December 24, 2025

Dear Shareholders,

As we close out 2025 and look forward to 2026 and beyond, we do so with a certain amount of excitement of things to come. On May 16, 2025, we filed Form 15-12G certification and notice of termination of registration under section 12(g) of the securities exchange act of 1934 or suspension of duty to file reports under sections 13 and 15(d) of the securities exchange act of 1934 decoupling from public markets.

During the last 6 months, TSOI was able to consolidate her assets and begin our process of becoming a biotechnology holding company. We also had significant breakthroughs with FDA concerning the status of our Phase 3 ARDS clinical trial using JadiCells. FDA, following a lengthy investigation, had requested an amendment to IND 19757 which we have fully submitted and await confirmation from FDA. Once confirmation is received TSOI will license our subsidiary Breathe Biologics to conduct that clinical trial and advance JadiCell towards a BLA.

In addition, and pursuant to the 21st Century Cures Act, TSOI will request Regenerative Medicine Advanced Therapy (RMAT) designation for our investigational product JadiCell, an umbilical-cord–derived mesenchymal-like stem cell population currently under active Phase 3 IND #19757 for the treatment of all causation acute respiratory distress syndrome (ARDS).

Our basis for this request is that ARDS remains a life-threatening pulmonary syndrome with mortality exceeding 35–45% in severe cases. JadiCell demonstrates repair of alveolar and endothelial structures through mitochondrial transfer, adenosine pathway activation (CD73/CD106), and cytokine modulation consistent with regenerative medicine criteria.

Importantly, JadiCell is manufactured in a fully xeno-free, serum-free system—eliminating animal proteins and reducing immunogenic and zoonotic risk—ensuring reproducibility and safety for clinical and commercial scalability.

Preliminary clinical evidence of Phase 1/2 data and Right-to-Try results demonstrate 100% survival under age 85 and 91% overall survival, substantially exceeding standard of care outcomes. The investigational product is fully defined now (following amendment of IND 19757) under DMF #18138 (amended) and protected under U.S. Patent Nos. 9,803,176 and 12,011,462.

In closing we thank all our shareholders for their patience in allowing us time to transition, consolidate, regroup, and plan for an exciting future. If interested you may always write the company at 4093 Oceanside Blvd. Suite B, Oceanside CA 92056 or by email to ir@tsoimail.com

Board of Directors, Therapeutic Solutions International, Inc.