$COV Commences Ovarian Cancer Screening Test Development. ▪️ Prototype development of CLEO’s multi-marker screening #bloodtest is underway ▪️ Screening represents a $150B global addressable market for population screening, to identify early-stage ovarian cancers in #asymptomatic women ▪️ #screeningtest development will run in parallel with CLEO’s initial pre-surgical test that is on track for #FDA submission in H1 CY2027 ▪️ Initial proof-of-concept screening test data expected early next Quarter, with the Company targeting finalisation of test panel architecture by end of CY2026. Link to release: bit.ly/4rqHLoC #CleoDX $COV.ax #ovarian #cancer #medtech #womenshealth ASX.COV #invest

@Cleodiagnostics Dayna Louca will present Cleo's #ovariancancer blood test opportunity at the MST Access Biotech & Healthcare Webinar Series on 6th October. The event will feature three innovative ASX-listed #biotech and #healthcare companies at the forefront of disease #diagnostics innovation. 𝗠𝗦𝗧 𝗔𝗰𝗰𝗲𝘀𝘀 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 & 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗪𝗲𝗯𝗶𝗻𝗮𝗿 𝗦𝗲𝗿𝗶𝗲𝘀: 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰𝘀 Hosted by Professor Bruce Robinson 📅 Tuesday 6th October 2026 🕰️ 4-5pm 🔗 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗵𝗲𝗿𝗲: lnkd.in/g8TX8a-D #CleoDX $COV.ax #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV Selects CLIA-Certified Laboratory for Pivotal U.S. Clinical Validation ▪️ CLEO has engaged #CLIA-certified U.S. laboratory, @Asuragen, to assist in executing its pivotal #clinicalvalidation program for its Pre-Surgical #ovariancancer Test ▪️ The program will generate clinical performance data from over 1,300 #samples to establish the #sensitivity, #specificity, #PPV and #NPV of CLEO’s test ▪️ Extends CLEO’s strategic relationship with @biotechne across commercial test kit manufacture, the Ella™ diagnostic platform and pivotal U.S. clinical testing. Link to release: bit.ly/3T1s1fd #CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV Receives First Batch of Commercially Manufactured Test Kits ▪️ #AnalyticalValidation set to commence following receipt of first production batch of #testkits manufactured by @biotechne (NASDAQ:TECH) ▪️ Three independently manufactured batches will be evaluated to demonstrate #assay precision, reproducibility, manufacturing consistency and analytical robustness ▪️ First batch to establish core #performance characteristics of CLEO’s eight-#biomarker assay, providing reference for subsequent production batches to be evaluated ▪️ AV will generate critical analytical performance data required to progress CLEO’s commercial assay into next #clinicalvalidation phase ▪️ CLEO continues to target planned #FDA 510(k) submission in H1 CY2027. Link to release: bit.ly/46ECKPM #CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

Appreciate @JMM_Australia (JMM) team for hosting Cleo Diagnostics at its East Coast #Investor event. Our message here was simple, #ovariancancer is often diagnosed late, resulting in a largely unchanged 5-year survival rate of just 49% (compared to #breastcancer with a 92% 5-year survival rate). It was pleasing to talk to many investors in the room about their own personal experiences and their shared support for a solution. The urgent need for early and accurate detection could not be stronger. CLEO's simple and accurate #bloodtest is built to close the gap. Our initial commercially available test is in the final stages ahead of FDA 510(k) submission in H1 CY2027. CLEO is pioneering the transformation of ovarian cancer detection with the ultimate goal of delivering positive outcomes for #womenshealth globally. Watch the presentation here: bit.ly/4xSCgBe ASX.COV #invest #ovariancancer #womenshealth #diagnostics #medtech #ASX

$COV.ax Enters Analytical Validation Phase ▪️ Following completion of commercial assay development and key preparation activities, CLEO now enters the formal pre-#FDA submission validation phase ▪ #analyticalvalidation expected to commence next month upon receipt of first manufactured batch of CLEO’s test kits from Bio-Techne ▪ Three-batch validation design adopted to demonstrate assay reproducibility and manufacturing consistency in accordance with FDA requirements ▪ #clinicalvalidation preparations advanced, supporting efficient progression towards FDA 510(k) submission in CY2027. Link to release: bit.ly/4wDlOUK #CleoDX #ovariancancer #cancer #medtech #womenshealth ASX.COV #invest

$COV to present this week at @VEvents_RIU Gold Coast Investment Showcase Event. Event details: When:  Thursday, 11 June 2026 Time:  11.15am AEST Where:  In-person - JW Marriott Gold Coast Resort & Spa, QLD. Register to attend: bit.ly/COVGCinvest #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth @jaxoncrabb ASX.COV #invest

CLEO Establishes U.S. Reimbursement Pathway Ahead of FDA Submission ▪️ CLEO to enter U.S. market under miscellaneous CPT code 81599 immediately post-FDA clearance, enabling early billing and real-world utilisation data capture ▪ Reimbursement determined via cross-walking to comparable multi-biomarker tests, which have reported reimbursement levels of ~US$500-US$900 per test, supporting CLEO’s initial pricing discussions ▪ Represents the first step toward securing a dedicated CPT code, supporting long-term reimbursement and commercial scale. Link to release: cdn-api.markitdigital.com/ap… #CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

Cleo Diagnostics Quarterly Activities Report March 2026. Link to release: bit.ly/MarchQuarter #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth #invest ASX.COV

$COV.ax Commences Kit #Manufacturing Program ahead of #FDA Submission. ▪️Initial phase of staged manufacturing program now underway with @biotechne to support production of CLEO’s test kits ▪ Follows completion of sample collection for CLEO’s pivotal #U.S. #clinicaltrial, marking transition to analytical validation and clinical sample testing ▪ Staged approach designed to reduce technical and manufacturing risk ahead of full-scale test kit production and FDA 510(k) submission. Link to release: bit.ly/4sZ45Vy #CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV.ax reaches Key Milestone with Completion of Sample Collection for Pivotal U.S. Clinical Trial. ▪️514 blood #samples collected for CLEO’s #clinicaltrial, representing a key step toward the Company’s #FDA submission for its Pre-Surgical #OvarianCancer Test ▪ 624 women enrolled across 19 U.S. sites, demonstrating strong trial execution supporting a robust final study dataset ▪ Binding manufacturing agreement for test kit production remains in the final stages following recent #biomarker panel optimisation ▪ Achieving sample target moves CLEO into final execution phase comprising pre-verification, analytical validation, sample testing, clinical data analysis & validation. Link to release: bit.ly/3Obrnt5 #CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV.ax Completes #Biomarker Panel #Optimisation Ahead of FDA 510(k) Submission. ▪️Biomarker panel expanded from five to eight biomarkers, improving analytical robustness, reproducibility and commercial manufacturability. ▪ Optimised panel has been designed for high #throughput Ella™ platform, supporting scalable global deployment without compromising #performance. ▪ Binding #manufacturing agreement imminent, with partner aligned and experienced in development and production of the selected biomarkers. ▪ Test kit production to support #FDA analytical validation activities to commence immediately following execution. Link to release: bit.ly/4lSUM7W #CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV.ax Confirms Next Generation Platform to Deliver its Ovarian Cancer Test. ▪️Bio-Techne’s Ella™ selected, a next-generation automated #ELISA platform, as the #immunoassay instrument for CLEO's #ovariancancer blood test. ▪️@biotechne (NASDAQ: TECH) is a global developer, manufacturer and supplier of high-quality reagents, analytical instruments and immunoassay technologies. ▪️The Ella™ platform can deliver materially improved assay sensitivity, precision and automation compared with conventional ELISA platforms. ▪️Binding agreement discussions well progressed with Bio-Techne for analytical validation to enable sample testing and clinical trial completion. ▪️Both parties aligned to enter long-term manufacturing supply agreement following completion of these activities. Link to release: bit.ly/4tCUXI1 #CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

February is Ovarian Cancer Awareness Month. Ovarian cancer is often called the “silent cancer” — not because it has no symptoms, but because the symptoms are vague, common, and frequently overlooked. At Cleo Diagnostics, we’re working to change that with our simple blood test for earlier, more accurate detection. Awareness matters. Earlier answers matter. #OCAM #CleoDX $COV.ax #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV End of Year Letter to Shareholders. Link to release: bit.ly/4pU4fwL #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV raises $5M to support U.S. market launch and accelerate screening test development. ▪ $5 million raised through a well-supported placement at $0.60 per share ▪ Funds will be used to support U.S. market entry and commercial launch of Pre-Surgical Ovarian Cancer Test and accelerate development of a mass screening test ▪ Placement introduces highly credentialed institutional and high net worth investors to the register, alongside support from existing shareholders. Link to release: bit.ly/4qfYI3x #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV strengthens cash position with ~$1.7m R&D Tax incentive refund. CLEO now holds a strong cash balance of ~$5.75 million as at 25th November 2025, meaning the Company remains well funded to execute on its key near-term milestones, including the completion of its U.S. pivotal clinical trial and FDA submission next year for its Pre-Surgical Ovarian Cancer Test. Link to release: bit.ly/481Ok9j #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV appoints its first U.S. Key Opinion Leader, Dr Nicholas Lambrou, a leading gynaecologic oncologist and surgical specialist. ▪ Dr Lambrou to support clinical advocacy, publication development, and presentation of CLEO’s technology at major U.S. scientific meetings ▪ KOL engagement represents a key U.S. market entry activity as a part of CLEO’s commercialisation strategy for its Pre Surgical Ovarian Cancer Test. Link to release: bit.ly/3K54PYR #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest