Slide 1: The future of lung health
The future of lung health 4DMedical Limited (ASX:4DX) Capital Raising Presentation 8 May 2023 Andreas Fouras CEO & Managing Director 4DMedical Limited ABN 31 161 684 831 1
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by 4DMedical Limited (ABN 31 161 684 831) (Company or 4DMedical) in connection with an offer of new ordinary shares and options in the Company (New Securities) by way of a placement to sophisticated and professional investors and a securities purchase p
Slide 3: Disclaimer
Disclaimer Forward looking statements This presentation may contain forward-looking statements regarding the Company’s intent, belief or current expectations with respect to its business and operations, market conditions, results of operations and financial conditions. Words such as ‘will’, ‘may’, ‘
Slide 4: Disclaimer: International Offer Restrictions
Disclaimer International Offer Restrictions This document does not constitute an offer of New Securities in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares e may not be offered or sold, in any country outside Austr
Slide 5: Executive Summary
Executive Summary • Receipts of $1.2m last quarter, up 67% QoQ • 5-year commercial contract signed with University of Miami for provision of XV Technology® – first hospital-based SaaS contract establishing a framework in the US Significant momentum in • Successful completion of first commercial scan
Slide 6: Commercialisation strategy: U.S. Department of Defense
Commercialisation strategy: U.S. Department of Defense Department of Defense; Military Health System About the Department of Defense What does it mean for 4DMedical? ➢ The Military Health System (MHS) within the ➢ Represents another significant milestone in Department of Defense is one of the larges
Slide 7: Corporate Overview: 4DX Share Price Performance
Corporate Overview 4DX Share Price Performance – Last 12 Months Share price chart at 3 May 2023 Trading Information 52 week high A$1.16 1.6 8,000,000 52 week low A$0.29 1.4 Number of shares 295.0M 7,000,000 1.2 Market capitalisation (3 May 2023) A$334.8M 6,000,000 Avg. daily volume (last 1 month) 2.
Slide 8: Introduction to 4DMedical
4DMedical Limited (ASX:4DX) Introduction to 4DMedical ➢ Who is 4DMedical: ▪ Software technology company commercializing its patented imaging platform, XV Technology® ▪ Utilizes proven, patented mathematic models and algorithms to convert lung scans into quantitative data ▪ Allows physicians to diagn
Slide 9: 4DMedical's technology advantage: XV lung ventilation analysis software
4DMedical’s technology advantage XV lung ventilation analysis software Respiratory cycle 9
Slide 10: 4DMedical's technology advantage
4DMedical’s technology advantage Our technology includes the advantages of existing modalities in a single platform Functional insight Comparable High-detail of spirometry radiation dose resolution at a regional level to X-ray of a CT scan Improved Faster, more efficient Competitive pricing clinical
Slide 11: Accelerating the commercialisation of our patented software products
4DMedical Limited (ASX:4DX) Accelerating the commercialisation of our patented software products 4DMedical Current product XV LVAS® CT LVAS™ CT:VQ Currently in software offering release (ventilation) (ventilation) (ventilation / perfusion) development Image acquisition modality X-ray XV Scanner CT (
Slide 12: Building a Software as a Service (SaaS) revenue model
Significant momentum in commercialisation Building a Software as a Service (SaaS) revenue model 4DMedical is making significant progress in executing on its commercialisation strategy ➢ Commercialisation underway in Australia with I-MED, largest radiology network in Australia ➢ Granted CPT Category
Slide 13: US SaaS commences with successful contract conversion with clinical trial partner
Commercialisation strategy: USA US SaaS commences with successful contract conversion with clinical trial partner Commercial contract signed with University of Miami ➢ On 5 April 2023, 4DMedical announced signing of a five-year contract with the University of Miami to provide XV Technology® ➢ Profes
Slide 14: Market opportunity
Market opportunity Capturing the USD $31.3b global market opportunity The global respiratory diagnostic market represents ~USD $31.3b1 per annum opportunity ➢ Approximately 378m respiratory diagnostic tests are performed per annum globally ➢ Existing lung diagnostics are decades out of date, not fit
Slide 15: Market opportunity
Market opportunity The demand for sophisticated respiratory diagnostics solutions is growing Expenditure (B) 17.5 Market opportunity by country1 Country Spend (USD) Procedures 15.0 US 13,716M 73.5M Others 4,964M 59.8M 12.5 Germany 2,678M 20.3M Computed Tomography (CT) X-ray Technology Japan 1,905M 2
Slide 16: US market opportunity – Veterans Affairs
US market opportunity – Veterans Affairs Meeting demand for expanding US health care for Veterans The US PACT Act represents USD $280b in additional funding over ten years for affected Veterans and was signed in August 2022 ➢ 3.5m US troops have been exposed to toxic burn pits since 1991 ➢ Recogniti
Slide 17: Commercialisation strategy
Commercialisation strategy Commercialisation driven by clinical utilization demonstrating medical necessity Clinical trials Commercial pilots Long term agreements Validating efficacy and utility Generating clinical use case Sustainable revenue generation Physicians gaining familiarity with Long term
Slide 18: Publication of clinical trials critical to reimbursement and commercialisation
Commercialisation strategy Publication of clinical trials critical to reimbursement and commercialisation BLVR Asthma Paediatric CF Lung Transplant ILD-WLL University of Miami Cleveland Clinic Johns Hopkins Alfred Hospital, Melbourne Prince Charles Hospital XV LVAS® XV LVAS® XV LVAS® XV LVAS® XV LVA
Slide 19: Commercialisation strategy: U.S.
Commercialisation strategy: U.S. Progress to reimbursement and long term agreements well advanced Commercial pilots State of play 2023 – 2024 Objectives Generating clinical use case ➢ Clinical trials and studies conducted across more ➢ CPT Category III code to go live July 2023 than eight leading in
Slide 20: Commercialisation strategy: Australia
Commercialisation strategy: Australia AU SaaS model gaining momentum with successful rollout State of play 2023 – 2024 Objectives ➢ XV Technology® rollout to 27 I-MED ➢ Continuing rollout of CT LVAS™ to I- sites MED, leveraging Australia’s high penetration of CT scanners Australia ➢ Launched CT LVAS
Slide 21: XV Scanner strategic rationale
Commercialisation strategy: Australia XV Scanner strategic rationale What is the XV Scanner? Strategic rationale ➢ World’s first dedicated lung scanner, enabled by Supports broader commercialisation efforts of $28.9m MRFF investment, now entering early-stage 4DMedical’s XV Technology® software, name
Slide 22: Significant progress in commercialisation of XV Scanner
Commercialisation strategy: Australia Significant progress in commercialisation of XV Scanner State of play 2023 – 2024 Objectives ➢ Delivered on project milestones and ➢ Seeking regulatory approval in US ensure receipt of funding of $9.5m in November 2022 ➢ Extend commercialisation opportunities in
Slide 23: Board of directors
Board of directors The Board has the right mix of medical and commercial sector experience Key Advisors Dr SAM HUPERT MBBS Advisory Board Member Co-founder and Chief Executive Officer of Pro Medicus Ltd (PME.ASX) which develops and markets health imaging software primarily for radiologists in the U.
Slide 24: Executive team
Executive team An Executive Team with the right skills and experience to commercialise 4DMedical Dr ANDREAS FOURAS PhD RACHAEL TENKATEN Dr AIDAN JAMISON PhD NICHOLE MURRAY CEO Chief of Staff Senior Vice President Engineering Vice President Regulatory Affairs & Quality Award-winning aerospace enginee
Slide 25: Details of the Offer
Details of the Offer 4DMedical is raising up to ~A$35m via a Placement of ~A$20m and a A$15m Share Purchase Plan • A placement to sophisticated and professional investors of ~$20m, comprising: Placement • The issue of approximately 22 million new, ordinary fully paid 4DMedical shares (New Shares) un
Slide 26: Indicative Timetable
Indicative Timetable Indicative capital raising timetable Trading halt Thursday, 4 May 2023 Record Date for the SPP 7.00pm Friday, 5 May 2023 Capital raising announced and trading halt lifted Monday, 8 May 2023 Lodgement of Prospectus for Placement and SPP Wednesday, 10 May 2023 SPP opens Wednesday,
Slide 27: Use of Funds
Use of Funds Capital Raising Use of Funds Amount Funds Required Sources of Funds Use of Funds Description ($M AUD) ($M AUD) Funding required for driving advocacy and Cash Position (31 Mar 23) $36.8m VA Commercialisation $3.7m engagement with KOL and industry Expansion of US GTM and Expansion of cust
Slide 28: Key Risks
Key Risks * The following summary is not intended to be an exhaustive list of the risk factors to which 4DMedical is exposed. The Directors consider that, on receipt of funds from the Placement and SPP, 4DMedical will have sufficient working capital to carry out its objectives. However, financial re
Slide 29: Key Risks
Key Risks The successful operation of 4DMedical in part relies on 4DMedical’s ability to retain its existing key management personnel who have intimate knowledge of Key personnel risk the business and its products. The loss of any key members of management, or the inability to attract additional ski
Slide 30: Key Risks
Key Risks 4DMedical’s business There is a risk that 4DMedical may fail to achieve commercialisation and distribution goals. 4DMedical technology needs to find acceptance in a competitive may not achieve its market. Market acceptance depends on numerous factors (including convincing current and poten
Slide 31: The future of lung health
The future of lung health 4DMedical Limited (ASX:4DX) Investor Presentation 8 May 2023 4DMedical Limited (ASX:4DX) Julian Sutton Non-Executive Director jsutton@4dmedical.com Investor Relations The Capital Network Julia Maguire +61 2 8999 3699 julia@thecapitalnetwork.com.au Copyright ©4DMedical Limit
Slide 32: Commercialisation
Commercialisation 4D lung ventilation analysis 32
Slide 33: VA opportunity progressing from clinical trial to commercial pilot
Commercialisation strategy: US Veterans Affairs VA opportunity progressing from clinical trial to commercial pilot State of play 2023 – 2024 Objectives ➢ Mechanism for reimbursement established ➢ Connecting with VA IT infrastructure – ➢ Commenced engagement with US legislators obtaining ‘Authorizati
Slide 34: Technology
Technology 4D lung ventilation analysis 34
Slide 35: Accelerating Progress
4DMedical Limited (ASX:4DX) Accelerating Progress Clinical Trials >> Advocacy >> Commercial Pilots >> Long term commercial agreements ➢ Significant investment in trials ➢ PACT Act passed into law - including ➢ Generating clinical use cases and across leading institutions such as $280b for US Veteran
Slide 36: Demonstrating clinical application
Demonstrating clinical application Use case scenarios 36
Slide 37: Reliability and repeatability
Demonstrating clinical application Reliability and repeatability Subject Baseline ➢ Age: 30s; Sex: Male Indications ➢ Healthy male with no signs of disease Summary TV VH VDP ➢ XV LVAS® validated assessment of regional lung function 0.77 44.5 13.8 Follow-up scan (3 months post baseline scan) ➢ 0XV Te
Slide 38: Silicosis
Demonstrating clinical application Silicosis Subject Baseline ➢ Age: 36; Sex: Male Indications ➢ Novel treatment for a Severe Progressive Silicosis related Occupational Lung Disease Summary ➢ At baseline, there are advanced changes of chronic, complicated silicosis as marked by TV VH VDP nodular coa
Slide 39: COPD
Demonstrating clinical application COPD Subject ➢ Age: 60; Sex: Male Indications ➢ Prior biologics therapeutic for re-current exacerbation of moderate obstructive lung disease Summary ➢ SOB for further investigation ➢ At baseline CT was unremarkable. Placed on biologics for history of exacerbation ➢
Slide 40: Long Covid-19
Demonstrating clinical application Long Covid-19 Subject Baseline ➢ Age: 52; Sex: Female Indications ➢ Long Covid symptoms Summary ➢ Patient hospitalised for COVID-19 TV VH VDP ➢ During admission chest CT observed peripheral ground-glass and consolidative 0.50 54.5 17.3 pulmonary opacities. (no XV L
Slide 41: Technology opportunity
Technology opportunity 4DMedical has the solution for historical respiratory diagnostics challenges Spirometry - 1846 X – Ray 1895 CT - 1971 Nuclear Medicine - 1971 ➢ 20.8% of procedures, Cost of ➢ 11.8% of procedures, Cost of ➢ 0.4% of procedures, Cost of ➢ 67.0% of procedures, Cost of complete PFT
Slide 42: Product pipeline
Product pipeline Extending accessibility 42
Slide 43: Value proposition of CT:VQ and nuclear medicine
Product pipeline Value proposition of CT:VQ and nuclear medicine CT:VQ Nuclear Medicine – current state Providing enhanced patient experience and efficiencies Clinical Care: ➢ Nuclear medicine enables perfusion (blood) analysis • Workflow transition from nuclear medicine to CT/radiology capability d
Slide 44: PACT Act – what does it mean for 4DMedical
Commercialisation strategy: US Veterans Affairs PACT Act – what does it mean for 4DMedical What is the PACT Act? What does this mean for 4DMedical? ➢ PACT Act - $280bn expansion of VA health care and benefits ➢ 4DMedical has technology to enable VA to screen veterans for Veterans exposed to burn pit