Bcal Diagnostics Limited · ASX:BDX
Bcal Diagnostics — Corporate Update (August 2023)
27 slides from Bcal Diagnostics's corporate update, Aug 8, 2023
Slide 1: BCAL Diagnostics Investor Education Update and Webinar
ASX Announcement 8 August 2023 BCAL Diagnostics Investor Education Update and Webinar BCAL Diagnostics Limited (“BCAL” or “the Company”) (ASX: BDX) is pleased to attach an investor eduction update . BCAL will host a webinar today, please see details below. Investor Webinar Details BCAL will be hosti
Slide 2: About BCAL Diagnostics
About BCAL Diagnostics BCAL Diagnostics Limited is an Australian screening and diagnostic company committed to the early, accurate diagnosis of breast cancer, and therefore early intervention and improved outcomes for women. Over the past decade BCAL has developed a non-invasive blood test for the d
Slide 3: A revolution for breast cancer detection and management
A revolution for breast cancer detection and management. BCAL has developed and is commercialising a novel proprietary test to enable more effective detection and management of breast cancer.
Slide 4: 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 Not An Offer Ltd ABN 51 142 051 223 (BCAL or the Company). BCAL as at the date of this Presentation. Circumstances may change an
Slide 5: Company Metrics
Company Metrics ASX Code BDX 7.00mm Share Price $0.145 6.00mm 0.14 7 August 2023 5.00mm 0.12 Shares on Issue 211.4M 4.00mm 0.10 3.00mm Unlisted Options 11.5M 2.00mm 0.08 0.06 Cash $3.2M 1.00mm 30 June 2023 0 0.04 Top 20 Shareholders 66.6% BDX Volume BDX Share Price BC AL D I A G N O S T I C S LIMITE
Slide 6: Our Mission
Our Mission Our Mission To deliver global customers an effective, best-in-class, breast cancer detection and rule-out test, benefiting physicians and patients alike. A paradigm shift for managing and caring for breast cancer. BC AL D I A G N O S T I C S LIMITE D 04
Slide 7: Executive Summary
Executive Summary BC AL D I A G N O S T I C S LIMITE D 05
Slide 8: BCAL is a cancer diagnostics company providing proprietary detection and rule-out tests
BCAL is a cancer diagnostics company providing physician customers with proprietary detection and rule-out tests for BREASTESTTM is uniquely positioned to breast cancer (BREASTESTTM) address the unmet need for a more effective, patient friendly and accurate test for the early detection of breast can
Slide 9: BCAL recently announced outstanding results from a clinical study
BCAL has recently received outstanding results from a clinical study it sponsored with Precion Inc. The results show that BREASTESTTM can be replicated using standard equipment used in commercial laboratories throughout the world. These results confirm the impressive sensitivity of 90% and specifici
Slide 10: BREASTEST outperforms mammography
BREASTEST™ outperforms mammography Samples analysed by BCAL in Sydney on an OrbiTrap LC/MS Instrument Samples analysed by Precion in USA on a Triple Quad LC/MS Instrument 1 0. 9 Sydney 0. Precion Study 8 Study 0. 7 353 Cancer patients 0. 6 390 Cancer patients 268 Negative patients 0. 266 Negative pa
Slide 11: The compelling global opportunity that we address
The compelling global opportunity that we address 1 in 7 women in Australia Breast cancer is the second leading cause of cancer death will receive a breast cancer diagnosis during their lifetime. in the US after lung cancer. Breast cancer is the most common cancer in women 1 in 39 women currently di
Slide 12: Limitations of mammography
Limitations of mammography Prone to self-exclusion painful, Not definitive uncomfortable, cultural 20% of breast cancers reasons. are missed – false negatives. Most effective above 50 y/o due Limited to breast density accuracy and fatty tissue prone to false positives. Limited remote Guidelines limi
Slide 13: BREASTEST outperforms existing standards of care
BREASTESTTM outperforms existing standards of care There is currently no completely effective detection or rule out test available for breast cancer . 94.6% 74.2% 54.5% 85.5% 67.2% 76.8% 90 .5% 52.6% 90% 85.5% MRI M a m m o g r a ph y Ultrasound C o n t r a s t - e nha nce d BR E ASTE ST™ mammograph
Slide 14: An effective and accurate blood test should increase the screening detection rate
“ An effective and accurate blood test should increase the screening detection rate and reduce mortality “ Dr Gillian Lamoury, Radiation Oncologist, Sydney, in a paper presented at ASCO 2023: Lipidomic signature from plasma to detect localised breast cancer BC AL D I A G N O S T I C S LIMITE D 12
Slide 15: Commercialisation of BREASTEST on track for 2HCY24
Commercialisation of BREASTESTTM on track for 2HCY24 14 years of development IPO in 2021 raised funds to accelerate development BCAL commenced operating in 2009. BCAL has met prospectus forecasts in developing BREASTESTTM. Over 2,000 independent patient and control samples tested Uses liquid chromat
Slide 16: Executive Team - Australia
Board of Directors Jayne Shaw 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 Successful businesswoman, entrepreneur and Health poli
Slide 17: Clinical and Scientific advisors - Australia; Key People - USA
Key People - USA Advisor Dr. John Hurrell, PhD Dr. Kim Ekroos, PhD Dr. David Peake, PhD Dr. Raji Pillai, PhD David Darling Chief Executive Officer Scientific Advisor Scientific Lead, Technology Transfer Regulatory Consultant Consultant More than 35 years' experience in life sciences Founder and CEO
Slide 18: The greatest challenges in detecting and managing breast cancer in young women
“ The greatest challenges in detecting and managing breast cancer in young women are: 1. There are no effective breast screening options available for young women. 2. There is no complementary technology OR education alternatives for breast screening or testing for young women. Therefore, the probab
Slide 19: Intended use at launch: high-risk patients
Intended use at launch: BREASTEST™ will have a significant impact on these high-risk patients Patients with abnormal High risk dense breast Patients with known genetic mammograms requiring population. risk of breast cancer. further investigation. Half of women aged below 50 have BREASTEST™ could all
Slide 20: Long term intended use objectives
Long term intended use objectives BREASTESTTM targeting large and diverse groups of at-risk patients 1 Patients who do not currently get screened. 2 Patients with abnormal mammography findings. It is estimated that up to 90% of patients with initial abnormal mammography findings are ultimately class
Slide 21: BCAL's state-of-the-art lipid test
BCAL’s state-of-the-art lipid test BREASTESTTM with automated analysis BREASTEST™ At collection centre Transit At testing laboratory Plasma Erythrocytes Whole Blood Blood Pre-processing: sample Sample preparation: Sample Analysis: Extracts Data analysis for collection spin, separate and freeze plasm
Slide 22: Discovery pipeline: using AI/machine learning techniques to develop diagnostic algorithms
Discovery pipeline: using AI/machine learning techniques to develop diagnostic algorithms Unseen samples Test set Lipids or Variables Validation : Train/Tes ☐ Accuracy t split ☐ Sensitivity ☐ Specificity ☐ Robustness Samples Lipid signatures Model Trainin Panel Predictive g set identification modell
Slide 23: BCAL's clinical evidence development for key breast cancer types
BCAL’s clinical evidence development for key breast cancer types Cohort Cohort Cohort Cohort 1 2 3 4 N = 88 N =200 N =201 N =301 IDC IDC IDC D C I S ( S t age s 0 ) ( Stages 1 - 4 ) ( Stages 1 -2) ( Stages 1 -2) I DC ( L a te St a g e s) I LC ( Ea r l y St a g e s) Control IDC DCIS ILC IDC: Invasive
Slide 24: Journey to commercial launch and revenue
Journey Journey to to Commercial commercial launchLaunch and Revenue and revenue Analytical validation studies > Development of future products Commercial infrastructure development > Health outcome studies > Biomarkers locked down Australian Intended LDT Australia use defined Development and Clinic
Slide 25: Commercial market launch in Australia is on-track for 2024
Commercial market launch in Australia is on-track for 2024 BREASTEST™ commercialisation pathway will include Medicare reimbursement in Australia (we expect soon after launch), out-of-pocket payment in New Zealand. The USA is Medicare (USA) for all patients over 65 years, private payer insurance for
Slide 26: BREASTEST has strong and growing Intellectual Property Protection
BREASTEST™ has strong and growing Intellectual Property Protection Issued * Pending* In Progress 20 24
Slide 27: Thank You
Thank You info@bcaldiagnostics.com t +61 (0) 407 983 270 Suite 506, Lvl 5, 50 Clarence Street, Sydney NSW 2000 www.bcaldiagnostics.com