
disclosed by the Company indicates: a) pterostilbene suppresses
inflammatory cytokines TNF-alpha, IL-1 beta and IL-6; b)
pterostilbene inhibits death of neurons caused by inflammatory
mediators; c) pterostilbene stimulates production of regenerative
factors from cells in the brain such as BDNF, NGF, FGF-1, and
FGF-2; and d) pterostilbene allows/enhances proliferation of
endogenous brain stem cells.
Cellular, Biological, and Pharmaceutical Patents:
09-02-15 Preventative Methods and Therapeutic or Pharmaceutical
Compositions for the Treatment or Prevention of Pregnancy
Complications
09-15-15 Diagnostic Methods For The Assessment Of Pregnancy
Complications
09-25-15 A Medical Device For Reducing The Risk Of Preterm-Labor
And Preterm-Birth
03-29-17 Stimulation of Immunity to Tumor Stem Cell Specific
Proteins by Peptide Immunization
03-29-17 Activated Leukocyte Extract for Repair of Innate Immunity
in Cancer Patients
03-29-17 Augmentation of Anti-Tumor Immunity by Mifepristone and
Analogues Thereof
03-29-17 Methods of Re-Activating Dormant Memory Cells with
Anticancer Activity
12-05-18 Treatment of Chronic Traumatic Encephalopathy via RNA
Administration
01-09-19 Autologous Neurogenic Cells and Uses Thereof for
Professional Athletes at Risk of Chronic Traumatic
Encephalopathy
01-21-19 Prevention and Reversion of Chronic Traumatic
Encephalopathy through Administration of “Educated” Monocytes and
Progenitors Thereof
11-04-19 Cellular, Organ, and Whole-Body Rejuvenation Utilizing
Cord Blood Plasma and Pterostilbene
05-11-2020 Treatment of COVID-19 Lung Injury Using Umbilical Cord
Plasma Based Compositions
06-22-2020 Treatment of SARS-CoV-2 with Dendritic Cells for Innate
and/or Adaptive Immunity
06-30-2020 Augmentation of Natural Killer Cell Activity and
Induction of Cytotoxic Immunity Using Leukocyte Lysate Activated
Allogeneic Dendritic Cells: StemVacs™
*The data provided here is partial and does not contain all
materials submitted for publication and is preliminary until peer
review is complete. These statements have not been evaluated by the
Food and Drug Administration. These products are not intended to
diagnose, treat, cure, or prevent any disease.
Dental
SandBox Dental Labs, Inc. – is a wholly-owned
subsidiary of TSOI consisting of a future dental laboratory to
manufacture and fill prescriptions from dentists who will use our
proprietary Sleep Appliance to treat their patients with mild to
moderate obstructive sleep apnea. The Company needs to seek
regulatory approval for its device to treat sleep apnea. As of June
30, 2020, formal operations have not commenced.
Immune-Oncology – Right To Try
In
May of 2018 President Donald J. Trump signed into the law, the
Right To Try bill. In 2015/2016 TSOI began and completed a
10-patient clinical trial of advanced cancer patients in Mexico at
the Pan Am Cancer Treatment Center located in Tijuana Mexico using
our dendritic cell vaccine code named StemVacs. TSOI has since
generated GCP documentation for the previously treated 10 patients
into a Phase I trial, which will be presented to the FDA by TSOI as
part of an Ex-US trial compliant with 21 CFR 312.120 Foreign
clinical studies not conducted under an IND. This is a required
step to conform to the new Right To Try law.
StemVacs1: is an autologous subcutaneously administered
vaccine comprised of immune stimulatory peptides resembling cancer
stem cell specific proteins.
StemVacs1 is an autologous immunotherapy platform that consists of
5 components. The overarching approach to the StemVacs1
Immunotherapy Platform is as follows:
20
1.Treat
innate immune suppression: Administration of oral
apigenin/NanoStilbene (Cancer DeTox Product) to decrease immune
suppressive toxic molecules made by tumor and tumor
microenvironment.
2.Treat
adaptive immune suppression: Administration of MemoryMune to
activate dormant memory cells recognizing the tumor. Administration
of LymphoBoost to repair deficient IL-12
production.
3.Stimulation
of immune response to cancer stem cells (StemVacs).
4.Consolidation
and maintenance of immunity: Cycles of StemVacs, supported by
innaMune and LymphoBoost
StemVacs2: is an allogeneic immunotherapy for prophylaxis
and/or treatment of SARS-CoV-2 by administration of dendritic cells
in a manner and frequency sufficient to induce activation of innate
and/or adaptive immune responses. In one embodiment the invention
teaches administration of dendritic cells pulsed with one or more
innate immune stimulants in a manner endowing said dendritic cell
with ability to induce augmentation of natural killer (NK) cell
number and/or activity. In another embodiment the invention teaches
the use of dendritic cells stimulated with innate immune activators
in a manner to allow for uptake of viral particles and presentation
of viral epitopes to T cells in order to stimulate immunological
activation and/or memory responses.
Chronic Traumatic
Encephalopathy (CTE), and Traumatic Brain Injury
(TBI) – Right To Try
On
December 10, 2018, Therapeutic Solutions International, Inc.,
announced the signing of an agreement between TSOI and Jadi Cell
LLC for licensing of the Jadi Cell universal donor adult stem cell,
as covered in US Patent No.: 9,803,176 B2 for use in Chronic
Traumatic Encephalopathy (CTE), and Traumatic Brain Injury
(TBI).
The
Jadi Cell product, which belongs to the mesenchymal stem cell (MSC)
family of cells, is a unique adult stem cell, which produces higher
levels of therapeutic factors compared to other stem cells. The
cells have demonstrated safety in animal models and pilot human
trials. The Jadi Cell product is generated from umbilical cords,
which are a source of medical waste and available in large
quantities at inexpensive prices.
Chronic Traumatic Encephalopathy (CTE) is caused by repetitive
concussive/sub-concussive hits to the head sustained over a period
of years and is often found in football players. The condition is
characterized by memory loss, impulsive/erratic behavior, impaired
judgment, aggression, depression, and dementia. In many patients
with CTE, it is anatomically characterized by brain atrophy,
reduced mass of frontal and temporal cortices, and medial temporal
lobe.
Traumatic brain injury (TBI) is an insult to the brain, not of a
degenerative or congenital nature, but caused by external physical
force that may produce a diminished or altered state of
consciousness, which results in an impairment of cognitive
abilities or physical functioning.
CTE
represents a significant unmet medical need which we believe is
amenable to stem cell intervention. We are eager to accelerate
treatments and potential cures for debilitating conditions such as
CTE and traumatic brain injury and plan to leverage New regulatory
pathways such as the recently approved “Right to Try” Law to
deliver these medicines as soon as possible to patients which
currently have no other options.
The
Jadi Cell product because of its advanced stage of development in
contrast to other stem cell types, which require years, if not
decades of development before entry into American patients, will
allow us we believe to be treating patients within 12 months.
Currently means of isolating, producing, scaling up, and delivery
of the cells has all been worked out by Jadi Cell and
Collaborators.
GOVERNMENT REGULATION
The
Company’s business is subject to varying degrees of regulation by a
number of government authorities in the United States, including
the United States Food and Drug Administration (FDA), the Federal
Trade Commission (FTC), and the Consumer Product Safety Commission.
The Company will be subject to additional agencies and regulations
if it enters the manufacturing business. Various agencies of the
state and localities in which we operate and in which our products
are sold also regulate our business, such as the California
Department of Health Services, Food and Drug Branch. The areas of
our business that these and other authorities regulate include,
among others:
·product
claims and advertising;
·product
labels;
·product
ingredients; and
·how
we package, distribute, import, export, sell and store our
products.
21
The
FDA, in particular, regulates the formulation, manufacturing,
packaging, storage, labeling, promotion, distribution and sale of
vitamins and other nutritional supplements in the United States,
while the FTC regulates marketing and advertising claims. The FDA
issued a final rule called “Statements Made for Dietary Supplements
Concerning the Effect of the Product on the Structure or Function
of the Body,” which includes regulations requiring companies, their
suppliers and manufacturers to meet Good Manufacturing Practices in
the preparation, packaging, storage and shipment of their products.
Management is committed to meeting or exceeding the standards set
by the FDA.
The
FDA has also issued regulations governing the labeling and
marketing of dietary and nutritional supplement products. They
include:
·the
identification of dietary or nutritional supplements and their
nutrition and ingredient labeling;
·requirements
related to the wording used for claims about nutrients, health
claims, and statements of nutritional support;
·labeling
requirements for dietary or nutritional supplements for which “high
potency” and “antioxidant” claims are made;
·notification
procedures for statements on dietary and nutritional supplements;
and
·pre-market
notification procedures for new dietary ingredients in nutritional
supplements.
The
Dietary Supplement Health and Education Act of 1994 (DSHEA) revised
the existing provisions of the Federal Food, Drug and Cosmetic Act
concerning the composition and labeling of dietary supplements and
defined dietary supplements to include vitamins, minerals, herbs,
amino acids and other dietary substances used to supplement diets.
DSHEA generally provides a regulatory framework to help ensure
safe, quality dietary supplements and the dissemination of accurate
information about such products. The FDA is generally prohibited
from regulating active ingredients in dietary supplements as drugs
unless product claims, such as claims that a product may heal,
mitigate, cure or prevent an illness, disease or malady, trigger
drug status.
The
Company is also subject to a variety of other regulations in the
United States, including those relating to taxes, labor and
employment, import and export, and intellectual property.
Critical Accounting Policies and Estimates
The
discussion and analysis of our financial condition and results of
operations are based on our unaudited condensed consolidated
financial statements, which have been prepared in accordance with
U.S. generally accepted accounting principles. The preparation of
these unaudited condensed consolidated financial statements
requires us to make estimates and judgments that affect the
reported amounts of assets, liabilities, revenues and expenses, and
related disclosure of contingent assets and liabilities. We
evaluate our estimates on an ongoing basis. We base our estimates
on historical experience and on other assumptions that we believe
to be reasonable under the circumstances, the results of which form
the basis for making judgments about the carrying values of assets
and liabilities that re not readily apparent from other sources.
Actual results may differ materially from these estimates under
different assumptions or conditions.
Recent Accounting Pronouncements
Recent accounting pronouncements are disclosed in Note 2 to the
accompanying unaudited condensed consolidated financial statements
included in Item 1 of this Quarterly Report on form 10-Q.
Results of Operations
You
should read the following discussion of our financial condition and
results of operations together with the unaudited financial
statements and the notes to the unaudited financial statements
included in this quarterly report. This discussion contains
forward-looking statements that reflect our plans, estimates and
beliefs. Our actual results may differ materially from those
anticipated in these forward-looking statements.
Overview
Currently,
the Company is focused on immune modulation for the treatment of
several specific diseases. Immune modulation refers to the ability
to upregulate (make more active) or downregulate (make less active)
one’s immune system.
22
Activating
one’s immune system is now an accepted method to cure certain
cancers, reduce recovery time from viral or bacterial infections
and to prevent illness. Additionally, inhibiting one’s immune
system is vital for reducing inflammation, autoimmune disorders and
allergic reactions.
Nutraceutical Division – TSOI has been producing
high quality nutraceuticals. Its current flagship product,
NanoStilbene™ PKE, is prepared by low-energy emulsification which
allows for better solubility, stability, and the release
performance of pterostilbene nanoparticles. The pterostilbene
placed in a nanoemulsion droplet is free from air, light, and hard
environment; therefore, as a delivery system, nanoemulsion’s
improve the bioavailability of pterostilbene but also protect it
from oxidation and hydrolysis, while it possesses an ability of
sustained release at the same time.
Cellular Division – TSOI recently obtained
exclusive rights to a patented adult stem cell for development of
therapeutics in the area of chronic traumatic encephalopathy (CTE)
and traumatic brain injury (TBI).
The
stem cell licensed, termed “JadiCell” is unique in that it
possesses features of mesenchymal stem cells, however, outperforms
these cells in terms of a) enhanced growth factor production; b)
augmented ability to secrete exosomes; and c) superior angiogenic
and neurogenic ability.
For the three and six months ended June 30, 2020 and
2019
We
had net loss of $889,004 for the three months ended June 30, 2020,
compared to a net loss of $228,020 for the three months ended June
30, 2019, an increase of $660,984. This increase was mainly due to
increases in stock-based compensation, research and development and
losses on changes in derivative liabilities. We had net loss of
$856,686 for the six months ended June 30, 2020, compared to a net
loss of $603,166 for the six months ended June 30, 2019, an
increase of $253,520. This increase was mainly due to increases in
stock-based compensation, research and development and losses on
changes in derivative liabilities.
Net
sales increased $5,090, from $8,931 to $14,021, for the three
months ended June 30, 2019 and June 30, 2020, respectively. Net
sales increased $22,140, from $11,395 to $33,535, for the six
months ended June 30, 2019 and June 30, 2020, respectively.
Cost
of goods sold increased $1,427, from $1,036 to $2,463, for the
three months ended June 30, 2019 and June 30, 2020, respectively.
Cost of goods sold increased $4,771, from $1,182 to $5,953, for the
six months ended June 30, 2019 and June 30, 2020, respectively.
These increases were mainly a result of the increases in net sales
for products in 2020 and 2019.
Operating expenses for the three-month periods ended June 30, 2020
and 2019 were $683,756 and $202,127, an increase of $481,629.
Operating expenses for the six-month periods ended June 30, 2020
and 2019 were $822,126 and $637,035, an increase of $185,121. This
increase was mainly due to a significant increase in stock-based
compensation as well as increases in legal and professional fees
and research and development expenses.
General and administrative expenses decreased $1,366, from $20,138
to $18,772 for the three months ended June 33, 2019 and 2020,
respectively. General and administrative expenses increased $582,
from $33,621 to $34,203 for the six months ended June 33, 2019 and
2020, respectively. This decrease was mainly attributable to less
expenses during the three and six months ended June 30, 2020.
Salaries, wages, and related expenses decreased $43,739, from
$98,982 to $55,243 for the three months ended June 30, 2019 and
2020, respectively. Salaries, wages, and related expenses decreased
$96,975, from $205,388 to $108,413 for the six months ended June
30, 2019 and 2020, respectively. This decrease was mainly due to a
decrease in wage related expenses for the three and six months
ended June 30, 2020.
Officer’s and director’s compensation increased from $0 to
$151,500, for the three months ended June 30, 2019 and 2020,
respectively. This was mainly due an issuance to Restricted Stock
Awards to three officers and one director for the three months
ended June 30, 2020. There were no such issuances during the
three months ended June 30, 2019. Stock compensation decreased from
$225,000 to $151,500, for the six months ended June 30, 2019 and
2020, respectively.
Consulting fees decreased $16,925 from $50,966 to $34,041 for the
three months ended June 30, 2019 and 2020, respectively, due to a
decrease in overall consulting services. Consulting fees
decreased $13,091 from $84,351 to $71,260 for the six months ended
June 30, 2019 and 2020, respectively, due to a decrease in overall
consulting services.
Legal
and professional fees increased $68,619, from $25,809 to $94,428
for the three months ended June 30, 2019 and 2020, respectively.
Legal and professional fees increased $44,565, from $82,443 to
$127,008 for the six months ended June 30, 2019 and 2020. These
increases were mainly related to shares issued for legal and
accounting services during the three and six months ended June 30,
2020. No such issuances occurred during the three and six months
ended June 30, 2019.
23
Research and development increased $323,540, from $6,232 to
$329,772 for the three months ended June 30, 2019 and 2020,
respectively. Research and development increased $323,540, from
$6,232 to $329,772 for the six months ended June 30, 2019 and 2020.
These increases were mainly related to shares issued for research
and development during the three and six months ended June 20,
2020. No such issuances occurred during the three and six months
ended June 30, 2019.
Loss
on derivatives liability increased $63,360, from $19,133 to
$82,493, for the three months ended June 30, 2019 and 2020,
respectively. This increase was mainly due to an increase in the
amount of new convertible notes issued during the current
three-month period. Loss on derivatives liability decreased
approximately $123,812, from $227,060 to $103,248, for the six
months ended June 30, 2019 and 2020, respectively This decrease was
mainly due to a reduction in the amount of new convertible notes
being issued during the current six-month period.
Change in fair derivatives liabilities gains decreased $106,146
from a gain of $88,020 to a loss of ($18,126) for the three months
ended June 30, 2019 and 2020, respectively. This change was mainly
due to the difference in the spread between the closing stock price
and respective exercise prices at each period end upon which the
derivative liability values are based upon. Change in fair
derivatives liabilities losses decreased $222,615 from $440,891 to
$218,276 for the six months ended June 30, 2019 and 2020,
respectively. This decrease was largely due to a reduction in the
balance of convertible notes outstanding upon which the derivative
liability is recorded.
Net
interest expense decreased $7,688 from $102,675 to $94,987 for the
three months ended June 30, 2019 and 2020, respectively. Net
interest expense decreased $34,053 from $190,175 to $156,122 for
the six months ended June 30, 2019 and 2020, respectively. This
decrease was mainly due to decreased debt balances.
Liquidity and Capital Resources
We
have experienced recurring losses over the past years which have
resulted in accumulated deficits of approximately $9.7 million and
a working capital deficit of approximately $1.9 million at June 30,
2020. These conditions raise significant doubt about the Company’s
ability to continue as a going concern. The Company’s ability to
continue as a going concern is contingent upon its ability to
secure additional financing, increase sales of its products and
attain profitable operations. It is the intent of management to
continue to raise additional capital. However, there can be no
assurance that the Company will be able to secure such additional
funds or obtain such on terms satisfactory to the Company, if at
all.
There
is no guarantee we will receive the required financing to complete
our business strategies, and it is uncertain whether future
financing will be available to us on acceptable terms. If financing
is not available on satisfactory terms, we may be unable to
continue, develop or expand our operations.
Off Balance Sheet Arrangements
We
currently do not have any off-balance sheet arrangements.
Item 3. Quantitative and Qualitative Disclosures about Market
Risk
As a
Smaller Reporting Company as defined by Rule 12b-2 of the Exchange
Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled
disclosure reporting obligations and therefore are not required to
provide this information requested by this item.
Item 4. Controls and Procedures
A. Disclosure Controls and Procedures
As
required by Rule 13a-15(b) under the Securities Exchange Act of
1934, or Exchange Act, our principal executive officer and
principal financial officer evaluated our disclosure controls and
procedures (as defined in Rule 13a-15(e) under the Exchange Act) as
of March 31, 2020. Based on this evaluation, these officers
concluded that as of the end of the period covered by this
Quarterly Report on Form 10-Q, these disclosure controls and
procedures were not operating effectively to ensure that the
information required to be disclosed by the Company in reports it
files or submits under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in the
rules and forms of the SEC and include controls and procedures
designed to ensure that such information is accumulated and
communicated to our management, including our principal executive
officer, to allow timely decisions regarding required
disclosure.
Because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that all
control issues, if any, within the Company have been detected.
These inherent limitations include the realities that judgments in
decision-making can be faulty and that breakdowns can occur because
of simple error or mistake.
24
B. Changes in Internal Control over Financial
Reporting
There were no changes
in our internal control over financial reporting that occurred
during our fiscal quarter ended June 30, 2020 that materially
affected, or are reasonable likely to materially affect, our
internal control over financial reporting.
Our management,
including the Chief Executive Officer assessed the effectiveness of
our internal control over financial reporting as of June 30, 2020.
In making our assessment, we used the framework and criteria set
forth by the Committee of Sponsoring Organizations of the Treadway
Commission (“COSO”) (2013). Based on that assessment, our
management has identified certain material weaknesses in our
internal control over financial reporting.
Our management
concluded that as of June 30, 2020, our internal control over
financial reporting was not effective, and that material weaknesses
existed in the following areas as of June 30, 2020.
(1)we
do not employ full time in-house personnel with the technical
knowledge to identify and address some of the reporting issues
surrounding certain complex or non-routine transactions. With
respect to material, complex and non-routine transactions,
management has and will continue to seek guidance from third-party
experts and/or consultants to gain a thorough understanding of
these transactions;
(2)we
have inadequate segregation of duties consistent with the control
objectives including but not limited to the disbursement process,
transaction or account changes, and the performance of account
reconciliations and approval;
(3)we
have ineffective controls over the period end financial disclosure
and reporting process caused by insufficient accounting staff.
25
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, claims are made against us in the ordinary
course of business, which could result in litigation. Claims and
associated litigation are subject to inherent uncertainties and
unfavorable outcomes could occur, such as monetary damages, fines,
penalties or injunctions prohibiting us from selling one or more
products or engaging in other activities. The occurrence of an
unfavorable outcome in any specific period could have a material
adverse effect on our results of operations for that period or
future periods.
However, as of the date of this report, management believes the
outcome of currently identified potential claims and lawsuits will
not have a material adverse effect on our financial condition or
results of operations.
Item 1A.
Risk Factors
No material
changes to risk factors have occurred as previously disclosed in
Item 1A of our Annual Report on Form 10-K for the year ended
December 31, 2019, which was filed with the SEC on May 21,
2020.
Item 2.
Unregistered Sales of Equity Securities and Use of
Proceeds
On March 2,
2020 we issued 8,333,333 shares of common stock for the partial
conversion of $10,000 for a convertible note dated August 28,
2019.
On
March 12, 2020 we issued 11,764,706 shares of common stock for the
partial conversion of $10,000 for convertible note dated August 28,
2019.
On
March 26, 2020 we issued 21,818,182 shares of common stock for the
partial conversion of $12,000 for convertible note dated August 28,
2019.
On June 4, 2020, we issued 24,733,333 shares of common stock
for the complete conversion of $29,680 for convertible note dated
October 30, 2019.
On
June 4, 2020, we issued 5,000,000 shares of common stock, valued at
$0.0023 per share, for consulting services.
On
June 4, 2020 we issued 70,000,000 shares of common stock, valued at
$0.023 each to three officers and one director of the Company under
a Restricted Stock Award.
On
June 8, 2020, we issued 10,000,000 shares of common stock, valued
at $0.0033 per share, for consulting services.
On
June 9, 2020, we issued 18,292,818 shares of common stock for the
complete conversion of $60,000 for convertible note dated June 9,
2020.
On
June 11, 2020 we issued 40,000,000 shares of common stock, valued
at $0.0046 each to three officers and one director of the Company
under a Restricted Stock Award.
On
June 15, 2020 we issued 3,000,000 shares of common stock, valued at
$0.0017 each to one officer and one director of the Company under a
Restricted Stock Award.
On
June 15, 2020, we issued 10,000,000 shares of common stock, valued
at $0.0023 per share, to the medical officer for consulting
services.
On
June 16, 2020, we issued 33,566,667 shares of common stock for the
complete conversion of $40,280 for convertible note dated December
12, 2019.
On
June 22, 2020, we issued 13,634,482 shares of common stock, valued
at $0.005 per share, for an investment in the Company’s Private
Placement.
On
June 22, 2020, we issued 8,000,000 shares of common stock, valued
at $0.0029 per share, for a donation in Triton Funds LP pursuant to
the Donation Agreement (“DA”) and Registration Rights Agreement
(“RRA”) dated January 24, 2020.
26
On
June 25, 2020, we issued 10,000,000 shares of common stock, valued
at $0.0083 per share, to the medical officer for consulting
services.
On
June 29, 2020, we issued 344,827 shares of common stock, valued at
$0.0029 per share, for an investment in the Company’s Private
Placement.
On
June 29, 2020, we issued 2,200,000 shares of common stock, valued
at $0.005 per share, for an investment in the Company’s Private
Placement.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
No
disclosure required.
Item 5. Other Information
None.
Item 6. Exhibits
EXHIBIT
NUMBER
|
|
DESCRIPTION
|
31.1
|
|
Rule 13a-14(a)/Section 302 Certification of Principal Executive
Officer
|
31.2
|
|
Rule 13a-14(a)/Section 302 Certification of Principal Financial
Officer
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section 1350/Rule
13a-14(b)
|
27
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.
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Date:
August 19, 2020
By:
/s/ Timothy
G. Dixon
Timothy G. Dixon
President and Chief Executive Officer
(Principal Executive Officer)
28