Advancing a Regenerative Immunology Platform in Pulmonary Medicine
Breathe Biologics is a clinical-stage pulmonary biotechnology company advancing JadiCell™, an investigational allogeneic mesenchymal cell platform being developed for serious inflammatory and degenerative pulmonary disease.
A Clinical-Stage, Pulmonary-Focused Biotechnology Company
Breathe Biologics is focused on translating regenerative cellular biology into rigorous clinical development for serious pulmonary diseases with substantial unmet medical need.
Differentiated Platform
JadiCell™ is derived from the subepithelial layer of umbilical cord tissue using proprietary methods and is supported by an intellectual-property portfolio covering key aspects of the platform.
Human Clinical Evidence
Published randomized clinical research in COVID-19-associated ARDS provides human safety, biomarker, and exploratory clinical observations supporting continued investigation.
Pulmonary Development Strategy
Development is centered on serious respiratory diseases involving inflammatory injury, immune dysregulation, endothelial dysfunction, epithelial damage, and abnormal tissue repair.
Allogeneic Manufacturing
A donor-derived manufacturing model is designed to support standardized cell banking, controlled expansion, cryopreservation, product characterization, and clinical distribution.
Intellectual Property
JadiCell™ is supported by proprietary intellectual property, including U.S. Patent No. 9,803,176 B2 relating to cells derived from the subepithelial layer of umbilical cord tissue.
Strategic Optionality
The platform may support scientific, clinical, manufacturing, investment, licensing, co-development, and other strategic collaboration opportunities.
Investor Information: JadiCell™ is investigational. Safety and efficacy have not been established for any indication. References to potential applications or development opportunities should not be interpreted as regulatory approval or established clinical benefit.
Breathe Biologics at a Glance
Clinical-Stage Pulmonary Regenerative Biotechnology
Clinical-stage biotechnology company focused on pulmonary regenerative medicine.
Investigational allogeneic mesenchymal cell platform.
Phase 3 clinical development.
Severe inflammatory and degenerative respiratory disorders.
A Living Cellular Therapy With Multi-Pathway Biology
Rather than relying on durable tissue engraftment, the biological rationale for JadiCell™ centers primarily on paracrine signaling, immune modulation, regenerative mediators, and potential restoration of tissue homeostasis.
Building on Published Human Clinical Research
Published randomized clinical research in COVID-19-associated ARDS provides an important foundation for continued investigation of JadiCell™ in severe inflammatory pulmonary disease.
Acute Respiratory Distress Syndrome
Phase 3 Lead Pulmonary Development ProgramPublished research in COVID-19-associated ARDS reported encouraging safety findings together with exploratory clinical and biomarker observations.
Pharmacodynamic analyses have explored inflammatory signaling and soluble TNF receptor pathways associated with treatment.
A registered randomized controlled Phase 3 study is designed to further investigate JadiCell™ in moderate-to-severe ARDS.
Clinical Evidence Qualification: Published early-stage findings require confirmation in adequately powered controlled clinical trials and should not be interpreted as establishing efficacy.
A Focused Pulmonary Development Strategy
Breathe Biologics is pursuing a pulmonary-focused development strategy centered on ARDS and COPD, with selected additional disease areas identified as potential future IND opportunities.
ARDS
Lead late-stage program in Acute Respiratory Distress Syndrome.
COPD
Pulmonary development pathway in Chronic Obstructive Pulmonary Disease.
Pulmonary Fibrosis / ILD
Potential future pulmonary development opportunity.
Pulmonary Vascular Disease
Potential future pulmonary development opportunity.
Bronchiectasis
Potential future pulmonary development opportunity.
Pipeline Qualification: Pulmonary Fibrosis / ILD, Bronchiectasis, and Pulmonary Vascular Disease are identified as potential future IND opportunities. Their inclusion does not establish an active clinical program, IND authorization, regulatory approval, clinical efficacy, or a commitment to initiate development.
Intellectual Property & Manufacturing
The long-term development of an allogeneic cellular therapy depends on both proprietary biology and a reproducible manufacturing strategy.
Intellectual Property
JadiCell™ is supported by a proprietary intellectual-property portfolio centered on cells isolated from the subepithelial layer of umbilical cord tissue.
- U.S. Patent No. 9,803,176 B2
- Proprietary tissue source
- Cell isolation methodology
- Cell characterization
- Expansion and manufacturing methods
- Therapeutic applications
Allogeneic Manufacturing
The manufacturing model is designed around donor qualification, cell banking, controlled expansion, product characterization, cryopreservation, and clinical distribution.
- Master and working cell banks
- Controlled cell expansion
- Identity and viability testing
- Sterility and purity testing
- Potency characterization
- Cryopreserved clinical product
Building Value Through Focused Development & Collaboration
Breathe Biologics is pursuing a development strategy that combines pulmonary specialization with external scientific, clinical, manufacturing, financial, and strategic capabilities.
Clinical Advancement
Progress the lead ARDS program through rigorous clinical investigation and generation of meaningful human evidence.
Pulmonary Development
Advance the COPD pathway and evaluate potential future pulmonary opportunities using disease biology, translational evidence, regulatory feasibility, and strategic fit.
Strategic Collaboration
Explore relationships with pharmaceutical companies, biotechnology organizations, investors, research institutions, and other strategic partners.
Corporate Information
Corporate, scientific, and strategic materials for investors, pharmaceutical and biotechnology organizations, and potential strategic partners.
Corporate / Investor Presentation
September 2026 overview of the Breathe Biologics platform, clinical development, pulmonary pipeline, manufacturing and CMC, intellectual property, financing strategy, and strategic opportunity.
View Presentation →Scientific Publications
Peer-reviewed clinical and translational literature relevant to JadiCell™ and pulmonary regenerative medicine.
View Resources →Strategic Inquiries
Qualified organizations may contact Breathe Biologics regarding investment, partnering, licensing, or other strategic discussions.
Contact Breathe Biologics →Forward-Looking Information: Information regarding future clinical development, regulatory activities, manufacturing, financing, commercialization, collaborations, intellectual property, or other future events may constitute forward-looking statements and is subject to risks and uncertainties. Actual events and results may differ materially from expectations.
Connect With Breathe Biologics
Breathe Biologics welcomes appropriate inquiries from life-science investors, pharmaceutical and biotechnology organizations, government and non-dilutive funding stakeholders, and potential strategic partners interested in the company's pulmonary development platform.