Bcal Diagnostics Limited · ASX:BDX
Bcal Diagnostics — Spark+ Australian Equities Day (September 2024)
24 slides from Bcal Diagnostics's conference presentation, September 2024
Slide 1: Spark+ Australian Equities Day Presentation
BCAL DIAGNOSTICS LIMITED ASX: BDX Spark+ Australian Equities Day Presentation DRIVING A NEW PARADIGM IN BREAST CANCER DIAGNOSTICS Executive Chair, Jayne Shaw September 2024 CORPORATE PRESENTATION
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 16 September 2024 $0.12 Shares on Issue 358.6M Unlisted Options 4.5M Cash 31 August 2024 $8.8M Top 20 Shareholders 52% CORPORATE PRESENTATION 3
Slide 4: A Lipid Blood Test with Automated Analysis
A LIPID BLOOD TEST WITH AUTOMATED ANALYSIS ~$300 Proposed cost of test to the } ALEARNING patient, following LIPIDOMIC PLATFORM THAT INCORPORATES AI MACHINE independent research and AND LEVERAGES ROBUST SCIENTIFIC RESEARCH focus group BREASTEST® AT COLLECTION CENTRE TRANSIT AT TESTING LABORATORY Log
Slide 5: Corporate Presentation
~~ DR DAVID SPEAKMAN SURGICAL ONCOLOGIST
Slide 6: A Global Commercial Opportunity
A GLOBAL COMMERCIAL OPPORTUNITY Breast cancer is the world’s most prevalent cancer in women { WCRFI 2.1 Million $2.3B On average Mammograms 13% 2023 to $6.9B 57 People in AUS in 2021 BSA of women in the 2033 are or will be diagnosed with US will develop breast cancer everyday an invasive form of bre
Slide 7: BREASTEST Will Be Used as a Screening Tool
BREASTEST® WILL BE USED AS A SCREENING TOOL SCREENING DIAGNOSTICS Contrast enhanced BREASTEST® Mammography Ultrasound 3D Mammography MRI mammography ▪ Simple blood test ▪ Painful procedure ▪ Used for mass/lesion ▪ Painful procedure ▪ Painful procedure ▪ High sensitivity differentiation, no ▪ Solves
Slide 8: Focus Market Segments
FOCUS MARKET SEGMENTS } FOUR INITIAL KEY TARGET SEGMENTS 1 } 2 } 3 } 4 Adjunct to current Dense breast tissue Those who are not Interval testing standard of care ~40% if women have dense or screened Phase 1 of launch; extremely dense breast tissue; 1.5 million people who; ▪ 8/10,000 women will prese
Slide 9: Regulatory Pathway to Commercialisation
REGULATORY PATHWAY TO COMMERCIALISATION SEPTEMBER 2024 DECEMBER 2024 Establish: “Medical Testing Laboratory” NATA is responsible for accrediting ISO 15189 Laboratory NATA laboratories that develop/manufacture In National Pathology Accreditation Advisory accreditation Vitro Diagnostics (IVDs) in-hous
Slide 10: Market Access: Australia Soft Launch
MARKET ACCESS: AUSTRALIA SOFT LAUNCH Launch of BREASTEST® in Australia late 2024 & first revenues 01 02 NSW & VIC launch Scale nationally • Initial focus on Sydney and Melbourne • Focus on raising awareness in CY2024 • Leveraging existing sample collection sites, prioritising • Nationwide market acc
Slide 11: BCAL Is Working with Clinicians from Leading Centres Around the Globe
BCAL IS WORKING WITH CLINICIANS FROM LEADING CENTRES AROUND THE GLOBE ▪ Lakeview Private Hospital ▪ Royal North Shore Hospital ▪ Dudley Private Hospital ▪ BreastScreen RPAH ▪ Westmead Breast Cancer Institute A pilot study assessing the feasibility of using the BCAL test for early diagnosis of breast
Slide 12: Australian Distribution Landscape
AUSTRALIAN DISTRIBUTION LANDSCAPE CORPORATE PRESENTATION 12
Slide 13: Comprehensive Education Program
COMPREHENSIVE EDUCATION PROGRAM Establish BREASTEST® as effective, best-in-class screening technology for breast cancer Lab diagnostics network Community Advocacy Referral network GPs Breast Surgeons /Pathology Digital market groups/ entry strategies • Social media • Continued support • Build a robu
Slide 14: US Operations Commenced
US OPERATIONS COMMENCED Laboratory •Established BCAL US subsidiary •Lease of US premises secured and key laboratory equipment purchased •The US program offers BCAL an opportunity to accelerate and validate new products on US patient centric data and gain an in-county understanding of the US diagnost
Slide 15: Publications and Manuscripts
PUBLICATIONS AND MANUSCRIPTS •Peer-reviewed publications are a crucial part of developing novel technologies like BREASTEST® •BCAL is working on multiple research articles detailing the discovery and development of BREASTEST® •The first original research paper is expected to be published in a respec
Slide 16: BREASTEST Has a Strong and Growing Intellectual Property Estate
BREASTEST® HAS A STRONG AND GROWING INTELLECTUAL PROPERTY ESTATES Expected Title IP covered Jurisdiction Status Patent number Priority date expiry date Methods for detecting cancer* Use of plasma lipids as a diagnostic method to detect breast and lung cancer AU (AU1) Granted AU Pat. No. 2011270968 2
Slide 17: Soft Commercial Launch on Track for Late 2024
SOFT COMMERCIAL LAUNCH ON TRACK FOR LATE 2024 } Commercial strategy to advance relationships with existing partners to launch BREASTEST in ® specialised clinics with first revenues expected to be delivered immediately following launch. MAY ’24 NOV ’24 AUG ’24 APR ’24 OCT ’24 DEC ‘24 JUN ’24 JAN ‘25
Slide 18: BCAL – Investment Highlights
BCAL – INVESTMENT HIGHLIGHTS ▪ NATA accreditation scheduled for September 2024, a key part of the inhouse IVD regulatory pathway ▪ Commencement of US operations in September 2024 BREASTEST® ▪ Soft commercial launch in Australia in late 2024 a blood test ▪ Commercial launch to initially leverage exis
Slide 19: Thank you
Thank you Jayne Shaw Shane Ryan Executive Chair Chief Executive Officer jshaw@bcaldiagnostics.com sryan@bcaldiagnostics.com DRIVING A NEW PARADIGM IN BREAST CANCER DIAGNOSTICS BCAL Diagnostics Limited ABN 51 142 051 223 Suite 506, Lvl 5, 50 Clarence Street Sydney NSW 2000 CORPORATE PRESENTATION 19 w
Slide 20: Appendix
APPENDIX CORPORATE PRESENTATION 20
Slide 21: Financial Year 2024 Highlights
FINANCIAL YEAR 2024 HIGHLIGHTS Scientific progress ▪ Completed a clinical study in collaboration with Precion Inc of North Carolina (USA). The study included a total of 656 samples, being 390 breast cancer patients and 266 healthy controls and achieved a sensitivity of 90% and a specificity of 85.5%
Slide 22: Financial Year 2024 Highlights
FINANCIAL YEAR 2024 HIGHLIGHTS Intellectual property • The Company’s IP portfolio continues to grow, with several patents and trademarks progressing through to grant and registration in a number of targeted jurisdiction. A European patent was granted, increasing the number of patents granted to eigh
Slide 23: Highly Experienced Board and Management
HIGHLY EXPERIENCED BOARD AND MANAGEMENT Jayne Shaw Hon Ron Phillips AO Mark Burrows AO Jonathan Trollip Dr. John Hurrell PhD Dr David Darling Executive Chair Non-executive Director Independent Independent Independent Non-Executive Director Successful businesswoman, Health policy expert, previously N
Slide 24: Clinic Advisory Board
CLINIC 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 Speakman Prof Bruce Mann Dr Corinne Ooi A/Prof. James French Prof. Elisabeth Elder Chief Medical Offi
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