Bcal Diagnostics Limited · ASX:BDX
Bcal Diagnostics — Shareholder Meeting (November 2022)
22 slides from Bcal Diagnostics's shareholder meeting presentation, Nov 30, 2022
Slide 1: A Patient-Friendly Breast Cancer Blood Test
rsonal use only A PATIENT-FRIENDLY BREAST CANCER BLOOD TEST BCAL Diagnostics Limited (ASX:BDX) Presentation – November 2022 BCAL DIAGNOSTICS LIMITED 1 AGM PRESENTATION – NOVEMBER 2022
Slide 2: Important Notice & Disclaimer
IMPORTANT NOTICE & DISCLAIMER This presentation (Presentation) has been prepared by BCAL Diagnostics Ltd ABN 51 142 051 223 (BCAL or the Company). The information in this Presentation is of a general background nature, is in summary form and does not purport to be complete. The information in this P
Slide 3: BCAL is commercialising a blood test for early breast cancer diagnosis
BCAL is commercialising a rsonal use only blood test for early breast cancer diagnosis There are currently NO simple early detection and monitoring testing options for breast cancer BCAL DIAGNOSTICS LIMITED 3 AGM PRESENTATION – NOVEMBER 2022
Slide 4: Introduction
INTRODUCTION 1 7 in Currently the primary rsonal use only means for detecting breast cancer is self examination for women Women affected by Up to 50% of women under 40 and breast cancer over 30 yo are mammography for women globally excluded from within the guidelines, 40-75 mammography The BCAL prop
Slide 5: Limitations of Mammography
LIMITATIONS OF MAMMOGRAPHY Not definitive (20% Prone to self- rsonal use only of breast cancers exclusion (painful, are missed – false uncomfortable, negatives) cultural reasons) Limited Most effective accuracy above 50yo due (prone to false to breast density positives) and fatty tissue Guide lines
Slide 6: Mammographic Breast Density 'Problem' for Mammographic Screening
MAMMOGRAPHIC BREAST DENSITY ‘PROBLEM’ FOR MAMMOGRAPHIC SCREENING • Density due to fibroglandular rsonal use only tissue is highest in young women and decreases with age • High density is a problem at any age but particularly in young women (below 50yo) • Dense fibroglandular tissue (white) can obscu
Slide 7: rsonal use only
At BCAL we want to improve rsonal use only access to breast screening for all women and to provide an additional value added tool to clinicians and patients in the screening, diagnosis and monitoring of breast cancer BCAL DIAGNOSTICS LIMITED 7 AGM PRESENTATION – NOVEMBER 2022
Slide 8: Breast Cancer Is a Leading Cause of Death
BREAST CANCER IS A LEADING CAUSE OF DEATH Estimated 1-in-7 women at risk of a breast cancer diagnosis rsonal use only Follow-on market Initial market US Australia Global 2,000,000 627,000 281,550 43,600 Annual Annual 20,000 3,000 Annual Annual new cases deaths Annual Annual new cases deaths new case
Slide 9: How the BCAL Test Works
HOW THE BCAL TEST WORKS Patient-friendly test, easy to collect as any blood test rsonal use only BCAL Blood Test Data analysis of Extracted lipids are Plasma is of the lipid content of Blood collected at The lipids are analysed by Liquid separated from the the plasma shows the standard blood extract
Slide 10: Lipids Are Essential for Rapid Cell Growth
LIPIDS ARE ESSENTIAL FOR RAPID CELL GROWTH Cells contain the nucleus and Lipids are a source of energy, building rsonal use only essential organelles surrounded blocks and signal messengers for tumour by a membrane cell growth Deregulation of lipid metabolism is a very early step in the transformati
Slide 11: Summary of Early Clinical Studies
SUMMARY OF EARLY CLINICAL STUDIES Studies carried out on Extracellular vesicles (EVs ) rsonal use only Cohort 1 Cohort 2 Cohort 3 Cohort 4 N=88 N=200 N=201 N=301 Control IDC Late stages DCIS ILC IDC Stages 1-4 Stages 1&2 Stages 1&2 Stage 0 DCIS ILC Stages 1-4 IDC: Invasive ductal carcinoma DCIS: Duc
Slide 12: Algorithm Development and Biomarkers
ALGORITHM DEVELOPMENT AND BIOMARKERS Panels of lipids combine the discriminating power of individual lipids to deliver a likelihood of cancer for a new sample. Algorithms are trained on the BCAL cohorts of cancer patients and matched controls. The focus is on detection of early-stage cancer. rsonal
Slide 13: Sensitivity and Specificity Is Consistently Strong
SENSITIVITY AND SPECIFICITY IS CONSISTENTLY STRONG Lipids were extracted from Extracellular vesicles (EV’s) Cohort 2 Cohort 3 AUC: 0.85 AUC: 0.93 rsonal use only 1.0 1.0 True Positive Rate True Positive Rate 0.8 0.8 0.6 0.6 Cohort 2,3,4 0.4 0.4 AUC: 0.88 1.0 0.2 0.2 True Positive Rate SENSITIVITY 0.
Slide 14: Plasma Samples for Sub-Study
PLASMA SAMPLES FOR 250 SUB-STUDY The plasma samples analysed rsonal use only in the 250 sub study are a 160 subset of Cohorts 3 and 4, 140 containing all cancer 120 subtypes: DCIS, IDC and ILC 100 80 60 40 20 0 Cohort 1 Cohort 2 Cohort 3 Cohort 4 IDC Breast Cancer Samples ILC Breast Cancer Samples D
Slide 15: Performance of Top Lipids Comparable in Plasma and Extracellular Vesicles
PERFORMANCE OF THE TOP LIPIDS OF INTEREST IS COMPARABLE IN PLASMA AND EXTRACELLULAR VESICLES rsonal use only Performance Plasma 250 EV 250 samples Plasma 250 samples (LOOCV) Samples EV 250 samples Accuracy 0.78 0.79 Sensitivity 0.81 0.79 Specificity 0.74 0.78 Pos Pred Value 0.82 0.84 SENSITIVITY Neg
Slide 16: Plasma Performance Is Strong in Cancer Subtypes
PLASMA PERFORMANCE IS STRONG IN CANCER SUBTYPES Plasma BCAL– DCIS vs Control Plasma BCAL– IDC vs Control rsonal use only Performance DCIS vs IDC vs all ILC vs all all (LOOCV) Control Control Control Accuracy 0.83 0.8 0.84 Sensitivity 0.78 0.69 0.81 Specificity 0.85 0.86 0.85 Pos Pred Value 0.71 0.71
Slide 17: Application of AI and ML Techniques
APPLICATION OF AI AND ML TECHNIQUES Recent analysis of the data by AI/ML obtained from the 250 plasma sample study has lead to an improvement of the lipid signature to between patients with and without breast cancer. rsonal use only A second patent application is under development Lipid 1 Lipid 2 Li
Slide 18: BCAL Milestones and Inflection Points
BCAL MILESTONES AND INFLECTION POINTS Regulatory LDT Australia submission Development Development and Clinical Future rsonal use only Services Lab established TGA/ FDA Products Australian Focus Monitoring Study Groups Study Biomarkers Analytical locked down Validation LDT Australia Australian Launch
Slide 19: Board of Directors
Board of Directors rsonal use only Jayne Shaw The Hon Ron Phillips AO Jonathan Trollip Dr. Merilyn Sleigh Mark Burrows AO Executive Chair Non-executive Director Independent Non-executive Director Independent Non-executive Director Independent Non-executive director • Successful businesswoman, • Heal
Slide 20: Key People - USA
Key People - USA rsonal use only Dr David Peake, PhD Brian Kolasinski Dr. John Hurrell Kim Ekroos, PhD Dr Raji Pillai PhD Scientific Lead, Technology Director, Business Strategy and Chief Executive Officer Scientific Advisor Regulatory Consultant Transfer Development • More than 35 years experience
Slide 21: Technical Milestones Achieved in 2022
TECHNICAL MILESTONES ACHIEVED IN 2022 A lipidomic signature has been identified in the blood of breast cancer patients rsonal use only The signature is seen in all breast cancer types tested and at the earliest stages of the disease A Provisional patent application has been filed by the Company: a s
Slide 22: Summary of Progress
SUMMARY OF PROGRESS There is a large unmet need for a simple, accurate blood test for breast cancer rsonal use only The BCAL blood test has high sensitivity, specificity and accuracy for the detection of breast cancer It is cheaper, easier and more accessible than mammography, the current gold stand
BCAL Diagnostics — Shareholder Meeting (November 2022) on 6ix