If You Invested in Therapeutic Solutions Intl Inc (TSOI)

Therapeutic Solutions International, Inc. (TSOI) is a clinical-stage biotechnology company that focuses on immune modulation and regenerative medicine for the treatment of several specific diseases. According to company statements, it develops and advances stem cell therapies, immunotherapies, and science-backed nutraceuticals aimed at conditions involving cancer, lung inflammation, neurological disorders, and psychiatric disease.

The company has publicly described itself as an "innovation factory" in applied immunology and regenerative medicine, building a portfolio of intellectual property, trade secrets, collaborations, and subsidiary companies. Its work spans clinical-stage stem cell products, gene therapy–related approaches, and nutraceutical formulations that target immune pathways.

Core Therapeutic Focus and Technologies

Therapeutic Solutions International reports that it is focused on immune modulation for multiple disease areas. A central asset is its JadiCell universal donor mesenchymal stem cell product, which the company associates with treatment of lung injury, COVID-19–related conditions, acute respiratory distress syndrome (ARDS), epilepsy, and amyotrophic lateral sclerosis (ALS). The company has disclosed that the U.S. Food and Drug Administration has cleared a Phase III trial of JadiCells for COVID-19, and that it holds or licenses patents covering the use of these cells in brain and lung diseases.

The company has also announced data suggesting that JadiCell administration can influence immune cell populations and amplify therapeutic effects in models of lung inflammation. In addition, it has reported findings that JadiCells may facilitate gene therapy–mediated differentiation of therapeutic cells in vivo, and it has filed patent applications on these mechanisms.

Beyond cell therapy, Therapeutic Solutions International has developed QuadraMune, a nutraceutical composition that the company describes as commercially available. It has announced multiple U.S. patents related to QuadraMune, including claims involving inhibition of the enzyme indoleamine 2,3-dioxygenase, approaches to prevention and treatment of SARS-CoV-2 and COVID-19, protection and restoration of brain function after neurological damage, and upregulation of regulatory T cells for suppression of suicidal ideation. The company has also reported a patent covering the ability of QuadraMune and similar compositions to stimulate natural killer (NK) cell activity in patients with COVID-19.

Subsidiaries and Spin-Off Strategy

Therapeutic Solutions International has publicly emphasized a strategy of forming dedicated subsidiary companies to advance specific indications and technologies. The company has stated that, as technologies pass proof-of-concept, placing them into independent entities can allow more focused development and create additional opportunities for licensing and transactions.

Examples of subsidiaries and pre–spin-off entities described by the company include:

• Breathe Biologics, referenced by the company as one of the subsidiaries representing part of the future of its technology and science, and a focus area as it restructures its public market presence.
• Campbell Neurosciences, Inc., described as an immunology-based suicide prevention company and a pre–spin-off entity. It is working on the CampbellCell, characterized as a stem cell product for psychiatric disease, and the Campbell Score, a blood/saliva test for suicidal propensities. The company has indicated plans for Campbell Neurosciences to seek a public listing and has discussed a loyalty dividend of Campbell Neurosciences shares to TSOI shareholders.
• Res Nova Bio, Inc., an immunotherapy-focused oncology subsidiary. Res Nova Bio is developing FloraStilbene, a drug that combines the active ingredient in the abortion pill (RU486) with pterostilbene. Therapeutic Solutions International has reported that FloraStilbene is manufactured by a compounding pharmacy and is available by prescription under Right To Try, and that early data from advanced cancer patients showed clinical signals of tumor response without adverse events related to drug administration.
• Epilepsy Bio, Inc., a subsidiary formed to commercialize intellectual property and findings related to cellular and immunological approaches to epilepsy. The company has linked this entity to pilot human data using JadiCells in advanced epilepsy and to ongoing mechanistic work in human cells and animal models.
• ALS Biologics Inc, a subsidiary dedicated to assets related to ALS. The company has associated ALS Biologics with its ALScell (JadiCell) product and with the goal of improving outcomes in neurodegenerative conditions through practical techniques derived from patient experiences.

Intellectual Property and Clinical Development

Therapeutic Solutions International highlights intellectual property as a core asset. It has disclosed ownership or licensing of patents on stem cell products such as JadiCells, on nutraceutical compositions like QuadraMune, and on methods involving immune modulation in oncology, virology, neurology, and psychiatry. The company has cited numerous issued patents and patent applications covering mechanisms of action, therapeutic uses, and combinations with immune and gene therapy approaches.

The company describes itself as a clinical-stage stem cell and immunotherapy organization. It reports holding a Phase III Investigational New Drug (IND) application for treatment of COVID-19 using JadiCells and working on a new application for all-cause ARDS. It has also noted preclinical and early clinical work in chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, epilepsy, ALS, and oncology, as well as use of Right To Try pathways for certain products.

Voluntary Delisting and "Going Dark"

In an announcement dated April 23, 2025, Therapeutic Solutions International stated that its Board of Directors, with the consent of a majority of eligible voting shareholders, approved a voluntary withdrawal of its class of securities from listing and registration on its exchange and OTC Markets pursuant to 17 CFR 240.12d2-2(c). The company reported that this decision was disclosed in a Form 8-K filing and that it intends to file Form 25 to remove its securities from listing and/or registration, followed by Form 15 to terminate registration after the applicable waiting periods.

In that statement, the company characterized the move as a voluntary delisting and a decision to "go dark" from the public markets. It attributed the decision to what it described as an increasingly hostile market environment, including predatory trading, toxic financings, and short selling, and noted a substantial decline in its market capitalization over several years. The company indicated that it sees delisting as a way to step back from what it views as a harmful trading environment and to focus on rebuilding internally.

Therapeutic Solutions International emphasized that it does not view itself as ceasing operations. Instead, it stated that it plans to concentrate on its subsidiaries, naming Breathe Biologics, Campbell Neurosciences, and Res Nova Bio as key areas of focus. The company also mentioned the possibility of monetizing subsidiaries through sale or partnerships and expressed an intention, if such transactions occur, to consider returning a portion of proceeds to shareholders through dividends or stock buy-backs, while presenting these comments as a statement of intent rather than a completed action.

Legal and Market-Related Actions

The company has reported taking legal action in response to what it describes as defamatory and libelous online postings. In a civil action filed in the Superior Court of the State of California for the County of San Diego, Therapeutic Solutions International seeks to obtain the identities of certain individuals or entities posting on financial message boards. The company has stated that the purpose is to enjoin further defamatory communications and seek recovery for alleged injuries.

Industry Classification

For classification purposes, Therapeutic Solutions International is associated with the Manufacturing sector and has been categorized under Tobacco Manufacturing. However, the company’s own public communications focus on biotechnology, stem cell therapy, immunotherapy, and nutraceutical development centered on immune modulation and regenerative medicine, rather than on tobacco-related products.

Frequently Asked Questions about Therapeutic Solutions International (TSOI)

The following questions and answers summarize key points drawn from the company’s public statements and news releases.