UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

[X]QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2017March 31, 2021

[  ]  TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE TRANSITION PERIOD FROM ________TO ________

Commission File Number:000-54554

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

(Exact Name of Registrant as Specified in Its Charter)

4093 Oceanside Boulevard, Suite B

Oceanside, California 92056

(Address of principal executive offices, including zip code)

(760) 295-7208

701 Wild Rose Lane

Elk City, Idaho 83525

(Address of principal executive offices, including zip code)

(760) 295-7208

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [   ]

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [   ]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”filer,” “smaller reporting company,” and “smaller reporting“emerging growth company” in Rule 12b-2 of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [   ] No [X]

As of November 15, 2017,May 13, 2021, the Registrant had 806,501,0002,251,001,716 outstanding shares of Common Stock with a par value of $0.001 per share.

1

IMPORTANT PREFATORY NOTE

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements contained in this report and the information incorporated by reference herein may contain “forward-looking statements” (as such term is defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements, which involve risks and uncertainties, reflect our current expectations, intentions, or strategies regarding our possible future results of operations, performance, and achievements. Forward-looking statements include, without limitation: statements regarding future products or product development; statements regarding future selling, general and administrative costs and research and development spending; statements regarding our product development strategy; and statements regarding future financial performance, results of operations, capital expenditures and sufficiency of capital resources to fund our operating requirements. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and applicable rules of the Securities and Exchange Commission and common law.

These forward-looking statements may be identified in this report and the information incorporated by reference by words such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “intend”, “plan”, “predict”, “project”, “should” and similar terms and expressions, including references to assumptions and strategies. These statements reflect our current beliefs and are based on information currently available to us. Accordingly, these statements are subject to certain risks, uncertainties, and contingencies, which could cause our actual results, performance, or achievements to differ materially from those expressed in, or implied by, such statements.

The following factors are among those that may cause actual results to differ materially from our forward-looking statements:

·Need for additional capital;  

·Limited operating history in our new business model;  

·Limited experience introducing new products;  

·Our ability to successfully expand our operations and manage our future growth;  

·Difficulty in managing our growth and expansion;  

·Dilutive effects of any raising of additional capital;  

·The deterioration of global economic conditions and the decline of consumer confidence and spending;  

·Material weaknesses reported in our internal control over financial reporting;  

·Our ability to protect intellectual property rights and the value of our products;  

·The potential for product liability claims against us;  

·Our dependence on third party manufacturers to manufacture our products;  

·Our common stock is currently classified as a penny stock;  

·Our stock price may experience future volatility;  

·The illiquidity of our common stock; and  

·Substantial sales of shares of our common stock.  

·Other factors not specifically described above, including the other risks, uncertainties, and contingencies described under “Description of Business”, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Items 1 and 7 of our Annual Report on Form 10-K for the year ended December 31, 2016.2020.  

When considering these forward-looking statements, you should keep in mind the cautionary statements in this report and the documents incorporated by reference. We have no obligation and do not undertake to update or revise any such forward-looking statements to reflect events or circumstances after the date of this report.

Actual results may vary materially from those in such forward-looking statements as a result of various factors. No assurance can be given that the risk factors described in this Quarterly Report on Form 10-Q are all of the factors that could cause actual results to vary materially from the forward-looking statements. References in this Quarterly Report on Form 10-Q to the “Company,” “TSOI,” “we,” “our,” and “us” refer to Therapeutic Solutions International, Inc.

2

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

INDEX

3

PART I Financial Information

Item 1.Financial Statements 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

See accompanying notes to condensed consolidated financial statements.

4

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

See accompanying notes to condensed consolidated financial statements.

5

Therapeutic Solutions International, Inc.

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

Condensed Consolidated StatementStatements of Changes in Shareholders' Deficit

For the nine month period ended September 30, 2017

(Unaudited)

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.

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2017March 31, 2021

Note 2 – Summary of Significant Accounting Policies (continued)(Continued)

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 2021 and 2020, 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 $331,618 and $437,549 at March 31, 2021 and December 31, 2020, 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, 2021, 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 liabilities for the three months ended March 31, 2021:

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2021

Note 2 – Summary of Significant Accounting Policies (Continued)

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.

Comprehensive Loss

Comprehensive loss for the periods reported was comprised solely of the Company’s net loss.

Net LossIncome (Loss) Per Share

Basic net lossincome (loss) per share is calculated based oncomputed by dividing net income (loss) available to common stockholders by the weighted-average number of common shares outstanding. Diluted net loss per share is calculated using the weighted-averageweighted average number of common shares outstanding plusduring 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 outstanding. Potentialhad been issued, if such additional common shares outstanding are excluded from the calculation ofwere dilutive. In periods in which a net loss is incurred, basic and diluted net loss per share when their effect is anti-dilutive. As of September 30, 2017, outstandingare the same, and additional potential common shares outstanding includedare excluded as their effect would be antidilutive.

For the periods ended March 31, 2021 and 2020, a total of 454,438,795 and 1,099,838,839, respectively, potential common shares, consisting of shares underlying outstanding convertible debt and amountednotes payable were excluded as their inclusion would be antidilutive due to 133,989,887 shares.the net loss during the period. 

RecentProperty and Equipment

Property and equipment are recorded at cost, less accumulated depreciation. Expenditures for major additions and improvements are capitalized and minor replacements, maintenance, and repairs are charged to expense as incurred. When property and equipment are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations for the respective period. Depreciation is calculated using the straight-line method over the term of the agreement. Depreciation expense for the three months ended March 31, 2021 and 2020 was $195 and $0, respectively.

Intangible Assets

Intangible assets consisted primarily of intellectual properties such as proprietary nutraceutical formulations. Intellectual assets are capitalized in accordance with ASC Topic 350 “Intangibles – Goodwill and Other.” Intangible assets with finite lives are amortized over their respective estimated lives and reviewed for impairment whenever events or other changes in circumstances indicate that the carrying amount may not be recoverable. Amortization expense for the three months ended March 31, 2021 and 2020 was $1,648 and $1,648, 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 $19,697 and $0 for the three months ended March 31, 2021 and 2020, respectively.

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2021

Note 2 – Summary of Significant Accounting PronouncementsPolicies (Continued)

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.

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. ASU 2016-02 will beThe Company recorded a Right-of-use asset of $52,904 and a Lease Liability of $52,904 as of March 31, 2021.

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 Companytransition 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 first quarteramendments in an interim period should reflect any adjustments as of 2019 and will be adopted on a modified retrospective transition basis for leases existing at, or entered into after, the beginning of the earliest comparativeannual period presentedthat includes that interim period, and all amendments must be adopted in the financial statements.same period. The Company is currently evaluatinghas reviewed the impactprovisions of this standard on its consolidated financial statements.

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The new standard, is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 will be effective for the Company in the first quarter of 2018 and allows for full retrospective or a modified retrospective adoption approach. The adoption of this standardbut it is not expected to have a materialsignificant impact on the Company’sCompany.

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.

In August 2020, the FASB issued Accounting Standards (“ASU”) No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which clarifies if an entity must determine whether a contract qualifies for a scope exception from derivative accounting. This guidance must be applied to freestanding financial positioninstruments and embedded features that have all the characteristics of a derivative instrument and freestanding financial instruments that potentially are settled in an entity’s own stock, regardless of whether the instrument has all the characteristics of a derivative instrument. The analysis to determine whether a contract meets this scope exception includes two criteria: (1) the contract is indexed to an entity’s own stock and (2) the contract is equity classified. If both of those criteria are not met, the contract must be recognized as an asset or resultsa liability. Under Section 815-40-25 on recognition, an entity must determine whether a contract meets specific conditions to be classified as equity (referred to as the settlement criterion). This guidance is effective for the Company for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted. The Company has reviewed the provisions of operations.the new standard, but it is not expected to have a significant impact on the Company.

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2021

Note 3 –- Restricted Cash

Other non-current assets includeIncluded 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, 2018,2021 and is used as collateral for a Company credit card, pursuant to a security agreement dated June 20, 2011.2011.

Note 4 – Prepaid expense and other current assets

Prepaid expenses and other current assets consist of the following:

Note 45 – Property and Equipment

Fixed assets consisted of the following:

Depreciation expense for the three months ended March 31, 2021 and 2020 was $195 and $0, respectively.

Note 6 – Other Assets

Other assets consist of the following:

Prepaid consulting agreements are for one to two years and are expensed monthly over the term of the agreement. The net licenses amount consists of the following:

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2021

Note 7 - Notes Payable-Related PartiesParty

At September 30, 2017March 31, 2021 and December 31, 2016,2020, the Company has unsecured interest bearinginterest-bearing demand notes outstanding to certain officers and directors amounting to $415,063$949,827 and $296,951,$944,098, respectively. Interest accrued on these notes during the ninethree months ended September 30, 2017March 31, 2021 and 20162020 was $18,876$6,478 and $6,149,$6,837, respectively. Of these, $251,000 are convertible into common stock at prices ranging from $0.004 and $0.005.

Note 58 – Convertible Notes Payable

On July 24, 2017 and September 7, 2017,In January 2021, the Company entered into two $28,000a convertible promissory notesnote with principal amount totaling $53,500 with a third party for which the proceeds were used for operations. The Company received net proceeds of $50,000, and thus a $6,000$3,500 original issuance discount was recorded. As of March 31, 2021, the Company also had outstanding convertible promissory notes with principal totaling $232,500 issued at various dates throughout the year ended December 31, 2020. The convertible promissory notes incur interest at 12% per annum for which $28,000 plus accrued interest are dueand mature on April 30, 2018 and June 15, 2018.dates ranging from October 5, 2021 to January 25, 2022. 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%61% of the average of the three (3) lowest trading priceprices of the Company's common stock during the fifteen (15) trading days immediately preceding the applicable conversion date. The trading price is defined within the agreement as the closing bid price on the applicable trading market. The Company has the option to prepay the convertible notes in the first 180 days from closing subject to prepayment penalties ranging from 120 of120% 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, 2021 a total of 133,898,887454,438,795 common shares in connection with thethese promissory notes.

9

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2017

Note 5 – 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 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.

On July 24, 2017 and September 7, 2017,For the convertible note issuance dates,issued during the three months ended March 31, 2021, the Company valued the conversion feature on the date of issuance resulting in an initial liability of $133,968.$398,255. Since the fair value of the derivatives werederivative was in excess of the proceeds received of $50,000, a full discount to convertible notes payable and a day one loss on derivative liabilities of $83,968$348,255 was recorded. Therecorded during the three months ended March 31, 2021. Upon issuance, the Company valued the conversion feature using the Black-Scholes option pricing model with the following assumptions: conversion prices ranging fromprice of $0.003 to $0.004,$0.0039, the closing stock price of the Company's common stock on the date of valuation ranging from $0.008 to $0.009,of $0.031, an expected dividend yield of 0%, expected volatility ranging from 299% to 319%of 255%, risk-free interest rates ranging from 1.21% to 1.23%rate of 0.18%, and an expected term of 0.77 years. one year.

On September 30, 2017,March 31, 2021, the derivative liabilities on the five convertible notes were revalued at $98,683$331,618 resulting in a gain of $35,285$504,186 for the three months ended March 31, 2021 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:conversion exercise price of $0.004,$0.0454, the closing stock price of the Company's common stock on the date of valuation of $0.008,$0.073, an expected dividend yield of 0%, expected volatility ranging from 330% to 341%of 231%, risk-free interest rate of 1.31%0.18%, and an expected term ranging from 0.580.5 to 0.710.8 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 and nine months ended September 30, 2017,March 31, 2021 and 2020, the Company amortized $9,092$66,856 and $47,769 to interest expense.expense, respectively. As of September 30, 2017,March 31, 2021, discounts of $46,908$181,806 remained for which will be amortized through June 30, 2018.January 2022.

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2021

Note 9 – 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, 2021, we have 2,244,453,070 shares of common stock and no preferred shares issued and outstanding. 

In 2020, we issued 192,375,737 shares of common stock for an investment in the Company’s Private Placement of $607,500.

In 2020, we issued 173,500,000 shares of common stock, valued at $669,750 for consulting services.

In 2020, we issued 78,681,818 shares of common stock, valued at $495,900 for salaries.

In 2020, we issued 174,556,025 shares of common stock for the conversion of convertible notes of $703,152.

In 2021, we issued 3,411,679 shares of common stock for an investment in the Company’s Private Placement of $217,500.

In 2021, we issued 2,500,000 shares of common stock, valued at $172,500 for consulting services.

In 2021, we issued 4,800,000 shares of common stock, valued at $60,000 for salaries.

Note 6 –10– Subsequent Events

On October 2, 2017,April 12, 2021, we issued 2,500,0001,771,758 shares of common stock for the partial conversion of $61,480 for convertible note dated October 19, 2020.

On April 12, 2021, we issued 923,728 shares of common stock for $54,500 of accrued salaries.

On April 12, 2021, we issued 500,000 shares of common stock, valued at $0.0095$0.059 per share, for consulting services.

On October 20, 2017,April 19, 2021, we issued 12,500,000500,000 shares of common stock, valued at $0.004$0.054per share, for consulting services.

On April 19, 2021, we issued 160,000 shares of common stock, valued at $0.05 per share, for an investment in the Company’s Private PlacementPlacement.

On April 20, 2021, we issued 2,693,160 shares of common stock for the complete conversion of $18,044 for convertible note dated October 19, 2020.

In accordance with ASC 855, the Company has analyzed its operations subsequent to March 31, 2021 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.

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2021

Note 11 – Commitments and Contingencies

Effective May 1, 2017, the Company entered into a fourth amendment to a related party.Lease Agreement for property located in Oceanside, CA. On March 1, 2020, the Company entered into a fifth amendment to the lease agreement for property located in Oceanside, CA. The amendment extends the expiration date to April 20, 2023 with escalating monthly payments ranging from $2,024 to $2,153. The lease consists of approximately 1,700 square feet. Total rent expense for the three months is $6,072.

Future minimum lease payments as of March 31, 2021 are as follows:

10

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis contains forward-looking statements within the meaning of the federal securities laws. The safe harbor provided in section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934 (“statutory safe harbors”) shall apply to forward-looking information provided pursuant to the statements made in this filing by the Company. We urge you to carefully review our description and examples of forward-looking statements included in the section entitled “Cautionary Note Regarding Forward-Looking Statements” at the beginning of this report. Forward-looking statements speak only as of the date of this report and we undertake no obligation to publicly update any forward-looking statements to reflect new information, events or circumstances after the date of this report. Actual events or results may differ materially from such statements. In evaluating such statements, we urge you to specifically consider various factors identified in this report, any of which could cause actual results to differ materially from those indicated by such forward-looking statements. The following discussion and analysis should be read in conjunction with the accompanying financial statements and related notes, as well as the Financial Statements and related notes in our Annual Report on Form 10-K for the fiscal year ended December 31, 20162020 and the risk factors discussed therein.

General

Our principal executive office is located at 4093 Oceanside Blvd., Suite B, Oceanside, California 92056,701 Wild Rose Lane, Elk City, Idaho, 83525, 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

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.

On December 17, 2020, Therapeutic Solutions International, Inc. Board of Directors made a decision to move our corporate headquarters to Elk City, Idaho 83525 and has purchased real property at 701 Wild Rose Lane and 50 Bullock Lane, Elk City Idaho 83525. The Company will continue to maintain a satellite office at the current address of 4093 Oceanside Blvd., Suite B, Oceanside CA, 92056.

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,schizophrenia, suicidal ideation, traumatic brain injury, and for daily health.

Nutraceutical Division – TSOI has been producing very high quality nutraceuticals. Its current flagship product, ProJuvenol^®,NanoStilbeneä 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 patented proprietary mixture containingnanoemulsion droplet is free from air, light, and hard environment; therefore, as a delivery system, nanoemulsion’s can improve the bioavailability of pterostilbene – onebut also protect it from oxidation and hydrolysis, while it possesses an ability of sustained release at the most potent antioxidants known. On June 20th, 2017, TSOIsame time. Recently the Company was granted U.S. Patent No.: 9,682,047 for ProJuvenol^® titled “Augmentation of Oncology Immunotherapies by Pterostilbene Containing Compositions”.approved to sell certain nutraceuticals on the Amazon Platform. In addition we recently launched 4 newto this our products are now listed in Liposomal formulation. TheyRangeMe. RangeMe.com is an online platform that enables retail buyers to efficiently discover innovative and emerging products while empowering suppliers to manage and grow their brands with the tools, insights, and services they need. With 10,000+ Retail buyers our products are CoQ10, Curcumin, Glutathione,now placed in front of them in our category of dietary supplements and Vitamin-C in 16oz bottles.nutraceuticals.

OmniBiome, Inc., (“OMNI”) - is a majority-owned subsidiary of TSOI, incorporated in the State of Delaware on October 20, 2015, where the intellectual property surrounding probiotics is housed. OMNI is focused on therapeutic / RX approaches to either utilize or intervene with systemic effects of the vaginal, lactal-duct and oral microbiomes for improving maternal heathcare and resulting birth outcomes. The Officers and Directors of the Company are also Officers and Directors of OMNI. As of September 30, 2017 and November 15, 2017, TSOI owns approximately 73.75% of the outstanding share of OMNI. As of September 30, 2017 and November 15, 2017, formal operations have not commenced.

Emvolio, Inc., (“EMVO”) – is a wholly-owned subsidiary of TSOI, incorporated in the State of Delaware on October 3, 2016, where the intellectual property surrounding immune-oncology is housed. EMVO intends to develop products that can be used together to attack cancer at different levels, as well as to be used alone or in combination with existing therapies. The Officers and Directors of the Company are also the Officers and Directors of EMVO. As of September 30, 2017 and November 15, 2017, formal operations have not commenced.

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SandBox Dental Labs, Inc., is a wholly-owned subsidiary of TSOI consisting of a dental laboratory to manufacture and fill prescriptions from dentists who will use our exclusively licensed Sleep Appliance to treat their patients with mild to moderate obstructive sleep apnea. The Officers and Directors of the Company are also the Officers and Directors of SandBox. As of September 26, 2017, limited operations have begun.

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) and Lung Pathology (LP).

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. On March 4, 2021 the Company received an IND Serial # 27377 for a clinical trial of 10 patients with CTE.

In addition, 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.”

The Company has also developed an allogenic version of StemVacs and has filed patents to cover activating universal donor immune system cells called dendritic cells in a manner so that upon injection they reprogram the body’s NK cells.

Most recently the Company announced filing of a patent for a new hybrid cell created by the Company capable of training the immune system to kill blood vessels feeding cancer, but sparing healthy blood vessels. These discoveries are an extension of previous findings from the Company showing that StemVacs is capable of suppressing new blood vessel production.  

Nutraceutical Division (TSOI)

·ProJuvenol^® is a patented, (US No.: 9,682,047) and powerful synergistic blend of complex anti-aging ingredients inspiredin capsules.  

·NanoStilbeneä 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 nature to help promote cellular rejuvenation and healthy functionality for everyday living, based uponprescription only, derived from the ‘047 patent.  

·NeuroStilbene is an intranasal form of pterostilbene one of nature’s unique and intelligent antioxidants/anti-inflammatories. ProJuvenol includesdelivered via spray application inside the nostril, derived from the ‘047 patent.  

·NanoPlus is a scientifically valid blend of interactive ingredients with anti-agingNanoStilbene and cellular protective properties to help support optimal healthNano Cannabidiol which are an easily absorbed Nanoparticles formulation of Pterostilbene and provide the benefits of mental alertness and physical well-being.Cannabidiol.  

Pterostilbene (pronounced “tero-STILL-bean”) has created a buzz·Nano Cannabidiol is an easily absorbed Nanoparticle formulation of Cannabidiol Isolate in the worldrange of nutrition research. Scientists discovered this powerful antioxidant several decades ago75-90 nanometers. This product is built on the same nano platform as NanoStilbene and have since found that it rivals its cousin resveratrol’s multi-functional abilities,is delivered at a concentration of 200mg per milliliter.  

·NanoPSA is a blend of NanoStilbene™ and may actually exceed its anti-agingBroccoli Sprout Extract (BSE) providing 74mg of BSE and health promoting potential. Found naturally in blueberries, pterostilbene has been shown in emerging experimental studies to exhibit up to 7 times greater bioavailability than resveratrol as well as better metabolic stability. This translates to potentially higher levels125mg 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, in the blood upon ingestion,sulforaphane, epigallocatechingallate, and longer lasting effects in the body compared to resveratrol. More simply put, it remains active in your body for a much greater period of time and during this enhanced bio-available period your body has the opportunity to allow it to utilize this powerful antioxidant molecule.thymoquinone.

A large body of experimental research has now documented a wide range of potential health effects associated with pterostilbene. In fact, the more researchers study pterostilbene, the greater its human health potential becomes. In addition to being a powerful antioxidant, emerging experimental research suggests this plant compound may also help regulate cell growth, promote fat metabolism, support glucose utilization, influence brain function, and improve the body’s natural detoxification enzymes that are required to help protect cells against potentially damaging compounds from the environment.

Patents:

TSOI filed a patent in July 2015 covering the use of its ProJuvenol^®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^®ProJuvenol®, to reduce oxidative stress produced by cancer cells, which in turn protects the immune system from cancer mediated immune suppression. On June 20th, 2017, TSOIThat patent, U.S. No.: 9,682,047 was granted U.S. Patent No.: 9,682,047 for ProJuvenol^® titled “Augmentation of Oncology Immunotherapies by Pterostilbene Containing Compositions”.on 6-20-2017.

Immuno-Oncology, described by Science Magazine as ‘Breakthrough of the Year’ offers the possibility of not only killing tumor cells in a non-toxic manner, but also establishing immunological memory, which patrols the body and destroys recurrent tumor cells. While great progress has been made in developing drugs that stimulate the immune system to recognize and kill tumors, a major pitfall of current approaches is that tumors produce chemicals and oxidative stress that suppresses the immune system, thus limiting efficacy of immune therapies.

Pterostilbene, which is chemically related to resveratrol, has been published to possess anticancer, antioxidant, and anti-inflammatory activities. In the Granted U.S. Patent No.: 9,682,047 for ProJuvenol^® for example, contains a claim covering the combination of pterostilbene, the active ingredient in ProJuvenol^®, together with an FDA-approved immunotherapeutic drug named Proleukin^® (aldesleukin), which is a recombinant form of the cytokine interleukin-2 (IL-2) for treatment of cancer.

Proleukin^® is one of the first immunotherapeutic drugs approved by the FDA, being indicated for treatment of metastatic melanoma and metastatic renal cell carcinoma1. Scientists working with Therapeutic Solutions International performed animal studies showing that administration of pterostilbene increased efficacy of Proleukin^® in melanoma models. In the studies performed to obtain FDA approval for Proleukin^® responses were seen in 16% of patients2. Based on animal data, it is hoped that the response rate of Proleukin® can be increased by administration of products containing pterostilbene, such as ProJuvenol^®.

In addition, on April 28, 2016, the Company filed a patent application covering the use of ProJuvenol^©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.

Then on

On October 16, 2017, TSOI announced the filing of an additionalCompany filed a patent on the use of pterostilbene. The invention pertains to utilization of pterostilbene for augmenting immunogenicity of cancer cells treated with various therapies and isapplication titled as "Synergistic Inhibition of Glioma Using Pterostilbene and Analogues Thereof"

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This third pterostilbene patent represents several years of research and literature review and 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.

WhatOn 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 particularly interesting isan 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, appearsthe active ingredient in commercially available NanoStilbene™, augments the ability of cord blood plasma to make cancer cells more visible to the immune system subsequent to their being attacked by conventional drug approaches, specifically, we observed that this increase of immunogenicity that pterostilbene causes in chemotherapy treated cancer cells allows for enhanced immunity to cancer cells that have escaped chemotherapy, thus theoretically enhancing patient prognosis.suppress biological properties associated with aging.

TSOI markets currently several other nutraceuticals, they include Liposomal CoQ10, Curcumin,On May 4, 2020, the Company filed a patent application titled “Nutraceuticals for the Prevention, Inhibition and Vitamin-C, all powerful antioxidants.Treatment of SARS-Cov-2 and Associated COVID-19” developed to address issues of susceptibility, inflammation, and viral immunity, for COVID-19 patients.

On June 22, 20162020, the Company announced the additionfiled a patent application titled “Treatment of fourSARS-CoV-2 with Dendritic Cells for Innate and/or Adaptive Immunity” with new consumer productsdata showing its clinical-stage cancer immunotherapeutic product StemVacs™ appears to our nutraceutical division.

The four new products are allreduce innate immune induced inflammation in Liposome formulas. Many orally consumed nutrients are absorbed from 4%lungs while stimulating immune cells known to 19%! Those same nutrientspossess antiviral properties. StemVacs™ is a cell-based drug comprised of dendritic cells activated in a Liposomal Delivery Systemproprietary manner which when administered stimulates a type of immune system cell termed “natural killer” or NK cells. Numerous studies have shown that NK cells are absorbed at a much higher levelinvolved in protecting the bloodstream. Liposomes have layers that can encapsulatebody from cancer and from viruses. The FDA has allowed for clinical trials of COVID-19 patients using an ingredient and serve to protect the ingredient from the environment as well as act as a slow release mechanism. A liposome is a microscopic, fluid-filled pouch whose walls are made of layers of phospholipids identical in makeup to the phospholipids that make up cell membranes.

Liposomes represent a versatile and advanced nano-delivery system for a wide range of biologically active compounds. Liposomes have been used to improve the therapeutic index of new or established ingredients by modifying their absorption, reducing metabolism, and prolonging biological half-life.

Liposomes can be used to deliver substances to the blood stream and even target cells much more efficiently than normal. The liposomes offer a unique delivery system for nutrients because these microscopic spheres are so tiny that absorption becomes almost perfect.

The four high absorption formulas are Liposomal Vitamin-C, CoQ10, Curcumin, and Glutathione, sold in 16oz bottles.

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FUTURE BUSINESS DESCRIPTION

Dental

SandBox Dental Labs, Inc.

SandBox Dental Labs, Inc., (SandBox) is a wholly-owned subsidiary of TSOI consisting of a dental laboratory to manufacture and fill prescriptions from dentists who will use our exclusively licensed Sleep Appliance to treat their patients with mild to moderate obstructive sleep apnea. The Officers and Directors of the Company are also Officers and Directors of SandBox. As of September 36, 2017, limited operations have begun.NK cell-based drug termed CYNK-001.

On June 26, 2017, SandBox Dental Labs, Inc.,30, 2020, the Company filed a 510(k)patent application withtitled “Augmentation of Natural Killer Cell Activity and Induction of Cytotoxic Immunity Using Leukocyte Lysate Activated Allogeneic Dendritic Cells: StemVacs™” which describes the U.S. Foodprocess of preparing allogeneic dendritic cells utilizing a leukocyte lysate based approach. These data support development of StemVacs for conditions that would benefit from NK activation such as cancer and Drug Administration (FDA) for market clearance of their custom oral appliance to treat mild to moderate obstructive sleep apnea (OSA).COVID-19.

On July 13, 2020, the Company filed a patent application titled “Prevention of Pathological Coagulation in COVID-19 and other Inflammatory Conditions” with new data showing that the ingredients of QuadraMune™ suppress expression of an inflammation stimulated molecule which is known to induce coagulation of blood.  Inhibition of this coagulation-promoting molecule, called Tissue Factor, was synergistic with all four ingredients of QuadraMune™ when combined.  Tissue Factor is known to be associated with COVID-19 disease and is the culprit for clotting associated conditions such as deep vein thrombosis and atherothrombosis.

On July 22, 2020, the Company filed a patent application titled “Additive and/or Synergistic Combinations of Metformin with Nutraceuticals for the Prevention, Inhibition and Treatment of SARS-Cov-2 and Associated COVID-19” showing potent synergy between QuadraMune™ and the antidiabetic drug metformin in treating COVID-19 associated lung damage models. It was discovered that the ability of QuadraMune™ to protect the lungs from inflammation that resembles coronavirus-induced pathology is markedly amplified by concurrent administration of metformin.  At a mechanistic level, it was shown that metformin increased the ability of QuadraMune™ to a) increase the number of “healing macrophages” (“M2” macrophages); b) augment production of anti-inflammatory and regenerative proteins; and c) suppress production of pathological inflammatory proteins.

On July 28, 2020, the Company filed a patent application titled “Neuroprotection and Neuroregeneration by Pterostilbene and Compositions Thereof” with new data demonstrating that the blueberry derived compound pterostilbene possesses numerous brain protective and potentially brain regenerative activities. The SandBox Dental Sleep Appliance, named Morpheus (CE Markeddata disclosed by the Company indicates: a) pterostilbene suppresses inflammatory cytokines TNF-alpha, IL-1 beta and IL-6; b) pterostilbene inhibits death of neurons caused by inflammatory mediators; c) pterostilbene stimulates production of regenerative factors from cells in the European Unionbrain such as Sleepwell by S4S UK Ltd., our supplier,BDNF, NGF, FGF-1, and MDSA in Australia, by inventor), has been tested by its original inventor (known clinically as MDSA) in a randomized controlled cross over trial against CPAPFGF-2; and a placebo, and it is also oned) pterostilbene allows/enhances proliferation of the most technologically advanced and patient friendly MAS’s (mandibular advancement splint) on the market. The full clinical trial information is not contained in this document, but the headline success rate of Morpheus (MDSA) was 80.3% in fully apneic patients.endogenous brain stem cells.

The appliance combinesOn August 05, 2020 the Company filed a high clinical success rate with key features that make it more comfortablepatent application titled “Prevention of Neuroinflammation associated Memory Loss Using Nutraceutical Compositions” which discloses means, methods, and flexibletherapeutic compositions for the patient.

Unlike some MAS devices, our appliance is fully patient adjustable negating the need for further clinical visits for simple titration. Should the patient need to modify the degreeprevention of mandibular advancement they can simply adjust with the key provided.memory loss during situations of neuroinflammation.

Our applianceOn August 21, 2020 the Company filed a patent application titled “Methods of Determining Risk of Suicide and/or Suicidal Ideation by Immunological Assessment” which discloses means and methods of identifying risk of suicide and/or suicidal ideation by assessment of immunologically related cytokines and cells. In one embodiment, a score, termed the “Campbell Score” is also uniquely designed with internal splint fixing, allowing the lipsdevised based on assessment of serum cytokines, ability of immune cells to be closed around the device preventing the dry lipsmake cytokines when stimulated ex vivo, and excess salivation associated with some splints. High levelsability of patient comfort meant that during clinical trials over 98% of patients found the device acceptable.immune cells to produce neurotransmitters when stimulated ex-vivo.

Our appliance is a laboratory-manufactured device molded specifically to patient impressions. As a soft, slim-line two-piece device it allows full lateral movement while retaining high levels of patient comfort and custom made accuracy. By allowing a degree of movement during the night the device remains in the mouth unlike some devices that may dislocate. In addition the lateral movement provides a solution to some patients who experience TMJ stress with a fixed block device.

Key Benefits:

Full lateral movement 

Full patient adjustability 

High Patient Comfort 

Clinically proven and effective 

Internal fixings improve comfort 

Fetal-Maternal Health

OmniBiome, Inc.

OmniBiome, Inc. (OMNI), a majority-owned subsidiary of TSOI, is focused on therapeutic / Rx approaches to either utilize or intervene with the systemic effects of the vaginal, lactal-duct and oral microbiomes for improving maternal healthcare and resulting birth outcomes. The Officers and Directors ofOn August 28, 2020 the Company are also officersfiled a patent application titled “Upregulation of Therapeutic T Regulatory Cells and DirectorsSuppression of OMNI. AsSuicidal Ideations in Response to Inflammation by Administration of September 30, 2017Nutraceutical Compositions Alone or Combined with Minocycline” which discloses compositions of matter, treatments and August 11, 2017, TSOI owns approximately 73.75%protocols useful for induction of the outstanding shares of OMNI. As of September 30, 2017 and November 15, 2017 operations have not commenced.

The Company will focus initially on developing CLIA Dx services for both pre-pregnancy-associated and pregnancy-associated conditions or diseases where there is a substantive link with microbiome dysbiosis (disruption or imbalance),T regulatory cells in response to inflammation, as well as on restoring eubiosis (proper balance).inhibition of suicidal ideations and/or neuroinflammation. In some embodiments the invention teaches the administration of a therapeutic combination of ingredients comprising of minocycline, pterostilbene, nigella sativa, sulforaphane, and epigallocatechin-3-gallate (EGCG) to a mammal undergoing upregulation of inflammatory mediators.

On September 14, 2020, the Company filed a patent application titled “Immunotherapy of Schizophrenia and Schizophrenia Associated Suicidal Ideation/Suicide” Disclosed are methods, means, and protocols of modifying the immune system so as to induce an immunologically tolerant state insofar as T regulatory cell number and/or activity is augmented in a patient suffering from schizophrenia. In parallel OmniBiome will build a databaseone embodiment T regulatory cells are administered to the patient from exogenous sources, be they allogeneic or autologous. In other embodiments, T regulatory cells are generated endogenously through administration of aggregated patient data that will later inform development of Rx / therapeutic and medical device & drug-device combination approaches for treating the same conditions immature dendritic cells, mesenchymal stem cells, and/or diseases.

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MicroBiome Targetspharmaceutical means.

Certain microbiome target markets offer immediate revenue-generating business opportunitiesOn September 24, 2020, the Company filed a patent application titled “Personalized Immunotherapies for Reduction of Brain Inflammation and Suicide Prevention” that discloses means, methods and compositions of matter useful for reduction of brain inflammation and prevention of suicidal ideations and suicidal attempts. In one embodiment the invention provides utilization of autologous platelet rich plasma, alone, or admixed with regenerative/anti-inflammatory adjuvants, for reduction of neural inflammation. In one embodiment autologous PRP is admixed with oxytocin and administered intranasally in a patient at risk of suicidal ideation. In another embodiment, PRP is admixed with fortified and non-fortified nigella sativa oil and administered intranasally. Other embodiments include utilization of autologous stromal vascular fraction cells alone and/or admixed with regenerative/anti-inflammatory adjuvants.

On October 18, 2020, the Company filed a patent application titled “Nutraceutical Reduction Prevention and/or Reversion of Multiple Sclerosis” that discloses compositions of matter, protocols, and treatment means for preventing and/or reversing multiple sclerosis in a mammal. In one embodiment administration of compositions containing pterostilbene, and/or nigella sativa, and/or sulforaphane, and/or epigallocatechin-3-gallate (EGCG) are provided.

On October 27, 2020, the Company filed a patent application titled “”Protection/Regeneration of Neurological Function by Endothelial Protection/Rejuvenation using Stem Cells for Treatment of Conditions such as vaginalChronic Traumatic Encephalopathy and lactal-duct microbiome banking & transplantsSchizophrenia” which therapeutic compounds, protocols, and compositions of matter useful for treatment of neurological conditions. In one embodiment the invention teaches the treatment of chronic traumatic encephalopathy (CTE) through protecting/regenerating the endothelial by administration of cells such as stem cells. In one embodiment stem cells are administered in order to protect the endothelium from motherapoptosis and to childpreserve the blood brain barrier. In another embodiment stem cells are administered together with endothelial progenitor cells in order to regenerate neural endothelium. In other embodiments preservation of brain integrity in conditions of degeneration is accomplished by administration of stem cells and/or endothelial cells.

On November 24, 2020, the Company filed a patent application titled “Stimulation of NK Cell Activity by QuadraMune Alone and together with Metformin” that disclosed means, compounds, and compositions of matter useful for stimulation of natural killer cell activity. In some embodiments the invention teaches the administration of a therapeutic combination of ingredients comprising of metformin, pterostilbene, nigella sativa, sulforaphane, and epigallocatechin-3-gallate (EGCG) to a mammal in need of natural killer cell immune modulation. In another embodiment, the invention teaches administration of said therapeutic combination to a mammal infected with said SARS-CoV-2. In some embodiments dosage of said therapeutic combination is based on inflammatory and/or immunological parameters observed in patients with COVID-19.

On December 8, 2020 the Company filed a patent application titled "Treatment of Major Depressive Disorder and Suicidal Ideations Through Stimulation of Hippocampal Neurogenesis Utilizing Plant-Based Approaches" that teaches means and methods of treating major depressive disorder and/or other disorders that predispose to suicide by administration of nutraceutical means, wherein said nutraceuticals are administered at a frequency and/or concentration sufficient to induce proliferation of endogenous neural progenitor cells.  In one embodiment said nutraceuticals are comprised of green tea extract, and/or nigella sativa, and/or pterostilbene, and/or sulforaphane.  In some embodiment’s nutraceutical compositions are utilized to overcome treatment resistant of currently used antidepressants.

On December 21, 2020 the Company filed a patent application titled “Immunotherapy for Opioid Addiction” which teaches means, methods and compositions of matter useful for reduction of brain inflammation and prevention of opioid addiction and/or tolerance.  In one embodiment the invention provides utilization of platelet rich plasma (PRP), alone, or admixed with regenerative/anti-inflammatory adjuvants, for reduction of neural inflammation.  In one embodiments PRP is admixed with oxytocin and administered intranasally in a patient at risk of opioid addiction.  In another embodiment, PRP is admixed with fortified and non-fortified nigella sativa oil, and/or pterostilbene and administered intranasally. Other embodiments include utilization of autologous stromal vascular fraction cells alone and/or admixed with regenerative/anti-inflammatory adjuvants.

On January 26, 2021 the Company filed a patent application titled “Stimulation of Dendritic Cell Activity by Homotaurine and Analogues Thereof” which discloses means, methods, and compositions of matter useful for enhancement of dendritic cell activity. In one embodiment the invention provides the use of GABA agonists such as homotaurine for stimulation of dendritic cell activity. In one embodiment said dendritic cell activity is enhancement of natural killer cell activity and/or of T cell activity. In one embodiment NK cell activity is ability to induce cytotoxicity in neoplastically transformed cells, whereas T cell activity is either cytokine production for CD4 cells or cytotoxicity for CD8 cells.

On February 8, 2021 the Company filed a patent application titled “Stimulation of Natural Kill Cell Memory by Administration of Dendritic Cells” which teaches means, methods and compositions of matter useful for induction of natural killer cell memory by administration of dendritic cells and/or exosomes thereof. In one embodiment a mammal suffering from cancer is administered allogeneic cord blood derived dendritic cells that are not pulsed exogenously. In one embodiment the dendritic cells are stimulated to possess chemotactic activity towards the tumor by culture of dendritic cell progenitors in hypoxia. Natural killer cell memory is induced, in part, by triggering of upregulation of cytokines associated with homeostatic expansion such as interleukin 7 and interleukin 15.

On February 22, 2021 the Company filed a patent application titled “Ex Vivo Generation of Immunocytes Recognizing Brother of the Regulator of Imprinted Sites (BORIS) Expressing Cancer Stem Cells” that discloses means, methods and compositions of matter useful for induction of immunity towards cancer stem cells by providing a dendritic cell, wherein said dendritic cells express BORIS and/or peptides derived from BORIS, wherein said dendritic cell is cultured in the casepresence of C-section-born babies, babiesone or more immunocytes. In one embodiment said dendritic cells are derived from umbilical cord blood sources and allogeneic to T cells, which are expanded ex vivo and used for the purposes of non-nursing mothers, and children under 5 years of age receiving broad-spectrum antibioticsimmunotherapy.

OmniBiome’s main focus will be on developing Dx / Rx products & servicesOn March 4, 2021 the Company filed a patent application titled “Therapeutic Monocytes for pregnancy-associated conditions Prevention of Suicidal Ideation” that discloses compositions of matter, protocols, and therapeutic means for treatment of suicidal ideations and/or diseases where there issuppression of suicidal attempts.  In one embodiment the invention provides the use of umbilical cord derived monocytes as a documented means of treatment.  In another embodiment, monocytes are de-differentiated from adult monocytes using reprogramming means to create monocyte capable of producing anti-inflammatory as well as regenerative properties useful in reducing suicidal ideations and/or substantive putative link with microbiome dysbiosis and resulting inflammatory cascadesattempts.

In parallelOn March 16, 2021 the Company will lookfiled a patent application titled “Pluripotent Stem Cell Derived Dendritic Cells and Engineered Dendritic Cells for Cancer Immunotherapy” that disclosed populations of dendritic cells generated from stem cells capable of inducing immunity towards cancer.  In one embodiment said dendritic cells are generated from allogeneic inducible pluripotent stem cells, for some uses, said pluripotent stem cells are genetically engineered/edited to create alliancesinduce cancer specific immunity and/or out-license its Medical Device / Drug Device Combinations patent portfolio.resist immunosuppressive effect of tumor derived microenvironment.  In one embodiment pluripotent stem cells are transfected with cancer stem cell antigens such as BORIS and/or NR2F6.

TheOn March 23, 2021 the Company also plansfiled a patent application titled “Chimeric Cells Comprising Dendritic Cells and Endothelial Cells Resembling Tumor Endothelium” that teaches means, methods and compositions of matter useful for induction of immunological responses towards tumor endothelial cells. In one embodiment the invention teaches fusion of dendritic cells and cells resembling tumor endothelial cells and administration of such chimeric cells as an immunotherapy for stimulation of tumor endothelial cell destruction.  In other embodiments pluripotent stem cells are utilized to in-license microbiome - and pregnancy-related Rx & Dx innovations from universities and research institutes –generate dendritic cells, wherein said dendritic cells are fused with several having been identified.

In-House Patentspluripotent stem cell derived endothelial cells created in a manner to resemble tumor endothelial cells.

On March 29, 2017 OmniBiome announced2021 the filingCompany filed a patent application titled “Compositions Capable of a new patent titled "ModulationStimulating Immunity Towards Tumor Blood Vessels” which discloses novel means, protocols, and compositions of Oral Microbiomematter for Treatmenteliciting an immune response against blood vessels supplying neoplastic tissue. In one embodiment pluripotent stem cells are transfected with one or more genes capable of Periodontitis."

This product will be marketed as a probiotic pasteeliciting immunity. In some embodiments such genes are engineered under control of specific promoters to be used in oral appliances similarallow for various specificities of activity. In one specific embodiment pluripotent stem cells engineered to bleaching trays.

Licensed Patents

Omni is the licenseeendow properties capable of inducing expression of the following patents:

Patent titled "Prevention of Pregnancy Complications by Probiotic Administration."

Patent titled "Preventative Methods and Therapeutic or Pharmaceutical Compositions for the Treatment or Prevention of Pregnancy Complications" covers utility of vaccines and various agents to alter pathological conditions in which the maternal immune system induces a process of inflammation that culminates in placental alterations leading to either fetal loss or preterm labor.

Patent titled "Diagnostic Methods For The Assessment Of Pregnancy Complications" a cytokine-based diagnostic kit aimed at stratifying risk of preterm labor and other pregnancy associated complications.

Patent titled "A Medical Device For Reducing The Risk Of Preterm-Labor And Preterm-Birth" covering various medical devices aimed at immune modulating the cervical microenvironment in order to prevent preterm labor.

Immune-Oncology

Emvolio, Inc.

Emvolio, Inc., (EMVO) is a wholly-owned subsidiary of TSOI where the intellectual property surrounding immune-oncology is housed. The Company intends to develop products that can be used together to attack cancer at different levels, as well as to be used alone or in combination with existing therapies. The Officers and Directors of the Company are also Officers and Directors of EMVO. As of September 30, 2017 and November 15, 2017, formal operations have not commenced.

On April 10, 2017, TSOI licensed to EMVO a patent titled “Targeting the Tumor Microenvironment through Nutraceutical Based Immunoadjuvants” known clinically as “StemVacs”α-Gal epitope (Galα1,3Galα1,4GlcNAc-R).

On April 13, 2021 the Company filed a patent application titled “Amelioration and Treatment of Opioid Addiction” that discloses compositions of matter, protocols and treatment means for reducing and/or preventing opioid addiction. In one embodiment the invention teaches intranasal administration of umbilical cord blood plasma, or extracts thereof, together with pterostilbene or pterostilbene containing nanoparticles, and/or oxytocin, and/or human chorionic gonadotropin.  

*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 Autologous is a subcutaneously administered vaccine comprised of immune stimulatory peptides resembling cancer stem cell specific proteins.

StemVacs Allogeneic is a subcutaneously administered vaccine comprised of immune stimulatory peptides resembling cancer stem cell specific proteins.

StemVacs-VAllogeneic is a subcutaneously administered vaccine comprised of dendritic cells generated from stem cells capable of inducing immunity towards cancer.

StemVacs-V Allogeneic iPSC a novel chimeric cell product generated by fusing StemVacs-V with iPSC derived endothelial cells which are cultured in a manner to make them replicate cancer stem cells. The final product is a subcutaneously administered vaccine.

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), Traumatic Brain Injury (TBI), and Lung Patholgy.

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). In addition, on February 10, 2021 we obtained exclusive rights under the same for use of US Patent No.: 9,803,176 B2 in the treatment of acute respiratory distress syndrome (ARDS) and other lung pathologies. The JadiCell was reported in a publication from the University of Miami following a Phase 1/2 clinical trial, demonstrating intravenous administration of JadiCells, resulted in a significant survival improvement in COVID-19 patients. The Phase 1/2 double blind, placebo-controlled trial treated 12 2017, EMVOadvanced COVID-19 patients with 100 million JadiCells™ intravenously at days 0 and 3, and 12 patients received placebo control.  At 28 days 91% of JadiCell™ treated patients survived whereas only 42% of patients in the placebo group survived.  There were no adverse effects associated with JadiCell™ administration. For those treated with the JadiCell under the age of 85 the survival rate was 100% and in those over 85 the survival rate was 91% making the JadiCell the most effective therapy to date in the entire world to treat ARDS.

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.

On Decemeber 17, 2020 the Company filed an Investigational New Drug (IND) application #17448seeking permission from the Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial assessing safety and signals of efficacy for usetreatment of its StemVacs cancer immunotherapeutic licensed to EMVO by TSOI, inChronic Traumatic Encephalopathy (CTE) patients with solid tumors. The trial seeks to establish safety and immune response ofJadiCells™. On March 4, 2021 the cancer, targeting a new personalized dendritic cell vaccine.Company received formal notice from FDA that our IND has been assigned serial # 27377.

On May 01, 2017, TSOI licensed to EMVO a patent titled “Targeting the Tumor Microenvironment through Nutraceutical Based Immunoadjuvants” known clinically as “Cancer Metabolic Detox”.

On May 17, 2017, TSOI licensed to EMVO a patent titled “Activated Leukocyte Extract for Repair of Innate Immunity in Cancer Patients” known clinically as “innaMune”.Sars/CoV2 Clinical Programs

On June 01, 2017, TSOI licensed8, 2020 the Company announced the initiation of a clinical trial aimed at demonstrating safety and efficacy of its immune-boosting formulation QuadraMune™. The trial is anticipated to EMVOrecruit 500 subjects at risk of SARS-CoV-2 infection, the type of coronavirus which causes COVID-19. The new clinical trial has been granted ClinicalTrials.gov Identifier: NCT04421391 and is listed and registered on the Federal Clinical Trial registry.

The Company announced recently submission of a patent titled “Augmentationpublication providing preclinical data which supports repositioning of Anti-Tumor Immunityits Cancer Immunotherapy StemVacs™ as a candidate for treatment of COVID-19. StemVacs™ is based on activating universal donor immune system cells called dendritic cells in a manner so that upon injection they reprogram the body’s “Natural Killer” cells.

Natural killer cells are the most potent cell type in the body in terms of killing viruses. Unfortunately, natural killer cells also produce chemicals called cytokines which at high concentrations can be lethal. The current data suggests that StemVacs™ can activate natural killer cells while at the same time suppressing lung inflammation. This dual mechanism of action makes StemVacs™ a promising candidate for treatment of coronavirus.

Schizophrenia/Suicide Clinical Programs

On October 29, 2020 the Company announced publication on the NIH clinical trials website of its newly initiated trial aiming to validate a blood-based diagnostic for predicting suicide risk and is listed as NCT04606875.

The Campbell Score™, which is a patent-pending method of quantifying inflammatory-associated biological markers, has previously been shown in pilot investigator-initiated studies to correlate with propensity for suicide. Based on positive feedback from collaborators, the Company decided to initiate a formal clinical trial to validate correlations between the Campbell Score™ and established psychiatric assessment tools of suicidal propensity.  Currently the only means of quantifying predisposition to suicide is based on psychological, question-based techniques.

On December 31, 2020 the Company signed license agreements with Campbell Neurosciences Inc., a partially owned company, for access to the 9 patents filed related to the previous Campbell Neurosciences Division.  The patents are:

1.63/128759 Immunotherapy for Opioid Addiction  

2.63/122862 Treatment of Major Depressive Disorder and Suicidal Ideations Through Stimulation of Hippocampal Neurogenesis Utilizing Plant-Based Approaches  

3.63/105964 Protection/Regeneration of Neurological Function by MifepristoneEndothelial Protection/Rejuvenation using Stem Cells for Treatment of Conditions such as Chronic Traumatic Encephalopathy and Analogues Thereof” known clinically as “LymphoBoost”.Schizophrenia  

4.17/030416 Personalized Immunotherapies for Reduction of Brain Inflammation and Suicide Prevention  

5.63/077723 Immunotherapy of Schizophrenia and Schizophrenia Associated Suicidal Ideation/Suicide  

6.63/071381 Upregulation of Therapeutic T Regulatory Cells and Suppression of Suicidal Ideations in Response to Inflammation by Administration of Nutraceutical Compositions Alone or Combined with Minocycline  

7.63/068388 Methods of Determining Risk of Suicide and/or Suicidal Ideation by Immunological Assessment  

8.63/061202 Prevention of Neuroinflammation associated Memory Loss Using Nutraceutical Compositions  

9.63/057315 Neuroprotection and Neuroregeneration by Pterostilbene and Compositions Thereof  

Additionally, Campbell Neurosciences Inc. has entered into purchase agreements with Therapeutic Solutions International ensuring a continued supply, at a discounted rate, of nutraceuticals which are being explored for antiinflammation/suicide prevention activity.

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On June 12, 2017, TSOI licensed to EMVO a patent titled “Methods of Re-Activating Dormant Memory Cells with Anticancer Activity” known clinically as “MemoryMune”.

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.

The FDA has also issued regulations governing the labeling and marketing of dietary and nutritional supplement products. They include:

·the identification of dietary or nutritional supplements and their nutrition and ingredient labeling;  

·requirements related to the wording used for claims about nutrients, health claims, and statements of nutritional support;  

·labeling requirements for dietary or nutritional supplements for which “high potency” and “antioxidant” claims are made;  

·notification procedures for statements on dietary and nutritional supplements; and  

·pre-market notification procedures for new dietary ingredients in nutritional supplements.  

The Dietary Supplement Health and Education Act of 1994 (DSHEA) revised the existing provisions of the Federal Food, Drug and Cosmetic Act concerning the composition and labeling of dietary supplements and defined dietary supplements to include vitamins, minerals, herbs, amino acids and other dietary substances used to supplement diets. DSHEA generally provides a regulatory framework to help ensure safe, quality dietary supplements and the dissemination of accurate information about such products. The FDA is generally prohibited from regulating active ingredients in dietary supplements as drugs unless product claims, such as claims that a product may heal, mitigate, cure or prevent an illness, disease or malady, trigger drug status.

The Company is also subject to a variety of other regulations in the United States, including those relating to taxes, labor and employment, import and export, and intellectual property.

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations are based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. We evaluate our estimates on an ongoing basis. We base our estimates on historical experience and on other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that re not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

There have been no material changes to the critical accounting policies as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2016, which was filed with the SEC on June 7, 2017.

Recent Accounting Pronouncements

Recent accounting pronouncements are disclosed in Note 2 to the accompanying unaudited condensed consolidated financial statements included in Item 1 of this Quarterly Report on form 10-Q.

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Results of Operations

You should read the following discussion of our financial condition and results of operations together with the unaudited financial statements and the notes to the unaudited financial statements included in this quarterly report. This discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results may differ materially from those anticipated in these forward-looking statements.

Overview

Currently the Company is focused on immune modulation for the treatment of several specific diseases. Immune modulation refers to the ability to upregulate (make more active) or downregulate (make less active) one’s immune system.

Activating one’s immune system is now an accepted method to curetreat 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, schizophrenia, suicidal ideation, traumatic brain injury, and for daily health.

Nutraceutical Division– TSOI has been producing very high quality nutraceuticals. Its current flagship product, ProJuvenol^®,NanoStilbeneä 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. Recently the Company was approved to sell certain nutraceuticals on the Amazon Platform. In addition to this our products are now listed in RangeMe. RangeMe.com is an online platform that enables retail buyers to efficiently discover innovative and emerging products while empowering suppliers to manage and grow their brands with the tools, insights, and services they need. With 10,000+ Retail buyers our products are now placed in front of them in our category of dietary supplements and nutraceuticals.

Cellular Division – TSOI recently obtained exclusive rights to a patented proprietary mixture containing pterostilbene – oneadult stem cell for development of therapeutics in the most potent antioxidants known.area of chronic traumatic encephalopathy (CTE) and traumatic brain injury (TBI) and Lung Pathology (LP).

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. On June 20th, 2017, TSOI was granted U.S. Patent No.: 9,682,047March 4, 2021 the Company received an IND Serial # 27377 for ProJuvenol^® titled “Augmentationa clinical trial of Oncology Immunotherapies by Pterostilbene Containing Compositions”. 10 patients with CTE.

In addition, wethe 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.”

The Company has also developed an allogenic version of StemVacs and has filed patents to cover activating universal donor immune system cells called dendritic cells in a manner so that upon injection they reprogram the body’s NK cells.

Most recently launched 4the Company announced filing of a patent for a new products in Liposomal formulation. Theyhybrid cell created by the Company capable of training the immune system to kill blood vessels feeding cancer, but sparing healthy blood vessels. These discoveries are CoQ10, Curcumin, Glutathione, and Vitamin-C in 16oz bottles.an extension of previous findings from the Company showing that StemVacs is capable of suppressing new blood vessel production.  

For the three months ended March 31, 2021 and nine months ended September 30, 2017 and 20162020

We had a net loss of $266,763$186,923 for the three months ended September 30, 2017,March 31, 2021, compared to a net lossincome of $182,748$32,136 for the three months ended September 30, 2016,March 31, 2020, an increasedecrease of $84,015.$219,059. This increase was mainly due to increases in Salaries, wages and related expenses, consulting fees and legal and professional fees. We had a net loss of $700,573 for the nine months ended September 30, 2017, compared to a net loss of $691,200 for the nine months ended September 30, 2016, an increase of $9,373. This increase was mainly due to increases in legal and professional fees and decreases in general and administration expenses and consulting fees. .

Net sales decreased $691, from $1,321 to $630, for the three months ended September 30, 2016 and September 30, 2017, respectively. Net sales slightly decreased $663, from $2,586 to $1,923, for the nine months ended September 30, 2016 and September 30, 2017, respectively.

Cost of goods sold decreased $203, from $394 to $191, for the three months ended September 30, 2016 and September 30, 2017, respectively. Cost of goods sold decreased $134, from $750 to $616, for the nine months ended September 30, 2016 and September 30, 2017, respectively.

Operating expenses for the three month periods ended September 30, 2017 and 2016 were $208,156 and $180,309, an increase of $27,847. This increasedecrease was mainly due to increases in salaries, wages and related costs, interest expenses consulting fees and legallosses on changes in derivative liabilities.

Net sales increased $1,547, from $19,514 to $21,061, for the three months ended March 31, 2020 and professional fees. March 31, 2021, respectively.

Cost of goods sold increased $1,631, from $3,490 to $11,081, for the three months ended March 31, 2020 and March 31, 2021, respectively. These increases were mainly a result of the increases in net sales for products in 2021 and 2020.

Operating expenses for the nine monththree-month periods ended September 30, 2017March 31, 2021 and 20162020 were $628,522$270,906 and $683,419, a decrease$138,400, an increase of $54,897.$132,506. This decreaseincrease was mainly due to decreasesincreases in Generalgeneral and Administrationadministrative, salaries, wages and related expenses, and consulting fees along with increases in legal and professional fees.fees, and research and development.

General and administrative expenses decreased $3,371,increased $1,948, from $26,065$15,431 to $22,694,$36,811 for the three months ended September 30, 2016March 31, 2020 and 2017,2021, respectively. General and administrative expenses decreased $26,349, from $101,786 to $75,437, for the nine months ended September 30, 2016 and 2017, respectively. These decreases were mainly due decreased bad debt expense in the comparable quarters in 2017 vs 2016.

Salaries, wages, and related expenses increased $5,625,decreased $51,293, from $89,911$53,170 to $95,536$104,463 for the three months ended September 30, 2016March 31, 2020 and 2017,2021, respectively. Salaries, wages and related expenses increased $12,200, from $267,638 to $279,838 for the nine months ended September 30, 2016 and 2017, respectively. These increases areThis increase was mainly due to an increase in wage related expenses.

Selling expenses decreased $485, from $1,197 to $712, for the three months ended September 30, 2016 and 2017, respectively. This was mainly due a decrease in selling and marketing expenses related to the Company’s products during the period. Selling expenses increased $1,581, from $957 to $2,538, for the nine months ended September 30, 2016 and 2017, respectively. This increase was mainly due to selling and marketing expenses related to the Company’s products.March 31, 2021.

Consulting fees increased $20,950$3,964 from $2,000$37,219 to $22,950$41,183 for the three months ended September 30, 2016March 31, 2020 and 2017,2021, respectively, due to an increase in overall consulting services. Consulting fees decreased $119,100 from $148,750 to $29,650 for the nine months ended September 30, 2016 and 2017, respectively, due to a decrease in overall consulting services.

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Legal and professional fees increased $3,090,$36,172, from $61,136$32,580 to $64,226$68,752 for the three months ended September 30, 2016March 31, 2020 and 2017,2021, respectively, due to an increase in independent public accounting fees and legal expense. Legal

Research and professional feesdevelopment increased $58,647,$19,697, from $158,298$0 to $216,945,$19,697 for the ninethree months ended September 30, 2016March 31, 2020 and 2017,2021, respectively, due to an increase in independent public accounting fees and legal expense.overall consulting services. 

Research and Development costs increased $2,038,Loss on derivatives liability decreased approximately $327,500, from $0$20,755 to $2,038,$348,255, for the three months ended September 30, 2016March 31, 2020 and 2017,2021, respectively. This decrease was mainly due to a reduction in the amount of new convertible notes being issued during the current period.

Change in fair derivatives liabilities gains increased approximately $267,784 from $236,402 to $504,186 for the three months ended March 31, 2020 and 2021, respectively. This increase was mainlylargely due to increased research and development expenses for the comparable three month periods. Research and Development costs increased $18,124, from $5,990 to $24,114, for the nine months ended September 30, 2016 and 2017, respectively. Thisan increase was mainly due to research and development expenses incurred in the first three monthsbalance of 2017.convertible notes outstanding upon which the derivative liability is recorded.

Net interest expense increased $6,997$20,793 from $3,366$61,135 to $10,363$81,928 for the three months ended September 30, 2016March 31, 2020 and 2017, respectively. This increase was mainly due to increased debt balances. Net interest expense increased $15,058 from $9,617 to $24,675 for the nine months ended September 30, 2016 and 2017,2021, respectively. This increase was mainly due to increased debt balances.

Loss on derivative liabilities increased $83,968, from $0 to $83,968, for the three and nine months ended September 30, 2016 and 2017, respectively. This increase was due to a loss incurred on derivative liabilities during the three months ended September 30, 2017.

Change in fair value of derivative liability was $35,285 for the three and nine months ended September 30, 2017 verses $0 for the three and nine months ended September 30, 2016. This change was due to a change in derivative liability during the three months ended September 30, 2017.

Liquidity and Capital Resources

As of September 30, 2017, the Company has incurredWe have experienced recurring losses over the past years which have resulted in accumulated deficits of $4,973,767, has not yet generated material revenue from operations,approximately $11.2 million and will require additional funds to maintain its operations. Management does not expect existing cash resources asa working capital deficit of September 30, 2017 to be sufficient to fund the Company’s operations forapproximately $2 million at least twelve months from the issuance date of these interim financial statements.March 31, 2021. 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. These factorsconditions raise substantialsignificant doubt regardingabout the Company’s ability to continue as a going concern within one year after the consolidated financial statements are issued.concern. The Company’s ability to continue as a going concern is dependentcontingent upon its ability to generate futuresecure additional financing, increase sales of its products and attain profitable operations and obtainoperations. It is 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 by raising additional capital through equity offerings, debt financings, collaborations and/or licensing arrangements. If adequate funds are not available on acceptable terms, the Company may be required to delay, reduce the scopeintent of or curtail, its 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

As of September 30, 2017, our cash and cash equivalents were $5,283 compared to $21,910 at December 31, 2016. Our current cash reserves are not adequate to fund our operations for the 12 month period subsequent to the issuance of our financial statement contained in Item 1. Cash used in operating activities for the nine months ended September 30, 2017 was $306,862, compared to $287,806 for the same period in 2016. The increase was primarily due to decreased prepaid expenses, and increased accrued expenses and other current liabilities. For the nine months ended September 30, 2017 net cash provided in financing activities was $290,235, compared to $330,856 for the same period in 2016. The decrease was mainly due a decrease in the issuance of common stock. At September 30, 2017, we had negative working capital of $1,117,132, compared to negative working capital of $611,558 at December 31, 2016. This increase was mainly due to an overall increase in current liabilities. The Company plansmanagement to continue to reduce costs and seekraise additional funding for operations.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. Our independent registered public accounting firm has stated in their opinion on our 2016 annual financial statements dated June 7, 2017, that there is substantial doubt about our ability to continue as a going concern.

Off Balance Sheet Arrangements

We currently do not have any off-balance sheet arrangements.

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Item 3. Quantitative and Qualitative Disclosures about Market Risk

As a Smaller Reporting Company as defined by Rule 12b-2 of the Exchange Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations and therefore are not required to provide this information requested by this item.

Item 4. Controls and Procedures

A.Disclosure Controls and Procedures

As required by Rule 13a-15(b) under the Securities Exchange Act of 1934, or Exchange Act, our principal executive officer and principal financial officer evaluated our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of September 30, 2017.March 31, 2020. Based on this evaluation, these officers concluded that as of the end of the period covered by this Quarterly Report on Form 10-Q, these disclosure controls and procedures were not operating effectively to ensure that the information required to be disclosed by the Company in reports it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC and include controls and procedures designed to ensure that such information is accumulated and communicated to our management, including our principal executive officer, and principal financial officer, to allow timely decisions regarding required disclosure.

Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake.

B.Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during our fiscal quarter ended September 30, 2017March 31, 2021 that materially affected, or are reasonable likely to materially affect, our internal control over financial reporting.

Our management, including the Chief Executive Officer and Chief Financial Officer assessed the effectiveness of our internal control over financial reporting as of September 30, 2017.March 31, 2021. In making our assessment, we used the framework and criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) (2013). Based on that assessment, our management has identified certain material weaknesses in our internal control over financial reporting.

Our management concluded that as of September 30, 2017March 31, 2021, our internal control over financial reporting was not effective, and that material weaknesses existed in the following areas as of September 30, 2017:March 31, 2021.

(1)we do not employ full time in-house personnel with the technical knowledge to identify and address some of the reporting issues surrounding certain complex or non-routine transactions. With respect to material, complex and non-routine transactions, management has and will continue to seek guidance from third-party experts and/or consultants to gain a thorough understanding of these transactions;  

(2)we have inadequate segregation of duties consistent with the control objectives including but not limited to the disbursement process, transaction or account changes, and the performance of account reconciliations and approval ;approval;  

(3)we have ineffective controls over the period end financial disclosure and reporting process caused by insufficient accounting staff.  

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PART II - OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, claims are made against us in the ordinary course of business, which could result in litigation. Claims and associated litigation are subject to inherent uncertainties and unfavorable outcomes could occur, such as monetary damages, fines, penalties or injunctions prohibiting us from selling one or more products or engaging in other activities. The occurrence of an unfavorable outcome in any specific period could have a material adverse effect on our results of operations for that period or future periods.

However, as of the date of this report, management believes the outcome of currently identified potential claims and lawsuits will not have a material adverse effect on our financial condition or results of operations.

Item 1A. Risk Factors

No material changes to risk factors have occurred as previously disclosed in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2016,2020, which was filed with the SEC on June 7, 2017.April 9, 2021.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

.

On March 2, 2020 we issued 8,333,333 shares of common stock for the partial conversion of $10,000 for a convertible note dated August 28, 2019.

On March 12, 2020 we issued 11,764,706 shares of common stock for the partial conversion of $10,000 for convertible note dated August 28, 2019.

On March 26, 2020 we issued 21,818,182 shares of common stock for the partial conversion of $12,000 for convertible note dated August 28, 2019.

 On June 4, 2020, we issued 24,733,333 shares of common stock for the complete conversion of $29,680 for convertible note dated October 30, 2019.

On June 4, 2020, we issued 5,000,000 shares of common stock, valued at $0.0023 per share, for consulting services.

On June 4, 2020 we issued 70,000,000 shares of common stock, valued at $0.023 each to three officers and one director of the Company under a Restricted Stock Award.

On June 8, 2020, we issued 10,000,000 shares of common stock, valued at $0.0033 per share, for consulting services.

On June 9, 2020, we issued 18,292,818 shares of common stock for the complete conversion of $60,000 for convertible note dated June 9, 2020.

On June 11, 2020 we issued 40,000,000 shares of common stock, valued at $0.0046 each to three officers and one director of the Company under a Restricted Stock Award.

On June 15, 2020 we issued 3,000,000 shares of common stock, valued at $0.0017 each to one officer and one director of the Company under a Restricted Stock Award.

On June 15, 2020, we issued 10,000,000 shares of common stock, valued at $0.0023 per share, to the medical officer for consulting services.

On June 16, 2020, we issued 33,566,667 shares of common stock for the complete conversion of $40,280 for convertible note dated December 12, 2019.

On June 22, 2020, we issued 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 July 17, 2020 we issued 7,500,000 shares of common stock, valued at $0.0064 each to two officers, and one director of the Company under a Restricted Stock Award.On July 17, 2020, we issued 2,000,000 shares of common stock, valued at $0.0064 per share, for consulting services.

On July 31, 2020 we issued 12,000,000 shares of common stock, valued at .0077 each to three officers, and one director of the Company under a Restricted Stock Award.

On August 4, 2016,2020, we issued 8,969,230 shares of common stock for the complete conversion of $34,980 for convertible note dated February 4, 2020.

On August 26, 2020, we issued 10,000,000 shares of common stock, valued at $0.005 per share, for consulting services.

On September 23, 2020, we issued 1,000,000 shares of common stock, valued at $0.0085 per share, for consulting services.

On September 29, 2020, we issued 2,500,000 shares of common stock, valued at $0.0025$0.0075 per share, for consulting services.

On January 22, 2016,October 1, 2020 we issued 2,500,00015,000,000 shares of common stock, valued at $0.0035 per share, for consulting services$0.0071 each to a Directortwo officers, and one director of the Company.Company under a Restricted Stock Award.

On February 1, 2016,October 5, 2020 we issued 2,500,00010,000,000 shares of common stock, valued at $0.003$0.0086 each to one officer, and one director of the Company under a Restricted Stock Award.

On October 28, 2020, we issued 7,420,000 shares of common stock for the complete conversion of $29,680 for convertible note dated February 4, 2020.

On October 1, 2020, we issued 15,000,000 shares of common stock, valued at $0.0071 per share, each to two officers, and one director of the Company under a Restricted Stock Award.

On October 5, 2020, we issued 10,000,000 shares of common stock, valued at $0.0086 per share each to one officer and one director of the Company under a Restricted Stock Award.

On October 28, 2020, we issued 7,420,000 shares of common stock for the complete conversion of $29,680 for convertible note dated April 27, 2020.

On December 8, 2020, we issued 7,931,034 shares of common stock for the partial conversion of $23,000 for convertible note dated June 5, 2020.

On December 9, 2020, we issued 7,786,207 shares of common stock for the complete conversion of $22,580 for convertible note dated June 5, 2020.

On December 17, 2020, we issued 10,000,000 shares of common stock, valued at $0.0067 per share each to one officer and one director of the Company under a Restricted Stock Award.

On December 30, 2020, we issued 6,000,000 shares of common stock, valued at $0.006 per share each to one officer and one director of the Company under a Restricted Stock Award.

On January 22, 2021, we issued 4,800,000 shares of common stock for $60,000 of accrued salaries.

On February 3, 2021, we issued 1,500,000 shares of common stock, valued at $0.029 per share, for consulting services.

On February 5, 2016,9, 2021, we issued 8,000,000300,752 shares of common stock, valued at $0.0025$0.0665 per share, for an investment in the Company’s Private Placement.

On February 22, 2016, we issued 5,451,000 shares of common stock, valued at $0.003 per share, in regard to a License Agreement (Form 8-K filed on February 25, 2016).

On February 26, 2016,15, 2021, we issued 1,000,000 shares of common stock, valued at $0.0025 per share, for an investment in the Company’s Private Placement from a Director of the Company.

On March 7, 2016, we issued 10,000,000 shares of common stock, valued at $0.0025 per share, for consulting services.

On March 21, 2016, we issued 100,000,000 shares of common stock, valued at $0.0025 per share, for an investment in the Company’s Private Placement to a related party.

On March 21, 2016, we issued 800,000 shares of common stock, valued at $0.0025$0.05 per share, for an investment in the Company’s Private Placement.

On May 2, 2016,February 16, 2021, we issued 1,000,000147,058 shares of common stock, valued at $0.0025 per share, for an investment in the Company’s Private Placement and 1,000,000 shares of common stock, valued at $0.0053 per share, for consulting services.

On May 26, 2016, we issued 2,500,000 shares of common stock, valued at $0.0066 per share, for consulting services.

On May 26, 2016, we issued 2,000,000 shares of common stock, valued at $0.0025$0.068 per share, for an investment in the Company’s Private Placement.

On May 31, 2016, we issued 2,500,000 shares of common stock, valued at $0.0066 per share, for legal services.

On September 16, 2016, we issued 12,500,000 shares of common stock, valued at $0.004 per share, for an investment in the Company’s Private Placement to a related party.

On October 18, 2016, we issued 40,000,000 shares valued at $0.0045 to the officers and directors of the Company for services, and 5,000,000 shares valued at $0.0045 for consulting services to a related party.

On JanuaryFebruary 17, 2017, we issued 12,500,000 shares of common stock, valued at $0.004 per share, for an investment in the Company’s private placement to a related party.

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On March 2, 2017, we issued 12,500,000 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 3, 2017,2021, we issued 1,000,000 shares of common stock, valued at $0.0067$0.129 per share, for consulting services.

On April 20, 2017, we issued a six month convertible note in the amount of $100,000 with an annual interest rate of 10% to a related party.

On May 8, 2017,February 19, 2021, we issued 10,000,000681,818 shares of common stock, valued at $0.008 per share, for legal services and 1,000,000 shares of common stock, valued at $0.004$0.055 per share, for an investment in the Company’s Private Placement.

On July 6, 2017,March 25, 2021, we issued 2,000,0001,282,051 shares of common stock, valued at $0.0083 per share, for consulting services.

On July 24, 2017, we issued a six month convertible note in the amount of $28,000 with an annual interest rate of 12%.

On August 21, 2017, we issued 6,250,000 shares of common stock, valued at $0.004$0.078 per share, for an investment in the Company’s Private Placement.

On August 21, 2017, we issued 1,000,000 shares of common stock, valued at $0.0053 per share, for consulting services.

On August 28, 2017, we issued 2,000,000 shares of common stock, valued at $0.0063 per share, for consulting services.

On September 7, 2017, we issued a six month convertible note in the amount of $28,000 with an annual interest rate of 12%.

On September 20, 2017, we issued 3,000,000 shares of common stock, valued at $0.004 per share, for an investment in the Company’s Private Placement.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

No disclosure required.

Item 5. Other Information

None.

Item 6. Exhibits

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

22Date: May 13, 2021 

By:/s/Timothy G. Dixon

Timothy G. Dixon

President and Chief Executive Officer

(Principal Executive Officer)

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