THERAPEUTIC SOLUTIONS INTERNATIONAL, INC. (Form: 10-Q, Received: 05/16/2023 14:33:02)

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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 ☐

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 ☐

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.

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

As of May 15, 2023, 3,021,589,908 shares of the registrant’s common stock, par value of $0.001 per shares, were outstanding.

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:

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.

	●	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, 2022.

		PAGE
	PART 1. Financial Information

Item 1.	Financial Statements (Unaudited)	F-1

	Condensed Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022 (Audited)	F-1

	Condensed Consolidated Statements of Operations for the three months ended March 31, 2023 and 2022	F-2

	Condensed Consolidated Statement of Changes in Shareholders’ Equity (Deficit) for the Period from January 1, 2023 to March 31, 2023 and January 1, 2022 to March 31, 2022	F-3

	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 2022	F-4

	Notes to Condensed Consolidated Financial Statements	F-5

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	4
Item 3.	Item 3. Quantitative and Qualitative Disclosures about Market Risk	24
Item 4.	Item 4. Controls and Procedures	24

	PART II. Other Information
Item 1.	Legal Proceedings	25
Item 1A.	Risk Factors	25
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	25
Item 3.	Defaults upon Senior Securities	26
Item 4.	Mine Safety Disclosures	26
Item 5.	Other Information	26
Item 6.	Exhibits	26
	Signatures	27

	March 31, 2023			December 31, 2022
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	18,531		$	18,040
Restricted cash		11,003			11,003
Accounts receivable		17,726			25,398
Inventory		35,685			42,428
Prepaid expenses and other current assets		117,506			212,352
Total current assets		200,451			309,221

Property and equipment, net		270,358			273,078
Right-of-use asset		144,226			8,612
Other assets		2,934,774			3,014,620

Total assets	$	3,549,809		$	3,605,531

LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)

Current liabilities:
Accounts payable	$	391,712		$	401,992
Accounts payable-related parties		7,217			7,209
Accounts payable
Accrued expenses and other current liabilities		544,913			531,783
Lease liability		24,119			8,612
Notes payable, current portion		4,638			4,638
Convertible notes payable, net of discount of $146,464 and $175,063, at March 31, 2023 and December 31, 2022, respectively		60,536			65,187
Notes payable-related parties, net		995,143			988,672
Notes payable
Derivative liabilities		227,077			202,144
Total current liabilities		2,255,355			2,210,237

LONG TERM LIABILITIES
Notes payable, net of current portion		9,296			10,507
Lease liability, net of current portion		120,107			-
TOTAL LIABILITIES		2,384,758			2,220,744

Commitments and contingencies		-			-

Shareholders' Equity (Deficit):
Preferred stock, $0.001 par value; 5,000,000 shares authorized, 2 shares and 2 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively		-			-
Common stock, $0.001 par value; 4,500,000,000 shares authorized; 2,748,956,631 and 2,617,390,830 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively.		2,748,958			2,617,392
Additional paid-in capital		16,677,708			16,334,129
Shares to be issued		9,324			126,324
Subscription receivable		(21,000	)		(21,000	)
Accumulated deficit		(18,249,939	)		(17,672,058	)
Total shareholders' equity (deficit)		1,165,051			1,384,787

Total liabilities and shareholders' equity (deficit)	$	3,549,809		$	3,605,531

	For the Three Months Ended March 31, 2023			For the Three Months Ended March 31, 2022

Net sales	$	23,123		$	84,898
Cost of goods sold		8,466			15,938

Gross profit		14,657			68,960

Operating expenses:
General and administrative		119,401			40,007
Salaries, wages, and related costs		110,525			114,285
Consulting fees		69,284			87,116
Legal and professional fees		92,587			50,092
Research and development		52,727			304,159
Total operating expenses		444,524			595,659

Loss from operations		(429,867	)		(526,699	)

Other income (expense):
Loss on derivative liabilities		18,134			(66,532	)
Change in fair value of derivative liabilities		(44,336	)		142,306
Interest expense		(121,812	)		(149,998	)
Total other income (expense)		(148,014	)		(74,224	)

LOSS BEFORE PROVISION FOR INCOME TAXES		(577,881	)		(600,923	)

Provision for income taxes		-			-

Net loss	$	(577,881	)	$	(600,923	)

Net loss per share - basic and diluted	$	(0.00	)	$	(0.00	)

Weighted average shares outstanding - basic and diluted		2,692,056,744			2,393,701,868

	Shares		Amount		Shares		Amount		Capital		Issued		Receivable			Deficit			Deficit

	Series A Preferred Stock				Common Stock				Additional Paid-in		Shares to be		Subscription			Accumulated			Total Shareholders’
	Shares		Amount		Shares		Amount		Capital		Issued		Receivable			Deficit			Deficit
December 31, 2021		-	$	-		2,311,123,860	$	2,311,125	$	10,899,139	$	-	$	(21,000	)	$	(13,994,246	)	$	(804,982	)

Common stock issued for salaries		-		-		1,034,482		1,034		28,965		-		-			-			29,999
Common stock issued for cash		-		-		44,500,000		44,500		400,500		-		(100,000	)		-			345,000
Common stock issued for license		-		-		149,402,390		149,402		2,958,168		-		-			-			3,107,570
Common stock issued for conversion of convertible notes, accrued interest, and derivative liabilities		-		-		8,937,448		8,937		219,428		-		-			-			228,365
Net loss		-		-		-		-		-		-		-			(600,923	)		(600,923	)

March 31, 2022		-	$	-		2,514,998,180	$	2,514,998	$	14,506,200	$	-	$	(121,000	)	$	(14,595,169	)	$	2,305,029

☐	Large accelerated filer	☐	Accelerated filer
☒	Non-accelerated filer	☒	Smaller reporting company
☐	Emerging growth company

	For the Three Months Ended March 31, 2023			For the Three Months Ended March 31, 2022

Cash flows from operating activities
Net loss	$	(577,881	)	$	(600,923	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation to related parties		19,600			-
Loss on derivative liabilities		(18,134	)		66,532
Change in fair value of derivative liabilities		44,336			(142,306	)
Amortization of prepaid stock-based compensation		60,943			303,056
Amortization of debt discount		106,664			134,031
Patent amortization		74,194			5,693
Depreciation		2,720			1,163
Changes in operating assets and liabilities:
Accounts receivable		7,672			(19,721	)
Inventory		6,743			383
Prepaid expenses and other current assets		37,605			17,021
Right-of-use asset		10,630			6,261
Accounts payable		(10,283	)		(21,586	)
Accounts payable - related parties		8			(2,451	)
Accrued expenses and other current liabilities		44,735			44,243
Lease liability		(10,630	)		(6,261	)
Net cash used in operating activities		(201,078	)		(214,865	)

CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of license		-			(200,000	)
Issuance of note receivable		1,951			-
Net cash used in investing activities		1,951			(200,000	)

Cash flows from financing activities
Payments on notes payable to related party		(8	)		(2,404	)
Proceeds from convertible notes payable		70,750			145,000
Payments on notes payable		(1,210	)		(1,077	)
Proceeds from sale of common stock		130,086			345,000
Net cash provided by financing activities		199,618			486,519

Net increase (decrease) in cash, cash equivalents and restricted cash		491			71,654
Cash, cash equivalents and restricted cash at beginning of period		29,043			104,259
Cash, cash equivalents and restricted cash at end of period	$	29,534		$	175,913

Supplemental cash flow information:
Cash paid for interest	$	663		$	710
Cash paid for income taxes	$	-		$	-

Non-cash investing and financing transactions:
Original issuance discount on convertible notes payable	$	8,500		$	11,250
Debt discount recorded in connection with derivative liability	$	69,565		$	145,000
Common stock issued in conversion of convertible notes payable and interest	$	188,459		$	228,365
Common stock issued for accrued salaries	$	20,000		$	29,999
Accrued interest added to principal	$	6,479		$	6,478
Common stock issued for license	$	146,244		$	3,107,570
Common stock issued for subscription receivable	$	-		$	100,000
Right of use asset and lease liability	$	146,244		$	-

Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets:
Cash and cash equivalents	$	18,531		$	165,690
Restricted cash		11,003			10,223
Total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows:	$	29,534		$	175,913

	1)	Identify the contract with a customer.

	2)	Identify the performance obligations in the contract.

	3)	Determine the transaction price.

	4)	Allocate the transaction price to the performance obligations in the contract.

	5)	Recognize revenue when (or as) the entity satisfies a performance obligation.

Balance, December 31, 2022	$	202,144
Issuance of new derivative liabilities		77,856
Conversions		(97,259	)
Change in fair market value of derivative liabilities		44,336
Balance, March 31, 2023	$	227,077

	March 31, 2023		December 31, 2022

Prepaid consulting	$	84,918	$	148,550
Insurance		856		1,141
Prepaid costs		31,732		62,661
Total	$	117,506	$	212,352

	March 31, 2023			December 31, 2022

Land	$	235,223		$	235,223
Vehicles		50,514			50,514
Computer hardware		6,135			6,135
Office furniture and equipment		7,912			7,912
Shipping and other equipment		1,575			1,575
Total		301,359			301,359
Accumulated depreciation		(31,001	)		(28,281	)
Property and equipment, net	$	270,358		$	273,078

	March 31, 2023			December 31, 2022

Licenses	$	3,261,122		$	3,261,122
Accumulated amortization		(332,355	)		(258,162	)
Licenses, net	$	2,928,767		$	3,002,960

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

	●	NanoStilbene® is an easily absorbed nanoemulsion of nanoparticle pterostilbene derived from the ‘047 patent.

	●	DermalStilbene is a topical form of pterostilbene delivered via spray application onto skin, derived from the ‘047 patent.

	●	IsoStilbene an injectable formulation of pterostilbene is available by prescription only, derived from the ‘047 patent.

	●	NeuroStilbene is an intranasal form of pterostilbene delivered via spray application inside the nostril, derived from the ‘047 patent.

	●	NanoPSA is a blend of NanoStilbene® and Broccoli Sprout Extract (BSE) providing 74mg of BSE and 125mg of our patented NanoStilbene, a proprietary formulation of nanoparticle pterostilbene.

	●	NLRP3 Trifecta is a two-product combo and consists of one bottle of NanoPSA and one bottle of GTE-50 green tea extract.

	●	QuadraMune® is a multi-patented synergistic blend of pterostilbene, sulforaphane, epigallocatechingallate, and thymoquinone.

	●	product claims and advertising;
	●	product labels;
	●	product ingredients; and
	●	how we package, distribute, import, export, sell and store our products.

	●	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.

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

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

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

EXHIBIT NUMBER		DESCRIPTION
31.1		Rule 13a-14(a)/Section 302 Certification of Principal Executive Officer
31.2		Rule 13a-14(a)/Section 302 Certification of Principal Financial Officer
32.1		Certification pursuant to 18 U.S.C. Section 1350/Rule 13a-14(b)
101.INS		Inline XBRL Instance Document
101.SCH		Inline XBRL Taxonomy Extension Schema Linkbase Document.
101.CAL		Inline XBRL Taxonomy Calculation Linkbase Document.
101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB		Inline XBRL Taxonomy Label Linkbase Document.
101.PRE		Inline XBRL Taxonomy Presentation Linkbase Document.
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

Date: May 15, 2023

By:	/s/ Timothy G. Dixon
	Timothy G. Dixon
	President and Chief Executive Officer
	(Principal Executive Officer)

Dated: May 15, 2023

/s/ Timothy G. Dixon
Timothy G. Dixon
President and Chief Executive Officer
(Principal Executive Officer)

By:	/s/ Timothy G. Dixon
	Timothy G. Dixon
	Chief Executive Officer and President
	(Principal Executive Officer)
	Chief Financial Officer
	(Principal Financial Officer)