Bcal Diagnostics Limited · ASX:BDX
Bcal Diagnostics — Investor Presentation (March 2024)
26 slides from Bcal Diagnostics's investor presentation, Mar 6, 2024
Slide 1: Corporate Presentation
BCAL DIAGNOSTICS LIMITED ASX: BDX CORPORATE PRESENTATION 6 MARCH 2024 Jayne Shaw | John Hurrell | Shane Ryan 1
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation (Presentation) has been prepared by BCAL Diagnostics The forward-looking statements are based on information available to BCAL Not An Offer Ltd ABN 51 142 051 223 (BCAL or the Company). as at the date of this Presentation. Circumstances may change an
Slide 3: BCAL BREASTEST: Driving a New Paradigm in Breast Cancer Diagnostics
BCAL BREASTEST DRIVING A NEW PARADIGM IN BREAST CANCER DIAGNOSTICS 3
Slide 4: Founded in 2010, BCAL Diagnostics is an Australian diagnostic company
Founded in 2010, BCAL Diagnostics is an Australian diagnostic company focused on revolutionising early detection and screening for breast cancer for women worldwide 4
Slide 5: H1 Highlights
H1 HIGHLIGHTS 1 3 Scientific Laboratory & Corporate progress Processing developments Partnerships Breakthrough results from NATA accreditation Formation of Clinical Sample collection clinical study with Precion application well underway Advisory Board partnerships with KIMS Institute and Indo-Americ
Slide 6: Significant Scientific Progress
SIGNIFICANT SCIENTIFIC PROGRESS PRECION STUDY BLOOD PROCESSING OPTIMISATION The analysis undertaken achieved an impressive Completed all studies to determine the tolerable sensitivity of 90% and a specificity of 85.5% in limits and instructions for collection, transportation, internal validation stu
Slide 7: Final Stage Ahead of Commercial Launch
FINAL STAGE AHEAD OF COMMERCIAL LAUNCH LAB ACCREDITATION SENSIBLE STUDY National Association of Testing Authorities BCAL has initiated a further internally- (NATA) under the ISO 15189 requirements managed clinical study, the SENSIBLE study, and National Pathology Accreditation using samples from Aus
Slide 8: Corporate Developments
CORPORATE DEVELOPMENTS Strategic changes to expedite commercialisation pathway • Formation of Clinical Advisory Board to assist the company in clinical utility decisions • Made up of leading breast cancer clinicians and researchers • Simon Preston appointed as Director of Clinical Research • Bringin
Slide 9: BREASTEST
BREASTEST A blood test that detects breast cancer that will be ready for use in Australian women in late 2024 14 years of clinical development with research originating in Sydney in 2010 Developed in clinical studies using cutting edge lipidomics in more than 2500 patient samples Launch in Australia
Slide 10: Investment Highlights
INVESTMENT HIGHLIGHTS A BLOOD TEST TO DETECT BREAST CANCER 1. Revenue generation following Australian market launch in late 2024 5. Leverages AI-driven technology in BCAL-owned laboratory and operated Biobank, distinguishing from competitors by collecting its own samples with strong 2. A complementa
Slide 11: Commercial Pathway
COMMERCIAL PATHWAY 3 GLOBALISE A 3-year roadmap to saving lives underpinned by a reproducible lipidomic platform and a proprietary biobank of growing data 3 • Publish in scientific literature the clinical and utility performance of BREASTEST to underpin other market launches • Secure government fund
Slide 12: A Major Commercial Opportunity
A MAJOR COMMERCIAL OPPORTUNITY 2.1 Million Breast cancer is the world’s most prevalent cancer in women Mammograms in 2021 WCRFI BSA 13% of women in the US will On average 57 People develop an invasive form of breast cancer are or will be diagnosed with breast cancer in their lifetime everyday BCNA 2
Slide 13: Early Diagnosis Saves Lives and Costs to the Healthcare System
EARLY DIAGNOSIS SAVES LIVES AND COSTS TO THE HEALTHCARE SYSTEM BREAST CANCER STAGES STAGE 0 STAGE 1 STAGE 2 STAGE 3 STAGE 4 BCAL is 28% focused on 100% improving the 98% 93% SURVIVAL SURVIVAL SURVIVAL SURVIVAL 72% RATE RATE RATE RATE SURVIVAL outcomes for RATE $16,390 $44,367 $86,383 $110,364 $418,5
Slide 14: Limitations of Mammography: Current Breast Cancer Screening
LIMITATIONS OF MAMMOGRAPHY: CURRENT BREAST • Guidelines limit access to those over 40yo CANCER SCREENING • Most effective above 50yo due to lower breast Breast density is the least addressed common risk factor for breast density and fatty tissue cancer accounting for up to 50% of cases. • Limited re
Slide 15: 2.1 Million Mammogram Screenings
2.1 MILLION MAMMOGRAM SCREENINGS occurred in Australia in 2023, well short of the expected 4million 44% women think 42% waiting two years for a 28% mammogram is Of all new of eligible cancer cases in women do not too long women will be get screened (BMC Cancer) breast cancer (BreastScreen Australia)
Slide 16: BREASTEST Integrated Existing Standards of Care
BREASTESTTM INTEGRATED EXISTING STANDARDS OF CARE 94.6% 74.2% 54.5% 85.5% 67.2% 76.8% 90 .5% 52.6% 90% 85.5% MRI Mammography Ultrasound Contrast-enhanced BREAS TES T mammography A cancer detection test requires a balance of SENSITIVITY Internal validation of BREASTESTTM shows sensitivity (ability to
Slide 17: Path to Market
PATH TO MARKET Strategy defined to provide a sequenced path to market Adjunct test Monitoring Surveillance Diagnostic Adjunct test to Monitor breast Monitor women Comprehensive traditional cancer patients who carry gene breast cancer mammogram through the mutations or screening for screening disease
Slide 18: Detecting Lipid Signatures from Breast Cancers
DETECTING LIPID SIGNATURES FROM BREAST CANCERS Lipids are fats and a source of energy for cell growth. Deregulation of lipid metabolism is a very early step in a normal cell becoming a cancerous cell. Deregulated lipids can spill over into the blood’s plasma which is indicative of cancer growth. BCA
Slide 19: Lipid Blood Test with Automated Analysis
LIPID BLOOD TEST ~$300 Proposed cost of test WITH AUTOMATED ANALYSIS to the patient, following independent research and focus group During Phase 1 of the commercial launch, BCAL will manage the pathology logistics to ensure quality control and ongoing sample storage to further develop its AI data an
Slide 20: BCAL Is Working with Clinicians from Leading Centers Around the Globe
BCAL IS WORKING WITH CLINICIANS FROM LEADING CENTERS AROUND THE GLOBE Comprehensive Breast Centre Endeavor Health & Lakeview Private Hospital Dudley Private Hospital The Royal Melbourne Hospital US lab partner The Royal Women’s Hospital 1 site, Prospective Monash Health Peter MacCallum Cancer Centre
Slide 21: International Intellectual Property (IP) Protection
INTERNATIONAL INTELLECTUAL PROPERTY (IP) PROTECTION Issued* Granted as a method for detecting cancer Pending as a diagnostic signature InIn Progress as a diagnostic signature Progress Australian Provisional Patent Oct 31, 2023 Application No. 2023903491. 21
Slide 22: Clinical Advisory Board
Clinical Advisory Board Eminent and influential Breast Clinicians form a National Key Opinion Leader & Clinical Excellence Forum to enhance trust, provide advice and inform the BCAL program Dr David Prof Bruce Dr Corinne Ooi A/Prof. James Prof. Elisabeth Speakman Mann French Elder Former CMO at Pete
Slide 23: Clinical Advisory Board
Clinical Advisory Board A/Prof. Cindy Dr Samriti Sood A/Prof. Gillian Dr Mary Richard Dr Sally Baron- Mak Lamoury OAM Hay Leading Sydney based Sydney qualified and Specialist Oncoplastic Radiation Oncologist with a Radiologist with sub- Medical Oncologist with specialty in Breast cancer. trained Bre
Slide 24: Commercial Launch on Track for Late 2024
COMMERCIAL LAUNCH ON TRACK FOR LATE 2024 Commercial strategy to advance relationships with existing partners to launch BREASTEST in specialised clinics with first revenues to be delivered immediately following launch. MAY ’24 NOV ’24 AUG ’24 APR ’24 OCT ’24 DEC ‘24 JUN ’24 JAN ‘25 SEP ’24 JUL ’24 BR
Slide 25: Board of Directors
BOARD OF DIRECTORS Jayne Shaw Hon Ron Phillips AO Jonathan Trollip David Darling Mark Burrows AO EXECUTIVE NON-EXECUTIVE INDEPENDENT NON-EXECUTIVE INDEPENDENT NON-EXECUTIVE INDEPENDENT NON-EXECUTIVE CHAIR DIRECTOR DIRECTOR DIRECTOR DIRECTOR Successful businesswoman, Health policy expert, previously
Slide 26: Thank you
Thank you Jayne Shaw John Hurrell Executive Chair Chief Executive Officer jshaw@bcaldiagnostics.com jhurrell@bcaldiagnostics.com BCAL Diagnostics Limited ABN 51 142 051 223 Suite 506, Lvl 5, 50 Clarence Street Sydney NSW 2000 www.bcaldiagnostics.com 26
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