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 welcome to CEO insights I'm Marilyn dezman with investing news.com I'm speaking with Richard Alman CEO and executive director of Australia based Cleo Diagnostics hi Richard hi Marie nice to meet you nice to meet you as well let's start our conversation with just you providing an overview of Cleo di Diagnostics and your unique B value proposition so Cleo Diagnostics is a relatively new company we listed on the ASX just last August and we are bringing to Market um portfolio of products to

address a very problematic clinical need and that is a simple blood test for the accurate and early detection of ovarian cancer now while this is a very nasty disease and there are no real existing screening tests for ovarian cancer no real Diagnostics that perform very well so it means that the addressable market for such a product is extremely large and the technology that we are utilizing is supported by gold standard clinical evidence the technology originally came from a research program at the Hudson Institute of Medical

Research here in Melbourne which is has been running for over 10 years um headed by our chief scientist Dr Andrew Andrew stens and the product is supported by an extremely robust intellectual property position we have granted patents both here in Australia and in the USA and shortly to be granted in Europe supporting the product but I think most importantly from an investment perspective one of the strengths of the company is that we've invested a lot of time and effort building the commercialization strategy and the

subsequent um clinical implementation strategy and it's very common for Diagnostic companies to think that once they've achieved regulatory approvals then they've got instant sales and it's not true of course so we've put a lot of effort into building the platform that will allow us to achieve those sales fairly early on in the lifetime of the company right so let's talk a little bit more I guess U so the the screening that that you've developed for ovarian cancer could be a game changer for Women's

Health could you sort of explain why that is and why it's important for uh for this space absolutely now ovarian cancer is a very NY disease very Insidious very difficult to diagnose um quite often um a patient will not have any symptoms until the disease is very Advanced and the result of that is that most cases of of ovarian cancer are detected very late stage four by and large and the key outcome from that of course is that the 5e survival for aarian cancer is somewhat under 50% now that doesn't mean that 50% of

patients Will Survive 5 years that's just your likelihood of living for 5 years or more the the actual outcomes are worse than that and the reason behind that is all about early detection now ovarian cancer like most solid tumors can be very successfully treated with surgery if it's caught early the success rate for surgery for stage one ovarian cancer is over 90% And one of the things that we are very excited about in Cleo is that our prototype test data for early stage cancer is Extreme promising and we are

hoping that this technology will be a GameChanger for women so what's the uh what makes this technology unique in the market and could you talk about some you know you've done some clinical studies on it and what some some of the highlights from that from the resort for those I can indeed um let me just tell you a little bit about the existing gold standard methods for diagnosing novarian cancer first because this is important when we're comparing Cleo's products there is an existing biom marker in the

marketplace called ca125 and this only has an accuracy of about 50% so no better than tossing a coin whether you have the disease or not um the standard of care is probably ultrasound um but even the combination of ultrasound with ca125 provides incorrect results about 20% of the time so a lot of the early clinical studies that we've done with Cleo's technology has been evaluating how well our biomarket panel performs in comparison to those existing gold standards and our prototype test

currently has a sensitivity and specificity of a little over 95% which is significantly higher than anything else that's in the marketplace at the moment um it has an accuracy for detecting early stage cancer in excess of 80% and it's this really those combination of figures which is driving our excitement and pushing us to bring this to Market as quick as possible so you're you're back to commercialization like what where's the um technology at right now and what's the path to

commercialization so we've developed a three-phase commercialization strategy um so that we'll be essentially bringing forward three different products but all based on the same underlying technology um and the reason for that really is that it allows us to bring the mar the product to Market much quicker now that first product will be something we call a pre-surgical triage test and that test is designed to identify whether a lady with symptoms has got ovarian cancer or whether she's got some sort of benign

ovarian disease like an ovarian cyst now the reason that is so important is that if the lady does have ovarian cancer then their chance of chances of having a good outcome is much better if they are assigned to a surgical oncologist straight away now at the moment that doesn't necessarily happen a lot of ovarian cancers are passed to general surgeons and the outcome is significantly worse for those patients now the flip side of the coin of course is if a lady has benign disease they can be assigned a general surgeon or they

may not need surgery at all because at the moment there's no way of diagnosing ovarian cancer pre-surgically a definitive diagnosis is only made after surgery so what that means is if you don't have ovarian cancer you've actually had your ovaries removed to find that out and you can't simply put them back again so this type of test has a significant clinical benefit to patients now the second product that we'll be bringing to Market is a recurrence test and that's designed for

use in patients who've had that initial surgery and whether their cancer is recurring or not now it's the unfortunate reality at the moment that most patients with ovarian cancer will recur within 18 months after having that initial surgery so this type of test if we can identify that recurrence earlier it's not about um generating cures with this type of test unfortunately but it does allow doctors to offer a second line treatment much earlier and improve their quality of life now the third sty test that we're

bringing to Market is what we call the the Holy Grail in ovarian cancer and that's a general screening test for the general population um perhaps to be offered at the same time as mammographic screening for breast cancer for example be a simple blood test um to identify very early on whether you have ovarian cancer or not now that is a significant medical breakthrough if we can bring that to Market because there is no such ex uh existing screening test for ovarian cancer at the moment and the key thing which allows us

to envisage that we can do that is the ability of our technology to detect early stage cancer no so which um what are the plans for where which Market to launch this are marking to the launching to the US market when it's available and what's the progress on that and also could you talk about some of the upcoming catalysts for this absolutely so we have a a very strong strategic plan in place and we will be launching that triage test in the USA first the reason being is that there are existing commercial

tests for ovarian cancer on Market in the USA which have FDA approval now that means that we can submit Cleo's test for FDA approval in a very short time frame um we aring to do that in approximately 24 months time and because we are benchmarking Cleo's technology against an existing test it means that the clinical trial requirements are actually quite small and we do not have to um generate an extremely large clinical trial it's only about 500 patients and it's a simple benchmarking exercise of Cleo's

technology against those existing tests now we already know that Cleo's performance is extremely good and significantly better in those um existing tests so we are very optimistic that that FDA approval process will be quite short um we're estimating about 60 days after submission of our FDA package the strategy after that of course is to take the product to Europe and to Australia and the strategy um in both jurisdictions is that we'll utilize that FDA application and put forward um a

application to both Europe and the TGA who will conduct something called a Conformity assessment to see whether the package that we put forward to the FDA meets their requirements and it's not quite a a rubber stamping exercise but it's not far off if we get that paperwork initially with the FDA cor correct um in terms of catalysts a lot of these catalysts that we'll be announcing over the next 24 months are really related to that project management plan over the next 24 months and they will include things like the

manufacturing process um we are speaking to a number of potential manufacturers full of kit at the moment um and that will be announced to the market quite soon I would think um we'll also be coning the clinical studies that we need for that FDA application within the coming weeks and months and the other catalysts that will be announcing to the market over the next 24 months are essentially tick foxes on that project management plan and providing we execute our jobs in a timely manner um that that FDA package

will be submitted in approximately 24 months time now clearly the most important Catalyst that will be announcing to the market will be that FDA application and it's such an important announcement for the company because we uh are putting steps in place at the moment so that we can start implementing that initial test in the clinics as soon as possible after that FDA approval and as I mentioned earlier on this is something which um I think that a lot of diagnostic companies don't think of until after they've got

their EG approval um and if they don't think of these things they often have this dead space after FDA approval where they don't get any sales so one of the things that we are working very hard on at the moment to address that and ensure that we get sales um after the r approval is that we're putting in a number of building blocks for the company to make sure that we've got early adopters in the clinics ready to go straight away and perhaps two of the things that I'll just mention very briefly is about

external collaborators and key opinion leaders who will be working with the company we will be establishing two very large International research collaborations with a couple of very famous International cancer research organizations one in the USA one in Europe in the near future and we are supporting the products with a very robust publication strategy and I'm talking here about scientific and medical Publications in in the medical literature now the reason these Publications are so important is

that they essentially are the key marketing collateral for Cleo very early on in our commercialization process they tell the doctors how well Cleo's technology is performing but they also allow us to open discussions with the Private health insurers particularly in the USA because this provides evidence to those companies whether they should reimburse Cleo's tests or not and the third Place those Publications are useful is because they allow us to make a case to get into the clinical guidelines not

just in the USA But Here in Australia and in Europe as well now if Cleo's tests are in those medical guidelines that provides a very strong drive for clinicians to start using Cleo's tests sounds like a you know important part of that strategy so when you're speaking to um investors right now what do you tell them uh if they ask you why is now the good time to get involved or get involved with clear B sticks what makes you a compelling investment opportunities I think the the the key to

this and I'm going to go back to our very robust project management plan because we released our first clinical validation data just a few months ago in October in the next week or so we will be announcing our first clinical utility data and what I mean by clinical utility data is how well Cleo's test works in the clinic for providing useful clinical information to the doctor um and that first clinical utility data will be explaining to doctors how well Cleo's technology works over and above the existing biomarker

ca125 and that initial clinical utility data tells us um that Cleo's technology correctly identified most of the cancer cases that were missed by that existing test ca125 extremely important data for the clinician to see now to answer your question in more detail about why people should invest in Clearo at the moment I think the importance of these announcement ments that we're putting out at the moment and in the coming 6 to 12 months is to show the market and give them confidence that

we are executing on our project management plan um one of the things that we were very conscious of when we were putting these strategic plans in place for the company is that we didn't want to be a blackbox company and not release information to the market until we've got reg approval um essentially we will be updating the market as we tick off each of these project management milestones and I think that's very important for a biotch company um it's quite often in my experience that we see other biotechs in

the space um that don't release information on a regular basis and it doesn't help investors to have confidence and I think that's something we are very conscious of um and we are not an R&D company we are a commercialization company aiming to generate Revenue at a very early stage in the lifetime of the company um and I think it's very important um that we have these catalysts on our project management plan and we take them off over the next 12 months certainly a technology that I think we um you know

something that we need especially for um improving Women's Health thanks Richard for sharing your um company insights today uh and good luck to all your um Endeavors this year fantastic thank you and thanks everyone for watching join us again next time for another d conversation on CEO insights if you like this video make sure you subscribe to our Channel and turn on notifications so you don't miss future updates and interviews see you next [Music] time for