Rhythm Biosciences Recruits First Patient At ColoSTAT’s Lyell McEwin Study Site

The Melbourne-based Rhythm Biosciences Limited (ASX:RHY), established in 2017, is a company that develops and commercialises a screening and diagnostic tool for the early stage detection of colorectal cancer in the global mass market. Its flagship product ColoSTAT® is a minimally invasive, affordable and effective blood test designed for laboratory use with no additional operator training or infrastructure.

Recently on March 18^th, Adelaide-based Lyell McEwin Hospital, which is Rhythm Biosciences’ study site for the 1,000-patient prospective clinical trial of the blood test ColoSTAT® (As announced on 20 February), reportedly recruited the first patient for the same.Â

ColoSTAT® has the potential to save many lives through early screening, reduces morbidity and mortality rates, and healthcare costs related to colorectal cancer. The trial is necessarily a prospective, cross-sectional, multi-centre study to examine the diagnostic performance of ColoSTAT® relative to colonoscopy, along with other comparisons to the prominently used Faecal Immunochemical Test. The ethics approval for the trial was received on February 8^th, 2019 from the Human Research Ethics Committee (HREC) of the Central Adelaide Local Area Health Network (CALHN).

Colorectal cancer is estimated to cause around 850,000 deaths every year in the industrial world globally. Although curable in 90% of the cases when detected early, participation in the screening is low. The company aims to sign up more hospitals to the ColoSTAT® trial in the upcoming months to simplify screening and increase participation.

Meanwhile, the ongoing trial is expected to be completed by the fourth quarter of 2019, and the final study report will encompass the critical components for CE Mark & TGA registration and ultimately the approval to market ColoSTAT® in 2020.

In mid-February 2019, the CRO Plunkett Consulting Group, a biopharmaceutical and medical device development organisation, was assigned the mandate to manage operations of the trial (monitoring, data collection and recruitment) while Sonic Clinical Trials was appointed to look after sample collection, processing, analytical testing, transport, recording of results etc.

As per Rhythm Biosciences’ half-year report for the six months to December 31st, 2018, the revenue from ordinary activities amounted to $ 365,265, and the loss from ordinary activities after tax attributable to the owners stood at $ 1.47 million, up on $ 681,322 recorded in the previous corresponding period (pcp), half-year ended December 31st, 2017. At the end of the concerned period, the net cash and cash equivalents amounted to approximately $ 6.43 million, down on $ 8.79 million recorded at the end of pcp. There were significant cash outflows of $ 1.22 million from operating activities and $ 99,468 from investing activities. Further, the financing activities also added up $ 33,742 to the net cash outflows. The cash available at the beginning of the period was $ 7.78 million accumulated from proceeds from the issue of shares under the financing activities carried out in the pcp.

RHY has a market cap of $ 17.63 million to date, with ~ 100.75 million outstanding shares. At the end of the market trading on March 18th, 2019, the RHY stock price closed at AUD 0.170, down 2.857% intra-day.

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