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Proteomics International Laboratories Ltd Ignite Investment Summit Disciplined Path to Commercial Success 14 October 2026 ASX: PIQ | ACN: 169 979 971 | Perth, Western Australia
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Disclaimer This Presentation is provided by Proteomics International Laboratories Ltd (Proteomics International, Proteomics, the Company, ASX: PIQ). You should not rely upon anything in this presentation and/or any information obtained from the Company, its Directors or their associates in deciding whether or not to seek to purchase the shares of the Company. This is not an offer to subscribe for securities in the Company. The Presentation may contain quantitative statements of anticipated future performance such as projections, forecasts, calculations, forward-looking statements or estimates all of which are based on certain assumptions (Forward Looking Statements). The Forward Looking Statements may involve subjective judgements and are based on a large number of assumptions and are subject to significant uncertainties and contingencies, many of which are outside the control of the Company and may not prove to be correct. No representation or warranty is made that any Forward Looking Statements will be achieved, or occur, or that the assumptions upon which they are based are reasonable or the calculations from which they have been derived are correct. Actual future events may vary significantly from the Forward Looking Statements. Each Recipient should undertake their own independent review of the Forward Looking Statements, including the assumptions on which they are based and the financial calculations from which they are derived. 1
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Disciplined Path to Commercial Success Proteomics International has repositioned the business for commercial execution, advancing three lead tests through validation, market access and reimbursement pathways, while maintaining disciplined capital allocation. Transforming form research to commercial execution Focusing the business on clear commercial priorities, stronger accountability and disciplined capital allocation. Expanding through distribution partners Leveraging the Healius collection network (1,900 collection centres in Australia) and referrer relationships. Engaging a US distribution partner is the next priority. Advancing three lead tests that address unmet needs Advancing Promarker®D, Promarker®Eso and Promarker®Endo to address unmet needs in diabetic kidney cancer, oesophageal disease and endometriosis. Progressing reimbursement pathways Pursuing reimbursement in Australia and the US through evidence generation and dossier development, with private pay supporting initial market access. Targeting significant and addressable markets Targeting sizeable patient populations and building adoption to support potential recurring test revenue. Executing our strategic roadmap Focusing on commercialisation, innovation, scaling processes and infrastructure, and building capabilities to create sustainable long term value. 2 EXECUTIVE SUMMARY
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COMPANY OVERVIEW About Us Proteomics International (ASX: PIQ) develops proprietary blood tests for disease prediction and diagnosis. We deliver laboratory testing and clinical reporting, while distribution partners provide market access to clinicians and patients. Target Unmet Clinical Needs • Identify high value diagnostic gaps • Target diseases with delayed or inadequate diagnosis • Focus on tests that can improve clinical decision making Build the Promarker® Portfolio • Promarker®D: diabetic kidney disease • Promarker®Eso: oesophageal cancer • Promarker®Endo: endometriosis • Advance new tests through the development pipeline Operate Integrated Clinical Laboratories • Accredited NATA laboratory operations in Australia • CLIA/CAP laboratory capability in the US • Deliver testing, clinical reporting and quality assurance • Scale operations to support commercial demand Drive Market Access • Distributor-led commercial model • Healius partnership provides national Australian access • Private-pay launch while reimbursement is pursued • Build US distribution and payer access Leverage our Proprietary Platform • Discover disease- associated protein biomarkers • Combine biomarkers into proprietary test models • Develop and clinically validate new diagnostic tests • Protect innovation through intellectual property 3
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Dr James Williams Non- Executive Chair PhD, MBA, BSc (Hons) GAICD Seasoned life sciences executive with experience from startup to commercialisation. Former CEO/CTO/Chair across multiple biotech companies including Dimerix and iCeutica. Contributed to development of five FDA-approved drugs, devices, and diagnostics. Vicki Robinson Non-Executive Director LLB (Hons), BCom, MAICD Experienced non-executive and former Wesfarmers senior executive with 20+ years in legal and commercial leadership. Served on Wesfarmers Leadership Team and as Company Secretary across group entities. Deep experience in strategy, M&A, governance, risk, and regulatory environments. Paul House Non-Executive Director BEng (Hons), GAICD Senior executive with 25+ years across multinational corporations and consulting. CEO of Imdex (ASX: IMD); former MD of SGS India and CFO/COO in global roles. Strong track record in operational leadership, finance, and international growth. Aaron Brinkworth Non-Executive Director BHIthSc, GAICD Global pharmaceutical executive with 22+ years at Gilead Sciences (Nasdaq: GILD). Led Asia Pacific commercial, market access, and strategic licensing functions. Deep experience in scaling sales, marketing, and distribution across complex regions. David Morris CEO & Managing Director BBus, BAppSc, GAICD Global healthcare and medtech executive with 25+ years experience including at Cochlear, Nanosonics and Polynovo. Proven track record in commercial growth, product commercialisation, and international expansion. Deep experience in strategy, regulatory pathways, and global market development across US, Europe, and Asia. Board of Directors 4 COMPANY OVERVIEW
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Science of Proteomics Genes carry the instructions. Proteins reveal how those instructions play out in health and disease. Translating that insight into reliable diagnostic and prognostic tests requires precision, standardisation and deep technical expertise. Genes Provide the Instructions Genes are sections of DNA that contain instructions for making proteins. Cells use these instructions to produce the proteins the body needs. Proteins Perform Biological Functions Proteins build and repair tissues, regulate cell activity and drive biological reactions. Proteomics studies proteins to understand what is happening in the body. Protein Changes Signal Disease Disease can alter the levels of particular proteins. Measuring combinations of these changes can help identify disease or assess the risk of developing it. Measure Proteins to Detect Disease Proteomics International identifies protein biomarkers and develops simple blood tests that measure them, to help clinicians assess disease risk and support diagnosis. Protein A increases Protein B decreases Typical level Example with disease 5 PLATFORM
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Innovation Portfolio – Four Tests Proteomics International provides a suite of four prognostic and diagnostic tests targeting specific clinical areas of unmet need. Our priority is to validate and commercialise these tests before developing new tests for other medical conditions. Promarker D Prognostic blood test to predict the risk of diabetes related chronic kidney disease up to 4 years before symptoms appear, enabling earlier clinical intervention and ongoing monitoring. Promarker Eso Diagnostic blood test for patients with chronic reflux that detects specific protein changes to rule out oesophageal adenocarcinoma, thus reducing the need for invasive surveillance endoscopy procedures. Promarker Endo Diagnostic blood test for patients with symptoms suggestive of endometriosis, that reduces the extensive delays in diagnosis and management. OxiDx Proprietary platform for measuring oxidative stress, focusing on diagnostic or specialised applications where there is clear clinical value and economic benefits. 6 PORTFOLIO
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Promarker D Innovation Portfolio – Promarker Tests Clinical Value Clinical Performance Clinical Pathway Value Proposition The Promarker Portfolio tests address distinct clinical pathways, supporting earlier risk identification, more targeted referral and more efficient use of healthcare resources. Identifies Type 2 Diabetes (T2D) patients at higher risk of diabetic kidney disease 76% Sensitivity, 92% Specificity Diabetes management and renal-risk pathways Value from earlier intervention and lower downstream kidney disease costs Promarker Eso Promarker Endo Triages reflux patients for endoscopy referral 91% Sensitivity, 98% Specificity GI referral pathways with potential to reduce unnecessary endoscopy Value from avoiding unnecessary invasive procedures Supports assessment of women with suspected endometriosis Sensitivity is 90% for stage IV, 84% for stages III–IV, 80% for stages II–IV, and 68% for stages (I–IV). Specificity is 71% across all groups. Women’s health pathways and earlier specialist referral Value from faster diagnosis and more efficient referral Note 1: Sensitivity (True Positive Rate), The proportion of actual positives correctly identified. Specificity (True Negative Rate) The proportion of actual negatives correctly identified. NPV (Negative Predictive Value) The probability that someone with a negative test truly does not have the condition. AUC (Area Under the ROC Curve) A summary measure of a model’s ability to distinguish between classes (disease versus no disease). 7 PORTFOLIO
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Innovation Portfolio – Market Potential We have assessed the market opportunities for our three primary tests in both Australia and the United States. Our analysis indicates that the serviceable obtainable market opportunity is substantial, offering significant growth potential. Sources: Population data from ABS and U.S. Census Bureau 2025 estimates. Promarker D: AIHW/NDSS (AU); U.S. Census Bureau/CDC (US). Promarker Eso: AIHW/RACGP (AU); NIDDK/U.S. reflux studies (US). Promarker Endo: ABS/AIHW (AU); U.S. Census Bureau/women’s health literature (US). Market Potential Australia – Annual Test Volumes (‘000) Market Potential USA – Annual Test Volumes (‘000) 50 15 20 100 60 115 130 90 195 0 50 100 150 200 Promarker Endo Promarker Eso Promarker D TAM SAM SOM 360 240 390 1,200 960 2,600 1,500 1,400 4,400 0 1,000 2,000 3,000 4,000 Promarker Endo Promarker Eso Promarker D TAM S AM SOM Definitions: Total Addressable Market (TAM) assumes unconstrained access and reimbursement. Serviceable Available Market (SAM) considers challenges associated with pathway, workflow, and reimbursement. Serviceable Obtainable Market (SOM) reflects realistic medium-term commercial penetration opportunities. 1. Promarker D assumptions: T2D patients in active care, pre-advanced CKD. Tested once every 4 years. 65% of diagnosed T2D addressable. SAM 60% of TAM; SOM 15% of SAM. 2. Promarker Eso assumptions: Chronic reflux patients with appropriate risk factors. Tested once every 3 years. 15% of managed reflux patients. SAM 70% of TAM; SOM 25% of SAM. 3. Promarker Endo assumptions: Reproductive-age women (15–49) with suspected endometriosis. Tested once per clinical work-up. 10% prevalence; 55% undiagnosed; 35% enter active work-up annually. SAM 80% of TAM; SOM 30% of SAM. 8 MARKET POTENTIAL
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Patient Care Ecosystem Patient Clinician Pathology Network Proteomics The patient journey involves clear roles for patients, clinicians, distributors, and labs. Proteomics International handles development and testing, while partners manage market access, ensuring accountability and quality from collection to result. IDENTIFY ANALYSE INFORM ACT COLLECT Presents and consents Provide blood sample Receives results via clinician Receives personalised care advice Assesses and orders test Interprets test result Manages treatment or referral Enables access and ordering Collects blood and manages logistics Tracks samples and turnaround Supports report delivery Supports repeat testing Defines indications Sets collection standards Performs testing and quality control Issues decision ready report Captures outcomes 9 CLINICAL PATHWAY
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Healius Distribution Partnership Exclusive Australian pathology distribution for the Promarker® portfolio. Healius provides national market access through its collection network and referrer relationships, while Proteomics delivers testing and clinical reporting. DISTRIBUTION MODEL Commercial Rollout • Promarker D and Promarker Eso controlled market release in WA and NT on 14 Sep 2026. • National rollout in FY27 Q2. • Initial private pay patient prices: Promarker D A$495 and Promarker Eso A$997. • Promarker Endo commercially available during FY27 Q3, pricing to be confirmed. Proteomics • Performs testing in accredited laboratories. • Provides clinical reporting and scientific support. • Maintains quality and regulatory compliance. • Leads product development and clinical evidence. • Exclusive Australian pathology distributor. • Approximately 1,900 collection centres. • Collects specimens and distributes pathology services. • Supports referrer engagement and market access. Strategic Rationale • National reach through existing pathology infrastructure. • Access established GP and specialist referrers. • Avoid building a proprietary collection network. • Integrate tests into routine clinical workflows. 10
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Strategic Framework for Execution Enterprise objectives create a clear framework aligning strategy with execution, focusing on areas of commercial execution, innovation, operations, and organisational capabilities to deliver lasting value for patients, partners, and investors. ENTERPRISE PRIORITIES DRIVE COMMERCIAL EXECUTION • Transform clinically validated diagnostics into a scalable business model • Establish distributor led market access in Australia and the USA • Promote adoption via phased market launches • Integrate tests into routine clinical practice • Secure reimbursement and payer coverage with robust evidence OPTIMISE OPERATIONS • Deliver dependable test access with scalable, consistent service • Implement standardised systems and workflows • Expand laboratory operations in response to demand • Increase efficiency in turnaround times and throughput • Strengthen quality control and regulatory compliance BUILD ORGANISATION CAPABILITIES • Establish a clear structure, roles and responsibilities • Strengthen leadership capabilities • Attract and retain key technical and commercial talent • Embed disciplined performance management • Foster a culture centered on commercialisation, execution, quality, and compliance DELIVER SUSTAINABLE VALUE • Prioritise growing revenue and sustainable profit margins • Maintain capital efficiency alongside rigorous cost control • Adopt a proactive approach to risk management • Develop strategic growth options through partnerships to drive expansion • Increase long term shareholder value INNOVATE PORTFOLIO • Develop products with strong commercial and reimbursement potential • Conduct biomarker research based on clear clinical needs • Maintain strict scientific and clinical standards • Produce dependable clinical and economic evidence • Ensure robust intellectual property portfolio 11
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Execution Plan – The Next 3 Years The strategic roadmap outlines the 3 year plan focused on commercialisation, fostering innovation, scaling processes and infrastructure, and enhancing our capabilities to achieve sustainable long term value. STRATEGIC ROADMAP RESET FY26 H2 Discontinued the DTC business model Engaged with potential distribution partners in Australia and the USA Continued Promarker Endo assay validation Continued refinement of Promarker Eso assay and streamlined lab protocols Restructured the leadership team and organisation Commenced the OxiDX strategic review Reviewed IP portfolio ADVANCE FY27 H2 • Promarker Endo commercially available in Australia • Appoint distributor partners in the USA • Establish Proteomics team in the USA • Optimise test turnaround times, reporting, and customer experience • Prepare reimbursement dossiers and commence submissions for Australia and USA ACCELERATE FY28 • Broaden distributor network coverage • Increase awareness and test utilisation across clinical indications • Expand laboratory capacity and support functions in line with demand • Manage reimbursement submissions and engagement processes • Publish clinical utility and health economic evidence to support adoption and reimbursement ACHIEVE FY29 • Enhance distributor performance management • Expand product portfolio pipeline • Streamline laboratory and commercial operations • Improve operating leverage • Develop strategic growth options to drive product and geographic expansion ACCESS FY27 H1 Advanced laboratory processes, quality systems, and information systems in Australia Appointed distributor partner in Australia Commence phased, controlled market releases in Australia Develop reimbursement strategy for Australia and the USA Refined and Validated Promarker Endo 12
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Proteomics International Laboratories Ltd APPENDIX 14 October 2026 ASX: PIQ | ACN: 169 979 971 | Perth, Western Australia
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PRODUCT OVERVIEW Promarker D – Chronic Kidney Disease Prognostic blood test to predict the risk of diabetes related chronic kidney disease up to 4 years before symptoms appear, enabling earlier clinical intervention and ongoing monitoring. Clinical Value Identifies high risk patients with diabetes before irreversible kidney damage occurs. Market Opportunity SOM reflects realistic medium term annual commercial opportunities. ~20,000 patients in Australia and ~390,000 in the USA. Clinical Performance 76% Sensitivity, 92% Specificity. Clinical Pathway Blood sample taken during regular diabetes check ups guides monitoring by GPs and nephrologists and is done every 4 years. Intellectual Property Global patent portfolio covering biomarkers, and clinical applications. Key Actions • Execute the Australian rollout with Healius to drive test adoption. • Appoint a US distribution partner to establish market access. • Engage the clinical advisory board in clinical development and education. • Pursue reimbursement in Australia and US to enable funded access. • Expand lab capacity with demand to reduce turnaround times. Reimbursement Initial private pay in Australia and the USA, with plans for insurance and public funding; obtained the CMS PLA code in USA. Note 1: Sensitivity (True Positive Rate), The proportion of actual positives correctly identified. Specificity (True Negative Rate) The proportion of actual negatives correctly identified. NPV (Negative Predictive Value) The probability that someone with a negative test truly does not have the condition. AUC (Area Under the ROC Curve) A summary measure of a model’s ability to distinguish between classes (disease versus no disease). Note 2: CMS (Centers for Medicare & Medicaid Services). PLA (Proprietary Laboratory Analysis) A code recognised by CMS that uniquely identifies a specific proprietary clinical laboratory test for Medicare pricing and billing purposes. 14
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SYMPTOMS PATIENT JOURNEY Promarker D – Chronic Kidney Disease Promarker D enables a shift from reactive CKD treatment to proactive risk-based care, identifying risk earlier, guiding targeted intervention, and helping reduce late-stage cost burden. EVALUATION MANAGEMENT Promarker D Standard of Care (SOC) Sources: National Kidney Foundation; CDC; KDIGO 2024 CKD Guideline; Peters et al. (2019); NICE MIB312 (2022); Fusfeld et al. (2022); AIHW Chronic Kidney Disease: Australian Facts; Essue et al., BMC Nephrology (2013); Randall et al., BMC Health Services Research (2024). Risk Becomes Visible • Routine diabetes testing flags CKD risk • Earlier insight supports monitoring and prevention Earlier Prognostic Insight • Blood-based triage added to routine diabetes care • Flags risk up to four years before damage Care Starts Sooner • High-risk patients prioritised for therapy and monitoring • Low-risk patients may avoid unnecessary escalation CKD Remains Hidden • CKD can progress silently in type 2 diabetes • Symptoms may appear after significant kidney damage Diagnosis Follows Damage • eGFR and uACR confirm damage after it occurs • Irreversible damage may already be present Care Intensifies Late • Treatment escalates after CKD is confirmed • Late-stage care may require dialysis or transplant Value Time Horizon Up to 4 years earlier risk insight Versus 5–15 years silent CKD Patient Journey Routine GP test triage Versus ~1 in 2 T2D patients develop CKD Economic Burden Cost of test A$495 Versus Monitoring CKD A$3K-4K pa, Dialysis ~A$50K- 85K pa 15
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PRODUCT OVERVIEW Promarker Eso – Oesophageal Cancer Minimally invasive diagnostic blood test for patients with chronic reflux that detects specific protein changes to rule out oesophageal adenocarcinoma, reducing the need for invasive surveillance endoscopy procedures. Clinical Value Identifies patients with chronic reflux at risk of oesophageal cancer, reducing the need for invasive surveillance endoscopic procedures. Market Opportunity SOM reflects realistic medium term annual commercial opportunities. ~15,000 patients in Australia and ~240,000 in the USA. Clinical Performance 91% Sensitivity, 98% Specificity. Clinical Pathway Blood sample taken during regular check ups guides monitoring by GPs and gastroenterologists and is done every 3 years. Intellectual Property Globally granted patent family protecting key biomarkers and clinical applications. Reimbursement Initial private pay in Australia and the USA, with plans for insurance and public funding. Key Actions • Execute the Australian rollout with Healius to drive test adoption. • Appoint a US distribution partner to establish market access. • Engage the clinical advisory board in clinical development and education. • Pursue reimbursement in Australia and US to enable funded access. • Expand lab capacity with demand to reduce turnaround times. Note 1: Sensitivity (True Positive Rate), The proportion of actual positives correctly identified. Specificity (True Negative Rate) The proportion of actual negatives correctly identified. NPV (Negative Predictive Value) The probability that someone with a negative test truly does not have the condition. AUC (Area Under the ROC Curve) A summary measure of a model’s ability to distinguish between classes (disease versus no disease). 16
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SYMPTOMS PATIENT JOURNEY Promarker Eso – Oesophageal Cancer Promarker Eso could shift oesophageal cancer risk assessment from procedure-led surveillance to a faster, lower-burden blood-test triage pathway. EVALUATION MANAGEMENT Promarker Eso Standard of Care (SOC) Sources: Sheahan et al., Proteomes (2025); Wani et al., Gastroenterology (2025); Pilonis et al., Lancet Oncology (2022); Holmberg et al., eClinicalMedicine (2023); Medical Costs Finder & CostDoc, Endoscopy Cost (2026). Routine Symptom Management • Chronic reflux managed with medication • Referral after repeat GP/PPI therapy Endoscopy-Led Evaluation • Specialist referral adds time, cost and anxiety • Endoscopy requires sedation and time off work Broad Surveillance Pathway • Similar surveillance for low- and high-risk patients • Late detection remains a recognised shortcoming Value Time Horizon Blood test triage in weeks Versus 1–3+ years repeat management Patient Journey Lower-burden blood test triage Versus Endoscopy pathway Economic Burden (SoC) Cost of test A$997 Versus Endoscopy cost ~A$2,500 every 2 to 3 years Measurable Risk Insight • Blood test indicated for appropriate chronic reflux patients • Risk information added to routine clinical management Earlier Risk Stratification • Blood-based triage supports referral decisions • No sedation, scheduling or time off work Targeted Care Decisions • Low-risk patients continue GP led reflux care • High-risk patients prioritised for endoscopy review 17
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PRODUCT OVERVIEW Promarker Endo – Endometriosis Diagnostic blood test for patients with symptoms suggestive of endometriosis, thus reducing the extensive delays in diagnosis and management. Clinical Value Identifies patients with a high risk of endometriosis, shortening the typical 7-10 year delay in diagnosis. Market Opportunity SOM reflects realistic medium term annual commercial opportunities. ~50,000 patients in Australia and ~360,000 in the USA. Clinical Performance Sensitivity is 90% for stage IV , 84% for stages III–IV , 80% for stages II–IV , and 68% for stages (I–IV). Specificity is 71% across all groups. Clinical Pathway Blood sample is taken to help GPs and gynaecologists evaluate patients who may have endometriosis. Intellectual Property Broad international patent portfolio with initial patents secured. Reimbursement Initial private pay in Australia and the USA, with plans for insurance and public funding. Key Actions • Complete applicable quality, accreditation and regulatory requirements and prepare for clinical deployment. • Execute the Australian rollout with Healius to drive test adoption. • Appoint a US distribution partner to establish market access. • Engage the clinical advisory board in clinical development and education. • Pursue reimbursement in Australia and US to enable funded access. Note 1: Sensitivity (True Positive Rate), The proportion of actual positives correctly identified. Specificity (True Negative Rate) The proportion of actual negatives correctly identified. NPV (Negative Predictive Value) The probability that someone with a negative test truly does not have the condition. AUC (Area Under the ROC Curve) A summary measure of a model’s ability to distinguish between classes (disease versus no disease). 18
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SYMPTOMS PATIENT JOURNEY Promarker Endo – Endometriosis Promarker Endo could shorten the path from symptoms to clarity, using a blood-test risk triage to support earlier referral and more targeted care. EVALUATION MANAGEMENT Promarker Endo Standard of Care (SOC) Sources: AIHW Endometriosis in Australia (2023); Nnoaham et al., American Journal of Obstetrics & Gynecology (2019); Crump et al., AJGP (2024); ESHRE Guideline (2022); RANZCOG Endometriosis Guideline (2024); Armour et al., PLOS One (2019); Schoeman et al., Human Reproduction (2025) Symptoms Often Normalised • Pelvic pain and fatigue may be normalised • Multiple consultations Diagnosis Takes Years • GP, imaging and specialist review before confirmation • 4–11 yrs to diagnosis; including imaging, and laparoscopy Care Escalates Late • No definitive care pathway • Delayed care adds pain, fertility risk and quality of life burden Value Time Horizon Weeks Versus 4–11 years Patient Journey Blood test triage Versus Imaging and laparoscopy Economic Burden (SoC) Cost of test TBC Versus Average cost per patient is ~A$3K to $5K pa, plus significant cost of lost productivity Symptoms Assessed Objectively • Objective blood-test risk insight • Fewer repeat consultations Earlier Risk Stratification • Blood-based triage guides referrals • Clarity in weeks, not years Risk-Guided Intervention • Earlier referral for at-risk patients • Treatment focused on likely benefit 19
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PRODUCT OVERVIEW OxiDx – Oxidative Stress Platform Proprietary platform for measuring oxidative stress, focusing on diagnostic or specialised applications where there is clear clinical value and economic benefits. Clinical Value Provides an objective measurement of oxidative stress in specialised environments where standardised tests are unavailable. Market Opportunity SOM reflects realistic medium term annual commercial opportunities. ~60,000 tests in Australia and ~1,200,000 test in the USA. Clinical Performance Established platform technology with performance assessed on a per indication basis. Clinical Pathway Blood sample is taken to help doctors or specialists evaluate patient’s oxidative stress levels and manage changes over time. Intellectual Property Patents granted across key markets. Reimbursement Initial private pay in Australia and the USA. Key Actions • Continue to collect clinical and real world evidence • Develop elite athlete and equine business models and confirm priority segments • Confirm capital investment required to progress from research stage to a commercial business • Determine strategic options and best approach to commercialisation and technology development 1. OxiDx assumptions: 25,000 elite athletes in Australia. 500,000 elite athletes in the USA. Assume 12 tests per year. SAM 65% of TAM; SOM 30% of S AM. Does not include Equine market potential. Sources: Population data from ABS and U.S. Census Bureau 2025 estimates. Australian Government (Dept. of Health and Aged Care); Australian Institute of Sport (AIS); Australian Sports Commission ( AusPlay); National Collegiate Athletic Association (NCAA); United States Olympic & Paralympic Committee (USOPC) 20
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Distribution Partnerships to Accelerate Adoption The distributor model delivers faster adoption, lower execution risk, and superior capital efficiency compared to any direct or hybrid alternative. DISTRIBUTION MODEL Key Success Factors • Builds upon experiences from earlier direct and hybrid models • Leverages trusted diagnostic and provider networks • Avoids costs, complications, and risks associated with proprietary infrastructure • Integrates seamlessly into current clinical workflows • Reduces operational and compliance risks through proven and validated platforms • Establishes a scalable and repeatable commercial model to support long term growth Characteristics of the Distribution Model Distributor Access Distributor provides clinician access via their established networks Seamless Integration Ordering, sample collection, and logistics are incorporated into existing distributor workflows Regulated Testing Testing is conducted in Proteomics’ laboratories following regulatory guidelines Quality Assurance Proteomics oversees quality control, regulatory compliance, and reporting 21
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Reimbursement Pathways – Australia Australia provides a national reimbursement framework for prognostic and diagnostic tests. Achieving Medicare Benefits Schedule (MBS) listing is a medium term objective that will serve as a significant driver of growth. REIMBURSEMENT PATHWAYS Reimbursement Process Private Pay Commercialisation begins outside Medicare, generating early revenue and real world Australian evidence Evidence Accumulation Clinical and health economic information is collected to demonstrate the impact on decisions and patient outcomes MSAC Evaluation The Medical Services Advisory Committee (MSAC) independently evaluates the test and assigns a relevant MBS item number MBS Listing Approval grants a nationwide MBS listing, expanding accessibility and promoting increased volume Key Considerations • A national reimbursement framework for tests is established • Company tests are gathering clinical and heath economic evidence • MBS listing is a key medium term growth objective • MSAC may approve, delay, or reject pending more evidence • Timelines are long, but understood • MBS listing secures long term patient access 22
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Reimbursement Pathways – USA In the United States, reimbursement for prognostic and diagnostic tests are decentralised and based on evidence, growing incrementally through private and public funding. REIMBURSEMENT PATHWAYS Key Considerations • The USA has no unified reimbursement system; coverage is split between Medicare, Medicaid and various private payers • Ongoing engagement with multiple payers is essential • Early progress often comes from private payers and hospital networks • Reimbursement and coverage timelines differ and expand over time • Unlike Australia’s MBS, the USA requires multiple negotiations with many payers Private Pay Commercialisation begins with private pay options, hospital networks, and employer sponsored programs Evidence Accumulation Clinical and health economic information is collected during clinical use alongside individual payer coverage decisions MolDX Evaluation Medicare reimbursement depends on MolDX approval, which requires a detailed review of analytical validity, clinical utility, and medical necessity Expanded Coverage Coverage progressively extends across different regions and payer groups through CMS/MAC for Local Coverage Determination (LCD) Reimbursement Process Note 1: MolDX (Molecular Diagnostic Services Program) A CMS program that evaluates molecular tests to determine if they are reliable, clinically useful, and medically necessary for Medicare coverage. CMS (Centers for Medicare & Medicaid Services) The U.S. federal agency that oversees Medicare and sets national coverage policies. MAC (Medicare Administrative Contractor) Regional contractors that process claims and make local coverage decisions for Medicare. LCD (Local Coverage Determination) A region-specific policy that defines when a service or test is covered by Medicare. 23
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Proteomics International Laboratories Ltd ASX: PIQ | ACN: 169 979 971 | Perth, Western Australia