Volitionrx Limited · AMEX:VNRX

Volitionrx — Investor Day (October 2020)

47 slides from Volitionrx's investor day presentation, October 2020

  1. Slide 1: Capital Markets Event

    Capital Markets Event October 2020 Volition© 2020

  2. 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

  3. Slide 3: Welcome

    Welcome Volition©Veterinary 2020 Diagnostics© 2019 Confidential

  4. Slide 4: Agenda

    Agenda • Introduction & Business Update - Cameron Reynolds • Introducing the Nu.Q™ Vet Cancer Screening Test • Heather Wilson-Robles, Chief Medical Officer VVDD • Gaetan Michel, CEO VVDD • Blood Cancer in Humans – Jason Terrell, Chief Medical Officer • Summary – Cameron Reynolds • Q&A session • Conc

  5. Slide 5: Our Pandemic Focus

    Our Pandemic Focus • Safety of team • Maintaining operations • Strengthening our balance sheet • Securing our supply • Focusing on simplicity - Nu.Q™H3.1 assay • Ongoing programs will be updated at the Q Volition© 2020

  6. Slide 6: COVID-19 Pandemic Operational Update

    COVID-19 Pandemic Operational Update Current status Currently identified risks ✓ Non-Laboratory staff working from home - Consumables and antibody supply chain ✓ Lab remains open and is operating near has slowed, so additional suppliers sought capacity (TAMU lab two-week closure) and plans to bring

  7. Slide 7: Securing supply & developing internal expertise

    Securing supply & developing internal expertise • Currently fitting out a NEW 10,000 square ft neighboring facility in Belgium, known as “Silver One” – due to open by the end of October • This facility will: • Be the production hub for all of our products and components • Be a service lab so that we

  8. Slide 8: COVID-19 Product Development

    COVID-19 Product Development • Our goal is to develop a clinically useful prognostic product • The preliminary study results demonstrated the Area Under the Curve (AUC) for a single Nu.Q™ assay was 98.7% PCR positive versus control subjects, with 100% sensitivity at 94% specificity. A second Nu.Q™ a

  9. Slide 9: Keeping things Simple – Nu.Q H3.1 assay

    Keeping things Simple – Nu.Q™H3.1 assay Continue to develop other assays to form panels for more complex cancers (colorectal, lung etc) • CE Mark achieved • Highest ever single assay results in many studies • Will utilize for; • Nu.Q™ Vet Cancer Screening Test • Blood Cancer Studies • COVID-19 and N

  10. Slide 10: Heather Wilson-Robles, Chief Medical Officer

    Heather Wilson-Robles, Chief Medical Officer Volition Veterinary Diagnostics Development© 2020

  11. Slide 11: High Unmet Needs

    High Unmet Needs • Similar to the human diagnostic market there are no simple, easy to use, blood tests to help diagnose or monitor cancer • Consequently, cancer in dogs is diagnosed late and through costly and/or potentially painful procedures such as scans and/or biopsies • Human proteins such as

  12. Slide 12: Epigenetic Organization of the Genome

    Epigenetic Organization of the Genome The genome is 3 billion base pairs. If un-coiled it would measure 5 feet long Nucleosomes are formed by 150 base pairs of DNA wrapping around a protein core “bead” which enables DNA to condense into chromosomes There are multiple layers of epigenetic mechanisms

  13. Slide 13: Key Functions of Epigenetic Regulation

    Key Functions of Epigenetic Regulation Gene Expression DNA Damage DNA Replication https://www.sciencedirect.com/science/article/a https://pubmed.ncbi.nlm.nih.gov/23751185/ bs/pii/S0022283614002757 Volition Veterinary Diagnostics Development© 2020

  14. Slide 14: Nu.Q - The Basic Concept

    Nu.QTM - The Basic Concept • Cancer & cell death results in chromatin fragmentation and release of nucleosomes into the blood. • Nucleosomes contain >200 possible modifications that regulate every fundamental cellular process. • Measuring nucleosome levels and modifications in circulation have the p

  15. Slide 15: Nu.Q Technology

    Nu.QTM Technology • Proprietary epigenetic immunoassay platform • Determine levels of circulating nucleosomes HRP Reporter Detection • Profiles nucleosome epitopes Antibody • Histone post translation modifications Nucleosome • Histone variants • DNA modifications • Flexibility of platform and divers

  16. Slide 16: Methods – data presented at VCS 2020

    Methods – data presented at VCS 2020 • Samples collected internally from Texas A&M Veterinary clinic and NIH’s DCTC Biobank • Samples were collected form 134 normal healthy dogs, 127 dog with Lymphoma and 73 dogs with hemangiosarcoma • A variety of breeds, weights and cancer stages were represented

  17. Slide 17: Nucleosome Levels are Consistently Low Across Normal Canines

    Nucleosome Levels are Consistently Low Across Normal Canines Variability in Nucleosome Levels Across Normal Samples H3.1 Nucleosomes (ng/mL) 600 400 200 0 Healthy Dogs Volition Veterinary Diagnostics Development© 2020 Confidential

  18. Slide 18: Nucleosome Levels are Elevated in Lymphoma and Variable across Patients

    Nucleosome Levels are Elevated in Lymphoma and Variable across Patients Elevated Nucleosome Levels in Lymphoma (LSA) Variability in Nucleosome Levels Across Lymphoma Samples 8000 H3.1 Nucleosomes (ng/mL) H3.1 Nucleosomes (ng/mL) 6000 7000 5500 6000 5000 5000 4500 4000 4000 3500 2500 2000 2000 1500 1

  19. Slide 19: Nu.Q Vet Cancer Screening Test Detecting Lymphoma

    Nu.QTM Vet Cancer Screening Test has High Specificity and Sensitivity in Detecting Lymphoma 1 0.9 AUC=87.3% 0.8 0.7 TPF (Sensitivity) Cutoff Sensitivity Specificity 0.6 0.5 67.41 ng/ml 74% 100% 0.4 No 48.12 ng/ml 81% 90% 0.3 discrimination 0.2 All samples 0.1 (0,873) 0 0 0.2 0.4 0.6 0.8 1 FPF (1 - S

  20. Slide 20: Nucleosome Levels are Elevated in Hemangiosarcoma

    Nucleosome Levels are Elevated in Hemangiosarcoma and Variable across Patients Elevated Nucleosome Levels Variability in Nucleosome Levels Across Hemangiosarcoma Samples in Hemangiosarcoma (HSA) 4000 H3.1 Nucleosomes (ng/mL) 3500 H3.1 Nucleosomes (ng/mL) 4000 **** 3000 3500 2500 3000 2000 2500 1500

  21. Slide 21: Nu.Q Test Detecting Hemangiosarcoma

    Nu.QTM Vet Cancer Screening Tests also has High Specificity and Sensitivity in Detecting Hemangiosarcoma 1 0.9 AUC=97.6% 0.8 0.7 TPF (Sensitivity) Cutoff Sensitivity Specificity 0.6 0.5 67.4 ng/ml 89% 100% 0.4 48.1 ng/ml 95% 90% 0.3 0.2 0.1 0 0 0.2 0.4 0.6 0.8 1 FPF (1 - Specificity) Volition Veteri

  22. Slide 22: Conclusions

    Conclusions • The Nu.QTM Vet Cancer Screening Test can be used to measure nucleosome levels in canines • Nucleosome levels are consistently low in healthy dogs and elevated in both lymphoma and hemangiosarcoma • The Nu.QTM Vet Cancer Screening Test gives good clinical discrimination with an AUC of 8

  23. Slide 23: Ongoing and Possible Future Studies

    Ongoing and Possible Future Studies • Longitudinal study ongoing • The H3.1Nu.QTM assay also shows promise as a marker for treatment efficacy and remission monitoring Volition Veterinary Diagnostics Development© 2020 Confidential

  24. Slide 24: Nucleosome Levels Vary across Course of Disease and Treatment

    Nucleosome Levels Vary across Course of Disease and Treatment Cujo: Trends in Nucleosome Concentrations Otis: Trends in Nucleosome Concentrations During Treatment for LSA During Treatment for HSA 800 800 H3.1 Nucleosomes (ng/mL) H3.1 Nucleosomes (ng/mL) 600 Nucleosomes Nucleosomes 600 400 CRP 200 40

  25. Slide 25: Ongoing and Possible Future Studies

    Ongoing and Possible Future Studies • Longitudinal study ongoing • The H3.1Nu.QTM assay also shows promise as a marker for treatment efficacy and remission monitoring • Other Cancers – Histiocytic sarcoma next. • Other hematopoietic cancers. • Other species. Volition Veterinary Diagnostics Developme

  26. Slide 26: Gaetan Michel, Chief Executive Officer

    Gaetan Michel Chief Executive Officer Volition Veterinary Diagnostics Development© 2020

  27. Slide 27: Significant Market Opportunity

    Significant Market Opportunity • 38% of U.S. Households have a dog – the highest rate since measuring began in 1982 VS Approx. 6 million Approx. 1.66 million • Approx. 77 million dogs cancer diagnoses in cancer diagnoses in DOGS in the U.S. HUMANS in the • 85% of owners consider their U.S. each year

  28. Slide 28: Our Product Proposition

    Our Product Proposition • Currently, dogs suspected of having cancer are required to undergo a variety of diagnostic tests that may be expensive, time consuming and/or painful for the animal. • We hope to change this with the introduction of the Nu.Q™ Vet Cancer Screening Test – a simple, low-cost,

  29. Slide 29: Our Product Proposition – Reason to Believe

    Our Product Proposition – Reason to Believe • In a study of over 330 dogs, at 100% specificity, the Nu.QTM Vet Cancer Screening Test identified 74% of lymphomas and 89% of hemangiosarcoma versus control1. (Control dogs= 134, Lymphoma=127 client owned dogs, Hemangiosarcoma= 73 client owned dogs). • T

  30. Slide 30: Nu.Q Vet Cancer Screening Test Launch Plan

    Nu.Q™ Vet Cancer Screening Test Launch Plan ✓ Establish lab facility – test will be processed at TAMU GI Lab • Create Awareness • Develop Credibility • Generate Trial • Cultivate Advocacy Volition Veterinary Diagnostics Development© 2020

  31. Slide 31: Key Customers

    Key Customers • Key Opinion Leaders • Veterinary Oncology Specialists • GP Veterinarians • Pet Owners Volition Veterinary Diagnostics Development© 2020

  32. Slide 32: Key Opinion Leaders

    Key Opinion Leaders • Hosted a Roundtable • Generated Expert-Led Report for distribution to Specialists at VCS • Collaborating further with participating KOLs and expanding our network Volition Veterinary Diagnostics Development© 2020

  33. Slide 33: Veterinary Oncology Specialists

    Veterinary Oncology Specialists • Presented abstracts at VCS Conference and hosted busy virtual exhibition stand • Targeting Top ten U.S. University Hospitals and Texas Hospitals for “Lunch & Learn” sessions throughout November / December • Marketing Campaign items include the Expert Led Report and

  34. Slide 34: GP Veterinarians

    GP Veterinarians • Focusing initially on TEXAS • 4770 GP Veterinarians • 7.5 million dog population ~ 10% of the U.S. market • Marketing Campaign items include; • Expert Led Report • Product Flyer • Paid social media advertising • GP Veterinary focused Webinar • CE Program Volition Veterinary Diagno

  35. Slide 35: Pet Owners

    Pet Owners • Simple leaflet for the Veterinarian to share with Pet Owners • Direct campaign 2021 once the product is established with Veterinarians. Volition Veterinary Diagnostics Development© 2020

  36. Slide 36: Exciting Times... launch is almost here!

    Exciting Times... ..launch is almost here! Volition Veterinary Diagnostics Development© 2020

  37. Slide 37: Research findings often transferrable between humans & dogs

    Research findings often transferrable between humans & dogs AND…..dogs & humans Nucleosomes found in humans & dogs Volition Veterinary Diagnostics Development© 2020

  38. Slide 38: Jason Terrell, Chief Medical Officer

    Jason Terrell, Chief Medical Officer Volition© 2020

  39. Slide 39: Setting the Scene – Blood Cancer

    Setting the Scene – Blood Cancer 700,000 …and approximately new cases of 415,000 NHL, AML and deaths each Non-specific ALL globally each year symptoms year….. often delays diagnosis. Volition© 2020

  40. Slide 40: Study Results to date

    Study Results to date Volition© 2019 2020 Confidential

  41. Slide 41: Blood Cancer – Summary of Studies to Date

    Blood Cancer – Summary of Studies to Date • Cohort Size: Total Healthy = 144, Cancer = 280 (however split into multiple smaller studies) • Cancer: NHL / ALL/ AML • Clinical Question: Cancer vs Healthy • Study Results: • Single Nu.Q™H3.1 assay produces excellent AUCs ranging from 85% to 88% for both

  42. Slide 42: Blood Cancer – Planned Studies: U.S. Regulatory Trial

    Blood Cancer – Planned Studies NHL Pre-Treatment Original Diagnosis U.S. Regulatory Trial • U.S. CRO Selected • 1,000 patients including cohorts for all 8 most common aggressive subtypes • Total trial duration is 22 months including set-up (IRB approvals, site training, etc) and wrap-up (data analys

  43. Slide 43: Blood Cancer – Planned Studies: U.S. Treatment Response Study

    Blood Cancer – Planned Studies U.S. Treatment Response Study • DLBCL is most common aggressive subtype (35% of all NHL) and responds rapidly to treatment • U.S. CRO selected to prospectively collect 30 subjects • 6-month collection of 6 serial samples corresponding to rounds of chemo • Benefits of s

  44. Slide 44: Summary

    Summary Cameron Reynolds Volition©Veterinary 2020 Diagnostics© 2019 Confidential

  45. Slide 45: Our Pandemic Focus

    Our Pandemic Focus • Safety of team • Maintaining operations • Strengthening our balance sheet • Securing our supply • Ongoing programs will be updated at the Q • Focusing on simplicity - Nu.Q™H3.1 assay Volition© 2020

  46. Slide 46: Questions & Answers

    Questions & Answers Volition©Veterinary 2020 Diagnostics© 2019 Confidential

  47. Slide 47: Thank you for your interest in Volition

    Thank you for your interest in Volition For more information email mediarelations@volition.com Volition© 2020 Confidential

VolitionRx — Investor Day (October 2020) on 6ix