Cleodx

$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

Reminder: $COV to present today at @VEvents_RIU TechKnow Invest Webinar Event. Register below to view. Event details: When:  Tuesday, 18 November 2025 Time:  from 12pm AEDT Where:  Virtual Register: bit.ly/COVtechknowNov… #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth @chapter1advisor @David_TaskerIR @jaxoncrabb ASX.COV #invest

article: @SmallCapsASX CLEO Diagnostics Expands US Addressable Market for Pre-Surgical Ovarian Cancer Test smallcaps.com.au/article/cleo-d…

article: @StockheadAU Health Check: It’s all the way in the USA as ASX medtechs ramp up in Trumpland stockhead.com.au/health/its-all…

$COV significantly expands U.S. addressable market for its pre-surgical #ovariancancer test. ▪ Updated U.S. insurance data identifies over ~2 million women per year could benefit from CLEO’s Pre-Surgical Ovarian Cancer Test ▪ Findings reinforce the unmet need and significant commercial potential for CLEO’s patented technology ▪ Data will inform a broader health economic study to support CLEO’s market entry, reimbursement and early revenue generation. Link to release: bit.ly/43Jdyqk #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

Reminder: $COV to present today at JMM Sydney Opera House Virtual Event. Event details: When:  Tuesday, 28 October 2025 Time:  10.50 AEDT  (event commences 10.00am) Where:  Virtual - register at bit.ly/COVJMMvirtual #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV Chief Scientific Officer, Dr Andrew Stephens & Head of Corporate Development, Dayna Louca, will present at the @JMM_Australia Sydney Opera House Investor Event this week. Investors can still register to attend the follow up virtual event on Tuesday, 28 October 👉 Register here - lnkd.in/gWfyZ_Rc Cleo Diagnostics (ASX:COV) is transforming ovarian cancer detection with it accurate and simple blood test. Ovarian cancer is often diagnosed late, resulting in an alarming 5-year survival rate of just 49%, compared to #breastcancer which has a 92% 5-year survival rate - highlighting the urgent need for earlier detection. For more information, go to cleodx.com or email us at office@cleodx.com #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV continues on pathway for U.S. regulatory approval with positive feedback received following second FDA pre-submission meeting. ▪ FDA guidance supports CLEO’s clinical trial design and regulatory positioning. ▪ Feedback reinforces alignment with FDA expectations, reduces regulatory risk and positions CLEO strongly ahead of its upcoming 510(k) submission. Link to release: bit.ly/3HWoCcc #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV commences Health Economic Study to support U.S. market entry. ▪ Partnership with EntityRisk to provide evidence-based insight into the economic value of Cleo’s Ovarian Cancer Pre-Surgical Test in the U.S. ▪ Partnership with Norstella to examine detailed physician and claims data to identify high-value launch markets and maximise early adoption potential. ▪ Refined Total Addressable Market estimate to accelerate payor reimbursement negotiations, and drive investor confidence ahead of commercialisation. Link to release: bit.ly/3UtS7Vk #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV Quarterly Activities Report - June 2025. Cleo Diagnostics is bringing to market a simple blood test for the accurate and early diagnosis of ovarian cancer. Link to release: bit.ly/45dw3nS #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

Video Replay: $COV Investor Webinar of 25 June. The webinar features updates on the Company’s progress and commercialisation pathway for its simple blood test for the accurate and early detection of Ovarian Cancer. Link to video: bit.ly/469gVsT #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

$COV strengthens its planned FDA Submission following approval from U.S. National Cancer Institute (NCI) to access blood samples from the Prostate, Lung, Colorectal and Ovarian Cancer (PLCO) Screening Trial. CLEO will use samples from PLCO biobank to: ▪️Generate data to strengthen its FDA 510(k) submission for the Pre-Surgical Test ▪️Accelerate development and commercialisation of its Screening Test. Recruitment for U.S. clinical trials ongoing with completion anticipated Q4 CY2025. Link to release: bit.ly/3ZLtkz0 #CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest