VolitionRx Limited · AMEX:VNRX
VolitionRx — Investor Presentation (September 2022)
62 slides from VolitionRx's investor presentation, September 2022
Slide 1: The Cancer Test: Early Detection Can Save Lives
The Cancer Test: Early Detection Can Save Lives Property of Volition Veterinary Diagnostics Development© 2022 Slide 1
Slide 2: Section Table
Section Table Canine Cancer: Cancer Screening Circulating Case Future Products FAQs At a Glance Nucleosomes Studies in Development Property of Volition Veterinary Diagnostics Development© 2022 Slide 2
Slide 3: Canine Cancer: At a Glance
Canine Cancer: At a Glance Canine Cancer: Cancer Screening Circulating Case Future Products FAQs At a Glance Nucleosomes Studies in Development Property of Volition Veterinary Diagnostics Development© 2022 Slide 3
Slide 4: Pet dogs in the U.S. and pet owner attitudes
Number of pet dogs in the U.S.1 Pets improve our health2 Approximately 76% of pet 84 million owners report improved health 69 million3 91% of pet owners2 U.S. households have a pet dog Say they would be more likely to maintain regular check-ups with their veterinarian 1.Larkin, M. (2021). Pet popula
Slide 5: Dogs diagnosed with cancer annually
Human/Canine Cancer4 Dogs Diagnosed with Cancer Annually5 25-40% of all Approximately humans and dogs 6 million develop cancer Nearly 50% Early Detection Of dogs over the age of 10 will Can lead to improved treatment outcomes develop cancer 4.Sarver, A., Makielski, K., DePauw, T., Schulte, A., & Mod
Slide 6: Our mission: early detection and treatment
Cancer is an emotional word It is a disease we have all been touched by Early detection and treatment Crucial to achieving the best clinical outcomes Our mission To develop an accessible and affordable screening tests Together We can give your pet the best chance at successful treatment Property of
Slide 7: Cancer Screening Today
Cancer Screening Today Canine Cancer: Cancer Screening Circulating Case Future Products FAQs At a Glance Nucleosomes Studies in Development Property of Volition Veterinary Diagnostics Development© 2022 Slide 7
Slide 8: What is Screening?
What is Screening? Screening refers to tests performed on healthy, asymptomatic patients who may have disease but do not yet have symptoms. Screening tests have become a Some (human) cancers that routine part of exams. screening tests aim to identify: Breast (Mammogram) There are few cancer screenin
Slide 9: Types of Screening: Liquid Biopsy
Types of Screening: Liquid Biopsy Liquid biopsy tests are revolutionizing oncology and large-scale human clinical studies involving hundreds of thousands of participants necessary for regulatory approval of a human screening test are in progress. Blood is commonly sampled, Liquid biopsy can be inexp
Slide 10: The Value of Screening
The Value of Screening Timeline of cancer development in the body, and where screening occurs within the process Healthy Abnormal Pre-Invasive Invasive Metastatic Cells Cells Cancer Cancer Cancer Screening Symptom Onset Early Diagnosis Property of Volition Veterinary Diagnostics Development© 2022 Sl
Slide 11: Who to Screen (and When)
Who to Screen (and When) Screening is recommended for healthy dogs as part of annual check-ups Cancer screening is recommended Screening asymptomatic patients for high-risk populations: could help identify cancer earlier. All dogs (7 years and older) Dogs with an increased risk due to breed Liquid b
Slide 12: Circulating Nucleosomes in Cancer
Circulating Nucleosomes in Cancer9,10,11,12 Nucleosomes are small fragments of chromosome composed of a segment of DNA wrapped. Cancer and cell death release nucleosomes into the blood. Nucleosomes can be measured using antibodies. Measuring nucleosome levels can prognostic and diagnostic markers fo
Slide 13: Clinical Evidence
Clinical Evidence13,14,15 Nucleosome Concentrations in Healthy Dogs and Dogs With Cancer 662 dogs were included 134 healthy and in this study 528 with cancer different This cohort included breeds, weights, a variety of dogs and cancer stages 7 cancers were Lymphoma evaluated in this study Hemangiosa
Slide 14: The Cancer Test
The 97% specificity Detects 76% of systemic cancer Cancer Test Lymphoma – 77% A simple, affordable, Hemangiosarcoma – 82% easy-to-use blood test Histiocytic Sarcoma – 54% Localized tumors are least likely to cause elevated plasma nucleosomes Property of Volition Veterinary Diagnostics Development© 2
Slide 15: The Nu.Q Vet Cancer Test
The Nu.Q® Vet Cancer Test The Nu.Q® Vet Cancer Test is recommended for all dogs over the age of 7, and younger dogs aged 4 and older with an increased risk of cancer such as: Labrador French Golden German Great Dane Miniature Siberian Bernese Retriever Bulldog Retriever Shepard Schnauzer Husky Mount
Slide 16: How to Submit a Sample
How to Submit a Sample Samples will be run through the Texas A&M GI Laboratory To create an account 1. Patients should be fasted 4. Spin the sample in-house (minimum 4 hours). 1600xg for 10 minutes within one hour of sampling. Draw down 2-5mL of blood 2. from peripheral vein. 5. Remove plasma place
Slide 17: The Nu.Q Vet Cancer Test Results Key
The Nu.Q® Vet Cancer Test Results Key Colors correspond with Nu.Q® levels, which may identify cancer is present: Nucleosome spikes Green Level Yellow Level may occur when patients have not The Nu.Q® Vet Cancer Test been fasted for a identifies patients who may have minimum 4 hours. cancer. Low Risk
Slide 18: The Nu.Q Vet Pathway
The Nu.Q® Vet Pathway The pathway to diagnosis and staging may include some of the following: Exam Laboratory Tests • Gathering information about the pet’s • Biochemistry Panel history • CBC • Physical exam to discover • Urinalysis abnormalities • Coagulation Test* • Masses or lesions • Immunophenot
Slide 19: Summary
Summary The Nu.Q® Vet Cancer Test is recommended for all dogs over the age of 7, and younger dogs aged 4 and older with an increased risk of cancer as a part of annual wellness exams. Accessible Affordable Reliable With no special kits A routine blood draw, At 97% specificity, the required, this tes
Slide 20: Circulating Nucleosomes
Circulating Nucleosomes Canine Cancer: Cancer Screening Circulating Case Future Products FAQs At a Glance Nucleosomes Studies in Development Property of Volition Veterinary Diagnostics Development© 2022 Slide 20
Slide 21: Canine Lymphoma: At a Glance
Canine Lymphoma: At a Glance16,17 Among the most common cancers diagnosed in dogs. There are over 30 described Some are life threatening, others types of canine lymphoma. are managed as chronic disease. Performing a biopsy is the best Chemotherapy is the most way to diagnose effective therapy for mo
Slide 22: Circulating Nucleosomes in Dogs with Lymphoma
Circulating Nucleosomes in Dogs with Lymphoma Lymphoma vs Healthy AUC 87.8% @97% specificity detects 77% LSA Dolan, C, Wilson-Robles, H et al. Characterizing Circulating Nucleosomes in the plasma of dogs with lymphoma BMC Vet Res 17, 276 (2021) Property of Volition Veterinary Diagnostics Development
Slide 23: Lymphoma: Disease Type/Stage
Lymphoma: Disease Type/Stage At 97% specificity, the Nu.Q® Vet Cancer Test was able to detect 77% of lymphoma Stage I Stage II Stage III Stage IV Stage V 63.6% 14.3% 75.7% 81.6% 81.8% 7 of 11 cases detected 1 of 7 cases detected 28 of 37 cases detected 31 of 39 cases detected 27 of 33 cases detected
Slide 24: Hemangiosarcoma: At a Glance
Hemangiosarcoma: At a Glance18 A highly malignant cancer arising from cells that normal create blood vessels. It is often diagnosed via biopsy. Superficial skin tumors appear as In most cases, the cause of a red to purple colored region of hemangiosarcoma is unknown. skin Can also appear as a bump t
Slide 25: Circulating Nucleosomes in Dogs with Hemangiosarcoma
Circulating Nucleosomes in Dogs with Hemangiosarcoma Hemangiosarcoma vs Healthy AUC 92.9% @97% specificity detects 82% HSA Wilson-Robles, H., Miller, T., Jarvis, J. et al. Characterizing circulating nucleosomes in the plasma of dogs with hemangiosarcoma. BMC Vet Res 17, 231 (2021) Property of Voliti
Slide 26: Hemangiosarcoma: Disease Type/Stage
Hemangiosarcoma: Disease Type/Stage At 97% specificity, the Nu.Q® Vet Cancer Test was able to detect 82% of hemangiosarcoma Stage I Stage II Stage III 66.7% 76% 90% 6 of 9 cases detected 19 of 25 cases detected 7 of 11 cases detected Wilson-Robles, H., Miller, T., Jarvis, J. et al. Characterizing ci
Slide 27: Clinical Staging System for Hemangiosarcoma
Clinical Staging System for Hemangiosarcoma Primary Tumor (T) • T0: no evidence of tumor • T1: Tumor <5 cm diameter & confined to primary tissues • T2: Tumor >5 cm or ruptured, invading SQ tissues • T3: Tumor invading adjacent structures, including muscle Regional LN (N) Stage T N M • N0: no regiona
Slide 28: Nucleosome Concentration by Hemangiosarcoma Location
Nucleosome Concentration by Hemangiosarcoma Location Wilson-Robles, H., Miller, T., Jarvis, J. et al. Characterizing circulating nucleosomes in the plasma of dogs with hemangiosarcoma. BMC Vet Res 17, 231 (2021) Property of Volition Veterinary Diagnostics Development© 2022 Slide 29
Slide 29: Case Studies
Case Studies Canine Cancer: Cancer Screening Circulating Case Future Products FAQs At a Glance Nucleosomes Studies in Development Property of Volition Veterinary Diagnostics Development© 2022 Slide 31
Slide 30: Case 1: Otis
Case 1: Otis 12-year-old MN Catahoula mix History of subcutaneous hemangiosarcoma removed 2 years ago Presenting for an annual recheck • Doing well at home Physical exam: • Moderate dental tartar • Grade 1 murmur (new) • Mild arthritic changes to hips & elbows Property of Volition Veterinary Diagnos
Slide 31: Case 1: Otis Wellness Exam
Case 1: Otis Wellness Exam Plan: routine blood work & Nu.Q® Vet Cancer Test CBC: • Stress leukogram • Slightly thrombocytopenia: 192,000 Chemistry panel: • Mild hyperglobulinemia: 4.6 Urinalysis: • No significant findings HW test and Fecal float: • Negative Property of Volition Veterinary Diagnostic
Slide 32: Case 1: Otis Orange Level
Case 1: Otis ORANGE Nu.Q® Vet Cancer Test : LEVEL • Cancer Suspicion: High Risk Interpretation: • Plasma nucleosome concentrations in the orange level are consistent with common canine cancers including lymphoma and hemangiosarcoma. • This test is not able to differentiate severe/systemic inflammati
Slide 33: Case 1 Otis: What Do You Do?
Case 1 Otis: What Do You Do? ORANGE LEVEL Chest Abdominal Advanced Radiographs Ultrasound Imaging Or Referral Property of Volition Veterinary Diagnostics Development© 2022 Slide 35
Slide 34: Case 1: Otis
Case 1: Otis ORANGE LEVEL Property of Volition Veterinary Diagnostics Development© 2022 Slide 36
Slide 35: Case 2: Belle
Case 2: Belle 5-Year-Old FS Golden Retriever Presenting for annual wellness exam • Doing well at home • Mild lethargy since they got a new puppy Physical exam: No significant findings Property of Volition Veterinary Diagnostics Development© 2022 Slide 37
Slide 36: Case 2: Belle Wellness Exam
Case 2: Belle Wellness Exam Plan: routine blood work & Nu.Q® Vet Cancer Test CBC: • Slightly thrombocytopenia: 134,000 • Otherwise, normal Chemistry panel: • Mild elevation in Alk Phos: 243 mg/dL Urinalysis: • No significant findings Property of Volition Veterinary Diagnostics Development© 2022 Slid
Slide 37: Case 2: Belle Orange Level
Case 2: Belle Nu.Q® Vet Cancer Test: ORANGE • Cancer Suspicion: High Risk LEVEL Interpretation: • Plasma nucleosome concentrations in the orange level are consistent with common canine cancers including lymphoma and hemangiosarcoma. • Test is not able to differentiate severe/systemic inflammation fr
Slide 38: Case 2 Belle: What Do You Do?
Case 2 Belle: What Do You Do? ORANGE LEVEL Abdominal Chest FNA or Biopsy Ultrasound Radiographs Or Refer to oncologist • AUS: splenomegaly with severely mottled appearance (“moth eaten”) • AUS-guided splenic aspirates: high grade lymphoma Property of Volition Veterinary Diagnostics Development© 2022
Slide 39: Case 3: Hank
Case 3: Hank 10-year-old MN Great Dane Mix Presenting for 2-week history of progressive left forelimb lameness Physical exam: • Firm painful mass associated with left carpus • Toe touching lame to non-weight bearing • Rest of exam unremarkable Property of Volition Veterinary Diagnostics Development©
Slide 40: Case 3: Hank
Case 3: Hank Owner agrees to minimum database, Nu.Q® Vet Cancer Test, & sedation for carpal radiographs CBC • Stress leukogram • Mild thrombocytosis: 479,000 Chemistry panel: • Mild elevation in Alk Phos: 283 mg/dL Urinalysis • USG 1.040 • 2+ proteinuria Property of Volition Veterinary Diagnostics D
Slide 41: Case 3 Hank: Radiographs of Carpus
Case 3 Hank: Radiographs of Carpus Property of Volition Veterinary Diagnostics Development© 2022 Slide 43
Slide 42: Case 3: Hank
Case 3: Hank Nu.Q® Vet Cancer Test : GREEN LEVEL Cancer Suspicion: LOW RISK Interpretation: • Plasma nucleosome concentrations in the green level are consistent with those found in healthy animals of over age of 1 year & all genders. • Not all neoplastic conditions are detectable using elevated plas
Slide 43: Case 3 Hank: What Do You Do?
Case 3 Hank: What Do You Do? GREEN LEVEL Start FNA or Biopsy Antifungal Retest in Or Refer to 1 month Therapy an oncologist Bone aspirate: sarcoma, ALP-stain positive • Consistent with osteosarcoma NOTE: The current Nu.Q® Vet Cancer Test more reliably detects systemic cancers rather than soft tissue
Slide 44: Case 4: Percy
Case 4: Percy • 8-year-old FS Bichon Frise • Presents for annual wellness check & doing well Physical exam: • Moderate dental tartar • Dermal mass over left lateral flank • No other significant findings Plan: routine blood work & Nu.Q® Vet Cancer Test • Owner declines aspirate Property of Volition V
Slide 45: Case 4: Percy
Case 4: Percy YELLOW Nu.Q® Vet Cancer Test : LEVEL • Cancer Suspicion: “GRAY ZONE” Interpretation: • Plasma nucleosome concentrations at the yellow level can be seen in early-stage cancer or cancers with low levels of circulating nucleosomes including lymphoma and hemangiosarcoma. • Test not able to
Slide 46: Case 4 Percy: What Do You Do?
Case 4 Percy: What Do You Do? YELLOW LEVEL Upon questioning owner, you determine Percy was not fasted • Owner forgot to pull food & she was fed breakfast • What do you do with these results? Refer for a Fast & retest Retest in full work up later this week 1 month with & FNA mass oncologist Property
Slide 47: Case 4: Percy
Case 4: Percy • Repeat test and FNA: Owner agreed to fast & bring dog back in am • Nu.Q® Vet Cancer Test : • Cancer Suspicion: LOW RISK GREEN LEVEL Nu.Q® Interpretation: • Green level consistent with in healthy animals of over age of 1 year • Not all neoplastic conditions are detectable using elevat
Slide 48: Future Products in Development
Future Products in Development Canine Cancer: Cancer Screening Circulating Case Future Products FAQs At a Glance Nucleosomes Studies in Development Property of Volition Veterinary Diagnostics Development© 2022 Slide 51
Slide 49: Future Products in Development
Future Products in Development Point of Care Test Volition has entered a licensing agreement with Heska. We anticipate a launch in early 2023. Differential Diagnosis We are currently working on developing additional assays to add to the Nu.Q® test to better differentiate other conditions from cancer
Slide 50: Future Products in Development
Future Products in Development19,20 Disease Progression and Treatment Monitoring16,17 Most patients achieving clinical remission showed healthy plasma nucleosome levels i.e., “a Nu.Q® Vet test result” in the low, healthy dog range. The Nu.Q® Vet Cancer Test may therefore be a useful tool to monitor
Slide 51: Disease Progression and Treatment Monitoring: Case Studies
Disease Progression and Treatment Monitoring: Case Studies V= vincristine C= Cytoxan Roxy D= doxorubicin M= mitoxantrone Del= treatment R= recheck. 6 year-old FS Rottweiler Roxy presented to TAMU in December 2019 with generalized lymphadenopathy. Out of remission – she had previously been diagnosed
Slide 52: Roxy Disease Progression and Treatment Monitoring
Roxy Disease Progression and Treatment Monitoring: Case Studies The Chart Interpretation Both CRP and Nu.Q® are high at diagnosis, TK-1 is not. CRP fluctuates throughout the protocol and the TK-1 is consistently low. The Nu.Q® value correlates better with her response and disease progress. By week 3
Slide 53: Disease Progression and Treatment Monitoring: Case Studies
Disease Progression and Treatment Monitoring: Case Studies Abbigail 5 year-old FS Miniature Schnauzer V= vincristine C= Cytoxan D= doxorubicin M= mitoxantrone Del= treatment R= recheck. Abbigail presented to TAMU in 2020 with submandibular lymphadenopathy. Cytology diagnosed lymphoma; flow cytometry
Slide 54: Abbigail Disease Progression and Treatment Monitoring
Abbigail Disease Progression and Treatment Monitoring: Case Studies The Chart Interpretation Abbigail had one of the highest Nu.Q® values we have After a rest or delay, her Nu.Q® value increases – seen and continues to remain high – though she does demonstrating that we have minimal control of her d
Slide 55: Abbigail Disease Progression and Treatment Monitoring
Abbigail Disease Progression and Treatment Monitoring: Case Studies Result Abbigail’s Nu.Q® value remains low at her 1st monthly recheck. 2nd monthly recheck, the Nu.Q® value is high – but still deemed to be in clinical remission based on PE and restaging 3rd monthly recheck – she is clearly out of
Slide 56: Materials Available for Download
Materials Available for Download Product Brochure Veterinary VeterinaryResources Resources Race Approved Webinars & Case Studies Property of Volition Veterinary Diagnostics Development© 2022 Slide 59
Slide 57: Frequently Asked Questions
Frequently Asked Questions Canine Cancer: Cancer Screening Circulating Case Future Products FAQs At a Glance Nucleosomes Studies in Development Property of Volition Veterinary Diagnostics Development© 2022 Slide 60
Slide 58: FAQs
FAQs Will this test tell me if my dog has What types of cancer has the cancer? Nu.Q® Vet Cancer Test been able to detect? No, the release of nucleosomes into the blood is At 97% specificity, the Nu.Q® Vet Cancer Test common to many different types of cancers. was shown to detect 76% of systemic canc
Slide 59: FAQs
FAQs Do pre-existing or other clinical conditions impact results? Nucleosome Spikes May Diseases That Do Not Occur in the Following At 97% specificity, Impact Nu.Q® Vet Cancer Test the Results was shown to detect 76% of systemic cancers Immune Mediated Disease Chronic Inflammatory Conditions Systemi
Slide 60: FAQs
FAQs What Should I Do if My Patient has NOT Been Fasted? Dogs that have not been fasted may have slightly elevated Nu.Q® levels. What to do? Repeat the test at a later date. Ensure patient has been fasted minimum 4 hours. If levels remain high, additional testing may be necessary. Property of Voliti
Slide 61: References
References 1. Larkin, M. (2021). Pet population still on the rise, with fewer pets per household. American Veterinary Medical Association. Retrieved 9 July 2022, from https://www.avma.org/javma-news/2021-12-01/pet-population-still-rise-fewer-pets-household. 2. Survey of U.S. Pet Owners | HABRI. HABR
Slide 62: Additional Questions?
Additional Questions? You can reach us online, via e-mail, DM us, our call our hotline for a free oncology consult Veterinary.volition.com AskNu.Qvet@volition.com Volition Veterinary (979) 709-2348 Property of Volition Veterinary Diagnostics Development© 2022 Slide 65