Consensus community valuation
I believe the opportunity for Rhythm is huge, if they can execute a commercial strategy well.
Currently the most common procedure is at home faecal tests, which detect blood in the faeces. These are prone to false positives and not suitable for IBS or haemorrhoid sufferers. If a postive result the patient is sent for a colonoscopy, which can be extremely expensive. ColoSTAT accuracy & specificity has tested better than the standard currently used faecal tests.
The company claims ColoSTATs main benefits are less invasive, more accurate, more cost effective and reducing the incidents of false positives.
In response to @GavCo concerns. The company aims to sell directly to pathology testing labs, and marketing the availability of a blood test to Doctors, who in turn can recommend ColoSTAT in lieu of their regular at home faecal testing.
Regarding competition. There are alternatives on the market or in clinical trials currently. ColoSTAT test will be used in standard lab testing where protein biomarkers are detected. Volution Rx Nu.Q is a similar solution which is still in trial phase. Applied Proteomics Simpli Pro Colon is another, which I cant seem to find much information on, perhaps someone knows whether this is on market and the effectiveness?
The other blood based tests on or entering the market are molecular tests which require specialist instruments and analysis. They also require extraction of DNA/RNA prior to testing. This can all be very expensive in comparison.
Exec Chairman (Otto Buttula) and CEO (Glenn Gilbert) hosted the call.
Rhythm's initial product, ColoSTAT® is a simple, low-cost blood test for the early detection of colorectal cancer for global mass-market screening. IP protection secured in all major international jurisdictions.
Not much new, call was brief (25 minutes)
Topics covered:
Big Picture
The vision is that ColoSTAT becomes part of standard range of blood tests for +45 years old. Empasised the simplicity of the end-to-end testing and reporting process. And the fact that ColoSTAT can integrate with all major existing pathology machines. Belief that more people will screen with blood test as part of routine testing and therefore bowel cancer detected earlier.
Trial 7 - the final test for Regulatory Approval - extremely confident that Test 7 will meet all requirements for regulatory approval. All blood tests completed and data entered. Statistical analysis is underway and drafting is underway. TGA filing will occur this half.
Expansion possibilities - the bio-markers being used in ColoSTAT are also applicable to screening or other cancers - breast, pancreatic, lung, gastric and cervical. Believe that they can accelerate from existing platform to accurate blood testing for these additional cancers in short time periods, months to proof of concept.
TGA submission will happen first half, already closely connected to studies, no concerns about gaining approval, have to work the process.
CY'22 Catalysts
- Clinical Trial (Study 7) results and clinical study report completion;
- Technical file complete for ARTG listing for TGA submission and approval;
- Identify and progress partnering / commercialisation deals (Domestic and International);
- International country submissions / registration updates;
- Advance platform technology expansion program (progress updates); and
- Target first revenues late CY'22.
Questions
Are there expectations to raise further capital? "not at all"
Can you tell us about partner discussions underway? "Talking with companies in varying stages in every significant jurisdiction. Well known names that you would expect."
Where first? Think US with Clearlab might be first.
Any indications of test pricing? We've typically been using $50. PSA test is $40 reimbursed in Australia at the moment but ColoSTAT more accurate than the PSA test. Think pricing will be variable - government pricing at high volumes may be lower. Partly competing with colonoscopy at multiple thousands - ColoSTAT potential pre-screening before colonoscopy which interests health insurers. Making significant progress on cost of goods.