Bcal Diagnostics Limited · ASX:BDX
Bcal Diagnostics — Investor Presentation (July 2021)
28 slides from Bcal Diagnostics's investor presentation, Jul 21, 2021
Slide 1: Commercialising a Blood Test to Transform Breast Cancer Diagnosis
COMMERCIALISING A BLOOD TEST TO TRANSFORM BREAST CANCER DIAGNOSIS BCAL Diagnostics Limited Investor Presentation – July 2021 BCAL DIAGNOSTICS LIMITED 1 INVESTOR ROADSHOW – JULY 2021
Slide 2: Important Notice & Disclaimer
IMPORTANT NOTICE & DISCLAIMER Not a prospectus or an offer of securities Future performance This presentation has been prepared by BCAL Diagnostics Ltd ABN 51 142 051 223 (BCAL or the This presentation contains certain "forward-looking statements". The words "expect", "anticipate", Company). This pr
Slide 3: Contents
CONTENTS 1. Introduction 4 2. Industry and market 7 3. Company overview 16 4. Key people 24 BCAL DIAGNOSTICS LIMITED 3 INVESTOR ROADSHOW – JULY 2021
Slide 4: 1. Introduction
1. INTRODUCTION BCAL DIAGNOSTICS LIMITED 4 INVESTOR ROADSHOW – JULY 2021
Slide 5: BCAL Diagnostic Overview
BCAL DIAGNOSTIC OVERVIEW BCAL Diagnostic Test A viable blood test for breast cancer diagnosis: BCAL Diagnostics has developed a non-invasive blood based diagnostic approach to complement current imaging technologies Blood collected at standard blood collection point Patient, clinician & health provi
Slide 6: Why BCAL
WHY BCAL Breast cancer blood test product ready for major patient study Blood test for range Promising results Widens population Staged rollout Initial territories Highly of breast cancers to date for screening strategy defined experienced team No comprehensive Showed accurate Suitable for under 40s
Slide 7: 2. Industry & Market
2. INDUSTRY & MARKET BCAL DIAGNOSTICS LIMITED 7 INVESTOR ROADSHOW – JULY 2021
Slide 8: Incidence of Breast Cancer
INCIDENCE OF BREAST CANCER Estimated 1-in-7 women at risk of a breast cancer diagnosis Follow-on market Initial market US Australia Global 2,000,000 627,000 250,000 40,000 Annual Annual 20,000 3,000 Annual Annual new cases deaths Annual Annual new cases deaths new cases deaths Follow-on market Initi
Slide 9: Early Diagnosis Is Important
EARLY DIAGNOSIS IS IMPORTANT Early breast cancer diagnosis leads to better survivability Breast cancer stage 1-4 survivability Source: https://www.pinkribbon.org.pk/stages-breast-cancer/ BCAL DIAGNOSTICS LIMITED 9 INVESTOR ROADSHOW – JULY 2021
Slide 10: Current Screening Process
CURRENT SCREENING PROCESS Early breast cancer diagnosis leads to better survivability Discovery Screening Testing Treatment 39m mammograms p.a. 10% go to 20% require completed in US alone biopsy treatment Surgery Self-examination Mammogram Biopsy Opportunity for an Chemotherapy adjunct test to mammo
Slide 11: Limitations of Mammography
LIMITATIONS OF MAMMOGRAPHY 50% of women choose to self-exclude Not definitive (20% of Prone to self- breast cancers are exclusion (painful, missed – false uncomfortable, negatives) cultural reasons) Limited accuracy Limited by breast (prone to false density positives) Over 40 y/o Limited remote only
Slide 12: Breast Cancer Diagnostics Global Market Size
BREAST CANCER DIAGNOSTICS GLOBAL MARKET SIZE No blood test for breast cancer diagnosis 39m mammograms p.a. completed in US alone US$8.7B Human Epidermal Growth Factor IVD blood & Receptor 2 (HER2) has proved useful CAGR: 7.3% $2.5B plasma tests but only relevant for a quarter of breast cancers US$5.
Slide 13: No Routine Monitoring & Early Detection Tests in High Risk Groups
NO ROUTINE MONITORING & EARLY DETECTION TESTS IN HIGH RISK GROUPS LEADS TO DRASTIC ACTION Some women who carry the BRCA1 and BRCA2 gene elect to have mastectomies • If a woman has inherited a fault in their BRCA1 and BRCA2 genes, she has a high chance of developing breast or ovarian cancer • Current
Slide 14: 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 Early Warning Diagnostic 2. Monitor 3. Monitor 4. 1. Adjunct test breast cancer women who Comprehensive to traditional patients carry the
Slide 15: Opportunity for Blood Test
OPPORTUNITY FOR BLOOD TEST Altered lipid expression can be detected using a relatively simple process to the user Plasma contains vesicles. 18 lipid candidate markers that Breast-cancer altered lipids Breast cancer cells emerge reveal differences between breast can be detected in a blood exhibiting
Slide 16: 3. Company Overview
3. COMPANY OVERVIEW BCAL DIAGNOSTICS LIMITED 16 INVESTOR ROADSHOW – JULY 2021
Slide 17: Key Development/Scientific Milestones
KEY DEVELOPMENT/SCIENTIFIC MILESTONES Significant development to date to bring BCAL to current position 2017-2021 Completed studies whose results showed accurate identification of cancer especially in early stages, independent of age, with 91% specificity and 87% accuracy in some cohorts using18 can
Slide 18: 2017-2021 Testing Results
2017-2021 TESTING RESULTS Reproduced and replicated in Australia results from US proof-of-concept testing from 2013 to 2017 Findings • Identified 2 panels of 18 candidate lipid markers • Robustly and reproducibly discriminate between control and cancer (91% Specificity and 87% accuracy in Set 5) • D
Slide 19: Clinical Study Program
CLINICAL STUDY PROGRAM Study 1, Stage 1 Study 1, Stage 2 Study 2 Collection type Single Single Multiple Aim Feasibility of BCAL as adjunct test to Test as adjunct test to mammogram Monitoring tool for recurrence mammogram and establish workflow Target findings • Initial performance of 18 candidate •
Slide 20: Key Partnership – GenesisCare
KEY PARTNERSHIP – GENESISCARE 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 participati
Slide 21: Commercial Pathway
COMMERCIAL PATHWAY 2021 2022 2023 2024 Ongoing 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 D
Slide 22: 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 GenesisCare Louisville (USA) (New Zealand) Clinic (Australia) (Australia) IVD kit r
Slide 23: Patent Summary
PATENT SUMMARY Application title Filing date Application number Status 371 date1: PENDING – Notice of Appeal filed May 6, 2019; response to Methods for Detection Cancer US 13/805,352 Dec. 19, 2012 outstanding final Office action due December 6, 2019 PENDING – Waiting for next action by CIPO; Next an
Slide 24: 4. Key People
4. KEY PEOPLE BCAL DIAGNOSTICS LIMITED 24 INVESTOR ROADSHOW – JULY 2021
Slide 25: 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 26: Key People
KEY PEOPLE Dr. Jane Ryan, PhD Guy Robertson Dr. Amani Batarseh Alison Cook (Mew), MSc Chief Product Development Adviser Chief Financial Officer & Company Secretary Chief Scientist Regulatory and Commercialisation Manager • Over 30 years of international pharmaceutical • A Finance Director/Chief Fina
Slide 27: Scientific Advisory Board
SCIENTIFIC ADVISORY BOARD Dr. Kim Ekroos A/Prof. Craig Gedye Dr. Sanjay Warrier (Associate Prof.) Prof. Peter Meikle Dr. Mary Rickard OAM MBBS, BSc(Med)(HonsII), DRACR, DDU, MPH, PhD, Lipidomics Consulting BSc(Hons), MBChB, FRACP, PhD BSc (Med) MBBS FRACS MS PhD, Baker IDI Lipidomics Melbourne RANZC
Slide 28: BCAL DIAGNOSTICS LIMITED INVESTOR ROADSHOW – JULY 2021
,,, ,,, BCAL DIAGNOSTICS LIMITED 28 INVESTOR ROADSHOW – JULY 2021