Respiratory Development Platform

Pulmonary Pipeline

Breathe Biologics is advancing JadiCell™ through a pulmonary-focused development strategy spanning late-stage ARDS development, a COPD development pathway, and carefully selected areas of potential future investigation.

ARDS — Phase 3 COPD — Phase 2 Pathway Pulmonary-Focused Development Investigational Platform
Platform

A Multi-Indication Respiratory Development Strategy

JadiCell™ is being developed as an investigational regenerative immunology platform for severe pulmonary diseases characterized by inflammatory injury, immune dysregulation, endothelial and epithelial dysfunction, and maladaptive tissue remodeling.

The current strategy prioritizes Acute Respiratory Distress Syndrome (ARDS) as the lead late-stage program and Chronic Obstructive Pulmonary Disease (COPD) as a continued development pathway.

Additional pulmonary disease areas shown on this page are identified only as potential future indications and should not be interpreted as active clinical programs.

Pulmonary Development Platform

A Multi-Indication Respiratory Pipeline

JadiCell™ is being advanced through a pulmonary-focused strategy centered on ARDS, COPD, and selected areas of potential future investigation.

JadiCell™
Pulmonary Platform
Investigational Cellular Therapy
ARDS Phase 3

Lead late-stage clinical development program.

COPD Phase 2 Pathway in Development

Continued development pathway in chronic obstructive pulmonary disease.

Pulmonary Fibrosis / ILD Potential Future Indication

Not presented as an active clinical program.

Bronchiectasis Potential Future Indication

Not presented as an active clinical program.

Pulmonary Vascular Disease Potential Future Indication

Not presented as an active clinical program.

Phase 3
Phase 2 Pathway in Development
Potential Future Indication
Pipeline qualification: The diagram reflects Breathe Biologics' current pulmonary development strategy. Pulmonary Fibrosis / ILD, Bronchiectasis, and Pulmonary Vascular Disease are presented only as potential future indications and do not represent active clinical programs, regulatory authorization, or established efficacy of JadiCell™ in those diseases.
Lead Program

Acute Respiratory Distress Syndrome

ARDS represents the lead clinical-development indication within the JadiCell™ pulmonary platform.

Phase 3

ARDS

Acute Respiratory Distress Syndrome is characterized by severe inflammatory lung injury, disruption of the alveolar-capillary barrier, pulmonary edema, impaired oxygenation, and respiratory failure.

Development Status

JadiCell™ is being evaluated through a registered Phase 3 development program in ARDS.

Evidence Foundation

Published Phase 1/2a research in COVID-19-associated ARDS provides human clinical and biomarker observations supporting continued investigation.

Development Rationale

Severe Inflammatory Lung Injury

The development rationale centers on immune dysregulation, inflammatory cytokine signaling, endothelial dysfunction, epithelial injury, alveolar-capillary barrier disruption, and impaired tissue recovery.

Clinical Development

Future conclusions regarding safety and efficacy require appropriately controlled clinical evaluation.

Development Program

Chronic Obstructive Pulmonary Disease

COPD represents an additional pulmonary development pathway for the JadiCell™ platform.

Phase 2 Pathway in Development

COPD

Chronic Obstructive Pulmonary Disease is characterized by persistent airflow limitation, chronic inflammation, recurrent exacerbations, and progressive impairment of pulmonary function.

Development Status

Breathe Biologics is pursuing a Phase 2 development pathway for JadiCell™ in COPD.

Biological Rationale

Inflammation & Tissue Injury

Potential areas of biological relevance include immune dysregulation, oxidative injury, epithelial dysfunction, endothelial injury, and chronic inflammatory signaling.

Qualification

Biological rationale does not establish clinical benefit, and therapeutic activity must be evaluated through appropriately controlled clinical studies.

Potential Future Indications

Areas of Potential Future Pulmonary Evaluation

The following disease areas may be considered for future evaluation based on biological rationale and strategic fit. They are not presented as active JadiCell™ clinical programs.

01

Pulmonary Fibrosis / ILD

Potential Future Indication. Fibrotic and interstitial pulmonary diseases characterized by progressive scarring, epithelial injury, immune dysregulation, and impaired pulmonary function.

02

Bronchiectasis

Potential Future Indication. Chronic airway disease associated with infection, inflammation, structural airway injury, and maladaptive remodeling.

03

Pulmonary Vascular Disease

Potential Future Indication. Pulmonary vascular dysfunction may involve inflammation, endothelial injury, vascular remodeling, and right-ventricular stress.

Important: Pulmonary Fibrosis / ILD, Bronchiectasis, and Pulmonary Vascular Disease are identified only as potential future indications. Their inclusion does not establish an active clinical program, IND authorization, clinical efficacy, or a commitment to initiate development in these disease areas.

Portfolio Strategy

Selection Criteria for Future Indications

Future pulmonary-development decisions are intended to be guided by scientific, clinical, regulatory, manufacturing, and strategic considerations.

Strength of biological rationale
Regulatory feasibility
Clinically meaningful endpoints
Trial-site and patient availability
Ability to identify responsive phenotypes
Manufacturing and dose requirements
Safety considerations
Strategic / public-health relevance

Medical Affairs qualification: The inclusion of a disease on this platform map indicates an area of current development or potential future evaluation as specifically identified above. It does not establish regulatory authorization, clinical efficacy, or superiority over existing therapy.