Volitionrx Limited · AMEX:VNRX
Volitionrx — Casting a new light on sepsis management Webinar, February 2025
43 slides from Volitionrx's conference presentation, February 2025
Slide 1: Casting a new light on sepsis management
NYSE:VNRX Casting a new light on sepsis management February 2025 Property of Volition© 2025 Slide 1
Slide 2: Forward Looking Statements and Disclaimer
Forward Looking Statements and Disclaimer Statements in this document may be “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncer
Slide 3: Speakers
Speakers Speakers Mr. Gael Forterre Dr. Andrew Retter MBBS, MRCP, FRCPath (Haem), DICM, FFICM Chief Commercial Officer Clinical Lead in Critical Care Medicine, ECMO and Thrombosis Chief Medical Officer at VolitionRx, UK Property of Volition© 2025 Slide 3
Slide 4: Investment Highlights
Investment Highlights Vet Commercial Progress Strong IP Worldwide • Nu.Q® Vet Cancer test now available in 20 countries • 81 patents granted • Sold >110,000 tests and test components Q1-Q3 2024 • 129 pending internationally • Received $23 million in upfront and milestone payments to-date • Patent co
Slide 5: What sets us apart?
What sets us apart? • Our tests are simple, low-cost accessible routine blood tests • Platform agnostic, can be adapted to any diagnostic workflow • Manual, Reference Lab, Specialist Lab and Point of Care Six Hours 45 minutes <10 minutes <15 minutes • Our expanding Intellectual Property portfolio •
Slide 6: Go-to-Market Strategy
Go-to-Market Strategy Strategy implemented • Extensive product R&D conducted by Volition and its research partners • Direct and Indirect sales of CE Marked product(s) Europe as Centers of Excellence hospitals evaluate for routine clinical use • Monetize broad IP through commercial contracts with upf
Slide 7: Go to Market Strategy - HUMAN
Go to Market Strategy - HUMAN • Utilize granted CE mark for NETs to drive adoption in the EU working with KOLs and hospital networks for wide-ranging NETs utility. Early revenue (pre- US FDA) clinical use in Europe. • Focused partner led launch worldwide of product in sepsis on existing widely adopt
Slide 8: Commercialization of Current European CE marked IVDD Product Strategy
Commercialization of Current European CE marked IVDD Product Strategy • Very broad granted clinical utility for all NETs related diseases • Both direct and indirect through IDS, (Revvity) sales of the CE Marked product • Kits already purchased by three hospitals (centers of excellence) for clinical
Slide 9: Focused Sepsis Licensing Strategy
Focused Sepsis Licensing Strategy Aim to open up wide scale international adoption on existing platforms, with existing labs and sales pipelines • TAM Sepsis – testing and monitoring ICU patients alone is a ~$1B+ opportunity • Other addressable markets include Acute Kidney Injury (AKI), Acute Respir
Slide 10: Dr. Andrew Retter
Dr. Andrew Retter MBBS, MRCP, FRCPath (Haem), DICM, FFICM Clinical Lead in Critical Care Medicine, ECMO and Thrombosis Chief Medical Officer at VolitionRx, UK Property of Volition© 2025 Slide 10
Slide 11: Conflicts of interest to declare
Conflicts of interest to declare • Employee and shareholder of VolitionRX Limited Property of Volition© 2025 Slide 11
Slide 12: The Burden of Sepsis
The Burden of Sepsis 1 in 5 deaths worldwide are associated with sepsis It’s the number 1... Almost 50 million cases resulting in 11 Cause of death in hospitals Over 40% of survivors million deaths suffer from long-term Over 40% of cases are Cause for hospital physical or children under 5 years rea
Slide 13: Who is at risk?
Who is at risk? Anyone can get sepsis. It is indiscriminate of: Age Ethnicity Socio-Economic status Property of Volition© 2025 Slide 13
Slide 14: Unmet Needs
Unmet Needs • Current diagnosis is empirical, multi-factorial and subjective. • CURRENT methods of assessment (SOFA and APACHE II) are both complex & slow. • Accepted need for improved diagnostics1. 1. Rudd et al. 2020 The Lancet doi: 10.1016/S0140-6736(19)32989-7. Property of Volition© 2025 Slide 1
Slide 15: Volition's Mission
Volition’s Mission Develop a low-cost, easy-to-use, rapid diagnostic test to save lives and improve outcomes for patients worldwide. We are here to present Nu.Q® NETs H3.1 assay, a novel, clinically relevant biomarker which has the potential to change the management of patients with sepsis. Property
Slide 16: Why is H3.1 key: The biology & scientific rationale
Why is H3.1 key: The biology & scientific rationale Property of Volition© 2025 Slide 16
Slide 17: Nucleosomes and histones
Nucleosomes and histones: Property of Volition© 2025 Slide 17
Slide 18: Nucleosomes and histones
Nucleosomes and histones: Key message: The H3.1 assay can detect nucleosomes using chemiluminescence technology and provide a result within 15 minutes The lower limit of quantification is 20ng/ml The upper limit of quantification is 20,000ng/ml Property of Volition© 2025 Slide 18
Slide 19: H3.1 as a Damage-Associated Molecular Protein
H3.1 as a Damage-Associated Molecular Protein Silk et al, Cell Death & Disease, 2017 http://dx.doi.org/10.1038/cddis.2017.52 Property of Volition© 2025 Slide 19
Slide 20: H3.1 sits as a triumvirate of innate immunity, inflammation and coagulation
H3.1 sits as a triumvirate of innate immunity, inflammation and coagulation. The majority of extracellular pathology is due to the indiscriminate binding of anionic components of the circulation and vasculature. Property of Volition© 2025 Slide 20
Slide 21: Extracellular Histones and Organ Injury
Extracellular Histones and Organ Injury Silk et al, Cell Death & Disease, 2017 http://dx.doi.org/10.1038/cddis.2017.52 Property of Volition© 2025 Slide 21
Slide 22: Bacteria Alveolus Platelet plug
Bacteria Alveolus Active TF TF rich microparticles Monocyte H3.1 Pathogen PRR Elastase, Cathepsin G, Coagulation PSGL1 Myeloperoxidase, complement are enhanced Monocyte Reactive oxygen species P-selectin Platelet plug Property of Volition© 2025 Slide 22
Slide 23: The role of H3.1 in NETosis
The role of H3.1 in NETosis: …proving we are measuring what we say we are measuring! Property of Volition© 2025 Slide 23
Slide 24: H3.1 Nucleosome Levels Increase With NETosis
H3.1 Nucleosome Levels Increase With NETosis Zukas et al, Journal of Thrombosis & Hemastasis, 2024 https://doi.org/10.1016/j.jtha.2024.05.028 JTH Commentary, Sept 2024 https://doi.org/10.1016/j.jtha.2024.06.016 Property of Volition© 2025 Slide 24
Slide 25: Kinetic Information
Kinetic Information H3.1 is not impacted by height, weight, age, sex1 H3.1 is not impacted by the circadian rhythm2 1. Neumann et al, under review 2. RHU Records Data Set, data on file Property of Volition© 2025 Slide 25
Slide 26: Innovation Lab Publications
Innovation Lab Publications Property of Volition© 2025 Slide 26
Slide 27: "The NET Effect" - Neutrophil extracellular traps in sepsis
“The NET Effect” - Neutrophil extracellular traps: a potential key component of the dysregulated host immune response in sepsis Published Paper The key take home messages are: 1. Neutrophils are key cells in fighting off invading pathogens. They can swallow up invading micororgansisms. They can also
Slide 28: Clinical Data
Clinical Data Property of Volition© 2025 Slide 28
Slide 29: Studies at Centers of Excellence: >3000 patients
Studies at Centers of Excellence: >3000 patients Study Country Description Cohort Size Status SISPCT Germany Retrospective analysis of 971 intensive care Completed. Manuscript prospectively collected patients under review. Available on cohort Multiple timepoints MedRXIV Amsterdam UMC Netherlands Ret
Slide 30: Executive Summary: consolidated conclusions
Executive Summary: consolidated conclusions Results from three independent studies totalling over 3,000 patients These findings are consistent across cohorts1-3 An elevated H3.1 level reflects a dysregulated immune response and is associated with: • a risk of increased mortality • an increased risk
Slide 31: Prognostic value of admission H3.1 nucleosome levels in sepsis-associated AKI
Prognostic value of admission H3.1 nucleosome levels in sepsis- associated acute kidney injury: a secondary analysis of the SISPCT randomised clinical trial Caroline Neumann et al This is the first publication of a large independent cohort of Intensive Care patients. We analysed H3.1 nucleosome leve
Slide 32: Correlation between admission H3.1 nucleosome levels and white cell count
Correlation between admission H3.1 nucleosome levels and white cell count 1. Neumann et al, under review Property of Volition© 2025 Slide 32
Slide 33: Mortality risk for different levels of H3.1 on admission
Mortality risk for different levels of H3.1 on admission 1. Neumann et al, under review Property of Volition© 2025 Slide 33
Slide 34: H3.1 nucleosome levels at admission and mortality risk over time
Association between log-transformed H3.1 nucleosome levels at admission and mortality risk over time in sepsis patients Forest plot demonstrating the hazard ratios (HRs) with 95% confidence intervals (CIs) for mortality at days 7, 14, 28 and 90 in relation to admission H3.1 nucleosome levels (log-10
Slide 35: Forest plots of hazard ratios for RRT outcomes
Forest plots of hazard ratios for RRT outcomes Forest plot showing adjusted hazard ratios with 95% confidence intervals (CIs) for renal replacement therapy (RRT) outcomes at different time points after admission in sepsis and septic shock patients (n=831). The analysis demonstrates consistent hazard
Slide 36: Plasma H3.1 nucleosomes as biomarkers of sepsis and organ failure
Plasma H3.1 nucleosomes as biomarkers of sepsis and organ failure Daan F.L. Filippini et al It is our largest study yet; 1713 patients with 4283 samples analyzed from a well characterized cohort and a highly respected consortium. • The key take home message is that organ failure and inflammation in
Slide 37: Plasma H3.1 nucleosomes as biomarkers of sepsis and organ failure
Plasma H3.1 nucleosomes as biomarkers of sepsis and organ failure, Daan F.L. Filippini et al. Data on File. Manuscript submitted Property of Volition© 2025 Slide 37
Slide 38: Summary
Summary • We have shared a taster of clinical data and scientific evidence to support the use of our proprietary Nu.Q® NETs H3.1 assay • We believe the data supports the fact that H3.1 will become an integral biomarker in the management of sepsis; it is both a marker of badness and a cause of conseq
Slide 39: Summary
Summary Property of Volition© 2025 Slide 39
Slide 40: Licensing Portfolio: Platform stable, reproducible
Licensing Portfolio: Platform stable, reproducible Application Proof of Concept Viability study Final Validation study Licensed Animal Canine Cancer Screening Launched Canine Cancer Monitoring Feline Cancer Automated test In negotiation Human Regulatory/Adoption study Sepsis Data room available Canc
Slide 41: Investment Summary: NYSE:VNRX
Investment Summary: NYSE:VNRX • Listed NYSE, commercial stage diagnostics company — developing low-cost, early detection and treatment monitoring diagnostics in human and animal health • Disease areas – global killers: Cancer, Sepsis; significant market opportunities, >$10’s Billion • $23 million in
Slide 42: Question & Answer Session
Question & Answer Session Lou Batchelor Property of Volition© 2025 Slide 42
Slide 43: Thank you for your interest in Volition.
Thank you for your interest in Volition. For more details, please visit www.volition.com Property of Volition© 2025 Slide 43
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