Bcal Diagnostics Limited · ASX:BDX
Bcal Diagnostics — Shareholder Meeting (November 2021)
28 slides from Bcal Diagnostics's shareholder meeting presentation, November 2021
Slide 1: A Patient-Friendly Breast Cancer Blood Test
A PATIENT-FRIENDLY BREAST CANCER BLOOD TEST BCAL Diagnostics Limited (ASX:BDX) AGM Presentation – November 2021 BCAL DIAGNOSTICS LIMITED 1 AGM PRESENTATION – NOVEMBER 2021
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 Snapshot
BCAL SNAPSHOT BCAL is commercialising a blood test for breast cancer diagnosis There are currently NO routine early detection and monitoring testing options for breast cancer globally BCAL DIAGNOSTICS LIMITED 3 AGM PRESENTATION – NOVEMBER 2021
Slide 4: Investment Highlights
INVESTMENT HIGHLIGHTS A more effective, patient-friendly breast cancer test Blood test for range Widens population for of breast cancers screening including where none currently under 40s and those exists in rural areas Cheaper and easier to Clear rollout administer compared strategy with staged to
Slide 5: 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 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 cases deaths Follow-
Slide 6: Early Diagnosis Is Critical
EARLY DIAGNOSIS IS CRITICAL Early breast cancer diagnosis leads to better survivability Stages of breast cancer Stage 0 Stage 1 Stage 2 Stage 3 Stage 4 Breast cancer survivability 100% 98% 93% survival rate survival rate survival rate 72% survival rate 28% survival rate BCAL DIAGNOSTICS LIMITED 6 AG
Slide 7: Diagnosis a Bottleneck to Survivability
DIAGNOSIS A BOTTLENECK TO SURVIVABILITY Early breast cancer diagnosis leads to better survivability ~47m mammograms 3.8m women p.a Also, 8m false negatives, p.a. completed in undergo unnecessary leading to delay of critical US, EU and Australia biopsies treatment Discovery Screening Testing Treatmen
Slide 8: No Early Detection Tests for Breast Cancer
NO EARLY DETECTION TESTS FOR BREAST CANCER No blood test for breast cancer 39m mammograms p.a. completed in US alone US$8.7B Human Epidermal Growth Factor Receptor 2 (HER2) has proved useful CAGR: 7.3% $2.5B IVD blood & plasma tests but only relevant for a quarter of breast cancers US$5.0B Gold stan
Slide 9: Key Development / Scientific Milestones
KEY DEVELOPMENT / SCIENTIFIC MILESTONES Significant development to date to bring BCAL to current position 2018-2021 Completed studies whose results showed accurate identification of cancer especially in early stages, independent of age, with 91% sensitivity and 87% accuracy from 18 lipid markers Coh
Slide 10: Rollout Strategy
ROLLOUT STRATEGY Clinical studies will provide data to support each of these claims Strategy defined to provide a sequenced path to market Adjunct test Monitoring Predictive Screening 2. Monitor 3. Monitor 4. 1. Adjunct test breast cancer women who Comprehensive to traditional patients carry the bre
Slide 11: Biomarkers Open Door for Blood Test
BIOMARKERS OPEN DOOR FOR BLOOD TEST Altered lipid expression can be detected using a relatively simple process Breast-cancer altered lipids in plasma can be detected in a blood test using BCAL’s lipid biomarker algorithm 18 lipid candidate markers that reveal differences between breast cancer and no
Slide 12: How It Works
HOW IT WORKS Patient-friendly test, easy to collect as any blood test BCAL Blood Test Data analysis of Evaluation by Extracellular markers Blood collected at Extraction of Liquid vesicles (EV) (AI & ML algorithm standard blood markers for Chromatography enrichment from to drive higher collection poi
Slide 13: Studies 2018 to Date
STUDIES 2018 TO DATE 2018-2021 Results Cohort 1 Cohort 2 Cohort 3 Cohort 4 N=90 N=200 N=201 N=301 Proof of concept studies US 2013- Control 2017 IDC DCIS ILC Commencing BCAL Trial 1 2022 • Cohort refers to a group of people who share a certain characteristic, in this case presence of Trial to determ
Slide 14: 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. Small a
Slide 15: Algorithm Performance 2018-2021
ALGORITHM PERFORMANCE 2018-2021 Findings • Identified a panel of 18 candidate lipid markers • Robustly and reproducibly discriminate between control and breast cancer in early stages Reproducible performance for Early detection 100 90 80 • Early cancer could be detected 70 from lipid profiles 60 • D
Slide 16: Clinical Study Program
CLINICAL STUDY PROGRAM Study 1, Stage 1 Study 1, Stage 2 Study 2 Collection type Single Single Multiple Feasibility of BCAL as adjunct test to Aim Test as adjunct test to mammogram Monitoring tool for recurrence mammogram and establish workflow • Evaluate 18 markers before and after • Initial perfor
Slide 17: Near Term Targets
NEAR TERM TARGETS H2 2021 H1 2022 H2 2022 H1 2023 H2 2023 Finalise biomarkers Sign NATA accredited lab Prepare for in-house IVD Analytical performance Provide data for the technical file for regulatory Cohort 5 (1,000 samples) submission Pivotal Clinical Trial BCAL DIAGNOSTICS LIMITED 17 AGM PRESENT
Slide 18: Achievements FY21
ACHIEVEMENTS FY21 • Established & built out a strong scientific team. • Completed analysis of cohort 4 n=301, reinforcing strong data. • Updated patent claims in the USA, Canada and Europe using new findings. • Establishing a quality system in preparation for ISO certification. • Executed commercial
Slide 19: Key Partners
KEY PARTNERS Strong group of university and commercial partners to accelerate commercialisation Intellectual Research and Clinical Downstream property Development studies partners University of Izon The Sydney Breast Genesis Care Louisville (USA) (New Zealand) Clinic (Australia) (Australia) IVD kit
Slide 20: Key Partnership – GenesisCare
KEY PARTNERSHIP – GENESIS CARE CRO and Market entry partner in Australia, UK, Spain and the USA Over 440 centres globally including in key territories Master Services Agreement signed with GenesisCare as Contract research organisation (CRO) and market entry partner UK 14 centres Currently participat
Slide 21: Commercial Pathway
COMMERCIAL PATHWAY 2021 2022 2023 2024 2025+ Clinical Study 1 Stage 1 Clinical Study 1 Stage 2 and Study 2 Complete studies 1 and 2 to provide documentation for regulatory submissions in Australia, EU and US Regulatory Regulatory submissions to Australia, EU and US markets LDT Develop Laboratory Dev
Slide 22: 4. Key People
4. KEY PEOPLE BCAL DIAGNOSTICS LIMITED 22 AGM PRESENTATION – NOVEMBER 2021
Slide 23: Board of Directors
BOARD OF DIRECTORS 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 • Co-owner of Sydney Breast Clinic and • Co-owner
Slide 24: Key People
KEY PEOPLE Dr. Jane Ryan, PhD Guy Robertson Dr. Amani Batarseh Alison Cook (Mew), MSc Chief Operating Officer Chief Financial Officer & Company Secretary Chief Scientist Regulatory and Commercialisation Manager • Over 30 years of international pharmaceutical • A Finance Director/Chief Financial Offi
Slide 25: Scientific Advisory Board
SCIENTIFIC ADVISORY BOARD Dr Kim Ekroos A/Prof Craig Gedye Prof Peter Meikle PhD, Lipidomics Consulting BSc(Hons), MBChB, FRACP, PhD PhD, Baker IDI Lipidomics Melbourne • Founder and CEO of Lipidomics Consulting Ltd., a consulting business • A medical oncologist and cancer researcher working for peo
Slide 26: Clinical Advisory Board
CLINICAL ADVISORY BOARD A/Prof Sanjay Warrier (Associate Prof.) A/Prof Cindy Mak MBBS (Hons) Prof Mary Rickard OAM BSc (Med) MBBS FRACS MS Sydney University FRACS MBBS, BSc(Med)(HonsII), DRACR, DDU, MPH, RANZCR • Consultant Breast Oncology and Oncoplastic Surgeon at Chris O’Brien • Completed her med
Slide 27: In Summary
IN SUMMARY A more effective, patient-friendly breast cancer test Blood test for range Widens population for of breast cancers screening including where none currently under 40s and those exist in rural areas Cheaper and easier to Clear rollout administer compared strategy with staged to mammography,
Slide 28: BCAL DIAGNOSTICS LIMITED AGM PRESENTATION – NOVEMBER 2021
,,, ,,, BCAL DIAGNOSTICS LIMITED 28 AGM PRESENTATION – NOVEMBER 2021
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