Volitionrx Limited · AMEX:VNRX
Volitionrx — Investor Presentation (November 2023)
54 slides from Volitionrx's investor presentation, November 2023
Slide 1: Corporate Deck
Corporate Deck November 2023 Property Propertyof Volition©©2023 ofVolition 2023 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: Our mission is to save lives and improve outcomes
Our mission is to save lives and improve outcomes for millions of people and animals worldwide. Property Propertyof Volition©©2023 ofVolition 2023 Slide 3
Slide 4: Who We Are
Who We Are • Diagnostic company focusing on epigenetic markers • Epigenetics = on top of, or in addition to the genome • Human and Veterinary use cases: • Screening • Monitoring (disease progression and response to treatment) • Clinical & Regulatory Product Development Focus = Sepsis • We believe ou
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 <10 minutes 45 minutes 20 minutes <15 minutes • Our Intellectual Property • 87 patent
Slide 6: Our Potential Opportunities Are BIG!
Our Potential Opportunities Are BIG! $Billions$ Property Propertyof Volition©©2023 ofVolition 2023 Slide 6
Slide 7: The Commercial Strategy
The Commercial Strategy Licensing Property Propertyof Volition©©2023 ofVolition 2023 Slide 7
Slide 8: Commercial Strategy
Commercial Strategy Overall strategy • R&D conducted by Volition and its research partners • Volition monetizes IP with upfront payments, milestone payments, royalties and sales of key components • Commercialisation via global players and in fragmented markets, regional companies Partner with establ
Slide 9: Our Technologies
Our Technologies Chromatin Chromosome Nucleosome Cancer and cell death cause chromatin CTCF fragmentation Sequence only present on CTCF in cancer Property of Volition© 2023 Slide 9
Slide 10: Early cancer detection by plasma CTCF transcription factor analysis
Early cancer detection by plasma CTCF transcription factor analysis Poster Presentation ESMO 2023 Hot off the Press! Property of Volition© 2023 Slide 10
Slide 11: Liquid biopsy for ctDNA
Liquid biopsy for ctDNA Is like looking for a needle in a haystack… 99.9% 0.1% ...and the needle is made of hay! Nucleosomes and ctDNA released into the blood Property of Volition© 2023 Slide 11
Slide 12: Liquid biopsy for ctDNA
Liquid biopsy for ctDNA Wet chemistry pathway Amplification DNA Sample & library NGS Bioinformatics extraction preparation Methylated Septin-9 PCR Method unchanged since liquid biopsy first conceived What can you do with tens of millions of DNA sequences – other than sequence them? Property of Volit
Slide 13: Liquid biopsy for ctDNA
Liquid biopsy for ctDNA CTCF 99.9% 0.1% Then you can do a You need to physically separate PCR test as simple some or all of the ctDNA as a COVID-19 test (nearly) Property of Volition© 2023 Slide 13
Slide 14: Novel wet chemistry pathway for ctDNA analysis
Novel wet chemistry pathway for ctDNA analysis NEW wet chemistry pathway PCR of CTCF Sample sequences ChIP collection uniquely present (Capture) in cancer First novel wet chemistry pathway for liquid biopsy First report of plasma TF-ChIP (Capture) Property of Volition© 2023 Slide 14
Slide 15: Hypothesis in action
Hypothesis in action Sequence present on nucleosomes Sequence is present in in healthy nucleosomes and in CTCF cancer Healthy Cancer CTCF CTCF Nucleosome Nucleosome Property of Volition© 2023 Slide 15
Slide 16: Hypothesis in action
Hypothesis in action Physically separate the CTCF from all the nucleosomes Healthy Cancer CTCF CTCF Property of Volition© 2023 Slide 16
Slide 17: Hypothesis in action
Hypothesis in action Then cfDNA fragment with that sequence tumour derived Healthy Cancer CANCER CANCER CANCER Property of Volition© 2023 Slide 17
Slide 18: Hypothesis in action
Hypothesis in action ctDNA Healthy Cancer ctDNA ctDNA ctDNA Property of Volition© 2023 Slide 18
Slide 19: Clinical Experiment Results
Clinical Experiment Results Property of Volition© 2023 Slide 19
Slide 20: Leukemia detection with single and dual qPCR assays
A single qPCR assay discovered on Leukemia detected Healthy Cancer 61% of leukaemia cases at 98% specificity 1 1 1 0.249 1 1 1 1 0.28 352.139 Adding a second qPCR detected 74% of leukemia 1 1 3.89 137.663 35.383 4.155 cases at 96% specificity 1 6.17 2.85 1 41.643 30.274 6.39 20.252 0.83 4.857 0.66 1
Slide 21: Colorectal cancer 2-qPCR assay detection
Another 2-qPCR assay detected 77% of colorectal cancer cases at 92% specificity ROC curve: Leukaemia (single qPCR assay) Blood test almost as good as fecal 100 FIT test for colorectal cancer with biomarkers developed on 80 . leukemia. Sensitivity% 60 We are now developing individual 40 biomarkers sp
Slide 22: Proof of principle for multi-cancer early detection using a 2-qPCR assay
Proof of principle for multi-cancer early detection using a 2-qPCR assay (90% specificity) Solid cancers patients positive sensitivity • CRC 13 9 69% • Breast 10 5 50% • Prostate 10 5 50% • Liver 10 6 60% TOTAL 43 25 58% Solid cancers patients positive sensitivity • Stage I 9 4 44% • Stage II 9 3 33
Slide 23: Comparison ChIP/PCR with traditional NGS/ctDNA assays
Comparison ChIP/PCR with traditional NGS/ ctDNA assays Traditional NGS/ ctDNA assay ChIP/PCR • Cost >$1000 • ~$100 • Too complex to be fully automated • Can be automated • High technology labs only • Any hospital lab • Turnaround - days or weeks • Turnaround 1 day (less if automated) • Library prepa
Slide 24: Our Nu.Q Product Pillars
Our Nu.Q Product Pillars Confidential – Property Property of Volition © 2023 of Volition© 2023 Slide 24
Slide 25: How does the Nu.Q Test work?
How does the Nu.Q® Test work? The Nu.Q® Test is a proprietary epigenetic immunoassay platform that determines levels of circulating nucleosomes in the blood. Property of Volition© 2023 Slide 25
Slide 26: Nu.Q Product Pillars
Nu.Q® Product Pillars TAM1 TAM1 $600M $11B 2023 2023 TAM1 $22B 2024/25 1. VNRX TAM Model (Vet, NETs,, Discover) Property of Volition© 2023 Slide 26
Slide 27: Nu.Q Vet Cancer Test
Nu.Q® Vet Cancer Test Property of Volition Veterinary Diagnostics Development© 2023 Slide 27
Slide 28: Early detection
Number of pet dogs in the US1 Early detection can lead to improved treatment outcomes Approximately “Healthy” animals can tolerate 84 million treatment better Treatment can then often be more cost-effective Early detection also opens up Nearly 50% opportunities for therapeutic product of dogs over t
Slide 29: Why Nu.Q
Why Nu.Q® Screening healthy patients enables early intervention and more proactive discussions around treatment. A simple blood draw, the Nu.Q® Vet Cancer Test doesn’t require special equipment. Veterinarians can seamlessly integrate into wellness plans to foster a more holistic approach to pet heal
Slide 30: Clinical Evidence
Clinical Evidence Peer-reviewed and published case series1. of 662 dogs (134 healthy and 528 with cancer) 7 common cancers were evaluated in this study Lymphoma Malignant melanoma Hemangiosarcoma Mast cell tumors Osteosarcoma Histiocytic sarcoma Soft tissue sarcoma 1. Wilson-Robles, H.M., Bygott, T.
Slide 31: When to Screen
When to Screen Healthy dogs with a high risk of developing cancer due to age or breed predisposition. During routine wellness exams, alongside other blood panels. At 6-month vaccine booster appointments, as an additional data point to track trends Property of Volition Veterinary Diagnostics Developm
Slide 32: Milestones and Progress
Milestones and Progress Signed exclusive agreement with Heska providing exclusivity at the point of care (POC) $10M upfront and $18M milestone payments POC expected to launch in near future $13M milestone payments anticipated upon launch of canine screening and monitoring POC tests Ongoing revenue f
Slide 33: Milestones and Progress
Milestones and Progress Signed a global supply agreement with IDEXX Laboratories to provide test through worldwide reference lab network Launched in US in Q1 2023 IDEXX continues their US lab expansion, and is expected to roll out internationally in 2024 Property of Volition Veterinary Diagnostics D
Slide 34: Global Growth Strategy
Global Growth Strategy Reference lab test is available in Italy and France through ScilVet, a Heska subsidiary We anticipate further expansion into Europe through ScilVet upon the launch of POC. Test is also distributed in Portugal through DNATech, the leading diagnostic company in that market. Laun
Slide 35: Global Reach: Today
Global Reach: Today Property of Volition Veterinary Diagnostics Development© 2023 Slide 37
Slide 36: Global Reach Targets: 2024
Global Reach Targets: 2024 Property of Volition Veterinary Diagnostics Development© 2023 Slide 38
Slide 37: Development Pipeline
Development Pipeline Monitoring Cancer in NETosis Application Cats Property of Volition Veterinary Diagnostics Development© 2023 Slide 39
Slide 38: Sepsis & Thrombosis
Sepsis & Thrombosis Property of Volition© 2023 Slide 40
Slide 39: NETs – a recent breakthrough in medical science
NETs – a recent breakthrough in medical science Neutrophil Extracellular Traps (NETs): • are produced by ejecting chromosomal cell material out of the cell • catch and kill bacteria and viruses unwound can sterilize blood in minutes chromosomes Recent studies have pointed to the pivotal role of NETs
Slide 40: Property of Volition © 2023 Slide Slide
Property of Volition© 2023 Slide Slide 42 19
Slide 41: Sepsis places heavy health, social & economic burden
Sepsis places heavy health, social & economic burden 3 Almost 50M cases1 11M deaths1 42% children under 5 years of age1 Economic burdenof sepsis ~$62 billion p.a. in the U.S alone & 1. Sakr Y, Jaschinski U, Wittebole X, Szakmany T, Lipman J, Ñamendys-Silva SA, Martin-Loeches I, Leone M, Lupu MN, V
Slide 42: Sepsis – current challenges
Sepsis – current challenges • The rapid identification and treatment of sepsis significantly improves patient outcomes and reduces complications and long- term morbidity1. • The risk of death from sepsis increases by 7.6% for each hour of delay in appropriate antibiotic therapy2. • CURRENT methods o
Slide 43: Our Building Blocks
Our Building Blocks Property of Volition© 2023 Slide 45
Slide 44: Our focus…
Our focus… To develop a low cost, easy to use diagnostic test to stratify risk of sepsis particularly those at risk of progressing to multiple organ failure; in addition to monitoring the disease progression and response to treatment. The Nu.Q® NETs assay: • has demonstrated potential in the early d
Slide 45: Updates
Updates • Successful KOL event held in Athens – report available on the Volition website • First data from a Center of Excellence published – Professor Monneret’s team Property of Volition© 2023 Slide 47
Slide 46: Association of NETosis and Nucleosome Biomarkers with Mortality in Septic Shock
Association of Increase of NETosis and Nucleosome Biomarkers measured by Nu.Q® NETs assay with Mortality in Septic Shock 151 septic shock patients Nu.Q® NETs levels (ng/mL) log10 (SEPSIS‐3 definition, Nu.Q® NETs levels (ng/mL) log10 IMMUNOSEPSIS cohort). Plasma samples obtained at day (D) 1‐2, D 3‐4
Slide 47: Updates ctd'
Updates ctd’ • Successful KOL event held in Athens – report available on the Volition website • First data from a Center of Excellence published – Professor Monneret’s team • New Center of Excellence Study underway at Guys & St Thomas NHS Foundation Trust • Active Discussions on-going with the FDA •
Slide 48: Summary & Financial Update
Summary & Financial Update Property Propertyof Volition©©2023 ofVolition 2023 Slide 52
Slide 49: Summary
Summary • Diagnostic company focusing on epigenetic markers – breakthrough method of early cancer detection presented at ESMO 2023 • Human and Veterinary use cases for screening & monitoring life altering diseases • We believe our addressable markets are significant - $70 billion TAM • Focus on two
Slide 50: Key Financials Third Quarter 2023
Key Financials Third Quarter 2023 NYSE American Market: VNRX Market Cap: $65.1m* 52-week range: $0.58-$2.74* Cash used in operating activities:12-month average ~$2.5m/mth** Cash-on-hand: ~$10.8m** Subsequent to quarter end * As of received approval Nov 13, 2023 of approx. $6 **As of million funding
Slide 51: Questions?
Questions? Thank you for your interest in Volition. For more details, please visit www.volition.com Property Propertyof Volition©©2023 ofVolition 2023 Slide 55
Slide 52: The Team
The Team Property Propertyof Volition©©2023 ofVolition 2023 Slide 56
Slide 53: Executive Team
Executive Team Dill Faulkes PhD, Executive Chairman - Dill Faulkes has over 30 years of entrepreneurial and managerial experience as the founder and CEO of several software companies within the United Kingdom and the United States. As the Founder and one of the Benefactors of the Dill Faulkes Educat
Slide 54: Executive Team
Executive Team Jake Micallef PhD MBA, Chief Scientific Officer - Jake is an experienced scientist with expertise in research and development and in the management of biotechnical companies, including manufacturing and establishing operations. He received his BSc and a PhD in Physical Chemistry from