Study 7 clinical study

I think it's time we had a discussion about Study 7, the clinical study which is the final one required before Rhythm starts applying for regulatory clearances.

Perhaps a timeline might inform the discussion:

26 November 2018: AGM presentation: Study 7 Clinical Trial on track for completion in 2019.

9 February 2019: ASX announcement: Rhythm received ethics approval for a 1,000-patient prospective clinical trial of its blood test ColoSTAT® for the early detection of colorectal cancer. "This is an exciting development as we take our first steps for clinical trial
commencement."

20 February 2019: ASX announcement: Adelaide’s Lyell McEwin Hospital to be the first study site for the Study 7 clinical trial. Rhythm appointed boutique CRO Plunkett Consulting Group to manage the operations of the trial and Sonic Clinical Trials
(SCT) to test the samples.

"The study protocol approved by the Central Adelaide Local Area Health Network’s (CALHN) Human Research Ethics Committee (HREC) describes a prospective, cross-sectional, multi-centre study to evaluate the diagnostic performance of the ColoSTAT® In Vitro Diagnostic relative to colonoscopy (Primary endpoint). Secondary endpoints of the study include assessing the ability of ColoSTAT® to detect advanced adenomas to colonoscopy and a comparison of the performance of ColoSTAT® with the currently used Faecal Immune Test (FIT); both relative to colonoscopy. Along with the technical performance and validation documentation being developed as part of the ColoSTAT® product development program, the final study report of this clinical trial (expected Q4 CY19) will form key components for CE Mark & TGA registration and ultimately the approval to market ColoSTAT® in 2020."

18 March 2019: ASX announcement: first patient signed up by Lyell McEwin Hospital. "Study 7 is expected to be completed by Q4 2019."

18 June 2019: ASX announcement: Monash Health, the second hospital to join the prospective clinical trial of ColoSTAT®, with the first patients already recruited.

26 June 2019: ASX announcement: The Alfred Hospital, the third hospital to join the trial.

19 September 2019: ASX announcement: but hang on, they don't yet have the reagents ready to use in the "upcoming clinical trial (Study 7).

25 October 2019: ASX announcement: Otto Buttula comes on board as the new chairman of Rhythm Biosciences.

28 October 2019: AGM presentation: the recruitment for Study 7 has commenced and the reagent development program is "advanced".

23 July 2020: ASX announcement: the $6m raise through the placement and entitlement is announced. It was all done and dusted by the beginning of September 2020. Otto goes huge by putting in $1.5m at 6 cents a pop.

10 September 2020: ASX announcement: John Hunter Hospital, part of the Hunter New England Health network, the fifth hospital to join Study 7 (must have missed the announcement about the fourth hospital).

23 September 2020: ASX announcement: Illawarra Health & Medical Research Institute, based at the University of Wollongong, the sixth site to join the trial.

27 October 2020: ASX announcement: Northern Beaches Clinical Research (NBCR), based in Sydney’s northern suburbs, the seventh site to join the trial.

12 November 2020: ASX announcement: ColoSTAT prototype test-kit completed.

19 November 2020: investor presentation: Clinical trial based on "< 1,000" patients and estimated to be completed by "Q2FY'22", and the reagent development program completed.

21 December 2020: investor presentation: unchanged - Clinical trial based on "< 1,000" patients and estimated to be completed by "Q2FY'22".

19 January 2020: ASX announcement: Concord Repatriation General Hospital, based in Sydney’s Inner West and Bendigo Cancer Centre based in the Bendigo Hospital, joined the trial (eighth and ninth sites).

28 January 2021: Quarterly report: Rhythm have adopted a competitive recruitment remuneration strategy across all trial sites, whereby each site is remunerated (excluding non-material one off set up costs) for the number of patients they recruit to the trial. Also, the Royal Melbourne Hospital was the fourth site signed up. With the impact of COVID-19 affecting Rhythm’s partner suppliers, the Company is unable at this time to provide a specific, updated timeframe for the achievement of its key milestones, associated with the clinical trial, CE Mark and TGA regulatory submissions.

11 February 2021: ASX announcement: Sunshine Coast University Hospital, Queensland, joins as the tenth site as part of the trial.

So my take on things is that the company said in late 2018 that it would complete Study 7 by the end of calendar 2019 but in September 2019 it states that the reagents are not ready yet (and presumably without the reagents the clinical trial cannot begin). Since September 2020 they have signed up 6 hospitals and by November 2020 they announced that the reagent and prototype test-kit programs have been completed. They are now blaming COVID and maybe some of the hospitals they signed up for the delays.

In my document review I could not find a single time the company explained what Study 7 actually consists of, how long it takes to get results from a single patient and why it is now over a year overdue. I reckon COVID is an additional problem rather than the core reason for the delays - no doubt COVID has disrupted things more recently but Study 7 was supposed to have been done and dusted long before COVID hit. I suspect the delay in completing the reagent development program and /or test-kits was more of a factor, after all, why would they run their clinical trial not using the finished product (biomarkers, algorithms, reagents).

What have I missed or misunderstood? I remain comfortable that the company is making progress and I appreciate the sizzle and momentum they have been generating in recent months. But I don't like having the feeling that the company is holding back on what is the make or break issue, which is how the clinical trial is progressing.