Bcal Diagnostics Limited · ASX:BDX
Bcal Diagnostics — Investor Presentation (March 2025)
32 slides from Bcal Diagnostics's investor presentation, Mar 24, 2025
Slide 1: Investor Presentation Singapore & Hong Kong
INVESTOR PRESENTATION Singapore & Hong Kong ADVANCING BREAST CANCER SCREENING WITH A NON-INVASIVE BLOOD TEST JAYNE SHAW I Executive Chair & Co-Founder SHANE RYAN I Chief Executive Officer 24 - 27 MARCH 2025
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: Company Metrics
COMPANY METRICS ASX Code BDX Share Price $0.098 21 Mar 2025 Shares on Issue 365.9M Unlisted Options 4.5M Cash $7.0M 31 December 2024 Top 20 Shareholders 52% 3
Slide 4: Agenda
AGENDA 5 Introducing BREASTEST plus 9 Addressing An Unmet Need 16 Company Overview 22 Experienced Team 4
Slide 5: Introducing BREASTEST plus
INTRODUCING BREASTEST plus ADVANCING BREAST CANCER SCREENING WITH A NON-INVASIVE BLOOD TEST
Slide 6: BREASTEST plus - Early Detection Non-Invasive Blood Test
BREASTEST plus - EARLY DETECTION NON-INVASIVE BLOOD TEST BCAL Diagnostics is an Australian and US-based biotechnology company dedicated to advancing early and accurate breast cancer detection Our Mission: For over a decade, BCAL has been committed to developing innovative, accessible technologies th
Slide 7: BREASTEST plus and imaging for comprehensive screening
BREASTEST plus TM A blood test to complement breast imaging results and rule out the presence of breast cancer TM BREASTEST plus Mammography icon set Mammogram stock vector & Clinical Examination, and imaging for comprehensive + Family History & Other Risk Factors screening TM BREASTEST plus IS THE
Slide 8: BREASTEST plus Test Performance
BREASTEST plus TEST PERFORMANCE BREASTEST plusTM is an ideal precision medicine test to complement breast imaging procedures and clinical factors to confidently rule-out breast cancers in women with a higher breast density BREASTEST plusTM performance in intended population category D SENSITIVITY SP
Slide 9: Addressing An Unmet Need
ADDRESSING AN UNMET NEED ADVANCING BREAST CANCER SCREENING WITH A NON-INVASIVE BLOOD TEST
Slide 10: Rising Global Incidence of Breast Cancer
RISING GLOBAL INCIDENCE OF BREAST CANCER 60% OF GLOBAL BREAST CANCER DEATHS OCCUR IN ECONOMICALLY UNITED STATES DEVELOPING COUNTRIES GLOBAL 317,0001 42,9002 ANNUAL ANNUAL 2.3m3 685,0003 NEW CASES DEATHS ANNUAL ANNUAL 1 in 8 NEW CASES DEATHS 40 MILLION SCREENING BREAST CANCER IN WOMEN HONG KONG MAMMO
Slide 11: Early Diagnosis Saves Lives
EARLY DIAGNOSIS SAVES LIVES AND COSTS TO THE HEALTHCARE SYSTEM Breast Cancer Stages BCAL is focused on improving the outcomes for women with breast cancer STAGE 0 STAGE 1 STAGE 2 STAGE 3 STAGE 4 28% 100% 98% 93% SURVIVAL SURVIVAL SURVIVAL SURVIVAL 72% RATE RATE RATE RATE SURVIVAL RATE $16,390 $44,36
Slide 12: Breast Density's Impact on Mammogram Accuracy
BREAST DENSITY'S IMPACT ON MAMMOGRAM ACCURACY A mammogram is required to assess breast density Breast density refers to white regions on a mammogram which contain fibroglandular tissue. Dense breasts can obscure cancer detection Women with dense breasts are 4—5x more likely to develop breast cancer
Slide 13: Unmet Need in Current Breast Imaging
UNMET NEED IN CURRENT BREAST IMAGING Mammography sensitivity1 drops from: 90% to 64% In low density breasts In high density breasts Millions of women face: • Fear of missed cancers • Unnecessary stress & procedures from false positives • Significant healthcare costs without better imaging solutions
Slide 14: The Current Australian Screening Landscape
THE CURRENT AUSTRALIAN SCREENING LANDSCAPE 1/200 women that screen have breast cancer… …yet up to 10% of Balancing cancer women will undergo detection & further investigation unnecessary investigation is an ongoing challenge <50yr ~1.8M ~50% 2 3 21,000 1 Limited guidance or tools 2D mammograms are o
Slide 15: Exciting Future for R&D at BCAL Diagnostics
Imaging Potential strategic Tissue partner EXCITING FUTURE FOR R&D AT BCAL DIAGNOSTICS Blood BCAL opportunity Therapy selection Therapy selection Treatment Tumour burden response Diagnosis Recurrence Relapse MRD Patient journey Screening Prognosis Post-therapy Surveillance / recurrence Metastatic th
Slide 16: Company Overview
COMPANY OVERVIEW ADVANCING BREAST CANCER SCREENING WITH A NON-INVASIVE BLOOD TEST
Slide 17: Development Path to Date
DEVELOPMENT PATH TO DATE CLINICAL IN VITRO PROOF OF CONCEPT STUDIES COHORT TESTING AUSTRALIAN CLINICAL STUDIES PRECION STUDIES STUDIES 2010-2013 2013-2017 2017-2021 2021-2024 2022-2023 Completed invitro “Proof of concept” studies Completed studies whose results showed Australian clinical studies Bre
Slide 18: Detecting Lipid Signatures in Breast Cancer
DETECTING LIPID SIGNATURES IN BREAST CANCER 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 BCAL has
Slide 19: A Lipid Blood Test with Automated Analysis
A LIPID BLOOD TEST WITH AUTOMATED ANALYSIS A LIPIDOMIC PLATFORM THAT INCORPORATES AI MACHINE LEARNING AND LEVERAGES ROBUST SCIENTIFIC RESEARCH BREASTEST plus * with mammogram to rule out breast cancer Logistics & processing AT COLLECTION CENTRE TRANSIT AT TESTING LABORATORY scaling confirmed Plasma
Slide 20: BREASTEST plus Complements Mammogram
BREASTEST plusTM COMPLEMENTS MAMMOGRAM SCREENING DIAGNOSTICS Contrast enhanced BREASTEST plus Mammography Ultrasound 3D Mammography MRI Needle Biopsy mammography Simple blood test to rule Effective for early breast Used for mass/lesion Clearer images than 2D Improved sensitivity – High sensitivity T
Slide 21: BREASTEST plus Market Rollout
BREASTEST plusTM MARKET ROLLOUT FOUR INITIAL KEY TARGET SEGMENTS Adjunct to current standard of care Dense breast tissue Those who are not screened Interval testing Phase 1 of BCAL launch; ~ 50% of women have dense or 1.5 million people who; ▪ 8/10,000 women will present with a ▪ Working with existi
Slide 22: Highly Experienced Leadership Team
HIGHLY EXPERIENCED LEADERSHIP TEAM WITH COMMERCIAL EXPERTISE TO DRIVE LAUNCH Shane Ryan MBA Dr David Speakman Kim Kirkham Dr Simon Preston PhD Dr Klaus-Peter Adam Chief Executive Officer Medical Laboratory Director & Chair National Clinical Program Director Director Clinical Research Director of US
Slide 23: Clinic Advisory Board
CLINIC ADVISORY BOARD EMINENT AND INFLUENTIAL BREAST CLINICIANS FORM A BREAST CANCER CLINICAL ADVISORY BOARD TO ENHANCE TRUST, PROVIDE ADVICE AND INFORM THE BCAL PROGRAM Dr David Speakman Prof Bruce Mann Dr Corinne Ooi A/Prof. James French Prof. Elisabeth Elder Former Chief Medical Director of Breas
Slide 24: Working with Clinicians from Leading Centres Around the Globe
WORKING WITH CLINICIANS FROM LEADING CENTRES AROUND THE GLOBE BUILDING FOUNDATION FOR SUCCESS IN THE USA INC. MORE THAN 4 MILLION WOMEN IN THE US ARE LIVING WITH BREAST CANCER AND MORE THAN A QUARTER OF A MILLION WOMEN REQUIRE ONGOING IN AUS ARE LIVING WITH BREAST CANCER AND SCREENING1 A pilot study
Slide 25: Scientific Research & BREASTEST plus Development
SCIENTIFIC RESEARCH & BREASTEST plusTM DEVELOPMENT VERIFICATION VALIDATION Verification of signature Analytical Method Validation EARLY DISCOVERY LATE DISCOVERY Optimised method Algorithm Validation 20 lipids > 7 Clinical Validation Self-funded private company 454 lipid species annotated Early R&D o
Slide 26: Strong IP Portfolio
STRONG IP PORTFOLIO IN-LICENSED BCAL DEVELOPED AND OWNED Expected Expected Title Jurisdiction Status Patent number expiry Title Jurisdiction Status Patent number expiry date date Methods for detecting cancer* AU Granted AU Pat. No. 2011270968 22 June 2031 Diagnostic signature AU Granted 2023258393 1
Slide 27: Rising Global Incidence Driving Diagnostics
RISING GLOBAL INCIDENCE DRIVING DIAGNOSTICS 2.3 MILLION NEW CASES ANNUALLY - 12% OF ALL NEW CANCER CASES Expected to pass 3 million new cases and 1 million deaths by 2040 Global Breast Cancer Diagnostics Market5 BCAL laboratory 45 USD (bn) UNITED STATES and collections 40 317,0001 42,9002 sites esta
Slide 28: Commercial Pathway
COMMERCIAL PATHWAY 01 Australian Launch & US Foundation ▪ Launch of BREASTEST plus in March 2025 in AUS – initially at A 3-YEAR ROADMAP TO IMPROVING OUTCOMES FOR WOMEN Sydney Breast Clinic - NSW & VIC clinician sites to follow UNDERPINNED BY A REPRODUCIBLE ▪ Accelerate awareness with Breast Surgeons
Slide 29: Delivering Our Strategic Objectives
DELIVERING OUR STRATEGIC OBJECTIVES NOV 24 OCT 24 MAY 23 MAR 25 MAY 25 DEC 24 SEP 24 APR 25 JAN 25 JUN 25 FEB 25 Opened North Ryde, NSW Australia Laboratory Opened US operations including US Research Lab BCAL signs agreements to collect patient samples with two healthcare providers in USA Executed c
Slide 30: Commercial Strategy FY25/26
COMMERCIAL STRATEGY FY25/26 BREASTEST plusTM SUPPLEMENTS MAMMOGRAPHY AS A RULE OUT TEST FOR BREAST CANCER Q1 2025 Q2 2025 1H FY26 MILESTONE JAN - MAR APR - JUN JUL - DEC IMPACT Initial market entry, real-world validation, and BREASTEST plusTM launch at Sydney Breast Clinic first revenues Expansion o
Slide 31: Investment Highlights
INVESTMENT HIGHLIGHTS ▪ Breakthrough Blood Test Technology – A first-in-class blood test* used in breast cancer detection as adjunct to mammogram ▪ BREASTEST plus TM Launched – In market at Sydney Breast Clinic available to eligible patients 18 and over, with a focused rollout in NSW & VIC to follow
Slide 32: Thank You
THANK YOU Jayne Shaw Shane Ryan Executive Chair Chief Executive Officer jshaw@bcaldiagnostics.com sryan@bcaldiagnostics.com Want To Learn More? info@bcaldiagnostics.com Investor & Media Enquiries www.bcaldiagnostics.com Tanya Thomas Director Investor Relations & Communications Tthomas@bcaldiagnostic
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