Therapeutic

Severe Community Acquired Pneumonia & clinical rationale

The therapy

Leveraging its platform, StemInov has developed WhartSep® treating severe community-acquired pneumonia (CAP) associated with ARDS and sepsis

A Wharton-jelly mesenchymal stem cell therapy

THERAPY

The only treatment for severe Community Acquired Pneumonia (CAP) worsening to ARDS and sepsis in ICU settings

1 treatment, 3 actions

Immunomodulatory
Anti-bacterial
Lung protective

Phase IIa-ready by Q1-2027

Documented safety,
no clinical Phase I needed

Promising results in 3 preclinical models (mice, rabbits, pigs)

Better survival
Decreased inflammation
Lung protection
Decreased bacterial load

1 patent

ARDS: Acute Respiratory Distress Syndrome

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Severe Community Acquired Pneumonia (CAP) & clinical rationale

Severe CAP can progress to ARDS or sepsis with high-mortality in ICU settings

The disease escalates fast : current care is only supportive

Moderate pneumonia

Fever, cough, dyspnea

Severe pneumonia

Lung inflammation, rising O₂ need

Worsening hypoxemia

High risk of ARDS

ARDS / sepsis

Bilateral lung failure, organ failure

Recovery or death

35–45% mortality¹, long sequelae

Care pathway

Medical Ward

Emergency Dept.

ICU (Intensive Care Unit)

ICU / Out-patient

Antibiotics throughout the care pathway : but no targeted therapy addressing the immune cascade

WhartSep® positions in ICU Settings

i.v. injections within 48h of hospitalization : acting on inflammation, infection and tissue repair before the cascade turns fatal

✓ Prevent progression

✓ Reduce mortality

✓ Shorten ICU course

1 Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries

Severe CAP is a life-threatening disease with high mortality

A severe disease devastating lungs

> Severe CAP often worsens into ARDS, sepsis or septic shock

> Fluid leaks into the alveoli, causing lung stiffness and impaired oxygen transfer

> Can rapidly progress in ICU¹ to mechanical ventilation, multi-organ failure, and death

A high burden, mortal disease

> ~1.4M cases globally

>30 to 45% mortality rate

>Market estimated at $1.3bn (2033)²

>€30k (EU) / $71k (US) estimated cost per patient

Supportive current standard of care

> Current standard-of-care relies only on mechanical ventilation to maintain oxygen levels and antibiotic therapies

> Extended ventilation can increase complications and lead to long recovery and persistent symptoms

> There is no targeted therapy addressing the immune cascade

Significant unmet medical need

2 Data Bridge Market Research : $3.3B CAP drug market, and severe CAP representing 40% of cases

WhartSep® aims to reduce mortality of patients with severe CAP associated with ARDS and sepsis

Clinical Trial Highlights

POPULATION

Patients with severe CAP associated with ARDS or sepsis

Treated with antibiotics and vasopressors
With ventilation support

ADMINISTRATION

Mode

IV route on top of antibiotics

Duration

3 consecutive daily injections

EFFICACY

Mortality

All-cause mortality rate at Day 28 and Day 90

Lung function

Ventilator dependence
Lung function measure

Infection control

Bacterial clearance
Secondary infections

Hospital stay

ICU and hospital length of stay

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Mode of action in the lung

WJ-MSCs are trapped in lung alveoli after i.v. injection, where they secrete signals to tackle the root cause of modulatory inflammation and bacterial persistence

Promises and challenges of personalized medicine to guide ARDS therapy, Critical Care
https://link.springer.com/article/10.1186/s13054-021-03822-z

WJ-MSCs are trapped in inflamed lung alveoli

WJ-MSCs dial down destructive immune responses by shifting pro-inflammatory signals (TNF-α, IL-6, M2-like macrophages) toward healing ones (IL-10, PGE2, TGF-β), preventing further damage and cytokine storms

Simultaneously, WJ-MSCs deploy antimicrobial peptides directly against bacteria, boosting macrophage phagocytosis to clear infections

WJ-MSCs transfer healthy mitochondria to stressed lung macrophages and epithelial cells, restoring energy production and fluid balance, which helps to rebuild the alveolar-capillary barrier

They also limit harmful neutrophil and leukocyte adhesion, minimizing scarring and fibrosis and promoting epithelial repair

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