UNITED STATES SECURITIES AND EXCHANGE COMMISSION
AMENDMENT NO.
2 TO
FORM S-1
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
THERAPEUTIC
SOLUTIONS INTERNATIONAL,
INC.
(Exact
name of Registrant as Specified in Its Charter)
Nevada
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2833
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45-1226465
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(State
or other jurisdiction of
incorporation or organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer
Identification No.)
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4093 Oceanside Blvd, Suite B
Oceanside, California 92056
760-295-7208
(Address, including zip code, and telephone number, including area
code, of registrant's principal executive offices)
Timothy G. Dixon, CEO
4093 Oceanside Blvd, Suite B
Oceanside, California 92056
760-295-7208
Email:
timdixon@tsoimail.com
(Name,
address, including zip code, and telephone number including area
code, of agent for service)
Copies
to:
H.D. Kelso & Associates
Hugh D. Kelso III, Esq, Managing Attorney
8799 Balboa Avenue, Suite 155 San Diego, CA 92123
Ph:
619-840-5056
Email: hdklawfirm@yahoo.com
Approximate date of commencement of proposed sale to the public: As
soon as practicable after the effective date of this registration
statement.
If
any of the securities being registered on this form are to be
offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, check the following box. [X]
If
this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same offering. [ ]
If
this Form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [
]
If
this Form is a post-effective amendment filed pursuant to Rule
462(d) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [
]
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
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[ ]
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Accelerated filer
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[ ]
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Non-accelerated
filer
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[X]
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Smaller reporting
company
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[X]
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Emerging growth
company
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[ ]
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If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 7(a)(2)(B) of the Securities Act. [
]
1
Calculation
of Registration Fee
Title of Each Class of Securities to be Registered
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Amount to be Registered
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Proposed Maximum Offering Price Per Unit
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Proposed Maximum Aggregate Offering Price
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Amount of Registration Fee
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Common
Stock
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167,848,153 (1)
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$0.003
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$500,000.00
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$64.90
(2)
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Note
1: Includes 159,848,153 shares purchased pursuant to the Common Stock Purchase Agreement
(“CSPA”) dated January 24, 2020 by and between Triton Funds LP and
the Company and 8,000,000 (0.0001 par value) shares donated by the
Company to Triton Funds LP pursuant to the Donation Agreement
(“DA”) and Registration Rights Agreement (“RRA”) dated January 24,
2020, each being attached hereto as Exhibits 1.1, 1.2 and 1.3,
respectively.
Note
2: Estimated solely for the purpose of calculating the amount of
the registration fee pursuant to Rule 457(o) under the Securities
Act of 1933, as amended.
2
THE
REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE
OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE
REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES
THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE
IN ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR
UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH
DATE AS THE COMMISSION, ACTING PURSUANT TO SECTION 8(A), MAY
DETERMINE.
PROSPECTUS
THE
INFORMATION IN THIS PRELIMINARY PROSPECTUS MAY NOT BE COMPLETE AND
MAY BE CHANGED. WE AND THE SELLING STOCKHOLDERS MAY NOT SELL THESE
SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS
NOT AN OFFER TO SELL THESE SECURITIES AND IT IS NOT SOLICITING AN
OFFER TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE
IS NOT PERMITTED.
SUBJECT TO COMPLETION, DATED July 18, 2020
PRELIMINARY PROSPECTUS
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
167,848,153 SHARES OF COMMON STOCK AT $.003 PER SHARE
This
prospectus relates to the resale by the selling stockholders of up
to 167,848,153 shares of our common stock. The selling stockholders
acquired the shares being offered in this prospectus pursuant to
the Common Stock Purchase Agreement (“CSPA”) dated January 24, 2020
by and between Triton Funds LP and the Company and 8,000,000 shares
donated by the Company to Triton Funds LLC pursuant to the Donation
Agreement (“DA”) and Registration Rights Agreement (“RRA”) dated
January 24, 2020.
The
selling stockholders, or their pledgees, donees, transferees or
other successors-in-interest, may offer the shares of our common
stock for resale in the over-the-counter market, in isolated
transactions, or in a combination of such methods of sale. The
selling stockholders will sell their shares at prevailing market
prices or privately negotiated prices. There will be no
underwriter’s discounts or commissions, except for the charges to a
selling shareholder for sales through a broker-dealer. All net
proceeds from a sale will go to the selling shareholder and not to
us. We will pay the expenses of registering these shares.
Our
stock is quoted on OTCQB under the symbol “TSOI.” On July 08 ,
2020, the last reported sale price of shares of our common stock on
the OTCQB Marketplace was $0. 007 .
Investing in our common stock involves risks. You should
carefully consider the Risk Factors beginning on page 6 of this
prospectus.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal
offense.
The
date of this prospectus is July 8 , 2020
3
TABLE OF CONTENTS
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Page
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PROSPECTUS
SUMMARY
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1
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RISK
FACTORS
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7
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FORWARD-LOOKING
STATEMENTS
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12
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USE OF
PROCEEDS
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12
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MARKET FOR OUR
COMMON STOCK
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12
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MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
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14
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CHANGES IN AND
DISAGREEMENTS WITH ACCOUNTANTS
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22
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BUSINESS
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22
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LEGAL
PROCEEDINGS
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28
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MANAGEMENT
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29
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EXECUTIVE
COMPENSATION
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33
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SECURITY OWNERSHIP
OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
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34
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SELLING
STOCKHOLDERS
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34
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DESCRIPTION OF
SECURITIES
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35
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PLAN OF
DISTRIBUTION
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35
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LEGAL
MATTERS
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37
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EXPERTS
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38
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DISCLOSURE OF
COMMISSION POLICY ON INDEMNIFICATION
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38
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INDEX TO FINANCIAL
STATEMENTS AND EXHIBITS
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38
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UNDERTAKINGS
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II-1
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We
have not authorized anyone to provide you with information
different from that contained in this prospectus. The selling
stockholders are offering to sell, and seeking offers to buy,
shares of our common stock only in jurisdictions where offers and
sales are permitted. The information contained in this prospectus
is accurate only as of the date of this prospectus, regardless of
the time of delivery of this prospectus or of any sale of common
stock.
For
investors outside the U.S.: We have not and the selling
stockholders have not done anything that would permit this offering
or possession or distribution of this prospectus in any
jurisdiction where action for that purpose is required, other than
in the U.S. You are required to inform yourselves about and to
observe any restrictions relating to the offering of the shares of
common stock and the distribution and possession of this prospectus
outside of the U.S.
Unless otherwise indicated, any reference to “our company”, “we”,
“us”, or “our” refers to Therapeutic Solutions International, Inc.,
a Nevada corporation.
4
PROSPECTUS SUMMARY
The following summary highlights material information contained
in this prospectus. This summary does not contain all the
information you should consider before investing in the securities.
Before making an investment decision, you should read the entire
prospectus carefully, including the “Risk Factors” section, the
financial statements and the notes to the financial
statements.
Therapeutic Solutions International, Inc.
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.
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, improve maternal and fetal health, fight periodontal
disease, and for daily health.
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 can 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.
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.
In addition, The
Company announced plans to utilize its clinical-stage cancer
immunotherapy StemVacs™ for treatment of COVID-19 patients.
Previously the Company has filed data with the FDA, as part of IND
#17448, which demonstrated that treatment of cancer patients with
StemVacs™ resulted in enhanced activity of a type of immunological
cell called “natural killer” cells, otherwise known as “NK
cells.”
NK cells have
been published to inhibit SARS-CoV-2, the virus which causes
COVID-19. More importantly, companies such as Celularity have been
cleared by the FDA to administer pre-made NK cells for the
treatment of COVID-19 as part of clinical trials.
Nutraceutical Division (TSOI)
ProJuvenol® is a patented, (US No.: 9,682,047)
and powerful synergistic blend of complex anti-aging ingredients in
capsules.
NanoStilbene ™
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.
1
IsoStilbene
an injectable formulation of
pterostilbene is available by prescription only, derived
from the ‘047 patent.
NeuroStilbene
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 Nano Cannabidiol which are an easily
absorbed Nanoparticles formulation of Pterostilbene and
Cannabidiol.
Nano Cannabidiol 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.
QuadraMune ™
is a synergistic blend of
pterostilbene, sulforaphane, epigallocatechingallate, and
thymoquinone.
Nutraceutical 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.
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 its commercially available NanoStilbene™ product,
augments the ability of cord blood plasma to suppress biological
properties associated with aging.
2
On May 4, 2020,
the Company filed a patent application titled “Nutraceuticals for
the Prevention, Inhibition and Treatment of SARSCov-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” suggesting that QuadraMune™
administration 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” covering suppression of
the indolamine 2,3 deoxygenase (IDO) pathway by QuadraMune™
administration.
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™
On
May 15, 2018 TSOI announced Institutional Review Board (IRB)
clearance to initiate a pilot pharmacokinetic trial of
“NanoStilbene.” Then on July
02, 2018 the Company announced receiving pilot clinical data
providing proof of concept that NanoStilbene more effectively
increases blood levels of the molecule as compared to conventional
formulations. The clinical trial involved the administration of
NanoStilbene in comparison to powder in capsule form pterostilbene
with healthy volunteers, whom underwent a series of blood draws to
determine the concentration of the compound.
NanoStilbene Administration Results in Superior Pharmacokinetic
Profile
Compared to Pterostilbene Administration
Blood
was collected in EDTA tubes and plasma collected subsequent to
centrifugation at 700g for 10 minutes. Collection time points were
prior to administration of test compound, as well as at times 2hr,
4hr, 6hr, 8hr, 10hr, and 12 hrs. Test compounds were 10 ml of
NanoStilbene (provided by Therapeutic Solutions International) and
6 capsules of 50 mg pterostilbene (VitaMonk). A wash out period of
3 days was allowed between two test compound administration.
3
Results
The
results were that at peak concentration NanoStilbene (Square) had a
55% increase in serum levels over the traditional powder (Triangle)
form of pterostilbene. The data also shows the half-life to be
double to that of the powder form.
The
data in Granted U.S. Patent No.: 9,682,047 strongly suggest that
pterostilbene administration may be an inexpensive and safe method
of augmenting efficacy of numerous immunotherapeutic drugs.
Although cancer immunotherapy has revolutionized the prognosis of
many patients, the majority of patients still possess poor or
suboptimal responses to this approach.
Clinical Trial of NanoStilbene for Immune Derepression in
Advanced Cancer
12
patients with advanced cancer
ECOG
>2
300mg
NanoStilbene Oral daily (300mg PTER)
Assessments pre and 1, 2, and 3 weeks after treatment
Inflammatory Markers Decrease
·TNF,
IL-6, CRP
Immune Markers Increased
·IFN
gamma from stimulated PBMC
·NK
Cytolysis activity
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Pterostilbene, being a methyl ether of resveratrol, is known to
possess anti-inflammatory and anticancer activity in various model
systems. It is known that in advanced cancer, excess inflammatory
signaling may be associated with reduction in CD3 zeta chain
signaling and inhibited function of natural killer (NK) cells.
Given
the importance of NK cells in the activity of various
Immunotherapeutics, we sought to determine whether administration
of a nanoparticle formulation of pterostilbene may reverse cancer
associated suppression of NK activity. An initial study in heathy
volunteers was performed to elucidate amount of NanoStilbene needed
to be administered to achieve sufficient plasma concentration for
induction of anti-inflammatory activity.
Subsequent to this, the selected NanoStilbene dose was administered
to twelve patients with advanced solid cancers for 3 weeks. Daily
treatment with 300mg of NanoStilbene caused reduction in serum
levels of inflammatory markers TNF-alpha, IL-6, and CRP. Assessment
of peripheral blood mononuclear cell ability to generate IFN-gamma
subsequent to stimulation with anti-CD3 and anti-CD28 was
increased.
Additionally, NK cytotoxicity was augmented. These results suggest
that NanoStilbene may be a useful adjuvant to immunotherapy of
cancer rescuing T cell and NK cell activities.
Augmentation of NK cell function may stimulate efficacy of approved
therapies that depend on an active NK compartment such as
Herceptin, Rituximab, and Cetuximab.
These
results suggest that NanoStilbene may be a useful adjuvant to
immunotherapy of cancer rescuing T cell and NK cell activities.
Augmentation of NK cell function may stimulate efficacy of approved
therapies that depend on an active NK compartment such as
Herceptin, Rituximab, and Cetuximab.
*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.
4
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.
StemVacs is an immunotherapy platform that consists of 5
components. The overarching approach to the StemVacs Immunotherapy
Platform is as follows:
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
StemVacs: StemVacs is a subcutaneously administered vaccine
comprised of immune stimulatory peptides resembling cancer stem
cell specific proteins.
Cancer Metabolic DeTox: This is an orally administered agent
that is derived from various herbs termed apigenin. The unique
property of apigenin is that it inhibits a cancer associated
metabolic pathway that degrades the amino acid tryptophan.
Specifically, apigenin inhibits the enzyme indolamine 2,3
deoxygenase (IDO), which is responsible for breaking down
tryptophan in the vicinity of the tumor and generating by-products
such as kynurenine. It is known that immune activation is dependent
on tryptophan being present in the tumor environment. The depletion
of tryptophan and generation of kynurenine by tumor cells and tumor
associated cells is a major cause of immune suppression in cancer.
By administering Cancer Metabolic DeTox, the innate arm of the
immune system has a chance to regenerate. This positions the
patient for better outcome after administration of specific immune
stimulating vaccines.
MemoryMune: This is a product derived from a two-step
culture process of donor blood cells. The product MemoryMune
reawakens dormant immune memory cells. It is known that many cancer
patients possess memory T cells that enter the tumor, however, once
inside the tumor these cells are inactivated. MemoryMune contains a
unique combination of growth factors specific for immune system
cells called “cytokines”.
LymphoBoost: LymphoBoost is a proprietary formulation of
Misoprostol, a drug approved for another indication, which we have
shown to be capable of stimulating lymphocytes, particularly NK
cells and T cells, both critical in maintaining anti-tumor
immunity.
innaMune: This is a biological product derived from tissue
culture of blood cells derived from healthy donors. It is a
combination of cytokines that maintain activity of innate immune
system cells, as well as having ability to shift M2 macrophages to
M1.
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.
5
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.
Current
Operations
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.
Through this prospectus, certain selling stockholders are offering
up to 167,848,153 shares of our common stock. Each of the selling
stockholders acquired their shares in the closing of the Common
Stock Purchase Agreement (“CSPA”) dated January 24, 2020 by and
between Triton Funds LP and the Company and 8,000,000 shares
donated by the Company to Triton Funds LP pursuant to the Donation
Agreement (“DA”) and Registration Rights Agreement (“RRA”) dated
January 24, 2020.
Our
principal executive offices are located at 4093 Oceanside Blvd,
Ste. B, Oceanside, CA 92056. Our telephone no. is (760) 295-7208.
Our website address is www.therapeuticsolutionsint.com. Information
contained on our website or connected thereto does not constitute a
part of, and is not incorporated by reference into, this prospectus
or the registration statement of which it forms a part.
The Offering
Common stock offered
by selling stockholders:
|
|
Up to
167,848,153 outstanding shares of common stock.
|
Offering price:
|
|
$0.003
|
Common stock
outstanding:
|
|
|
Before offering
|
|
1,947,438,492
|
After offering
|
|
2,115,286,645
|
Use of proceeds:
|
|
We
will not receive any proceeds from the sale of the common stock by
the selling stockholders.
|
OTCQB Marketplace
symbol:
|
|
Shares of our common stock are currently quoted on the OTCQB
Marketplace under the symbol “TSOI.”
|
6
RISK FACTORS
Investment in our common stock has a high degree of risk. Before
you invest you should carefully consider the risks and
uncertainties described below and the other information in this
prospectus. If any of the following risks actually occur, our
business, operating results and financial condition could be harmed
and the value of our common stock could go down. This means you
could lose all or a part of your investment.
Risks Related to our Business and Industry
We
have identified material
weaknesses in our
internal control over
financial reporting.
We
are required to comply with the provisions of Section 404 of the
Sarbanes-Oxley Act of 2002, which require us to maintain an ongoing
evaluation and integration of the internal controls of our
business.
We
evaluated our existing controls as of December 31, 2019. Our Chief
Executive Officer and Chief Financial Officer identified material
weaknesses in our internal control over financial reporting. A
“material weakness” is a control deficiency, or combination of
control deficiencies in internal control over financial reporting
such that there is a reasonable possibility that a material
misstatement of the annual or interim financial statements will not
be prevented or detected. Readers are directed to review that
portion of this Form 10-K entitled Item 9A Controls and Procedures
for a detailed disclosure.
Under
Section 404 and the SEC’s rules, a company cannot find that its
internal control over financial reporting is effective if any
“material weaknesses” exist in its controls over financial
reporting.
Our
liquidity and capital
resources are very
limited.
Our
ability to fund operating activities is also dependent upon our
ability to access external sources of financing and our ability to
effectively manage our expenses in relation to revenues. Our
ability to fund working capital and anticipated capital
expenditures will depend on our future performance, which is
subject to general economic conditions specific to the health,
supplements and nutrition products industries, consumer demand for
our products, competition and other factors that are beyond our
control. There can be no assurance that our operations and access
to external sources of financing will continue to provide resources
sufficient to satisfy our liabilities arising in the ordinary
course of business.
We
will require significant
additional external
financing to implement
our business
plan.
We
will require external financing to sustain our operations, support
our expansion, achieve or maintain profitability, or, should we
become subject to unforeseen events or circumstances, continue as a
going concern. There can be no assurance that we will be able to
secure any such external financing, or, if we are able to secure
such external financing, that it will be on terms favorable, or
even acceptable, to us. Any inability to achieve or sustain
profitability or otherwise secure external financing would have a
material adverse effect on our business, financial condition, and
results of operations, raising substantial doubts as to our ability
to continue as a going concern, and we may ultimately be forced to
seek protection from creditors under the bankruptcy laws or cease
operations, which may result in a substantial or complete loss of
your invested capital.
We
may not be
able to effectively
manage our potential
growth and the
execution of our
business plan.
Our
potential growth and the execution of our business plan together
are likely to place significant strain on our managerial,
operational and financial resources. To effectively manage our
potential growth and execute our business plan, we will need to,
among other things:
·retain
additional personnel across several departments in the
Company;
·develop
strong customer loyalty for new products in a crowded competitive
marketplace;
·continue
to establish and continue to increase awareness of our
brands;
·price
our products and services at points which will allow us to maximize
sales while at the same time maximizing gross profit
margins;
·establish,
maintain, expand and manage multiple relationships with various
vendors, strategic partners, licensees and other third parties,
including suppliers of the products we sell on our website and
elsewhere, warehousing distributors, shipping companies and
others;
·rapidly
respond to competitive developments, particularly when new
high-demand products become available;
·build
an operations structure to support our business and provide
efficient and effective customer service and support;
·expand
our IT infrastructure to respond to increasing customer traffic to
our website, demand for content from site users and to manage
growing e-commerce transactions;
7
·establish
and maintain effective financial and management controls, reporting
systems and procedures;
·control
our expenses;
·provide
competitive employee salaries and benefit packages; and,
·avoid
lawsuits and other adverse claims.
There
can be no assurance that we will be able to accomplish any or all
of the above goals. If we prove unable to effectively execute our
business plan or manage our growth, it is likely to have a material
adverse effect on our business, financial condition, including
liquidity and profitability, and our results of operations.
If
our proposed product
sales model does
not successfully operate
at a profit
our growth strategy
may be
impeded.
To
effectively expand and meet our growth objectives our products
sales model must be executed upon in a profitable manner.
Profitability is dependent upon a variety of factors, some beyond
our control, including, but not limited to the amount of traffic we
can consistently attract to our brand, to retail sales in “brick
and mortar” retailers, to our website, and our ability to stock or
otherwise make available products that our customers purchase, our
ability to stock or otherwise make available the best new products
as they enter the market, our ability to provide consistent and
superior customer service, the general economic conditions,
particularly in the U.S., that could impact the amount of money
customers spend collectively on the products we sell, and/or that
could reduce the amount of money our average customer spends,
and/or could reduce the number or frequency of repeat orders for
products, and/or could result in customers finding products in
other venues if they can find those products for a lower price.
Other factors that could impact our ability to execute on our
business model in a profitable manner include, but are not limited
to, competition in our markets, recruiting, training and retaining
qualified personnel and management, maintenance of required local,
state and federal governmental approvals and permits, costs
associated with principal component products and supplies, delivery
shortages or interruptions, consumer trends, our ability to finance
operations externally, changes in supply or prices of the products
we sell and disruptions or business failures among our product
suppliers, distributors, warehouses or shippers. Any failure to
operate in a profitable manner could hurt our ability to meet our
growth objectives by attracting licensees, and our business,
financial condition, including liquidity and profitability, and our
results of operations would be negatively affected.
If
we cannot stock,
warehouse or otherwise
provide product to
customers in a
consistent, reliable and
cost-effective manner our
growth strategy may
be impeded.
As
our growth strategy depends to a large extent on our ability to
sell various products to consumers on our website and in
traditional “brick and mortar” retailers, if we cannot supply those
products in a consistent, reliable and cost-effective manner, we
may lose customers. To accomplish a consistent, reliable and
cost-effective method for supplying product to customers, we must
successfully
engage with suppliers at a number of levels, including warehousing
agreements, stocking agreements and other forms of distribution.
Our ability to conclude such arrangements with specific product
suppliers may involve the need for trade finance, purchasing
agreement finance and other capital. In addition, we may encounter
problems in fulfilling orders due to business conditions among the
products companies themselves, many of which problems are beyond
our control. If we are unable to establish and continue such
agreements and structures with products companies, our growth
strategy may be impeded, which could negatively affect our
business, financial condition, including liquidity and
profitability, and our results of operations.
We
face significant
competition for our
products.
The
markets in which we operate are intensely competitive, continually
evolving and, in some cases, subject to rapid change. Our
competitors include:
·traditional
and well-established companies with recognized and well patronized
brands in the nutritional supplements and health products industry
segment;
·entrenched
nutritional supplements and health products companies with
well-known customer on-line services and portals and other
high-traffic web sites that provide sales access to healthcare and
nutritional supplements and related products; and
·companies
that focus on providing on-line and/or off-line healthcare related
content, including some that promote competitor brands.
Many
of our competitors have greater financial, technical, product
development, marketing and other resources than we do. These
companies may be better known than we are and have more customers
than we do. We cannot provide assurance that we will be able to
compete successfully against these companies or any alliances they
have formed or may form. If we are unable to compete with one or
more of our competitors, our growth strategy may be impeded, which
could negatively affect our business, financial condition,
including liquidity and profitability, and our results of
operations.
8
Product
revenue.
Although we intend and continue to develop and introduce new
nutraceutical products, we currently market and sell
ProJuvenol®, NanoStilbene, DermalStilbene, IsoStilbene,
and NeuroStilbene, Nano Cannabidiol, Nano Plus, and NanoPSA, all
powerful antioxidants. We currently do not have a broad portfolio
of other products completed that we could rely on to support our
operations if we were to experience any difficulty with the
manufacture, marketing, sale, or distribution of our current
products.
Government
regulation could
adversely affect our
business.
Our
products and their associated component ingredients are subject to
existing and potential government regulation. Our failure, or the
failure of our business partners or third-party providers, to
accurately anticipate the application of laws and regulations
affecting our products and the manner in which we deliver them, or
any failure to comply, could create liability for us, result in
adverse publicity, or negatively affect our business. In addition,
new laws and regulations, or new interpretations of existing laws
and regulations, may be adopted with respect to consumer protection
and other issues, including pricing, products liability, copyrights
and patents, distribution and characteristics and quality of
products and services. We cannot predict whether these laws or
regulations will change or how such changes will affect our
business. Any of this government regulation could impact our growth
strategy, which could negatively affect our business, financial
condition, including liquidity and profitability, and our results
of operations.
The
Company’s success may
depend upon its
ability to protect
its patents and
proprietary
technology.
The
Company owns patents for several of its products and relies upon
the protection afforded by its patents and trade secrets to protect
its technology. The Company’s success may depend upon its ability
to protect its intellectual property. However, the enforcement of
intellectual property rights can be both expensive and time
consuming. Therefore, the Company may not be able to devote the
resources necessary to prevent infringement of its intellectual
property. Also, the Company’s competitors may develop or acquire
substantially similar technologies without infringing the Company’s
patents or trade secrets. For these reasons, the Company cannot be
certain that its patents and proprietary technology will provide it
with a competitive advantage.
Third
parties may claim
that we are
infringing their
intellectual property,
and we could
suffer significant
litigation or licensing
expense or be
prevented from providing
certain services, and
which may otherwise
harm our
business.
We
could be subject to claims that we are misappropriating or
infringing intellectual property, trade secrets or other
proprietary rights of others. These claims, even if not
meritorious, could be expensive to defend and divert management’s
attention from our operations. If we become liable to third parties
for infringing these rights, we could be required to pay
substantial damage awards and to develop non-infringing products,
obtain a license or cease selling the products that use or contain
the infringing intellectual property. We may be unable to develop
non-infringing products or obtain a license on commercially
reasonable terms, or at all. Any claims against our company for
infringement could impede our growth strategy, which could
negatively affect our business, financial condition, including
liquidity and profitability, and our results of operations.
We
may be subject
to claims brought
against us as
a result of
product liability
claims.
The
Company presently does not carry products liability insurance
covering its development, marketing and sale of the products it
intends to sell. However, the Company intends and expects to
acquire adequate and reasonable products liability insurance after
the business is funded. There is no guarantee that the amount of
funds raised by virtue of this offering will be adequate to acquire
or maintain such insurance. Should the Company not acquire adequate
funding to obtain products liability insurance, its uninsured
operations would expose the Company and its shareholders to
material risks should products liability claims arise. Any claims
can be costly to defend, and any successful products liability
claim against the Company could materially impact the ability of
the Company to continue as a going concern and therefore place your
total investment in the Company at risk of being a complete
loss.
9
We
may be subject
to claims brought
against us as
a result of
product associated
content we
provide.
Consumers are reasonably expected to access health-related
information regarding our products through our on-line web site. If
our content, or content we obtain from third parties, contains
inaccuracies, it is possible that consumers or others may sue us
for various causes of action. Although our planned web site
contains terms and conditions, including disclaimers of liability,
that are intended to reduce or eliminate our liability, the law
governing the validity and enforceability of on-line agreements
with consumers that provide the terms and conditions for use of our
public or private portals are unenforceable. A finding by a court
that these agreements are invalid and that we are subject to
liability could harm our business and require costly changes to our
business. We have planned editorial procedures in place to provide
quality control of the information that we publish or provide.
However, we cannot assure you that our editorial and other quality
control procedures will be sufficient to ensure that there are no
errors or omissions in particular content. Even if potential claims
do not result in liability to us, the fact that we would need to
investigate and defend against these claims could be expensive and
time consuming and could divert management’s attention away from
our operations. In addition, our business is in part based on
establishing a reputation amongst consumers that our portals as
trustworthy and dependable sources of healthcare information.
Allegations of impropriety or inaccuracy, even if unfounded, could
therefore harm our reputation and business, which could negatively
affect our business, financial condition, including liquidity and
profitability, and our results of operations.
Changes
in commodity and
other operating costs
or supply chain
and business disruptions
could adversely affect
our results of
operations.
Changes in product costs are a part of our business; any increase
in the prices that suppliers charge for their products could
adversely affect our operating results. We remain susceptible to
increases in prices as a result of factors beyond our control, such
as general economic conditions, seasonal fluctuations, weather
conditions, demand, safety concerns, product recalls, labor
disputes and government regulations. We rely on third-party
distribution companies to deliver ingredients to our manufacturers
and ultimately our products to customers. Interruption of
distribution services due to financial distress or other issues
could adversely affect our operations.
We
face substantial
competition in attracting
and retaining qualified
senior management and
key personnel and
may be unable
to develop and
grow our business
if we cannot
attract and retain
such senior management
and key
personnel.
As an
early stage company, our ability to develop and grow our business,
to a large extent, depends upon our ability to attract, hire and
retain highly qualified and knowledgeable senior management and key
personnel who possess the skills and experience necessary to
satisfy our business needs. Our ability to attract and retain such
senior management and key personnel will depend on numerous
factors, including our ability to offer salaries, benefits and
professional growth opportunities that are comparable with and
competitive to those offered by more established companies
operating in our marketplace. We may be required to invest
significant time and resources in attracting and retaining
additional senior management and key personnel as needed. Moreover,
many of the companies with which we will compete for any such
individuals have greater financial and other resources, affording
them the ability to undertake more extensive and aggressive hiring
campaigns, than we can. The normal running of our operations may be
interrupted, and our financial condition and results of operations
negatively affected, as a result of any inability on our part to
attract or retain the services of qualified and experienced senior
management and key personnel, or should our prospective key
personnel refuse to serve, or, once appointed, leave prior to a
suitable replacement being found.
COVID-19
On January 30,
2020, the World Health Organization declared the COVID-19 outbreak
a “Public Health Emergency of International Concern” and on March
10, 2020, declared it to be a pandemic. Actions taken around the
world to help mitigate the spread of the COVID-19 include
restrictions on travel, quarantines in certain areas, and forced
closures for certain types of public places and businesses.
COVID-19, and actions taken to mitigate it, have had and are
expected to continue to have an adverse impact on the economies and
financial markets of many countries, including the geographical
area in which the Company operates. While it is unknown how long
these conditions will last and what the complete financial effect
will be to the Company, COVID-19 has had an adverse effect on our
business, including our supply chains and distribution systems.
While we are taking diligent steps to mitigate disruptions to our
supply chain, we are unable to predict the extent or nature of
these impacts, at this time, to our future financial condition and
results of operations.
Risks Related to Our Common Stock
Because there is currently a
limited public trading market for our common stock, investor may
not be able to resell stock.
Our
stock is now traded in OTC Markets under the stock symbol TSOI,
which results in a very illiquid and limited market for our common
stock.
10
There is currently no liquid trading market for our common
stock, and we cannot ensure that one will ever develop or be
sustained.
The
trading market for our common stock is currently not liquid. We
cannot predict how liquid the market for our common stock might
become. Our common stock is quoted in OTC Markets under the symbol
TSOI.
Our common
stock may be deemed a “penny stock”, which would make it more
difficult for investors to sell their shares.
Our
common stock is subject to the “penny stock” rules adopted under
the Exchange Act. The penny stock rules apply to companies whose
common stock is not listed on the NASDAQ Stock Market or other
national securities exchange and trades at less than $4.00 per
share, other than companies that have had average revenue of at
least $6,000,000 for the last three years or that have tangible net
worth of at least $5,000,000 ($2,000,000 if the company has been
operating for three or more years). These rules require, among
other things, that brokers who trade penny stock to persons other
than “established customers” complete certain documentation, make
suitability inquiries of investors and provide investors with
certain information concerning trading in the security, including a
risk disclosure document and quote information under certain
circumstances. Many brokers have decided not to trade penny stocks
because of the requirements of the penny stock rules and, as a
result, the number of broker-dealers willing to act as market
makers in such securities is limited. If we remain subject to the
penny stock rules for any significant period, it could have an
adverse effect on the market, if any, for our securities and
investors may find it more difficult to dispose of our
securities.
Offers or availability for sale of a substantial number of
shares of our common stock may cause the price of our common stock
to decline.
If
our stockholders have the right to sell substantial amounts of
common stock in the public market, e.g. upon the expiration of any
statutory holding period under Rule 144, it could create a
circumstance commonly referred to as an “overhang” and in
anticipation of which the market price of our common stock could
fall. The existence of an overhang, whether or not sales have
occurred or are occurring, also could make our ability to raise
additional financing through the sale of equity or equity-related
securities in the future, at a time and price that we deem
reasonable or appropriate, more difficult.
The elimination
of monetary liability against our directors and officers under the
Company’s Articles of Incorporation and Nevada law, and the
existence of indemnification rights to our directors, officers and
employees, may result in substantial expenditures by the
Company.
Article 6 of our Articles of Incorporation exculpates our directors
and officers from certain monetary liabilities. Article 7 of our
Articles of Incorporation provides that we shall indemnify all
directors (and all persons serving at our request as a director or
officer of another corporation) to the fullest extent permitted by
Nevada law.
Further pursuant to Article 7, the expenses of the indemnified
person incurred in defending a civil suit or proceeding must be
paid by us as incurred and in advance of the final disposition of
the action, suit, or proceeding under receipt of an undertaking by
or on behalf of the indemnified person to repay the amount if it is
ultimately determined by a court of competent jurisdiction that he
or she is not entitled to be indemnified by us.
The foregoing
indemnification obligations could result in us incurring
substantial expenditures, which we may be unable to recoup. These
provisions and resultant costs may also discourage us from bringing
a lawsuit against directors and officers for breaches of their
fiduciary duties even though such actions, if successful, might
otherwise benefit us and our stockholders.
Public company
compliance may make it more difficult to attract and retain
officers and directors.
The
Sarbanes-Oxley Act and related rules implemented by the SEC have
required changes in corporate governance practices of public
companies. As a public entity, these rules and regulations increase
compliance costs and make certain activities more time consuming
and costly. As a public entity, these rules and regulations also
make it more difficult and expensive for us to obtain director and
officer liability insurance and we may be required to accept
reduced policy limits and coverage. As a result, it may be more
difficult for us to attract and retain qualified persons to serve
as directors or as executive officers.
11
We do not plan
to pay any cash or stock dividends in the foreseeable
future.
The
payment of dividends upon our capital stock is solely within the
discretion of our future board of directors and is dependent upon
our financial condition, results of operations, capital
requirements, restrictions contained in our future financing
instruments and any other factors our board of directors may deem
relevant. We have never declared or paid any cash or stock
dividends on our capital stock and we currently anticipate that we
will retain earnings, if any, to finance the development and
expansion of our business and, as such, do not intend on paying any
cash or stock dividends in the foreseeable future.
FORWARD-LOOKING STATEMENTS
This
prospectus contains not only statements that are historical facts,
but also statements that are forward-looking. Forward-looking
statements are, by their very nature, uncertain and risky.
Forward-looking statements can be identified by the use of
forward-looking terminology such as the words “believes,”
“intends,” “may,” “should,” “anticipates,” “expects,” “could,”
“plans,” or comparable terminology. These risks and uncertainties
include the following:
·international,
national and local general economic and market
conditions;
·our
ability to successfully introduce our products to market;
·our
ability to sustain, manage, or forecast growth;
·our
ability to successfully make acquisitions of new technologies; new
product development and introduction;
·existing
government regulations and changes in, or the failure to comply
with, government regulations;
·adverse
publicity;
·competition;
the failure to secure and maintain significant customers or
suppliers;
·fluctuations
and difficulty in forecasting operating results;
·changes
in business strategy or development plans;
·results
of testing and clinical trials of our products; business
disruptions;
·the
ability to attract and retain qualified personnel;
·the
ability to protect technology; and
·other
risks that might be detailed from time to time.
Although the forward-looking statements in this prospectus reflect
the good faith judgment of our management, such statements can only
be based on facts and factors currently known by them.
Consequently, and because forward-looking statements are inherently
subject to risks and uncertainties, the actual results and outcomes
may differ materially from the results and outcomes discussed in
the forward-looking statements. You are urged to carefully review
and consider the various disclosures made by us in this prospectus
as we attempt to advise interested parties of the risks and factors
that may affect our business, financial condition, and results of
operations and prospects.
USE OF PROCEEDS
We will not receive
any proceeds from the sale of the common stock by the selling
stockholders.
MARKET FOR OUR COMMON STOCK
Market Information
Our
common stock is quoted on the OTCQB under the symbol “TSOI.” The
table below sets forth for the periods indicated the quarterly high
and low bid prices as reported by OTC Markets. Limited trading
volume has occurred during these periods. These quotations reflect
inter-dealer prices, without retail mark-up, mark-down, or
commission and may not necessarily represent actual
transactions.
|
|
Quarter
|
|
High
|
|
Low
|
FISCAL QUARTER ENDING MARCH 31, 2020
|
|
First
|
|
$
|
0.0015
|
|
$
|
0.0013
|
|
|
Quarter
|
|
High
|
|
Low
|
FISCAL YEAR ENDING
DECEMBER 31, 2019
|
|
First
|
|
$
|
0.0048
|
|
$
|
0.0039
|
|
|
Second
|
|
$
|
0.0016
|
|
$
|
0.001
|
|
|
Third
|
|
$
|
0.0018
|
|
$
|
0.0015
|
|
|
Fourth
|
|
$
|
0.0037
|
|
$
|
0.0028
|
12
|
|
Quarter
|
|
High
|
|
Low
|
FISCAL YEAR ENDED
DECEMBER 31, 2018
|
|
First
|
|
$
|
0.008
|
|
$
|
0.0053
|
|
|
Second
|
|
$
|
0.025
|
|
$
|
0.0073
|
|
|
Third
|
|
$
|
0.011
|
|
$
|
0.009
|
|
|
Fourth
|
|
$
|
0.0059
|
|
$
|
0.0043
|
Our
common stock is considered to be penny stock under rules
promulgated by the Securities and Exchange Commission (the
“SEC”). Under these rules, broker-dealers participating in
transactions in these securities must first deliver a risk
disclosure document which describes risks associated with these
stocks, broker-dealers’ duties, customers’ rights and remedies,
market and other information, and make suitability determinations
approving the customers for these stock transactions based on
financial situation, investment experience and objectives.
Broker-dealers must also disclose these restrictions in writing,
provide monthly account statements to customers, and obtain
specific written consent of each customer. With these restrictions,
the likely effect of designation as a penny stock is to decrease
the willingness of broker-dealers to make a market for the stock,
to decrease the liquidity of the stock and increase the transaction
cost of sales and purchases of these stocks compared to other
securities.
We
have granted registration rights only to the selling stockholders
herein. We have not proposed to publicly offer any shares of our
common stock in a primary offering.
Availability of Rule 144
Rule
144 is not available for the resale of securities issued by
companies that are, or previously were, shell companies, such as
our company. Paragraph (i) of Rule 144 prohibits the use of the
rule for resale of securities issued by any shell companies (other
than business combination related shell companies) or any issuer
that has been at any time previously a shell company, except where
the following conditions are met:
· the
issuer of the securities that was formerly a shell company has
ceased to be a shell company;
·the
issuer of the securities is subject to the reporting requirements
of Section 13 or 15(d) of the Exchange Act;
·the
issuer of the securities has filed all Exchange Act reports and
material required to be filed, as applicable, during the preceding
12 months (or such shorter period that the issuer was required to
file such reports and materials), other than Current Reports on
Form 8-K; and
·at
least one year has elapsed from the time that the issuer filed
current comprehensive disclosure with the SEC reflecting its status
as an entity that is not a shell company.
Holders
As of
the close of business on July 08, 2020, we had approximately 198
holders of our common stock. The number of record holders was
determined from the records of our transfer agent and does not
include beneficial owners of common stock whose shares are held in
the names of various security brokers, dealers, and registered
clearing agencies. We have appointed New Horizon Transfer 215-515
West Pender Street, Vancouver, BC V6B 6H5, 604-876-5526, to act as
transfer agent for the common stock.
Dividends
We
have not declared or paid any cash dividends on our common stock
during the two fiscal years ended December 31, 2018 and December
31, 2019, or in any subsequent period. We do not anticipate or
contemplate paying dividends on our common stock. The only
restrictions that limit the ability to pay dividends on common
equity, or that are likely to do so in the future, are those
restrictions imposed by law.
Securities Authorized for Issuance under Equity Compensation
Plans
The
following table sets forth as of the most recent fiscal year ended
December 31, 2019, certain information with respect to compensation
plans (including individual compensation arrangements) under which
our common stock is authorized for issuance:
13
Plan Category
|
(a)
Number of Securities to be Issued Upon Exercise of Outstanding
Options, Warrants and Rights
|
(b)
Weighted Average Exercise Price of Outstanding Options, Warrants,
and Rights
|
(c)
Number of Securities Remaining Available for Future Issuance Under
Equity Compensation Plans (Excluding Securities Reflected in Column
(a) and (b))
|
Equity compensation
plans approved by security holders:
|
0
|
0
|
0
|
Equity compensation
plans not approved by security holders:
|
0
|
0
|
0
|
Total:
|
0
|
0
|
0
|
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and
analysis contain 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, 2018 and
Form 10-Q for quarter ending September 30, 2019, each attached
hereto as Exhibits 13.1 and 13.2, respectively, 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, improve maternal and fetal health, fight periodontal
disease, and for daily health.
14
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 can 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.
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.
In addition, The
Company announced plans to utilize its clinical-stage cancer
immunotherapy StemVacs™ for treatment of COVID-19 patients.
Previously the Company has filed data with the FDA, as part of IND
#17448, which demonstrated that treatment of cancer patients with
StemVacs™ resulted in enhanced activity of a type of immunological
cell called “natural killer” cells, otherwise known as “NK
cells.”
NK cells have
been published to inhibit SARS-CoV-2, the virus which causes
COVID-19. More importantly, companies such as Celularity have been
cleared by the FDA to administer pre-made NK cells for the
treatment of COVID-19 as part of clinical trials.
Nutraceutical Division (TSOI)
ProJuvenol® is a patented, (US No.: 9,682,047)
and powerful synergistic blend of complex anti-aging ingredients in
capsules.
NanoStilbene 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.
NeuroStilbene 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 Nano Cannabidiol
which are an easily absorbed Nanoparticles formulation of
Pterostilbene and Cannabidiol.
Nano Cannabidiol 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.
QuadraMune ™
is a synergistic blend of
pterostilbene, sulforaphane, epigallocatechingallate, and
thymoquinone.
Nutraceutical 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.
15
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.
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 its commercially available NanoStilbene™ product,
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 SARSCov-
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” suggesting that QuadraMune™
administration 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” covering suppression of
the indolamine 2,3 deoxygenase (IDO) pathway by QuadraMune™
administration.
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
16
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™
On
May 15, 2018 TSOI announced Institutional Review Board (IRB)
clearance to initiate a pilot pharmacokinetic trial of
“NanoStilbene.” Then on July
02, 2018 the Company announced receiving pilot clinical data
providing proof of concept that NanoStilbene more effectively
increases blood levels of the molecule as compared to conventional
formulations. The clinical trial involved the administration of
NanoStilbene in comparison to powder in capsule form pterostilbene
with healthy volunteers, whom underwent a series of blood draws to
determine the concentration of the compound.
NanoStilbene Administration Results in Superior Pharmacokinetic
Profile
Compared to Pterostilbene Administration
Blood
was collected in EDTA tubes and plasma collected subsequent to
centrifugation at 700g for 10 minutes. Collection time points were
prior to administration of test compound, as well as at times 2hr,
4hr, 6hr, 8hr, 10hr, and 12 hrs. Test compounds were 10 ml of
NanoStilbene (provided by Therapeutic Solutions International) and
6 capsules of 50 mg pterostilbene (VitaMonk). A wash out period of
3 days was allowed between two test compound administration.
Results
The
results were that at peak concentration NanoStilbene (Square) had a
55% increase in serum levels over the traditional powder (Triangle)
form of pterostilbene. The data also shows the half-life to be
double to that of the powder form.
The
data in Granted U.S. Patent No.: 9,682,047 strongly suggest that
pterostilbene administration may be an inexpensive and safe method
of augmenting efficacy of numerous immunotherapeutic drugs.
Although cancer immunotherapy has revolutionized the prognosis of
many patients, the majority of patients still possess poor or
suboptimal responses to this approach.
Clinical Trial of NanoStilbene for Immune Derepression in
Advanced Cancer
12
patients with advanced cancer
ECOG
>2
300mg
NanoStilbene Oral daily (300mg PTER)
Assessments pre and 1, 2, and 3 weeks after treatment
Inflammatory Markers Decrease
·TNF,
IL-6, CRP
Immune Markers Increased
·IFN
gamma from stimulated PBMC
·NK
Cytolysis activity
|
|
17
Pterostilbene, being a methyl ether of resveratrol, is known to
possess anti-inflammatory and anticancer activity in various model
systems. It is known that in advanced cancer, excess inflammatory
signaling may be associated with reduction in CD3 zeta chain
signaling and inhibited function of natural killer (NK) cells.
Given
the importance of NK cells in the activity of various
Immunotherapeutics, we sought to determine whether administration
of a nanoparticle formulation of pterostilbene may reverse cancer
associated suppression of NK activity. An initial study in heathy
volunteers was performed to elucidate amount of NanoStilbene needed
to be administered to achieve sufficient plasma concentration for
induction of anti-inflammatory activity.
Subsequent to this, the selected NanoStilbene dose was administered
to twelve patients with advanced solid cancers for 3 weeks. Daily
treatment with 300mg of NanoStilbene caused reduction in serum
levels of inflammatory markers TNF-alpha, IL-6, and CRP. Assessment
of peripheral blood mononuclear cell ability to generate IFN-gamma
subsequent to stimulation with anti-CD3 and anti-CD28 was
increased.
Additionally, NK cytotoxicity was augmented. These results suggest
that NanoStilbene may be a useful adjuvant to immunotherapy of
cancer rescuing T cell and NK cell activities.
Augmentation of NK cell function may stimulate efficacy of approved
therapies that depend on an active NK compartment such as
Herceptin, Rituximab, and Cetuximab.
These
results suggest that NanoStilbene may be a useful adjuvant to
immunotherapy of cancer rescuing T cell and NK cell activities.
Augmentation of NK cell function may stimulate efficacy of approved
therapies that depend on an active NK compartment such as
Herceptin, Rituximab, and Cetuximab.
*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.
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.
StemVacs is an immunotherapy platform that consists of 5
components. The overarching approach to the StemVacs Immunotherapy
Platform is as follows:
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
StemVacs: StemVacs is a subcutaneously administered vaccine
comprised of immune stimulatory peptides resembling cancer stem
cell specific proteins.
Cancer Metabolic DeTox: This is an orally administered agent
that is derived from various herbs termed apigenin. The unique
property of apigenin is that it inhibits a cancer associated
metabolic pathway that degrades the amino acid tryptophan.
Specifically, apigenin inhibits the enzyme indolamine 2,3
deoxygenase (IDO), which is responsible for breaking down
tryptophan in the vicinity of the tumor and generating by-products
such as kynurenine. It is known that immune activation is dependent
on tryptophan being present in the tumor environment. The depletion
of tryptophan and generation of kynurenine by tumor cells and tumor
associated cells is a major cause of immune suppression in cancer.
By administering Cancer Metabolic DeTox, the innate arm of the
immune system has a chance to regenerate. This positions the
patient for better outcome after administration of specific immune
stimulating vaccines.
18
MemoryMune: This is a product derived from a two-step
culture process of donor blood cells. The product MemoryMune
reawakens dormant immune memory cells. It is known that many cancer
patients possess memory T cells that enter the tumor, however, once
inside the tumor these cells are inactivated. MemoryMune contains a
unique combination of growth factors specific for immune system
cells called “cytokines”.
LymphoBoost: LymphoBoost is a proprietary formulation of
Misoprostol, a drug approved for another indication, which we have
shown to be capable of stimulating lymphocytes, particularly NK
cells and T cells, both critical in maintaining anti-tumor
immunity.
innaMune: This is a biological product derived from tissue
culture of blood cells derived from healthy donors. It is a
combination of cytokines that maintain activity of innate immune
system cells, as well as having ability to shift M2 macrophages to
M1.
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.
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.
19
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 audited and condensed consolidated
financial statements, which have been prepared in accordance with
U.S. generally accepted accounting principles. The preparation of
these audited and 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 are not readily apparent from other sources.
Actual results may differ materially from these estimates under
different assumptions or conditions.
The Company adopted
the new accounting pronouncement ASC 842, Leases for the nine
months ended September 30, 2019.
Recent Accounting
Pronouncements
Recent accounting pronouncements are disclosed in Note 2 to the
accompanying annual audited condensed consolidated financial
statements included in Item 1 of the Annual Report on form 10-K
attached as Exhibit 13.2.
Results of
Operations
You
should read the following discussion of our financial condition and
results of operations together with the audited and unaudited
interim financial statements and the notes to the audited and
unaudited interim financial statements included. 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.
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 flagship product,
ProJuvenol®, is a proprietary mixture containing
pterostilbene – one of the most potent antioxidants known. TSOI
filed a patent application for ProJuvenol® on 07-
08-2015 titled: “Augmentation of Oncology Immunotherapies by
Pterostilbene Containing Compositions”.
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).
20
Results of Operations
We had a net
loss of approximately $1.7 million in 2019 compared to a net loss
of approximately $1.9 million in 2018.
Net
sales increased $24,011 from $3,484 to $27,495, for the years ended
December 31, 2018 and 2019, respectively. This increase was mainly
due to an increase in sales of the Company’s nutraceutical line of
products.
Cost of goods sold increased $858,
from $2,157 to $3,015, for the years ended December 31, 2018 and
2019, respectively. This increase was mainly due to higher net
sales of the Company’s new nutraceutical line of products in 2019
vs 2018.
Operating
expenses for the years ended December 31, 2019 and 2018 were
approximately $1.1 million and $1.2 million, respectively, a
decrease of $100,000. This decrease was mainly due a combination of
decreased general and administrative expenses, decreased salaries,
wages and related costs, an increase in consulting fees, a decrease
in legal and accounting fees, and a decrease in research and
development.
General and administrative expenses decreased approximately
$337,000, from $408,000 to $71,000, for the years ended December
31, 2018 and 2019, respectively. This decrease was mainly due to a
decrease in bad debt, marketing and insurance during the year.
Salaries, wages and related expenses decreased approximately
$110,000, from $415,000 to $305,000,for the years ended December
31, 2018 and 2019, respectively. This decrease was mainly due to a
decrease in officers’ salaries.
Consulting fees increased approximately $468,000 from $113,000 to
$181,000 for the years ended December 31, 2018 and 2019,
respectively, due to an increase in overall consulting services
during 2019.
Legal and
professional fees decreased approximately $62,000, from $190,000 to
$128,000 for the years ended December 31, 2018 and 2019,
respectively, due to a decrease in overall accounting, patent and
general counsel services.
Research and
development costs decreased approximately $47,000, from $75,000 to
$28,000for the years ended December 31, 2018 and 2019,
respectively. This decrease in was mainly due to research and
development expenses related to the Company’s nutraceutical line of
products.
Total
loss from derivatives liabilities decreased approximately $122,000
from $425,000 to $303,000 for the years ended December 31, 2018 and
2019, respectively. This decrease was due to a derivative liability
expense from certain convertible notes in 2019 compared to
2018.
Net
interest expense increased approximately $109,000 from $242,000 to
$351,000 for the years ended December 31, 2018 and 2019,
respectively. This increase was mainly due to increased debt
balances.
Liquidity and
Capital Resources
We
have experienced recurring losses over the past years which have
resulted in accumulated deficits of approximately $8.8 million and
a working capital deficit of approximately $2 million at December
31, 2019. 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.
As of December
31, 2019, we had approximately $26,000 in cash and cash
equivalents, representing an increase in cash and cash equivalents
of approximately $4,000 from December 31, 2018. Sources of cash
were predominantly from the sale of equity and debt. We anticipate
that our current sources of liquidity, including cash and cash
equivalents, together with our current projections of cash flow
from operating activities, will provide us with liquidity into the
third quarter of 2020.
21
Cash Flows
from Operating Activities
Our cash flows
from operating activities are significantly affected by our cash
outflows to support the growth of our business in areas such as
R&D and G&A expenses. Our operating cash flows are also
affected by our working capital needs to support personnel related
expenditures, accounts payable and other current assets and
liabilities.
During the year ended December 31,
2019, cash used in operating activities was $315,609,
which was primarily the result of our net loss incurred of
$1,697,322, partially offset by increases in the various accounts
payable and accrued liability accounts totaling $283,093 and
non-cash expenses including stock-based compensation of $468,000,
loss on derivative liabilities of $352,934, and amortization of
debt discount of $278,593.
During the year
ended December 31, 2018, cash used in operating activities was
$469,172, which was primarily the result of our net loss incurred
of $1,866,912, and increases in prepaids and other current assets
of $112,467 and the right-of-use asset of $47,086. This was
partially offset by non-cash expenses including stock-based
compensation of $623,250, loss on derivative liabilities of
$388,121, and amortization of debt discount of $194,985.
Cash Flows
from Financing Activities
During the year
ended December 31, 2019, net cash provided by financing activities
was $314,741, compared to $491,540 during the year ended December
31, 2018. The decrease of approximately $177,000 in net cash
provided by financing activities is mainly attributable to a
decrease of $173,000 in cash received from the sale of common stock
due to the Company’s declining stock price. Other cash flows
provided by financing activities during the year ended December 31,
2019 included proceeds from convertible notes payable to related
and third parties totaling $275,000 offset by payments on notes
payable to related parties of $3,689 and payments on convertible
notes payable of $33,000. Other cash flows provided by financing
activities during the year ended December 31, 2018 included
proceeds from convertible notes payable to third parties totaling
$245,000 offset by payments on notes payable to related parties of
$2,460.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
On
January 3, 2019, the Board of Directors engaged Fruci &
Associates II, PLLC (“Fruci”), as the Company's independent
registered public accounting firm for the year ending December 31,
2018. The Company filed a Form 8-K on January 7, 2019 in regard to
this change.
BUSINESS DESCRIPTION
Background
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 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, improve maternal and fetal health, fight periodontal
disease, and for daily health.
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 can 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).
22
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.
In addition, The
Company announced plans to utilize its clinical-stage cancer
immunotherapy StemVacs™ for treatment of COVID-19 patients.
Previously the Company has filed data with the FDA, as part of IND
#17448, which demonstrated that treatment of cancer patients with
StemVacs™ resulted in enhanced activity of a type of immunological
cell called “natural killer” cells, otherwise known as “NK
cells.”
NK cells have
been published to inhibit SARS-CoV-2, the virus which causes
COVID-19. More importantly, companies such as Celularity have been
cleared by the FDA to administer pre-made NK cells for the
treatment of COVID-19 as part of clinical trials.
Nutraceutical Division (TSOI)
ProJuvenol® is a patented, (US No.: 9,682,047)
and powerful synergistic blend of complex anti-aging ingredients in
capsules.
NanoStilbene ™
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.
NeuroStilbene
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 Nano Cannabidiol
which are an easily absorbed Nanoparticles formulation of
Pterostilbene and Cannabidiol.
Nano Cannabidiol 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.
QuadraMune ™
is a synergistic blend of
pterostilbene, sulforaphane, epigallocatechingallate, and
thymoquinone.
Nutraceutical 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.
23
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.
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 its commercially available NanoStilbene™ product,
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 SARSCov-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” suggesting that QuadraMune™
administration 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” covering suppression of
the indolamine 2,3 deoxygenase (IDO) pathway by QuadraMune™
administration.
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™
24
On
May 15, 2018 TSOI announced Institutional Review Board (IRB)
clearance to initiate a pilot pharmacokinetic trial of
“NanoStilbene.” Then on July
02, 2018 the Company announced receiving pilot clinical data
providing proof of concept that NanoStilbene more effectively
increases blood levels of the molecule as compared to conventional
formulations. The clinical trial involved the administration of
NanoStilbene in comparison to powder in capsule form pterostilbene
with healthy volunteers, whom underwent a series of blood draws to
determine the concentration of the compound.
NanoStilbene Administration Results in Superior Pharmacokinetic
Profile
Compared to Pterostilbene Administration
Blood
was collected in EDTA tubes and plasma collected subsequent to
centrifugation at 700g for 10 minutes. Collection time points were
prior to administration of test compound, as well as at times 2hr,
4hr, 6hr, 8hr, 10hr, and 12 hrs. Test compounds were 10 ml of
NanoStilbene (provided by Therapeutic Solutions International) and
6 capsules of 50 mg pterostilbene (VitaMonk). A wash out period of
3 days was allowed between two test compound administration.
Results
The
results were that at peak concentration NanoStilbene (Square) had a
55% increase in serum levels over the traditional powder (Triangle)
form of pterostilbene. The data also shows the half-life to be
double to that of the powder form.
The
data in Granted U.S. Patent No.: 9,682,047 strongly suggest that
pterostilbene administration may be an inexpensive and safe method
of augmenting efficacy of numerous immunotherapeutic drugs.
Although cancer immunotherapy has revolutionized the prognosis of
many patients, the majority of patients still possess poor or
suboptimal responses to this approach.
Clinical Trial of NanoStilbene for Immune Derepression in
Advanced Cancer
12
patients with advanced cancer
ECOG
>2
300mg
NanoStilbene Oral daily (300mg PTER)
Assessments pre and 1, 2, and 3 weeks after treatment
Inflammatory Markers Decrease
·TNF,
IL-6, CRP
Immune Markers Increased
·IFN
gamma from stimulated PBMC
·NK
Cytolysis activity
|
|
Pterostilbene, being a methyl ether of resveratrol, is known to
possess anti-inflammatory and anticancer activity in various model
systems. It is known that in advanced cancer, excess inflammatory
signaling may be associated with reduction in CD3 zeta chain
signaling and inhibited function of natural killer (NK) cells.
25
Given
the importance of NK cells in the activity of various
Immunotherapeutics, we sought to determine whether administration
of a nanoparticle formulation of pterostilbene may reverse cancer
associated suppression of NK activity. An initial study in heathy
volunteers was performed to elucidate amount of NanoStilbene needed
to be administered to achieve sufficient plasma concentration for
induction of anti-inflammatory activity.
Subsequent to this, the selected NanoStilbene dose was administered
to twelve patients with advanced solid cancers for 3 weeks. Daily
treatment with 300mg of NanoStilbene caused reduction in serum
levels of inflammatory markers TNF-alpha, IL-6, and CRP. Assessment
of peripheral blood mononuclear cell ability to generate IFN-gamma
subsequent to stimulation with anti-CD3 and anti-CD28 was
increased.
Additionally, NK cytotoxicity was augmented. These results suggest
that NanoStilbene may be a useful adjuvant to immunotherapy of
cancer rescuing T cell and NK cell activities.
Augmentation of NK cell function may stimulate efficacy of approved
therapies that depend on an active NK compartment such as
Herceptin, Rituximab, and Cetuximab.
These
results suggest that NanoStilbene may be a useful adjuvant to
immunotherapy of cancer rescuing T cell and NK cell activities.
Augmentation of NK cell function may stimulate efficacy of approved
therapies that depend on an active NK compartment such as
Herceptin, Rituximab, and Cetuximab.
*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.
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.
StemVacs is an immunotherapy platform that consists of 5
components. The overarching approach to the StemVacs Immunotherapy
Platform is as follows:
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
StemVacs: StemVacs is a subcutaneously administered vaccine
comprised of immune stimulatory peptides resembling cancer stem
cell specific proteins.
Cancer Metabolic DeTox: This is an orally administered agent
that is derived from various herbs termed apigenin. The unique
property of apigenin is that it inhibits a cancer associated
metabolic pathway that degrades the amino acid tryptophan.
Specifically, apigenin inhibits the enzyme indolamine 2,3
deoxygenase (IDO), which is responsible for breaking down
tryptophan in the vicinity of the tumor and generating by-products
such as kynurenine. It is known that immune activation is dependent
on tryptophan being present in the tumor environment. The depletion
of tryptophan and generation of kynurenine by tumor cells and tumor
associated cells is a major cause of immune suppression in cancer.
By administering Cancer Metabolic DeTox, the innate arm of the
immune system has a chance to regenerate. This positions the
patient for better outcome after administration of specific immune
stimulating vaccines.
26
MemoryMune: This is a product derived from a two-step
culture process of donor blood cells. The product MemoryMune
reawakens dormant immune memory cells. It is known that many cancer
patients possess memory T cells that enter the tumor, however, once
inside the tumor these cells are inactivated. MemoryMune contains a
unique combination of growth factors specific for immune system
cells called “cytokines”.
LymphoBoost: LymphoBoost is a proprietary formulation of
Misoprostol, a drug approved for another indication, which we have
shown to be capable of stimulating lymphocytes, particularly NK
cells and T cells, both critical in maintaining anti-tumor
immunity.
innaMune: This is a biological product derived from tissue
culture of blood cells derived from healthy donors. It is a
combination of cytokines that maintain activity of innate immune
system cells, as well as having ability to shift M2 macrophages to
M1.
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.
27
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.
Employees
We
currently have two employees.
LEGAL PROCEEDINGS
During the past ten years there have been no events under any
bankruptcy act, no criminal proceedings and no judgments,
injunctions, orders or decrees material to the evaluation of the
ability and integrity of any of the persons nominated to become
directors or executive officers upon closing of the Merger
Agreement, and none of these persons has been involved in any
judicial or administrative proceedings resulting from involvement
in mail or wire fraud or fraud in connection with any business
entity, any judicial or administrative proceedings based on
violations of federal or state securities, commodities, banking or
insurance laws or regulations, or any disciplinary sanctions or
orders imposed by a stock, commodities or derivatives exchange or
other self-regulatory organization.
From
time to time, we may become involved in various lawsuits and legal
proceedings, which arise in the ordinary course of business.
However, litigation is subject to inherent uncertainties, and an
adverse result in these or other matters may arise from time to
time that may harm our business. We are currently not aware of any
such legal proceedings or claims that we believe will have,
individually or in the aggregate, a material adverse effect on our
business, financial condition or operating results.
28
MANAGEMENT
Current Management
The
following table sets forth information concerning our directors and
executive officers:
Name
|
|
Position
|
|
Age
|
Executive
Officers:
|
|
|
|
|
Timothy G. Dixon
|
|
President and Chief
Executive Officer
|
|
61
|
James Veltmeyer,
MD
|
|
Chief Medical
Officer
|
|
56
|
Feng Lin, MD, PhD
|
|
Chief Scientific
Officer
|
|
51
|
Directors:
|
|
|
|
|
Thomas E. Ichim,
PhD
|
|
Director
|
|
42
|
Directors are elected annually at the annual meeting of
shareholders. Each director holds office until the next annual
meeting of shareholders at which his or her term expires and until
his or her successor is elected and qualified, or until his or her
earlier death, resignation or removal pursuant to our bylaws.
Officers are elected by our board of directors at the annual
meeting of our board of directors held each year immediately
following the annual meeting of the shareholders, and each officer
holds office until the next annual meeting at which officers are to
be elected and until his or her successor is elected and qualified,
or until his or her earlier resignation or removal pursuant to our
bylaws.
Business Experience of Executive Officers and
Directors
Timothy G. Dixon, CEO, President, and Chairman
Mr.
Dixon currently serves as Chief Executive Officer, President, and
Chairman of Therapeutic Solutions International, Inc. Mr. Dixon
also serves as President and Chairman of SandBox Dental Labs, Inc.
Mr. Dixon also served as President and Chairman of Emvolio, Inc.
and previously served as the President of TMD Courses, Inc. from
2006 to 2012 and; as the President of Splint Decisions Inc. from
2010 to 2011.
Mr.
Dixon has attended hundreds of hours of continuing medical/dental
education throughout the years and has produced many educational
DVD’s used by dental professionals worldwide on the subject of
parafunctional control, migraine prevention, therapeutic Botox
injections, migraine pathophysiology, dental sleep medicine, and
other therapeutic protocols. Mr. Dixon also has extensive
experience in dealing with corporate compliance matters with the
U.S. Food and Drug Administration, (FDA) as well as many
international regulatory bodies.
James Veltmeyer,
MD – Chief Medical Officer
Dr.
Veltmeyer is a board-certified family physician in La Mesa,
California. A graduate of UC San Diego and the Ross University
School of Medicine, he completed his residency through the UC San
Francisco system where he became Chief of Family Medicine
Residency, overseeing 36 doctors.
Dr.
Veltmeyer, a member of the San Diego Critical Care Medical Group,
has been elected for four years (2012, 2014, 2016, and 2017) by his
colleagues in the San Diego County Medical Society as a “Physician
of Exceptional Excellence,” the most prestigious honor awarded to a
“Top Doctor” in San Diego County. He is among a select group of San
Diego physicians who was chosen four of the last fifteen years and
he consistently ranks in the top 1% to 2% for patient satisfaction.
He is currently the Chief of the Department of Family Medicine at
Sharp Grossmont Hospital where he provides senior leadership to
over 200 doctors.
Feng Lin, MD,
Ph.D., – Chief Scientific Officer
Dr.
Lin has a stellar track record of drug development in the area of
immunology and immuno-oncology having worked with the public
company Inovio Pharmaceuticals, where he developed technologies for
gene delivery and therapeutic DNA vaccines against cancer and
infectious diseases in both R&D and clinical settings.
Subsequently, Dr. Lin served as Director of Chinese Operations for
MediStem Inc, which was acquired by Intrexon in May 2014. It was
the rapid clinical translation model developed by Dr. Lin at
MediStem that resulted in the company’s accelerated FDA clearance
to begin clinical trials, which resulted in the sale of the
company.
Dr.
Lin received his postdoctoral training at the Sanford-Burnham
Medical Research Institute and his MD and Ph.D. at the Xiangya
Medical School of Central South University, China. He has authored
over 20 peer-reviewed scientific publications, including several in
top journals such as Science, Cell, and Cancer Cell. He holds
several patents.
29
Thomas E. Ichim, Ph.D.,
Director
Dr.
Ichim was appointed to the Board of Directors on January 22, 2016.
Dr. Ichim also served as Chief Executive Officer of Emvolio, Inc.
Dr. Ichim is a seasoned biotechnology entrepreneur with a track
record of scientific excellence. He has founded/co-founded several
companies including Batu Biologics, Inc., Medvax Pharma Corp,
ToleroTech, Inc, bioRASI, and OncoMune LLC. To date he has
published 121 peer-reviewed articles and is co-editor of the
textbooks “RNA Interference: From Bench to Clinical Translation”
and “Immuno-Oncology Text Book.”
Dr.
Ichim is an ad-hoc editor and sits on several editorial boards. Dr.
Ichim is inventor on over 135 patents and patent applications. Dr.
Ichim has extensive experience with stem cell therapy and cellular
product development through FDA regulatory pathways. Dr. Ichim
spent over 7 years as the President and Chief Scientific Officer of
Medistem, developing and commercializing a novel stem cell, the
Endometrial Regenerative Cell, through drug discovery,
optimization, preclinical testing, IND filing, and up through Phase
II clinical trials with the FDA. Dr. Ichim has extensive experience
in product development, regulatory filings, and business
development.
Dr.
Ichim has a BSc in Biology from the University of Waterloo,
Waterloo, Ontario, Canada, a MSc in Microbiology and Immunology a
University of Western Ontario, London, Ontario, Canada and a Ph.D.
in Immunology from the University of Sciences Arts and Technology,
Olveston Monserrat.
Scientific Advisory Board
Santosh Kesari, MD, Ph.D.
Dr.
Santosh Kesari is a board-certified neurologist and
neuro-oncologist and is currently Chair, Department of
Translational Neuro-Oncology and Neurotherapeutics, John Wayne
Cancer Institute.
He is
also Director of Neuro-Oncology, Providence Saint John’s Health
Center and Member, Los Angeles Biomedical Research Institute. Dr.
Kesari is ranked among the top 1% of neuro-oncologists and
neurologists in the nation, according to Castle Connolly Medical
Ltd and an internationally recognized scientist and clinician. He
is a winner of an Innovation Award by the San Diego Business
Journal. He is on the advisory board of American Brain Tumor
Association, San Diego Brain Tumor Foundation, Chris Elliott Fund,
Nicolas Conor Institute, Voices Against Brain Cancer, and
Philippine Brain Tumor Alliance. He has been the author of over 250
scientific publications, reviews, or books. He is the inventor on
several patents and patent applications, and founder and advisor to
many cancer and neurosciences focused biotech startups.
Dr.
Kesari has had a long-standing interest in cancer stem cells and
studies their role in the formation of brain tumors and resistance
to treatment. He believes that in order to cure patients with brain
tumors we first need to gain a better molecular and biological
understanding of the disease. A physician/scientist, Kesari
harnesses his experience in surgery, chemotherapy, immunotherapy,
radiation therapy and novel devices to help develop Precision
Therapeutic Strategies that will advance medicine to a new stage in
the battle against brain tumors and eradicate the disease.
Francesco Marincola, MD
Dr.
Francesco Marincola is currently Chief Science Officer at Refuge
Biotechnologies, Menlo Park, California. Most recently, he served
as a distinguished research fellow and strategist for immune
oncology discovery at AbbVie, Inc Previously, he was the Inaugural
Chief Research Officer of Sidra Medical and Research Centre in
Doha, Qatar. He was previously a tenured Senior Investigator at the
U.S. National Institutes of Health. He is past-President of the
Society for the Immunotherapy of Cancer and Editor-in-Chief of the
Journal of Translational Medicine.
Dr.
Marincola received his MD summa cum laude from the University of
Milan and did his surgery training at Stanford University,
California. His scientific work deepened the understanding of the
mechanisms leading to rejection of tumors or transplanted organs by
the immune system and development of autoimmunity. With over 500
peer-reviewed scientific papers, Dr. Marincola is considered one of
the world’s leading experts in cancer immunotherapy.
Pablo Guzman, MD
Dr.
Pablo Guzman is a cardiologist in Fort Lauderdale, Florida where he
is on staff at Holy Cross Hospital. He received his medical degree
from University of Puerto Rico School of Medicine and his
Cardiology Fellowship at The Johns Hopkins Hospital where he then
spent the first part of his career continuing his basic science and
clinical research along with his clinical duties. His CV includes
over 25 papers published in peer-reviewed journals and more than 15
abstracts.
30
He is
a Fellow of the American College of Cardiology and practiced for
more than 30 years. Dr. Guzman is well experienced in basic and
clinical research, having participated in many clinical trials. He
is also the acting Chief Medical Officer of Variant
Pharmaceuticals, a Specialty Pharma company developing treatments
for kidney diseases.
Juergen Winkler, MD
Dr.
Juergen Winkler is presently practicing at Quantum Functional
Medicine in Carlsbad, CA, which he founded in July of 2012. In 2005
he was the co-founder of Genesis Health Systems (Integrative Cancer
and Medical Treatment Center) located in Oceanside, CA. He has been
a featured speaker for: the NSCC Women’s Health Seminar, Annual
IPT/IPTLD Integrative Cancer Care Conference (Multiple years),
Health Freedom Expo 2011 & 2012, the Japanese Society of
Oxidative Medicine in Osaka Japan, ACOSPM 2010 & 2011
conferences, NSCC Health and Wellness Series 2013, and various
other events. He is the physician author of Chapter 5 in the Defeat
Cancer book and has been a featured physician in the Townsend
Letter.
Nassir Azimi, MD
Dr.
Nassir Azimi is a cardiologist in La Mesa, California and attended
Dartmouth Medical School and completed his residency at the
University of Colorado. He finished his four year fellowship in
Cardiovascular and Peripheral Interventions at Yale University in
New Haven. Dr. Azimi has been in private practice for over 13 years
establishing a thriving clinical practice for cardiac patients as
well as treating patients for peripheral vascular disease. He is
active in Interventional Cardiology and Peripheral Interventions.
Dr. Azimi is the director of La Mesa Cardiac Center’s Nuclear
Cardiology Laboratory. He is also an investigator in multiple
clinical research studies for various cardiac and peripheral
diseases.
He
has been recognized as San Diego’s Top Interventional Cardiologists
by San Diego Magazine 2013,2014,2016, 2017 and also by Castle
Connoly for 2013, 2014, 2015,2016, 2017, and 2018. He is a former
chief of biomedical ethics (6 years), former chief of Medicine and
former chief of Endovascular Medicine as well as Vice Chief of
Cardiology at SGH. He is on the board of directors of the
California ACC where he serves as chair of the public relations
committee. He is on Editorial Review Board for multiple medical
journals. He is a national speaker on various topics in cardiology
and internal medicine.
Barry Glassman, DMD
Dr.
Barry Glassman, DMD, DAAPM, DAACP, FICCMO, Diplomate ABDSM, FADI,
is a Diplomate of the American Academy of Craniofacial Pain and the
American Academy of Pain Management, as well as a Fellow of the
International College of Craniomandibular Orthopedics and the
Academy of Dentistry International, he is also on staff at the
Lehigh Valley Hospital where he serves as a resident instructor of
Craniofacial Pain and Dysfunction and Dental Sleep Medicine.
Dr.
Glassman is a Diplomate of the Academy of Dental Sleep Medicine. He
is on the staff at the Sacred Heart Hospital Sleep Disorder Center,
as well as serving as the Chief Dental Consultant to three other
sleep centers in the Lehigh Valley. A popular and dynamic speaker,
Dr. Glassman lectures internationally, as well as throughout the
United States. In addition to his extensive schedule which includes
guest lecture appearances and in-depth courses on joint
dysfunction, chronic pain, headache, sleep disorders, and migraine
headache, Dr. Glassman is a frequent speaker at major chronic pain
and joint dysfunction professional conferences.
University of Pittsburgh: Bachelor of Science 1969, Pittsburgh,
Pennsylvania University of Pittsburgh School of Dental Medicine;
D.M.D. 1973, Pittsburgh Pennsylvania Post Graduate Hours in
Craniomandibular Dysfunction and Sleep Disorders: Over 2500
Vijay Mahant, Ph.D.
Dr.
Vijay Mahant has been involved in Research and Development in the
medical industry for close to 30 years. Working in the FDA
regulated medical industry, he has headed R&D activities for
several bio-medical companies as well as being the founder, CEO
& Chairman of MediLite, Inc.
Dr.
Mahant has specialized in the areas of assay development, has
numerous patents to his credit and has published extensively. Dr.
Mahant received his B.S. in Biochemistry from the University of
Salford, UK; a M.S. in Medicinal Chemistry and a Ph.D. in Medical
Biochemistry from Lougborough University of Technology, UK.
David P. Hajjar, Ph.D.
Dr.
David P. Hajjar is currently Professor of Biochemistry, at Weill
Cornell Medical College and Professor of Pathology and Laboratory
Medicine, Weill Cornell Medical College.
31
Professor Hajjar was also a Frank H.T. Rhodes Distinguished
Professor of Cardiovascular Biology and Genetics, Pathology and
Laboratory Medicine, Weill Cornell Medical College from 1998 –
2014. Currently Dr. Hajjar is Dean Emeritus and was Executive Vice
Provost at Cornell University.
The
principal aim of Dr. Hajjar’s work is to define the mechanisms by
which Nitric Oxide (NO) and prostaglandin synthetic pathways
interact to alter eicosanoid biosynthesis as well as to investigate
the impact of these mediators on atherosclerosis and thrombosis.
Over the years, he has defined the roles and mechanisms of these
complex signaling interactions in order to gain an understanding of
the pathophysiological processes in atherosclerosis using animal
models and the consequences of pharmacological interventions.
In
recent work, he has showed that the enzyme prostaglandin H2
synthase (PGHS, also known as cyclooxygenase) regulates the
production of eicosanoids that modulate physiologic processes in
the vessel wall, contributing to atherosclerosis and thrombosis.
Dr. Hajjar demonstrated that various forms of NOx can have
different modulatory effects on the activity of PGHS-1, the
predominant isozyme in platelets. These and other studies revealed
that the active heme center of PGHS-1 regulates
peroxynitrite-induced modification and loss of enzyme reactivity,
indicating that heme may play a decisive role in catalyzing these
processes in PGHS-1 when exposed to nitrative stress in an
inflammatory setting. Collectively, these studies show for the
first time that iNOS influences PGHS expression and its activity,
which can contribute to modification of an important enzyme
involved in inflammation during atherosclerosis. Since iNOS-derived
species are required for robust atherosclerosis-associated
peroxynitrite production in peripheral organs, these studies have
contributed importantly to our understanding of the complex
alterations in eicosanoid metabolism that occur during the
pathogenesis of heart disease where inflammation occurs.
Family Relationships
There
are no family relationships between any director or executive
officer.
Director Independence
We do
not have standing compensation, nominating, or audit committees of
the board of directors, or committees performing similar functions.
We intend to form these committees in the near future.
Certain Relationships and Related
Transactions
Our
Board of Directors currently consists of two directors, one of whom
is an officer of the Company. As of December 31, 2019, we disclose
that we had no independent directors.
In
general, it is our policy to submit all proposed related party
transactions (those of the kind and size that may require
disclosure under Regulation S-K, Item 404) to the Board of
Directors for approval. The Board of Directors only approves those
transactions that are on terms comparable to, or more beneficial to
us than, those that could be obtained in arm’s length dealings with
an unrelated third party. Examples of related party transactions
covered by our policy are transactions in which any of the
following individuals has or will have a direct or indirect
material interest: any of our directors or executive officers, any
person who is known to us to be the beneficial owner of more than
5% of our common stock, and any immediate family member of one of
our directors or executive officers or person known to us to be the
beneficial owner of more than 5% of our common stock.
32
EXECUTIVE COMPENSATION
Executive Compensation
Currently, our “Named Executive Officers,” consists of our
principal executive officer only, and as of the date of this
Prospectus Mr. Dixon is under an employment agreement entitling him
to $174,000 per year salary. A bulk of this salary is being
accrued. Compensation does not include bonus or other forms of
compensation other than stock awards as indicated below.
Summary Compensation Table
The
following table summarizes the compensation paid, with respect to
three months ended March 31, 2020 and to year ended 2019 for
services rendered to us in all capacities, to each person who
served as an executive officer of the Company.
Name and Principal
Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)
|
Option
Awards
($)
|
Nonequity
Incentive Plan Compensation
($)
|
All
Other Compensation
($)
|
Total
($)
|
Timothy G. Dixon
|
2020
(2)
|
36,000
(1)
|
-
|
-
|
-
|
-
|
-
|
36,000
|
President, CEO and
CFO
|
2019
|
145,700 (3)
|
-
|
140,000
|
-
|
-
|
-
|
285,700
|
|
|
|
|
|
|
|
|
|
Dr. James
Veltmeyer
|
2019
|
-
|
-
|
50,000
|
-
|
-
|
-
|
50,000
|
Chief Medical
Officer
|
2018
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
|
|
|
Feng Lin
|
2019
|
-
|
-
|
26,000
|
-
|
-
|
-
|
26,000
|
Chief Scientific
Officer
|
2018
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
|
|
|
Gerry B. Berg
|
2019
|
128,800 (3)
|
-
|
75,000
|
-
|
-
|
-
|
203,800
|
Former Vice
President, Former CFO
|
2018
|
174,000 (4)
|
-
|
106,500
|
-
|
-
|
-
|
280,500
|
(1)
$30,000 was accrued and unpaid as of March 31,2020
(2)
as of March 31, 2020 .
(3)
$110,000 was accrued and unpaid as of December 31, 2019
Equity Awards
Equity awards were paid to Timothy G. Dixon, Chief Executive
Officer, in the amount of fifty million (50,000,000) shares of
restricted common stock, Thomas E. Ichim, Director, received fifty
million (50,000,000) shares of restricted common stock, and Feng
Lin, CSO, received twenty million (20,000,000) shares of restricted
common stock during the year ended December 31, 2019.
Compensation of Directors
No
compensation was paid to or earned as a director during the years
ended December 31, 2018, and December 31, 2019.
33
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
The
following table and footnotes thereto sets forth information
regarding the number of shares of common stock beneficially owned
by (i) each director and named executive officer of our company,
(ii) each person known by us to be the beneficial owner of 5% or
more of its issued and outstanding shares of common stock, and
(iii) all named executive officers and directors of the Company as
a group. In calculating any percentage in the following table of
common stock beneficially owned by one or more persons named
therein, the following table assumes 1,947,438,492 shares of common
stock issued and outstanding. Unless otherwise further indicated in
the following table, the footnotes thereto and/or elsewhere in this
prospectus, the persons and entities named in the following table
have sole voting and sole investment power with respect to the
shares set forth opposite the shareholder’s name, subject to
community property laws, where applicable. Unless as otherwise
indicated in the following table and/or the footnotes thereto, the
address of each person beneficially owning in excess of 5% of the
outstanding common stock named in the following table is: 4093
Oceanside Blvd. Suite B, Oceanside CA 92056.
The following table sets forth, as of
July 8, 2020, information regarding the ownership of the Company’s
outstanding shares of common stock by (i) each person known to
management to own, beneficially or of record, more than 5% of the
outstanding shares of our common stock, (ii) each director of the
Company, (iii) each executive officer of the Company, and (iv) all
directors and executive officers as a group. As of July 8 , 2020,
we have 1,947,438,492 shares of our common stock were
outstanding.
Name of Beneficial
Owners
|
|
Amount and Nature of Beneficial Ownership
|
|
Percent of Shares Outstanding
|
Timothy G. Dixon
(1)
|
|
249,557,489
|
|
12.81%
|
Gerry B. Berg
|
|
137,750,001
|
|
7.07%
|
Thomas E. Ichim
(2)
|
|
138,500,000
|
|
7.11%
|
Robert F. Graham
|
|
102,500,000
|
|
5.26%
|
John Peck, Jr.
|
|
289,533,333
|
|
14.88%
|
All directors and
executive officers as a group (2 persons) (1)(2)
|
|
388,057,489
|
|
19.92%
|
(1) Under SEC
rules (i) a person is deemed to be the beneficial owner of shares
if that person has, either alone or with others, the power to vote
or dispose of those shares. The persons named in the table have
sole voting and dispositive power with respect to all shares shown
as beneficially owned by them, subject to community property laws
where applicable.
SELLING STOCKHOLDERS
The
table below sets forth information concerning the resale of the
shares of common stock by the selling stockholders. We will not
receive any proceeds from the resale of the common stock by the
selling stockholders. None of the selling stockholders is a
registered broker-dealer.
The
following table also sets forth the name of each person who is
offering the resale of shares of common stock by this prospectus,
the number of shares of common stock beneficially owned by each
person, the number of shares of common stock that may be sold in
this offering and the percentage each person will own after the
offering, assuming they sell all of the shares offered.
Name
|
|
Amount
Beneficial
Ownership
Before Offering
|
|
|
Percentage
of
Common Stock
Owned Before
Offering1
|
|
|
Amount to be
Offered for the
Security Holders’
Account
|
|
|
Amount to be
Beneficially
Owned After
Offering1
|
|
|
Percentage
of
Common
Stock Owned
After Offering2
|
|
Triton Funds LP
|
|
0
|
|
|
|
0.0%
|
|
|
|
159,848,153
|
|
|
|
|
|
|
8.20%
|
|
Triton Funds LLC
|
|
|
|
|
|
0.0%
|
|
|
|
8,000,000
|
|
|
|
|
|
|
0.03%
|
|
TOTAL
|
|
0
|
|
|
|
0.0%
|
|
|
|
|
|
|
|
|
|
|
|
|
Each
of the selling stockholders received his, her, or its shares to be
registered in the acquisition transaction which closed on January
24, 2020.
Selling Shareholder Disclosure: Ashkan Mapar exercises voting and
dispositive power with respect to the shares of common stock that
are beneficially owned by Triton Funds LP.
34
The
number and percentage of shares beneficially owned is determined in
accordance with Rule 13d-3 of the Exchange Act and the information
is not necessarily indicative of beneficial ownership for any other
purpose. Under such rule, beneficial ownership includes any shares
as to which the selling shareholder has sole or shared voting power
or investment power and also any shares, which the selling
shareholder has the right to acquire within 60 days.
DESCRIPTION OF SECURITIES
General
Our
authorized capital stock consists of an aggregate of 3,500,000,000
shares, comprised of common stock, par value $0.001 per share,
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 July 8, 2020, we have
1,947,438,492 shares of Common Stock and no preferred shares issued
and outstanding.
Common Stock
Holders of shares of our Common Stock are entitled to one vote for
each Common Share held on all matters submitted to a vote of our
security holders and do not have cumulative voting rights.
Accordingly, holders of a majority of the shares of our Common
Stock entitled to vote in any election of directors may elect all
of the directors standing for election. Subject to preferences that
may be applicable to any shares of preferred stock outstanding at
the time, holders of shares of our Common Stock are entitled to
receive dividends ratably, if any, as may be declared from time to
time by our board of directors out of funds legally available
therefore.
Upon
our liquidation, dissolution or winding, holders of shares of our
Common Stock are entitled to receive ratably, our net assets
available after the payment of:
·all
secured liabilities, including any then outstanding secured debt
securities which we may have issued as of such time;
·all
unsecured liabilities, including any then outstanding unsecured
debt securities which we may have issued as of such time;
and
·all
liquidation preferences on any then outstanding preferred
stock.
Holders of shares of our Common Stock have no preemptive,
subscription, redemption or conversion rights, and there are no
redemption or sinking fund provisions applicable to our Common
Shares. The outstanding shares of our Common Stock are, and the
shares offered by us in this Offering will be, when issued and paid
for, duly authorized, validly issued, fully paid and
non-assessable. The rights, preferences and privileges of holders
of shares of our Common Stock are subject to, and may be adversely
affected by, the rights of the holders of shares of any series of
preferred stock that we may designate and issue in the future.
The
payment of dividends upon our shares of our Common Stock is solely
within the discretion of our board of directors and dependent upon
our financial condition, results of operations, capital
requirements, restrictions contained in our current or future
financing instruments and any other factors our board of directors
may deem relevant. We have never declared or paid any dividends on
our Common Shares. We currently intend to retain our future
earnings, if any, to finance the development and expansion of our
business and, as such, do not intend on paying any dividends in the
foreseeable future.
Dividend Policy
We
have never declared or paid any cash dividends on our common
stock.
PLAN OF DISTRIBUTION
We
are registering outstanding shares of our common stock to permit
the resale of such shares of common stock by the selling
stockholders, from time to time after the date of this prospectus.
We have agreed to maintain the effectiveness of the registration
statement of which this prospectus is a part for the selling
stockholders until the earlier of (i) the date on which all of the
shares included for it in the registration statement may be sold
pursuant to Rule 144 without volume restrictions or public
information requirements and any and all restrictive legends have
been removed from the shares, (ii) when all of the shares have been
disposed of pursuant to the registration statement, or (iii)
December 31, 2020. We will not receive any of the proceeds from the
sale by the selling stockholders of such shares of our common
stock. We will bear all fees and expenses incident to our
obligation to register these shares of common stock.
35
The
selling stockholders will sell their shares at prevailing market
prices or privately negotiated prices. These sales may be effected
in transactions, which may involve crosses or block transactions,
in any one or more of the following methods:
·on any
national securities exchange or quotation service on which the
securities may be listed or quoted at the time of sale;
·in the
over-the-counter market;
·in
transactions otherwise than on these exchanges or systems or in the
over-the-counter market;
·through
the writing of options, whether such options are listed on an
options exchange or otherwise;
·ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
·block
trades in which the broker-dealer will attempt to sell the shares
as agent but may position and resell a portion of the block as
principal to facilitate the transaction;
·purchases
by a broker-dealer as principal and resale by the broker-dealer for
its account;
·an
exchange distribution in accordance with the rules of the
applicable exchange;
·privately
negotiated transactions;
·short
sales;
·sales
pursuant to Rule 144;
·broker-dealers
which have agreed with the selling security holders to sell a
specified number of such shares at a stipulated price per
share;
·a
combination of any such methods of sale; and
·any
other method permitted pursuant to applicable law.
If
the selling stockholders effect such transactions by selling shares
of our common stock to or through underwriters, broker-dealers or
agents, such underwriters, broker-dealers or agents may receive
commissions in the form of discounts, concessions or commissions
from the selling stockholders or commissions from purchasers of the
shares of common stock for whom they may act as agent or to whom
they may sell as principal (which discounts, concessions or
commissions as to particular underwriters, broker-dealers or agents
may be in excess of those customary in the types of transactions
involved). In connection with sales of the shares of our common
stock or otherwise, the selling stockholders may enter into hedging
transactions with broker-dealers, which may in turn engage in short
sales of the shares of common stock in the course of hedging in
positions they assume. The selling stockholders may also sell
shares of our common stock short and deliver shares of common stock
covered by this prospectus to close out short positions and to
return borrowed shares in connection with such short sales. To the
knowledge of management, no selling shareholder has taken, or plans
to take, a short position in our stock prior to the effectiveness
of the registration statement of which this prospectus is a part.
The selling stockholders may also loan or pledge shares of our
common stock to broker-dealers that in turn may sell such
shares.
The
selling stockholders may pledge or grant a security interest in
some or all of the shares of our common stock owned by them and, if
they default in the performance of their secured obligations, the
pledgees or secured parties may offer and sell the shares of common
stock from time to time pursuant to this prospectus or any
amendment to this prospectus under Rule 424(b)(3) or other
applicable provision of the Securities Act amending, if necessary,
the list of selling stockholders to include the pledgee, transferee
or other successors in interest as selling stockholders under this
prospectus. The selling stockholders also may transfer and donate
the shares of common stock in other circumstances in which case the
transferees, donees, pledgees or other successors in interest will
be the selling beneficial owners for purposes of this
prospectus.
The
selling stockholders and any broker-dealer participating in the
distribution of the shares of common stock may be deemed to be
“underwriters” within the meaning of the Securities Act, and any
commission paid, or any discounts or concessions allowed to, any
such broker-dealer may be deemed to be underwriting commissions or
discounts under the Securities Act. At the time a particular
offering of the shares of common stock is made, a prospectus
supplement, if required, will be distributed which will set forth
the aggregate amount of shares of common stock being offered and
the terms of the offering, including the name or names of any
broker-dealers or agents, any discounts, commissions and other
terms constituting compensation from the selling stockholders and
any discounts, commissions or concessions allowed or reallowed or
paid to broker-dealers.
Under
the securities laws of some states, the shares of our common stock
may be sold in such states only through registered or licensed
brokers or dealers. In addition, in some states the shares of
common stock may not be sold unless such shares have been
registered or qualified for sale in such state or an exemption from
registration or qualification is available and is complied
with.
There
can be no assurance that any selling shareholder will sell any or
all of the shares of common stock registered pursuant to the
registration statement, of which this prospectus forms a part.
36
The
selling stockholders and any other person participating in such
distribution will be subject to applicable provisions of the
Exchange Act and the rules and regulations thereunder, including,
without limitation, Regulation M of the Exchange Act, which may
limit the timing of purchases and sales of any of the shares of
common stock by the selling stockholders and any other
participating person. Regulation M may also restrict the ability of
any person engaged in the distribution of the shares of common
stock to engage in market-making activities with respect to the
shares of common stock. All of the foregoing may affect the
marketability of the shares of common stock and the ability of any
person or entity to engage in market-making activities with respect
to the shares of common stock.
We
will pay all expenses of the registration of the shares of common
stock pursuant to the registration rights provisions contained in
the registration rights agreements between us and the selling
stockholders; provided, however, that a selling shareholder will
pay all underwriting discounts and selling commissions, if any. We
will indemnify the selling stockholders against liabilities,
including some liabilities under the Securities Act, in accordance
with the registration rights agreements, or the selling
stockholders will be entitled to contribution. We may be
indemnified by the selling stockholders against civil liabilities,
including liabilities under the Securities Act, that may arise from
any written information furnished to us by the selling stockholders
specifically for use in this prospectus, in accordance with the
related registration rights provisions, or we may be entitled to
contribution.
The
selling stockholders have advised us that they have not entered
into any agreements, understandings or arrangements with any
underwriters or broker-dealers regarding the sale of the shares,
nor is there an underwriter or coordinating broker acting in
connection with the proposed sale of the shares by the selling
stockholders. If we are notified by any one or more selling
stockholders that any material arrangement has been entered into
with a broker-dealer for the sale of shares through a block trade,
special offering, exchange distribution or secondary distribution
or a purchase by a broker or dealer, we will file, or cause to be
filed, a supplement to this prospectus, if required, pursuant to
Rule 424(b) under the Securities Act, disclosing (i) the name of
each such selling shareholder and of the participating
broker-dealer(s), (ii) the number of shares involved, (iii) the
price at which such shares were sold, (iv) the commissions paid or
discounts or concessions allowed to such broker-dealer(s), where
applicable, (v) that such broker-dealer(s) did not conduct any
investigation to verify the information set out or incorporated by
reference in this prospectus, and (vi) other facts material to the
transaction.
Once
sold under the registration statement, of which this prospectus
forms a part, the shares of common stock will be freely tradable in
the hands of persons other than our affiliates.
The
selling stockholders are not restricted as to the price or prices
at which they may sell their shares. Sales of the shares may have
an adverse effect on the market price of the common stock.
LEGAL MATTERS
RULE
415
Certain securities being registered on this Form are to be offered
on a delayed basis pursuant to CSPA (Exhibit 1.1) wherein the
Closing shall occur no later than five (5) Business Days after a
Purchase Notice Date which Registrant has the right to make such
Notice upon a Minimum Closing Price of the Common Stock that is
equal to or greater than $0.005.
The
common stock registered hereunder may be sold by us or any of the
selling stockholders, separately, or in combination with us, at
various times within the Commitment period under the CSPA which
terminates on or before December 31, 2020.
RULE
144 SHARES
Currently, none of our securities may be resold pursuant to Rule
144.
The
securities sold in this offering can only be resold through
registration under Section 5 of the Securities Act of 1933, Section
4(1), if available, for non-affiliates or by meeting the conditions
of Rule 144(i). A holder of our securities may not rely on the safe
harbor from being deemed statutory underwriter under Section 2(11)
of the Securities Act, as provided by Rule 144, to resell his or
her securities. “Form 10 information” is, generally speaking, the
same type of information as we are required to disclose in this
Prospectus, but without an offering of securities.
Hugh
D. Kelso III, Esq., has opined on the validity of the shares of
common stock being offered hereby (see Exhibit 23.3).
Instruction 1 to Item 509 of Regulation S-K requires disclosing
whether the interest of any expert or counsel named in the
Prospectus exceeds $50,000. The interest of any expert or counsel
named in the Prospectus does not exceed $50,000 according to
Instruction 1 Item 509 of Regulation S-K.
37
EXPERTS
Our
financial statements for the year ended December 31, 2018 and the
year ended December 31, 2019, were audited by Fruci &
Associates II PLLC for year ended December 31, 2019, and are
included in reliance upon such reports given upon the authority of
Fruci & Associates II PLLC, as experts in accounting and
auditing (see Index to Financials, F-1 and F-2, respectively .
Consent to use for this S-1 received. (see Exhibit 23.1 and 23.2,
respectively ).
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers or
persons controlling the registrant pursuant to the foregoing
provisions, the registrant has been informed that in the opinion of
the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Act and is therefore
unenforceable.
ADDITIONAL INFORMATION
Upon
the effective date of the registration statement of which this
prospectus is a part, we will be required to file reports and other
documents with the SEC. We have attached a copy of our annual
report (see Exhibit 13.1). You may also read and copy any materials
we file with the SEC at the public reference room of the SEC at 100
F Street, NE., Washington, DC 20549, between the hours of 10:00
a.m. and 3:00 p.m., except federal holidays and official closings,
at the Public Reference Room. You may obtain information on the
operation of the Public Reference Room by calling the SEC at
1-800-SEC-0330. Our SEC filings are also available to you on the
Internet website for the SEC at http://www.sec.gov.
INDEX TO
FINANCIAL STATEMENTS
Report of Independent
Registered Public Accounting Firms
|
F-1
|
|
|
Consolidated Balance
Sheets as of December 31, 2019 and 2018
|
F-2
|
|
|
Consolidated
Statements of Operations two full years ended December 31, 2019 and
for December 31, 2018
|
F-3
|
|
|
Consolidated
Statements of Stockholders’ Deficit two full years ended December
31, 2019 and for December 31, 2018
|
F-4
|
|
|
Consolidated
Statements of Cash Flows for two full years ended December 31, 2019
and for December 31, 2018
|
F-5
|
|
|
Notes to Consolidated
Financial Statements
|
F-6
|
38
INDEX TO EXHIBITS
Incorporated by Reference
|
|
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Form
|
|
File No.
|
|
Exhibit
|
|
Filed
Herewith
|
1.1
|
|
Common Stock Purchase
Agreement
|
|
S-1
|
|
333-236338
|
|
1.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.2
|
|
Donation
Agreement
|
|
S-1
|
|
333-236338
|
|
1.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.3
|
|
Registration Rights
Agreement
|
|
S-1
|
|
333-236338
|
|
1.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13.1
|
|
Annual Report FY
2019
|
|
10-K
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23.1
|
|
Auditor’s Consent re:
S-1
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
23.3
|
|
Attorney Opinion
Letter re: S-1
|
|
S-1
|
|
333-236338
|
|
23.3
|
|
|
39
F-1
THERAPEUTIC SOLUTIONS
INTERNATIONAL, INC.
Consolidated Balance Sheets
|
|
December
31,
2019
|
|
December
31,
2018
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash
and cash equivalents
|
$
|
26,410
|
$
|
22,397
|
Restricted cash
|
|
10,187
|
|
10,173
|
Accounts receivable
|
|
2,904
|
|
-
|
Inventory
|
|
5,180
|
|
-
|
Prepaid
expenses and other current assets
|
|
89,379
|
|
113,521
|
Right-of-use asset
|
|
5,619
|
|
-
|
Total
current assets
|
|
139,679
|
|
146,091
|
|
|
|
|
|
Other
assets
|
|
171,322
|
|
60,840
|
|
|
|
|
|
Total
assets
|
$
|
311,001
|
$
|
206,931
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
Accounts payable
|
$
|
324,936
|
$
|
320,812
|
Accounts payable-related parties
|
|
12,715
|
|
7,981
|
Accrued expenses and other current liabilities
|
|
505,072
|
|
717,723
|
Lease liability
|
|
5,619
|
|
-
|
Convertible notes payable, net of discount of $105,525 and
$105,556,
at December 31, 2019 and 2018, respectively
|
|
38,475
|
|
45,784
|
Notes payable-related parties, net
|
|
937,528
|
|
458,487
|
Derivative liabilities
|
|
521,700
|
|
466,612
|
Total current liabilities
|
|
2,346,045
|
|
2,017,399
|
|
|
|
|
|
Commitments and contingencies
|
|
-
|
|
-
|
|
|
|
|
|
Shareholders' Deficit:
|
|
|
|
|
Preferred stock, $ 0.001 par value; 5,000,000 shares authorized
|
|
-
|
|
-
|
Common stock, $ 0.001 par value; 3,500,000,000 shares authorized;
1,614,627,811 and 1,011,063,182 shares issued and outstanding at
December 31, 2019 and 2018, respectively.
|
|
1,614,628
|
|
1,011,063
|
Additional paid-in capital
|
|
5,183,228
|
|
4,314,047
|
Accumulated deficit
|
|
(8,832,900)
|
|
(7,135,578)
|
Total shareholders' deficit
|
|
(2,035,044)
|
|
(1,810,468)
|
|
|
|
|
|
Total
liabilities and shareholders' deficit
|
$
|
311,001
|
$
|
206,931
|
|
|
|
|
|
See
accompanying notes to consolidated financial statements.
|
F-2
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Statements of Operations
|
|
For the
Year
Ended
December
31,
2019
|
|
For the
Year
Ended
December
31,
2018
|
Net
sales
|
$
|
27,495
|
$
|
3,484
|
Cost of
goods sold
|
|
3,015
|
|
2,157
|
|
|
|
|
|
Gross
profit
|
|
24,480
|
|
1,327
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
General
and administrative
|
|
70,537
|
|
408,364
|
Salaries, wages, and related costs
|
|
305,133
|
|
415,072
|
Stock
compensation
|
|
355,000
|
|
-
|
Consulting fees
|
|
181,374
|
|
112,877
|
Legal
and professional fees
|
|
127,917
|
|
189,853
|
Research and development
|
|
27,685
|
|
74,970
|
Total
operating expenses
|
|
1,067,646
|
|
1,201,136
|
|
|
|
|
|
Loss
from operations
|
|
(1,043,166)
|
|
(1,199,809)
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
Loss on
derivatives liabilities
|
|
(352,934)
|
|
(388,121)
|
Change
in fair value of derivative liabilities
|
|
49,521
|
|
(37,230)
|
Interest expense
|
|
(350,743)
|
|
(241,752)
|
Total
other income (expense)
|
|
(654,156)
|
|
(667,103)
|
|
|
|
|
|
Net
loss
|
$
|
(1,697,322)
|
$
|
(1,866,912)
|
|
|
|
|
|
Net
loss per share - basic and diluted
|
$
|
(0.00)
|
$
|
(0.00)
|
|
|
|
|
|
Weighted average shares outstanding - basic and diluted
|
|
1,284,150,496
|
|
896,851,647
|
|
|
|
|
|
See
accompanying notes to consolidated financial statements.
|
See
accompanying notes to consolidated financial statements.
F-3
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Statement of Changes in Shareholders'
Deficit
For
the Years Ended December 31, 2019 and 2018
|
Common Stock
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Total
Shareholders'
Deficit
|
December 31, 2017
|
806,501,000
|
$
|
806,501
|
$
|
3,147,811
|
$
|
(5,268,666)
|
$
|
(1,314,354)
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for services
|
77,500,000
|
|
77,500
|
|
545,750
|
|
-
|
|
623,250
|
Common stock issued upon conversion of convertible notes
payable
|
66,062,182
|
|
66,062
|
|
432,486
|
|
-
|
|
498,548
|
Common stock sold
|
61,000,000
|
|
61,000
|
|
188,000
|
|
-
|
|
249,000
|
Net loss
|
-
|
|
-
|
|
-
|
|
(1,866,912)
|
|
(1,866,912)
|
December 31, 2018
|
1,011,063,182
|
|
1,011,063
|
|
4,314,047
|
|
(7,135,578)
|
|
(1,810,468)
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for services
|
200,000,000
|
|
200,000
|
|
268,000
|
|
-
|
|
468,000
|
Common stock issued upon conversion of convertible notes
payable
|
235,561,296
|
|
235,562
|
|
526,702
|
|
-
|
|
762,264
|
Common stock issued for a license
|
95,970,000
|
|
95,970
|
|
57,582
|
|
-
|
|
153,552
|
Common stock sold
|
72,033,333
|
|
72,033
|
|
4,397
|
|
-
|
|
76,430
|
Beneficial conversion feature on note payable
|
-
|
|
-
|
|
12,500
|
|
-
|
|
12,500
|
Net loss
|
-
|
|
-
|
|
-
|
|
(1,697,322)
|
|
(1,697,322)
|
December 31, 2019
|
1,614,627,811
|
$
|
1,614,628
|
$
|
5,183,228
|
$
|
(8,832,900)
|
$
|
(2,035,044)
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes to consolidated financial statements.
F-4
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Statements of Cash Flows
|
|
For
the Year
Ended
December 31,
2019
|
|
For
the Year
Ended
December 31,
2018
|
Cash flows from
operating activities
|
|
|
|
|
Net
loss
|
$
|
(1,697,322)
|
$
|
(1,866,912)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
Stock-based compensation to consultants
|
|
113,000
|
|
303,750
|
Stock-based compensation to related parties
|
|
355,000
|
|
319,500
|
Loss on derivative liabilities
|
|
352,934
|
|
388,121
|
Change in fair value of derivatives liabilities
|
|
(49,521)
|
|
37,230
|
Amortization of debt discount
|
|
278,593
|
|
194,985
|
Patent amortization
|
|
6,591
|
|
-
|
Changes in operating assets and liabilities:
|
|
|
|
|
Accounts receivable
|
|
(2,904)
|
|
-
|
Inventory
|
|
(5,180)
|
|
1,515
|
Prepaid expenses and other current assets
|
|
60,621
|
|
(112,467)
|
Right-of-use asset
|
|
(5,619)
|
|
(47,086)
|
Accounts payable
|
|
4,122
|
|
(22,998)
|
Accounts payable - related parties
|
|
4,734
|
|
7,981
|
Accrued expenses and other current liabilities
|
|
268,618
|
|
327,209
|
Lease liability
|
|
5,619
|
|
-
|
Net cash used in
operating activities
|
|
(310,714)
|
|
(469,172)
|
|
|
|
|
|
Cash flows from
financing activities
|
|
|
|
|
Payments on notes payable to related party
|
|
(3,689)
|
|
(2,460)
|
Proceeds from convertible notes payable to related party
|
|
25,000
|
|
-
|
Payments on convertible notes payable
|
|
(33,000)
|
|
-
|
Proceeds from convertible notes payable
|
|
250,000
|
|
245,000
|
Proceeds from sale of common stock
|
|
76,430
|
|
249,000
|
Net cash provided
by financing activities
|
|
314,741
|
|
491,540
|
|
|
|
|
|
Net
increase (decrease) in cash, cash equivalents and restricted
cash
|
|
4,027
|
|
22,368
|
Cash,
cash equivalents and restricted cash at beginning of year
|
|
32,570
|
|
10,202
|
Cash,
cash equivalents and restricted cash at end of year
|
$
|
36,597
|
$
|
32,570
|
|
|
|
|
|
Supplemental cash
flow information:
|
|
|
|
|
Cash
paid for interest
|
$
|
21,581
|
$
|
4,608
|
Cash
paid for income taxes
|
$
|
-
|
$
|
1,600
|
|
|
|
|
|
Non-cash investing
and financing transactions:
|
|
|
|
|
Original issuance discount on convertible notes payable
|
$
|
-
|
$
|
27,000
|
Debt
discount recorded in connection with derivative liability
|
$
|
250,000
|
$
|
245,000
|
Common
stock issued in conversion of convertible notes payable and
interest
|
$
|
762,264
|
$
|
498,548
|
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
|
$
|
430,715
|
$
|
-
|
Accrued interest added to principal
|
$
|
35,614
|
$
|
-
|
|
|
|
|
|
Reconciliation of
cash, cash equivalents and restricted cash to the
|
|
|
|
|
consolidated
balance sheets:
|
|
|
|
|
Cash
and cash equivalents
|
$
|
26,410
|
$
|
22,397
|
Restricted cash
|
|
10,187
|
|
10,173
|
Total cash, cash
equivalents, and restricted cash shown in the
|
|
|
|
|
consolidated statements of cash flows:
|
$
|
36,597
|
$
|
32,570
|
See
accompanying notes to consolidated financial statements.
F-5
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial
Statements
December 31, 2019
Note 1 – Nature of business
Therapeutic Solutions International, Inc. (“TSI” 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 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.
TSI
is developing a range of immune-modulatory agents to target certain
cancers, improve maternal and fetal health, fight periodontal
disease, and for daily health.
Nutraceutical Division – TSI 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 can 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 – TSI 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.
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.
Management does not expect existing cash as of December 31, 2019 or
as of March 31, 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 December 31, 2019, the Company has
incurred losses totaling $8.8 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 and classification of
liabilities that might be necessary should the Company be unable to
continue as a going concern.
F-6
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 2 – Basis of presentation and significant accounting
policies
Basis of Presentation
The
consolidated financial statements and accompanying notes have been
prepared in accordance with U.S. generally accepted accounting
principles (“U.S. GAAP”). In the opinion of the Company’s
management, the consolidated financial statements include all
adjustments, which include only normal recurring adjustments,
necessary for the fair presentation of the Company’s financial
position for the periods presented.
Principles of Consolidation
The
accompanying consolidated financial statements include the accounts
of Therapeutic Solutions International, Inc. and its wholly-owned
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.
Wholesale
policies:
Delivery.
The Goods shall be deemed delivered when Buyer has accepted
delivery at the above-referenced location. The shipping method
shall be determined by Seller, but Buyer will not be responsible
for shipping costs.
Purchase
Price & Payments. Seller agrees to sell the Goods to Buyer
for Fifty Percent (50%) off Sellers listed retail price (see
Exhibit A). Seller will provide an invoice to Buyer at the time of
delivery. All invoices must be paid, in full, within thirty (30)
days. Any balances not paid within thirty (30) days will be subject
to a five percent (5%) late payment penalty. In the event Buyer
exceeds the aggregate of $500,000.00 worth of aforementioned
products having been purchased, delivered, and paid for, Buyer will
be entitled to an additional Five Percent (5%) discount up to the
aggregate of $750,000.00. In the event Buyer exceeds the aggregate
of $750,000.00 worth of aforementioned products having been
purchased, delivered, and paid for, Buyer will be entitled to an
additional Five Percent (5%) discount up to the aggregate of
$1,500,000.00. All future sales after initial $1,500,000 in
aggregate purchases will be sold at 60% off retail.
Inspection of
Goods & Rejection. Buyer is entitled to inspect the Goods
upon delivery. If the Goods are unacceptable for any reason, Buyer
must reject them at the time of delivery up to five (5) business
days from the date of delivery. If Buyer has not rejected the Goods
within five (5) business days from the date of delivery, Buyer
shall have waived any right to reject that specific delivery of
Goods. In the event Buyer rejects the Goods, Buyer shall allow
Seller a reasonable time to cure the deficiency. A reasonable time
period shall be determined by industry standards for the particular
Goods, as well as the Seller and Buyer.
Risk of
Loss. Risk of loss will be on the Seller until the time when
the Buyer accepts delivery. Seller shall maintain any and all
necessary insurance in order to insure the Goods against loss at
Seller’s own expense
F-7
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 2 – Basis of presentation and significant accounting
policies (Continued)
Retail policies
of e-commerce:
Returns.
We will gladly accept the return of products that are defective due
to defects in manufacturing and/or workmanship. Fulfillment
mistakes that may be made which result in the shipment of incorrect
products to you will also be accepted for return.
Shipping.
Shipping Time -- Most orders will ship the next business day,
provided the product ordered is in stock. Orders are not processed
or shipped on Saturday or Sunday, except by prior arrangement. We
cannot guarantee when an order will arrive. Consider any shipping
or transit time offered to you by this site or other parties only
as an estimate. We encourage you to order in a timely fashion to
avoid delays caused by shipping or product availability.
Out of
Stock. We will ship your product as it becomes available.
Usually, products ship by the next business day. However, there may
be times when the product you have ordered is out-of-stock, which
will delay fulfilling your order. We will keep you informed of any
products that you have ordered that are out-of-stock and
unavailable for immediate shipment. You may cancel your order at
any time prior to shipping.
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.
Inventories
Inventories are stated at lower of cost (using the first-in,
first-out method, “FIFO”) or market. Inventories consist of
purchased materials and assembly items.
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 2019 and 2018, 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 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 $521,700 and $466,612 at December 31, 2019 and 2018,
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.
F-8
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 2 – Basis of presentation and significant accounting
policies (Continued)
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 December 31, 2018,
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 years ended
December 31, 2019 and 2018:
Balance, December 31,
2017
|
$
|
107,769
|
|
|
|
Issuance of new
derivative liabilities
|
|
633,122
|
Conversions to
paid-in capital
|
|
(311,509)
|
Change in fair market
value of derivative liabilities
|
|
37,230
|
|
|
|
Balance, December 31,
2018
|
|
466,612
|
|
|
|
Issuance of new
derivative liabilities
|
|
602,934
|
Conversions to
paid-in capital
|
|
(498,325)
|
Change in fair market
value of derivative liabilities
|
|
(49,521)
|
Balance, December 31,
2019
|
$
|
521,700
|
Use of Estimates
Estimates were made relating to valuation allowances, impairment of
assets, share-based compensation expense and accruals. Actual
results could differ materially from those estimates.
Comprehensive Loss
Comprehensive loss for the periods reported was comprised solely of
the Company’s net loss.
Net Loss Per Share
Basic
loss per share is computed by dividing net income available to
common stockholders by the weighted average number of common shares
outstanding during the period of computation. Diluted loss per
share is computed similar to basic 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.
Since we had net losses for all the periods presented, basic and
diluted loss per share are the same, and additional potential
common shares have been excluded as their effect would be
antidilutive.
As of
December 31, 2019 and 2018, a total of 181,588,903 and 226,902,346,
respectively, potential common shares, consisting of shares
underlying outstanding convertible notes payable were excluded as
their inclusion would be antidilutive.
F-9
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 2 – Basis of presentation and significant accounting
policies (Continued)
Depreciation and Amortization
Depreciation is calculated using the straight line method over the
estimated useful lives of the assets. Amortization is computed
using the straight line method over the term of the agreement.
During the years ended December 31, 2019 and 2018, there was no
depreciation or amortization expense as all fixed assets have been
fully depreciated.
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 years ended December 31, 2019 and 2018
was $6,591 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 $27,685 and $74,970 for the years
ended December 31, 2019 and 2018, 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.
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. The effective date for public
companies is for fiscal years beginning after December 15, 2018,
and interim periods within those fiscal years. For all other
entities, the effective date is fiscal years beginning after
December 15, 2019. The Company adopted during the year ended
December 31, 2018 for which there was no impact on the consolidated
financial statements.
Leases
On 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. ASU 2016-02
became effective for the Company in the first quarter of 2019 and
was adopted on a modified retrospective transition basis for leases
existing at, or entered into after, the beginning of the earliest
comparative period presented in the financial statements. The
Company recorded a Right-of-use asset and a Lease Liability of
$5,619 as of December 31, 2019.
F-10
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 2 – Basis of presentation and significant accounting
policies (Continued)
Recent Accounting Pronouncements
In August 2018, the FASB
issued ASU No. 2018-13, Fair Value Measurement (Topic 820) –
Disclosure Framework – Changes to the Disclosure Requirements for
Fair Value Measurement. The new guidance improves and clarifies the
fair value measurement disclosure requirement of ASC 820. The new
disclosure requirements include the changes in unrealized gains or
losses included in other comprehensive income for recurring Level 3
fair value measurement held at the end of the reporting period and
the explicit requirement to disclose the range and weighted average
used to develop significant unobservable inputs for Level 3 fair
value measurements. The other provisions of ASU 2018-13 also
include eliminated and modified disclosure requirements. The
guidance is effective for fiscal years beginning after December 15,
2019, with early adoption permitted, including in an interim period
for which financial statements have not been issued or made
available for issuance. The Company has evaluated the impact of
adoption of this ASU and determined that it will have no
significant impact on its consolidated financial
statements.
In December 2019, the FASB
issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the
Accounting for Income Taxes. ASU 2019-12 eliminated certain
exceptions and changed guidance on other matters. The exceptions
relate to the allocation of income taxes in separate company
financial statements, tax accounting for equity method investments
and accounting for income taxes when the interim period
year-to-date loss exceeds the anticipated full year loss. Changes
relate to the accounting for franchise taxes that are income-based
and non-income-based, determining if a step up in tax basis is part
of a business combination or if it is a separate transaction, when
enacted tax law changes should be included in the annual effective
tax rate computation, and the allocation of taxes in separate
company financial statements to a legal entity that is not subject
to income tax. The new standard is effective for fiscal years, and
interim periods within those fiscal years, beginning after December
15, 2020, with early adoption permitted. The Company is currently
evaluating the potential impact but does not believe there will be
an impact of the adoption of this standard on its results of
operations, financial position and cash flows and related
disclosures.
Note 3 – Restricted cash
Included in current assets is a $10,000 certificate of deposit with
an annual interest rate of 0.6%. This certificate matures on June
17, 2020, and is used as collateral for a Company credit card,
pursuant to a security agreement dated June 20, 2011.
Note 4 – Prepaid expense and other current assets
Prepaid expenses and other current assets consist of the
following:
|
|
December 31,
2019
|
|
December 31,
2018
|
Prepaid
consulting
|
$
|
88,261
|
$
|
111,655
|
Insurance
|
|
-
|
|
848
|
Prepaid costs
|
|
1,118
|
|
1,018
|
Total
|
$
|
89,379
|
$
|
113,521
|
Note 5 – Fixed assets
Fixed
assets consist of the following:
|
|
December 31,
2019
|
|
December 31,
2018
|
Computer hardware
|
$
|
10,747
|
$
|
10,747
|
Office furniture and
equipment
|
|
3,639
|
|
3,639
|
Shipping and other
equipment
|
|
1,575
|
|
1,575
|
Total
|
|
15,961
|
|
15,961
|
Accumulated
depreciation
|
|
(15,961)
|
|
(15,961)
|
Property and
equipment, net
|
$
|
-
|
$
|
-
|
Depreciation expense was $0 for December 31, 2019 and 2018.
F-11
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 6 – Other assets
Other
assets consist of the following:
|
|
December 31,
2019
|
|
December 31,
2018
|
Prepaid
consulting
|
$
|
20,238
|
$
|
56,717
|
Deposit
|
|
4,123
|
|
4,123
|
Licenses, net
|
|
146,961
|
|
-
|
Total
|
$
|
171,322
|
$
|
60,840
|
Prepaid consulting agreements are for one to two years and are
expensed monthly over the term of the agreement. The net licenses
amount above consists of the following:
|
|
December 31,
2019
|
|
December 31,
2018
|
|
|
|
|
|
License
|
$
|
153,552
|
$
|
-
|
Accumulated
amortization
|
|
(6,591)
|
|
-
|
Licenses, net
|
$
|
146,961
|
$
|
-
|
As of June 1,
2019, we entered into a license agreement, which will be amortized
over the life of the Patent. The Patent expires December 31,
2032. The Exclusive Patent License to the Jadi Cell is for use
under the designated areas of CTE (Chronic Traumatic
Encephalopathy), and TBI (Traumatic Brain Injury). The Jadi Cell is
an cGMP grade and Research grade manufactured allogenic mesenchymal
stem cells derived from US Patent No.: 9,803,176 B2. Forward
looking the Company intends to file an Investigational New Drug
Application (IND) for brain injured patients who have been
intensively cared for and mechanically ventilated due to covid-19
illness and a second IND for CTE/TBI as well in keeping with the
spirit of the licensing agreement to advance the Jadi Cell through
to FDA Approval for CTE/TBI.
F-12
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 7 – Convertible notes payable
On
January 3, 2018, February 27, 2018, May 1, 2018, June 5, 2018, July
2, 2018, August 6, 2018, October 3, 2018, November 15, 2018, and
December 6, 2018, the Company entered into five $28,000 convertible
promissory notes and four $33,000 convertible promissory notes with
third parties for which the proceeds were used for operations. The
Company received net proceeds of $245,000 and a $27,000 original
issuance discount was recorded. The convertible promissory notes
incur interest at 12% per annum for which $28,000 plus accrued
interest were due on October 15, 2018, November 20, 2018, February
15, 2019, April 15, 2019 and May 30, 2019 and $33,000 plus accrued
interest were due March 30, 2019, July 30, 2019, August 30, 2019,
and September 30, 2019. The convertible promissory notes were
convertible to shares of the Company's common stock 180 days after
issuance. The conversion price per share was equal to 55% of the
average of the three (3) lowest trading price of the Company's
common stock during the fifteen (15) trading days immediately
preceding the applicable conversion date. The Company had the
option to prepay the convertible notes in the first 180 days from
closing subject to prepayment penalties ranging from 120 of 145% of
principal balance plus interest, depending upon the date of
prepayment. The convertible promissory notes included various
default provisions for which the default interest rate increases to
22% per annum with the outstanding principal and accrued interest
increasing by 150%.
On
January 2, 2019, February 7, 2019, March 11, 2019, April 23, 2019,
August 28, 2019, October 30, 2019 and December 13, 2019, the
Company entered into two $28,000 convertible promissory notes,
three $33,000 convertible promissory notes, one $78,000 convertible
promissory note and one $38,000 convertible promissory note with a
third party for which the proceeds were used for operations. The
Company received net proceeds of $250,000 and a $21,000 original
issuance discount was recorded. The convertible promissory notes
incur interest at 12% per annum for which $28,000 plus accrued
interest are due on January 30, 2020 and October 30, 2020 and
$33,000 plus accrued interest are/were due October 30, 2019,
November 30, 2019 and February 28, 2020 and $78,000 plus accrued
interest is due June 30, 2020 and $38,000 plus accrued interest is
due June 30, 2020. 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 55% 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 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
convertible promissory note dated February 7, 2019 was paid in full
on July 26, 2019. The Company was required to reserve at December
31, 2019, a total of 872,670,108 common shares in connection with
the 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 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.
For
the nine notes issued during the year ended December 31, 2018, the
Company valued the conversion feature on the date of issuance
resulting in initial liability of $633,121. Since the fair value of
the derivatives were in excess of the proceeds received of
$245,000, a full discount to convertible notes payable and a day
one loss on derivative liabilities of $388,121 was recorded during
the year ended December 31, 2018. Upon issuance, the Company valued
the conversion feature using the Black-Scholes option pricing model
with the following assumptions: conversion prices ranging from
$0.002 to $0.006, the closing stock price of the Company's common
stock on the date of valuation ranging from $0.0045 to $0.0220, an
expected dividend yield of 0%, expected volatility ranging from
214% to 304%, risk-free interest rates ranging from 1.81% to 2.70%,
and an expected term ranging from 0.76 to 0.82 years.
F-13
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 7 – Convertible notes payable (Continued)
During the year ended December 31, 2018, five of the $28,000
convertible notes and one of the $33,000 convertible notes were
converted into 63,848,737 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 year ended
December 31, 2018, the Company recorded a gain of $165,563 related
to the change of fair value of the derivative liability and
recorded $311,509 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 $0.0033 to $0.005 the closing stock price of the Company's
common stock on the date of valuation ranging from $0.0028 to
$0.02720, an expected dividend yield of 0%, expected volatility
ranging from 185% to 277%, risk-free interest rates ranging from
1.81% to 2.70%, and expected terms ranging from 0.07 to 0.75
years.
On
December 31, 2018, the derivative liabilities on the remaining five
convertible notes were revalued at $466,612 resulting in a loss of
$202,793 for the year ended December 31, 2018 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 $0.002, the
closing stock price of the Company's common stock on the date of
valuation of $0.0055, an expected dividend yield of 0%, expected
volatility ranging from 248% to 279%, risk-free interest rate of
2.63%, and an expected term ranging from 0.29 to 0.75 years.
For
the seven notes issued during the year ended December 31, 2019, the
Company valued the conversion feature on the date of issuance
resulting in initial liability of $602,934. Since the fair value of
the derivatives were in excess of the proceeds received of
$250,000, a full discount to convertible notes payable and a day
one loss on derivative liabilities of $352,934 was recorded during
the year ended December 31, 2019. Upon issuance, the Company valued
the conversion feature using the Black-Scholes option pricing model
with the following assumptions: conversion prices ranging from
$0.001 to $0.003, the closing stock price of the Company's common
stock on the date of valuation ranging from $0.002 to $0.009, an
expected dividend yield of 0%, expected volatility ranging from
236% to 262%, risk-free interest rates ranging from 1.55% to 2.60%,
and an expected term ranging from 0.81 to 1 years.
During the year ended December 31, 2019, three of the $28,000
convertible notes and five of the $33,000 convertible notes were
converted into 235,561,296 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 year ended
December 31, 2019, the Company recorded a gain of $310,347 related
to the change of fair value of the derivative liability and
recorded $498,324 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 $0.0004 to $0.002, the closing stock price of the Company's
common stock on the date of valuation ranging from $0.001 to
$0.009, an expected dividend yield of 0%, expected volatility
ranging from 214% to 263%, risk-free interest rates ranging from
1.56% to 2.59%, and expected terms ranging from 0.26 to 0.38
years.
On
December 31, 2019, the derivative liabilities on the remaining
three convertible notes were revalued at $521,700 resulting in a
loss of $260,826 for the year ended December 31, 2019 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
$0.001, the closing stock price of the Company's common stock on
the date of valuation of $0.003, an expected dividend yield of 0%,
expected volatility ranging from 245% to 262%, risk-free interest
rate of 1.59%, and an expected term ranging from 0.5 to 0.95
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 years ended December 31,
2019 and 2018, the Company amortized $278,593 and $194,985 to
interest expense, respectively. As of December 31, 2019, discounts
of $105,525 remained for which will be amortized through December
2020.
F-14
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 8 – Notes payable-related parties
Notes payable-related parties
consist of:
|
|
December 31,
2019
|
|
December 31,
2018
|
|
|
|
|
|
Note
payable – Scientific Advisory Board Member, unsecured, including
interest at 10% per annum, with a maturity date of December
31, 2019
|
|
18,162
|
$
|
17,015
|
|
|
|
|
|
Three
notes payable – Chief Executive Officer, unsecured, including
interest at 8%, 10% and 10% per annum, respectively, with maturity
date of December 31, 2019
|
|
37,671
|
|
138,105
|
|
|
|
|
|
One
note payable – Chief Executive Officer, unsecured, no interest,
paid from a % of revenues
|
|
534,700
|
|
-
|
|
|
|
|
|
Note
payable – Chief Financial Officer, unsecured, including interest at
8% per annum, with a maturity date of December 31, 2019
|
|
105,600
|
|
99,200
|
|
|
|
|
|
Three
notes payable – Business Advisory Board Member, unsecured,
including interest at 8% and 10% per annum, convertible into common
stock at $0.005 and $0.004,respectively, with maturity date of
April 20, 2019
|
|
246,334
|
|
204,167
|
|
|
942,467
|
|
458,487
|
Less debt
discount
|
|
(4,939)
|
|
-
|
|
$
|
937,528
|
$
|
458,487
|
Note 9 – Related party
transactions
As of
December 31, 2019 and 2018, the Company had
accrued officers’ salary of $439,534 and $663,100, respectively.
One of the officers settled with the company for a note payable
that is unsecured and doesn’t accrue interest and will be paid as
0.5% of revenues. This decreased accrued officers’ salary.
On
October 25, 2018, we issued 15,000,000 shares of common stock,
valued at $0.0071 each to two officers and one director of the
Company under a Restricted Stock Award.
On
December 12, 2019, we issued 100,000,000 shares of common stock,
valued at $0.0013 each to one officer and one director of the
Company under a Restricted Stock Award.
F-15
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 10 – Income
taxes
The
Company is subject to United States federal and state income taxes
at an approximate rate of 30%. The reconciliation of the provision
for income taxes at the United States federal statutory rate
compared to the Company’s income tax expense as reported is as
follows:
|
|
December 31,
2019
|
|
December 31,
2018
|
Expected income tax
at statutory rate
|
$
|
(356,438)
|
$
|
(391,884)
|
State tax
|
|
168
|
|
168
|
Permanent
differences
|
|
220,501
|
|
253,768
|
Other
|
|
6,556
|
|
(11,756)
|
Change in valuation
allowance
|
|
129,213
|
|
149,704
|
Provision for income
taxes
|
$
|
-
|
$
|
-
|
The
significant components of deferred income tax assets and
liabilities at December 31, 2019 and 2018 are as follows:
|
|
December 31,
2019
|
|
December 31,
2018
|
Net operating loss
carry-forward
|
$
|
1,450,896
|
$
|
1,321,683
|
Valuation
allowance
|
|
(1,450,896)
|
|
(1,321,683)
|
Net deferred tax
asset
|
$
|
-
|
$
|
-
|
The
Company has net operating losses carried forward of approximately
$5.7 million and $5 million as of December 31, 2019 and 2018,
respectively, available to offset taxable income in future years
which expire beginning in fiscal 2032.
As of
and for the years ended December 31, 2019 and 2018, management does
not believe the Company has any uncertain tax positions.
Accordingly, there are no recognized tax benefits at December 31,
2019 and 2018.
The
Company is subject to tax in the United States and files tax
returns in the U.S. Federal jurisdiction and California state
jurisdiction. The Company is subject to U.S. Federal, state and
local income tax examinations by tax authorities starting in 2016.
The Company currently is not under examination by any tax
authority.
Note 11 – Equity
Our
authorized capital stock consists of an aggregate of 3,505,000,000
shares, comprised of 3,500,000,000 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 December 31, 2019, we
have 1,614,627,811 shares of common stock and no preferred shares
issued and outstanding.
On
January 26, 2018, we issued 2,424,242 shares of common stock for
the partial conversion of $8,000 for convertible note dated July
24, 2017.
On
February 1, 2018, we issued 6,376,471 shares of common stock for
the conversion of the balance of $20,000 for convertible note dated
July 24, 2017.
On
February 1, 2018, we issued 5,000,000 shares of common stock,
valued at $0.009 per share, for consulting services.
On
February 1, 2018, we issued 2,500,000 shares of common stock,
valued at $0.009 per share, for consulting services.
On
February 20, 2018, we issued 15,000,000 shares of common stock,
valued at $0.004 per share, for an investment in the Company’s
Private Placement to a related party.
F-16
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 11 – Equity (Continued)
On
February 20, 2018, we issued 2,500,000 shares of common stock,
valued at $0.0062 per share, for consulting services.
On
April 14, 2018, we issued 2,500,000 shares of common stock, valued
at $0.004 per share, for an investment in the Company’s Private
Placement to a related party.
On
April 14, 2018, we issued 5,000,000 shares of common stock, valued
at $0.0057 per share, for consulting services.
On
April 27, 2018, we issued 3,225,806 shares of common stock for the
partial conversion of $8,000 for convertible note dated September
7, 2017.
On
May 1, 2018, we issued 4,137,931 shares of common stock for the
partial conversion of $12,000 for convertible note dated September
7, 2017.
On
May 2, 2018, we issued 25,000,000 shares of common stock, valued at
$0.004 per share, for an investment in the Company’s Private
Placement to a related party.
On
May 21, 2018, we issued 2,742,857 shares of common stock for the
partial conversion of $6,000 for convertible note dated September
7, 2017.
On
June 15, 2018, we issued 8,500,000 shares of common stock, valued
at $0.004 per share, for an investment in the Company’s Private
Placement.
On
July 3, 2018, we issued 5,000,000 shares of common stock, valued at
$0.004 per share, for an investment in the Company’s Private
Placement.
On
July 9, 2018, we issued 4,166,667 shares of common stock for the
partial conversion of $15,000 for convertible note dated January 3,
2018.
On
July 12, 2018, we issued 4,077,778 shares of common stock for the
partial conversion of $13,000 for convertible note dated January 3,
2018.
On
July 19, 2018, we issued 2,500,000 shares of common stock, valued
at $0.015 per share, to a Scientific Advisory Board member for
consulting services.
On
August 7, 2018, we issued 11,000,000 shares of common stock at
$0.011 per share, for consulting services.
On
September 5, 2018, we issued 3,260,870 shares of common stock for
the partial conversion of $15,000 for convertible note dated
February 27, 2018.
On
September 10, 2018, we issued 3,262,222 shares of common stock for
the partial conversion of $13,000 for convertible note dated
February 27, 2018.
On
September 19, 2018, we issued 5,000,000 shares of common stock,
valued at $0.005 per share, for an investment in the Company’s
Private Placement.
On
September 19, 2018, we issued 1,500,000 shares of common stock,
valued at $0.01 per share, to a Scientific Advisory Board member
for consulting services.
On
October 25, 2018, we issued 15,000,000 shares of common stock,
valued at .0071 each to two officers and one director of the
Company under a Restricted Stock Award.
On
November 15, 2018, we issued 2,500,000 shares of common stock,
valued at $0.008 per share, to a Scientific Advisory Board member
for consulting services.
F-17
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 11 – Equity (Continued)
On
November 23, 2018, we issued 3,805,899 shares of common stock for
the partial conversion of $12,000 for convertible note dated May 1,
2018.
On
November 26, 2018, we issued 4,347,826 shares of common stock for
the partial conversion of $10,000 for convertible note dated May 1,
2018.
On
November 28, 2018, we issued 3,657,143 shares of common stock for
the partial conversion of $6,000 for convertible note dated May 1,
2018.
On
December 7, 2018, we issued 8,823,529 shares of common stock for
the partial conversion of $15,000 for convertible note dated June
5, 2018.
On
December 14, 2018, we issued 5,882,353 shares of common stock for
the partial conversion of $10,000 for convertible note dated June
5, 2018.
On
December 17, 2018, we issued 5,870588 shares of common stock for
the partial conversion of $8,000 for convertible note dated June 5,
2018.
On
January 3, 2019, we issued 15,000,000 shares of common stock,
valued at $0.0071 each to two officers and one director of the
Company under a Restricted Stock Award.
On
January 3, 2019, we issued 10,000,000 shares of common stock,
valued at $0.005 per share, to a Scientific Advisory Board member
for consulting services.
On
January 7, 2019, we issued 7,500,000 shares of common stock for the
partial conversion of $12,000 for convertible note dated July 2,
2018.
On
January 9, 2019, we issued 6,250,000 shares of common stock for the
partial conversion of $10,000 for convertible note dated July 2,
2018.
On
January 9, 2019, we issued 4,800,000 shares of common stock for the
partial conversion of $7,680 for convertible note dated July 2,
2018.
On
February 8, 2019, we issued 8,333,333 shares of common stock for
the partial conversion of $10,000 for convertible note dated August
6, 2018.
On
February 12, 2019, we issued 8,155,556 shares of common stock for
the partial conversion of $14,680 for convertible note dated August
6, 2018.
On
April 15, 2019, we issued 6,000,000 shares of common stock for the
partial conversion of $12,000 for convertible note dated October 3,
2018.
On
April 24, 2019, we issued 11,490,000 shares of common stock for the
partial conversion of $22,980 for convertible note dated October 3,
2018.
On
May 20, 2019, we issued 6,666,667 shares of common stock for the
partial conversion of $12,000 for convertible note dated November
15, 2018.
On
May 24, 2019, we issued 12,766,667 shares of common stock for the
partial conversion of $22,980 for convertible note dated November
15, 2018.
On
June 11, 2019, we issued 21,818,182 shares of common stock for the
partial conversion of $24,000 for convertible note dated December
6, 2018.
F-18
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 11 – Equity (Continued)
On
June 18, 2019, we issued 95,970,000 shares of common stock, valued
at $0.0016 per share, for a license.
On
June 18, 2019, we issued 15,000,000 shares of common stock, valued
at $0.0016 per share, to a Scientific Advisory Board member for
consulting services.
On
June 19, 2019, we issued 12,200,000 shares of common stock for the
partial conversion of $10,980 for convertible note dated December
6, 2018.
On
June 28, 2019, we issued 12,000,000 shares of common stock, valued
at $0.0015 per share, for an investment in the Company’s Private
Placement.
On
July 8, 2019, we issued 24,590,164 shares of common stock for the
partial conversion of $15,000 for convertible note dated January 2,
2019.
On
July 11, 2019, we issued 32,754,098 shares of common stock for the
partial conversion of $19,980 for convertible note dated January 2,
2019.
On
July 23, 2019, we issued 56,033,333 shares of common stock, valued
at $0.0009 per share, for an investment in the Company’s Private
Placement.
On
August 5, 2019, we issued 4,000,000 shares of common stock, valued
at $0.002 per share, for an investment in the Company’s Private
Placement.
On
September 12, 2019, we issued 10,000,000 shares of common stock for
the partial conversion of $12,000 for convertible note dated March
11, 2019.
On
September 18, 2019, we issued 10,909,091 shares of common stock for
the partial conversion of $12,000 for convertible note dated March
11, 2019.
On
September 20, 2019, we issued 5,737,374 shares of common stock for
the partial conversion of $5,680 for convertible note dated March
11, 2019.
On
October 29, 2019, we issued 12,345,679 shares of common stock for
the partial conversion of $10,000 for convertible note dated April
23, 2019.
On
October 31, 2019, we issued 18,987,342 shares of common stock for
the partial conversion of $15,000 for convertible note dated April
23, 2019.
On
November 4, 2019, we issued 14,257,143 shares of common stock for
the partial conversion of $9,980 for convertible note dated April
23, 2019.
On
December 12, 2019, we issued 30,000,000 shares of common stock,
valued at $0.0013 per share, for consulting services.
On
December 12, 2019, we issued 100,000,000 shares of common stock,
valued at $0.0013 each to one officer and one director of the
Company under a Restricted Stock Award.
F-19
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
Consolidated Notes to Financial Statements
December 31, 2019
Note 12 – 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.
Note
13 – Commitments and Contingencies
Effective May 1, 2017, the Company entered into a fourth amendment
to a Lease Agreement for property located in Oceanside, CA. The
lease consists of approximately 1,700 square feet and the amendment
is for a term of 36 months and expires on April 30, 2020.
During the year ended December 31, 2019 and 2018, the Company
incurred rent expense of $22,494 and $21,774.
Future minimum lease payments as of December 31, 2019 are as
follows:
For the year ending
December 31,
|
|
|
|
|
|
2020
|
$
|
7,492
|
Effective November 8, 2019, the Company entered into a royalty
agreement with one of the officers, refer to Note 9.
Note 14 – Subsequent events
On
February 3, 2020. we issued a annual convertible note in the amount
of $33,000 with an annual interest rate of 12%.
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 30, 2023 with
escalating monthly payments ranging from $2,024 to $2,153.
On
March 2, 2020, we issued 8,333,333 shares of common stock for the
partial conversion of $10,000 for the convertible note dated August
28, 2019.
On
March 5, 2020, we filed with the Nevada Secretary of State a
Certificate of Amendment to Articles of Incorporation to effect an
amendment (the “Amendment”) changing the number of authorized
shares of our common stock to 3,500,000,000 (and changing the total
number of authorized shares of stock to 3,505,000,000).
On
March 3, 2020, our stockholders acted by way of nonunanimous
majority written consent action (pursuant to a solicitation of
consents commenced on February 27, 2020, and in lieu of a special
meeting of stockholders) to approve the Amendment. The number of
shares giving written consent (i.e., voting) in favor of such
matter was 927,629,005 (57.45%); no shares were overtly “voted
against” the Amendment; and 686,998,806 shares did not participate
in the nonunanimous majority written consent action (42.55%).
On
March 12, 2020, we issued 11,764,706 shares of common stock for the
partial conversion of $10,000 for the 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 the convertible note dated August
28, 2019.
In accordance with ASC 855,
the Company has analyzed its operations subsequent to December 31,
2019 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.
F-20
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
Condensed
Consolidated Balance Sheets
|
|
March 31,
2020
|
|
December 31,
2019
|
|
|
(Unaudited)
|
|
(Audited)
|
ASSETS
|
|
|
Current
assets:
|
|
|
|
|
Cash
and cash equivalents
|
$
|
3,859
|
$
|
26,410
|
Restricted cash
|
|
10,187
|
|
10,187
|
Accounts receivable
|
|
3,625
|
|
2,904
|
Inventory
|
|
4,488
|
|
5,180
|
Prepaid expenses and other current assets
|
|
61,731
|
|
89,379
|
Right-of-use asset
|
|
24,137
|
|
5,619
|
Total current
assets
|
|
108,027
|
|
139,679
|
|
|
|
|
|
Other
assets
|
|
213,007
|
|
171,322
|
|
|
|
|
|
Total
assets
|
$
|
321,034
|
$
|
311,001
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
$
|
332,497
|
$
|
324,936
|
Accounts payable-related parties
|
|
10,700
|
|
12,715
|
Accrued expenses and other current liabilities
|
|
529,867
|
|
505,072
|
Lease
liability
|
|
24,137
|
|
5,619
|
Convertible notes payable, net of discount of $93,855 and $105,525,
at March 31, 2020 and December 31, 2019, respectively
|
|
56,455
|
|
38,475
|
Notes
payable-related parties, net
|
|
946,979
|
|
937,528
|
Derivative liabilities
|
|
303,097
|
|
521,700
|
Total current
liabilities
|
|
2,203,732
|
|
2,346,045
|
|
|
|
|
|
LONG
TERM LIABILITIES
|
|
|
|
|
Lease liability, net of current portion
|
|
55,254
|
|
-
|
TOTAL LIABILITIES
|
|
2,258,986
|
|
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; 3,500,000,000 shares authorized;
1,656,544,032 and 1,614,627,811 shares issued and outstanding at
March 31, 2020 and December 31, 2019, respectively.
|
|
1,656,544
|
|
1,614,628
|
Additional paid-in capital
|
|
5,206,268
|
|
5,183,228
|
Accumulated deficit
|
|
(8,800,764)
|
|
(8,832,900)
|
Total shareholders'
deficit
|
|
(1,937,952)
|
|
(2,035,044)
|
|
|
|
|
|
Total liabilities
and shareholders' deficit
|
$
|
321,034
|
$
|
311,001
|
See
accompanying notes to condensed consolidated financial
statements.
F-21
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
Condensed
Consolidated Statements of Operations
(Unaudited)
|
|
For the Three
Months Ended
March 31,
2020
|
|
For the Three
Months Ended
March 31,
2019
|
|
|
|
|
|
Net
sales
|
$
|
19,514
|
$
|
2,464
|
Cost of
goods sold
|
|
3,490
|
|
146
|
|
|
|
|
|
Gross
profit
|
|
16,024
|
|
2,318
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
General and administrative
|
|
15,431
|
|
13,483
|
Salaries, wages, and related costs
|
|
53,170
|
|
106,406
|
Stock
compensation
|
|
-
|
|
225,000
|
Consulting fees
|
|
37,219
|
|
33,385
|
Legal
and professional fees
|
|
32,580
|
|
56,634
|
Total operating
expenses
|
|
138,400
|
|
434,908
|
|
|
|
|
|
Loss
from operations
|
|
(122,376)
|
|
(432,590)
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
Loss
on derivatives liabilities
|
|
(20,755)
|
|
(207,927)
|
Change in fair value of derivative liabilities
|
|
236,402
|
|
352,871
|
Interest expense
|
|
(61,135)
|
|
(87,500)
|
Total other
income (expense)
|
|
154,512
|
|
57,444
|
|
|
|
|
|
Net
income (loss)
|
$
|
32,136
|
$
|
(375,146)
|
|
|
|
|
|
Net
income (loss) per share - basic
|
$
|
0.00
|
$
|
(0.00)
|
|
|
|
|
|
Net
income (loss) per share - diluted
|
$
|
0.00
|
$
|
(0.00)
|
|
|
|
|
|
Weighted average shares outstanding - basic
|
|
1,621,008,777
|
|
1,091,073,182
|
|
|
|
|
|
Weighted average shares outstanding - diluted
|
|
1,895,283,682
|
|
1,091,073,182
|
See
accompanying notes to condensed consolidated financial
statements.
F-22
Therapeutic
Solutions International, Inc.
Condensed
Consolidated Statements of Changes in Shareholders' Deficit
(Unaudited)
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Total
Stockholders'
Deficit
|
|
|
Shares
|
|
Amount
|
|
|
|
December
31, 2018
|
|
1,011,063,182
|
$
|
1,011,063
|
$
|
4,314,047
|
$
|
(7,135,578)
|
$
|
(1,810,468)
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for services
|
|
55,000,000
|
|
55,000
|
|
220,000
|
|
-
|
|
275,000
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued upon conversion of
convertible notes payable
|
|
35,038,889
|
|
35,039
|
|
174,981
|
|
-
|
|
210,020
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
-
|
|
-
|
|
-
|
|
(375,146)
|
|
(375,146)
|
|
|
|
|
|
|
|
|
|
|
|
March
31, 2019
|
|
1,101,102,071
|
$
|
1,101,102
|
$
|
4,709,028
|
$
|
(7,510,724)
|
$
|
(1,700,594)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Total
Stockholders' Deficit
|
|
|
Shares
|
|
Amount
|
|
|
|
December
31, 2019
|
|
1,614,627,811
|
$
|
1,614,628
|
$
|
5,183,228
|
$
|
(8,832,900)
|
$
|
(2,035,044)
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for conversion of convertible notes, accrued
interest and derivative liabilities
|
|
41,916,221
|
|
41,916
|
|
(9,916)
|
|
-
|
|
32,000
|
|
|
|
|
|
|
|
|
|
|
|
Relief of derivative liabilities
|
|
-
|
|
-
|
|
32,956
|
|
-
|
|
32,956
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
-
|
|
-
|
|
-
|
|
32,136
|
|
32,136
|
|
|
|
|
|
|
|
|
|
|
|
March
31, 2020
|
|
1,656,544,032
|
$
|
1,656,544
|
$
|
5,206,268
|
$
|
(8,800,764)
|
$
|
(1,937,952)
|
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes to condensed consolidated financial
statements.
F-23
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
|
|
For the
Three
Months
Ended
March
31, 2020
|
|
For the
Three
Months
Ended
March
31, 2019
|
Cash flows from
operating activities
|
|
|
|
|
Net
income (loss)
|
$
|
32,136
|
$
|
(375,146)
|
Adjustments to reconcile net income (loss) to net cash used in
operating activities:
|
|
|
|
|
Stock-based compensation to consultants
|
|
-
|
|
50,000
|
Stock-based compensation to related parties
|
|
-
|
|
225,000
|
Accrued interest, notes payable
|
|
5,310
|
|
-
|
Loss
on derivative liabilities
|
|
20,755
|
|
207,927
|
Change in fair value of derivatives liabilities
|
|
(236,402)
|
|
(352,871)
|
Amortization of debt discount
|
|
47,769
|
|
71,732
|
Patent amortization
|
|
1,648
|
|
-
|
Changes in operating assets and liabilities:
|
|
|
|
|
Accounts receivable
|
|
(721)
|
|
(1,475)
|
Inventory
|
|
692
|
|
-
|
Prepaid expenses and other current assets
|
|
37,219
|
|
(16,570)
|
Right-of-use asset
|
|
(71,422)
|
|
(22,116)
|
Accounts payable
|
|
7,562
|
|
(2,367)
|
Accounts payable - related parties
|
|
(2,015)
|
|
-
|
Accrued expenses and other current liabilities
|
|
31,632
|
|
87,711
|
Lease
liability
|
|
73,771
|
|
22,116
|
Net cash used in
operating activities
|
|
(29,515)
|
|
(106,059)
|
Cash flows from
financing activities
|
|
|
|
|
Payments on notes payable to related party
|
|
(485)
|
|
(747)
|
Proceeds from convertible notes payable
|
|
30,000
|
|
85,000
|
Net cash provided
by financing activities
|
|
29,515
|
|
84,253
|
Net
decrease in cash, cash equivalents and restricted cash
|
|
(22,551)
|
|
(21,806)
|
Cash,
cash equivalents and restricted cash at beginning of period
|
|
36,597
|
|
32,570
|
Cash,
cash equivalents and restricted cash at end of period
|
$
|
14,046
|
$
|
10,764
|
|
|
|
|
|
Supplemental cash
flow information:
|
|
|
|
|
Cash
paid for interest
|
$
|
1,220
|
$
|
812
|
Cash
paid for income taxes
|
$
|
-
|
$
|
-
|
|
|
|
|
|
Non-cash investing
and financing transactions:
|
|
|
|
|
Original issuance discount on convertible notes payable
|
$
|
3,000
|
$
|
9,000
|
Debt
discount recorded in connection with derivative liability
|
$
|
30,000
|
$
|
85,000
|
Common
stock issued in conversion of convertible notes payable and
interest
|
$
|
64,956
|
$
|
210,020
|
Accrued interest added to principal
|
$
|
12,147
|
$
|
-
|
|
|
|
|
|
Reconciliation of
cash, cash equivalents and restricted cash to the
|
|
|
|
|
consolidated
balance sheets:
|
|
|
|
|
Cash
and cash equivalents
|
$
|
3,859
|
$
|
592
|
Restricted cash
|
|
10,187
|
|
10,172
|
Total cash, cash
equivalents, and restricted cash shown in the
|
|
|
|
|
consolidated statements of cash flows:
|
$
|
14,046
|
$
|
10,764
|
See
accompanying notes to condensed consolidated financial
statements.
F-24
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31,
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, improve maternal and fetal health, fight periodontal
disease, and for daily health.
Nutraceutical
Division – TSOI has been producing high quality nutraceuticals.
Its current flagship product, NanoStilbene™ PKE, which 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 can 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
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.
Management does
not expect existing cash as of March 31, 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
March 31, 2020, the Company has incurred losses totaling $8.8
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.
F-25
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31,
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 months ended March 31, 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 liabilities in our financial
statements. Our policy is to settle instruments indexed to our
common shares on a first-in-first-out basis.
F-26
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31,
2020
Note
2 – Summary of Significant Accounting Policies (Continued)
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 $303,097 and $521,700 at March 31, 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 March 31, 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 three
months ended March 31, 2020:
Balance- December 31,
2019
|
$
|
521,700
|
Issuance of new
derivative liabilities
|
|
50,755
|
Conversions to
paid-in capital
|
|
(32,956)
|
Change in fair market
value of derivative liabilities
|
|
(236,402)
|
Balance- March 31,
2020
|
$
|
303,097
|
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.
F-27
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31,
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.
Depreciation and
Amortization
Depreciation is
calculated using the straight-line method over the estimated useful
lives of the assets. Amortization is computed using the
straight-line method over the term of the agreement. During the
three months ended March 31, 2020 and 2019, there was no
depreciation or amortization expense as all fixed assets have been
fully depreciated.
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 three months ended March 31, 2020 and
2019 was $1,648 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 $(505) and $2,676 for the three months
ended March 31, 2020 and 2019, respectively. Research and
Development expenses are included in General and Administrative
expenses.
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.
F-28
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31,
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 $77,041 and a Lease Liability of
$79,391 as of March 31, 2020. The lease was amended to expire on
April 30, 2023.
Future
minimum lease payments as of March 31, 2020 are as follows:
For the quarter
ending March 31,
|
|
|
2021
|
$
|
24,792
|
2022
|
|
25,572
|
2023
|
|
6,459
|
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.
F-29
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31,
2020
Note
4 – Other Assets
Other
assets consist of the following:
|
|
March
31,
|
|
|
December 31,
|
|
|
2020
|
|
|
2019
|
Prepaid
consulting
|
$
|
10,667
|
|
$
|
20,238
|
Deposit
|
|
4,123
|
|
|
4,123
|
Licenses, net
|
|
145,313
|
|
|
146,961
|
Right to use
asset
|
|
52,904
|
|
|
-
|
Total
|
$
|
213,007
|
|
$
|
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
above consists of the following:
|
|
March
31,
|
|
|
December 31,
|
|
|
2020
|
|
|
2019
|
License
|
$
|
153,552
|
|
$
|
153,552
|
Accumulated
amortization
|
|
(8,239)
|
|
|
(6,591)
|
Licenses, net
|
$
|
145,313
|
|
$
|
146,961
|
As of June 1,
2019, we entered into a license agreement, which will be amortized
over the life of the Patent. The Patent expires December 31, 2032.
The Exclusive Patent License to the Jadi Cell is for use under the
designated areas of CTE (Chronic Traumatic Encephalopathy), and TDI
(Traumatic Brain Injury). The Jadi Cell is am cGMP grade and
Research grade manufactured allogenic mesenchymal stem cells
derived from US Patent No.: 9,803,176 B2. Forward looking the
Company intends to file an investigative New Drug Application (IND)
for brain injured patients who have been intensively cared for and
mechanically ventilated due to COVID-19 illness and a second IND
for CTE/TBI as well in keeping with the spirit of the licensing
agreement to advance the Jadi Cell through FDA Approval for
CTE/TBI.
Note
5 – Notes Payable-Related Party
At March 31, 2020 and December 31, 2019, the Company has unsecured
interest-bearing demand notes outstanding to certain officers and
directors amounting to $946,979 and $937,528, respectively.
Interest accrued on these notes during the three months ended March
31, 2020 and 2019 was $6,837 and $7,936, respectively. Of these,
$251,000 are convertible into common stock at prices ranging from
$0.004 and $0.005.
Note
6 – Convertible Notes Payable
On February 4,
2020, the Company entered into a $33,000 convertible promissory
note with a third party for which the proceeds were used for
operations. The Company received net proceeds of $30,000, and a
$3,000 original issuance discount was recorded. The convertible
promissory note incurs interest at 12% per annum and matures on
February 3, 2021. The convertible promissory note is 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 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 March 31, 2020 a total of
190,935,390 common shares in connection with this promissory
note.
F-30
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31,
2020
Note
6 – Convertible notes payable (Continued)
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.
For the one note
issued during the three months ended March 31, 2020, the Company
valued the conversion features on the date of issuance resulting in
an initial liability of $50,755. Since the fair value of the
derivative was in excess of the proceeds received of $30,000, a
full discount to convertible notes payable and a day one loss on
derivative liabilities of $20,755 was recorded during the three
months ended March 31, 2020. The Company valued the conversion
feature using the Black-Scholes option pricing model with the
following assumptions: conversion price of $0.0012, the closing
stock price of the Company's common stock on the date of valuation
of $0.0023, an expected dividend yield of 0%, expected volatility
of 239%, risk-free interest rate of 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
three months ended March 31, 2020, one convertible note with an
original principal value of $78,000 was partially converted into
41,916,221 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 three months ended March 31,
2020, the Company recorded $32,956 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 $0.002, an expected dividend yield of 0%, expected
volatility ranging from 197% to 220%, risk-free interest rates
ranging from 0.13% to 0.89%, and expected terms ranging from 0.26
to 0.33 years.
On March 31,
2020, the derivative liabilities on the remaining four convertible
notes were revalued at $303,097 resulting in a gain of $236,402 for
the three months ended March 31, 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 $0.0005, the closing stock
price of the Company's common stock on the date of valuation of
$0.0014, an expected dividend yield of 0%, expected volatility
ranging from 212% to 251%, risk-free interest rate of 0.17%, and an
expected term ranging from 0.25 to 0.85 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 three months ended March 31,
2020 and 2019, the Company amortized $44,670 and $71,732 to
interest expense, respectively. As of March 31, 2020, discounts of
$93,855 remained for which will be amortized through February 3,
2021.
Note
7 – Equity
Our authorized
capital stock consists of an aggregate of 3,505,000,000 shares,
comprised of 3,500,000,000 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 March 31, 2020, we
have 1,656,544,032 shares of common stock and no preferred shares
issued and outstanding. 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. There shares
were issued at below par which decreased Additional Paid-in
Capital.
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.
F-31
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31,
2020
Note
7 – Equity (continued)
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.
Note
8– Subsequent Events
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 $0.0021 per
share, for consulting services.
On June 4, 2020
we issued 70,000,000 shares of common stock, valued at .0021 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 $0.01 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 18,292,818 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 .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 .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.
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.
F-32
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
NOTES TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31,
2020
Note 8–
Subsequent Events (continued)
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.
In accordance with ASC 855, the Company
has analyzed its operations subsequent to March 31, 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 .
F-33
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Other Expenses of
Issuance and Distribution
The
following is an itemized statement of the estimated amounts of all
expenses payable by us in connection with the registration of the
common stock, other than underwriting discounts and commissions.
All amounts are estimates except the SEC registration fee.
Securities and
Exchange Commission - Registration Fee
|
$
|
64.90
|
State filing Fees
|
$
|
|
500.00
|
Edgarizing Costs
|
$
|
500.00
|
Accounting Fees and
Expenses
|
$
|
1,000.00
|
Legal Fees and
Expenses
|
$
|
20,000.000
|
Miscellaneous
|
$
|
0.00
|
Total
|
$
|
22,064.90
|
None of the expenses
of the offering will be paid by the selling security holders.
Indemnification of
Directors and Officers
Article 6 of our Articles of Incorporation exculpates our directors
and officers from certain monetary liabilities. Article 7 of our
Articles of Incorporation provides that we shall indemnify all
directors (and all persons serving at our request as a director or
officer of another corporation) to the fullest extent permitted by
Nevada law.
Further pursuant to Article 7, the expenses of the indemnified
person incurred in defending a civil suit or proceeding must be
paid by us as incurred and in advance of the final disposition of
the action, suit, or proceeding under receipt of an undertaking by
or on behalf of the indemnified person to repay the amount if it is
ultimately determined by a court of competent jurisdiction that he
or she is not entitled to be indemnified by us.
The
foregoing indemnification obligations could result in us incurring
substantial expenditures, which we may be unable to recoup. These
provisions and resultant costs may also discourage us from bringing
a lawsuit against directors and officers for breaches of their
fiduciary duties even though such actions, if successful, might
otherwise benefit us and our stockholders.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers or
persons controlling the registrant pursuant to the foregoing
provisions, the registrant has been informed that in the opinion of
the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Act and is therefore
unenforceable.
Recent Sales of Unregistered Securities
There
have been no recent sales of unregistered securities during the
relevant time period prior to this registration and prospectus.
Undertakings
The undersigned
registrant hereby undertakes:
(1)
To file, during any period in which offers, or sales are being
made, a post-effective amendment to this registration statement
to:
(i)
Include any prospectus required by section 10(a)(3) of the
Securities Act;
(ii) Reflect
in the prospectus any facts or events arising after the effective
date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high and of
the estimated maximum offering range may be reflected in the form
of prospectus filed with the SEC pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than
20% change in the maximum aggregate offering price set forth in the
“Calculation of Registration Fee” table in the effective
registration statement.
II-1
(iii) Include
any material or changed information with respect to the plan of
distribution not previously disclosed in the registration statement
or an material change to such information in the registration
statement.
(2) That, for
the purpose of determining any liability under the Securities Act,
each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to
be the initial bona fide offering thereof.
(3) To remove
from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination
of the offering.
(4) Each
prospectus filed pursuant to Rule 424(b) as part of a registration
statement relating to an offering, other than registration
statements relying on Rule 430B or other prospectuses filed in
reliance on Rule 430A, shall be deemed to be part of and included
in the registration statement as of the date it is first used after
effectiveness. Provided, however, that no statement made in a
registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or
prospectus that is part of the registration statement will, as to a
purchaser with a time of contract of sale prior to such first use,
supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement
or made in any such document immediately prior to such date of
first use.
(5) That, for
the purpose of determining liability under the Securities Act to
any purchaser in the initial distribution of the securities, the
undersigned registrant undertakes that in a primary offering of
securities of the undersigned registrant pursuant to this
registration statement, regardless of the underwriting method used
to sell the securities to the purchaser, if the securities are
offered or sold to such purchaser by means of any of the following
communications, the undersigned registrant will be a seller to the
purchaser and will be considered to offer or sell such securities
to such purchaser:
(i) Any
preliminary prospectus or prospectus of the undersigned registrant
relating to the offering required to be filed pursuant to Rule 424
of Regulation C of the Securities Act;
(ii) Any free
writing prospectus relating to the offering prepared by or on
behalf of the undersigned registrant or used or referred to by the
undersigned registrant;
(iii) The
portion of any other free writing prospectus relating to the
offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the
undersigned registrant; and
(iv) Any
other communication that is an offer in the offering made by the
undersigned registrant to the purchaser.
(6) Insofar
as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of
the registrant pursuant to the foregoing provisions, or otherwise,
the registrant has been advised that in the opinion of the SEC such
indemnification is against public policy as expressed in the Act
and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by
the registrant of expenses incurred or paid by a director, officer
or controlling person of the registrant in the successful defense
of any action, suit or proceeding) is asserted by such director,
officer or controlling person in connection with the securities
being registered, the registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in
the Act and will be governed by the final adjudication of such
issue.
II-2
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
registrant has duly caused this registration statement to be signed
on its behalf by the undersigned, thereunto duly authorized, in the
city of Oceanside, California, on July 10, 2020.
|
Therapeutic
Solutions International, Inc.
|
|
|
|
|
By:
|
/s/ Timothy G.
Dixon
|
|
|
Timothy G. Dixon,
CEO
|
Pursuant to the requirements of the Securities Act of 1933, this
registration statement has been signed by the following persons in
the capacities and on the dates stated.
Name
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Timothy G.
Dixon
|
|
|
|
|
Timothy G. Dixon
|
|
Chairman, President
& CEO
(Principal Executive
Officer)
|
|
July 10, 2020
|
/s/ Thomas Ichim
PhD
|
|
|
|
|
Thomas Ichim, PhD
|
|
Director
|
|
July 10 , 2020
|
II-3
[OUTSIDE BACK COVER]
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
[A
Nevada Corporation]
4093 Oceanside Blvd. Suite B
Oceanside, CA, 92058
Telephone (760) 295-7208
July 18, 2020
PROSPECTUS
167,848,153 OF COMMON STOCK AT $.003 PER SHARE
Until
December 31, 2020, all dealers that effect transactions in our
shares, whether or not participating in this offering, may be
required to deliver a prospectus pursuant to the CSPA. This is in
addition to the dealer’s obligation to deliver a prospectus when
acting as underwriters and with respect to their unsold allotments
or subscriptions.