Volitionrx Limited · AMEX:VNRX
Volitionrx — Investor Presentation (April 2025)
46 slides from Volitionrx's investor presentation, April 2025
Slide 1: A Look to the Future of Cancer Diagnostics
NYSE:VNRX A Look to the Future of Cancer Diagnostics April 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 Jake Micallef MBA MBBS, MRCP, FRCPath (Haem), DICM, PhD, MBA FFICM Chief Commercial Officer Chief Scientific Officer Clinical Lead in Critical Care Medicine, ECMO and Thrombosis Property of Volition© 2025 Chief Medical Officer at VolitionRx, UK S
Slide 4: Investment Highlights
Investment Highlights Vet Commercial Progress Large Unmet Needs • Nu.Q® Vet Cancer test now available in over 20 countries • Lung Cancer – screening, prognostics and MRD • Sold ~120,000 tests and test components 2024 represent a $4B opportunity • Received $23 million in upfront and milestone payment
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 • Drive adoption in the EU working with KOLs and hospital networks for wide- ranging utility. Early revenue (pre-US FDA) clinical use in Europe. • Sign licensing deals with partners to launch our Nu.Q® assays • On existing widely adopted current platforms, • Leveraging
Slide 8: Clinical Evidence
Clinical Evidence Dr. Andrew Retter Property of Volition© 2025 Slide 8
Slide 9: ~1 in 6 deaths worldwide are caused by cancer
~1 in 6 deaths worldwide are caused by cancer Lung cancer is the Almost 20 million leading cause of Lung cancer is typically NEW diagnoses pa cancer-related diagnosed at a late deaths... stage…as yet a robust ~10 million deaths screening method for 1.8 million deaths per diagnosis is not 1 in 5 peop
Slide 10: Nucleosomes and histones – altered in cancer and present in plasma
Nucleosomes and histones – altered in cancer and present in plasma DNA strand Nu.Q® Assays: • Low Cost • Low Sample Volume • Quick Turnaround Time • Adaptable to different platforms Nucleosomes (DNA-wrapped histones) Volition antibodies binding to nucleosomes Property of Volition© 2025 Slide 10
Slide 11: Potential applications of a blood test in lung cancer: Nu.Q addresses all five
Potential applications of a blood test in lung cancer: Nu.Q® addresses all five Property of Volition© 2025 Slide 11
Slide 12: Unmet needs in lung cancer disease management
Unmet needs in lung cancer disease management • Low-dose computed tomography (LDCT) recommended for screening BUT it often results in false-positives leading to further tests or unnecessary biopsies • Cancer patient follow-up generally performed by imaging techniques • However, limited sensitivity f
Slide 13: Unmet needs in lung cancer disease management
Unmet needs in lung cancer disease management Oncologists need a reliable, simple, reproducible, fast, cost-effective test to: • Help improve specificity for lung cancer screening • Help provide tailored treatment • Help detect disease recurrence early • Help assess response to treatment • Help supp
Slide 14: Study Overviews
Study Overviews • Range of studies from prospective and retrospective, blinded, longitudinal studies of lung cancer. • Cohort sizes – ranging from 70 to 1000+ patients. • Covering detection of lung cancer at diagnosis and during treatment • KEY Outcome measures to demonstrate CLINICAL UTILITY (corre
Slide 15: Study Country Cohort Key Results Status
Study Country Cohort Key Results Status Size NTU Lung Taiwan 806 patients • improve specificity of LDCT Published • avoid up to 50% of unnecessary biopsies NTU V Taiwan 500 patients • prospective study “Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Ongoing. Due Differentiation” Q4 25 OncoPro
Slide 16: Lung Cancer Package Summary
Lung Cancer Package Summary • Answer clear clinical question with direct impact on patient management • No existing solution Product #1 : Screening - H3.1/H3K27Me3 in combination with LDCT to • improve specificity of LDCT • avoid up to 50% of unnecessary biopsies Product #2 : Prognostic value - Base
Slide 17: Product #1: Accurate diagnosis of high-risk pulmonary nodules
Product #1 : Accurate diagnosis of high-risk pulmonary nodules using a non-invasive epigenetic biomarker test Epigenetic Model of Nu.Q® H3K27Me3 and Nu.Q® H3.1 Cut-off 0.755 True Class Pei-Hsing Chen et al, Paper published Property of Volition© 2025 Slide 17
Slide 18: Product #2: Baseline values of plasma H3K27Me3 predict survival in NSCLC
Product #2 : Baseline values of plasma H3K27Me3 predict survival in NSCLC patients in palliative care Key findings Nu.Q® at diagnosis predicts survival among NSCLC patients selected for palliative care. Identifies “long survivors” as a subset of patients who may benefit from curative care No other m
Slide 19: Product #2: Prognostic value of plasma Nu.Q H3K27Me3 during treatment
Product #2 :Prognostic value of plasma Nu.Q® H3K27Me3 during treatment of stage IV Non-Small Cell Lung Cancer Key findings • Nu.Q® is predictive of survival independently of treatment and mutational status • Alerts on the risk of early progression • Identifies a subset of patients who may benefit fr
Slide 20: NEW Poster March 2025
NEW Poster March 2025 Property of Volition© 2025 Slide 20
Slide 21: Interim analysis of CircanBis Cohort
Interim analysis of CircanBis Cohort H3K27Me3-nucleosome titers are increased in H3K27Me3-nucleosome titers are increased in ctDNA positive samples patients with low survival probability H3K27Me3-nucleosome is a strong prognostic biomarker in Non-Small Cell Lung Cancer: interim results from the anal
Slide 22: Interim analysis of CircanBis Cohort
Interim analysis of CircanBis Cohort H3K27Me3-nucleosome titers at diagnosis could help inform treatment decisions and patients’ monitoring thereby facilitating personalized care. H3K27Me3-nucleosome is a strong prognostic biomarker in Non-Small Cell Lung Cancer: interim results from the analysis of
Slide 23: Interim analysis of CircanBis Cohort
Interim analysis of CircanBis Cohort H3K27Me3-nucleosome titers at diagnosis could help inform treatment decisions and patients’ monitoring thereby facilitating personalized care. H3K27Me3-nucleosome is a strong prognostic biomarker in Non-Small Cell Lung Cancer: interim results from the analysis of
Slide 24: Interim analysis of CircanBis Cohort
Interim analysis of CircanBis Cohort H3K27Me3-nucleosome titers at diagnosis could help inform treatment decisions and patients’ monitoring thereby facilitating personalized care. H3K27Me3-nucleosome is a strong prognostic biomarker in Non-Small Cell Lung Cancer: interim results from the analysis of
Slide 25: Interim analysis of CircanBis Cohort
Interim analysis of CircanBis Cohort H3K27Me3-nucleosome titers at diagnosis could help inform treatment decisions and patients’ monitoring thereby facilitating personalized care. H3K27Me3-nucleosome is a strong prognostic biomarker in Non-Small Cell Lung Cancer: interim results from the analysis of
Slide 26: Product #3: Decision Tree
Product #3 : Decision Tree Grolleau et al, Biomolecules, Aug 2023, https://doi.org/10.3390/biom13081255 Property of Volition© 2025 Slide 26
Slide 27: Product #3: Decision Tree
Product #3 : Decision Tree Grolleau et al, Biomolecules, Aug 2023, https://doi.org/10.3390/biom13081255 Property of Volition© 2025 Slide 27
Slide 28: Product #3: Decision Tree
Product #3 : Decision Tree Grolleau et al, Biomolecules, Aug 2023, https://doi.org/10.3390/biom13081255 Property of Volition© 2025 Slide 28
Slide 29: Product #3: Decision Tree
Product #3 : Decision Tree Grolleau et al, Biomolecules, Aug 2023, https://doi.org/10.3390/biom13081255 Property of Volition© 2025 Slide 29
Slide 30: Product #3: Decision Tree
Product #3 : Decision Tree Grolleau et al, Biomolecules, Aug 2023, https://doi.org/10.3390/biom13081255 Property of Volition© 2025 Slide 30
Slide 31: Lung Cancer Package Summary
Lung Cancer Package Summary • Disease management • In combination • • In combination Aid for • In combination with LDCT treatment with NGS on with NGS liquid tissue decision biopsy • Prognostic • Treatment Value at response • HCL and diagnostic monitoring APHP • Minimal Residual • Project to start D
Slide 32: Study Country Cohort Key Results Status
Study Country Cohort Key Results Status Size NTU Lung Taiwan 806 patients • improve specificity of LDCT Published • avoid up to 50% of unnecessary biopsies NTU V Taiwan 500 patients • prospective study “Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Ongoing. Due Differentiation” Q4 25 OncoPro
Slide 33: Continuous new technology development
Continuous new technology development Early-stage cancer detection with a simple, rapid, low-cost Nu.Q® immunoassay test Dr. Jake Micallef Property of Volition© 2025 Slide 33
Slide 34: Nu.Q assay for cross-linked plasma cf-nucleosomes
Property of Volition© 2025 N on Crosslinked nucleosomes -h A H3.1-nucleosomes (ng/mL) os sy pi m ta pt liz om ed a In tic 1 100 10000 10 1000 fla he m al m th at y o M A ry ye M https://www.medrxiv.org/content/10.1101/2025.03.14.25323908v1 lo L m N a H Lu L n C g B RC Pr rea os s ta t B Li te i Pa l
Slide 35: Nu.Q assay for cross-linked plasma cf-nucleosomes
Nu.Q® assay for cross-linked plasma cf- nucleosomes 10000 H3.1-nucleosomes (ng/mL) Crosslinked 1000 100 10 1 Healthy Lung CRC Breast Prostate https://www.medrxiv.org/content/10.1101/2025.03.14.25323908v1 Property of Volition© 2025 Slide 35
Slide 36: Nu.Q assay for cross-linked plasma cf-nucleosomes
Nu.Q® assay for cross-linked plasma cf- nucleosomes 100 80 Sensitivity% 60 40 AUC=85.5% 20 0 0 20 40 60 80 100 100% - Specificity% https://www.medrxiv.org/content/10.1101/2025.03.14.25323908v1 Property of Volition© 2025 Slide 36
Slide 37: Early-stage detection
Early-stage detection 10000 H3.1-nucleosomes (ng/ml) 1000 Crosslinked 100 10 1 y I II III IV lth g e e e e a a a g g g H e St St St a St a https://www.medrxiv.org/content/10.1101/2025.03.14.25323908v1 Property of Volition© 2025 Slide 37
Slide 38: Nu.Q assay for cross-linked plasma cf-nucleosomes
Nu.Q® assay for cross-linked plasma cf- nucleosomes 167 bp nucleosome • Histone core charge +58 • Histone tail charge +98 • DNA charge -334 Net charge -178 Cell-free nucleosomes are unique plasma immunoassay analytes It is common practice to cross-link nucleosomes for ChIP in cell extracts Nucleosom
Slide 39: Nu.Q assay for cross-linked plasma cf-nucleosomes
Nu.Q® assay for cross-linked plasma cf- nucleosomes Damaged nucleosomes in samples from cancer patients are unstable and lost to assay – but stabilized by cross-linking. Preservation of damaged nucleosomes leads to sensitive early stage I cancer detection. New development distinguishes cancer and in
Slide 40: Patient centered diagnostics
Patient centered diagnostics EDTA plasma samples require rapid processing Streck plasma samples can be taken in a screening truck, sent to lab for later processing by our rapid, low-cost test. Property of Volition© 2025 Slide 40
Slide 41: Nu.Q assay for cross-linked plasma cf-nucleosomes
Nu.Q® assay for cross-linked plasma cf- nucleosomes Automated ~45-minute test (same as PSA or CEA) Available now as RUO assay (not FDA approved) Some potential applications • Low cost MCED worldwide • Aid to diagnosis in conjunction with scanning • Monitoring / Minimal Residual Disease https://www.m
Slide 42: Also…
Also… Property of Volition© 2025 Slide 42
Slide 43: Summary
Summary Property of Volition© 2025 Slide 43
Slide 44: 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 Human Regulatory/Adoption study Sepsis Data room active Cancer Lung Cancer Scr
Slide 45: 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 46: Question & Answer Session
Question & Answer Session Lou Batchelor Property of Volition© 2025 Slide 46