Good afternoon and welcome back. It's my pleasure now to introduce to you the Managing Director and Founder of Proteomics International, Dr. Richard Lipscombe. Good afternoon, Richard.
Hello, John. Good to chat with you again.
Yeah, likewise. Great to see you. Of course, the company's flagship product is PromarkerD for the detection, rather, of early onset kidney disease. Richard, it's been an interesting year for you guys. You're progressing the marketing of the tests in the U.S. and elsewhere. How have you seen it?
It's been a great year for us. As you said, the lead product is PromarkerD for diabetic kidney disease. We've got the other tests that are also coming to the market this year. For us, it's been a foundation year where we established our lab in the U.S. so that we can provide our tests under the regulatory banner there called CLIA, or laboratory developed tests. We can use that same lab for our other tests that are coming through. We've got accreditation to national standard here in Australia for clinical testing, so we can run our tests in our laboratory as well, which means that the rollout is current and we're in that ramp-up phase. It's been a very strong start to this financial year for us.
That's great. Great to hear. Let's run through the few slides that you've got there, and then we'll come back and dive into some of those areas in more detail.
Great. Yeah, what we want to emphasize is that we do have those four products in our diagnostic suite for diabetic kidney disease, esophageal cancer, and endometriosis, and a test for oxidative stress and OxiDx . They're each first-in-class diagnostics. They're addressing large markets with significant unmet medical needs. Importantly, the tests are validated in large clinical studies. We have the largest data sets for each of these tests in the world to show that our tests are doing what we say they're doing. That's a very important aspect of our development pipeline. Each of our tests shows significant advantages over standard of care. Also, to focus on the products that have been developed, we've got immunoassay and mass spectrometry platforms, but these tests are developed, they're patented, and they've got high margins. We're then using a customer-driven strategy where we're targeting primary care and GP clinics.
We have a digital platform which has been built, and we've got experts, key opinion leaders from around the world wanting to work with us because they see our tests as making a difference. We are funded to execute these launch strategies, and this is about strategic positioning to secure licensing agreements and additional partnerships in due course. Recapping on those three tests, what's the problem that we're solving? We're targeting major diseases which are currently detected late. The outcomes from those diseases are poor, poor for patients, poor for healthcare systems. We have diabetic kidney disease with PromarkerD. This is a predictive test that can tell who will develop kidney disease up to four years in advance. One in two people with diabetes will develop chronic kidney disease. It's a really significant issue. We have reimbursement pricing pending. We're looking forward to talking about that shortly.
Ramp-up phase, as I said, for Australia and the U.S. where the test is live. Endometriosis, very exciting tests garnering a lot of interest. This is a condition where the tissue grows outside of the uterus into areas where it shouldn't belong. It takes up to seven years to diagnose, and the current gold standard is invasive surgery and laparoscopy. This test we have launched pending this calendar year. The esophageal cancer test, think acid reflux. If you've got acid reflux, is it simply that or is it something more significant? Our test can help rule out esophageal cancer. It is an alternative to endoscopy, which is again a surgical procedure where a pipe is put down the throat and a biopsy taken. This test has just gone live in Australia with the U.S. pending. Finally, but not least, we have oxidative stress.
This is a unique diagnostic for assessing muscle damage and performance, particularly exciting results in the horse racing industry, but also for sports medicine in high-performance athletes and potential in animal welfare as well. What we want to emphasize is we're in that market launch and ramp-up phase. It's about maximum optionality for strategic partnering. We've been focused on getting the tests live. We've built the platform. That platform can be transferred into other partners. It provides us the fastest pathway to achieving product launch and revenues. We have reimbursement pricing imminent for PromarkerD. The other tests will follow. We know that process extremely well, and that will be pricing for the other tests through 2026 and beyond. The pricing is very important for reimbursement. We've demonstrated market sales and adoption. That's where we're currently being focused.
We're engaging with GPs and primary care physicians, growing market awareness. You can't get people interested in your test if it's not on the market, and that's what we've done. We've built that attractive platform, a digital platform, which appeals to both patients and primary care physicians and GPs. That's attracting the interest of larger partners, potential groups that we can work with to sell and market and further license our tests. We're in that phase of growing interest and awareness for strategic partnerships. We have ongoing dialogue with prospective partners. We have that maximum optionality, as I indicated. We can drive revenue through our existing platforms. We have the option to partner and do a non-exclusive agreement and still retain those digital platforms, or we can out-license completely. That's for each of the four tests that we have.
We will be a different route to market slightly for each of them. The primary route of that digital platform is built and will be used for each of the tests. We have a rich suite of milestones that we have already completed through financial year 2025. As I said, that was about building our platform, building our tests, getting them market ready, showing that the tests will work. We have established the laboratories in the U.S., in California for running clinical samples. Our laboratories in Western Australia can run clinical samples. We have a network of blood collection sites available in Australia. We have a catalyst-rich financial year ahead. It is focusing on the launch. We have initiated the sales so that we can generate revenues and increase that awareness for significant partnerships.
Both the diabetic kidney disease, esophageal cancer, and endometriosis tests are live or going live in the coming months. That opens the opportunity for us to do licensing deals. That is the real focus for now and through the first half of 2026. We will continue to generate new tests with our technology platform, that disruptive platform which gives us our market advantage as well. Then focusing on reimbursement and getting the pricing in place so that the insurers and the healthcare systems can pay for the tests, really focusing on the U.S. In summary, we have four first-in-class blood tests for major diseases and conditions with significant unmet need. We are in that ramp-up phase for PromarkerD and ProMarker Eso tests with first sales already achieved.
It is a commercial platform that's been developed to drive awareness of the tests both from a consumer and an industry perspective so that we can attract those strategic partners. Our proprietary platform technology does let us develop further tests. We have all the funding that we need in place to deliver the tests as we're discussing. We have the team, we have the infrastructure, and the certifications. It is a very exciting time for us, and we're looking forward to a very productive 2026, as I said.
The U.S. for PromarkerD. You said that you've launched the test in the United States, but you're waiting on reimbursement there. How does that work? What are patients doing today if they need the test today ahead of a reimbursement situation?
Yeah, the U.S. system is complicated at one level, but once you understand it, it makes a lot of sense. For today, it's a self-pay model, so patients pay out of pocket. Once the pricing is set, the insurance agencies can adopt that price and put the test onto their panels, and then patients can get the price of the test refunded through their insurance plans. In the interim, there is also a gap opportunity as well, gap payment, where patients have to spend a certain amount of money before their insurance kicks in anyway. The PromarkerD test is at a $390 U.S. test, which is a very affordable test. There is an appeal to using a test like ours, particularly as a screening test because the cost of dialysis and treating kidney disease is so high.
We're at that stage of early ramp-up. We're focusing on California as our primary market where we go through the processes and make sure that the logistics work well. The real driver will be post-pricing, which will be announced in the next few weeks, and that will become effective at the beginning of next year, and from there we can build.
Okay, so what level of reimbursement coverage would you expect from Medicare in California?
We're expecting a price of $390. That's what we're hoping for. The test that we're currently going through, that reimbursement pricing, is what we call our next generation test, which is our version two. Version one had a price set of $390 two years ago, and version two is, as effective diagnostically, a little bit simpler to use. We're anticipating the same price. We won't know until it's announced, but that's the figure that we're aspiring to.
That $390 U.S., that gets paid to you as the lab conducting the test. Is that right, or have you got to split that revenue with somebody else?
Correct. That's the benefit of us having our own facilities, is that the revenue comes directly to us. We're not paying royalties to others or receiving royalties from other groups who are running the tests. We have our own laboratory. We have the logistics in place, the blood collection. Obviously, there's the costs in collecting the samples and running the test itself, but it's a high-margin test, and that puts us in a good position.
In terms of attracting the test or publicizing the test to referring primary care physicians, who is your market and who are your referrers in the U.S.?
It is at two levels, John. We can do a digital marketing campaign, but the whole telehealth world is there. It is very strong in the U.S.. We have a platform that we built, myTEST.health, which allows patients to find out about our tests and order them directly if they wish. The other route is through primary care physicians. We have representatives on the ground in California who have been attending a whole suite of conferences run for GPs in the different areas of California over the last six weeks and interacting directly with the professional organizations and making them aware of our tests. We are finding that there is a huge amount of interest and that those doctors want to start ordering the test. They want to know about the pricing and when that is coming through.
The test itself is a no-brainer for them, particularly for diabetic kidney disease. It's the first one, and they want it for their patients.
Okay. Just one more question on reimbursement, if I may. It's a complex field, reimbursement in the U.S. Do you need to go down the avenue of getting local coverage determination for California, or is it going to be, I think, universal coverage across the entire country in the first instance?
We anticipate that there will be local coverage determination, but that would be nationwide. There are some nuances in that and slight discrepancies with different states from California, and that comes under what's called the MolDX banner. We would anticipate that coverage there would then be secured for the whole country. There are some more steps to go through to get that full Medicare reimbursement, so full Medicare coverage, and it's fully paid. That will be the next step once we've got pricing secured.
Okay. For calendar year 2026, I'm talking calendar year rather than fiscal year, you're coming into that new calendar year with, I suppose, a beachhead in the U.S. market in California. The next step is reimbursement from January 1. You can really ramp up the market in California. That is pretty much, well, it's a very large test market, I suppose, but it is a limited market release.
It's a limited market release, but we're in a dozen plus collection sites in the LA region of California, and that's greater than the population of Australia. So whilst it's a test market, it's a very substantial test market.
Yeah. Can you give us any indication of how your weekly test numbers are trending?
At this stage, very early days, so we haven't given guidance on that. The numbers have got a long way to go to get to the levels that we'd like, but that's to be expected. It's a new test. People are getting familiar with pricing. As the pricing comes through, we see opportunities for the volumes to grow. As I said, the other key point of this is awareness. Because the test is live in California, we're getting approached by other groups across the U.S. who say, "How do we get access to your test?" It is not just about sales volumes for us. It's about, as you said, building that beachhead and then getting awareness and strategic partnerships is the real key game.
Yes. That is interesting that you said that because you had the strategic partnership with Sonic a couple of years ago. It did not work out for various reasons. Now others are coming to you offering their services. I suppose you have once been twice shy, or do you think you will keep it in-house?
We have that benefit of being able to keep it in-house and white label it. We have that reference lab. We can take other people's samples and run it through because we're fully certified ourselves. That is a very strong position to be in. We have the test up and running in our facilities in the U.S., so the tech transfer to another laboratory is also a straightforward exercise. They can send their teams to our lab to see how it's running. We are in a much stronger position than we were a couple of years ago with the previous partnership.
Okay. Okay. Now the market size, one in two people, you said, with diabetes is at risk of developing diabetic kidney disease. Obviously, there's been an explosion in the level of diabetes over the last decade mainly due to fatty food content in our Western diet. How big do you believe that the market is in the U.S.?
The U.S. market's 30 million people approximately, 32 million with a number of people with diabetes. That is the target market. There is another 30-odd million people with prediabetes who will move into that diabetes bracket. All of those patients are either at risk or some of them already have chronic kidney disease. Our test can work out which patients they are and what we can do about it. It is a very large market.
Okay. Just to finish that point off, your test comes up with a higher, medium, or low risk of developing diabetic kidney disease. For those people who do require intervention, if they come back with a higher risk rating, what can be done to ensure that their kidneys don't give out or to at least preserve their life?
Yes. There is a number of classes of drugs now which have been used for diabetes, which are now being prescribed as renal protective. Ways of early treatment of diabetic kidney disease. There is a class called the SGLT2 inhibitors, which would be known to people with diabetes, and then GLP-1 agonists, and the exemplar is Ozempic, which everybody's heard of. That drug has been shown to have some benefits to be renal protective. There are a suite of drugs that are available for patients who have diabetes and are in a high-risk category of developing complications such as kidney disease.
Okay. They're in the value of the predictive test. What about the endocrinology? What about the endocrinologist market? You've talked about primary care. What about the specialist market, the endocrinologists?
Yes. Those experts need to be on board. Unfortunately, once the patients are at the point of seeing an endocrinologist, then it's already too late in terms of the kidney disease. We do have a number of endocrinologists who say, "We need to use this test earlier so that we see less patients at that later stage.
Okay. Okay. Let's switch back now and have a chat about the ProMarker Endo test, which has more recently been developed. It's got a lot of publicity. Endometriosis, certainly here in New South Wales, it has. Let's talk about that market. How big is that market, and where are you at with the development and marketing of it?
Yes. Both the endometriosis test and the other one that we have, esophageal cancer, they're both at that stage of following in the footsteps of PromarkerD. The endometriosis test, we have it at the point of it will go live in the coming weeks. That's our expectation in Australia. We have taken it into the U.S. subsequently. We have done a lot of development work. We have the technology that's been established. We've got fantastic clinical data, and we have the platforms in place to run the tests. We're finalising that workflow at the moment, but the Endo test is very close to going live in Australia.
Okay. Okay. So it's past regulatory hurdles at this point?
The regulatory hurdles, again, come back to different options. In Australia, we have what is known as the ISO 15189 path, which is a particular certification that's offered for clinical testing laboratories for specialized tests, and ours is in that category. The endometriosis test will come under that banner, and that's how we'll run the test. That's the certification we already have established for our laboratory for our existing tests.
Just heading down the same path with endometriosis, if the disease is detected earlier, what are the potential benefits to patients?
That's worth teasing out, John, because there's a whole range of areas there with endometriosis where the current standard of care is failing. Currently, several years to diagnose because patients aren't being believed. There's a reluctance to actually test those patients for the disease because that's invasive surgery. Invasive surgery, if the patient doesn't have endometriosis, sticking out a probe in and going around the abdomen can cause all the internal pain that might have been caused by endometriosis or may not have been there. The objective of our tests is to be able to identify which patients have a high likelihood of the disease or a low likelihood of the disease so that then they can be managed appropriately.
For some patients, they simply want to know that they've got endometriosis or that they don't, and then they can manage their pain in a different way. If our test identifies them as having endometriosis, then currently the gold standard treatment is surgery and laser ablation. There are drugs coming through that are being shown to help ameliorate the pain and the conditions. There's a lot of work going on in that area that's limited drug treatments, but there are some. There's a range of options, and that's what we're working with, with our different partners to explore how we could best utilise the test.
Okay. Tell us, Richard, is there an incumbent diagnostic that you're taking on in this market?
There's no established test for endometriosis. There's no blood tests. We are leading the world with this test. We are getting inquiries from around the world. We are putting together a key opinion leader board with experts from across the globe, from the U.S. and Europe, because they can't see any other test out there that can do what our tests can do and with the level of clinical data that we have to support its viability. We are in an excellent position for bringing that test through. From Australia, we'll take it into the U.S. quickly.
Okay. That's moving into the U.S. Presumably there's some leverage there for your CLIA lab that's now established in the U.S. You can equally run this test through that lab, that'll be a center of excellence if you like.
Exactly that. That's the reason that we established the lab with our first test. We're currently in the process of setting up our second test, which is esophageal cancer in that lab. That test is a little bit more advanced than the endo test. The workflow is the same. The lab in the U.S. and our labs in Australia are just following, we have a path and we have a series of, if you like, cabs lined up and the tests are getting in the cabs and they're following themselves to the destination. We are in an excellent position.
Okay. Excellent. Richard, lots happening there. What are your questions I'd like to ask, but what are your hiring intentions then for 2026, given you've got all this activity going on? Do you expect to be putting on a, do you expect to be increasing your labor force?
No, we do not. We put in place additional capabilities on the commercial side over the last year so that we have the team to be able to do the marketing as it sits, the engagement with the partners that we have. We have built the digital platforms. We are not going to put a sales force on the ground. That is not cost-effective for a company of our size. What we can do is have people who can train others, who can engage with KOLs, who can engage with primary care physicians and spread the word that way, and then find the right partner who ultimately would have the boots on the ground to do the real legwork. The objective for us currently is to make sure we have a team that can do those negotiations and engage with those partners. We have that team already.
I imagine there are extensive networks of women's health clinics. I know, in fact, that there are through the likes of Volpara and so on who are doing the breast density testing. Those sorts of organizations must be exceptionally powerful for women's health products such as this.
They are. We are talking with all the groups. The endometriosis test has a lot of excitement. We have a team of people working on that all the time. We are fielding inquiries regularly. We will continue to follow up with those and engage as we roll the test out into different markets and different levels. You will hear about it through those networks.
Richard, just finally, a couple of bullet points. What are the priorities then for calendar year 2026?
Getting the endometriosis test live across Australia and in the U.S., ramping up sales for the esophageal cancer and the D tests and partnering strategic partners for all of the above.
Okay. That's plenty to consider there. Now, Richard, it would be erroneous of me not to acknowledge your recent news. Congratulations on the announcement of your retirement in February next year. You've had a wonderful career, done a stellar job founding Proteomics International. Congratulations on your achievements over the last, well, over your entire career. It's been a wonderful career, and congratulations.
Thank you, John. Much appreciated. There is much more to come from the company, and we are in the stages of finalizing the appointment of the team that will take the company to the next level.
We look forward to that announcement in the not too distant future. It's great to see you. Thank you for joining us today.
Thank you.