Therapeutic Solutions International, Inc. · OTC:TSOI

Therapeutic Solutions International — Investor Presentation (September 2026)

12 slides from Therapeutic Solutions International's investor presentation, September 2026

  1. Slide 1: JadiCell UC-MSC Therapy

    MEDICAL AFFAIRS EDITION | SEPTEMBER 2026 BREATHE BIOLOGICS, INC. JadiCell UC-MSC Therapy BREATHE BIOLOGICS, INC. Transforming Hope Into Healing Phase 2b/3 IND #19757 91% vs 42% Allogeneic CLINICAL STAGE FDA ACTIVE IND PHASE 1/2A SURVIVAL OFF-THE-SHELF

  2. Slide 2: The ARDS Crisis: A Lethal Unmet Need

    DISEASE BURDEN OVERVIEW The ARDS Crisis: A Lethal Unmet Need 190,000+ 30–45% 75,000+ $1B+ ARDS is a life-threatening inflammatory lung condition characterized by rapid-onset respiratory failure and bilateral pulmonary infiltrates. No FDA- approved pharmacologic therapy exists targeting its underlyin

  3. Slide 3: Understanding ARDS: The Cytokine Storm

    ARDS PATHOPHYSIOLOGY Understanding ARDS: The Cytokine Storm STEP 1 — TRIGGER 01 STEP 4 — HYPOXEMIA 04 Systemic Insult Activates Immune Cascade Respiratory Failure & Bilateral Infiltrates Sepsis, trauma, viral pneumonia, or COVID-19 triggers a systemic PaO₂/FiO₂ <300 mmHg — hallmark ARDS threshold. B

  4. Slide 4: JadiCell: The Technology Platform

    JadiCell : The Technology Platform BREATHE BIOLOGICS · MEDICAL AFFAIRS EDITION CE L L TY PE 1 MANU FACTU RING 2 PATE NT 3 cGMP-Compliant Production Allogeneic UC-MSC U.S. Patent 9,803,176 B2 Diabetes Research Institute, University of Miami JadiCell is derived from the subepithelial layer of Propriet

  5. Slide 5: How JadiCell Works

    MEC HA NIS M OF A C TION BREATHE BIOLOGICS How JadiCell Works Systemic delivery → targeted immunomodulation → tissue regeneration 1 2 3 4 Intravenous Homing to Immuno- Tissue Administration Inflammation modulation Repair Two infusions MSCs traffic to sites Paracrine factors Promotes alveolar Day 0 &

  6. Slide 6: Phase 1/2a Trial Design NCT04355728

    Phase 1/2a Trial Design NCT04355728 PHASE 1/2A · PUBLISHED 2021 STUDY DESIGN PATIENT POPULATION TRI AL TYP E ARD S C L AS S I F ICAT ION Double-blind, Randomized, Placebo-controlled Moderate-to-Severe ARDS (COVID-19-induced) C L I N I C AL SI TE SETTING University of Miami Health System / Jackson Me

  7. Slide 7: Phase 1/2a: Landmark Clinical Outcomes

    PHASE 1/2A TRIAL · NCT04355728 · N=24 Phase 1/2a: Landmark Clinical Outcomes 91% 8× Statistically Zero JadiCell Survival at Day 31 Fewer Serious Adverse Events Significant Treatment-Related vs. 42% Control 2 vs. 16 cases Serious Adverse Events Faster Time to Recovery vs. Control Group SURVIVAL ENDPO

  8. Slide 8: Cytokine Storm Suppression: Immunomodulatory Evidence

    IMMUNOMODULATORY EVIDENCE · PHASE 1/2A DATA NCT04355728 Cytokine Storm Suppression: Immunomodulatory Evidence Ricordi et al., 2021 JadiCell treatment produced statistically significant reductions in key pro-inflammatory mediators driving ARDS severity. RELA T IV E C YT OKINE LEV ELS IL-6 Interleukin

  9. Slide 9: Phase 2b/3 Pivotal Trial: NCT07479043

    PHASE 2B/3 PIVOTAL TRIAL IND #19757 ACTIVE Phase 2b/3 Pivotal Trial: NCT07479043 BREATHE BIOLOGICS, INC. I N D STATU S IND #19757 Active — FDA regulatory clearance secured for Phase 2b/3 progression T RI AL RE G I S T RATION NCT07479043 registered; double-blind, randomized, controlled, multi-center

  10. Slide 10: Regulatory Pathway & Intellectual Property

    Regulatory Pathway & Intellectual Property IND #19757 | FDA OTAT | 21 CFR 312 IND STATUS FDA OFFICE TRIAL PHASE IND #19757 — Active with FDA Regulated by the FDA Office of Tissues and Advanced Phase 2b/3 Pivotal Trial — NCT07479043 21 CFR 312 Investigational New Drug pathway. Full Therapies (OTAT) —

  11. Slide 11: Expanding the JadiCell Platform: Future Indications

    PLATFORM EXPANSION & PIPELINE Expanding the JadiCell Platform: Future Indications ● ACTIVE — PHASE 2B/3 NEAR-TERM MID-TERM EXPLORATORY ARDS Sepsis-Induced ARDS Trauma-Related ARDS Viral Respiratory Failure Phase 1/2a signal supports exploration Emerging preclinical rationale Influenza, RSV — broad v

  12. Slide 12: Key Takeaways

    FINAL SUMMARY 1 ARDS is a lethal unmet need with no FDA-approved disease-modifying therapy — 190,000+ cases/year in the U.S. and a mortality Key rate of 30–45%, representing an urgent therapeutic gap. Takeaways 2 JadiCell is an allogeneic, off-the-shelf UC-MSC therapy manufactured under cGMP standar

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