Edgar Filing: THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

Form 10-K/A Amended Annual Report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

________________

FORM 10-K/A

(Amendment No. 1)

X .

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

For the fiscal year ended December 31, 2015

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

For the transition period from to

Commission File Number: 000-54554

_______________________________

Therapeutic Solutions International, Inc.

(Exact name of registrant as specified in its charter)


Nevada		45-1226465
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

4093 Oceanside Boulevard, Suite B

Oceanside, California 92056

(Address of principal executive offices, including zip code)

(760) 295-7208

(Registrant's telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

None

Securities registered pursuant to Section 12(g) of the Act:

Title of class

Common Stock, $0.001 par value per share

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes . No X .

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.

Yes . No X .

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

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 . No X .

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. X .

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

Large accelerated filer .

Accelerated filer .

Non-accelerated filer .

(Do not check if a smaller reporting company)

Smaller reporting company X .

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

The aggregate market value of the voting and non-voting common equity held by non-affiliates was $389,268 based on a closing price of $0.0028 as of June 30, 2015.

As of October 25, 2016, 740,251,000 shares of the registrant’s common stock, par value of $0.001 per share, were outstanding.

INDEX

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.


		PAGE NO
PART I

ITEM 1	BUSINESS	6
ITEM 1A	RISK FACTORS	12
ITEM 1B	UNRESOLVED STAFF COMMENTS	17
7ITEM 2	PROPERTIES	17
ITEM 3	LEGAL PROCEEDINGS	17
ITEM 4	MINE SAFETY DISCLOSURES	17

PART II

ITEM 5	MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES	18
ITEM 6	SELECTED FINANCIAL DATA	20
ITEM 7	MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	20
ITEM 7A	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	25
ITEM 8	FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA	26
ITEM 9	CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	26
ITEM 9A	CONTROLS AND PROCEDURES	26
ITEM 9B	OTHER INFORMATION	27

PART III

ITEM 10	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	27
ITEM 11	EXECUTIVE COMPENSATION	31
ITEM 12	SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS	32
ITEM 13	CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE	32
ITEM 14	PRINCIPAL ACCOUNTANT FEES AND SERVICES	32

PART IV

ITEM 15	EXHIBITS AND FINANCIAL STATEMENT SCHEDULES	33

SIGNATURES		35

PART I.

Explanatory Note

Theapeutic Solutions International, Inc. (the Company) is filing this Amendment No. 1 on Form 10-K/A (the Amended Form 10-K) to its Annual Report on Form 10-K for the fiscal year ended December 31, 2015 (the Original Form 10-K), which was originally filed with the Securities and Exchange Commission (SEC) on October 31, 2016 (the Original Filing Date), to amend and restate management’s conclusions regarding the effectiveness of disclosure controls and procedures and internal control over financial reporting as of December 31, 2015.

Management has concluded that its disclosure controls and procedures and internal control over financial reporting were not effective as of December 31, 2015 due to a material weakness in its internal control over financial reporting.

The Company’s consolidated financial statements as of and for the year ended December 31, 2015, which were included in the Original Filing, have not changed as a result of the material weakness. See Item 9A., “Controls and Procedures,” for discussion of management’s disclosure controls and procedures, management’s restated, annual report on internal control over financial reporting, changes in internal control over financial reporting. Accordingly, the Company hereby amends and replaces in its entirety Items 9A and adds a Risk Factor releated to Internal Comtrol in the Original Filing.

As required by Rule 12b-15, the Company’s principal executive officer and principal financial officer are providing new currently dated certifications. In addition, the Company is filing a new consent of PLS CPA, A Professional Corp . Accordingly, the Company hereby amends Item 15 in the Original Filing to reflect the filing of the new certifications and consent.

Except as described above, this Amended Filing does not amend, update or change any other items or disclosures in the Original Filing and does not purport to reflect any information or events subsequent to the filing date of the Original Filing. As such, the Company’s consolidated financial statements as of and for the year ended December 31, 2015, which were included in the Original Filing, have not changed as a result of the material weakness. This Amended Filing speaks only as of the date the Original Filing was filed, and the Company has not undertaken herein to amend, supplement or update any information contained in the Original Filing to give effect to any subsequent events. Accordingly, this Amended Filing should be read in conjunction with the Company’s filings made with the Securities and Exchange Commission subsequent to the filing of the Original Filing.

IMPORTANT PREFATORY NOTE

On April 28, 2014, we received a letter from Mr. J. Christopher Jaczko, a lawyer with the Procopio law firm in San Diego who represents Boyd Research, Inc. and related parties. In his letter, Mr. Jaczko notified us that our license to use the international patents for our AMPSA device, pursuant to our license agreement with his clients effective January 1, 2013, was terminated. The ostensible reason Mr. Jaczko gave was our failure to make certain unspecified payments due under the license agreement to his clients. We disputed the termination, but believed that the costs involved with litigating the termination of the license was not in the best interest of the Company and its shareholders. Therefore, the Company decided to move in new direction.

MolecuVax, Inc.

The Company previously announced that MolecuVax, Inc. (MVAX) was a partially-owned subsidiary of TSOI. On September 30, 2016, Mr. Gerry Berg, and Mr. Timothy Dixon resigned as Officers and Directors of MVAX and cancelled any and all equity in MVAX and have asserted certain contractual rights of our licensed patent to MVAX dated February 5^th, 2016. Our departure and subsequent cancellation of stock was due to an attempt at a hostile take-over of the Board of Directors of MVAX by other board members. In addition, on October 12, 2016, Dr. Thomas Ichim also resigned from MVAX as CEO and Director.

Capo Therapeutics, Inc.

The Company previously announced that TSOI held an equity stake in Capo Therapeutics, Inc. (CAPO). On September 30, 2016, Mr. Gerry Berg, and Mr. Timothy Dixon resigned as Officers and Directors of CAPO and cancelled any and all equity in CAPO. Our departure and subsequent cancellation of stock was due to an attempt at a hostile take-over of the Board of Directors of CAPO by other board members.

FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements, including statements about our business strategy, uncertainty regarding our future operating results and our profitability, anticipated sources of funds and all plans, objectives, expectations and intentions and any statements regarding future potential revenue, gross margins and our prospects for fiscal 2014 and thereafter. These statements may appear in a number of places and can be identified by the use of forward-looking terminology such as "may," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "future," "intend," or "certain" or the negative of these terms or other variations or comparable terminology, or by discussions of strategy.

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.

Actual results may vary materially from those in such forward-looking statements as a result of various factors, including those identified in "Item 1A. Risk Factors" and elsewhere in this document. No assurance can be given that the risk factors described in this Annual Report on Form 10-K are all of the factors that could cause actual results to vary materially from the forward-looking statements. Forward-looking statements are not guarantees of future performance. They involve risks, uncertainties, and assumptions. The Company's future results and shareholder values may differ materially from those expressed in these forward-looking statements. Readers are cautioned not to put undue reliance on any forward-looking statements. Forward-looking statements also include statements in which words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “consider,” or similar expressions are used. References in this Annual Report on Form 10-K to the “Company,” “TSOI,” “we,” “our,” and “us” refer to Therapeutic Solutions International, Inc.

ITEM 1

BUSINESS.

Corporate History

Therapeutic Solutions International, Inc. is a Nevada corporation which was incorporated on August 6, 2007 under the name “Friendly Auto Dealers, Inc.” In the first quarter of 2011, we acquired Splint Decisions Inc., and changed our name from Friendly Auto Dealers, Inc., to Therapeutic Solutions International, Inc. and our ticker symbol from “FYAD” to “TSOI.” This Annual Report on Form 10-K, and the financial statements included herein, reflect the treatment of Splint Decisions Inc., as the “accounting acquirer” in the transaction. Our principal executive office is located at 4093 Oceanside Blvd., Suite B, Oceanside, California 92056, our telephone number is (760) 295-7208 and our website is www.therapeuticsolutionsint.com. The reference to our website does not constitute incorporation by reference of the information contained on our website.

Our common stock is currently quoted on the Pink Sheets under the symbol TSOI. There currently is a limited public market for our common stock. A limited public market for our stock could make it difficult to sell your shares in our stock. The Company is currently delinquent in its reporting obligations with the Securities and Exchange Commission (“SEC”). The Company has not filed quarterly reports for the periods ending, March 31, 2016 and June 30, 2016. The Company’s common stock listing on the Pink Sheets currently has a “Yield” symbol affiliated with it indicating that there is limited public information available about the Company. The “Yield” affiliation also serves as a warning to potential investors that the Company may not be publishing adequate public information and only has published limited financial information and is delinquent in its SEC filings.

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 until April 28, 2014

Until April 28, 2014 the Company sold (directly and through distributors and sublicensees), in non-US countries, plastic intraoral devices known as Anterior Midpoint Stop Appliances (“AMPSA Products”). Our customers were dentists and doctors. The AMPSA Products, which are used for the treatment and prevention of common neurological and temporomandibular disorders including migraine headaches, migraine pain and bruxism.

On April 28, 2014, we received a letter from Mr. J. Christopher Jaczko, a lawyer with the Procopio law firm in San Diego who represents Boyd Research, Inc. and related parties. In his letter, Mr. Jaczko notified us that our license to use the international patents for our AMPSA device, pursuant to our license agreement with his clients effective January 1, 2013, was terminated. The ostensible reason Mr. Jaczko gave was our failure to make certain unspecified payments due under the license agreement to his clients. We disputed the termination, but believed that the costs involved with litigating the termination of the New License was not in the best interest of the Company and its shareholders. Therefore, the Company decided to move in new direction.

CURRENT BUSINESS DESCRIPTION

Therapeutic Solutions International, Inc. (“TSI”), is a public company (OTC:TSOI) 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 a well-accepted method to cure certain cancers, reduce recovery time from viral or bacterial infections and to prevent illness. On the other hand, inhibiting one’s immune system is vital for reducing inflammation, autoimmune disorders and allergic reactions.

TSI is developing a range of immune-modulatory agents to target certain cancers, improve maternal and fetal health, fight periodontal disease, and for daily health. The following discusses the focus of TSI on each of these programs:

Nutraceutical Division – TSI has been producing high quality nutraceuticals. Its flagship product, ProJuvenol^®, is a proprietary mixture containing pterostilbene – one of the most potent antioxidants known. TSOI filed a patent application for ProJuvenol^® on 07-08-2015 titled: “Augmentation of Oncology Immunotherapies by Pterostilbene Containing Compositions” as well as a second patent application filed 04-27-2016 titled “Augmentation Of Stem Cell Activity Using Pterostilbene And Compositions Containing Pterostilbene”. In addition we recently introduced a line of “oncologist friendly nutraceuticals” in liposome formula. These include CoQ10, Curcumin, Glutathione, and Vitamin-C in 16oz bottles.

OmniBiome, Inc. - is a partially-owned subsidiary of TSI, incorporated in the State of Delaware on October 20, 2015, where the intellectual property surrounding probiotics is housed. Current programs focus on the use of probiotics to prevent pre-term labor and on using probiotics to reverse periodontal disease. Mr. Dixon and Mr. Berg, of the Company, are also officers and Directors of Omni. As of October 25, 2016, TSI owns approximately 73.75% of the outstanding shares of OmniBiome. Website: http://omnibiomeinc.com

Summary

TSI has assembled a first-rate scientific advisory board that is leading the company into the most exciting and potentially profitable fields of medicine – immune modulation. TSI expects to launch several products that improve people’s health and well-being over the next several months.

Principle Products and Services

Clinical Stage Dexosome

TSOI recently licensed in 2016 a Dexosome Clinical Stage Cancer Immunotherapy Product from Gustave Roussy European Cancer Centre. Planning is still underway as to next steps.

Dexosomes are exosome nanoparticles generated by dendritic cells, which have previously been used by investigators at Anosys, Inc., in collaboration with researchers at Duke University, for treatment of cancer patients as part of an FDA-cleared Phase I clinical trial¹. The licensed patent was invented by internationally-renowned immunologists Sebastian Amigorena, Doctor at the Curie Institute, and Laurence Zitvogel, Professor at Gustave Roussy. The patent covers means of generating therapeutically-effective dexosomes, which can act as a platform for loading any tumor antigen desired.

In the area of drug development, much of the risk is taking the technology from the lab to the patient. We are fortunate that the current technology has already been utilized in patients under FDA jurisdiction, and has demonstrated safety with signs of efficacy.

The in-licensing of the current patent augments previously filed patent applications by TSOI, including one filed in November 2015, covering uses of exosomes to stimulate both innate and adaptive arms of the immune response². The Company plans to leverage the experience of its newest Board Member, Dr. Thomas Ichim, to lead the Dexosome program back into clinical trials. Dr. Ichim has previously patented the manipulation of exosomes in the area of cancer therapy for alleviation of immune suppression³, as well as being published in the peer-reviewed literature in this area⁴,⁵.

¹ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC551593/

² http://www.therapeuticsolutionsint.com/index.php/2015-04-19-16-05-26/228-therapeutic-solutions-international-files-patent-on-anticancer-nanotechnology-based-immunotherapy

³ http://www.google.com/patents/US8288172

⁴ Ichim et al. Exosomes as a tumor immune escape mechanism: possible therapeutic implications. J Transl Med. 2008 Jul 22;6:37. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2504474/

⁵ Abusamra et al. Tumor exosomes expressing Fas ligand mediate CD8+ T-cell apoptosis. Blood Cells Mol Dis. 2005 Sep-Oct;35(2):169-73. http://www.ncbi.nlm.nih.gov/pubmed/16081306

Nutraceutical Division (TSOI)

ProJuvenol^® is a powerful synergistic blend of complex anti-aging ingredients inspired by nature to help promote cellular rejuvenation and healthy functionality for everyday living, based upon pterostilbene, one of nature's unique and intelligent antioxidants/anti-inflammatories. ProJuvenol includes a scientifically valid blend of interactive ingredients with anti-aging and cellular protective properties to help support optimal health and provide the benefits of mental alertness and physical well-being.

Pterostilbene (pronounced "tero-STILL-bean") has created a buzz in the world of nutrition research. Scientists discovered this powerful antioxidant several decades ago and have since found that it rivals its cousin resveratrol's multi-functional abilities, and may actually exceed its anti-aging 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 levels of pterostilbene in the blood upon ingestion, 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.

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 covering the use of its ProJuvenol^® product, as well as various pterostilbene compositions, for use in augmenting efficacy of existing immuno-oncology drugs that are currently on the market. The patent is based on the ability of pterostilbene, one of the major ingredients of ProJuvenol^®, to reduce oxidative stress produced by cancer cells, which in turn protects the immune system from cancer mediated immune suppression.

Immuno-Oncology, described by Science Magazine as 'Breakthrough of the Year¹' 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 anticancer²,³, antioxidant⁴, and anti-inflammatory activities⁵. Through the filing of the recent patent, the company is exploring whether its lead product, ProJuvenol®, may be useful as a nutraceutical adjuvant to conventional cancer immunotherapies.

The importance of proper nutrition in the context of immunotherapy cannot be overstated. Studies on one of the original cancer immunotherapies, interleukin-2, demonstrated that efficacy was related to anti-oxidant content in the patients at time of therapy⁶. Accordingly, we are seeking through the current work to identify whether our currently marketed product, ProJuvenol®, may be utilized as part of an integrative approach to building up the immune response of cancer patients.

¹ Couzin-Frankel J. Breakthrough of the year 2013. Cancer immunotherapy. Science. 2013;342:1432-3. https://www.sciencemag.org/content/342/6165/1432.summary

² Yang et al. Pterostilbene exerts antitumor activity via the Notch1 signaling pathway in human lung adenocarcinoma cells. PLoS One. 2013 May 3;8(5):e62652. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3643961/

³ Li et al. Pterostilbene acts through metastasis-associated protein 1 to inhibit tumor growth, progression and metastasis in prostate cancer. PLoS One. 2013;8(3):e57542. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3586048/

⁴ McCormack and McFadden. A review of pterostilbene antioxidant activity and disease modification. Oxid Med Cell Longev. 2013;2013:575482. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3649683/

⁵ Qureshi et al. Inhibition of nitric oxide and inflammatory cytokines in LPS-stimulated murine macrophages by resveratrol, a potent proteasome inhibitor. Lipids Health Dis. 2012 Jul 10;11:76. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3393619/

⁶ Marcus et al. Severe hypovitaminosis C occurring as the result of adoptive immunotherapy with high-dose interleukin 2 and lymphokine-activated killer cells. Cancer Res. 1987 Aug 1;47(15):4208-12.

In addition on April 28, 2016 the Company filed a patent application covering the use of ProJuvenol^© and its active ingredient pterostilbene for augmentation of stem cell activity. Diseases such as diabetes¹, cardiovascular disease², and neurodegenerative diseases³ 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 risk⁴ and undergo accelerated neurological recovery after stroke⁵ as compared to patients with lower numbers of such stem cells.

¹ Moon et al. Circ J. 2012;76(9):2273-9. http://www.ncbi.nlm.nih.gov/pubmed/22664650

² Hill et al. N Engl J Med. 2003 Feb 13;348(7):593-600. http://www.ncbi.nlm.nih.gov/pubmed/12584367

³ Lee et al. Neurology. 2009 May 26;72(21):1858-63 http://www.ncbi.nlm.nih.gov/pubmed/19470969

⁴ Hill et al. N Engl J Med. 2003 Feb 13;348(7):593-600. http://www.ncbi.nlm.nih.gov/pubmed/12584367

⁵ Sobrino et al. Stroke. 2007 Oct;38(10):2759-64. https://www.ncbi.nlm.nih.gov/pubmed/17761925

TSOI markets currently two other nutraceuticals, T-Rx^®, a testosterone booster, and Vital^® Female, an estrogen booster and has just introduced a line of “oncologist friendly nutraceuticals” in liposome formula. These include CoQ10, Curcumin, Glutathione, and Vitamin-C in 16oz bottles. Website: www.youcanordernow.com


	ProJuvenol^® - Is a powerful synergistic blend of complex anti-aging ingredients inspired by nature to help promote cellular rejuvenation and healthy functionality for everyday living. Based upon one of nature's unique and intelligent anti- oxidants/anti-inflammatories.
	T-Rx^® - Is specifically designed just for men and is formulated to assist in increasing testosterone levels and keeping them high. The result is a significant increase in testosterone levels, which assist in adding lean muscle mass, bone density, increased energy and the reduction of fat.
	VITAL^® - Is specifically formulated for women and is designed to increase energy, increase bone density, reduce fat and improve muscle tone. Additionally this supplement will also optimize hormone levels, increase libido, and decrease symptoms of stress and anxiety.
	Coenzyme Q10 (CoQ10) is a substance similar to a vitamin. It is found in every cell of the body. Your body makes CoQ10, and your cells use it to produce energy your body needs for cell growth and maintenance. It also functions as an antioxidant, which protects the body from damage caused by harmful molecules.
	Curcumin is an anti-inflammatory molecule in the turmeric root, a relative of ginger. The properties of curcumin can best be summarized as protective of the integrity of bio molecules in the body by being both a fabulous antioxidant and anti-inflammatory all rolled up in one.
	Glutathione is one of the most powerful antioxidants that the body produces and is used to bind and remove toxins, including heavy metals such as mercury and lead from the body. Levels may drop as result of oxidative stress due to disease, drugs, aging, toxic chemicals, inflammation and stress. Adequate levels of glutathione are necessary to provide important antioxidant protection.
	Vitamin-C is absorbed at approximately 19%, the balance remains in the gastrointestinal tract to attract water and loosen the bowels. Liposomalized vitamin C is absorbed much more efficiently than traditional delivery methods. A huge advance in both efficiency and effectiveness of supplemental nutrients.

Fetal-Maternal Health

OmniBiome, Inc.

OmniBiome, Inc. a partially-owned subsidiary 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. Mr. Dixon and Mr. Berg, of the Company, are also officers and Directors of Omni. As of October 25, 2016, TSI owns approximately 73.75% of the outstanding shares of OmniBiome. Website: www.omnibiomeinc.com

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), as well as on restoring eubiosis (proper balance).

In parallel OmniBiome will build a database of aggregated patient data that will later inform development of Rx / therapeutic and medical device & drug-device combination approaches for treating the same conditions or diseases.

MicroBiome Targets

Certain microbiome target markets offer immediate revenue-generating business opportunities such as vaginal and lactal-duct microbiome banking & transplants from mother to child in the case of C-section-born babies, babies of non-nursing mothers, and children under 5 years of age receiving broad-spectrum antibiotics

OmniBiome’s main focus will be on developing Dx / Rx products & services for pregnancy-associated conditions or diseases where there is a documented or substantive putative link with microbiome dysbiosis and resulting inflammatory cascades

In parallel the Company will look to create alliances and/or out-license its Medical Device / Drug Device Combinations patent portfolio.

The Company also plans to in-license microbiome - and pregnancy-related Rx & Dx innovations from universities and research institutes – with several having been identified.

The Human Microbiome Link

The following microbiomes combined recapitulate approximately 75 - 80 % of the gut microbiome, hence OmniBiome sees no need to focus on the gut microbiome

The Vaginal Microbiome comprises approximately 300 - 600 species of bacteria. 100s of species are transferred to the newborn child orally as the baby passes thru the birth canal. C-section-born children miss this important microbiome transfer

The Breast Milk Microbiome contains between 200 - 700 species of bacteria and is transferred to the child via nursing. Babies of non-nursing mothers miss this equally important transfer.

The Oral Microbiome diversity spectrum also covers 600 species shared with the baby via kissing and sharing eating utensils – with both the mother & the father.

Licensed Patents

Patent titled "Prevention of Pregnancy Complications by Probiotic Administration." Press Release of 7/22/2015.

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. Press Release of 9/8/2015.

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. Press Release of 9/21/2015.

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. Press Release of 9/29/2015.

E-COMMERCE WEBSITE

The Company’s current e-commerce website, www.youcanordernow.com, seeks to speak directly and clearly to the user with the Company’s established brand platform and function as a tactical extension of the Company’s sales message.

In developing and implementing the Company’s website, the Company will continue to:

Establish and integrate an enterprise solution that allows it to sell products securely over the Internet, www.youcanordernow.com;

Provide a mobile interface that allows customers and medical professionals to acquire product data and purchase from a mobile device such as an iPhone;

Publish articles, news and white papers containing relevant information;

Allow customers and medical professionals accessing the website to create a contact form with database capture; and,

Provide for links to other Social Media websites where the Company will establish its brand identity, including Face Book, Twitter, et al.

OTHER MARKETING EFFORTS

The Company currently uses a number of other marketing efforts using the growing social media channels, FaceBook, YouTube, Twitter, Instagram, etc, which currently are becoming increasing more relevant for our marketing strategy.

MANUFACTURING AND ORDER FULLFILLMENT

The Company has located and vetted redundant “Certified Good Manufacturing Practices” (cGMP) manufacturing and production facilities and the Company’s initial products will be produced, warehoused and shipped through its existing corporate offices.

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.

Employees

As of December 31, 2015, we had three full-time employees, all non-union. We believe that our relations with our employees are good.

ITEM 1A

RISK FACTORS

As a smaller reporting company we are not required to provide a statement of risk factors. However, we believe this information may be valuable to our shareholders for this filing. We reserve the right to not provide risk factors in our future filings. Our primary risk factors and other considerations include:

This Annual Report on Form 10-K contains forward-looking statements concerning our future programs, expenses, revenue, liquidity and cash needs as well as our plans and strategies. These forward-looking statements are based on current expectations and we assume no obligation to update this information, except as required by applicable laws and regulations. Numerous factors could cause actual results to differ significantly from the results described in these forward-looking statements, including the following risk factors.

Internal Control

Our management has concluded that our internal control over financial reporting is not effective. Material weaknesses in our internal control over financial reporting could cause our financial reporting to be unreliable and could lead to misinformation being disseminated to the public.

Our management concluded that as of December 31, 2015 our internal control over financial reporting was not effective, and that material weaknesses existed in the following areas as of December 31, 2015:

(1)

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

(2)

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

(3)

we have ineffective controls over the period end financial disclosure and reporting process caused by reliance on third-party experts and/or consultants and insufficient accounting staff; and

(4)

we do not have a functioning audit committee of the Board of Directors and our Board of Directors, in its performance of the functions generally associated with audit committees, lacks a majority of (indeed, lacks any) independent members and lacks a majority of (indeed, lacks any) outside directors, resulting in ineffective oversight in the establishment and monitoring of required internal controls, approvals and procedures.

Our liquidity and capital resources are very limited.

Our ability to fund operating activities is also dependent upon our ability to access external sources of financing and our ability to effectively manage our expenses in relation to revenues. Our ability to fund working capital and anticipated capital expenditures will depend on our future performance, which is subject to general economic conditions specific to the health, supplements and nutrition products industries, consumer demand for our products, competition and other factors that are beyond our control. There can be no assurance that our operations and access to external sources of financing will continue to provide resources sufficient to satisfy our liabilities arising in the ordinary course of business.

We will require significant additional external financing to implement our business plan.

We will require external financing to sustain our operations, support our expansion, achieve or maintain profitability, or, should we become subject to unforeseen events or circumstances, continue as a going concern. There can be no assurance that we will be able to secure any such external financing, or, if we are able to secure such external financing, that it will be on terms favorable, or even acceptable, to us. Any inability to achieve or sustain profitability or otherwise secure external financing would have a material adverse effect on our business, financial condition, and results of operations, raising substantial doubts as to our ability to continue as a going concern, and we may ultimately be forced to seek protection from creditors under the bankruptcy laws or cease operations, which may result in a substantial or complete loss of invested capital.

We may not be able to effectively manage our potential growth and the execution of our business plan.

Our potential growth and the execution of our business plan together are likely to place significant strain on our managerial, operational and financial resources. To effectively manage our potential growth and execute our business plan, we will need to, among other things:

retain additional personnel across several departments in the Company;

develop strong customer loyalty for new products in a crowded competitive marketplace;

continue to establish and continue to increase awareness of our brands;

price our products and services at points which will allow us to maximize sales while at the same time maximizing gross profit margins;

establish, maintain, expand and manage multiple relationships with various vendors, strategic partners, licensees and other third parties, including suppliers of the products we sell on our website and elsewhere, warehousing distributors, shipping companies and others;

rapidly respond to competitive developments, particularly when new high-demand products become available;

build an operations structure to support our business and provide efficient and effective customer service and support;

expand our IT infrastructure to respond to increasing customer traffic to our website, demand for content from site users and to manage growing e-commerce transactions;

establish and maintain effective financial and management controls, reporting systems and procedures;

control our expenses;

provide competitive employee salaries and benefit packages; and,

avoid lawsuits and other adverse claims.

There can be no assurance that we will be able to accomplish any or all of the above goals. If we prove unable to effectively execute our business plan or manage our growth, it is likely to have a material adverse effect on our business, financial condition, including liquidity and profitability, and our results of operations.

If our proposed product sales model does not successfully operate at a profit our growth strategy may be impeded.

To effectively expand and meet our growth objectives our products sales model must be executed upon in a profitable manner. Profitability is dependent upon a variety of factors, some beyond our control, including, but not limited to the amount of traffic we can consistently attract to our brand, to retail sales in “brick and mortar” retailers, to our website, and our ability to stock or otherwise make available products that our customers purchase, our ability to stock or otherwise make available the best new products as they enter the market, our ability to provide consistent and superior customer service, the general economic conditions, particularly in the U.S., that could impact the amount of money customers spend collectively on the products we sell, and/or that could reduce the amount of money our average customer spends, and/or could reduce the number or frequency of repeat orders for products, and/or could result in customers finding products in other venues if they can find those products for a lower price. Other factors that could impact our ability to execute on our business model in a profitable manner include, but are not limited to, competition in our markets, recruiting, training and retaining qualified personnel and management, maintenance of required local, state and federal governmental approvals and permits, costs associated with principal component products and supplies, delivery shortages or interruptions, consumer trends, our ability to finance operations externally, changes in supply or prices of the products we sell and disruptions or business failures among our product suppliers, distributors, warehouses or shippers. Any failure to operate in a profitable manner could hurt our ability to meet our growth objectives by attracting licensees, and our business, financial condition, including liquidity and profitability, and our results of operations would be negatively affected.

If we cannot stock, warehouse or otherwise provide product to customers in a consistent, reliable and cost-effective manner our growth strategy may be impeded.

As our growth strategy depends to a large extent on our ability to sell various products to consumers on our website and in traditional “brick and mortar” retailers, if we cannot supply those products in a consistent, reliable and cost-effective manner, we may lose customers. To accomplish a consistent, reliable and cost-effective method for supplying product to customers, we must successfully engage with suppliers at a number of levels, including warehousing agreements, stocking agreements and other forms of distribution. Our ability to conclude such arrangements with specific product suppliers may involve the need for trade finance, purchasing agreement finance and other capital. In addition, we may encounter problems in fulfilling orders due to business conditions among the products companies themselves, many of which problems are beyond our control. If we are unable to establish and continue such agreements and structures with products companies, our growth strategy may be impeded, which could negatively affect our business, financial condition, including liquidity and profitability, and our results of operations.

We face significant competition for our products.

The markets in which we operate are intensely competitive, continually evolving and, in some cases, subject to rapid change. Our competitors include:

traditional and well established companies with recognized and well patronized brands in the nutritional supplements and health products industry segment;

entrenched nutritional supplements and health products companies with well known customer on-line services and portals and other high-traffic web sites that provide sales access to healthcare and nutritional supplements and related products; and

companies that focus on providing on-line and/or off-line healthcare related content, including some that promote competitor brands.

Many of our competitors have greater financial, technical, product development, marketing and other resources than we do. These companies may be better known than we are and have more customers than we do. We cannot provide assurance that we will be able to compete successfully against these companies or any alliances they have formed or may form. If we are unable to compete with one or more of our competitors, our growth strategy may be impeded, which could negatively affect our business, financial condition, including liquidity and profitability, and our results of operations.

Government regulation could adversely affect our business.

Our products and their associated component ingredients are subject to existing and potential government regulation. Our failure, or the failure of our business partners or third party providers, to accurately anticipate the application of laws and regulations affecting our products and the manner in which we deliver them, or any failure to comply, could create liability for us, result in adverse publicity, or negatively affect our business. In addition, new laws and regulations, or new interpretations of existing laws and regulations, may be adopted with respect to consumer protection and other issues, including pricing, products liability, copyrights and patents, distribution and characteristics and quality of products and services. We cannot predict whether these laws or regulations will change or how such changes will affect our business. Any of this government regulation could impact our growth strategy, which could negatively affect our business, financial condition, including liquidity and profitability, and our results of operations.

Third parties may claim that we are infringing their intellectual property, and we could suffer significant litigation or licensing expense or be prevented from providing certain services, and which may otherwise harm our business.

We could be subject to claims that we are misappropriating or infringing intellectual property, trade secrets or other proprietary rights of others. These claims, even if not meritorious, could be expensive to defend and divert management’s attention from our operations. If we become liable to third parties for infringing these rights, we could be required to pay substantial damage awards and to develop non-infringing products, obtain a license or cease selling the products that use or contain the infringing intellectual property. We may be unable to develop non-infringing products or obtain a license on commercially reasonable terms, or at all. Any claims against our company for infringement could impede our growth strategy, which could negatively affect our business, financial condition, including liquidity and profitability, and our results of operations.

We may be subject to claims brought against us as a result of product associated content we provide.

Consumers are reasonably expected to access health-related information regarding our products through our on-line web site. If our content, or content we obtain from third parties, contains inaccuracies, it is possible that consumers or others may sue us for various causes of action. Although our planned web site contains terms and conditions, including disclaimers of liability, that are intended to reduce or eliminate our liability, the law governing the validity and enforceability of on-line agreements with consumers that provide the terms and conditions for use of our public or private portals are unenforceable. A finding by a court that these agreements are invalid and that we are subject to liability could harm our business and require costly changes to our business. We have planned editorial procedures in place to provide quality control of the information that we publish or provide. However, we cannot assure you that our editorial and other quality control procedures will be sufficient to ensure that there are no errors or omissions in particular content. Even if potential claims do not result in liability to us, the fact that we would need to investigate and defend against these claims could be expensive and time consuming and could divert management’s attention away from our operations. In addition, our business is in part based on establishing a reputation amongst consumers that our portals as trustworthy and dependable sources of healthcare information. Allegations of impropriety or inaccuracy, even if unfounded, could therefore harm our reputation and business, which could negatively affect our business, financial condition, including liquidity and profitability, and our results of operations.

Changes in commodity and other operating costs or supply chain and business disruptions could adversely affect our results of operations.

Changes in product costs are a part of our business; any increase in the prices that suppliers charge for their products could adversely affect our operating results. We remain susceptible to increases in prices as a result of factors beyond our control, such as general economic conditions, seasonal fluctuations, weather conditions, demand, safety concerns, product recalls, labor disputes and government regulations. We rely on third-party distribution companies to deliver ingredients to our manufacturers and ultimately our products to customers. Interruption of distribution services due to financial distress or other issues could adversely affect our operations.

We face substantial competition in attracting and retaining qualified senior management and key personnel and may be unable to develop and grow our business if we cannot attract and retain such senior management and key personnel.

As an early stage company, our ability to develop and grow our business, to a large extent, depends upon our ability to attract, hire and retain highly qualified and knowledgeable senior management and key personnel who possess the skills and experience necessary to satisfy our business needs. Our ability to attract and retain such senior management and key personnel will depend on numerous factors, including our ability to offer salaries, benefits and professional growth opportunities that are comparable with and competitive to those offered by more established companies operating in our marketplace. We may be required to invest significant time and resources in attracting and retaining additional senior management and key personnel as needed. Moreover, many of the companies with which we will compete for any such individuals have greater financial and other resources, affording them the ability to undertake more extensive and aggressive hiring campaigns, than we can. The normal running of our operations may be interrupted, and our financial condition and results of operations negatively affected, as a result of any inability on our part to attract or retain the services of qualified and experienced senior management and key personnel, or should our prospective key personnel refuse to serve, or, once appointed, leave prior to a suitable replacement being found.

Risks Associated With Our Restricted Securities

Because there is currently a limited public trading market for our common stock, investor may not be able to resell stock.

Our stock is now traded in OTC Markets under the stock symbol TSOI, which results in a very illiquid and limited market for our common stock.

The Company is currently delinquent in its reporting obligations with the Securities and Exchange Commission (“SEC”). The Company has not filed quarterly reports for the periods ending March 31, 2016 and June 30, 2016. The Company’s common stock listing on the Pink Sheets currently has a “Yield” symbol affiliated with it indicating that there is limited public information available about the Company. The “Yield” affiliation also serves as a warning to potential investors that the Company may not be publishing adequate public information and only has published limited financial information and is delinquent in its SEC filings.

We have identified material weaknesses in our internal control over financial reporting.

We are required to comply with the provisions of Section 404 of the Sarbanes-Oxley Act of 2002, which require us to maintain an ongoing evaluation and integration of the internal controls of our business.

We evaluated our existing controls as of December 31, 2015. Our Chief Executive Officer and Chief Financial Officer identified material weaknesses in our internal control over financial reporting. A “material weakness” is a control deficiency, or combination of control deficiencies in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected. Readers are directed to review that portion of this Form 10-K entitled Item 9A Controls and Procedures for a detailed disclosure.

Under Section 404 and the SEC’s rules, a company cannot find that its internal control over financial reporting is effective if any “material weaknesses” exist in its controls over financial reporting.

Our business changed materially on April 28, 2014 when we lost the right to sell AMPSA Products.

Boyd Research Inc. gave notice to TSOI that we were in default on amounts owed for International Patent Maintenance Fees on April 28, 2014.

Section8.2(a) of the License Agreement provides that “if TSOI fails to cure [its] default within the applicable cure period, Licensor shall have the right to immediately terminate this Agreement.”

TSOI disputed the amounts owed but ultimately was unable to cure this default and Boyd Research Inc. exercised their contractual rights under the August 24, 2012 MDRA and terminated our license agreement to market AMPSA products Internationally.

There is currently no liquid trading market for our common stock and we cannot ensure that one will ever develop or be sustained.

The trading market for our common stock is currently not liquid. We cannot predict how liquid the market for our common stock might become. Our common stock is quoted in OTC Markets under the symbol TSOI.

Our common stock may be deemed a “penny stock”, which would make it more difficult for investors to sell their shares.

Our common stock is subject to the “penny stock” rules adopted under the Exchange Act. The penny stock rules apply to companies whose common stock is not listed on the NASDAQ Stock Market or other national securities exchange and trades at less than $4.00 per share, other than companies that have had average revenue of at least $6,000,000 for the last three years or that have tangible net worth of at least $5,000,000 ($2,000,000 if the company has been operating for three or more years). These rules require, among other things, that brokers who trade penny stock to persons other than “established customers” complete certain documentation, make suitability inquiries of investors and provide investors with certain information concerning trading in the security, including a risk disclosure document and quote information under certain circumstances. Many brokers have decided not to trade penny stocks because of the requirements of the penny stock rules and, as a result, the number of broker-dealers willing to act as market makers in such securities is limited. If we remain subject to the penny stock rules for any significant period, it could have an adverse effect on the market, if any, for our securities and investors may find it more difficult to dispose of our securities.

Offers or availability for sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.

If our stockholders have the right to sell substantial amounts of common stock in the public market, e.g. upon the expiration of any statutory holding period under Rule 144, it could create a circumstance commonly referred to as an “overhang” and in anticipation of which the market price of our common stock could fall. The existence of an overhang, whether or not sales have occurred or are occurring, also could make our ability to raise additional financing through the sale of equity or equity-related securities in the future, at a time and price that we deem reasonable or appropriate, more difficult.

The elimination of monetary liability against our directors and officers under the Company’s Articles of Incorporation and Nevada law, and the existence of indemnification rights to our directors, officers and employees, may result in substantial expenditures by the Company.

Article 6 of our Articles of Incorporation exculpates our directors and officers from certain monetary liabilities. Article 7 of our Articles of Incorporation provides that we shall indemnify all directors (and all persons serving at our request as a director or officer of another corporation) to the fullest extent permitted by Nevada law.

Further pursuant to Article 7, the expenses of the indemnified person incurred in defending a civil suit or proceeding must be paid by us as incurred and in advance of the final disposition of the action, suit, or proceeding under receipt of an undertaking by or on behalf of the indemnified person to repay the amount if it is ultimately determined by a court of competent jurisdiction that he or she is not entitled to be indemnified by us.

The foregoing indemnification obligations could result in us incurring substantial expenditures, which we may be unable to recoup. These provisions and resultant costs may also discourage us from bringing a lawsuit against directors and officers for breaches of their fiduciary duties even though such actions, if successful, might otherwise benefit us and our stockholders.

Public company compliance may make it more difficult to attract and retain officers and directors.

The Sarbanes-Oxley Act and related rules implemented by the SEC have required changes in corporate governance practices of public companies. As a public entity, these rules and regulations increase compliance costs and make certain activities more time consuming and costly. As a public entity, these rules and regulations also make it more difficult and expensive for us to obtain director and officer liability insurance and we may be required to accept reduced policy limits and coverage. As a result, it may be more difficult for us to attract and retain qualified persons to serve as directors or as executive officers.

We do not plan to pay any cash or stock dividends in the foreseeable future.

The payment of dividends upon our capital stock is solely within the discretion of our future board of directors and is dependent upon our financial condition, results of operations, capital requirements, restrictions contained in our future financing instruments and any other factors our board of directors may deem relevant. We have never declared or paid any cash or stock dividends on our capital stock and we currently anticipate that we will retain earnings, if any, to finance the development and expansion of our business and, as such, do not intend on paying any cash or stock dividends in the foreseeable future.

ITEM 1B

UNRESOLVED STAFF COMMENTS

No disclosure required.

ITEM 2

PROPERTIES.

We do not own any real-estate property or manufacturing equipment. Our business is conducted in approximately 1,300 square feet of rented offices and warehouse space located at 4093 Oceanside Blvd., Suite B, Oceanside, CA 92056.

ITEM 3

LEGAL PROCEEDINGS.

None.

ITEM 4

MINE SAFETY DISCLOSURES.

No disclosure required.

PART II

ITEM 5

MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

Our stock is now traded in OTC Markets under the stock symbol TSOI, which results in a very illiquid and limited market for our common stock. As of the date of Annual Report on Form 10-K there are approximately 137 stockholders of record of our common stock.

The following table sets forth the quarterly high and low closing sales prices for our common stock from January 1, 2014 through December 31, 2015.


Quarter Ended	High	Low
December 31, 2015	$0.011	$0.0025
September 30, 2015	$0.023	$0.0026
June 30, 2015	$0.0043	$0.0018
March 31, 2015	$0.0063	$0.0011
December 31, 2014	$0.004	$0.002
September 30, 2014	$0.0033	$0.0019
June 30, 2014	$0.0045	$0.0023
March 31, 2014	$0.0055	$0.0026

Dividends

We did not declare or pay dividends during 2014 to 2015.

Issuances of Unregistered Securities

On March 31, 2014, we issued 2,500,000 shares of common stock, valued at $.0035 per share, for consulting services.

On March 31, 2014, we issued 2,500,000 shares of common stock, valued at $.004 per share, for consulting services.

On March 31, 2014, we issued 2,000,000 shares of common stock, valued at $.0035 per share, for consulting services.

On March 31, 2014, we issued 5,000,000 shares of common stock, valued at $.004 per share, for legal services.

On June 19, 2014, we issued 45,000,000 shares of common stock, valued at $.003 per share, to an officer of the Company for a conversion of notes payable for accrued wages.

On September 30, 2014, we issued 26,562,500, shares of common stock, valued at $.002 per share, to an officer of the Company for a conversion of notes payable for accrued wages.

On September 30, 2014, we issued 21,476,435shares of common stock, valued at $.002 per share, to an officer of the Company for a conversion of notes payable for accrued wages.

On September 30, 2014, we issued 26,562,500 shares of common stock, valued at $.002 per share, to an officer of the Company for a conversion of notes payable for accrued wages.

On September 30, 2014, we issued 21,250,000 shares of common stock, valued at $.002 per share, to an officer of the Company for a conversion of notes payable for accrued wages.

On September 30, 2014, we issued 7,682,165 shares of common stock, valued at $.002 per share, to an officer of the Company for a conversion of notes payable for accrued wages.

On December 9, 2014, we issued 100,000,000 shares of common stock, valued at $.0021 per share, in regard to a Material Definitive Agreement (Form 8-K filed on December 10, 2014).

On March 27, 2015, we issued 20,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On February 27, 2015, we issued 2,000,000 shares of common stock, valued at $.0025 per share, for consulting services.

On April 1, 2015, we issued 10,000,000 shares of common stock, valued at $.0025 per share, for consulting services.

On April 17, 2015, we issued 20,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On June 1, 2015, we issued 3,000,000 shares of common stock, valued at $.0026 per share, for consulting services.

On June 1, 2015, we issued 7,000,000 shares of common stock, valued at $.0025 per share, for legal services

On June 8, 2015, we issued 1,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On July 15, 2015, we issued 1,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On August 31, 2015, we issued 10,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On September 25, 2015, we issued 10,000,000 shares of common stock, valued at $.0046 per share, for consulting services.

On October 1, 2015, we issued 23,000,000 shares of common stock, valued at $.0063 per share, for consulting services.

On October 13, 2015, we issued 2,500,000 shares of common stock, valued at $.0060 per share, for consulting services.

On October 14, 2015, we issued 2,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On October 16, 2015, we issued 4,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On November 9, 2015, we issued 3,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On November 23, 2015, we issued 20,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On November 30, 2015, we issued 2,500,000 shares of common stock, valued at $.01 per share, for legal services.

On January 4, 2016, we issued 2,500,000 shares of common stock, valued at $.0025 per share, for consulting services.

On January 22, 2016, we issued 2,500,000 shares of common stock, valued at $.0035 per share, for consulting services.

On February 1, 2016, we issued 2,500,000 shares of common stock, valued at $.003 per share, for consulting services.

On February 5, 2016, we issued 8,000,000 shares of common stock, valued at $.0025 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 $.003 per share, in regard to a License Agreement (Form 8-K filed on February 25, 2016).

On February 26, 2016, we issued 1,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On March 7, 2016, we issued 10,000,000 shares of common stock, valued at $.0004 per share, for consulting services.

On March 21, 2016, we issued 100,800,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement.

On May 2, 2016, we issued 1,000,000 shares of common stock, valued at $.0025 per share, for an investment in the Company’s Private Placement and 1,000,000 shares of common stock, valued at $.0025 per share, for consulting services.

On May 26, 2016, we issued 2,500,000 shares of common stock, valued at $.0066 per share, for consulting services.

On May 26, 2016, we issued 2,000,000 shares of common stock, valued at $.0025 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 $.0066 per share, for legal services.

On July 27, 2016, we filed with the Nevada Secretary of State a Certificate of Amendment to Articles of Incorporation to effect an amendment (the “Amendment”) changing the number of authorized shares of our common stock to 990,000,000.

On September 16, 2016, we issued 12,500,000 shares of common stock, valued at $.004 per share, for an investment in the Company’s Private Placement.

On October 18, 2016, we issued 40,000,000 shares valued at $.0045 to the officers and directors of the Company for services, and 5,000,000 shares valued at $.0045 for consulting services.

Repurchases/Cancellation of Securities

We made no repurchases of our securities for the years ended 2014-2015.

ITEM 6

SELECTED FINANCIAL DATA.

No disclosure required.

ITEM 7

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion is intended to assist in the understanding and assessment of significant changes and trends related to the results of operations and financial condition of the Company. The following discussion contains forward-looking statements that involve risks and uncertainties. See “Forward-Looking Statements” elsewhere in this Annual Report on Form 10-K. This discussion and analysis should be read in conjunction with our financial statements and notes thereto included elsewhere in this Annual Report on Form 10-K for the fiscal year ended December 31, 2015.

Therapeutic Solutions International, Inc. is a Nevada corporation which was incorporated on August 6, 2007 under the name “Friendly Auto Dealers, Inc.” In the first quarter of 2011, we acquired Splint Decisions, Inc., and changed our name from Friendly Auto Dealers, Inc., to Therapeutic Solutions International, Inc., and our ticker symbol from “FYAD” to “TSOI.” This Annual Report on Form 10-K, and the financial statements included herein, reflect the treatment of Splint Decisions, Inc., as the “accounting acquirer” in the transaction. Our principal executive office is located at 4093 Oceanside Blvd., Suite B, Oceanside, California 92056, our telephone number is (760) 295-7208 and our website is www.therapeuticsolutionsint.com. The reference to our website does not constitute incorporation by reference of the information contained on our website.

Description of Business until April 28, 2014

Until April 28, 2014 the Company sold (directly and through distributors and sublicensees), in non-US countries, plastic intraoral devices known as Anterior Midpoint Stop Appliances (“AMPSA Products”). Our customers were dentists and doctors. The AMPSA Products are used for the treatment and prevention of common neurological and temporomandibular disorders including migraine headaches, migraine pain and bruxism.

On April 28, 2014, we received a letter from Mr. J. Christopher Jaczko, a lawyer with the Procopio law firm in San Diego who represents Boyd Research, Inc., and related parties. In his letter, Mr. Jaczko notified us that our license to use the international patents for our AMPSA device, pursuant to our license agreement with his clients effective January 1, 2013, was terminated. The ostensible reason Mr. Jaczko gave was our failure to make certain unspecified payments due under the license agreement to his clients. We disputed the termination, but believed that the costs involved with litigating the termination of the New License was not in the best interest of the Company and its shareholders. Therefore, the Company decided to move in new direction.

CURRENT BUSINESS DESCRIPTION

Therapeutic Solutions International is a public company (OTC:TSOI) 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.

TSI is developing a range of immune-modulatory agents to target certain cancers, improve maternal and fetal health, fight periodontal disease, and for daily health. TSI has created several subsidiaries and divisions to focus on each of these programs:

Nutraceutical Division – TSI has been producing very high quality nutraceuticals. Its flagship product, ProJuvenol^®, is a proprietary mixture containing pterostilbene – one of the most potent antioxidants known. TSOI filed a patent application for ProJuvenol^® on 07-08-2015 titled: “Augmentation of Oncology Immunotherapies by Pterostilbene Containing Compositions” as well as a second patent application filed 04-27-2016 titled “Augmentation Of Stem Cell Activity Using Pterostilbene And Compositions Containing Pterostilbene”. In addition we recently introduced a line of “oncologist friendly nutraceuticals” in liposome formula. These include CoQ10, Curcumin, Glutathione, and Vitamin-C in 16oz bottles..

OmniBiome, Inc. - is a partially-owned subsidiary of TSI where the intellectual property surrounding probiotics is housed. Current programs focus on the use of probiotics to prevent pre-term labor and on using probiotics to reverse periodontal disease. Mr. Dixon and Mr. Berg, of the Company, are also officers and Directors of Omni. As of October 25, 2016, TSI owns approximately 73.75% of the outstanding shares of OmniBiome. Website: http://omnibiomeinc.com

Summary

Clinical Stage Dexosome

TSOI recently licensed January 2016 a Dexosome Clinical Stage Cancer Immunotherapy Product from Gustave Roussy European Cancer Centre. Planning is still underway as to next steps.

¹ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC551593/

² http://www.therapeuticsolutionsint.com/index.php/2015-04-19-16-05-26/228-therapeutic-solutions-international-files-patent-on-anticancer-nanotechnology-based-immunotherapy

³ http://www.google.com/patents/US8288172

⁴ Ichim et al. Exosomes as a tumor immune escape mechanism: possible therapeutic implications. J Transl Med. 2008 Jul 22;6:37. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2504474/

⁵ Abusamra et al. Tumor exosomes expressing Fas ligand mediate CD8+ T-cell apoptosis. Blood Cells Mol Dis. 2005 Sep-Oct;35(2):169-73. http://www.ncbi.nlm.nih.gov/pubmed/16081306

Nutraceutical Division (TSOI)

ProJuvenol^® is a powerful synergistic blend of complex anti-aging ingredients inspired by nature to help promote cellular rejuvenation and healthy functionality for everyday living. Based upon pterostilbene, one of nature's unique and intelligent antioxidants/anti-inflammatories. ProJuvenol includes a scientifically valid blend of interactive ingredients with anti-aging and cellular protective properties to help support optimal health and provide the benefits of mental alertness and physical well-being.

Patents:

Pterostilbene, which is chemically related to resveratrol, has been published to possess anticancer²,³, antioxidant⁴, and anti-inflammatory activities⁵. Through the filing of the recent patent, the company is exploring whether its lead product, ProJuvenol^®, may be useful as a nutraceutical adjuvant to conventional cancer immunotherapies.

The importance of proper nutrition in the context of immunotherapy cannot be overstated. Studies on one of the original cancer immunotherapies, interleukin-2, demonstrated that efficacy was related to anti-oxidant content in the patients at time of therapy⁶. Accordingly, we are seeking through the current work to identify whether our currently marketed product, ProJuvenol^®, may be utilized as part of an integrative approach to building up the immune response of cancer patients.