Cleo Reports A$7.3M Cash and Expanded Trials for Ovarian Cancer Blood Test
Cleo Diagnostics reports steady progress in its U.S. and Australian clinical trials for an ovarian cancer blood test, maintaining a solid cash reserve of A$7.3 million as it prepares for FDA submission.
- Ongoing patient recruitment in U.S. clinical trials with expansion plans
- Australian trial broadened to include Royal Women’s Hospital and Siles Health
- On track for FDA submission of ovarian cancer diagnostic blood test
- Appointment of new Head of Operations with manufacturing expertise
- Cash reserves stand at A$7.311 million as of December 2024
Clinical Trial Progress in the U.S.
Cleo Diagnostics Limited (ASX:COV) has reported meaningful advancements in its December 2024 quarterly activities, particularly in its U.S. clinical trials aimed at validating its ovarian cancer diagnostic blood test. The company has completed onboarding and activation of seven medical recruitment centers and is actively recruiting patients. Plans are underway to expand the trial network by adding up to six more sites, a move designed to accelerate patient enrollment and meet critical data collection milestones.
Expansion of Australian Clinical Trials
On the domestic front, Cleo has broadened its Australian clinical trial by incorporating two significant healthcare providers: The Royal Women’s Hospital in Melbourne and the Siles Health network, which operates 13 clinics across Melbourne and regional Victoria. These additions bring respected specialists, Associate Professors Orla McNally and Charles Siles, as principal investigators, enhancing the trial’s clinical rigor and reach. This expansion underscores Cleo’s commitment to robust validation of its test in diverse healthcare settings.
Strategic Corporate Developments
Beyond clinical progress, Cleo is advancing its product development strategy for the pre-surgical triage market segment. The company is finalizing negotiations with its preferred manufacturing partner, pending completion of alpha prototype testing. The recent appointment of Nathan Hodgson, formerly of Merck Germany, as Head of Operations signals a strategic strengthening of operational capabilities, particularly in contract manufacturing and supply chain management.
Financial Position and Governance
Financially, Cleo maintains a healthy cash position with A$7.311 million in reserves as of 31 December 2024, providing a runway estimated to cover approximately seven quarters of operations at current cash burn rates. The company’s Annual General Meeting held in November 2024 saw all resolutions passed, including director re-elections and approval of a 10% placement facility, reflecting shareholder confidence in the company’s direction.
Looking Ahead
With clinical trials progressing and regulatory submission on track, Cleo is poised to potentially transform ovarian cancer diagnostics. The company’s modular execution strategy aims to address multiple detection markets, including surgical triage, recurrence, high-risk, and early-stage screening. However, the path to FDA approval and commercialisation remains contingent on successful trial outcomes and regulatory review.
Bottom Line?
Cleo’s clinical and operational momentum sets the stage for a pivotal FDA submission, but trial outcomes will be the ultimate market catalyst.
Questions in the middle?
- How quickly will patient recruitment accelerate with the expanded U.S. trial sites?
- What are the anticipated timelines for FDA submission and approval?
- How will the appointment of the new Head of Operations impact manufacturing scale-up?
