10-K 1 form10-k.htm
false FY 0001419051 0001419051 2023-01-01 2023-12-31 0001419051 2023-06-30 0001419051 2024-04-15 0001419051 2023-12-31 0001419051 2022-12-31 0001419051 us-gaap:NonrelatedPartyMember 2023-12-31 0001419051 us-gaap:NonrelatedPartyMember 2022-12-31 0001419051 us-gaap:RelatedPartyMember 2023-12-31 0001419051 us-gaap:RelatedPartyMember 2022-12-31 0001419051 2022-01-01 2022-12-31 0001419051 us-gaap:PreferredStockMember us-gaap:SeriesAPreferredStockMember 2021-12-31 0001419051 us-gaap:CommonStockMember 2021-12-31 0001419051 us-gaap:AdditionalPaidInCapitalMember 2021-12-31 0001419051 TSOI:SharesToBeIssuedMember 2021-12-31 0001419051 us-gaap:ReceivablesFromStockholderMember 2021-12-31 0001419051 us-gaap:RetainedEarningsMember 2021-12-31 0001419051 us-gaap:NoncontrollingInterestMember 2021-12-31 0001419051 2021-12-31 0001419051 us-gaap:PreferredStockMember us-gaap:SeriesAPreferredStockMember 2022-12-31 0001419051 us-gaap:CommonStockMember 2022-12-31 0001419051 us-gaap:AdditionalPaidInCapitalMember 2022-12-31 0001419051 TSOI:SharesToBeIssuedMember 2022-12-31 0001419051 us-gaap:ReceivablesFromStockholderMember 2022-12-31 0001419051 us-gaap:RetainedEarningsMember 2022-12-31 0001419051 us-gaap:NoncontrollingInterestMember 2022-12-31 0001419051 us-gaap:PreferredStockMember us-gaap:SeriesAPreferredStockMember 2022-01-01 2022-12-31 0001419051 us-gaap:CommonStockMember 2022-01-01 2022-12-31 0001419051 us-gaap:AdditionalPaidInCapitalMember 2022-01-01 2022-12-31 0001419051 TSOI:SharesToBeIssuedMember 2022-01-01 2022-12-31 0001419051 us-gaap:ReceivablesFromStockholderMember 2022-01-01 2022-12-31 0001419051 us-gaap:RetainedEarningsMember 2022-01-01 2022-12-31 0001419051 us-gaap:NoncontrollingInterestMember 2022-01-01 2022-12-31 0001419051 us-gaap:PreferredStockMember us-gaap:SeriesAPreferredStockMember 2023-01-01 2023-12-31 0001419051 us-gaap:CommonStockMember 2023-01-01 2023-12-31 0001419051 us-gaap:AdditionalPaidInCapitalMember 2023-01-01 2023-12-31 0001419051 TSOI:SharesToBeIssuedMember 2023-01-01 2023-12-31 0001419051 us-gaap:ReceivablesFromStockholderMember 2023-01-01 2023-12-31 0001419051 us-gaap:RetainedEarningsMember 2023-01-01 2023-12-31 0001419051 us-gaap:NoncontrollingInterestMember 2023-01-01 2023-12-31 0001419051 us-gaap:PreferredStockMember us-gaap:SeriesAPreferredStockMember 2023-12-31 0001419051 us-gaap:CommonStockMember 2023-12-31 0001419051 us-gaap:AdditionalPaidInCapitalMember 2023-12-31 0001419051 TSOI:SharesToBeIssuedMember 2023-12-31 0001419051 us-gaap:ReceivablesFromStockholderMember 2023-12-31 0001419051 us-gaap:RetainedEarningsMember 2023-12-31 0001419051 us-gaap:NoncontrollingInterestMember 2023-12-31 0001419051 TSOI:ResNovaBioIncMember 2023-12-31 0001419051 TSOI:CampbellNeurosciencesIncMember 2023-12-31 0001419051 srt:ScenarioPreviouslyReportedMember 2022-12-31 0001419051 srt:RestatementAdjustmentMember 2022-12-31 0001419051 srt:RevisionOfPriorPeriodReclassificationAdjustmentMember 2022-12-31 0001419051 srt:ScenarioPreviouslyReportedMember 2022-01-01 2022-12-31 0001419051 srt:RestatementAdjustmentMember 2022-01-01 2022-12-31 0001419051 srt:RevisionOfPriorPeriodReclassificationAdjustmentMember 2022-01-01 2022-12-31 0001419051 us-gaap:LandMember 2023-12-31 0001419051 us-gaap:LandMember 2022-12-31 0001419051 us-gaap:VehiclesMember 2023-12-31 0001419051 us-gaap:VehiclesMember 2022-12-31 0001419051 us-gaap:ComputerEquipmentMember 2023-12-31 0001419051 us-gaap:ComputerEquipmentMember 2022-12-31 0001419051 TSOI:OfficeFurnitureAndEquipmentMember 2023-12-31 0001419051 TSOI:OfficeFurnitureAndEquipmentMember 2022-12-31 0001419051 TSOI:ShippingAndOtherEquipmentMember 2023-12-31 0001419051 TSOI:ShippingAndOtherEquipmentMember 2022-12-31 0001419051 TSOI:NotesPayableOneMember us-gaap:RelatedPartyMember 2023-12-31 0001419051 TSOI:NotesPayableOneMember us-gaap:RelatedPartyMember 2022-12-31 0001419051 TSOI:NotesPayableTwoMember us-gaap:RelatedPartyMember 2023-12-31 0001419051 TSOI:NotesPayableTwoMember us-gaap:RelatedPartyMember 2022-12-31 0001419051 TSOI:NotesPayableThreeMember us-gaap:RelatedPartyMember 2023-12-31 0001419051 TSOI:NotesPayableThreeMember us-gaap:RelatedPartyMember 2022-12-31 0001419051 TSOI:NotesPayableFourMember us-gaap:RelatedPartyMember 2023-12-31 0001419051 TSOI:NotesPayableFourMember us-gaap:RelatedPartyMember 2022-12-31 0001419051 TSOI:NotesPayableFiveMember us-gaap:RelatedPartyMember 2023-12-31 0001419051 TSOI:NotesPayableFiveMember us-gaap:RelatedPartyMember 2022-12-31 0001419051 us-gaap:RelatedPartyMember TSOI:NotesPayableOneMember 2023-01-01 2023-12-31 0001419051 us-gaap:RelatedPartyMember TSOI:NotesPayableOneMember 2022-01-01 2022-12-31 0001419051 us-gaap:RelatedPartyMember TSOI:NotesPayableTwoMember 2023-01-01 2023-12-31 0001419051 us-gaap:RelatedPartyMember TSOI:NotesPayableTwoMember 2022-01-01 2022-12-31 0001419051 us-gaap:RelatedPartyMember TSOI:NotesPayableFourMember 2023-01-01 2023-12-31 0001419051 us-gaap:RelatedPartyMember TSOI:NotesPayableFourMember 2022-01-01 2022-12-31 0001419051 us-gaap:RelatedPartyMember TSOI:NotesPayableFiveMember 2023-01-01 2023-12-31 0001419051 us-gaap:RelatedPartyMember TSOI:NotesPayableFiveMember 2022-01-01 2022-12-31 0001419051 TSOI:OfficersAndDirectorsMember 2023-01-01 2023-12-31 0001419051 TSOI:OfficersAndDirectorsMember 2022-01-01 2022-12-31 0001419051 TSOI:ConvertiblePromissoryNoteMember 2023-12-31 0001419051 TSOI:ConvertiblePromissoryNoteMember 2022-12-31 0001419051 TSOI:ConvertiblePromissoryNoteMember 2023-01-01 2023-12-31 0001419051 TSOI:ConvertiblePromissoryNoteMember 2022-01-01 2022-12-31 0001419051 us-gaap:DerivativeMember 2023-01-01 2023-12-31 0001419051 us-gaap:MeasurementInputConversionPriceMember srt:MinimumMember 2023-12-31 0001419051 us-gaap:MeasurementInputConversionPriceMember srt:MaximumMember 2023-12-31 0001419051 us-gaap:MeasurementInputSharePriceMember srt:MinimumMember 2023-12-31 0001419051 us-gaap:MeasurementInputSharePriceMember srt:MaximumMember 2023-12-31 0001419051 us-gaap:MeasurementInputExpectedDividendRateMember 2023-12-31 0001419051 us-gaap:MeasurementInputPriceVolatilityMember srt:MinimumMember 2023-12-31 0001419051 us-gaap:MeasurementInputPriceVolatilityMember srt:MaximumMember 2023-12-31 0001419051 us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MinimumMember 2023-12-31 0001419051 us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MaximumMember 2023-12-31 0001419051 us-gaap:MeasurementInputExpectedTermMember 2023-01-01 2023-12-31 0001419051 TSOI:ConvertibleNotesMember 2023-01-01 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputConversionPriceMember srt:MinimumMember 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputConversionPriceMember srt:MaximumMember 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputSharePriceMember srt:MinimumMember 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputSharePriceMember srt:MaximumMember 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputExpectedDividendRateMember 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputPriceVolatilityMember srt:MinimumMember 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputPriceVolatilityMember srt:MaximumMember 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MinimumMember 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MaximumMember 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MinimumMember 2023-01-01 2023-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MaximumMember 2023-01-01 2023-12-31 0001419051 TSOI:RemainingConvertibleNotesMember 2023-12-31 0001419051 TSOI:RemainingConvertibleNotesMember 2023-01-01 2023-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputExercisePriceMember 2023-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputSharePriceMember 2023-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputExpectedDividendRateMember 2023-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputPriceVolatilityMember srt:MinimumMember 2023-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputPriceVolatilityMember srt:MaximumMember 2023-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputRiskFreeInterestRateMember 2023-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MinimumMember 2023-01-01 2023-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MaximumMember 2023-01-01 2023-12-31 0001419051 us-gaap:DerivativeMember 2022-01-01 2022-12-31 0001419051 us-gaap:MeasurementInputConversionPriceMember srt:MinimumMember 2022-12-31 0001419051 us-gaap:MeasurementInputConversionPriceMember srt:MaximumMember 2022-12-31 0001419051 us-gaap:MeasurementInputSharePriceMember srt:MinimumMember 2022-12-31 0001419051 us-gaap:MeasurementInputSharePriceMember srt:MaximumMember 2022-12-31 0001419051 us-gaap:MeasurementInputExpectedDividendRateMember 2022-12-31 0001419051 us-gaap:MeasurementInputPriceVolatilityMember srt:MinimumMember 2022-12-31 0001419051 us-gaap:MeasurementInputPriceVolatilityMember srt:MaximumMember 2022-12-31 0001419051 us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MinimumMember 2022-12-31 0001419051 us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MaximumMember 2022-12-31 0001419051 us-gaap:MeasurementInputExpectedTermMember 2022-01-01 2022-12-31 0001419051 TSOI:ConvertibleNotesMember 2022-01-01 2022-12-31 0001419051 TSOI:ConvertibleNotesMember 2022-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputConversionPriceMember srt:MinimumMember 2022-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputConversionPriceMember srt:MaximumMember 2022-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputSharePriceMember srt:MinimumMember 2022-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputSharePriceMember srt:MaximumMember 2022-12-31 0001419051 us-gaap:ConvertibleNotesPayableMember us-gaap:MeasurementInputExpectedDividendRateMember 2022-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputPriceVolatilityMember srt:MinimumMember 2022-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputPriceVolatilityMember srt:MaximumMember 2022-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MinimumMember 2022-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputRiskFreeInterestRateMember srt:MaximumMember 2022-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MinimumMember 2022-01-01 2022-12-31 0001419051 TSOI:ConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MaximumMember 2022-01-01 2022-12-31 0001419051 TSOI:RemainingConvertibleNotesMember 2022-12-31 0001419051 TSOI:RemainingConvertibleNotesMember 2022-01-01 2022-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputExercisePriceMember 2022-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputSharePriceMember 2022-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputExpectedDividendRateMember 2022-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputPriceVolatilityMember srt:MinimumMember 2022-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputPriceVolatilityMember srt:MaximumMember 2022-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputRiskFreeInterestRateMember 2022-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MinimumMember 2022-01-01 2022-12-31 0001419051 TSOI:RemainingConvertibleNotesMember us-gaap:MeasurementInputExpectedTermMember srt:MaximumMember 2022-01-01 2022-12-31 0001419051 TSOI:ConvertiblePromissoryNoteMember 2023-01-01 2023-12-31 0001419051 TSOI:ConvertiblePromissoryNoteMember 2022-01-01 2022-12-31 0001419051 TSOI:ConvertiblePromissoryNoteMember 2023-12-31 0001419051 srt:OfficerMember 2019-12-31 0001419051 srt:OfficerMember 2018-12-31 0001419051 TSOI:OneOfficersMember 2022-01-01 2022-12-31 0001419051 TSOI:FourOfficerAndOneDirectorMember 2022-04-05 2022-04-05 0001419051 TSOI:OneOfficerAndOneDirectorMember 2022-09-08 2022-09-08 0001419051 TSOI:FourOfficerOneDirectorMember 2022-11-02 2022-11-02 0001419051 TSOI:FourOfficerAndOneDirectorMember 2022-12-30 2022-12-30 0001419051 TSOI:OneOfficersMember 2023-01-09 2023-01-09 0001419051 TSOI:OneDirectorMember 2023-01-09 2023-01-09 0001419051 TSOI:OneOfficersMember 2023-04-20 2023-04-20 0001419051 us-gaap:RestrictedStockMember 2023-05-10 2023-05-10 0001419051 TSOI:OneOfficersMember 2023-10-16 2023-10-16 0001419051 TSOI:ThreeOfficerAndOneDirectorMember 2023-10-16 2023-10-16 0001419051 us-gaap:PrivatePlacementMember 2022-01-01 2022-12-31 0001419051 TSOI:ConsultingServicesMember 2022-01-01 2022-12-31 0001419051 TSOI:ConsultingServicesMember 2023-01-03 2023-01-03 0001419051 us-gaap:ConvertibleNotesPayableMember 2023-01-03 2023-01-03 0001419051 us-gaap:PrivatePlacementMember 2023-01-01 2023-12-31 0001419051 TSOI:ConsultingServicesMember 2023-01-01 2023-12-31 0001419051 us-gaap:ConvertibleNotesPayableMember 2023-01-01 2023-12-31 0001419051 2022-08-04 2022-08-04 0001419051 2022-08-09 0001419051 TSOI:ResNovaBioIncMember us-gaap:CommonStockMember 2023-12-31 0001419051 TSOI:CampbellNeurosciencesIncMember us-gaap:CommonStockMember 2023-12-31 0001419051 us-gaap:SubsequentEventMember 2024-04-12 2024-04-12 0001419051 2023-03-22 0001419051 2023-03-22 2023-03-22 0001419051 us-gaap:ConvertibleNotesPayableMember us-gaap:SubsequentEventMember 2024-01-24 2024-01-24 0001419051 us-gaap:PrivatePlacementMember us-gaap:SubsequentEventMember 2024-02-09 2024-02-09 0001419051 us-gaap:SeriesBPreferredStockMember us-gaap:SubsequentEventMember 2024-02-09 0001419051 us-gaap:CommonStockMember us-gaap:SubsequentEventMember 2024-02-09 0001419051 us-gaap:SubsequentEventMember 2024-02-22 2024-02-22 0001419051 TSOI:ConsultingServicesMember us-gaap:SubsequentEventMember 2024-02-26 2024-02-26 0001419051 TSOI:ConsultingServicesMember us-gaap:SubsequentEventMember 2024-02-26 0001419051 us-gaap:PrivatePlacementMember us-gaap:SubsequentEventMember 2024-02-26 2024-02-26 0001419051 us-gaap:SubsequentEventMember 2024-02-26 2024-02-26 0001419051 TSOI:ConsultingServicesMember us-gaap:SubsequentEventMember 2024-03-04 2024-03-04 0001419051 TSOI:ConsultingServicesMember us-gaap:SubsequentEventMember 2024-03-04 0001419051 us-gaap:PrivatePlacementMember us-gaap:SubsequentEventMember 2024-03-12 2024-03-12 0001419051 us-gaap:PrivatePlacementMember us-gaap:SubsequentEventMember us-gaap:SeriesBPreferredStockMember 2024-03-18 2024-03-18 0001419051 us-gaap:PrivatePlacementMember us-gaap:SubsequentEventMember 2024-03-27 2024-03-27 0001419051 TSOI:ConsultingServicesMember us-gaap:SubsequentEventMember 2024-03-27 2024-03-27 0001419051 TSOI:ConsultingServicesMember us-gaap:SubsequentEventMember 2024-03-27 iso4217:USD xbrli:shares iso4217:USD xbrli:shares xbrli:pure utr:sqft

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-K

 

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

 

For the fiscal year ended December 31, 2023

 

OR

 

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.)

 

701 Wild Rose Lane
Elk City, Idaho 83525
(Address of principal executive offices, including zip code)
 
(760) 295-7208
(Registrant’s telephone number, including area code)
 
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

 

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

 

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 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. ☒

 

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 Smaller reporting company
Emerging growth company    

 

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. 

 

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). 

 

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

 

The aggregate market value of the voting and non-voting common equity held by non-affiliates was $6,581,483 based on a closing price of $0.0021 as of June 30, 2023.

 

As of April 17, 2024, 4,230,116,869 shares of the registrant’s common stock, par value of $0.001 per shares, were outstanding.

 

 

 

 
 

 

INDEX

 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

 

    PAGE NO
PART I    
     
ITEM 1 BUSINESS 4
ITEM 1A RISK FACTORS 24
ITEM 1B CYBERSECURITY 29
ITEM 2 PROPERTIES 29
ITEM 3 LEGAL PROCEEDINGS 29
ITEM 4 MINE SAFETY DISCLOSURES 30
     
PART II    
     
ITEM 5 MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 30
ITEM 6 SELECTED FINANCIAL DATA 31
ITEM 7 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 31
ITEM 7A QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 34
ITEM 8 FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 34
ITEM 9 CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 34
ITEM 9A CONTROLS AND PROCEDURES 34
ITEM 9B OTHER INFORMATION 36
     
PART III    
     
ITEM 10 DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 36
ITEM 11 EXECUTIVE COMPENSATION 42
ITEM 12 SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 43
ITEM 13 CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 43
ITEM 14 PRINCIPAL ACCOUNTANT FEES AND SERVICES 44
     
PART IV    
     
ITEM 15 EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 44
     
SIGNATURES 45

 

2
 

 

PART I.

 

FORWARD-LOOKING STATEMENTS

 

This Annual Report on Form 10-K contains forward-looking statements within the meaning of federal securities laws, 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 2023 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.

 

3
 

 

ITEM 1 BUSINESS.

 

Corporate History

 

Therapeutic Solutions International, Inc. (“TSOI” or the “Company”) was organized August 6, 2007, under the name Friendly Auto Dealers, Inc., under the laws of the State of Nevada. In the first quarter of 2011 the Company changed its name from Friendly Auto Dealers, Inc. to Therapeutic Solutions International, Inc., and acquired Splint Decisions, Inc., a California corporation.

 

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

 

Business Description

 

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

 

Activating one’s immune system is now an accepted method to treat certain cancers, reduce recovery time from viral or bacterial infections and to prevent illness. Additionally, inhibiting one’s immune system is vital for reducing inflammation, autoimmune disorders, and allergic reactions.

 

TSOI is developing a range of immune-modulatory agents to target certain cancers, schizophrenia, suicidal ideation, traumatic brain injury, and for daily health.

 

Nutraceutical Division – TSOI has been producing high quality nutraceuticals. Its current flagship product, QuadraMune®, is a multi-patented synergistic blend of pterostilbene, sulforaphane, epigallocatechingallate, and thymoquinone. QuadraMune has been shown to increase Natural Killer Cell activity and healthy Cytokine production.

 

Regenerative Medicine – TSOI obtained exclusive rights to a patented adult stem cell for development of therapeutics in the area of chronic traumatic encephalopathy (CTE) and traumatic brain injury (TBI) and Lung Pathology (LP).

 

The stem cell licensed, termed “JadiCell” is unique in that it possesses features of mesenchymal stem cells, however, outperforms these cells in terms of a) enhanced growth factor production; b) augmented ability to secrete exosomes; and c) superior angiogenic and neurogenic ability. Subsequent to this acquisition the Company has filed an additional 22 patents on this population of unique mesenchymal like stromal cells.

 

Immunotherapies

 

TSOI has a large portfolio of immunotherapies that range from dendritic cell vaccines for cancers to Parkinson’s disease developed on our StemVacs platform.

 

4
 

 

Investigational Drug Applications:

 

Treatment of Metastatic Breast Cancer by StemVacs-V Cancer Immunotherapeutic IND transferred to Res Nova Bio, Inc.

 

The Primary Objective is safety and feasibility of StemVacs-V administration at 12 months as assessed by lack of adverse medical events. The Secondary Objective is efficacy as judged by tumor response, time to progression, and immunological monitoring.

 

Safety, Feasibility, and Immunomodulatory Activities of StemVacs in Patients with Advanced Solid Tumors

 

The Primary Objective is safety and feasibility of StemVacs administration at 12 months as assessed by lack of adverse medical events. The Secondary Objective is efficacy as judged by tumor response, time to progression, and immunological monitoring.

 

ARDScell Umbilical Cord-derived Mesenchymal Stem Cells for Patients with Acute Respiratory Distress Syndrome

 

The overall objective of this protocol is to confirm safety and determine effectiveness of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) infusions in subjects with ARDS.

 

The primary objective will be to assess effectiveness of UC-MSC treatment on proportion of patients alive and free of respiratory failure at Day 60 after randomization.

 

The secondary objectives will be to assess all-cause mortality at Day 60, survival at day 31, number of subjects experiencing serious adverse events (SAEs) by day 31, SAE-free survival, time to recovery (evaluated until day 60), and time to oxygen requirement equal or below 40% oxygen.

 

CTEcell Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy Patients transferred to CTE Biologics, Inc.

 

To determine safety and efficacy of 100 million intravenously administered CTEcell™ allogeneic umbilical cord mesenchymal stem cells. Efficacy will be determined by behavioral scores, brain imaging, and reduction in inflammatory markers. Toxicity of treatment was evaluated for the duration of the study and will be graded according to the criteria of the World Health Organization.

 

COPDcell Therapy IND transferred to Breathe Biologics, Inc.

 

To determine safety and efficacy of intravenously administered allogeneic JadiCell umbilical cord blood mesenchymal stem cells in patients with moderate-to-severe COPD. The Primary Endpoint, which is toxicity, will be assessed by number of adverse events (AEs). The Secondary Endpoint, which is efficacy will be evaluated at baseline and days 30, 60, and 90.

 

Orphan Drug Designation:

 

Rare diseases affect patients and their families. Over 7,000 rare diseases affect more than 30 million people in the United States. Many rare conditions are life threatening, and most do not have treatments.

 

The FDA works to enhance to the availability of treatments for rare diseases by evaluating information from product sponsors to determine if drugs meet the criteria for certain incentives and administering grants to provide funding for research on rare diseases.

 

The Orphan Drug Designation program provides orphan status to drugs and biologics for rare diseases that meet certain criteria. Orphan drug designation provides incentives including:

 

  Tax credits for qualified clinical trials
  Exemption from user fees
  Potential for seven years of market exclusivity after approval

 

On June 26, 2023, the Company applied for Orphan Drug Designation Using JadiCell Adult Stem Cells for Treatment of Acute Respiratory Distress Syndrome.

 

5
 

 

On July 12, 2023, the Company applied for Orphan Drug Designation Using JadiCell Adult Stem Cells for Treatment of Frontotemporal Dementia.

 

Nutraceutical Division (TSOI)

 

  ProJuvenol® is a patented, (US No.: 9,682,047) and powerful synergistic blend of complex anti-aging ingredients in capsules.
  NanoStilbene® is an easily absorbed nanoemulsion of nanoparticle pterostilbene derived from the ‘047 patent.
  DermalStilbene is a topical form of pterostilbene delivered via spray application onto skin, derived from the ‘047 patent.
  IsoStilbene an injectable formulation of pterostilbene is available by prescription only, derived from the ‘047 patent.
  NeuroStilbene is an intranasal form of pterostilbene delivered via spray application inside the nostril, derived from the ‘047 patent.
  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.

 

Patents:

 

On February 26, 2024, the Company filed a patent application titled “Stem Cell Facilitation of Gene Therapy Induced Differentiation or Transdifferentiation” that discloses methods, compositions of matter and procedures for enhancing insulin production through concurrent regenerative and genetic therapy. In one embodiment the invention teaches administration of regenerative cells concurrent with PDX-1 gene administration. Said regenerative cells include mesenchymal stem cells, hematopoietic stem cells, and tissue specific progenitor cells. In one specific embodiment endogenous stem cells are mobilized after administration of PDX-1 in order to increase differentiation of pancreatic progenitors. In one embodiment, coadministration of MDX1 gene together with mesenchymal stem cells is provided to treat conditions such as multiple sclerosis. Further enhancement of therapeutic activity is mediated through co-administration of T regulatory cells and/or agents that stimulate T regulatory cells.

 

On September 29, 2023, the Company filed a patent application titled “Immunological Enhancement of Transplanted Dopaminergic Cells by Administration of Donor Derived Neutrophil Progenitors” which disclosed compositions of matter, protocols and therapeutic means to enhance engraftment and viability of pluripotent stem cell derived dopaminergic cells by simultaneously administering donor derived neutrophils or neutrophil progenitors. In one embodiment said neutrophil progenitors are engineered to express tolerogenic molecules such as Fas Ligand. In another embodiment pluripotent stem cells are cultured in BMP4 containing media to generate embryoid bodies which are subsequently dissociated and treated with G-CSF and interleukin 10.

 

On July 18, 2023, the Company filed a patent application titled “Compositions for Preserving and/or Augmenting T and NK Cell Immunity in Cancer Patients” which discloses compositions of matter useful for preserving and/or augmenting T and NK cell immunity through prevention of T cell receptor zeta chain loss. In one embodiment a cancer patient is treated with a combination of pterostilbene and RU486 at a sufficient concentration and frequency to reduce loss of T cell receptor zeta chain caused by cancer. In one embodiment said RU486 and pterostilbene combination is administered together with one or more immunotherapeutic agents. In one embodiment said immunotherapeutic agents are activators of one or more toll like receptors.

 

6
 

 

On May 01, 2023, the Company filed a patent application titled “Aneurysm Treatment by Exosomes” which provides means of inhibition and/or treating aneurysms and other degenerated blood vessels through administration of regenerative cell derived exosomes, and/or regenerative cell derived apoptotic bodies. In one particular embodiment vessel regeneration is increased through administration of stem cell exosomes/or stem cell apoptotic bodies. Other embodiments include regeneration of vessels prone to aneurysms, repairing aneurysms of vessels, or acceleration of endothelialization after stent placement. Provided within the invention are methods of rejuvenating properties of said vessels associated with physiological health, examples of which include appropriate production of anti-coagulating/clotting factors, control of angiogenesis, and appropriate revascularization of injured tissue.

 

On March 13, 2023, the Company filed a patent application titled “Generation and Utility of B Cell Subsets for Treatment of Chronic Obstructive Pulmonary Disease” which disclosed are B cell subsets, generation of B cell subsets and utilization of B cell subsets for treatment of Chronic Obstructive Pulmonary Disease (COPD). In one embodiment B cells possessing a B regulatory phenotype are generated in vivo by administrating of mesenchymal stem cells. In another embodiment B regulatory cells are utilized to treat COPD in an interleukin-35 dependent manner. In another embodiment B regulatory cells possess the marker CD5 and produce interleukin-10.

 

On February 14, 2023, the Company filed a patent application titled “Enhancement of Anti-Angiogenic Cancer Immunotherapy by Abortogenic Agents” which discloses the parallels between pregnancy and cancer that have been historically made, however, the ability to leverage abortogenic immunity against neoplasia has not been widely examined. The current invention provides means of suppressing tumor associated immune inhibition through administration of progesterone and/or glucocorticoid receptor antagonists such as RU-486. In one embodiment the invention provides the concurrent utilization RI-486 and anti-angiogenic immunotherapy. In another embodiment, abortogenic inhibitors of immunity such as indolamine 2,3 dioxygenase are administered together with RU-486 and/or anti-angiogenic immunotherapy. Various antiangiogenic agents can be utilized in the practice of the invention including the ValloVax immunotherapy and/or the StemVacs-V therapy.

 

On January 09, 2023, the Company filed a patent application titled “Prediction of Stem Cell Therapy Responsiveness by Quantification of Pre-Existing B Regulatory Cells” which disclosed novel means of stratifying patients into potential of positive response to mesenchymal stem cell therapy based on quantification of pretreatment levels of B regulatory cells. In one embodiment quantification of cells concurrently expressing CD5 and CD19. In another embodiment B regulatory cells are CD19+CD39–IL10+. In one embodiment the selection of B regulatory cells is quantified by flow cytometric means and patients possessing more than 7 % IL-10 secreting CD19 cells are chosen for stem cell therapy. In some embodiments numbers of B regulatory cells are increased prior to treatment by administration of various interventions including providing GM-CSF, microbiome alteration or manipulation of oxidative stress.

 

On January 04, 2023, the Company filed a patent application titled “Enhanced Efficacy of Tolerogenic Vaccination” which disclosed means, methods, and compositions of matter useful for induction of antigen specific suppression of immunity and/or tolerogenesis through administration of tolerogenic agents together with antigens and/or modified antigens delivered via multiple intradermal injections. In one embodiment the invention teaches the use of a tattoo gun or a similar device to administer over an extended area of skin a compound which induces a tolerogenic microenvironment and subsequently administration of said antigen in the artificially created microenvironment. The essence of the disclosed invention is the superior tolerogenic effects observed when tolerogenic stimuli and antigen are administered over an extended area of skin through the use of a tattoo gun or similar device.

 

On November 14, 2022, the Company filed a patent titled “Treatment of Chronic Obstructive Pulmonary Disease with Myeloid Derived Suppressor Cells” which discloses compositions of matter, protocols, and treatment means for prevention and/or reversing Chronic Obstructive Pulmonary Disease (COPD) using myeloid derived suppressor cells as a monotherapy or adjuvant therapy. In one embodiment umbilical cord low density myeloid cells are expanded using interleukin-3 and GM-CSF and administered in an allogeneic manner to a mammal suffering from COPD. In some embodiments combinations of myeloid derived suppressor cells and mesenchymal stem cells are disclosed.

 

On October 24, 2022, the Company filed a patent application titled “Mesenchymal Stem Cell Therapy of Epilepsy and Seizure Disorders” which discloses novel compositions of matter and treatment methods for reducing and/or reversing epilepsy through administration of mesenchymal stem cells in order to induce immune modulation and/or regenerative processes. In one embodiment umbilical cord mesenchymal stem cells are administered to a patient suffering from epilepsy at a concentration and frequency sufficient to inhibit neuronal hyperactivation and/or reduce neuroinflammatory status of the patient.

 

7
 

 

On October 03, 2022, the Company filed a patent application titled “Stimulation of Pulmonary Regenerative Exosomes by Mesenchymal Stem Cells and Derivatives Thereof” which discloses therapeutic means for pulmonary degenerative conditions through the administration of mesenchymal stem cells in order to induce regenerative exosomes from dendritic cells expressing CD103. In one embodiment cultures of mesenchymal stem cells with dendritic cell progenitors are disclosed wherein said mesenchymal stem cells induce a modulation of STAT3 signaling in said dendritic cell endowing a regenerative property to said dendritic cells and exosomes derived from said cells.

 

On September 19, 2022, the Company filed a patent application titled “Treatment of Bipolar Disorder Using Mesenchymal Stem Cells and Modification of Mesenchymal Stem Cells” that discloses the utilization of mesenchymal stem cells, exosomes from mesenchymal stem cells, conditioned media from mesenchymal stem cells, apoptotic bodies from mesenchymal stem cells, and modified mesenchymal stem cells for treatment of bipolar disorder. In one embodiment mesenchymal stem cells isolated from umbilical cord tissue are treated with carbon monoxide at a concentration sufficient to induce activation of heme-oxygenase I and infused into a patient at risk or suffering from bipolar disorder.

 

On September 12, 2022, the Company filed a patent application titled “Treatment of COPD by Stimulation of Stem Cell Mobilization” which discloses means of inducing pulmonary regeneration and/or protection from oxidative stress by stimulation of endogenous stem cell mobilization together with one or more inhibitors of NF-kappa B and/or one or more inhibitors of oxidative stress. The invention discloses the unexpected finding that G-CSF administration enhances oxidative stress and pulmonary damage, however, coadministration with pterostilbene, results in synergistic suppression of COPD pathology.

 

On August 29, 2022, the Company filed a patent application titled “Gene Silencing Therapy of Acute Respiratory Disorder” that teaches treatment means, compositions of matter and protocols useful for suppression of acute respiratory disorder (ARDS) through induction of RNA interference in the pulmonary microenvironment alone and/or in conjunction with mucolytic and/or DNA disrupting agents. In one embodiment short interfering RNA (siRNA) is prepared which targets complement receptors C3R and/or C5R together with TNF-receptor, IL-6 receptor and/or TLR4 and TLR9. In some embodiments NanoStilbene is utilized as a delivery vehicle for siRNA delivery.

 

On August 12, 2022, the Company filed a patent application titled “Treatment of Chronic Obstructive Pulmonary Disease by Mesenchymal Stem Cell Apoptotic Bodies and Compositions Thereof” that discloses means, treatments and compositions of matter useful for treatment of chronic obstructive pulmonary disease (COPD). In one embodiment the invention provides the administration of mesenchymal stem cell apoptotic bodies alone or in combination with “regenerative adjuvants” to prevent and/or reverse reduction in lung function associated with COPD. In other embodiments the invention teaches the utilization of stem cell apoptotic bodies for induction of pulmonary regeneration directly or indirectly.

 

On July 29, 2022, the Company filed a patent application titled “Gene Modified iPSC Derived Cellular Compositions for Regeneration and Immune Modulation” that disclosed cells and cellular compositions useful for treatment of degenerative and/or autoimmune diseases derived from gene edited/gene modified pluripotent stem cells. In one embodiment pluripotent stem cell such as inducible pluripotent stem cells are gene modified to express tissue associated transcription factors such as pdx-1 if endodermal tissue is desired and cells are differentiated into regenerative-type cells such as along the mesenchymal lineage. In one embodiment the invention teaches transfection with IL-27 to induce expression of coinhibitory molecules for suppression of autoimmunity. In some embodiments the invention provides generation of iPSC derived MSC which cannot stimulate inflammation due to gene-editing based removal of inflammatory associated transcription factors.

 

On May 12, 2022, the Company filed a patent application titled “Inhibition and Reversion of Chronic Obstructive Pulmonary Disease (COPD) by Endothelial Cell Regeneration” that teaches means, treatment methods, and compositions of matter useful for prevention and/or reversion of chronic obstructive pulmonary disease (COPD). In one embodiment the invention provides the administration of mesenchymal stem cells and exosome thereof as a means of augmenting endogenous endothelial regeneration and/or endothelial regeneration stimulated by exogenous means. In some embodiments the invention provides administration of allogeneic mesenchymal stem cells together with autologous endothelial progenitor cells and/or mobilization of said autologous endothelial progenitor cells.

 

8
 

 

On March 7, 2022, the Company filed a patent application titled “Treatment of Trauma Associated Cognitive Dysfunction Using Mesenchymal Stem Cell Apoptotic Bodies and Compositions Thereof” which teaches means, treatments and compositions of matter useful for treatment of chemotherapy/radiotherapy associated cognitive dysfunction. In one embodiment the invention provides the administration of mesenchymal stem cell apoptotic bodies alone or in combination with “regenerative adjuvants” to prevent and/or reverse cognitive dysfunction associated with chemotherapy and/or radiation therapy. In other embodiments the invention teaches the utilization of stem cell apoptotic bodies for induction of neuroregeneration directly or indirectly.

 

On February 7, 2022, the Company filed a patent application titled “Treatment of COVID-19 Associated Cognitive Dysfunction by Nutraceutical Preparations” that teaches means and methods of treating cognitive dysfunction associated with COVID-19 and/or other associated with inflammatory conditions. In one embodiment treatment of COVID-19 cognitive dysfunction performed by administration of nutraceutical means, wherein said nutraceuticals are administered at a frequency and/or concentration sufficient to induce proliferation of endogenous neural progenitor cells and/or protect cells from inflammatory damage. In one embodiment said nutraceuticals are comprised of green tea extract, and/or nigella sativa, and/or pterostilbene, and/or sulforaphane. In some embodiments nutraceutical compositions are utilized to overcome treatment resistant of currently used antidepressants.

 

On November 1, 2021, the Company filed a patent application titled “Induction of Concurrent Pulmonary Immune Modulation and Regeneration by Protein Mediated Conjugation of Immune Regulatory Cells with Endogenous Progenitor Cells” that discloses means, methods and compositions of matter useful for treatment of inflammatory pulmonary diseases such as COVID-19 through administration of agents that facilitate interaction between immune modulatory cells and endogenous pulmonary progenitor cells. In one embodiment a bispecific antibody capable of facilitating the interaction between CD25 on T regulatory cells and CD47 on pulmonary epithelial stem cells is described.

 

On October 11, 2021, the Company filed a patent application titled “Umbilical Cord Derived Regenerative and Immune Modulatory Stem Cell Populations” which provides universal donor cellular populations derived from umbilical cords possessing ability to elicit immune modulation and evoke regeneration when administered into a mammalian host. Generation of cellular products for clinical use are provided including methodologies of expansion, characterization, and means of therapeutic implementation.

 

On October 4, 2021, the Company filed a patent application titled “Reduction of Neutrophil Extracellular Trap formation by Mesenchymal Stem Cells and their Exosomes” that disclosed methods of reducing lung inflammation in acute respiratory distress syndrome elicited by various factors such as COVID-19 infection by reduction of neutrophil extracellular trap formation through administration of mesenchymal stem cells and/or exosomes thereof. The invention provides means of inhibiting neutrophil release of extracellular traps by mesenchymal stem cells and/or exosomes derived from said mesenchymal stem cells. Additionally, synergies are provided between mesenchymal stem cells and/or exosomes derived from mesenchymal stem cells and agents approaches which reduce neutrophil extracellular trap formation.

 

On September 22, 2021, the Company filed a patent application titled “Stimulation of Mesenchymal Stem Cell Therapeutic Activities by T Regulatory Cells” teaches novel means of enhancing mesenchymal stem cell regenerative activities including, intra alia, production from pulmonary leakage and suppression of scar tissue formation by co-administration with T regulatory cells. In some embodiments the invention provides an interaction between T regulatory cells and mesenchymal stem cells in which T regulatory cells stimulate upregulation of mesenchymal stem cell activity in a GITR dependent manner.

 

On September 16, 2021, the Company filed a patent application titled “Ivermectin Compositions for Treatment of COVID-19” that discloses novel mechanisms of action of ivermectin therapy as related to treatment of COVID-19 and means of augmenting therapeutic activities by co-administration with one or more of the following: pterostilbene, thymoquinone, epigallocatechin-3-gallate, and sulforaphane. In one embodiment the invention provides enhanced reduction of inflammation induced pulmonary leakage without augmenting immune suppressive mechanisms.

 

9
 

 

On August 23, 2021, the Company filed a patent application titled “Umbilical Cord Mesenchymal Stem Cells for Treatment of Chronic Obstructive Pulmonary Disease and Lung Degeneration” that discloses means of treating lung degenerative diseases including chronic obstructive pulmonary disease (CODP) using umbilical cord mesenchymal stem cells such as JadiCells alone, and/or using said cells under conditions that are activated in order to endow enhanced regenerative activity. In one embodiment said activation of said mesenchymal stem cells is performed through stimulation with a toll like receptor agonist at a concentration and duration sufficient to induce a >50% increase in keratinocyte growth factor expression from said stem cells. In another embodiment the invention provides the use of JadiCells as a means of producing exosomes, wherein said exosomes possess therapeutic properties capable of reducing inflammation, fibrosis and degeneration associated with COPD, as well as stimulation of regenerative activity. In some JadiCells are activated by a treatment with Activated Protein C.

 

On August 18, 2021, the Company filed a patent application titled “Enhancement of Umbilical Cord Mesenchymal Stem Cell Therapeutic Activity by Stimulators of T Regulatory Cells and/or Cells Expressing CD73” that teaches compositions of matter and protocols useful for treatment of COVID-19 and/or other inflammatory pathologies through stimulation of T regulatory cells and/or T cells expressing CD73 using administration of umbilical cord derived mesenchymal stem cells such as JadiCells. In one embodiment dosage of JadiCells needed to treat a patient is determined by the increase of T regulatory cells and/or CD73 expressing cells that are increased in number and/or activity subsequent to a test dose of JadiCells. In another embodiment stimulators of T regulatory cells and/or CD73 expressing T cells are utilized together with JadiCells in order to augment therapeutic activity. In some embodiments administration of JadiCell is performed with low dose interleukin-2 as a treatment for COVID-19 or other inflammatory related pathologies.

 

On August 11, 2021, the Company filed a patent application titled “Induction of Neurogenesis using Umbilical Cord Derived Mesenchymal Stem Cells and Derivatives Thereof” that disclosed compositions of matter and protocols useful for treatment of neurological dysfunctions through stimulation of adult neurogenesis using administration of umbilical cord derived mesenchymal stem cells such as JadiCells. In one embodiment viral induced neuropathy is reduced by administration of JadiCells to stimulate neurogenesis. In another embodiment the neurogenic activity of selective serotonin reuptake inhibitors is enhanced by administration of JadiCells. In some embodiments administration of JadiCell exosomes, conditioned media, microvesicles and/or apoptotic bodies is utilized to stimulate neurogenesis.

 

On July 28, 2021, the Company filed a patent application titled “Neuroprotection and Neuroregeneration by Pterostilbene and Compositions Thereof” with new data demonstrating that the blueberry derived compound pterostilbene possesses numerous brain protective and potentially brain regenerative activities. The data disclosed by the Company indicates: a) pterostilbene suppresses inflammatory cytokines TNF-alpha, IL-1 beta and IL-6; b) pterostilbene inhibits death of neurons caused by inflammatory mediators; c) pterostilbene stimulates production of regenerative factors from cells in the brain such as BDNF, NGF, FGF-1, and FGF-2; and d) pterostilbene allows/enhances proliferation of endogenous brain stem cells.

Granted on November 23, 2022.

 

On July 6, 2021, the Company filed a patent application titled “Treatment of Parkinson’s Disease by Immune Modulation and Regenerative Means” in which we describe and disclose means, methods and compositions of matter for treatment Parkinson’s Disease through concurrent immune modulation and regenerative means. In one embodiment Parkinson’s Disease is treated by augmentation of T regulatory cell numbers and/or activity while concurrently providing regenerative cells such as mesenchymal stem cells, and/or dopamine secreting cells. In one embodiment administration of immunoglobulins such as IVIG together with low dose interleukin-2 and/or low dose naltrexone is disclosed as a preparatory means prior to administration of therapeutic cells such as stem cells. Other therapeutic means utilized in an adjuvant manner are also provided for hormonal rebalancing, transcranial magnetic stimulation, and deep brain stimulation.

 

On May 24, 2021, the Company filed a patent application titled “Immunotherapies for Targeting of Tumor Vasculature” that disclosed novel means, protocols, and compositions of matter for creating targeted immune responses and/or induction of immunological memory towards the tumor vasculature. In one embodiment pluripotent stem cells are transfected with one or more genes capable of eliciting immunity, induced to differentiate into endothelial-like cells which resemble the tumor endothelial cells, and utilized as a vaccine. In some embodiment’s genes are engineered under control of specific promoters to allow for various specificities of activity. In one specific embodiment pluripotent stem cells engineered to endow properties capable of inducing expression of the α- Gal epitope (Galα1,3Galα1,4GlcNAc-R). Addition of adjuvants to enhance antigen presentation of the vaccine composition, as well as means of stimulating systemic enhancement of circulating endothelial specific T cells are also disclosed.

 

Published on November 24, 2022.

 

10
 

 

On May 21, 2021, the Company filed a patent application titled “Lithium as a Monotherapy and/or Stem Cell Adjuvant Therapy for Pulmonary Fibrosis” that disclosed compositions of matter, therapeutics, and protocols useful for reduction and/or reversion of pulmonary fibrosis. In one specific embodiment lithium chloride is administered together with a regenerative cell in a patient suffering from, or at risk of pulmonary fibrosis. In one embodiment said lithium chloride is administered as an adjuvant to a regenerative therapy, wherein said regenerative therapy is a gene therapy, a protein therapy, a cell therapy, or a tissue transplant. In one embodiment lithium chloride, or a salt thereof is utilized alone, or with a regenerative means, to evoke preservation and/or elongation of telomere length in pulmonary tissue. In one embodiment the invention teaches administration of umbilical cord mesenchymal stem cells (MSC) and/or products derived from said cells in order to induce an inhibition of natural or pathological reduction of telomere length, to preserve telomere length or to enhance telomere length. In one embodiment the MSC described in the invention as useful are umbilical cord derived MSC. Published on November 24, 2022.

 

On May 17, 2021, the Company filed a patent application titled “Treatment of Major Depressive Disorder by Low Dose Interleukin-2” which teaches methods, compositions of matter, and protocols useful for treatment of major depressive disorder through administration of low dose interleukin- 2 at a concentration and/or frequency sufficient to increase expansion of T regulatory cell numbers and/or enhancement of T regulatory cell activity. In some embodiments administration of interleukin-2 is provided as means of enhancing efficacy of standard antidepressant therapies. Furthermore, administration of interleukin-2 receptor agonists is also described in the current invention as a treatment of major depressive disorder.

 

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

 

On March 29, 2021, the Company filed a patent application titled “Compositions Capable of Stimulating Immunity Towards Tumor Blood Vessels” which discloses novel means, protocols, and compositions of matter for eliciting an immune response against blood vessels supplying neoplastic tissue. In one embodiment pluripotent stem cells are transfected with one or more genes capable of eliciting immunity. In some embodiments such genes are engineered under control of specific promoters to allow for various specificities of activity. In one specific embodiment pluripotent stem cells engineered to endow properties capable of inducing expression of the α-Gal epitope (Galα1,3Galα1,4GlcNAc-R).

 

On March 23, 2021, the Company filed a patent application titled “Chimeric Cells Comprising Dendritic Cells and Endothelial Cells Resembling Tumor Endothelium” which disclosed are means, methods and compositions of matter useful for induction of immunological responses towards tumor endothelial cells. In one embodiment the invention teaches fusion of dendritic cells and cells resembling tumor endothelial cells and administration of such chimeric cells as an immunotherapy for stimulation of tumor endothelial cell destruction. In other embodiments pluripotent stem cells are utilized to generate dendritic cells, wherein said dendritic cells are fused with pluripotent stem cell derived endothelial cells created in a manner to resemble tumor endothelial cells.

 

On March 16, 2021, the Company filed a patent application titled “Pluripotent Stem Cell Derived Dendritic Cells and Engineered Dendritic Cells for Cancer Immunotherapy” which disclosed are populations of dendritic cells generated from stem cells capable of inducing immunity towards cancer. In one embodiment said dendritic cells are generated from allogeneic inducible pluripotent stem cells, for some uses, said pluripotent stem cells are genetically engineered/edited to induce cancer specific immunity and/or resist immunosuppressive effect of tumor derived microenvironment. In one embodiment pluripotent stem cells are transfected with cancer stem cell antigens such as BORIS and/or NR2F6.

 

11
 

 

On March 4, 2021, the Company filed a patent application titled “Therapeutic Monocytes for Prevention of Suicidal Ideation” that discloses compositions of matter, protocols, and therapeutic means for treatment of suicidal ideations and/or suppression of suicidal attempts. In one embodiment the invention provides the use of umbilical cord derived monocytes as a means of treatment. In another embodiment, monocytes are de-differentiated from adult monocytes using reprogramming means to create monocyte capable of producing anti-inflammatory as well as regenerative properties useful in reducing suicidal ideations and/or attempts. Published on September 8, 2022.

 

 

On February 2, 2021, the Company filed a patent application titled “Ex Vivo Generation of Immunocytes Recognizing Brother Of The Regulator of Imprinted Sites (BORIS) Expressing Cancer Stem Cells” that discusses means, methods and compositions of matter useful for induction of immunity towards cancer stem cells by providing a dendritic cell, wherein said dendritic cells express BORIS and/or peptides derived from BORIS, wherein said dendritic cell is cultured in the presence of one or more immunocytes. In one embodiment said dendritic cells are derived from umbilical cord blood sources and allogeneic to T cells, which are expanded ex vivo and used for the purposes of immunotherapy. Published on August 25, 2022.

 

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

 

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

 

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

 

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

 

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

 

12
 

 

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

 

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

 

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

 

On September 14, 2020, the Company filed a patent application titled “Immunotherapy of Schizophrenia and Schizophrenia Associated Suicidal Ideation/Suicide” Disclosed are methods, means, and protocols of modifying the immune system so as to induce an immunologically tolerant state insofar as T regulatory cell number and/or activity is augmented in a patient suffering from schizophrenia. In one embodiment T regulatory cells are administered to the patient from exogenous sources, be they allogeneic or autologous. In other embodiments, T regulatory cells are generated endogenously through administration of immature dendritic cells, mesenchymal stem cells, and/or pharmaceutical means.

 

On August 28, 2020, the Company filed a patent application titled “Upregulation of Therapeutic T Regulatory Cells and Suppression of Suicidal Ideations in Response to Inflammation by Administration of Nutraceutical Compositions Alone or Combined with Minocycline” which discloses compositions of matter, treatments and protocols useful for induction of T regulatory cells in response to inflammation, as well as inhibition of suicidal ideations and/or neuroinflammation. In some embodiments the invention teaches the administration of a therapeutic combination of ingredients comprising of minocycline, pterostilbene, nigella sativa, sulforaphane, and epigallocatechin-3-gallate (EGCG) to a mammal undergoing upregulation of inflammatory mediators.

 

On August 21, 2020, the Company filed a patent application titled “Methods of Determining Risk of Suicide and/or Suicidal Ideation by Immunological Assessment” which discloses means and methods of identifying risk of suicide and/or suicidal ideation by assessment of immunologically related cytokines and cells. In one embodiment, a score, termed the “Campbell Score” is devised based on assessment of serum cytokines, ability of immune cells to make cytokines when stimulated ex vivo, and ability of immune cells to produce neurotransmitters when stimulated ex-vivo. In one embodiment the concentration of interleukin-6 is utilized as a means of assessing suicidal propensity along, and/or in combination with metabolites of the enzyme indolamine 2,3 deoxygenase.

 

On August 05, 2020, the Company filed a patent application titled “Prevention of Neuroinflammation associated Memory Loss Using Nutraceutical Compositions” which discloses means, methods, and therapeutic compositions for prevention of memory loss during situations of neuroinflammation. In one embodiment the invention teaches administration of the therapeutic combination of ingredients comprising of pterostilbene, Nigella sativa, sulforaphane, and epigallocatechin-3-gallate (EGCG) to a mammal suffering from inflammation in order to preserver memory function.

 

13
 

 

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

 

On July 13, 2020, the Company filed a patent application titled “Prevention of Pathological Coagulation in COVID-19 and other Inflammatory Conditions” s directed to the utilization of pterostilbene, and/or nigella sativa extract, and/or sulforaphane, and/or Epigallocatechin gallate (EGCG) alone or in combination, for the prevention of pathological coagulation. In on embodiment a composition containing all four ingredients is administered to a patient at risk of hypercoagulation in order to prevent aberrant expression of pro-coagulation molecules and/or induce expression of molecules known to suppress coagulation. In one embodiment the invention teaches administration of pterostilbene, thymoquinone, sulforaphane, and EGCG as a means of decreasing expression of tissue factor.

 

On June 30, 2020, the Company filed a patent application titled “Augmentation of Natural Killer Cell Activity and Induction of Cytotoxic Immunity Using Leukocyte Lysate Activated Allogeneic Dendritic Cells: StemVacs™” which describes the process of preparing allogeneic dendritic cells utilizing a leukocyte lysate based approach. These data support development of StemVacs for conditions that would benefit from NK activation such as cancer and COVID-19.

 

On June 22, 2020, the Company filed a patent application titled “Treatment of SARS-CoV-2 with Dendritic Cells for Innate and/or Adaptive Immunity” that disclosed means, methods, and compositions of matter for prophylaxis and/or treatment of SARS-CoV-2 by administration of dendritic cells in a manner and frequency sufficient to induce activation of innate and/or adaptive immune responses. In one embodiment the invention teaches administration of dendritic cells pulsed with one or more innate immune stimulants in a manner endowing said dendritic cell with ability to induce augmentation of natural killer (NK) cell number and/or activity. In another embodiment the invention teaches the use of dendritic cells stimulated with innate immune activators in a manner to allow for uptake of viral particles and presentation of viral epitopes to T cells in order to stimulate immunological activation and/or memory responses.

 

On June 15, 2020, the Company filed a patent application titled “Nutraceuticals for Suppressing Indolamine 2,3 Deoxygenase” from new data showing QuadraMune™ significantly inhibited inflammation associated with memory impairment, as well as reduced levels of kynurenine. Elevation of kynurenine is associated with activation of indolamine 2,3 deoxygenase, an enzyme associated with inflammation and depression.

 

On June 11, 2020, the Company filed a patent application titled “Nutraceuticals for Reducing Myeloid Suppressor Cells” which disclosed compositions of matter, treatments and protocols useful for reduction of number and/or activity of myeloid suppressor cells (MSC). In some embodiments the invention teaches the administration of a therapeutic combination of ingredients comprising of pterostilbene, Nigella sativa, sulforaphane, and epigallocatechin-3-gallate (EGCG) to a mammal at possessing an increased number and/or activity of said MSC in which reduction of number and/or activity is desired. In another embodiment, the invention teaches administration of said therapeutic combination to a mammal infected with viral and/or bacterial infections and/or neoplasia. In some embodiments dosage of said therapeutic combination is based on inflammatory and/or immunological parameters observed in patients.

 

On May 11, 2020, the Company filed a patent application titled “Treatment of COVID-19 Lung Injury Using Umbilical Cord Plasma Based Compositions” which disclosed means, methods, and compositions of matter useful for the treatment of lung inflammation associated with viral and bacterial infections, as well as with systemic inflammation, through the administration of umbilical cord blood derived plasma-based compositions. In one embodiment the invention teaches administration of umbilical cord blood plasma together with pterostilbene, and/or sulforaphane, and/or thymoquinone, and/or Epigallocatechin gallate (EGCG) and/or n-acetylcysteine in an aerosolized manner to patients suffering from COVID-19 associated pulmonary deficiencies. In another embodiment, umbilical cord blood plasma is administered with immune-stimulatory agents in order to concurrently inhibit propagation of viral load in the lung while suppressing pulmonary deficiencies.

 

14
 

 

On May 4, 2020, the Company filed a patent application titled “Nutraceuticals for the Prevention, Inhibition and Treatment of SARS-Cov-2 and Associated COVID-19” which teaches compositions of matter, treatments and protocols useful for prevention of SARS-CoV-2 infection, as well as inhibition of viral propagation and acceleration of viral cure. In some embodiments the invention teaches the administration of a therapeutic combination of ingredients comprising of pterostilbene, nigella sativa, sulforaphane, and epigallocatechin-3-gallate (EGCG) to a mammal at risk of infection with SARS-CoV-2. In another embodiment, the invention teaches administration of said therapeutic combination to a mammal infected with said SARS-CoV-2. In some embodiments dosage of said therapeutic combination is based on inflammatory and/or immunological parameters observed in patients with COVID-19.

 

On November 4, 2019, the Company filed a patent application titled “Cellular, Organ, and Whole-Body Rejuvenation Utilizing Cord Blood Plasma and Pterostilbene” that disclosed methods, means, and protocols for stimulation of rejuvenation in single cells, organs, and organisms by administration of cord blood derived plasma, cord blood plasma concentrates, and cord blood derived exosomes together with pterostilbene. The invention describes the previously unexpected finding that addition of pterostilbene to cord blood enhances the rejuvenation properties of cord blood. Said rejuvenation properties include telomere preservation, reduction in beta galactosidase, and retention of cellular activities.

 

On September 9, 2019, the Company filed a patent application titled “Pterostilbene and Formulations Thereof for Protection of Hematopoiesis from Chemotherapy and Radiation” which disclosed compositions of matter useful for treatment and/or prevention of hematopoietic injury using pterostilbene and formulations thereof. In one embodiment nanoparticle delivered pterostilbene is administered subsequent to chemotherapy induced neutropenia in order to accelerate recovery of the hematopoietic compartment. In another embodiment, pterostilbene is provided concurrently with chemotherapy in order to concurrently assist the neoplasia killing action of the chemotherapy while protecting the bone marrow from suppression. In contrast to conventionally used agents that protect from neutropenia such as G-CSF and GM-CSF, the products disclosed can be chronically administered, thus allowing for concurrent use with chemotherapeutic or radiotherapeutic agents.

 

On January 21, 2019, the Company filed a patent application titled “Prevention and Reversion of Chronic Traumatic Encephalopathy through Administration of “Educated” Monocytes and Progenitors Thereof” that provides means of preventing and/or reversing chronic traumatic encephalopathy in a patient through the modulation of monocytes as well as monocytic progenitors. In one embodiment the invention teaches administration of monocytes that have been previously “educated” by exposure to mesenchymal stem cells in order to endow onto said monocytes properties associated with stimulation of neuroregenerative properties. In some embodiments monocytes are educated by treatment of monocytic progenitors with conditions capable of endowing anti-inflammatory and regenerative conditions, said conditions include culture with epigenetic modifying agents. In other embodiments, the invention teaches the manipulation of cord blood derived monocytes as a starting population of cells for education by culture with mesenchymal stem cells.

 

On January 21, 2019, the Company filed a patent application titled “Autologous Neurogenic Cells and Uses Thereof for Professional Athletes at Risk of Chronic Traumatic Encephalopathy” which disclosed are means, compositions of matter and methods of business for treating Chronic Traumatic Encephalopathy (CTE) using autologous primary cells and modified cells of autologous origin which have been banked. In one embodiment of the invention autologous dedifferentiation cells are generated and stored for future administration in patients which have suffered CTE. In other embodiments, dedifferentiated cells are differentiated into neurons or neuronal progenitor cells and subsequently administered locally or systemically or in a combination. In other embodiments autologous cells are maintained in an undifferentiated manner and/or neurologically differentiated state and utilized as a conditioning source in an extracorporeal circulatory system replicating clinical stage extracorporeal liver perfusion (ECLP) with substitution of autologous dedifferentiated, neurologically differentiated or a combination of said cells instead of hepatic cells.

 

15
 

 

On December 18, 2018, the Company filed a patent application titled “Treatment of Chronic Traumatic Encephalopathy via RNA Administration” which disclosed are protocols, treatment means, and compositions of matter useful for treatment of Chronic Traumatic Encephalopathy through administration of RNA or modified RNA molecules. In one embodiment said RNA is generated to activate various toll like receptors (TLR), of which said activation leads to production of cytokines which paradoxically lead to protection from Chronic Traumatic Encephalopathy, wherein said protection constitutes a) reduction in glial cell activation, b) neuronal apoptosis due to excitotoxicity; and c) stimulation of endogenous regenerative processes including endothelial progenitor cell mobilization, proliferation of neuronal progenitor cells in the dentate gyrus and subventricular zones. In one particular embodiment targeting of RNA molecules is performed to specific brain cells including pyramidal neurons through the use of liposomes, exosomes, apoptotic bodies, nanoparticles and shark or cameloid antibodies is disclosed.

 

On September 25, 2018, the Company filed a patent application titled “Pterostilbene and Formulations Thereof for Treatment of Pathological Immune Activation” that teaches treatments, protocols, and compositions of matter are described for reduction of pathological immune system activation. In one embodiment, pterostilbene and/or formulations thereof are administered in a patient suffering from cytokine release syndrome at a concentration and frequency sufficient to reduce abnormal cytokine production and thus treat the cause of said cytokine release syndrome. Formulations of pterostilbene are disclosed for rapid release, enhanced biodistribution, and targeting to cytokine releasing effectors are disclosed for use in the practice of the invention.

 

On September 17, 2018, the Company filed a patent application titled “Pterostilbene and Compositions Thereof for Prevention and Treatment of Chronic Traumatic Encephalopathy” that teaches means, methods, and compositions of matter useful for prevention of chronic traumatic encephalopathy. In one embodiment of the invention, disclosed is utilization of pterostilbene and/or pterostilbene based compounds for prevention and/or treatment of chronic traumatic encephalopathy. In one embodiment, the invention teaches administration of pterostilbene and/or pterostilbene based compounds for reduction of taupathy associated with chronic traumatic encephalopathy.

 

On August 13, 2018, the Company filed a patent application titled “Enhancement of Ozone Therapy using Pterostilbene” that disclosed methods, means and compositions of matter using pterostilbene for enhancing therapeutic efficacy of ozone therapy in the field of oncology. The invention provides previously unknown synergies between ozone administration together with pterostilbene at inducing direct and indirect cytotoxicity to cancer cells. The invention provides means of delivery, administration, and therapeutic protocols for treatment of cancer patients. In one embodiment combination of ozone therapy together with pterostilbene is utilized to overcome drug resistance.

 

On October 08, 2017, the Company filed a patent application titled “Synergistic Inhibition of Glioma Using Pterostilbene and Analogues Thereof” that teaches methods, means and compositions of matter for utilizing pterostilbene and analogues thereof for suppression of viability, metastasis and proliferation of glioma cells alone, or together with immunotherapy, chemotherapy, or radiotherapy means. In one embodiment said pterostilbene augments immunogenicity of glioblastoma cells so as to enhance killing by immune cells or complement subsequent to damage of said glioblastoma cells by chemotherapy, radiotherapy, or immunotherapy.

 

On April 26, 2017, the Company filed a patent application titled “Augmentation of Stem Cell Activity using Pterostilbene and Compositions Containing Pterostilbene” that disclosed means of augmenting circulating endogenous stem cells through administration of an effective amount of pterostilbene or derivatives thereof. In one embodiment a patient with reduced levels of circulating endothelial progenitor cells is treated with pterostilbene at a concentration and frequency sufficient to restore, and/or enhance levels of circulating endothelial progenitor cells (EPC). In another embodiment endogenous levels of stem cells are restored or enhanced by administration of pterostilbene, said endogenous stem cells comprising cells of the dentate gyrus, subventricular zone, hepatic stem cells, cardiac stem cells, and hematopoietic stem cells.

 

On March 29, 2017, the Company filed a patent application titled “Stimulation of Immunity to Tumor Stem Cell Specific Proteins by Peptide Immunization” that discloses treatment of cancer is disclosed through administration of proteins or specific peptides found on tumor stem cells in vivo, in a matter eliciting monocyte or dendritic cell migration in order to allow uptake of said administrated proteins or peptides, followed by administration of a maturation signal in vivo. The invention provides for treatment of cancer through induction of anticancer immunity and/or immunity towards tumor initiating stem cells.

 

16
 

 

On March 29, 2017, the Company filed a patent application titled “Targeting the Tumor Microenvironment through Nutraceutical Based Immunoadjuvants” that disclosed compositions useful for the treatment of cancer which modulate tumor associated immunosuppression, thus acting as immunoadjuvants. In one embodiment a composition containing apigenin, is provided, said composition useful for inhibition of tumor associated immune suppression mediated through the molecule indolamine 2,3 deoxygenase (IDO). In another embodiment, liposomal apigenin is administered as a means of decreasing IDO expression.

 

On March 29, 2017, the Company filed a patent application titled “Activated Leukocyte Extract for Repair of Innate Immunity in Cancer Patients” that disclosed are compositions, methods of use, and pharmaceutical preparations useful for modulation of immune responses. In one embodiment a composition is extracted polyvalently activated peripheral blood mononuclear cells through dialysis. Said immune modulator is useful for treatment of cancer and alleviation of cancer associated immune depression. In one embodiment, said immunomodulator acts as a costimulatory of T cell activation by modulation of cytokine production. In one embodiment said immune modulator is concentrated for miRNA species capable of activating innate immune cells.

 

On March 29, 2017, the Company filed a patent application titled “Augmentation of Anti-Tumor Immunity by Mifepristone and Analogues Thereof” which relates to compositions of matter and methods useful for improving a treatment outcome and/or an alteration of immunity in a condition that benefits from immune stimulation. In particular, one embodiment of the invention teaches administration of sufficient doses of mifepristone or a derivative, alone, or in combination with an immunotherapeutic such as, but not limited to, an antibody, a vaccine, a cytokine, or a medicament whose therapeutic activity is associated with immune modulation.

 

On March 29, 2017, the Company filed a patent application titled “Methods of Re-Activating Dormant Memory Cells with Anticancer Activity” that disclosed methods, protocols, and compositions of matter useful for stimulation of anticancer immune responses. In one embodiment of the invention culture of buffy coat cells is performed in an environment resembling non-physiological conditions. Buffy coat derived products are subsequently harvested, concentrated, and added to a culture of monocytes and lymphocytes. Conditioned media from said second culture is subsequently utilized as an injectable solution for stimulation of anticancer immunity.

 

On March 29, 2017, the Company filed a patent application titled “Modulation of Oral Microbiome for Treatment of Periodontitis” that disclosed methods, means, and compositions of matter useful for inhibition of, reduction in progression and reversion of periodontitis. In one embodiment the invention provides prebiotic and/or probiotic compositions which modulation the oral microbiome in order to ameliorate, prevent or reverse periodontitis. In one embodiment a composition is administered into the oral cavity containing Actinomyces naeslundii, Actinomyces odontolyticus, Streptococcus thermophilius, Lactobaccilus brevis and Lactobacilius plantarum. Administration may be performed using various means including a mouthwash, a patch, a toothpaste, or in a preferred embodiment said prebiotic and/or probiotic compositions are delivered via a mouth tray.

 

On July 20, 2016, the Company filed a patent application titled “Prevention of Pregnancy Complications by Probiotic Administration” which disclosed methods, protocols and compositions of matter for the treatment of pregnancy complications through immune modulation of a mammal in need. In one embodiment the invention provides probiotic compositions for immune modulation to decrease risk of pregnancy complications. Pregnancy complications include recurrent spontaneous abortions (RSA), preterm birth, pre-eclampsia including hemolysis elevated liver enzymes low platelets (HELP), premature rupture of the membrane, Antepartum hemorrhage including placental abruption, chorioamnionitis, Intrauterine growth restriction, placenta pravaevia, sequalae of intraamniotic infection. Published on January 26, 2017.

 

On July 20, 2016, the Company filed a patent application titled “Exosome Mediated Innate and Adaptive Immune Stimulation for Treatment of Cancer” that teaches means of stimulating innate and/or adaptive immunity to cancer by administration of exosomes. Stimulation of innate immunity involves modifying exosomes by chemical addition of innate immune stimulators, whereas stimulation of adaptive immunity involves pulsing dendritic cells generating exosomes with antigens, in some cases, pulsing with Brother of the Regulator of Imprinted Sites (BORIS) proteins, peptides, or altered peptide ligands thereof.

 

17
 

 

On July 8, 2015, the Company filed a patent application titled “Augmentation of Oncology Immunotherapies by Pterostilbene Containing Compositions” that disclosed compositions of matter and methods useful to augmentation of immune responses to tumors. In one embodiment, a pterostilbene containing composition is administered to a cancer patient at a sufficient concentration and frequency to induce de-repression of tumor targeting immune responses. In one specific embodiment of the present invention, pterostilbene enhances antibody dependent cellular toxicity (ADCC) and in turn augments efficacy of FDA approved antigen specific immunotherapeutics such as trastuzumab (Herceptin) and other monoclonal antibody therapies used for treating cancer.

 

Issued and Granted Patents:

 

On June 20, 2017, the US Patent and Trademark Office issued and granted U.S. Patent No.: 9,682,047 titled “Augmentation of oncology immunotherapies by pterostilbene containing compositions” that discloses compositions and methods useful to enhancing, improving, or eliciting anti-tumor immune responses are disclosed. A pterostilbene containing composition is administered to a cancer patient at a sufficient concentration and frequency to induce de-repression of tumor targeting immune responses. The composition enhances antibody dependent cellular toxicity (ADCC) and augments efficacy of antigen specific immunotherapeutics such as trastuzumab and other monoclonal antibody therapies useful for treating cancer.

See: https://patents.justia.com/patent/9682047.

 

On January 25, 2022, the US Patent and Trademark Office issued and granted U.S. Patent No.: 11,229,674 titled “Nutraceuticals for suppressing indolamine 2,3 deoxygenase” which disclosed are compositions of matter, treatments and protocols useful for reduction of expression and/or activity of indolamine 2,3 deoxygenase (IDO). In some embodiments the invention teaches the administration of a therapeutic combination of ingredients comprising of pterostilbene, Nigella sativa, sulforaphane, and epigallocatechin-3-gallate (EGCG) to a mammal at possessing an increased expression and/or activity of said IDO in which reduction of number and/or activity is desired. In another embodiment, the invention teaches administration of said therapeutic combination to a mammal infected with viral and/or bacterial infections and/or neoplasia. In some embodiments dosage of said therapeutic combination is based on inflammatory and/or immunological parameters observed in patients.

 

On March 08, 2022, the US Patent and Trademark Office issued and granted U.S. Patent No.: 11,266,707 titled “Nutraceuticals for the prevention, inhibition, and treatment of SARS-CoV-2 and associated COVID-19” that disclosed methods of treating or preventing complications associated with a SARS-CoV-2 infection, comprising: administration of a combination comprising: a) Green Tea and/or extract thereof; b) Blueberry and/or extract thereof; c) Nigella sativa and/or extract thereof; and d) broccoli and/or extract thereof in an amount and frequency sufficient to treat or prevent complications associated with said SARS-CoV-2 infection.

 

On November 23, 2022, the US Patent and Trademark Office issued and granted U.S. Patent No.: 11,504,410 titled “Neuroprotection and Neuroregeneration by Pterostilbene and Compositions Thereof” with new data demonstrating that the blueberry derived compound pterostilbene possesses numerous brain protective and potentially brain regenerative activities. The data disclosed by the Company indicates: a) pterostilbene suppresses inflammatory cytokines TNF-alpha, IL-1 beta and IL-6; b) pterostilbene inhibits death of neurons caused by inflammatory mediators; c) pterostilbene stimulates production of regenerative factors from cells in the brain such as BDNF, NGF, FGF-1, and FGF-2; and d) pterostilbene allows/enhances proliferation of endogenous brain stem cells.

 

On September 19, 2023, the US Patent and Trademark Office issued and granted U.S. Patent No.: 11,759,495 titled “Upregulation of Therapeutic T Regulatory Cells and Suppression of Suicidal Ideations in Response to Inflammation by Administration of Nutraceutical Compositions Alone or Combined with Minocycline” which discloses compositions of matter, treatments and protocols useful for induction of T regulatory cells in response to inflammation, as well as inhibition of suicidal ideations and/or neuroinflammation. In some embodiments the invention teaches the administration of a therapeutic combination of ingredients comprising of minocycline, pterostilbene, nigella sativa, sulforaphane, and epigallocatechin-3-gallate (EGCG) to a mammal undergoing upregulation of inflammatory mediators.

 

18
 

 

*The data provided here is partial and does not contain all materials submitted for publication and is preliminary until peer review is complete. These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

 

Aneurysm Treatment by Exosomes

 

On May 1, 2023, the Company announced launching VasoSome Vascular Inc., based on successful treatment of Aortic Aneurysms using patent pending exosome therapy.

 

At present there is no treatment available for AAA other than open surgical or endovascular repair, both of which carry significant risks. The Company is currently at an early stage of development but seeks to be first-in-man clinical trials.

 

Abdominal Aortic Aneurysms

An AAA is a localized dilation or “ballooning” of the abdominal aorta. Prevalence approaches 5% in men over 60 years and increases with age. About 7.5% of men over 65 years are affected. Aneurysm disease currently affects about 1.7m individuals in the United States. The prevalence is expected to exceed 3m by 2025 with the “baby boomers” reaching their seventh decade.

 

The natural history of AAA is progressive growth, leading to rupture and death. The growth rate is about 0.3cm per year and the rate of growth accelerates as the aneurysm gets bigger. Most AAA’s are asymptomatic and remain undetected …. until they rupture.

 

More than 80% of patients who suffer a ruptured AAA don’t survive long enough to reach a hospital and 50-70% of those who do reach a hospital don’t survive treatment. The likelihood of rupture increases dramatically as the AAA grows. At 5.5cm, the one year incidence of rupture is about 9%, rising to 33% as the aneurysm grows to 7cm. Ruptured AAA’s are a leading cause of death in the USA, and are the 10th leading cause of death for men over 55 years. In the US, 1-2% of all male deaths in the over 65 years cohort are due to AAA. Only 10% of patients with AAA are still alive 8 years after diagnosis compared to 65% of a similar normal population. Those who die lose an average of nine years of life.

 

Technology

 

VasoSome’s product VSX-001 is a proprietary nanoparticle derived from specialized stem cells that can be utilized in a “universal donor” manner, meaning it does not have to be matched with the donor. The product possesses numerous properties of stem cells, including inhibition of inflammation, suppression of damage to blood vessels, and ability to regenerate damaged tissue. Advantages of administering VSX-001 compared to stem cells include: a) VSX-001 is substantially smaller in size than stem cells, allowing for superior distribution; b) VSX-001 does not multiply, thus possessing a superior long-term safety profile; and c) VSX-001 can be manufactured more economically as compared to stem cells.

 

Acute Respiratory Distress Syndrome (ARDS)

 

On April 20, 2023, the Company filed with the USFDA an Investigational Drug Application (IND) to initiate a Phase III Clinical Trial for Acute Respiratory Distress Syndrome.

 

ARDS is a condition in which lung injury causes fluid to leak into the spaces between the capillaries and the alveoli. Pressure on the alveoli increases, and eventually fluid accumulates. Fluid in the lungs causes the alveoli to collapse, leading to a series of cascading problems, each further decreasing the lungs’ capacity to move oxygen into the blood, and directly impacting the body’s tissues and organs. ARDS afflicts approximately 198,000 Americans a year and is expected to reach a 19.5 billion dollar a year market by 2029.

 

19
 

 

Chronic Traumatic Encephalopathy (CTE), and Traumatic Brain Injury (TBI)

 

On December 10, 2018, Therapeutic Solutions International, Inc., announced the signing of an agreement between TSOI and Jadi Cell LLC for licensing of the Jadi Cell universal donor adult stem cell, as covered in US Patent No.: 9,803,176 B2 for use in Chronic Traumatic Encephalopathy (CTE), and Traumatic Brain Injury (TBI).

 

On December 17, 2020, the Company filed an Investigational New Drug (IND) application seeking permission from the Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial assessing safety and signals of efficacy for treatment of Chronic Traumatic Encephalopathy (CTE) patients with JadiCells™.

 

On May 25, 2023, the Company announced the creation of CTE Biologics, Inc. as a subsidiary company dedicated to commercializing the JadiCell adult stem cell platform for treatment of chronic traumatic encephalopathy.

 

On July 05, 2023, the Company signed license agreements with CTE Biologics for the exclusive use of US Patent Publication No.: 20220125852 titled as: “Protection and Regeneration of Neurological Function by Using Stem Cells” as well as the sale and transfer of Investigational New Drug Application titled as: Investigation of Umbilical Cord derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy Patients.

 

Chronic Traumatic Encephalopathy (CTE) is caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years and is often found in football players. The condition is characterized by memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia. In many patients with CTE, it is anatomically characterized by brain atrophy, reduced mass of frontal and temporal cortices, and medial temporal lobe.

 

Traumatic brain injury (TBI) is an insult to the brain, not of a degenerative or congenital nature, but caused by external physical force that may produce a diminished or altered state of consciousness, which results in an impairment of cognitive abilities or physical functioning.

 

CTE represents a significant unmet medical need which we believe is amenable to stem cell intervention. We are eager to accelerate treatments and potential cures for debilitating conditions such as CTE and traumatic brain injury and plan to leverage New regulatory pathways such as the recently approved “Right to Try” Law to deliver these medicines as soon as possible to patients which currently have no other options.

 

Schizophrenia/Suicide Clinical Programs

 

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

 

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

 

On December 31, 2020, the Company signed license agreements with Campbell Neurosciences Inc., a partially owned company, for access to the 11 patents filed related to the previous Campbell Neurosciences Division. The patents are:

 

Application No.: 63/128759 Immunotherapy for Opioid Addiction
Application No.: 63/122862 Treatment of Major Depressive Disorder and Suicidal Ideations Through Stimulation of Hippocampal Neurogenesis Utilizing Plant-Based Approaches
Application No.: 63/105964 Protection/Regeneration of Neurological Function by Endothelial Protection/Rejuvenation using Stem Cells for Treatment of Conditions such as Chronic Traumatic Encephalopathy and Schizophrenia
Application No.: 17/030416 Personalized Immunotherapies for Reduction of Brain Inflammation and Suicide Prevention
Application No.: 63/077723 Immunotherapy of Schizophrenia and Schizophrenia Associated Suicidal Ideation/Suicide

 

20
 

 

Application No.: 63/071381 Upregulation of Therapeutic T Regulatory Cells and Suppression of Suicidal Ideations in Response to Inflammation by Administration of Nutraceutical Compositions Alone or Combined with Minocycline
Application No.: 63/068388 Methods of Determining Risk of Suicide and/or Suicidal Ideation by Immunological Assessment
Application No.: 63/061202 Prevention of Neuroinflammation associated Memory Loss Using Nutraceutical Compositions
Application No.: 63/057315 Neuroprotection and Neuroregeneration by Pterostilbene and Compositions Thereof
Application Serial No. 63/174291 filed by Licensor and titled as: Amelioration and Treatment of Opioid Addiction.
Patent Application Serial No. 63/189630 filed by Licensor and titled as: Treatment of Major Depressive Disorder by Low Dose Interleukin-2.

 

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

 

Treatment of Chronic Obstructive Pulmonary Disease (COPD) Using COPDcell™ Universal Donor Adult Stem Cells

 

On October 7, 2022, the Company formed Breathe Biologics, Inc. and licensed to them a patent application titled “Umbilical Cord Mesenchymal Stem Cells for Treatment of Chronic Obstructive Pulmonary Disease and Lung Degeneration” that discloses means of treating lung degenerative diseases including chronic obstructive pulmonary disease (CODP) using umbilical cord mesenchymal stem cells such as COPDcell’s.

 

In addition, the Company has transferred ownership of the filed investigational drug application titled “JadiCell Therapy for COPD” to determine safety and efficacy of intravenously administered allogeneic JadiCell umbilical cord blood mesenchymal stem cells in patients with moderate-to-severe COPD. The Primary Endpoint, which is toxicity, will be assessed by number of adverse events (AEs). The Secondary Endpoint, which is efficacy will be evaluated at baseline and days 30, 60, and 90.

 

COPD is a consistently progressive, ultimately fatal disease for which no treatment exists capable of either reversing or even interrupting its course. It afflicts more than 5% of the population in many countries, and it accordingly represents the third most frequent cause of death in the U.S., where it accounts for more than 600 billion in health care costs, morbidity, and mortality.

 

COPD possesses several features making it ideal for stem cell-based interventions: a) the quality of life and lack of progress demands the ethical exploration of novel approaches. For example, bone marrow stem cells have been used in over a thousand cardiac patients with some indication of efficacy. Adipose-based stem cell therapies have been successfully used in thousands of race-horses and companion animals without adverse effects, as well as numerous clinical trials are ongoing and published human data reports no adverse effects.

 

Mesenchymal Stem Cells (MSCs) are potent immunomodulatory cells that recognize sites of injury, limit effector T cell reactions, and stimulate regulatory cell populations (i.e., T-regs) via growth factors, cytokines, and other mediators. Simultaneously, MSCs also stimulate local tissue regeneration via paracrine effects inducing angiogenic, anti-fibrotic and remodeling responses. Consequently, MSCs-based therapy represents a viable treatment option for autoimmune conditions and other inflammatory disorders, yielding beneficial effects in models of autoimmune Type 1 Diabetes, Systemic Lupus Erythematosus, Autoimmune Encephalomyelitis, Multiple Sclerosis, cardiac insufficiency, and organ transplantation. MSCs have been reported to inhibit inflammation and fibrosis in the lungs, have shown safety in clinical trials for ARDS, and have been recently suggested as useful to treat patients with severe COVID-19 based on their effects preventing or attenuating the immunopathogenic cytokine storm.

 

21
 

 

Unfortunately, evaluation of stem cell therapy in COPD has lagged behind other areas of regenerative investigation; b) the underlying cause of COPD appears to be inflammatory and/or immunologically mediated. The destruction of alveolar tissue is associated with T cell reactivity, pathological pulmonary macrophage activation, and auto-antibody production. Mesenchymal stem cells have been demonstrated to potently suppress autoreactive T cells, inhibit macrophage activation, and autoantibody responses. Additionally, mesenchymal stem cells can be purified in high concentrations from adipose stromal vascular tissue together with high concentrations of T regulatory cells, which in animal models are approximately 100 times more potent than peripheral T cells at secreting cytokines therapeutic for COPD such as IL-10. Additionally, use of adipose derived cells has yielded promising clinical results in autoimmune conditions such as multiple sclerosis; and c) Pulmonary stem cells capable of regenerating damaged parenchymal tissue have been reported. Administration of mesenchymal stem cells into neonatal oxygen-damaged lungs, which results in COPD-like alveoli dysplasia, has been demonstrated to yield improvements in two recent publications.

 

Based on the above rationale for stem cell-based COPD treatments, we are proposing a 10 patient Phase I safety trial to assess ability of our COPDcell, a type of umbilical cord derived stem cells to improve objective and quality of life parameters in patients with moderate to severe COPD.

 

MSCs can be derived in large number from the Umbilical Cord (UC). COPDcells are a type of UC-MSCs, which can be utilized in the allogeneic setting and have demonstrated safety and efficacy in clinical trials for a number of disease conditions including inflammatory and immune-based diseases. UC-MSCs have been shown to inhibit inflammation and fibrosis in the lungs.

 

Breast Cancer Immunotherapy

 

Recently the Company announced the formation of a Spin-Off Company, Res Nova Bio, Inc., dedicated to the development of cancer inhibiting anti-angiogenesis immunotherapies. Res Nova Bio has licensed from Therapeutic Solutions International intellectual property covering StemVacs-V which is our iPSC derived platform technology announced in May of 2021. The technology utilizes pluripotent stem cells called iPSCs in order to generate new cells which resemble tumor blood vessels that are made to act as a “therapeutic vaccine”. Specifically, the administration of StemVacs-V stimulates the immune system to selectively kill blood vessels that feed the tumor but not healthy blood vessels. It is believed that for every 1 tumor blood vessel cell that is killed, 200-300 tumor cells are also killed as a result.

 

In addition to the license, the Company has transferred ownership of the IND titled Treatment of Metastatic Breast Cancer by StemVacs-V Cancer Immunotherapeutic” to Res Nova Bio with the primary objective being safety and feasibility of StemVacs-V administration at 12 months as assessed by lack of adverse medical events. The secondary objective is efficacy as judged by tumor response, time to progression, and immunological monitoring.

 

Amyotrophic Lateral Sclerosis

In December 2023, the Company announced the formation of ALS Biologics Inc, a subsidiary company dedicated to accelerating development of the Company’s assets related to Amyotrophic Lateral Sclerosis, a progressive motor neuron degenerative disease for which no cure exists. The company was formed based on previous positive observations in patients treated with the Company’s ALScell™ (JadiCell™) product under the Right to Try Law.

The ALScell™ (aka JadiCell™) is unique in that it possesses features of mesenchymal stem cells, however, ALScells outperform these cells in terms of a) enhanced growth factor production; b) augmented ability to secrete exosomes; and c) superior angiogenic and neurogenic ability.

 

Epilepsy

 

On January 16, 2024, the Company announced the forming of Epilepsy Bio, Inc., focused on treatment methods for reducing and/or reversing epilepsy through administration of mesenchymal stem cells to induce immune modulation and/or regenerative processes.

 

Cellular Manufacturing and Cell Banking

 

On October 18, 2021, the Company announced the formation of Allogen Biologics Inc, a wholly owned subsidiary of TSOI. Allogen Biologics will house intellectual property and Standard Operating Procedures related to generation of the Company’s existing and anticipated cellular therapeutics. In addition, Allogen will house and maintain all relevant cell banks.

 

22
 

 

On May 10, 2022, Allogen Biologic, Inc, and Therapeutic Solutions International Inc, entered into an Exclusive Patent License Agreement (EPLA) for Patent Application Serial No. 63/254,469, filed by Licensor and titled as: Umbilical Cord Derived Regenerative and Immune Modulatory Stem Cell Populations.

 

On August 16, 2023, TSOI issued this press release “Therapeutic Solutions International Subsidiary Allogen Biologics Inc. Successfully Manufactures JadiCell Master Cell Bank to Provide Cells for Right to Try Use and Phase III ARDS Clinical Trial”.

 

Now that we have established our own Master Cell Bank with corresponding biomarker assays of CD73, CD90, CD105 >90%, and CD14, CD34, CD45 <10%, these aliquots, which are in process of 3rd party validation will remain in cryopreservation to age the cells for purposes of required immuno-assays to clear phase 3 in the future when cells reach acceptable age to satisfy FDA. MCB was established in August 2023 and our estimate is next August 2024 we will have adequately aged the cells to obtain clearance for phase 3 IND.

 

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.

 

23
 

 

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, 2023, we had three full-time employees, all non-union. We believe that our relations with our employees are good.

 

COMPETITION

 

The bio-technology, bio-pharma, and nutraceutical industries are subject to rapid technological change. Competition from domestic and foreign companies, large pharmaceutical companies and other interested businesses is intense and expected to increase. A number of companies with significantly greater resources are pursuing the development of pharmaceuticals, biologics, and nutraceuticals in our targeted areas.

 

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, 2023, our internal control over financial reporting was not effective, and that material weaknesses existed in the following areas as of December 31, 2023:

 

  (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; and

 

  (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.

 

24
 

 

Based on our current plan, we believe we will need additional capital to support our operations.

 

Based on our current business plan, we believe that our cash and cash equivalents at December 31, 2023 will not be sufficient to meet our anticipated cash requirements during the twelve-month period subsequent to the issuance of the financial statements included in this Annual Report on Form 10-K. Our current commercialization of products and clinical trial strategy will undergo continual prioritization and in the future we may adjust our commercialization efforts to preserve our existing cash. We need to raise additional capital to fund our operations. We may raise additional capital through equity offerings, debt financings, collaborations and/or licensing arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available, we may be required to delay, reduce the scope of, or curtail, our operations. To the extent that we raise additional funds by issuing equity securities, our shareholders will experience dilution, and debt financing or other preferred equity instruments, if available, may involve restrictive covenants.

 

There is substantial doubt about our ability to continue as a going concern.

 

Our recurring losses from operations raise substantial doubt about our ability to continue as a going concern, and as a result, our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements as of and for the year ended December 31, 2023, with respect to this uncertainty. This going concern uncertainty, and any future going concern uncertainty, could materially limit our ability to raise additional capital. We have incurred significant losses since our inception, and it is possible we will never achieve future profitability. As a result, we continue to incur significant general and administrative expenses related to our operations. As a result, we have incurred substantial net losses to date. Our net losses for the years ended December 31, 2022, and 2022 were $2.7 million and $3.7 million, respectively. As of December 31, 2023, we had an accumulated deficit of $20.1 million. The perception that we may not be able to continue as a going concern may cause potential partners or investors to choose not to deal with us due to concerns about our ability to meet our contractual and financial obligations.

 

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:

 

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.

 

25
 

 

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.
  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.

 

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.

 

26
 

 

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.

 

27
 

 

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.

 

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.

 

28
 

 

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 CYBERSECURITIES

 

Risk Management and Strategy

 

The Company invests in information technology systems for its e-commerce and Corporate websites. Such investments, including the implementation of technology updates, improves the Company’s customers’ experience, and supports both compliance and internal controls. The Company is actively attempting to identify and manage cybersecurity risks. Protecting company data, non-public customer and employee data, and the systems that collect, process, and maintain this information is a Company Priority.

 

Cybersecurity Risk

 

In recent years there has been an increased risk of information and security risks due to increased sophistication and activities of perpetrators of cyber attacks. The computers are used for our everyday business operations including mobile devices and other online means of activities to connect with our customers, employees, suppliers, and other parties. This extensive use gives rise to cybersecurity risks such as system disruption, theft, and release of confidential information. There is sensitive information stored in the systems and intellectual property, including employees, customers and other financial information.

 

In the future we may be required to expend additional resources to continue to enhance information security measures to investigate and remediate any information security vulnerabilities. We can provide no assurance that the measures we have implemented to prevent security breaches and cyber incidents will be effective in the event of a cyber-attack. Our Directors do not have enough expertise to monitor and manage such risks and will need to rely upon others to help us stay vigilant, process, report, and remediate any incidents.

 

ITEM 2 PROPERTIES.

 

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

 

ITEM 3 LEGAL PROCEEDINGS.

 

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

 

29
 

 

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

 

ITEM 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 213 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, 2022 through December 31, 2023.

 

Quarter Ended  High   Low 
December 31, 2023  $0.0012   $0.001 
September 30, 2023  $0.018   $0.0014 
June 30, 2023  $0.022   $0.0021 
March 31, 2023  $0.0027   $0.0023 
December 31, 2022  $0.0063   $0.0055 
September 30, 2022  $0.014   $0.0121 
June 30, 2022  $0.022   $0.0199 
March 31, 2022  $0.0257   $0.0241 

 

Dividends

 

We did not declare or pay dividends during 2022 to 2023.

 

Issuances of Unregistered Securities

 

In 2022, we issued 44,500,000 shares of common stock for an investment in the Company’s Private Placement of $445,000.

 

In 2022, we issued 28,302,577 shares of common stock, valued at $537,778 for consulting services.

 

In 2022, we issued 4,812,259 shares of common stock, valued at $67,399 for salaries.

 

In 2022, we issued 4,110,000 shares of common stock, valued at $51,742 for land development.

 

In 2022, we issued 149,402,390 shares of common stock, valued at $3,107,570 for an license.

 

In 2022, we issued 64,139,744 shares of common stock for the conversion of convertible notes of $1,313,772.

 

In 2023, we issued 556,632,297 shares of common stock for an investment in the Company’s Private Placement of $790,432.

 

 30 

 

 

In 2023, we issued 115,527,394 shares of common stock, valued at $176,911 for consulting services.

 

In 2023, we issued 64,081,632 shares of common stock, valued at $110,000 for salaries.

 

In 2023, we issued 60,000,000 shares of common stock, valued at $96,000 for land development.

 

In 2023, we issued 389,304,825 shares of common stock for the conversion of convertible notes of $928,816.

 

ITEM 6 SELECTED FINANCIAL DATA.

 

Not required for a “smaller reporting company”.

 

ITEM 7 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

The following discussion and analysis should be read in conjunction with the consolidated Financial Statements and Notes thereto appearing elsewhere in this Annual Report.

 

Overview

 

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

 

Activating one’s immune system is now an accepted method to treat certain cancers, reduce recovery time from viral or bacterial infections and to prevent illness. Additionally, inhibiting one’s immune system is vital for reducing inflammation, autoimmune disorders and allergic reactions.

 

TSOI is developing a range of immune-modulatory agents to target certain cancers, schizophrenia, suicidal ideation, traumatic brain injury, and for daily health.

 

Nutraceutical Division. TSOI has been producing high quality nutraceuticals. Its current flagship product, QuadraMune®, is a multi-patented synergistic blend of pterostilbene, sulforaphane, epigallocatechingallate, and thymoquinone. QuadraMune has been shown to increase Natural Killer Cell activity and healthy Cytokine production. Our synergistic blend of ingredients helps the immune system fight off common and complex ailments and promote healthy T Cell activity. Recently the Company was approved to sell certain nutraceuticals on the Amazon Platform.

 

Cellular Division. SOI recently obtained exclusive rights to a patented adult stem cell for development of therapeutics in the area of chronic traumatic encephalopathy (CTE), traumatic brain injury (TBI), and lung pathology.

 

The stem cell licensed, termed “JadiCell” is unique in that it possesses features of mesenchymal stem cells, however, outperforms these cells in terms of a) enhanced growth factor production; b) augmented ability to secrete exosomes; and c) superior angiogenic and neurogenic ability.

 

Chronic Traumatic Encephalopathy (CTE) is caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years and is often found in football players. The condition is characterized by memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia. In many patients with CTE, it is anatomically characterized by brain atrophy, reduced mass of frontal and temporal cortices, and medial temporal lobe. TSOI has previously filed several patents in the area of CTE based on modulating the brain microenvironment to enhance receptivity of regenerative cells such as stem cells. On March 4, 2021, the Company received an IND Serial # 27377 for a clinical trial of 10 patients with CTE.

 

 31 

 

 

On August 4th, 2021, the Company announced clearance from the Food and Drug Administration (FDA) to initiate a Phase III pivotal trial for registration of the Company’s JadiCell™ universal donor stem cell as a treatment for COVID-19 associated lung failure under IND # 19757. In previous studies the Company has demonstrated the superior activity of JadiCell™ to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, the JadiCell™ was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85 in a double-blind placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%.

 

In addition, the Company has filed data with the FDA, as part of IND #17448, which demonstrated that treatment of cancer patients with StemVacs™ resulted in enhanced activity of a type of immunological cell called “natural killer” cells, otherwise known as “NK cells.”

 

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

 

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

 

On May 9, 2022, the Company filed an Investigational New Drug Application for Treatment of Chronic Obstructive Pulmonary Disease (COPD) Using JadiCell™ Universal Donor Adult Stem Cells under IND Serial # 28508.

 

Results of Operations

 

We had a net loss of approximately $2.2 million in 2023 compared to a net loss of approximately $3.8 million in 2022.

 

Net sales decreased $107,773 from $206,767 to $98,994, for the years ended December 31, 2022 and 2023 respectively. This decrease was mainly due to an decrease in sales of the Company’s nutraceutical line of products.

 

Cost of goods sold decreased $42,672, from $79,440 to $36,768, for the years ended December 31, 2022 and 2023, respectively. This decrease was mainly due to lower net sales of the Company’s nutraceutical line of products in 2023 vs 2022.

 

Operating expenses for the years ended December 31, 2023 and 2022 were approximately $2 million and $3.4 million, respectively, a decrease of $1.4 million. This decrease was mainly due a combination of less selling expenses as sales decreased, and less research and development as we paid out more for patent expenses.

 

General and administrative expenses decreased approximately $23,000, from $497,000 to $474,960, for the years ended December 31, 2022 and 2023, respectively. This decrease was mainly due to a selling expenses decreased due to less sales.

 

Salaries, wages and related expenses decreased approximately $12,000, from $445,000 to $433,000, for the years ended December 31, 2022 and 2023, respectively. This decrease was mainly due to using an outside manufacturer instead of manufacturing in house.

 

Consulting fees decreased approximately $464,000, from $613,000 to $149,000 for the years ended December 31, 2022 and 2023, respectively, due to expired 2 year consulting agreements which were not renewed.

 

Legal and professional fees increased approximately $31,000, from $400,000 to $431,000 for the years ended December 31, 2022 and 2023, respectively, due to a increase in general counsel services handling filings with the SEC and new subsidiaries.

 

Research and development costs decreased approximately $891,000 from $1,452,000 to $561,000, for the years ended December 31, 2022 and 2023, respectively. This decrease was mainly due more patent fees and less cash for research and development.

 

 32 

 

 

Total loss from derivatives liabilities increased approximately $168,000 from a loss of $131,000 to a gain of $37,000 for the years ended December 31, 2022 and 2023, respectively. This increase was due to a derivative liability expense from certain convertible notes in 2023 compared to 2022.

 

Total change in fair value of derivatives liabilities decreased approximately $309,000 from a gain of $291,000 to a loss of $18,000 for the years ended December 31, 2022 and 2023, respectively. This decrease was due to a derivative liability expense from certain convertible notes in 2023 compared to 2022.

Net interest expense increased approximately $223,000 from $646,000 to $423,000 for the years ended December 31, 2022 and 2023, respectively. This increase was mainly due to increased debt balances.

 

Liquidity and Capital Resources

 

We have experienced recurring losses over the past years which have resulted in accumulated deficits of approximately $20 million and a working capital deficit of approximately $1.8 million at December 31, 2023. These conditions raise significant doubt about the Company’s ability to continue as a going concern. The Company’s ability to continue as a going concern is contingent upon its ability to secure additional financing, increase sales of its products and attain profitable operations. It is the intent of management to continue to raise additional capital. However, there can be no assurance that the Company will be able to secure such additional funds or obtain such on terms satisfactory to the Company, if at all.

 

There is no guarantee we will receive the required financing to complete our business strategies, and it is uncertain whether future financing will be available to us on acceptable terms. If financing is not available on satisfactory terms, we may be unable to continue, develop or expand our operations.

 

As of December 31, 2023, we had approximately $28,000 in cash and cash equivalents, representing a decrease in cash and cash equivalents of approximately $18,000 from December 31, 2022. Sources of cash were predominantly from the sale of equity and debt. We anticipate that our current sources of liquidity, including cash and cash equivalents, together with our current projections of cash flow from operating activities, will provide us with liquidity into the end of 2023.

 

Cash Flows from Operating Activities

 

Our cash flows from operating activities are significantly affected by our cash outflows to support the growth of our business in areas such as R&D and G&A expenses. Our operating cash flows are also affected by our working capital needs to support personnel related expenditures, accounts payable and other current assets and liabilities.

 

During the year ended December 31, 2023, cash used in operating activities was $1,055,290, which was primarily the result of our net loss incurred of $2,224,700, partially offset by increases in the various accounts payable and accrued liability accounts totaling $143,963 and non-cash expenses including stock-based compensation of $278,752 change in value on derivative liabilities of $17,836, amortization of debt discount of $384,744 and amortization and depreciation of $311,778.

 

Cash Flows from Investing Activities

 

During the year ended December 31, 2023, net cash used by investing activities was $24,000, compared to $0 during the year ended December 31, 2022. The decrease of approximately $24,000 in net cash used by investing activities is mainly attributable to a purchase of property and equipment and an issuance of notes receivables from the Company’s subsidiaries

 

 33 

 

 

Cash Flows from Financing Activities

 

During the year ended December 31, 2023, net cash provided by financing activities was $1,077,676, compared to $943,088 during the year ended December 31, 2022. The increase of approximately $357,000 in net cash provided by financing activities is mainly attributable to an increase of $1,012,932 in cash received from the sale of common stock. Other cash flows provided by financing activities during the year ended December 31, 2023 included proceeds from convertible notes payable to related and third parties totaling $292,000 offset by payments on notes payable to related parties and third parties of $5,000.

 

Off-Balance Sheet Arrangements.

 

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

 

ITEM 7A QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

Not required for a “smaller reporting company”.

 

ITEM 8 FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

 

Our financial statements and the accompanying notes that are filed as part of this Annual Report on Form 10-K are listed and set forth beginning on page F-1 immediately following the signature page of this Form 10-K.

 

ITEM 9 CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

 

None.

 

ITEM 9A CONTROLS AND PROCEDURES

 

Disclosure Controls and Procedures

 

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act is recorded, processed , summarized and reported , within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Securities Exchange Act is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

 

At the end of the period covered by this Annual Report on Form 10-K for the fiscal year ended December 31, 2023, an evaluation was carried out under the supervision of and with the participation of our management, including the Chief Executive Officer (“CEO”), of the effectiveness of the design and operations of our disclosure controls and procedures (as defined in Rule 13a-15I and Rule 15d-15(e) under the Exchange Act). Based on that evaluation the CEO has concluded that as of the end of the period covered by this Annual Report, our disclosure controls and procedures were not effective.

 

 34 

 

 

Internal Control Over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a- 15(f) promulgated under the Securities Exchange Act of 1934 as a process designed by, or under the supervision of, a company’s principal executive and principal financial officers and effected by a company’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

 

Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;

 

Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and

 

Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.

 

All internal control systems, no matter how well designed, have inherent limitations and can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

 

Our management, including the Chief Executive Officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In making our assessment, we used the framework and criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission(“COSO”) (2013) in Internal Control-Integrated Framework. Based on that assessment, our management has identified certain material weaknesses in our internal control over financial reporting.

 

  (1) Our management concluded that as of December 31, 2023, our internal control over financial reporting was not effective, and that material weaknesses existed in the following areas as of December 31, 2023 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.

 

Changes in Internal Control Over Financial Reporting

 

No substantial changes in our internal control over financial reporting occurred during 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, except that we have increased our use of external accounting services, adopted policies to improve timely reviews by management and coordination with accounting consultants, and engaged corporate and securities legal counsel with better capabilities than our previous provider’s.

 

 35 

 

 

ITEM 9B OTHER INFORMATION.

 

None

 

PART III

 

ITEM 10 DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.

 

The Company’s executive officers and directors and their respective ages as of December 31, 2023 are as follows:

 

Directors:

 

Name of Director   Age
Timothy G. Dixon   65
Dr. Thomas E. Ichim   48

 

Executive Officers:

 

Name   Position   Age
Executive Officers:        
Timothy G. Dixon   President and Chief Executive Officer   65
Famela Ramos   Vice President   47
James Veltmeyer, MD   Chief Medical Officer   58
Feng Lin, MD, PhD   Chief Scientific Officer   53

 

The term of office for each director is one year, or until the next annual meeting of the stockholders.

 

Biographical Information

 

Timothy G. Dixon

 

Mr. Dixon currently serves as Chief Executive Officer, President, and Chairman of Therapeutic Solutions International, Inc. He also currently serves as Chairman of Campbell Neurosciences, Inc., Allogen Biologics, Inc., ALS Biologics, Inc., CTE Biologics, Inc., Epilepsy Biologics, Inc., Res Nov Bio, Inc., VasoSome Vascular, Inc., and Breathe Biologics, Inc., all subsidiaries of TSOI. Mr. Dixon previously served as the President of TMD Courses, Inc. from 2006 to 2012 and; as the President of Splint Decisions Inc. from 2010 to 2011. Mr. Dixon also has extensive experience in dealing with corporate compliance matters with the U.S. Food and Drug Administration (FDA), as well as many international regulatory bodies. Mr. Dixon is inventor and co-inventor of 75+ patents and patents pending..

 

Thomas E. Ichim, Ph.D.

 

Dr. Ichim was appointed to the Board of Directors on January 22, 2016. Dr. Ichim also serves as CEO and Director of Campbell Neurosciences, Inc., Allogen Biologics, Inc., ALS Biologics, Inc., Breathe Biologics, Inc., and Director of Allogen Biologics, Inc., Epilepsy Biologics, Inc., Res Nov Bio, Inc., and VasoSome Vascular, Inc., all subsidiaries of TSOI. Dr. Ichim is a seasoned biotechnology entrepreneur with a track record of scientific excellence. He has founded/co-founded several companies including Batu Biologics, Inc., Medvax Pharma Corp, ToleroTech Inc, bioRASI, and OncoMune LLC. To date, he has published 121 peer-reviewed articles and is co-editor of the textbooks “RNA Interference: From Bench to Clinical Translation” and “Immuno-Oncology Text Book.”

 

 36 

 

 

Dr. Ichim is an ad-hoc editor and sits on several editorial boards. Dr. Ichim is an inventor on over 300 patents and patent applications. Dr. Ichim has extensive experience with stem cell therapy and cellular product development through FDA regulatory pathways. Dr. Ichim spent over 7 years as the President and Chief Scientific Officer of Medistem, developing and commercializing a novel stem cell, the Endometrial Regenerative Cell, through drug discovery, optimization, preclinical testing, IND filing, and up through Phase II clinical trials with the FDA. Dr. Ichim has extensive experience in product development, regulatory filings, and business development.

 

Dr. Ichim has a BSc in Biology from the University of Waterloo, Waterloo, Ontario, Canada, an MSc in Microbiology and Immunology a University of Western Ontario, London, Ontario, Canada and a Ph.D. in Immunology from the University of Sciences Arts and Technology, Olveston Monserrat.

 

James Veltmeyer, M.D., – Chief Medical Officer

 

Dr. Veltmeyer is a board-certified family physician in La Mesa, California. A graduate of UC San Diego and the Ross University School of Medicine, he completed his residency through the UC San Francisco system where he became Chief of Family Medicine Residency, overseeing 36 doctors.

 

Dr. Veltmeyer, a member of the San Diego Critical Care Medical Group, has been elected for four years (2012, 2014, 2016, and 2017) by his colleagues in the San Diego County Medical Society as a “Physician of Exceptional Excellence,” the most prestigious honor awarded to a “Top Doctor” in San Diego County. He is among a select group of San Diego physicians who was chosen four of the last fifteen years and he consistently ranks in the top 1% to 2% for patient satisfaction. He is currently the Chief of the Department of Family Medicine at Sharp Grossmont Hospital where he provides senior leadership to over 200 doctors.

 

Feng Lin, MD, Ph.D., – Chief Scientific Officer

 

Dr. Lin has a stellar track record of drug development in the area of immunology innumo-oncology having worked with the public company Inovio Pharmaceuticals, where he developed technologies for gene delivery and therapeutic DNA vaccines against cancer and infectious diseases in both R&D and clinical settings. Subsequently, Dr. Lin served as Director of Chinese Operations for MediStem Inc, which was acquired by Intrexon in May 2014. It was the rapid clinical translation model developed by Dr. Lin at MediStem that resulted in the company’s accelerated FDA clearance to begin clinical trials, which resulted in the sale of the company.

 

Dr. Lin received his postdoctoral training at the Sanford-Burnham Medical Research Institute and his MD and Ph.D. at the Xiangya Medical School of Central South University, China. He has authored over 20 peer-reviewed scientific publications, including several in top journals such as Science, Cell, and Cancer Cell. He holds several patents.

 

Famela Ramos – Vice President Business Development

 

Famela Ramos is a Nurse, a Researcher, and a Politician. Famela was running for Congress in the 53nd Congressional District. Ms. Ramos came to the United States from the Philippines at the age of two, when her father joined the United States Navy. Her parents worked tirelessly to support the family of 5 children, all of which became successful entrepreneurs and Government Employees. As a nurse, Famela has experience from the beginning of life, having practiced in pediatric nursing, to the end of life, having worked as a hospice nurse. Her excellence in nursing and research is attested by 7 peer reviewed publications that she collaborated with Academy and Industry in advancing cutting edge research in immunology and regenerative medicine.

 

The first paper, was a collaboration with the Moores Cancer Center and several biotechnology companies, describing the state of the art in cancer immunotherapy, and proposing future directions. The second paper discussed the possibility of stimulating regeneration of injured lung stem cells using specific types of laser and light based interventions, this was a collaboration between the University of Utah and the University of California, San Diego. The third paper, a collaboration between a nutraceutical company and Indiana University, demonstrated the beneficial effects of a nutritional supplement on circulating stem cells in healthy volunteers. The fourth publication was the first successful use of two different types of stem cells in a patient with heart failure, which resulted in a profound improvement. The fifth publication is a report of 114 patients that were treated with umbilical cord blood stem cells and demonstrated safety and signals of efficacy in collaboration with a Chinese Biotech company. The sixth publication was successful treatment of a spinal cord injury patient with stem cells. The seventh publication was the basis for an investigational new drug (IND) application to the FDA, describing use of fat stem cells to treat aplastic anemia.

 

 37 

 

 

Ms. Ramos has established the Right to Try Foundation, which assists companies in utilizing this new law that allows for accelerated patient access to experimental medication. Through this Foundation Ms Ramos facilitated the first utilization of a cancer vaccine in the United States, and has been assisting both public and private companies. Most recently the Foundation has collaborated on filing new patents for means of implementing the Right to Try Law. Ms. Ramos is a board member of Silent Voices, a Pregnancy Resource Center that provides counselling to woman in emergency pregnancies, alternatives to abortion, and for woman that do choose abortion, post abortion support. Ms. Ramos has been endorsed by business and community leaders as well as nationally known athletes including Dr. Peter Farrell, founder of Resmed, a $18 billion company, and Wes Chandler, an NFL Hall of Fame San Diego Charger.

 

Information with Respect to Our Board of Directors

 

The following is a brief description of the structure and certain functions of our Board of Directors. Each of the current directors is serving until his respective successor is duly elected, subject to earlier resignation. We do not have standing audit, compensation or nominating committees of our Board of Directors. However, the full Board of Directors performs all of the functions of a standing audit committee, compensation committee and nominating committee.

 

Audit Committee Related Function

 

We do not have a separately designated standing audit committee in place. Our full Board of Directors currently serves in that capacity. This is due to the small number of members of our Board of Directors, the small number of executive officers involved with our company, and the fact that we operate with few employees. Our Board of Directors will continue to evaluate, from time to time, whether a separately designated standing audit committee should be put in place. We do not have an audit committee charter.

 

The Board of Directors reviews with management and the Company’s independent public accountants the Company’s financial statements, the accounting principles applied in their preparation, the scope of the audit, any comments made by the independent accountants upon the financial condition of the Company and its accounting controls and procedures and such other matters as the Board of Directors deems appropriate. Because our common stock is traded on the OTC Markets Pink Sheet, we are not subject to the listing requirements of any securities exchange regarding audit committee related matters.

 

The Board of Directors consisted of two directors: Mr. Dixon and Dr. Ichim. Because we do not have an audit committee at all, we disclose that we do not have any “audit committee financial expert” serving on an audit committee.

 

Compensation Committee Related Function

 

We do not currently have a standing compensation committee, and do not have a compensation committee charter. The full Board of Directors currently has the responsibility of reviewing and establishing compensation for executive officers and making policy decisions concerning salaries and incentive compensation for executive officers of the Company.

 

The Company’s executive compensation program is administered by the Board of Directors, which determines the compensation of the Chief/Executive Officer/President and the Chief Financial Officer of the Company. In reviewing the compensation of the individual executive officers, the Board of Directors considers the recommendations of the Chief Executive Officer, other market information and current market conditions, as well as any existing employment agreements with them.

 

Nominating Committee Related Function

 

We do not currently have a standing nominating committee. We have not adopted procedures by which security holders may recommend nominees to serve on our board of directors.

 

 38 

 

 

SCIENTIFIC ADVISORY BOARD

 

The following are members of the Company’s Scientific Advisory Board as of December 31, 2023:

 

Dr. Santosh Kesari is a board-certified neurologist and neuro-oncologist and is currently Chair, Department of Translational Neuro-Oncology and Neurotherapeutics, John Wayne Cancer Institute.

 

He is also Director of Neuro-Oncology, Providence Saint John’s Health Center and Member, Los Angeles Biomedical Research Institute. Dr. Kesari is ranked among the top 1% of neuro-oncologists and neurologists in the nation, according to Castle Connolly Medical Ltd and an internationally recognized scientist and clinician. He is a winner of an Innovation Award by the San Diego Business Journal. He is on the advisory board of American Brain Tumor Association, San Diego Brain Tumor Foundation, Chris Elliott Fund, Nicolas Conor Institute, Voices Against Brain Cancer, and Philippine Brain Tumor Alliance. He has been the author of over 250 scientific publications, reviews, or books. He is the inventor on several patents and patent applications, and founder and advisor to many cancer and neurosciences biotech startups.

 

Dr. Kesari has had a long-standing interest in cancer stem cells and studies their role in the formation of brain tumors and resistance to treatment. He believes that in order to cure patients with brain tumors we first need to gain a better molecular and biological understanding of the disease. A physician/scientist, Kesari harnesses his experience in surgery, chemotherapy, immunotherapy, radiation therapy and novel devices to help develop Precision Therapeutic Strategies that will advance medicine to a new stage in the battle against brain tumors and eradicate the disease.

 

Dr. Francesco Marincola joined Kite in 2021 as Global Head of Cell Therapy Research. Before joining Kite, Francesco was President and Chief Scientific Officer at Refuge Biotechnologies where responsible for the development and implementation of research and clinical development strategies for adoptive cell therapy products and lead therapeutic programs based on nuclease deactivated CRISPR circuits. He is also a National Institutes of Health (NIH) tenured senior investigator in cancer immunotherapy and biomarker research, and spent 23 years at the NIH, including 15 years as the Chief of the Infectious Disease and Immunogenetics Section at the NIH Clinical Center. Previously, he also served as a distinguished research fellow in immune oncology discovery at AbbVie and as Chief Research Officer at Sidra Research in Doha, Qatar.

 

The former President of the Society for Immunotherapy of Cancer (SITC; 2013-2014), Francesco currently serves as Editor-in-Chief for several prominent peer-reviewed publications, including Journal of Translational Medicine, Translational Medicine Communications and Immunotherapy, and is the author of more than 600 peer-reviewed publications. He has edited several books including the SITC-affiliated Cancer Immunotherapy Principles and Practice Textbook.

 

Dr. Donald Banerji is a Clinical development professional with 33 years of global clinical research and development experience (Phase I-IV) in the pharmaceutical industry. Recently retired from Novartis as Global Clinical Development Head of Respiratory and Allergy Medicine. Recognized by peers and external scientific community as an expert in pulmonary and allergy drug development bringing several iconic brands to market with millions of patients benefitting from treatment through improving care and outcomes for patients with respiratory diseases. Managed multidisciplinary teams in the filing of several new drug applications. Responsibilities included strategic and tactical planning, regulatory interactions with global health authorities, appropriate resource and budgetary management and timely execution, approval of high-quality large drug development programs and delivery of groundbreaking data. These global programs over a span of 3 decades resulted in the approval and competitive labeling of 14 innovative medicines, including 3 inhaled steroids for asthma, a triple combination of 2 bronchodilator and an inhaled steroid for asthma, 3 non-steroidal inhaled controller drugs for asthma, 3 intranasal steroids for allergic rhinitis and 4 bronchodilator drugs for COPD. Signature achievements at Novartis included first to market with the development and approval of the first to market inhaled dual combination medicine in COPD (Ultibro) and the first to market triple combination medicine in asthma (Enerzair). With reimagining medicine as a core driver, these treatments changed the practice of medicine and were incorporated in global treatment guidelines for COPD and asthma. Recipient of numerous corporate awards including the highest scientific award of Distinguished Scientist 2016 for pioneering work in COPD. Published over 400 primary manuscripts and abstracts, including the landmark study FLAME in NEJM.

 

 39 

 

 

Dr. Boris Minev is a highly accomplished physician-scientist with extensive industrial and academic experience in Immuno-Oncology, oncolytic viruses and stem cell biology and applications. He has a significant track record in tumor immunology and cancer vaccine development, having worked closely on the development of the first cancer vaccine to be approved by a regulatory body (Melacine). Dr. Minev has also extensive expertise in immunotherapy clinical trial designs, logistics, and regulatory issues. He has a considerable supervision & management experience in industrial and academic settings and has excellent skills in biotech business development, communication, and collaboration. Previously he held a position as the Director of Immunotherapy and Translational Oncology at Genelux Corporation, where he was directing several preclinical and translational projects on oncolytic virotherapy, immunotherapy, and nanotechnology.

 

Dr. Minev is also an adjunct professor at the Moores UCSD Cancer Center. There, he served previously as Principal Investigator and Director, Laboratory of Tumor Immunology and Immunotherapy where, for more than 15 years, his research has been focused on the discovery of new target antigens for immunotherapy of cancer and the development of optimized cancer vaccines. Prior to that, Dr. Minev worked in Dr. Steven Rosenberg’s Tumor Immunology Section at the Surgery Branch of the National Cancer Institute.

 

Dr. Minev is an Advisory Board Member of the European Society for Translational Medicine (EUSTM). He is a member of the Scientific and Clinical Advisory Boards of several biotechnology companies and has been an advisor for Amgen, Johnson & Johnson, Geron Corporation, McKinsey Consulting and Thomson Current Drugs, among others. He is the recipient of the European Association of Cancer Research Fellowship and the Fogarty International Fellowship.

 

Dr. Pablo Guzman is a cardiologist in Fort Lauderdale, Florida where he is on staff at Holy Cross Hospital. He received his medical degree from University of Puerto Rico School of Medicine and his Cardiology Fellowship at The Johns Hopkins Hospital where he then spent the first part of his career continuing his basic science and clinical research along with his clinical duties. His CV includes over 25 papers published in peer-reviewed journals and more than 15 abstracts.

 

He is a Fellow of the American College of Cardiology and practiced for more than 30 years. Dr. Guzman is well experienced in basic and clinical research, having participated in many clinical trials. He is also the acting Chief Medical Officer of Variant Pharmaceuticals, a Specialty Pharma company developing treatments for kidney diseases.

 

Dr. Juergen Winkler is presently practicing at Quantum Functional Medicine in Carlsbad, CA, which he founded in July of 2012. In 2005 he was the co-founder of Genesis Health Systems (Integrative Cancer and Medical Treatment Center) located in Oceanside, CA. He has been a featured speaker for: the NSCC Women’s Health Seminar, Annual IPT/IPTLD Integrative Cancer Care Conference (Multiple years), Health Freedom Expo 2011 & 2012, the Japanese Society of Oxidative Medicine in Osaka Japan, ACOSPM 2010 & 2011 conferences, NSCC Health and Wellness Series 2013, and various other events. He is the physician author of Chapter 5 in the Defeat Cancer book and has been a featured physician in the Townsend Letter.

 

Dr. Nassir Azimi is a cardiologist in La Mesa, California and attended Dartmouth Medical School and completed his residency at the University of Colorado. He finished his four year fellowship in Cardiovascular and Peripheral Interventions at Yale University in New Haven. Dr. Azimi has been in private practice for over 13 years establishing a thriving clinical practice for cardiac patients as well as treating patients for peripheral vascular disease. He is active in Interventional Cardiology and Peripheral Interventions. Dr. Azimi is the director of La Mesa Cardiac Center’s Nuclear Cardiology Laboratory. He is also an investigator in multiple clinical research studies for various cardiac and peripheral diseases. He has been recognized as San Diego’s Top Interventional Cardiologists by San Diego Magazine 2013,2014,2016, 2017 and also by Castle Connoly for 2013, 2014, 2015,2016, 2017, and 2018. He is a former chief of biomedical ethics (6 years), former chief of Medicine and former chief of Endovascular Medicine as well as Vice Chief of Cardiology at SGH. He is on the board of directors of the California ACC where he serves as chair of the public relations committee. He is on Editorial Review Board for multiple medical journals. He is a national speaker on various topics in cardiology and internal medicine.

 

 40 

 

 

Dr. James Veltmeyer is a board-certified family physician in La Mesa, California. A graduate of UC San Diego and the Ross University School of Medicine, he completed his residency through the UC San Francisco system where he became Chief of Family Medicine Residency, overseeing 36 doctors. Dr. Veltmeyer, a member of the San Diego Critical Care Medical Group, has been elected for four years (2012, 2014, 2016, and 2017) by his colleagues in the San Diego County Medical Society as a “Physician of Exceptional Excellence,” the most prestigious honor awarded to a “Top Doctor” in San Diego County. He is among a select group of San Diego physicians who was chosen four of the last fifteen years and he consistently ranks in the top 1% to 2% for patient satisfaction. He is currently the Chief of the Department of Family Medicine at Sharp Grossmont Hospital where he provides senior leadership to over 200 doctors.

 

Dr. Barry Glassman, DMD, DAAPM, DAACP, FICCMO, Diplomate ABDSM, FADI, is a Diplomate of the American Academy of Craniofacial Pain and the American Academy of Pain Management, as well as a Fellow of the International College of Craniomandibular Orthopedics and the Academy of Dentistry International, he is also on staff at the Lehigh Valley Hospital where he serves as a resident instructor of Craniofacial Pain and Dysfunction and Dental Sleep Medicine.

 

Dr. Glassman is a Diplomate of the Academy of Dental Sleep Medicine. He is on the staff at the Sacred Heart Hospital Sleep Disorder Center, as well as serving as the Chief Dental Consultant to three other sleep centers in the Lehigh Valley. A popular and dynamic speaker, Dr. Glassman lectures internationally, as well as throughout the United States. In addition to his extensive schedule which includes guest lecture appearances and in-depth courses on joint dysfunction, chronic pain, headache, sleep disorders, and migraine headache, Dr. Glassman is a frequent speaker at major chronic pain and joint dysfunction professional conferences. A graduate of the University of Pittsburgh: Bachelor of Science 1969, Pittsburgh, Pennsylvania University of Pittsburgh School of Dental Medicine; D.M.D. 1973, Pittsburgh Pennsylvania Post Graduate Hours in Craniomandibular Dysfunction and Sleep Disorders: Over 2500

 

J. Christopher Mizer founded Vivaris in June of 1998. Vivaris (formerly Lake Erie Capital) invests in and acquires middle-market businesses in a broad range of industries that are leaders in their market niches. Mr. Mizer serves as the chairman of each of the portfolio companies and guides key strategic decisions and their execution. He also serves as the operating president on an interim basis when companies are going through periods of ownership succession and new management team members are being assembled.

 

Mr. Mizer is a former Vice President and Officer of the investment banking division of Key Capital Markets, where he focused on merger, acquisition, and financing projects for Fortune 500 clients, private companies, and successful entrepreneurs. Prior to joining Key Corp., he was Consultant in the Capital Markets practice with Ernst & Young. He began his career as a Research Assistant with The Center for Economic Issues, a think-tank focused on economic development. He earned the B.S. (biology, applied math), B.A. (economics), M.S. degrees (biology – neurogenetics), and MBA (finance, accounting) degrees from Case Western Reserve University. Mr. Mizer has taught business strategy, finance and entrepreneurship at the graduate level at Case Western Reserve University, John Carroll University, and the University of California, San Diego and at the undergraduate at San Diego State University.

 

Howard Leonhardt is an inventor and serial entrepreneur. He has 21 U.S. patents with over 100 patent claims for products for treating cardiovascular disease and has over 40 new patent claims pending. His TALENT (Taheri-Leonhardt) stent graft developed in the early 1990′s holds a leading world market share for repairing aortic aneurysms without surgery.

 

His inventions have treated over 500,000 patients in 60 countries. In early 1999 Leonhardt founded Bioheart, Inc. www.bioheartinc.com a leader in applying adult muscle stem cells to treat heart failure.. Leonhardt holds a Diploma in International Trade from Anoka Technical College. He attended the University of Minnesota,Anoka Ramsey College and UCLA Extension. He holds an honorary Doctorate in Biomedical Engineering from the University of Northern California and is an honorary alumnus of the University of Florida and Florida International University. He is co-leader of Startup California and Founder and Chairman of The California Stock Exchange TM (Cal-X) preparing to be the first social good impact stock exchange currently operating the Cal-X 30 Social Good Impact fund powered by Motif Investing- www.calstockexchange.com – He founded Cal-X Crowdfund Connect www.calxcrowdfund.com a crowdfunding campaign management co. and Cal-X Stars Business Accelerator, Inc.www.calxstars.com a business incubator and accelerator focused on cardiovascular life sciences and social good impact innovations.

 

 41 

 

 

There are 30 regenerative medtech and regenerative economy startups in the current portfolio class. His Leonhardt Ventures angels network has raised and put to work over $145 million in 32 companies to date, most of them founded by Leonhardt. BioLeonhardt www.bioleonhardt.com is developing the first implantable programmable and re-fillable stem cell pump. He leads CerebraCell for brain regeneration. EyeCell for eye regeneration and AortaCell for aorta regeneration and number of other organ regeneration spin offs from his patented core technologies. Leonhardt serves as state spokesperson in California for the JOBS ACT and Crowdfunding for Startup California and has given over 40 speeches on the subject. He has operated Leonhardt’s Launchpads NorCal at the University of Northern California Science & Technology Innovation Center in Rohnert Park, CA since 2008 and recently opened Leonhardt’s Launchpads Utah in Salt Lake City just off the campus of the University of Utah. He has served on the Board of Directors of the University of Northern California, a private biomedical engineering school, since 1999.

 

Section 16(a) Beneficial Ownership Reporting Compliance

 

Section 16(a) of the Exchange Act requires our directors and executive officers, and persons who own more than 10% of a registered class of our equity securities, to file with the SEC initial reports of ownership and reports of changes in ownership of common stock and other of our equity securities. Officers, directors and greater than 10% stockholders are required by SEC regulation to furnish us with copies of all Section 16(a) forms they file.

 

To our knowledge, based solely on a review of the copies of such reports furnished to us during the fiscal year ended December 31, 2023, all Section 16(a) filing requirements applicable to our officers, directors and greater than 10% beneficial owners were complied with.

 

Code of Ethics

 

We have adopted a Code of Ethics for our principal executive and financial officers. Our Code of Ethics was filed as an Exhibit to our Annual Report on Form 10-K for fiscal year 2010. We hereby undertake to provide a copy of this Code of Ethics to any person, without charge, upon request. Requests for a copy of this Code of Ethics may be made in writing addressed to: Therapeutic Solutions International, Inc., 4093 Oceanside Blvd, Suite B, Oceanside, California 92056, Attn: Corporate Secretary.

 

ITEM 11 EXECUTIVE COMPENSATION.

 

Summary Compensation Table

 

The following table summarizes the compensation paid, with respect to years ended December 31, 2023 and 2022 for services rendered to us in all capacities, to each person who served as an executive officer of the Company.

 

Name and Principal      Salary   Bonus   Stock Awards   Option Awards   Nonequity Incentive Plan Compensation   All Other Compensation   Total 
Position  Year   ($)   ($)   ($)   ($)   ($)   ($)   ($) 
Timothy G. Dixon   2023    240,000(1)  -    125,000    -    -    -    365,000 
President, CEO and CFO   2022    240,000(2)  -    140,800    -    -    -    380,800 
                                         
Dr. James Veltmeyer   2023    -    -    75,000    -    -    -    75,000 
Chief Medical Officer   2022    -    -    25,100    -    -    -    25,100 
                                         
Feng Lin   2023    -    -    15,000    -    -    -    15,000 
Chief Scientific Officer   2022    -    -    25,100    -    -    -    25,100 
                                         
Famela Ramos   2023    -    -    15,100    -    -    -    15,000 
Vice President   2022    -    -    25,100    -    -    -    25,100 

 

  (1) $120,000 was accrued and $110,000 paid with stock as of December 31, 2023
     
  (2) $120,000 was accrued and $67,400 paid with stock as of December 31, 2022

 

 42 

 

 

Outstanding Equity Awards

 

None

 

Employment Agreements

 

We do not have any employment agreements as of December 31, 2023.

 

Director Compensation

 

When our employees serve on our Board of Directors, we do not give them any additional compensation in respect of such Board service. Directors currently serve without compensation.

 

ITEM 12 SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.

 

The following table sets forth, as of December 31, 2023, information regarding the ownership of the Company’s outstanding shares of common stock by (i) each person known to management to own, beneficially or of record, more than 5% of the outstanding shares of our common stock, (ii) each director of the Company, (iii) each executive officer of the Company, and (iv) all directors and executive officers as a group. As of December 31, 2023, a total of 3,802,666,978 shares of our common stock were outstanding.

 

Name of Beneficial Owners  Amount and Nature of Beneficial Ownership   Percent of Shares Outstanding 
Timothy G. Dixon (1)   358,993,103    9.44%
Thomas E. Ichim (1)   142,000,000    3.73%
John Peck, Jr.   227,283,333    5.98%
Feng Lin   62,000,000    1.63%
James Veltmeyer   37,000,000    0.97%
Famela Ramos   6,000,000    0.16%
All directors and executive officers as a group (2 persons) (1)(2)   500,953,103    13.17%

 

  1) Under SEC rules (i) a person is deemed to be the beneficial owner of shares if that person has, either alone or with others, the power to vote or dispose of those shares. The persons named in the table have sole voting and dispositive power with respect to all shares shown as beneficially owned by them, subject to community property laws where applicable.

 

ITEM 13 CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.

 

Our Board of Directors currently consists of two directors, one of whom is an officer of the Company. As of December 31, 2023, we disclose that we had no independent directors.

 

In general, it is our policy to submit all proposed related party transactions (those of the kind and size that may require disclosure under Regulation S-K, Item 404) to the Board of Directors for approval. The Board of Directors only approves those transactions that are on terms comparable to, or more beneficial to us than, those that could be obtained in arm’s length dealings with an unrelated third party. Examples of related party transactions covered by our policy are transactions in which any of the following individuals has or will have a direct or indirect material interest: any of our directors or executive officers, any person who is known to us to be the beneficial owner of more than 5% of our common stock, and any immediate family member of one of our directors or executive officers or person known to us to be the beneficial owner of more than 5% of our common stock.

 

 43 

 

 

ITEM 14 PRINCIPAL ACCOUNTANT FEES AND SERVICES.

 

Representatives of our principal accountants, Fruci & Assoicates II, PLLC, will be available for the current year and for the most recently completed fiscal year at the stockholder’s meeting to provide the financial statements and be available for questions. At this time, we are not planning to have a stockholder’s meeting.

 

Audit Fees

 

The aggregate fees billed to us by our principal accountants, Fruci & Associates II, PLLC for auditing services for fiscal year 2023 was $68,625 (inclusive of the review of the quarterly reports on Form 10-Q) and for year 2022 was $66,100.

 

Audit-Related Fees, Tax Fees and All Other Fees

 

There were no fees billed to us by our principal accountant for fiscal year 2023 and 2022 for assurance and related services (audit-related fees), tax services or other products and services.

 

Audit Committee Matters

 

We do not have an audit committee. The executive officers and BOD perform the role of the audit committee. The executive officers and BOD review and approve the audit. The audit fees were 100% and the audit related fees were 0% of the total fees and were approved by the executive officers and BOD.

 

PART IV

 

ITEM 15 EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

 

a) The following documents have been filed as a part of this Annual Report on Form 10-K

 

  1. Financial Statements

 

    Page
Report of Independent Registered Public Accounting Firm (PCAOB ID #5525)   F-1
Consolidated Balance Sheets   F-2
Consolidated Statements of Operations   F-3
Consolidated Statement of Changes in Stockholders’ Deficit   F-4
Consolidated Statements of Cash Flows   F-5
Consolidated Notes to Financial Statements   F-6

 

  2. Financial Statement Schedules.

 

All schedules are omitted because they are not applicable or not required or because the required information is included in the Financial Statements or the Notes thereto.

 

  3. Exhibits.

 

The following exhibits are filed as part of, or incorporated by reference into, this Annual Report on Form 10-K:

 

EXHIBIT

NUMBER

  DESCRIPTION
3.1   Articles of Incorporation
3.1.1   Certificate of Merger, filed February 22, 2011
3.1.2   Certificate of Amendment to Articles of Incorporation filed October 15, 2012 (incorporated herein by reference to Form 8-K, filed on October 17, 2012)
3.2   Bylaws (incorporated herein by reference to Form SB-2, filed on November 21, 2007)
3.2.1   Bylaws amendments adopted August 22, 2012, August 24, 2012 and September 26, 2012 (incorporated herein by reference to Form 8-K, filed on October 17, 2012)
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)

 

 44 

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
   
  By: /s/ Timothy G. Dixon
    Timothy G. Dixon
    Chief Executive Officer and President
     
  Date: April 17, 2024
     
  By: /s/ Thomas E. Ichim
    Thomas E. Ichim
    Director
     
  Date: April 17, 2024

 

 45 

 

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Shareholders of Therapeutic Solutions International, Inc.

 

Opinion on the Financial Statements

 

We have audited the accompanying consolidated balance sheets of Therapeutic Solutions International, Inc. and subsidiaries (“the Company”) as of December 31, 2023 and 2022, and the related consolidated statements of operations, changes in shareholders’ deficit, and cash flows for each of the years in the two-year period ended December 31, 2023, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022 and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.

 

Going Concern

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has incurred significant losses since inception, has not generated material revenue from operations and requires additional funds to maintain its operations. This factor, among others, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to this matter are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Basis for Opinion

 

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

 

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

Critical Audit Matters

 

Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there were no critical audit matters.

 

 

Fruci & Associates II, PLLC – PCAOB ID #05525

We have served as the Company’s auditor since 2019.

 

Spokane, Washington

April 17, 2024

 

F-1
 

 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

Balance Sheets

 

   December 31,
2023
   December 31,
2022 (Restated)
 
         
ASSETS          
Current assets:          
Cash and cash equivalents  $27,823   $18,434 
Restricted cash   -    11,003 
Accounts receivable   19,196    25,398 
Inventory   22,574    42,428 
Prepaid expenses and other current assets   16,320    212,352 
Total current assets   85,913    309,615 
           
Property and equipment, net   374,355    273,078 
Right-of-use asset   125,557    8,612 
Other assets   2,706,187    3,014,620 
           
Total assets  $3,292,012   $3,605,925 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $397,674   $399,410 
Accounts payable-related parties   7,204    

9,791

 
Accrued expenses and other current liabilities   536,118    531,783 
Lease liability   20,525    8,612 
Notes payable, current portion   4,638    4,638 
Convertible notes payable, net of discount of $112,384 and $175,063, at December 31, 2023 and 2022, respectively   49,616    65,187 
Notes payable-related parties, net   702,741    988,672 
Derivative liabilities   181,070    202,144 
Total current liabilities   1,899,586    2,210,237 
           
LONG TERM LIABILITIES          
Notes payable, net of current portion   5,512    10,507 
Lease liability, net of current portion   105,032    - 
TOTAL LIABILITIES   2,010,130    2,220,744 
           
Commitments and contingencies   -    - 
           
Shareholders’ Equity:          
Preferred stock, $0.001 par value; 5,000,000 shares authorized, 2 shares and 2 shares issued and outstanding at December 31, 2023 and 2022, respectively   -    - 
Common stock, $0.001 par value; 5,500,000,000 and 3,500,000,000 shares authorized, respectively; 3,802,666,978 and 2,617,390,830 shares issued and outstanding at December 31, 2023 and 2022, respectively.   3,802,668    2,617,392 
Additional paid-in capital   17,670,092    16,655,643 
Shares to be issued   -    126,324 
Subscription receivable   (21,000)   (21,000)
Accumulated deficit   (20,326,465)   (18,156,651)
Total shareholders’ equity   1,125,295    1,221,708 
Non-controlling interest   156,587   163,473
Total shareholders’ equity - Therapeutic Solutions International, Inc.   1,281,882    1,385,181 
           
Total liabilities and shareholders’ equity  $3,292,012   $3,605,925 

 

See accompanying notes to consolidated financial statements.

 

F-2
 

 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

Consolidated Statements of Operations

 

   For the Year Ended December 31, 2023   For the Year Ended December 31, 2022 (Restated) 
         
Net sales  $98,994   $206,767 
Cost of goods sold   36,768    79,440 
           
Gross profit   62,226    127,327 
           
Operating expenses:          
General and administrative   474,960    497,151 
Salaries, wages, and related costs   433,324    444,865 
Consulting fees   148,570    612,658 
Legal and professional fees   431,197    399,902 
Research and development   560,654    1,452,128 
Total operating expenses   2,048,705    3,406,704 
           
Loss from operations   (1,986,479)   (3,279,377)
           
Other income (expense):          
Gain (loss) on derivative liabilities   36,985    (131,475)
Change in fair value of derivative liabilities   (17,836)   291,123 
Interest expense   (423,265)   (646,089)
Gain on extinguishment of debt   168,145    - 
Other expense   -    (110,642)
Total other income (expense)   (235,971)   (597,083)
           
Loss before provision for income taxes   (2,222,450)   (3,876,460)
           
Provision for income taxes   2,250    1,600 
           
Net loss before non-controlling interest   (2,224,700)   (3,878,060)
           
Loss attributable to non-controlling interest   (54,886)   (64,079)
           
Net loss attributable to Therapeutic Solutions International, Inc.  $(2,169,814)  $(3,813,981)
           
Net loss per share - basic and diluted  $(0.00)  $(0.00)
           
Weighted average shares outstanding - basic and diluted   3,168,900,801    2,528,062,958 

 

See accompanying notes to consolidated financial statements.

 

F-3
 

 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

Consolidated Statements of Changes in Shareholders’ Deficit

For the Years Ended December 31, 2023 and 2022

 

                                           
   Series A Preferred Stock   Common Stock  

Additional

Paid-in

   Shares to   Subscription   Accumulated   Non-controlling  

Total Shareholders’

Equity

 
   Shares   Amount   Shares   Amount   Capital   be Issued   Receivable   Deficit  

Interest

   (Deficit) 
December 31, 2021   -   $-    2,311,123,860   $2,311,125   $11,220,653   $-   $(21,000)  $(14,342,670)  $227,552   $(604,340)
                                                   
Common stock issued for services   -    -    32,412,577    32,413    557,107    102,000    -    -    -    691,520 
Common stock issued for prepaid fees   -    -    11,000,000    11,000    231,320    -    -    -    -    242,320 
Common stock issued for salaries   -    -    4,812,259    4,812    62,587    -    -    -    -    67,399 
Common stock issued for cash   -    -    44,500,000    44,500    400,500    -    -    -    -    445,000 
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   -    -    64,139,744    64,140    1,225,308    24,324    -    -    -    1,313,772 
Issuance of preferred stock   2    -    -    -    -    -    -    -    -    - 
Net loss   -    -    -    -    -    -    -    (3,813,981)   (64,079)   (3,878,060)
December 31, 2022   2   $-    2,617,390,830   $2,617,392   $16,655,643   $126,324   $(21,000)  $(18,156,651)  $163,473  $1,385,181 
                                                   
Common stock issued for services   -    -    115,257,394    115,257    163,654    (102,000)   -    -    -    176,911 
Common stock issued for salaries   -    -    64,081,632    64,082    45,918    -    -    -    -    110,000 
Common stock issued for cash   -    -    556,632,297    556,632    233,800    -    -    -    -    790,432 
Common stock issued by subsidiary for services   -    -    -    -    53,841    -    -    -    48,000    101,841 
Common stock issued for land development   -    -    60,000,000    60,000    36,000    -    -    -    -    96,000 
Common stock issued for conversion of convertible notes, accrued interest and derivative liabilities   -    -    389,304,825    389,305    481,236    (24,324)   -    -    -    846,217 
Net loss   -    -    -    -    -    -    -    (2,169,814)   (54,886)   (2,224,700)
December 31, 2023   2   $-    3,802,666,978   $3,802,668   $17,670,092   $-   $(21,000)  $(20,326,465)  $156,587  $1,281,882 

 

See accompanying notes to consolidated financial statements.

 

F-4
 

 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

Consolidated Statements of Cash Flows

 

   For the Year Ended December 31, 2023   For the Year Ended December 31, 2022 (Restated) 
         
Cash flows from operating activities          
Net loss  $(2,224,700)  $(3,878,060)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock-based compensation to consultants   101,841    380,820 
Stock-based compensation to related parties   176,911    310,700 
Loss on derivative liabilities   (36,985)   131,475 
Change in fair value of derivative liabilities   17,836    (291,123)
Gain on extinguishment of debt   (168,145)   - 
Amortization of prepaid stock-based compensation   116,793    951,748 
Amortization of debt discount   384,744    593,463 
Patent amortization   300,897    233,685 
Depreciation   10,881    10,946 
Changes in operating assets and liabilities:          
Accounts receivable   6,202    (8,785)
Inventory   19,854    (2,611)
Prepaid expenses and other current assets   94,618    354,989 
Right-of-use asset   29,299    25,572 
Accounts payable   (1,738)   15,166 
Accounts payable - related parties   (2,587)   (9,791)
Accrued expenses and other current liabilities   148,288    169,451 
Lease liability   (29,299)   (25,572)
Net cash used in operating activities   (1,055,290)   (1,037,927)
           
CASH FLOWS FROM INVESTING ACTIVITIES:          
Purchases of property and equipment   (16,158)   - 
Purchase of license   -    - 
Issuance of note receivable   (7,842)   - 
Net cash used in investing activities   (24,000)   - 
           
Cash flows from financing activities          
Payments on notes payable to related party   (21)   (2,453)
Proceeds from notes payable to related party   6,510    - 
Proceeds from convertible notes payable   285,750    505,000 
Payments on notes payable   (4,995)   (4,459)
Proceeds from sale of common stock   790,432    445,000 
Net cash provided by financing activities   1,077,676    943,088 
           
Net decrease in cash, cash equivalents and restricted cash   (1,614)   (94,839)
Cash, cash equivalents and restricted cash at beginning of period   29,437    124,276 
Cash, cash equivalents and restricted cash at end of period  $27,823   $29,437 
           
Supplemental cash flow information:          
Cash paid for interest  $2,761   $3,173 
Cash paid for income taxes  $1,450   $800 
           
Non-cash investing and financing transactions:          
Original issuance discount on convertible notes payable  $37,500   $39,000 
Debt discount recorded in connection with derivative liability  $284,565   $503,726 
Common stock issued in conversion of convertible notes payable and interest  $846,217   $1,313,772 
Common stock issued for prepaid fees  $-   $242,320 
Common stock issued for accrued salaries  $110,000   $67,399 
Accrued interest added to principal  $13,126   $25,914 
Common stock issued for license  $-   $3,107,570 
Common stock issued for land development  $96,000   $50,400 
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  $27,823   $18,434 
Restricted cash   -    11,003 
Total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows:  $27,823   $29,437 

 

See accompanying notes to consolidated financial statements.

 

F-5
 

 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

December 31, 2023

 

Note 1 – Organization and Business Description

 

Therapeutic Solutions International, Inc. (“TSOI” or the “Company”) was organized August 6, 2007, under the name Friendly Auto Dealers, Inc., under the laws of the State of Nevada. In the first quarter of 2011 the Company changed its name from Friendly Auto Dealers, Inc. to Therapeutic Solutions International, Inc., and acquired Splint Decisions, Inc., a California corporation.

 

Business Description

 

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

 

Activating one’s immune system is now an accepted method to treat certain cancers, reduce recovery time from viral or bacterial infections and to prevent illness. Additionally, inhibiting one’s immune system is vital for reducing inflammation, autoimmune disorders and allergic reactions.

 

TSOI is developing a range of immune-modulatory agents to target certain cancers, schizophrenia, suicidal ideation, traumatic brain injury, and for daily health.

 

Nutraceutical Division – TSOI has been producing high quality nutraceuticals. Its current flagship product, QuadraMune®, is a multi-patented synergistic blend of pterostilbene, sulforaphane, epigallocatechin-3-gallate, and thymoquinone. QuadraMune has been shown to increase Natural Killer Cell activity and healthy Cytokine production.

 

Regenerative Medicine – TSOI obtained exclusive rights to a patented adult stem cell for development of therapeutics in the area of chronic traumatic encephalopathy (CTE) and traumatic brain injury (TBI) and Lung Pathology (LP).

 

The stem cell licensed, termed “JadiCell” is unique in that it possesses features of mesenchymal stem cells, however, outperforms these cells in terms of a) enhanced growth factor production; b) augmented ability to secrete exosomes; and c) superior angiogenic and neurogenic ability. Subsequent to this acquisition the Company has filed an additional 22 patents on this population of unique mesenchymal like stromal cells.

 

Immunotherapies

 

TSOI has a large portfolio of immunotherapies that range from dendritic cell vaccines for cancers to parkinson’s disease developed on our StemVacs platform.

 

F-6
 

 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

December 31, 2023

 

Management does not expect existing cash as of December 31, 2023, to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these financial statements. These financial statements have been prepared on a going concern basis which assumed the Company will continue to realize its assets and discharge its liabilities in the normal course of business. As of December 31, 2023, the Company has incurred losses totaling $20.1 million since inception, has not yet generated material revenue from operations, and will require additional funds to maintain its operations. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern within one year after the consolidated financial statements are issued. The Company’s ability to continue as a going concern is dependent upon its ability to generate future profitable operations and obtain the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they become due. The Company intends to finance operating costs over the next twelve months through its existing financial resources and we may also raise additional capital through equity offerings, debt financings, collaborations and/or licensing arrangements. If adequate funds are not available on acceptable terms, we may be required to delay, reduce the scope of, or curtail, our operations. The accompanying consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

Note 2 – Basis of presentation and significant accounting policies

 

Basis of Presentation

 

The consolidated financial statements and accompanying notes have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). In the opinion of the Company’s management, the consolidated financial statements include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position for the periods presented.

 

Principles of Consolidation

 

The accompanying consolidated financial statements include the accounts of Therapeutic Solutions International, Inc., its wholly owned subsidiaries,its 68% owned subsidiary Res Nova Bio, Inc. and its 52% owned subsidiary Campbell Neurosciences, Inc. All significant intercompany balances and transactions have been eliminated in consolidation. No material activity in any subsidiaries. The Company reinstated the 2022 Financial Statements due to the evaluation of Campbell Neurosciences as a variable interest entity (VIE), having a controlling interest despite not having voting rights. The Company didn’t appropriately identify and consolidate the VIE.

 

Accounts Receivable

 

On January 1, 2023, the Company adopted ASU 2016-13 Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASC 326). This standard replaced the incurred loss methodology with an expected loss methodology that is referred to as the current expected credit loss (“CECL”) methodology. CECL requires an estimate of credit losses for the remaining estimated life of the financial asset using historical experience, current conditions, and reasonable and supportable forecasts and generally applies to financial assets measured at amortized cost, including loan receivables and held-to-maturity debt securities, and some off-balance sheet credit exposures such as unfunded commitments to extend credit. Financial assets measured at amortized cost will be presented at the net amount expected to be collected by using an 2 allowance for credit losses.

 

The company looks at historical losses, assesses current and future events to adjust historical information as necessary, and applies percentages to accounts receivable balances based on aging.

 

The company recorded an allowance for doubtful accounts of $6,807 as of both December 31, 2023 and 2022, respectively.

 

Revenue Recognition

 

The Company recognizes revenue in accordance with ASC 606, “Revenue from Contracts with Customers” (“ASC 606”). In accordance with ASC 606, the Company applies the following methodology to recognize revenue:

 

  1) Identify the contract with a customer.
     
  2) Identify the performance obligations in the contract.
     
  3) Determine the transaction price.
     
  4) Allocate the transaction price to the performance obligations in the contract.
     
  5) Recognize revenue when (or as) the entity satisfies a performance obligation.

 

ASC 606 provides that sales revenue is recognized when control of the promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company generally satisfies performance obligations upon shipment of the product or service to the customer. This is consistent with the time in which the customer obtains control of the product or service.

 

The sales were $98,994 and $206,767 as of December 31, 2023, and 2022, respectively.

 

Returns. Revenue is adjusted based on an estimate of the expected returns based on historical rates. Our estimate of the provision for returns is based upon our most recent historical experience of actual customer returns. Additionally, we consider other factors when estimating our current period return provision, including levels of inventory in our distribution channel as well as significant market changes which may impact future expected returns, and make adjustments to our current period provision for returns when it appears product returns may differ from our original estimates. These returns have not been significant to the Company’s revenues in the accompanying financial statements.

 

Wholesale policies:

 

Delivery. The Goods shall be deemed delivered when Buyer has accepted delivery at the above-referenced location. The shipping method shall be determined by Seller, but Buyer will not be responsible for shipping costs.

 

Purchase Price & Payments. Seller agrees to sell the Goods to Buyer for Fifty Percent (50%) off Sellers listed retail price. Seller will provide an invoice to Buyer at the time of delivery. All invoices must be paid, in full, within thirty (30) days. Any balances not paid within thirty (30) days will be subject to a five percent (5%) late payment penalty. In the event Buyer exceeds the aggregate of $500,000 worth of aforementioned products having been purchased, delivered, and paid for, Buyer will be entitled to an additional Five Percent (5%) discount up to the aggregate of $750,000.00. In the event Buyer exceeds the aggregate of $750,000 worth of aforementioned products having been purchased, delivered, and paid for, Buyer will be entitled to an additional Five Percent (5%) discount up to the aggregate of $1,500,000.00. All future sales after initial $1,500,000 in aggregate purchases will be sold at 60% off retail.

 

F-7
 

 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

December 31, 2023

 

Inspection of Goods & Rejection. Buyer is entitled to inspect the Goods upon delivery. If the Goods are unacceptable for any reason, Buyer must reject them at the time of delivery up to five (5) business days from the date of delivery. If Buyer has not rejected the Goods within five (5) business days from the date of delivery, Buyer shall have waived any right to reject that specific delivery of Goods. In the event Buyer rejects the Goods, Buyer shall allow Seller a reasonable time to cure the deficiency. A reasonable time period shall be determined by industry standards for the particular Goods, as well as the Seller and Buyer.

 

Risk of Loss. Risk of loss will be on the Seller until the time when the Buyer accepts delivery. Seller shall maintain any and all necessary insurance in order to insure the Goods against loss at Seller’s own expense

 

Retail policies of e-commerce:

 

Shipping. Shipping Time — Most orders will ship the next business day, provided the product ordered is in stock. Orders are not processed or shipped on Saturday or Sunday, except by prior arrangement. We cannot guarantee when an order will arrive. Consider any shipping or transit time offered to the customer by this site or other parties only as an estimate. We encourage the customer to order in a timely fashion to avoid delays caused by shipping or product availability. Fulfillment mistakes that may be made which result in the shipment of incorrect products to the customer will also be accepted for return.

 

Out of Stock. We will ship the customer’s product as it becomes available. Usually, products ship by the next business day. However, there may be times when the product the customer had ordered is out-of-stock, which will delay fulfilling the customer’s order. We will keep the customer informed of any products that the customer had ordered that are out-of-stock and unavailable for immediate shipment. The Customer may cancel their order at any time prior to shipping.

 

Cash and Cash Equivalents

 

The Company considers all highly liquid instruments with maturity of three months or less at the time of issuance to be cash equivalents.

 

Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash deposits. Accounts at each institution are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000. At December 31, 2023 and 2022, the Company had $0 in excess of the FDIC insured limit.

 

Inventories

 

Inventories are stated at lower of cost (using the first-in, first-out method, “FIFO”) or market. Inventories consist of purchased materials and assembly items.

 

Derivative Liabilities

 

A derivative is an instrument whose value is “derived” from an underlying instrument or index such as a future, forward, swap, option contract, or other financial instrument with similar characteristics, including certain derivative instruments embedded in other contracts and for hedging activities.

 

As a matter of policy, the Company does not invest in separable financial derivatives or engage in hedging transactions. However, the Company entered into certain debt financing transactions in fiscal 2023 and 2022, as disclosed in Note 7 containing certain conversion features that have resulted in the instruments being deemed derivatives. We evaluate such derivative instruments to properly classify such instruments within equity or as liabilities in our financial statements. Our policy is to settle instruments indexed to our common shares on a first-in-first-out basis.

 

The classification of a derivative instrument is reassessed at each reporting date. If the classification changes as a result of events during a reporting period, the instrument is reclassified as of the date of the event that caused the reclassification. There is no limit on the number of times a contract may be reclassified.

 

F-8
 

 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

December 31, 2023

 

Instruments classified as derivative liabilities are remeasured using the Black-Scholes model at each reporting period (or upon reclassification) and the change in fair value is recorded on our consolidated statement of operations. We recorded derivative liabilities of $181,070 and $202,144 at December 31, 2023 and 2022, respectively.

 

Fair Value of Financial Instruments

 

The Company’s financial instruments consist of cash and cash equivalents, prepaids, convertible notes, and payables. The carrying amount of cash and cash equivalents and payables approximates fair value because of the short-term nature of these items.

 

Fair value is an exit price, representing the amount that would be received from the sale of an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. Fair value measurements are required to be disclosed by level within the following fair value hierarchy:

 

Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.

 

Level 2 – Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.

 

Level 3 – Inputs lack observable market data to corroborate management’s estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.

 

When determining fair value, whenever possible the Company uses observable market data, and relies on unobservable inputs only when observable market data is not available. As of December 31, 2023 and 2022, the Company has level 3 fair value calculations on derivative liabilities.

 

The following is the change in derivative liability for the years ended December 31, 2023 and 2022:

 

Balance, December 31, 2021  $531,525 
      
Issuance of new derivative liabilities   674,971 
Conversions   (713,229)
Change in fair market value of derivative liabilities   (291,123)
      
Balance, December 31, 2022   202,144 
      
Issuance of new derivative liabilities   371,761 
Conversions   (410,671)
Change in fair market value of derivative liabilities   17,836 
Balance, December 31, 2023  $181,070 

 

Use of Estimates

 

Estimates were made relating to valuation allowances, impairment of assets, share-based compensation expense and accruals. Actual results could differ materially from those estimates.

 

Comprehensive Loss

 

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

 

Non-Controlling Interests

 

Non-controlling interests disclosed within the consolidated statement of operations represent the minority ownership’s 68% share of net losses of Res Nova Bio, Inc. and 52% share of net losses of Campbell Neurosciences, Inc. incurred during the year ended December 31, 2023.

 

Net Loss Per Share

 

Basic loss per share is computed by dividing net income available to common stockholders by the weighted average number of common shares outstanding during the period of computation. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if potential common shares had been issued, if such additional common shares were dilutive. Since we had net losses for all the periods presented, basic and diluted loss per share are the same, and additional potential common shares have been excluded as their effect would be antidilutive.

 

As of December 31, 2023, and 2022, a total of 1,151,186,465 and 267,136,056, respectively, potential common shares, consisting of shares underlying outstanding convertible notes payable were excluded as their inclusion would be antidilutive.

 

F-9
 

 

THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

December 31, 2023

 

Depreciation and Amortization

 

Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. Amortization is computed using the straight-line method over the term of the agreement. Depreciation expense for the year ended December 31, 2023, and 2022 was $10,881 and $10,946, respectively.

 

Intangible Assets

 

Intangible assets consisted primarily of intellectual properties such as proprietary nutraceutical formulations. Intellectual assets are capitalized in accordance with ASC Topic 350 “Intangibles – Goodwill and Other.” Intangible assets with finite lives are amortized over their respective estimated lives and reviewed for impairment whenever events or other changes in circumstances indicate that the carrying amount may not be recoverable. Amortization expense for the year ended December 31, 2023, and 2022 was $300,897 and $233,685, respectively.

 

Long-lived Assets

 

In accordance with ASC 360, Property, Plant and Equipment, the carrying value of intangible assets and other long-lived assets is reviewed on a regular basis for the existence of facts or circumstances that may suggest impairment. The Company recognizes impairment when the sum of the expected undiscounted future cash flows is less than the carrying amount of the asset. Impairment losses, if any, are measured as the excess of the carrying amount of the asset over its estimated fair value.

 

Shipping and Handling

 

The Company recognizes shipping and handling billed to customers as a component of net revenues, and the cost of shipping and handling within the general administrative expenses.

 

Advertising

 

Advertising costs are expensed as incurred. Advertising expense for the years ended December 31, 2023 and 2022 were $3,549 and $4,132, respectively.

 

Research and Development

 

Research and Development costs are expensed as incurred. Research and Development expenses were $560,654 and $1,452,128 for the year ended December 31, 2023, and 2022, respectively.

 

Income Taxes

 

The Company accounts for income taxes under ASC 740 “Income Taxes,” which codified SFAS 109, “Accounting for Income Taxes” and FIN 48 “Accounting for Uncertainty in Income Taxes – an Interpretation of FASB Statement No. 109.” Under the asset and liability method of ASC 740, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period the enactment occurs. A valuation allowance is provided for certain deferred tax assets if it is more likely than not that the Company will not realize tax assets through future operations.

 

Stock-Based Compensation

 

Compensation expense for stock issued to employees is determined as the fair value of consideration or services received or the fair value of the equity instruments issued, whichever is more reliably measured. The Financial Accounting Standards Board (FASB) issued ASU 2018-07 to expand the scope of Topic 718 to include share-based payments issued to nonemployees. The effective date for public companies is for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. For all other entities, the effective date is fiscal years beginning after December 15, 2019. The Company adopted during the year ended December 31, 2018 for which there was no impact on the consolidated financial statements. The Company issues shares for multiyear consulting agreements which are restricted and nonrefundable shares.

 

Leases

 

On February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The new standard requires lessees to recognize most leases on their balance sheets as lease liabilities w