Earnings release
Page 1
Proteomics International Laboratories Ltd ABN 78 169 979 971 Box 3008, Broadway, Nedlands, WA 6009, Australia T: +61 8 9389 1992 | E: enquiries@proteomicsinternational.com | W: www.proteomicsinternational.com 1/10 Part of the PILL Group ASX Release 28 July 2025 ASX code: PIQ Quarterly Activities Report Proteomics International Laboratories Ltd (Proteomics International; the Company; ASX: PIQ), a pioneer in precision diagnostics and precision medicine, is pleased to provide the following update on its business activities for the three months to 30 June 2025 and subsequent to the period end. Highlights include: • PIQ - $12 million capital raise completed through oversubscribed SPP will be used to drive and accelerate the launch of the Company’s suite of diagnostic tests. • Promarker®D – Diabetic Kidney Disease prediction o Simplified Next -gen test system released , providing an accurate high-throughput immunoassay that aligns closely with routine pathology workflows. o Launched into the USA at the 85th Scientific Sessions of the American Diabetes Association, the largest gathering of diabetes professionals in the world. o CPT PLA billing code granted by American Medical Association supporting reimbursement activities. o Update on launch activities in Australia and Rest of World. • Promarker®Eso – Esophageal Cancer diagnosis o Clinical validation results published in p eer-reviewed journal demonstrating the test’s accuracy for non-invasive diagnosis of esophageal adenocarcinoma. o Distinguished Clinical Advisory Board formed. • Promarker®Endo – Endometriosis diagnosis o Advances towards clinical use: Landmark results presented at World Congress confirm the test offers a viable, real-world solution for non-invasive diagnosis of endometriosis. o First patent granted for PromarkerEndo in Japan, validating the test’s novelty in the world's 4th largest healthcare market. • OxiDx – Oxidative stress monitoring o Chinese patent granted. o Peer-reviewed study published demonstrating OxiDx can detect oxidative stress and track muscle recovery after a horse race. • PIQ - $6m funding boost to expand precision diagnostics capability: Proteomics International’s WA Proteomics Facility to install new equipment infrastructure for higher throughput clinical testing. For personal use only
Page 2
Proteomics International Laboratories Ltd ABN 78 169 979 971 Box 3008, Broadway, Nedlands, WA 6009, Australia T: +61 8 9389 1992 | E: enquiries@proteomicsinternational.com | W: www.proteomicsinternational.com 2/10 Part of the PILL Group OPERATIONAL HIGHLIGHTS – ENABLING PRECISION MEDICINE Proteomics International’s activities fall into three strategic areas: I. Commercialisation of the Company’s pipeline of precision diagnostics II. Precision diagnostic tests in development III. Specialist accredited analytical services on a commercial basis The Company now has a suite of diagnostic tests entering commercialisation, with the PromarkerD test recently launched in Australia and the US A, and the PromarkerEndo, PromarkerEso and OxiDx tests each passing pivotal points in their advancement. Go-to-Market strategy for the Company’s suite of novel diagnostic tests Growth in telehealth and increased consumer demand for preventative care are creating sustained momentum for decentralised diagnostics, with the global telehealth market projected to reach US$112 billion this year and US$335 billion by 2032, recording a CAGR of 16.9%1. Proteomics International’s Go-to-Market route embraces this appetite for digital health by using a clinician driven strategy direct to the consumer (both patient and General Practitioner). This path serves as a prelude to potential out-licensing to major industry players in the diagnostics sector, providing maximum optionality for strategic partnering by achieving first sales and gaining market recognition of each test. PRECISION DIAGNOSTIC TESTS – THE PROMARKER® PIPELINE Proteomics International develops novel precision health and predictive diagnostic tests using its proprietary biomarker discovery platform called Promarker ®. This disruptive technology searches for protein ‘fingerprints’ in a sample and can identify protein biomarkers that distinguish between people who have a disease and people who do not, using only a standard blood test. It is a powerful advancement on genetic testing. The Promarker platform technology has broad applicability and is being used to produce multiple new diagnostic tests to address significant unmet medical and commercial needs. Promarker®D – predicting diabetic kidney disease Promarker®D is a blood test to predict the onset of diabetes-related chronic kidney disease (DKD) up to four years before symptoms appear. It provides a significant advancement in diabetes management by enabling early detection and intervention, which are crucial for preventing or delaying the progression of this serious complication to end stage renal disease (leading to dialysis or kidney transplant). Diabetes affects over 537 million people worldwide, and chronic kidney disease is a major complication, leading to severe health outcomes and increased mortality2. 1 www.fortunebusinessinsights.com/industry-reports/telemedicine-market-101067 2 International Diabetes Federation 2021 For personal use only
Page 3
Proteomics International Laboratories Ltd ABN 78 169 979 971 Box 3008, Broadway, Nedlands, WA 6009, Australia T: +61 8 9389 1992 | E: enquiries@proteomicsinternational.com | W: www.proteomicsinternational.com 3/10 Part of the PILL Group Promarker®D launched into the USA Diabetes affects over 32 million adults in the US A and has emerged as the largest single cause of end -stage renal disease, with DKD costing $130 billion per year in the USA3. [ASX: 20 June] The PromarkerD predictive test for DKD was launched in to the US A at the 85 th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, Illinois (20-23 June), the largest gathering of diabetes professionals in the world, and where the Company was represented by Chief Commercial Officer Phillip Prather, Head of Business Development Chuck Morrison, and newly appointed Director of US Sales, Mark Boyle. The US A launch signals a major commercial opportunity with the US A representing the largest global healthcare market. PromarkerD is now available to USA patients and primary care physicians through the Company's fully integrated digital solution for direct-to-consumer (DTC) engagement, mirroring the platform launched in Australia [ASX: 13 March] (see details below). Proteomics International is pursuing a stepped approach to the USA roll -out, initially offering the test via selected sites in California to refine the blood collection logistics before expanding statewide and then into other states. The staged US A launch of PromarkerD will benefit from the process and marketing insights gained during its Australian rollout. American Medical Association (AMA) grants next-generation Promarker®D test a dedicated billing code [ASX: 3 July] Proteomics International announce d the assignment of a dedicated CPT PLA reimbursement code ( 0579U) by the AMA for the next -generation of the PromarkerD test system , with the Centers for Medicare and Medicaid Services (CMS) set to make its pricing recommendation for the test in September. A CPT PLA code uniquely identifies a test for the testing laboratory, enabling healthcare providers to order the test, facilitates a billing pathway for payers, and permits monitoring of test usage. The newly-approved code will be effective for claims submitted on or after 1 October 2025. The PLA code was issued to Proteomics International USA Inc for the Company's CLIA certified reference laboratory [ASX: 28 February]. Next-gen Promarker®D test system released for predicting DKD [ASX: 23 June and 24 July] The Company announced the successful development and release of its next- generation PromarkerD test system, which has been engineered as a high-throughput immunoassay that aligns closely with routine pathology workflows. Simplified without compromising accuracy, the key performance data for the next-gen assay was presented at the ADA meeting as a Late Breaking Abstract and published in The Journal of Applied Laboratory Medicine. The next-generation PromarkerD now measures two plasma protein biomarkers (ApoA4 and CD5L) alongside age and estimated glomerular filtration rate (eGFR) to generate a personalised DKD risk score, demonstrating: - excellent predictive discrimination, with patients predicted as high-risk by PromarkerD having 44- fold greater odds of kidney decline versus the low-risk group; - exceptional predictive performance (AUC 0.88) and negative predictive value up to 97.4%, outperforming current standard of care tests; - excellent analytical precision, reproducibility, and stability, meeting stringent international laboratory guidelines; and - matches previously published performance identifying 86% of individuals at risk of DKD, all missed by standard tests [ASX: 11 March]. 3 US Renal Data System 2020 For personal use only
Page 4
Proteomics International Laboratories Ltd ABN 78 169 979 971 Box 3008, Broadway, Nedlands, WA 6009, Australia T: +61 8 9389 1992 | E: enquiries@proteomicsinternational.com | W: www.proteomicsinternational.com 4/10 Part of the PILL Group Update on launch of Promarker®D in Australia ➢ PromarkerD was launched into Australia on World Kidney Day [ASX: 13 March] and first sales have been achieved; diabetes affects 1.5 million adults in Australia. ➢ Critical steps to ensure the success of the Go-to-Market strategy are: o expanding the coverage of blood collection sites o embedding pathology request forms into General Practice management software o refining the sales and marketing to target clinicians and patients motivated to adopt the test ➢ The pilot launch in Western Australia and the Northern Territory has enabled the optimisation of sample collection logistics and the refining of the digital marketing campaign via the MyTest.Health platform to target appropriate patient groups. ➢ Proteomics International has entered into a commercial agreement with the Healius Group (including Dorevitch Pathology, Laverty Pathology, QML Pathology, TML Pathology and Western Diagnostic Pathology) to provide blood collection services across Australia for the Promarker tests. ➢ Proteomics International has also entered into commercial agreements with specialist digital health and marketing consultants to build its platforms and create tailored sales and marketing content. ➢ Key messaging revolves around highlight ing the early prediction and prevention as core differentiators vs the current standard of care tests (eGFR, albumin-to-creatinine ratio (ACR)) that are not predictive. ➢ The primary direct-to-consumer (DTC) Channels being utilised are: o MyTest.Health website (SEO-optimised, mobile-first, educational) o Social media (Meta, Instagram, YouTube) o Paid media (Google Ads, Meta Ads, native content) o Email marketing (lead nurture + re-engagement) o Webinars & online events (hosted with KOLs or patient groups) o GP endorsement integrated into patient self-request flows ➢ The Company , in conjunction with its digital marketing consultants , has a real -time process of reviewing and analysing campaigns to ensure effectiveness and efficient use of marketing spend. ➢ Key measurement and optimisation KPIs involved in this process are: o CAC (Customer Acquisition Cost) o Conversion rates (landing to test order) o ROI per channel; and o Customer retention or repeat test rate (e.g. annual monitoring) ➢ Sample analysis is performed in Proteomics International’s Perth laboratories under its established quality management system for clinical testing (equivalent to the US CLIA certification received for the Proteomics International USA Reference Laboratory). Formal ISO 15189 certification is pending. ➢ In addition to the above, t he Company is engaging with key stakeholders including primary care networks and patient advocacy groups to build awareness and adoption of the test. ➢ PromarkerD will be launched across Australia at the Australasian Diabetes Congress, 20-22 August, Gold Coast, where the Company will also present its latest results and host sessions with experts in the field of diabetes care. ➢ Ultimately, the market intelligence and process knowledge gained from the stepped Australian launch will be invaluable for the US launch of not only PromarkerD but also PromarkerEso & PromarkerEndo. Update on commercialisation of Promarker®D in Rest of World ➢ Sales are continuing in Puerto Rico and the Dominican Republic via licence partner Omics Global Solutions (OGS). ➢ OGS has received reimbursement of the test from insurers in the US territory of Puerto Rico. For personal use only
Page 5
Proteomics International Laboratories Ltd ABN 78 169 979 971 Box 3008, Broadway, Nedlands, WA 6009, Australia T: +61 8 9389 1992 | E: enquiries@proteomicsinternational.com | W: www.proteomicsinternational.com 5/10 Part of the PILL Group ➢ Proteomics International is engaged with potential Reference Laboratories in Europe to run the PromarkerD test. ➢ The Company is reviewing existing Distributor Agreements to ensure alignment with the revised go- to-market framework of direct-to-consumer sales and using central reference laboratories. Further information about Promarker®D is available through the www.PromarkerD.com web portal. Proteomics International recommends that patients concerned about DKD seek advice from their doctors. Country specific use of this product is subject to the relevant regulatory approvals. Further information on DKD is available through the www.mytest.health web portal. Promarker®Eso – diagnosing esophageal cancer Promarker®Eso is a blood test that detects specific protein changes to rule out esophageal adenocarcinoma (EAC). A major risk factor for e sophageal cancer is chronic acid reflux or ‘GERD’ (gastroesophageal reflux disease), and it is estimated that up to 20% of the USA population4 and 11% of patients visiting GP clinics in Australia have GERD5. EAC is the most common form of esophageal cancer, with the five-year survival rate for EAC being less than 20% because it is frequently diagnosed too late for effective treatment. Current gold-standard screening for the disease requires a specialist endoscopy, an invasive procedure that costs US$2,750 in the United States6 where total expenditure on treating EAC was US$2.9 billion in 2018. In the USA 6.1 million endoscopies with biopsy are performed annually7, but despite this up to 90% of EAC cases continue to go undetected8. Promarker®Eso blood test clinical validation results published [ASX: 5 June] As a prelude to clinical use, t he latest clinical validation results for Promarker®Eso were published in the peer-reviewed journal Proteomes. The study involved 259 serum samples across three independent patient cohorts from Australia and the USA, and delivered extremely strong diagnostic performance for disease detection, demonstrating 91 % sensitivity and 99% specificity in the primary validation cohort (panel C below). The first-in-class test provides a clear and simple ‘traffic light’ risk score - low, moderate, or high - indicating the likelihood of EAC for any patient and supporting clinical decision-making. Figure: PromarkerEso distribution of esophageal adenocarcinoma (EAC) and control sample probability scores. Results are classified into Low-, Moderate- and High-Risk categories: (A) development cohort (PROBE-NET), (B) initial validation cohort 1 (Ochsner), (C) primary validation cohort 2 (VCB). Actual outcomes are represented as blue dots (EAC) and black dots (Negative Controls or General Population). Lower and upper cutoffs (20% and 75% respectively) are represented by the red dotted lines. 4 www.yalemedicine.org/conditions/gerd-gastroesophageal-reflux-disease 5 www.racgp.org.au/afp/2015/october/gastro-oesophageal-reflux-disease-gord-in-australia 6 www.newchoicehealth.com/endoscopy/cost 7 Gastroenterology (2019): doi: 10.1053/j.gastro.2018.08.063 8 Gastroenterology (2022): doi: 10.1053/j.gastro.2022.03.037 For personal use only
Page 6
Proteomics International Laboratories Ltd ABN 78 169 979 971 Box 3008, Broadway, Nedlands, WA 6009, Australia T: +61 8 9389 1992 | E: enquiries@proteomicsinternational.com | W: www.proteomicsinternational.com 6/10 Part of the PILL Group Promarker®Eso next steps: ➢ Proteomics International is preparing its novel blood test for esophageal cancer for commercial launch using the logistics framework and digital direct -to-consumer platform employed for PromarkerD, and in parallel target primary care (GP’s) and patients at risk of EAC. ➢ Continuing to build awareness of the test with clinicians, KOL’s and advocacy groups in response to the growing incidence and awareness of GERD. ➢ The Australian launch initially planned for Q1/Q2 CY25 was moved back while Proteomics International finalise d sample collection logistics and its clinical laboratory certification for Promarker®D (as described above). ➢ Promarker®Eso will be launched at the 21st International Society for Diseases of the Esophagus (ISDE) World Congress, 18-20 September, Brisbane, where the Company will also present its latest results and host panel sessions with experts in the field of EAC. Promarker®Endo – diagnosing endometriosis Promarker®Endo is a blood test for the early diagnosis of endometriosis . This is a debilitating disease that affects one in nine women and girls worldwide9, often starting in adolescence. Endometriosis can cause symptoms such as pelvic pain, painful periods and infertility and occurs when tissue similar to the lining of the uterus grows in other parts of the body where it does not belong. Currently, there is no simple test for endometriosis, which takes an average of seven years to diagnose due to the reliance on invasive laparoscopy. The costs of this surgical procedure vary widely, with average direct costs of $3,000 and average out -of-pocket (private) costs of $690 in Australia, and average direct costs of US$21,268 and average out-of-pocket costs of $4,923 in the USA 10,11,12. The total burden of e ndometriosis costs in Australia alone are estimated as $9.7 billion each year13. Promarker®Endo advances toward clinical use – new results presented at World Congress on Endometriosis [ASX: 26 May] Proteomics International announced another milestone for Promarker®Endo, with landmark results confirming that PromarkerEndo is fast transitioning from prototype to a clinically viable, real -world solution for non-invasive diagnosis of endometriosis. The results were presented at the 16th World Congress on Endometriosis in Sydney, 21-24 May attended by over 1,000 researchers, clinicians, industry leaders, and patient advocates from more than 50 countries. The study of over 700 people demonstrated high diagnostic accuracy with 83% sensitivity and 95% specificity across all stages of the disease using a simple ‘traffic light’ risk score - low, moderate, or high - indicating the likelihood of endometriosis for any patient. Figure: Promarker®Endo distribution of endometriosis stages and control sample probability scores. Results are classified into Low-, Moderate- and High-Risk categories: E ndometriosis Stage I (N=228), Stage II (N - 64), Stage III (n=57), Stage IV (N=87), General population controls (N=142), Symptomatic controls (N=126). Actual patient outcomes are shown in colored bars as categorised by PromarkerEndo, for example, the majority of symptomatic controls (green bars) were categorised as low risk, however, some individuals are categorized moderate and high -risk of having endometriosis. 9 World Health Organisation (WHO.org); www.who.int/news-room/fact-sheets/detail/endometriosis 10 medicalcostsfinder.health.gov.au/service/?id=H14&mode=IH 11 Human Reproduction (2016); doi.org/10.1093/humrep/dev335 12 endometriosis.net/clinical/cost-laparoscopy-surgery 13 endometriosisaustralia.org For personal use only
Page 7
Proteomics International Laboratories Ltd ABN 78 169 979 971 Box 3008, Broadway, Nedlands, WA 6009, Australia T: +61 8 9389 1992 | E: enquiries@proteomicsinternational.com | W: www.proteomicsinternational.com 7/10 Part of the PILL Group First patent granted in Japan for Promarker®Endo technology [ASX: 30 June] Proteomics International was granted a patent for Promarker®Endo in Japan for its proprietary diagnostic blood test, validating the novelty of the test in the world's fourth largest healthcare market14. This is the first patent for PromarkerEndo granted in any jurisdiction globally. Proteomics International is pursuing patent protection for the Promarker ®Endo technology in multiple key jurisdictions, including applications pending in Australia, Canada, China, Europe, India, Singapore, Sout h Korea and the United States. Promarker®Endo next steps: ➢ Promarker®Endo commercialisation planning underway with target launch date H2 CY25 in Australia. The launch will leverage the logistics framework and digital direct-to-consumer platform built for other Promarker tests. ➢ Analytical methodology is being adapted for use in a clinical environment under the ISO15189 (clinical testing) pathway. ➢ Partnering discussions are advancing in key markets for licensing in women’s health and fertility. ➢ Continuing to build awareness of the test with clinicians, KOL’s and advocacy groups in response to the upsurge in demand for better diagnosis of endometriosis. OxiDx – monitoring muscle damage and recovery Oxidative stress is implicated in over 70 health conditions, with levels often reflective of a person’s health condition15. Target applications include high-performance athletes and the horse racing industry, where the OxiDx test can be used to measure levels of muscle damage via a simple fingerpick blood sample to detect protein biomarkers in the blood. In professional sports, muscle injuries are the most frequent cause of incapacity, accounting for up to 55% of all injuries. Similarly, in the horse racing industry, 85% of thoroughbreds sustain at least one injury during their two- and three-year-old racing seasons16, potentially as a result of undetected muscle injuries. In 2023, $1.2 billion was spent on treating potentially avoidable sports injuries in Australia17. Chinese patent granted [ASX: 15 May] OxiDx Pty Ltd, a subsidiary of Proteomics International, secured new intellectual property protection in China following the grant of a patent for the platform technology which precisely measures levels of oxidative stress. The patent families now extend to Australia, China, Europe, Japan and USA, with further jurisdictions pending. OxiDx test detects muscle damage in thoroughbred racehorses [ASX: 14 July] Study published showing OxiDx can track muscle recovery after a horse race. OxiDx next steps: ➢ Exploring commercial opportunities in high performance athletes, sports teams and the horse racing industry in Australia and USA. ➢ Field study underway to assess the ability of the OxiDx test to predict muscle damage in racehorses. ➢ Proteomics International aims to launch the new test in Australia through its OxiDx subsidiary in H2 CY25, and then expand into the USA via the Company’s US Reference Laboratory. 14 OECD Health Data Statistics 15 Doi: 10.1373/clinchem.2005.061408 16Animals (2023); doi: 10.3390/ani13030490 17 Australian Institute of Health and Welfare (2023): Economics of sports and physical activity participation and injury For personal use only
Page 8
Proteomics International Laboratories Ltd ABN 78 169 979 971 Box 3008, Broadway, Nedlands, WA 6009, Australia T: +61 8 9389 1992 | E: enquiries@proteomicsinternational.com | W: www.proteomicsinternational.com 8/10 Part of the PILL Group ANALYTICAL SERVICES The demand for analytical services remains steady, covering the areas of pharmacokinetic testing, biosimilars and proteomics analysis, food testing, and biomarker discovery on a contract basis. The Company continues to look for opportunities to grow these revenues, targeting the clinical trials sector for both pharmacokinetic testing and the development of companion/complementary diagnostics (CDx) through biomarker analysis. EVENTS AND MARKETING During the quarter, Proteomics International was represented at several significant industry and clinical/ scientific conferences: AUS-Omics, Cairns (18–21 May), the World Congress on Endometriosis , Sydney (21– 24 May), the Clinical Trials Summit, Mumbai (11–12 June), and the American Diabetes Association Scientific Sessions, Chicago (20 –23 June). The Company also co -hosted an educational session on endometriosis management in primary care with Gedeon Richter Australia in Perth (4 June). For investor engagement, Managing Director, Dr Richard Lipscombe was invited to present virtually at the JMM Biotech Forum [ASX: 10 April], and the Morgan Stanley Alpha ex-100 Conference [ASX: 8 April 2025], and interviewed for ’ At the Helm’ with Bell Potter Direct and Money News (2GB/6PR Radio). Proteomics International in the media The Company’s diagnostic pipeline, commercialised products, ongoing commercialisation efforts, and publication of clinical findings continue to receive widespread media coverage including from 2GB Radio, the New England Times, Daily Mail UK, ListCorp, The Australian and Bloomberg Prognosis18. Forthcoming Events During the next quarter, Proteomics International will be represented at the following events and conferences: • 30th GPCE Melbourne (General Practice Conference & Exhibition); 11-13 July, Melbourne, Victoria • 19th Bioshares Biotech Summit; 7-8 August, Hobart, Tasmania • Australasian Diabetes Congress; 20-22 August, Gold Coast, Queensland • 60th ANZSN Congress (Australia New Zealand Society of Nephrology); 30 August-3 September, Perth, Western Australia • Combined Biological Sciences Meeting; 19 September, Perth, Western Australia • 21st ISDE World Congress (International Society for Diseases of the Esophagus ); 18-20 September, Brisbane, Queensland These events align with the Company's objective of actively engaging with potential users of its technology to foster awareness, adoption and uptake of its novel diagnostic tests. All PIQ announcements and related shareholder information are available from the Company’s website19. FINANCIAL AND CORPORATE HIGHLIGHTS Proteomics International’s business model is to commercialise its pipeline of novel diagnostic tests, exemplified by Promarker®D, Promarker®Endo, Promarker®Eso and OxiDx, in major markets across the world, and offset the cash burn from R&D and product development through its analytical services revenue, coupled with the R&D tax incentive rebate. This diversified model enables the group to make optimum use of its resources. 18 www.proteomics.com.au/newsroom/inthemedia/news-media/ 19 www.proteomics.com.au/investors/ investors/asx/ For personal use only
Page 9
Proteomics International Laboratories Ltd ABN 78 169 979 971 Box 3008, Broadway, Nedlands, WA 6009, Australia T: +61 8 9389 1992 | E: enquiries@proteomicsinternational.com | W: www.proteomicsinternational.com 9/10 Part of the PILL Group Proteomics International receives major funding boost to expand its precision diagnostics capability [ASX: 1 July] Proteomics International operates its laboratories as part of the WA Proteomics Facility , a collaborative Public Private Partnership jointly managed by Proteomics International and The University of Western Australia [ASX: 26 November 2019, 20 October 2022]. The Facility brings together deep scientific and technological expertise across human health and agriculture. The Facility will enjoy a $6 million boost to its equipment infrastructure to accelerate advances in precision medical diagnostics and agricultural proteomics, which will enable higher throughput clinical testing . This expansion comprises a $ 4 million co -investment over three years by the WA State Government and Bioplatforms Australia, plus $1 million each from UWA and Proteomics International. Proteomics International completes a highly successful A$12 million capital raise [ASX: 5 June] Proteomics International raised a total of $12 million comprising $7.5 million via a heavily oversubscribed and scaled back Shareholder Share Purchase Plan, complementing the $4 million Institutional placement and $0.5 million placement to Directors and Key Management Personnel [ASX 22 April]. The funds raised will be used to drive and accelerate the commercialisation of the Company’s suite of diagnostic tests, specifically the: • Launch and roll-out of three Promarker® tests in Australia • Launch and roll-out of three Promarker® tests in USA • Systems upgrade to provide clinical diagnostic tests in Australia • Establishment of laboratory platforms for Promarker®D, Promarker®Eso & Promarker®Endo tests in USA • Progression and launch of pipeline tests including OxiDx Revenue & Expenditure Proteomics International achieved cash receipts from customers for the June quarter of $201,000 (March quarter: $84,000). The net operating cash outflow for the June quarter was $3.2 million (cash inflow in March quarter: $2.2 million). Expenditure centred on the following areas: • Business development and commercialisation costs for the rollout of PromarkerD and PromarkerEso • Acceleration of the Go-to-Market strategies for PromarkerEndo and PromarkerEso • R&D for projects in the Promarker® diagnostics pipeline ASX Listing Rule 4.7C Payments at item 6.1 of Appendix 4C of $163,000 relate to normal remuneration of Executive and Non - Executive Directors. Cash Position At 30 June, the Company had cash reserves of $11.0 million (31 March: $3.1 million). The balance sheet will be further strengthened by a forecast Research and Development tax incentive rebate of circa $2 million to be received in the 1H FY25. Authorised by the Board of Proteomics International Laboratories Ltd (ASX: PIQ). ENDS For personal use only
Page 10
Proteomics International Laboratories Ltd ABN 78 169 979 971 Box 3008, Broadway, Nedlands, WA 6009, Australia T: +61 8 9389 1992 | E: enquiries@proteomicsinternational.com | W: www.proteomicsinternational.com 10/10 Part of the PILL Group About Proteomics International Laboratories (PILL) (www.proteomicsinternational.com) Proteomics International (Perth, Western Australia) is a wholly owned subsidiary and trading name of PILL (ASX: PIQ), a medical technology company at the forefront of precision diagnostics and bio-analytical services. The Company specialises in the area of proteomics – the industrial scale study of the structure and function of proteins. Proteomics International's mission is to improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease. Glossary Sensitivity (Sn) (true positive rate) The ability of a test to correctly identify those with the disease. E.g. sensitivity of 80% means that for every 100 people with disease, the test correctly diagnosed 80 with the condition. Specificity (Sp) (true negative rate) The ability of the test to correctly identify those without the disease. E.g. specificity of 75% means that for every 100 people without disease, a test correctly identifies 75 as not having the condition. Negative Predictive Value (NPV) The probability that people who get a negative test result truly do not have the disease. Also known as 'rule-out' rate, it is the probability that a negative test result is accurate. Positive Predictive Value (PPV) The probability that a patient with a positive (abnormal) test result actually has the disease. Odds Ration (OR) A measure of the strength of association between two events, E.g. an odds ratio of 1.2 means the chances of having a disease are 20% more likely than the odds of not having the disease, whereas an OR of 10, means you are 10 times more likely. to have the disease. Probability (P) The P value, or calculated probability, that an observation is true. Most authors refer to statistically significant as P < 0.05 and statistically highly significant as P < 0.001 (less than one in a thousand chance of being wrong). AUC "Area Under the ROC Curve". A receiver operating characteristic curve, or ROC curve, is a graphical plot that illustrates the performance of a classifier system. Interpreting AUC values Conventionally the clinical significance of AUC is: > 0.7 acceptable discrimination > 0.8 excellent discrimination > 0.9 outstanding discrimination For further information please contact: Dr Richard Lipscombe Dirk van Dissel Managing Director Investor Relations Proteomics International Laboratories Ltd Candour Advisory T: +61 8 9389 1992 T: +61 408 326 367 E: enquiries@proteomicsinternational.com E: dirk@candouradvisory.com.au Proteomics International (Europe) Plesmanweg 9, 7602 PD Almelo The Netherlands T: +31 85 40 11 173 E: Europe@PromarkerD.eu For personal use only
Page 11
Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B Name of entity Proteomics International Laboratories Ltd ABN Quarter ending ("current quarter") 78 169 979 971 Current Quarter Year to date $A'000 $A'000 1. Cash flows related to operating activities 1.1 Receipts from Customers 201 823 1.2 Payments for (a) research & development (822) (4,673) (b) product manufacturing & operating costs (823) (1,221) (c) advertising & marketing (460) (797) (d) leased assets 00 (e) staff costs (836) (2,186) (f) administration & corporate costs (478) (1,101) 1.3 Dividends received (see note 3) 0 0 1.4 44 235 1.5 Interest & other costs of finance paid (19) (42) 1.6 Income taxes paid 00 1.7 Government grants & tax incentives 0 2,358 1.8 Other (provide details if material) 00 1.9 Net cash from / (used in) operating activities (3,193) (6,604) 2. Cash flows related to investing activities 2.1 Payments to acquire: (a) entities 00 (b) businesses (see item 10) 0 0 (c) property, plant & equipment (3) (30) (d) investments 00 (e) intellectual property 0 0 (f) other non‐current assets 0 0 2.2 Proceeds from disposal of: 0 0 (a) entities 00 (b) businessess (see item 10) 0 0 (c) property, plant & equipment 0 0 (d) investments 00 (e) intellectual property 0 0 (f) other non‐current assets 0 0 2.3 Cash flows from loans to other entities 0 0 2.4 Dividends received (see note 3) 0 0 2.5 Other (provide details if material) 00 2.6 Net cash from / (used in) investing activities (3) (30) Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B 30 June 2025 Consolidated statement of cash flows Interest received ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms For personal use only
Page 12
Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B Current Quarter Year to date $A'000 $A'000 3. Cash flows from financing activities 3.1 Proceeds from issues of equity securities (excluding convertible debt securities) 12,032 12,032 3.2 Proceeds from issue of convertible debt securities 0 0 3.3 Proceeds from exercise of options 0 0 3.4 Transaction costs related to issues of equity securities or (827) (829) convertible debt securities 0 0 3.5 Proceeds from borrowings 0 0 3.6 Repayment of borrowings 0 0 3.7 Transaction costs related to loans & borrowings 0 0 3.8 Dividends paid 00 3.9 Other (provide details if material) (47) (173) 3.10 Net cash from / (used in) financing activities 11,158 11,030 4. Net increase / (decrease) in cash and cash equivalents for the period 4.1 Cash & cash equivalents at beginning of period 3,075 6,641 4.2 Net cash from / (used in) operating activities (see 1.9 above) (3,193) (6,604) 4.3 Net cash from / (used in) investing activities (item 2.6 above) (3) (30) 4.4 Net cash from / (used in financing activities (item 3.10 above) 11,158 11,030 4.5 Effect of movement in exchange rates on cash held 0 0 4.6 Cash & cash equivalents at end of quarter 11,037 11,037 5. Reconciliation of cash & cash equivalents at the end of the quarter (as shown in the Current Quarter Previous Quarter consolidated statement of cash flows) to the $A'000 $A'000 related items in the accounts 5.1 Bank balance 1,620 1,017 5.2 Cash deposits 9,417 2,058 5.3 Bank overdrafts 00 5.4 Other (provide details) 0 0 5.5 Cash & cash equivalents at end of quarter (should equal item 4.6 above) 6. Payments to related parties of the entity & their associates Current Quarter $A,000 6.1 163 6.2 0 Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an explanation for, such payments Payments at 6.1 relate to normal remuneration of Executive and Non‐Executive Directors Aggregate amount of payments to related parties and their associates included in item 1 Consolidated statement of cash flows 11,037 3,075 Aggregate amount of payments to related parties and their associates included in item 2 ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms For personal use only
Page 13
Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B 7. Financing facilities available Total facility amount Amount drawn at quarter end at quarter end $A'000 $A'000 7.1 Loan facilities 00 7.2 Credit standby arrangements 0 0 7.3 Other(please specify) 00 7.4 Total financing facilities 0 0 7.5 Unused financing facilities available at quarter end 0 7.6 Include in the box below a description of each facility above, including the lender, interest rate, maturity date and whether it is secured or unsecured. If any additional facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well. N/A 8. Estimated cash outflows for next quarter $A'000 8.1 Net cash from / (used in) operating activities (see 1.9 above) (3,193) 8.2 Cash and cash equivalents at quarter end (Item 4.6) 11,037 8.3 Unused financing facilities available at quarter end (Item 7.5) 0 8.4 Total available funding (Item 8.2 + Item 8.3) 11,037 8.5 Estimated quarters of funding available at quarter end (Item 8.4 divided by Item 8.1) 3.5* 8.6 If Item 8.5 is less than 2 quarters, please provide answers to the following questions: 8.6.1 Answer: 8.6.2 8.6.3 Note: where item 8.5 is less than 2 quarters, all of the questions 8.6.1, 8.6.2 and 8.6.3 above must be answered. *Excludes R&D tax incentive rebate of circa $2 million expected to be received in the December quarter. Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not? Answer: Answer: Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful? Does the entity expect to be able to continue its operations and to meet it's business objectives and, if so, on what basis? Note: the term "facility" includes all forms of financing arrangements available to the entity. Add notes as necessary for an understanding of the sources of finance available to the entity. ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms For personal use only
Page 14
Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B Compliance Statement 1 2T h i s statement gives a true and fair view of the matters disclosed. Date: Authorised by: The Board (Name the body or officer authorising release ‐ see note 4) Notes 1. 2. 3. 4. 5. If this report has been authorised for release to the market by your board of directors, you can insert here: "By the board". If it has been authorised for release to the market by a committee of your board of directors, you can insert here: "By the [name of board committee‐eg Audit and Risk Committee]". If it has been authorised for release to the market by a disclosure committee,you can insert here: "By the Disclosure Committee". The quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entities activities for the past quarter, how they have been financed and the effect this has had on the cash position. An entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is encouraged to do so. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of AASB 107: Statement of Cash Flows apply to this report. If this quarterly report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate Governance Council's Corporate Governance Principles and Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity have been properly maintained, that this report complies with the appropriate accounting standards and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a sound system of risk management and internal control which is operating effectively. This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A. ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms For personal use only