Cleo Diagnostics IPO raises $12 million to develop early-stage detection blood test for ovarian cancer

A novel and patented simple blood test which aims to detect ovarian cancer accurately and early, is the cornerstone of a successful $12 million initial public offering by medical technology company Cleo Diagnostics (ASX: COV).

The Melbourne-based business is focused on advancing its patented and licenced technology development activities after issuing 60 million shares at $0.20 each to public investors in Australia, New Zealand, Hong Kong and Singapore.

On admission to the Australian Stock Exchange, Cleo will have 128.5 million shares and 14 million options on issue and an indicative market capitalisation of $25.7 million.

The company appointed Taylor Collison as lead manager to the IPO and will issue it with 5 million options as partial consideration for its services.

It will commence trade on the ASX tomorrow under the ticker code ‘COV’.

Ovarian cancer detection

Proceeds from Cleo’s IPO will be used to advance a product development strategy for its cancer detection platform to deliver three detection tests for the Triage, Screening and Recurrence markets.

The Triage Test determines whether a pre-surgical ovarian mass is malignant prior to a patient being referred to an oncologist.

Cleo is currently working on test performance and regulatory compliance work on the pathway to US Food and Drug Administration compliance.

To date, the Test has produced strong results to accurately differentiate patients with malignant ovarian cancer from those with benign gynaecological conditions.

The Screening Test aims to identify early-stage ovarian cancer in patients who do not present any symptoms; while the post-surgical Recurrence Test will determine whether a cancer may return following surgical removal and chemotherapy.

The simple blood test measures the patented and novel CXCL10 biomarker, which is produced early and at high levels in all stages of malignant ovarian cancer but not in benign versions of the disease.

They are performed using a sample of the patient’s blood and are designed to be compatible with existing pathology equipment in diagnostic laboratories worldwide.

Initially, Cleo will prioritise bringing the Triage Test to market as its first commercial product, while continuing development and regulatory work on the Screening and Recurrence tests.

Research and development

The blood test is backed by over 10 years of scientific research and development at the Hudson Institute of Medical Research in Victoria and includes two clinical studies involving over 500 patients.

The work has attracted more than $5 million in funding from the National Health and Medical Research Council and Ovarian Cancer Research Foundation, and is supported by OCRF founder Professor Tom Jobling.

Cleo entered into an exclusive agreement with Hudson, giving it worldwide and exclusive rights to use, sub-licence, develop, modify and commercialise the intellectual property which underpins the ovarian cancer blood tests.

Non-invasive diagnostics

Cleo is focused on the development of non-invasive blood-based in vitro diagnostics tests to detect the presence and recurrence of ovarian cancer, which has the highest mortality rate of all gynaecological cancers in females worldwide.

There is no accurate, pre-surgical method to diagnose ovarian cancer, or to differentiate between malignant or non-cancerous (benign) disease.

Ovarian cancer can only be diagnosed following a biopsy after expensive, and invasive surgery to remove the ovaries.

Malignant masses have different clinical management requirements and early detection and diagnosis is vital for adequate clinical management prior to surgery.

Survival rate

Ovarian cancer involving malignant tumours has a low cure rate and despite treatment, over 70% of patients will develop recurrence of the disease within three years.

Currently, the five-year survival rate after a diagnosis of ovarian cancer is 49% and treatment involves expensive, invasive surgery and intensive chemotherapy.

It is estimated that by 2040, the number of women around the world diagnosed with ovarian cancer will rise almost 42% to 445,721 each year.

Most females with ovarian cancer are diagnosed in later life, with the disease being typically asymptomatic during early progression and symptoms easily missed or attributed to other illnesses.

Diagnosis frequently only occurs when the cancer has reached a late and serious stage (either Stage 3 or 4).

Improving standard of care

Cleo non-executive chairman, Adrien Wing, said the licenced blood tests could substantially improve existing standard of care.

“The opportunity presented to address ovarian cancer is urgent. An accurate and early detection blood test could shift survivability for ovarian cancer if the test can detect the cancer early enough.” he said.

“There is currently no accurate, pre-surgical method to diagnose ovarian cancer, or to accurately differentiate between malignant and benign masses.”

“This is simply not good enough… research shows that if accurately detected early, 94% of patients can live longer than five years after diagnosis,” Mr Wing said.

“When it comes to other female cancers such as cervical and breast, where early detection testing is available, survivability rates are now at 74% and 92% respectively.”