Bcal Diagnostics Limited · ASX:BDX
Bcal Diagnostics — Investor Presentation (August 2023)
32 slides from Bcal Diagnostics's investor presentation, August 2023
Slide 1: A revolution for breast cancer detection and management
A revolution for breast cancer detection and management. BCAL has dev eloped and is commercialising a no vel proprietary test to enable more effective detection and management of breast cancer.
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 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 3: Company Metrics
Company Metrics ASX Code BDX 7.00mm 0.16 Share Price $0.115 6.00mm 0.14 23 August 2023 5.00mm Shares on Issue 0.12 213.2M 4.00mm Pre-Offer 0.10 Unlisted Options 9.2M 3.00mm Performance Rights 8.3M 0.08 2.00mm Cash $3.2M* 1.00mm 0.06 30 June 2023 0 0.04 Top 20 Shareholders 66.6% * Excludes ~$2.5m R&D
Slide 4: 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 ST IC S LI MIT ED 04
Slide 5: Executive Summary
Executive Summary BC AL D I A G N O ST IC S LI MIT ED 05
Slide 6: 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 7: 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 8: 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 9: The compelling global opportunity that we address
The compelling global opportunity that we address 1 in 7women 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 die
Slide 10: 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 11: 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 Mam m og rap hy Ul tr as ound C o n t r a s t - en hanc ed B RE AS TES T™ m a m m ogra
Slide 12: 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 ST IC S LI MIT ED 12
Slide 13: 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 14: Board of Directors and 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 15: Key People - USA and Clinical and Scientific advisors
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 Founder and CEO of Lipido
Slide 16: 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 17: Intended use at launch
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 18: 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 19: BCAL's state-of-the-art lipid test BREASTEST with automated analysis
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 20: Discovery pipeline: using AI/machine learning to develop diagnostic algorithms
Discovery pipeline: using AI/machine learning techniques to develop diagnostic algorithms Unseen samples Test set Lipids or Variables Validation: Train/Test ☐ Accuracy split ☐ Sensitivity ☐ Specificity ☐ Robustness Samples Lipid signatures Model Training Panel Predictive set identification modelling
Slide 21: BCAL's clinical evidence development for key breast cancer types
BCAL’s clinical evidence development for key breast cancer types Cohort 1 Cohort 2 Cohort 3 Cohort 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 ( Lat e St a ges) I LC ( E arl y S t a ges) Control IDC DCIS ILC IDC: Invasive Ductal
Slide 22: Journey to Commercial Launch and Revenue
Journey Legal to Commercial Launch and Revenue statement BCAL intends to commercialise the Test and supply it as an in-house test once its laboratory has been accredited by the National Association of Testing Authorities (NATA) to perform the Test. NATA is the recognised national accreditation autho
Slide 23: Journey to Commercial Launch and Revenue
Journey Journey to Commercial to commercial Launch launch and revenue and Revenue BC AL D I A G N O ST IC S LI MIT ED 23
Slide 24: 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 25: BREASTEST has strong and growing Intellectual Property Protection
BREASTEST™ has strong and growing Intellectual Property Protection Issued * Pending* In Progress 20 25
Slide 26: The Offer Overview
Offer Overview The Offer BC AL D I A G NO S T I CS LI M I TE D 26 BC AL D I A G NO S T I CS LI M I TE D
Slide 27: Investment Opportunity
Investment Opportunity Raising AU$2.5 million for product development and to launch BREASTEST™ initially in Australia and New Zealand AU$ Physicians and cancer patients are highly-motivated to find detection and rule-out tests for small breast tumours and to create tests that provides simple and eas
Slide 28: Capital Raising Structure
Capital Raising Structure Placement to sophisticated and professional investors to raise gross proceeds of approximately $2.0 million of new ordinary shares (“New Shares”) under the company’s existing placement capacity per LR 7.1 & 7.1A (“Placement”). Offer size and structure In conjunction with th
Slide 29: Indicative Timetable
Indicative Timetable Summary of Key Dates Date Trading Halt and Placement bookbuild Thursday, 24 August 2023 SPP Record Date Friday, 25 August 2023 Company Announcement & Trading Halt lifted Monday, 28 August 2023 Despatch of SPP offer booklet & SPP opens Wednesday, 30 August 2023 Settlement of New
Slide 30: Key Risks
Key Risks This section contains some key risks associated with an investment in the Company. BCAL’s business is subject to several risk factors, both specific to its business and of a general nature which may impact on its future performance and forecasts. This is not an exhaustive list of relevant
Slide 31: Key Risks (continued)
Key Risks (continued) The intended use of BREASTTESTTM as a diagnostic tool in Australia requires approval from the TGA as a Class III device for an IVD. The No regulatory approval company is working closely with expert professional lawyers and taking all measures it can to maximise the chances of o
Slide 32: 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
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