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

 

2833

 

45-1226465

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification No.)

 

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

 

[   ]

 

Accelerated filer

 

[   ]

Non-accelerated filer

 

[X]

 

Smaller reporting company

 

[X]

 

 

 

 

Emerging growth company

 

[   ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. [   ]


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Calculation of Registration Fee

 

Title of Each Class of Securities to be Registered

Amount to be Registered

Proposed Maximum Offering Price Per Unit

Proposed Maximum Aggregate Offering Price

Amount of Registration Fee

Common Stock

167,848,153 (1)

$0.003

$500,000.00

$64.90 (2)

 

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.


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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


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TABLE OF CONTENTS

 

 

Page

PROSPECTUS SUMMARY

1

 

 

RISK FACTORS

7

 

 

FORWARD-LOOKING STATEMENTS

12

 

 

USE OF PROCEEDS

12

 

 

MARKET FOR OUR COMMON STOCK

12

 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

14

 

 

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS

22

 

 

BUSINESS

22

 

 

LEGAL PROCEEDINGS

28

 

 

MANAGEMENT

29

 

 

EXECUTIVE COMPENSATION

33

 

 

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

34

 

 

SELLING STOCKHOLDERS

34

 

 

DESCRIPTION OF SECURITIES

35

 

 

PLAN OF DISTRIBUTION

35

 

 

LEGAL MATTERS

37

 

 

EXPERTS

38

 

 

DISCLOSURE OF COMMISSION POLICY ON INDEMNIFICATION

38

 

 

INDEX TO FINANCIAL STATEMENTS AND EXHIBITS

38

 

 

UNDERTAKINGS

II-1

 

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.


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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.

 


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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.

 

PICTURE 8  


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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  

PICTURE 162  

 

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.

 


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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.

 


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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.

 


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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


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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.

 

PICTURE 8  

 

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  

PICTURE 162  


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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.

 

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.


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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.


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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).


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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.

 


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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).

 


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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.

 


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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™


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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.

 

PICTURE 8  

 

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  

PICTURE 162  

 

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.


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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.


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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. 


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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.


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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.


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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.


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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.


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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.


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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


 

TSI AUDIT REPORT.JPG  


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.


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