VolitionRX (VNRX) Status Update summary

Scientific and clinical update

• H3.1 nucleosome levels are a reliable biomarker for sepsis severity, correlating with mortality, acute kidney injury (AKI), multiple organ failure, and ARDS across over 3,000 patients and 14,000 measurements in large European cohorts.

• The test delivers results in 15 minutes using standard blood collection tubes, is unaffected by patient demographics or circadian rhythm, and uses chemiluminescence technology.

• Elevated H3.1 is linked to excessive immune response and organ damage, with robust validation confirming the neutrophil origin of the measured nucleosomes.

• H3.1 outperforms traditional biomarkers like CRP and interleukins in predicting sepsis-related AKI and mortality, and offers unique prognostic information beyond standard neutrophil counts.

• Initial H3.1 readings above 10,000 ng/mL predict 100% 14-day mortality, while lower levels correlate with reduced risk.

Clinical utility in organ failure

• H3.1 levels correlate with severity of AKI and predict need for renal replacement therapy (RRT) better than creatinine.

• A clinical model combining H3.1, platelet count, and urine output enhances prediction of RRT requirements.

• Higher H3.1 levels are linked to increased need for respiratory support and invasive ventilation.

• Animal studies indicate that removing H3.1 can improve outcomes, supporting its potential as both a diagnostic and therapeutic target.

• H3.1 provides a unique kinetic profile, suggesting it is central to sepsis pathology.

Background and unmet need

• Sepsis causes 11 million deaths annually, with 1 in 5 deaths worldwide associated with it and high healthcare costs, especially in the US ($62bn/year).

• Over 40% of sepsis cases are in children under 5, and survivors often face long-term effects.

• Current diagnostic methods for sepsis are empirical, complex, and slow, highlighting the need for improved, rapid diagnostics.