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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): December 22, 2023
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC. |
(Exact
Name of Registrant as Specified in its Charter) |
Nevada |
|
000-54554 |
|
45-1226465 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
Number) |
701
Wild Rose Lane |
Elk
City, Idaho 83525 |
(Address
of Principal Executive Offices and Zip Code) |
|
(760)
295-7208 |
(Issuer’s
telephone number) |
|
|
(Former
Name or Former Address, if Changed Since Last Report) |
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title of
each class |
|
Trading Symbol(s) |
|
Name of each exchange on which
registered |
Common Stock |
|
TSOI |
|
OTC Markets |
Item
8.01 Other Events – Letter to Shareholders and Interested Parties.
Dear
Shareholders and all Interested Parties,
As
we come to the end of another year at Therapeutic Solutions International (TSOI), we would like to take a moment to spotlight the numerous
accomplishments we have achieved throughout this year.
In
January, we introduced groundbreaking data and initiated a patent filing based on a surprising discovery. This discovery involves the
application of multiple microinjections containing peptides derived from myelin basic protein, combined with various agents designed
to inhibit the maturation of dendritic cells. The result? A significantly enhanced suppression of symptoms related to multiple sclerosis
within the experimental autoimmune encephalitis model, when compared to traditional administration methods1.
In
February, we inaugurated the Veltmeyer Institute for Advanced Biologics. Our primary mission is to offer patients access to JadiCell
adult stem cell treatments, specifically in the realm of brain and lung conditions, under the provisions of the Right to Try Law (`RTT)
when it is applicable. Additionally, we extend our services to cancer patients, providing a range of immunotherapies, including ValloVax
and FloraVax2.
In
April, we submitted a fresh Phase III clinical trial application to the FDA. This application seeks approval for the utilization of our
JadiCell in the treatment of acute respiratory distress syndrome (ARDS)3.
In
May, we introduced VasoSome Vascular, Inc., with a strong focus on addressing the critical issue of aortic aneurysms, often referred
to as the “living timebomb” condition. We are pioneering the use of stem cell-derived exosomes in our approach4.
Simultaneously
in May, we made an exciting announcement about the establishment of CTE Biologics, Inc., as a subsidiary company. This new entity is
wholly dedicated to the commercialization of the JadiCell adult stem cell platform, specifically for the treatment of chronic traumatic
encephalopathy5.
In
June, we applied to the FDA requesting “Orphan Drug Designation” for our JadiCell Adult Stem Cell Product, specifically for
the treatment of acute respiratory distress syndrome (ARDS). If granted, this designation would make JadiCells eligible for several significant
benefits and incentives. These include seven years of exclusive marketing rights, tax credits for clinical trials, eligibility for orphan
drug grants, and exemption from FDA New Drug Application fees6.
In
July, we continued our momentum by submitting another application to the FDA, this time seeking Orphan Drug Designation for JadiCell
in the treatment of Frontotemporal Dementia. Research has highlighted various inflammatory mechanisms as contributors to disease progression
in both chronic traumatic encephalopathy and frontotemporal dementia. One particularly intriguing aspect of our research revolves around
the capacity of JadiCells to not only inhibit inflammasome activation but also to target downstream chemical messengers within this inflammatory
pathway. Simultaneously, JadiCells demonstrate the ability to stimulate the regeneration of damaged neurons, making them a promising
candidate for addressing these challenging neurological conditions7.
In
August, we proudly announced a significant achievement within our subsidiary, Allogen Biologics, Inc. They successfully created a Master
Cell Bank (MCB) containing our JadiCell, which has undergone rigorous quality control testing. It is estimated that by August 2024, these
cells will have matured to a level that allows us to obtain clearance for Phase III Investigational New Drug (IND) trials. Importantly,
this MCB serves a dual purpose by not only supplying cells for clinical trials but also making them available for Right to Try (RTT)
cases in the interim period8.
In
the most recent month of December, we unveiled our latest endeavor by establishing our eighth subsidiary company, ALS Biologics, Inc.
This company is solely committed to addressing Amyotrophic Lateral Sclerosis (ALS), a debilitating motor neuron degenerative disease
that currently lacks a cure. The formation of ALS Biologics, Inc. was prompted by encouraging observations from patients who underwent
treatment with our ALScell™ (JadiCell™) product under the Right to Try Law at the Veltmeyer Institute9.
1
Therapeutic Solutions International Announces Antigen
Specific Blockade of Pathological Immune Response in Multiple Sclerosis Model Using “Tattoo
Gun” Immunization
2
Therapeutic Solutions International Launches Veltmeyer Institute for Advanced Biologics
3
Therapeutic Solutions International Files to Initiate Phase III Clinical Trial for Acute Respiratory
Distress Syndrome (ARDS) Leveraging Positive COVID-19 Data with JadiCell Stem Cell Therapy
4
Therapeutic Solutions International Launches VasoSome Vascular Inc Based on Successful Treatment
of Aortic Aneurysms using Patent Pending Exosome Therapy
5
Therapeutic Solutions International Launches Subsidiary Company to Commercialize Clinical Data
and IND for Treatment of Chronic Traumatic Encephalopathy (CTE) with JadiCell Universal Adult Stem Cells
6
Therapeutic Solutions International Files for Orphan Drug Designation Using JadiCell Adult Universal
Donor Stem Cells for Treatment of Acute Respiratory Distress Syndrome
7
Therapeutic Solutions International Files for Orphan Drug Designation Use of JadiCell Adult
Stem Cells for Treatment of Frontotemporal Dementia
8
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
9
Therapeutic Solutions International Announces Formation of ALS Biologics Inc to Commercialize
Regenerative Technologies Related to Dreaded Motor Neuron Disease
Furthermore,
the company has filed a total of six (6) new patent applications, and two (2) additional patents have been granted this year. As a result,
our patent portfolio has expanded to encompass 77 patents and patent applications. Additionally, our drug pipeline has seen substantial
growth, now comprising 34 drugs at various stages of testing and development.
The
incredible advancements in science and research owe their success to our immensely dedicated team of researchers, clinicians, partner
institutions, and other collaborators who steadfastly collaborate with TSOI year after year. Personally, I am eternally grateful to each
and every one of them.
This
year has also brought forth significant revelations, which we have meticulously documented through the submission of two 8K reports and,
most recently, two amicus briefs (See Exhibits 99, 99.1) filed in the United States Court of Appeals for the Federal Circuit. These filings
are associated with the case of RESTEM, LLC, (Appellant) v. JADI CELL, LLC, (Appellee), specifically identified as Case # 2023-2054.
This matter is currently under appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board, docketed as
No. IPR2021-01535. All of these developments are centered around our Exclusive World-Wide Patent Licensing for Lung and Brain applications
utilizing the JadiCell.
As
we set our sights on 2024, TSOI is committed to advancing its research and development initiatives. We aim to forge new frontiers in
medicine, with the aspiration of uncovering groundbreaking discoveries that will pave the way for innovative medications, fresh patent
applications, and investigational drug submissions. Furthermore, we have ambitious plans to introduce additional subsidiary companies
throughout 2024, with a specific focus on diseases such as epilepsy, multiple sclerosis, cognitive dysfunction, and various lung and
brain pathologies. These endeavors will leverage the power of regenerative medicine, immunotherapies, and other complementary approaches
to address these critical health challenges.
Our
maiden subsidiary, Campbell Neurosciences, Inc., has been diligently preparing for its transition to the public domain, following the
earlier announcement of a shareholder dividend this year. We are pleased to report that we have successfully concluded the sixth round
of inquiries and document submissions to FINRA. As a result, we anticipate the final stages of this process with FINRA, marking a significant
milestone on our path to taking Campbell Neurosciences public in 2024. This endeavor represents an innovative approach to bringing a
company to the public sphere, in alignment with the new corporate action proposal we have submitted to FINRA.
As
we conclude this year, we eagerly anticipate the opportunities that the new year will unfold. We extend our heartfelt gratitude to every
individual within TSOI who has dedicated their unwavering efforts throughout the past year. We also express our appreciation to our subsidiary
companies and their investors, as well as the steadfast support of our advocates and shareholders within TSOI. Together, we look ahead
to a promising future filled with innovation and progress.
Item
9.01 Financial Statements and Exhibits.
Exhibit
Index
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Date:
December 22, 2023
THERAPEUTIC
SOLUTIONS INTERNATIONAL, INC.
By:
|
/s/
Timothy Dixon
|
|
By:
|
/s/
Thomas Ichim |
Timothy Dixon |
|
Thomas Ichim |
Chief Executive Officer, Director |
|
Director |
Exhibit 99
Exhibit 99.1
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