Microba Life Sciences Limited

Hello, everyone. I'm very pleased to share an update on our progress following close of the quarter ended 31 March 2025. And for anyone new to Microba, after the quarterly update here, I'll zoom out and provide an overview of Microba's business. So if you're new, hold on and wait to that for the end. This is our standard disclaimer. I will move past that. So let me start by taking you through the strong numbers from the quarter. And that starts with our delivery of 240% year-on-year growth for our core diagnostic tests. So in Australia, we saw record months across the quarter for MetaExplore continuing to drive growth in test volume. And we just released yesterday in a press release landmark clinical study results for our MetaPanel test in inflammatory bowel disease patients. And that we signed a partnership with a major gastroenterology service provider to embed our testing into routine care. And in the UK, we made great progress in migrating from our legacy testing products there to our focus on Meta Explore, delivering strong month-on-month growth across the quarter, culminating in over 98% growth between Feb and March. And to exemplify that migration from legacy products in the UK, you just have to look at this chart. So firstly, what you can see is sales starting to take off. And second, you can see here on the other axis that we've already replaced around 40% of the legacy GI test sales with Meta Explore over just a handful of months. And so this has been achieved, remember, just through the early access program to a select group of clinicians. And at the end of the quarter, the UK team had built a significant wait list of clinicians eager to access our market-leading product here. So safe to say we're excited about what Q4 will deliver in the UK. And a quick reminder here that after years of work to distill the clinical value of microbiome testing and launch these world-leading meta-exploring meta-panel products into market. we've been strategically transitioning to focus 100% of our diagnostic team resourcing onto these core diagnostic products and making great progress in liberating our team's focus to continue accelerating growth of our core diagnostics. And so if you've got any questions on this transition, we did a whole deep dive on our diagnostic strategy just recently and unpacked this in detail and all of those materials are publicly available. So that transition of product and revenue mix has a impact to our Q3 revenues. But despite those changes, we delivered growth for personal testing and our supplements whilst transitioning from those legacy products. And importantly, are forecasting a strong Q4 and another strong year of growth with full year revenue forecast that we put out there to land between 15.25 and 16.25 million, representing between 26 and 34% growth for the full financial year. So another strong year that we're expecting. And aligned to this growth, there were a range of milestones and highlights from the quarter. We've summarized the key highlights here, but I'll take you through them in a little bit more detail on the following slides, which will span our continued momentum in Australia with our diagnostic test MetaExplorer MetaPanel, our growth in the UK with MetaExplorer, and a transition from a research and development heavy phase to a capital light sales and partnering focused phase for our therapeutics. So let's start by diving deep on our diagnostic results for the quarter. So we're seeing continued strong growth in clinical adoption for MetaExplorer in Australia, plain and simple. month-on-month record sales across the quarter with over 3,200 tests sold for the quarter, which was up over 200% year-on-year. And that was underpinned in this quarter by opening up and bringing new clinicians into the top of the funnel. And that saw growth in ordering clinicians with around 700 ordering clinicians for the quarter, which was up 130% year-on-year. And we did this whilst maintaining and not diluting our average referral rates per clinician, which was impressive. And so the team remained incredibly focused here, have a growth formula which is working and being supported by continued advancements in the product. And we've got several new feature relations scheduled in Q4 driving more clinical value and ease of use. Next, Metapanel in Australia. Here, we're in an active market development phase, and that's expected to take time. We're going to educate and develop these targeted clinicians and then have that flow through to meaningful adoption and sales. So how are we going on this market development work? Well, in short, the team are making great progress. So we've got those landmark study results for inflammatory bowel disease patients, which I'll speak to more on the next slide. The team have formally engaged multiple new care opinion leaders, and we inked a strategic partnership with major private gastroenterology clinic to, sorry, with a major private gastroenterology clinic to include metapanel into their clinical protocols. And I'll provide some more details on that in a moment. Yesterday, we announced these landmark clinical study results for our metapanel test in a press release. Now, this data was from two independent clinical studies performed by two key opinion leaders in inflammatory bowel disease, Dr. Graham Radford-Smith and Dr. Jake Bagan. And what these showed independently is that for inflammatory bowel disease patients experiencing a flare, metapod panel could identify a pathogen in 35% of them. And more than 60% of those pathogens would be completely missed. utilizing current routine testing methods. So why is this such a big deal? Well, a flare in these patients can lead to serious surgery. So detecting a treatable pathogen during a flare episode could provide a more effective path to remission through simply addressing a pathogenic infection and help avoid those unnecessary escalations of therapeutics and reduce the risk of treatment failure and minimize the need for surgical intervention. So those results could lead to a significant advancement in clinical management for the 7 million IBD sufferers globally. and support the integration of metapanel testing into standard of care protocols. So the team are now working on writing up and publishing these results in peer reviewed journals. And this is really exciting. These are really exciting clinical results for the metapanel test. And this flows nicely into our partnership with one of Australia's largest private gastroenterology services, which sees more than 10,000 patients annually. the colonoscopy clinic and integrated gut health clinic. Now, the aim and purpose of this partnership is to embed microbial testing into routine care to improve patient outcomes in gastroenterology. That's what we're trying to do. And the team at the Colonoscopy Clinic and Integrated Gut Health Clinic are real thought leaders and pioneers in providing the best care and pushing the boundaries of advanced precision care models in gastroenterology. So we couldn't have hoped for a better partner here. Now, the key components of this partnership are routine use of MediPanel and MediExplore to support diagnosis and treatment decision-making. joint clinical research and publication efforts to quantify the impact of microbes diagnostic tests on patient outcomes and to develop a next generation gastroenterology care model centered on microbes precision diagnostics. And important to call out, this is not conceptual. It's already started. The clinicians have already started using our tests and the studies and planning is already underway. We can't speak highly enough of this group and the work that we do with them here. We expect, can set the foundation for advancing the gastroenterology care model at a global level. So a really big partnership for us and excitement, excited on how this is going to play out for microbiome. I've spoken to our progress in the UK, but I don't want to skim past it, and I want to underscore it again so it isn't missed. Strong month-on-month growth. We saw over 98% month-on-month growth between February and March, and our MetaExplore tests at the end of March are already accounting now for around 40% of all GI tests sold as we migrate away from legacy products there in the UK. And aligned to strategy, the whole UK testing business has shifted and transitioned its focus onto Meta Explore. And remember here, we've only provided access to a limited number of clinicians under an early access program, but now accelerating to full market access by the end of June. And whilst we're focused on delivering all of this diagnostic growth, supplement revenues here have been maintained, which is good. And we have a small focus team designing the next phase of growth for this part of the business. So stay tuned on that for a future update. Final update here for our diagnostics business is our advancement into the US. So the US represents 60% of our target global addressable market. And, you know, put it plain and simple, it's time. It's time for us to start making our move into the US. Now the US is a big pie. And so we're gonna take it one slice and one bite at a time. So we've designed an entry strategy here with, which is one state, one city, one metro area to start. And I've said repeatedly that one of the unique elements for Microbup and our diagnostic products is that unlike most diagnostic companies and products who rely on reimbursement to have a market, because of the deficiency of standard of care and how many patients have unresolved gastrointestinal issues, a significant portion of patients are willing to pay out of pocket for what can be a potential life-changing result. So our strategy is to leverage that and not have reimbursement as a barrier to entry, but as an adoption accelerant. So stage one of our US strategy will be cash pay and deliver initial growth. And then we will have a reimbursement strategy which will progress in parallel and come online as an accelerant to access and to supercharge growth. And the focus of stage one of our entry strategy is to get into market with a small sales and operational team and demonstrate strong clinician adoption and patient referral rates, and then expand from there. And aligned to all of that, we expect to have first hires completed before the end of this year. Now let's close off diagnostics and let's switch gears for a moment to an update on progress in our strategy for our therapeutics. We are declaring an important transition of our therapeutic activities. We've invested for over five years to develop a rich pipeline of live biotherapeutic assets that have leveraged our world-leading data bank and deep preclinical and early clinical validation work. And we're now in position to shift gears from this R&D heavy mode that we've been in into a R&D light, capital light, partnering heavy and revenue focused mode. And with that, our focus with a small team is now on partnering to advance these assets to bring them to patients and deliver a return on investment for shareholders with two commercial streams to value return, which I'll speak to just now on the next slide. So stream one is live biotherapeutic. So these are the traditional drug route disrupting and advancing standard of care across multiple chronic diseases. Stream two is biotherapeutic. next-generation probiotics, disrupting the $79 billion probiotic market with new healthy human-derived products, advancing from the work that we've just completed with the world's largest probiotic manufacturer, International Flavors and Fragrances. So we put more information on all of that into the quarterly release itself, detailing the multiple partnering and non-diluted funding streams that the team are focused on. And this is an important transition. This is an important transition of our therapeutic activities from what has been an R&D heavy mode to an R&D light, capital light, partnering heavy, revenue focused mode. And I'm truly excited by what we can achieve. We've got a brilliant small team focused on accessing non-dilutive funding, and partnering these assets to bring them to patients and ultimately deliver a return on investment for shareholders. So what's the focus and upcoming catalyst? Well, in diagnostics, we're critically focused on growth of our diagnostic tests in Australia, accelerating to full market access of MetaExplorer in the United Kingdom and driving now to first access in the United States. And in therapeutics, We are executing our focused non-diluted funding work and two-track partnering activities that I just spoke to. At 31 March, 2025, we had $12.41 million in the bank. And so on that, I'll close the quarterly update here, but I'm gonna respond to a range of submitted questions which came through. And then for those new to the Microber story, I'm gonna do a quick recap on the whole Microber business. Stay tuned for the questions and then for those new, hold tight for the recap on the whole micro over business. So I'm gonna take these in no specific order, starting with a question at the top here. The growth is positive in Australia and the UK. Do you think this trajectory can continue? How big is the market? It's a big market. we have barely scratched the surface of it. We are only in the first thin slice of this with innovator and early adopter solo clinicians that fit a certain clinician profile in one of the smallest initial markets in Australia and then now kicking that off in the UK. And we have a whole roadmap expanding this one tightly defined customer segment at a time so huge market we are barely scratching the surface of it next question regarding the press release for the clinical studies on metapanel and results for inflammatory bowel disease patients experiencing a flare what could these results mean for metapanel sales Well, to best answer that, let's step back for a second. So the state of care and management for inflammatory bowel disease is unfortunately not great. For inflammatory bowel disease patients, every flare brings a fear and a range of questions. You know, will it pass quickly or is this gonna just spiral out of control? Will it mean an escalation to stronger medication and what are going to be the side effects or impacts of that? And, you know, the most haunting one, is this the time that I end up in life altering surgery with a bowel resection? There was actually a recent whole state of the nation report on IBD released by the federal health minister, Mark Butler. So one hundred and. 80,000, I think, patients in Australia, 7 million patients globally. One potential outcome is that this will ultimately lead to a complete change in the care model for inflammatory bowel disease, where metapanil is used as a standard of care for all patients experiencing a flare to detect a potential pathogenic cause of that flare, which would enable patients the avoidance of side effects of unnecessary therapeutic escalation, stop unnecessary escalation to surgery, you know, potentially enhance responsiveness to inflammatory bowel disease therapies and ultimately significantly improve patient outcomes. So to answer the question, it could have a material impact to sales as this messaging gets into market and impacts clinician behaviour. Next question here. Taking a first step into the US market is exciting, but it's also expensive and highly competitive. So how do you plan to mitigate risk and be successful when many have failed? As I said before, it's a big pie. And so we're going to take that one slice, one bite at a time so it's digestible. As I said, one state, one city, one metro area. Get in with a minimal operational and sales team. Execute a closed group early access program with influential clinicians. Prove that we can sell. Generate the referral rates that we expect and retain customers and then expand from there. So precision. one bite at a time and expand, align to sales and revenue traction. That's the strategy. Next one, what's the update on US reimbursement? So I'll recap on a bit of what I said before. And actually, I said in the recent diagnostic deep dive that we've done an immense amount of work on US reimbursement. I've got a 200-page document on all of the work that we've done here with some of the best advisors that we could possibly have. The strategy is focused on Medicare reimbursement before we go on to private payers. But importantly, as I said before, reimbursement is an accelerant for us, not a barrier to entry. So unlike many traditional diagnostics where you really don't have a market until you have reimbursement, because of the standard of care here, with these patients being so poor and that leading to so many chronically unwell people not getting a solution, paying $500 for a test to potentially get a life-changing new answer and resolution is acceptable and viable for a good slice of the market. So rather than reimbursement being a hard barrier to adoption, it really is an accelerant for us. increases speed of adoption, opens up more of the market. So we will continue to deliver life-changing results for patients unencumbered by reimbursement, very happy to pay out of pocket with a significant portion of that market being in that position. And in parallel, we'll execute a reimbursement strategy which will supercharge that and then just put wind in the sails of the growth team. So that's the strategy. Next question. Pleasing to see the partnership with the colonoscopy clinic. Is there the opportunity to do more partnerships like this and what impact could that have on growth? So the team at the colonoscopy clinic and integrated gut health clinic are world-class. The work that we're doing with them, we expect will not only immediately impact a lot of patients, in fact, it already is, but we expect could be seminal for the field in advancing the gastroenterology care model into a more precision model supported by our tests. And to answer the question, I think this is just the first example, you know, Every country, every state, every city should have one or more of these. And the team are active in finding and engaging them. So this is just the first great example of how we can engage in that way. Next question here. With the transition for micro-service therapeutics business, what does that mean for the MAP315 phase two clinical trial? It means it will happen. when the non-diluted funding is won to execute it. We won't use our existing funds and balance sheet capital from my crowbar. And we're not planning to raise new funds and dilute shareholders to do it. We have multiple activities underway to win the funding we need without diluting shareholders. And so that's our focus. That's our strategy. Next question here, having completed the allergy discovery program with international flavors and fragrances, what do we expect would happen next with them? And how does that fit into the next generation probiotic stream for the therapeutics business? From my perspective and the team's perspective, that $79 billion probiotics market is on the edge or precipice of a major transformation. So you look at all those products on the shelf, I typically say right idea, wrong organisms. So what we're expecting to see, and the science supports this, is a move from what has been largely food and environmental-based organisms that are not natural residents of the human microbiome into human-derived organisms that are natural residents of a healthy microbiome. And with the pool of data, our biobank assets, and now, you know, our supplement commercial capability, Microbra is in a really strong position for this next generation probiotic opportunity to partner and bring these assets to healthcare professionals, patients, and consumers across the globe and be a major part of this disruption to this $79 billion probiotic category. So the commercial focus of this stream is putting together structured, what we call pay-to-play product development and commercialization programs, leveraging all of our expertise, capability, and IP and where possible leverage in non-diluted federal and state grant-based funding. And as you called out in the question, we've already made great progress here. Microbe has already engaged the largest probiotic manufacturer in the world, IFF. We have just recently completed our multi-stage discovery program to develop novel microbiome-based treatments for multiple forms of allergy and naturally engaging them around next steps. So stay tuned. Next question. What is Microba doing to stay ahead of the curve when it comes to using new artificial intelligence techniques? Multiple things. We have staff using multiple AI models across the business, all the way from business intelligence reporting through to marketing content. In our software engineering team, for example, they're using multiple AI models to advance coding efficiency, but we're actively building an AI strategy with the intent to have us at the forefront of AI integration into our product and service. And that contemplates everything from customer service agents through to report results and interpretation. Perhaps like one example, we did some work where we developed an internal AI tool, which we called SALI, to support the team to produce our expert summaries that sit at the top of the report. They're historically done manually by our internal team of trained clinicians and pathologists. But by trialing SALI together with some other smart approaches, we created a solution that significantly reduced the time to produce those expert summaries at the top of the report, just down to a couple of minutes. And at a recent board meeting, I'll share, we discussed specific resourcing dedicated to our AI strategy. So we treat this as very important. And I believe we've got to be at the front of the pack here. And we have an incredible data position to enable us to do things with AI that others just simply can't. So data is key here, and we have the data. So that closes the quarterly results and the submitted questions. So for those that know the story well, feel free to check out And now for anyone new to the Microber story, stay tuned in and I'm gonna do a recap on the business. And that starts with what is Microber all about? Let me start by sharing an often unknown and surprising fact. And that is that your body is home to trillions of tiny microorganisms. And these tiny organisms are essential for your health. In fact, they are so essential that there are now more than 21,000 studies showing that they are key to how we develop and can treat chronic diseases. Important to call out, most of them, about 95% live in your gut, and we call this ecosystem of organisms your gut microbiome. So that, I hope, puts into context everything that I've just said in the last half an hour or so. Now, what are we targeting with all of this? Well, chronic diseases affect six in 10 people. They include everything from cancer, depression, diabetes, through bowel, heart, and many other diseases. But the exciting insight here is that there are now over 150 studies demonstrating that if we change these tiny organisms in our gut, we can improve and even treat these chronic diseases. And from this, my purpose vision is very clear. that testing and monitoring your gut microbiome is going to be a routine part of health and disease management with your doctor, and that novel microbiome therapeutics are going to be developed, commercialized, and routinely used to treat chronic diseases. And now we've taken together that microbiome diagnostics and therapeutics here indeed play a meaningful role in supporting these patients. This could ultimately be worth more than a trillion dollars. This is a huge market opportunity. Now, I recognize that's a big step. So rather than just believe me, you can just look to action and look to the action of the giants in the space of medical diagnostics who also see this opportunity and have come to Microbah and partnered with us at the forefront of this field. We've got a few of those, and one of those is Sonic Healthcare. a global diagnostics leader, and one of Australia's largest and most trusted healthcare companies who believed this so much that they became not only a major partner, but a major shareholder. And here's the quote from their CEO, Colin Goldschmidt, stating their thesis aligned to their strategic investment in us. So let's dive into the diagnostic business. We are in a leading position at the forefront of clinical microbiome diagnostics. And with the central impact that the microbiome plays in a range of diseases, there is a lot of opportunity here. Importantly, we've got to solve one thing well first. Today, we are laser focused on applying our technology and team to help patients suffering from gastrointestinal disease. Why? Well, 95% of those organisms live in your gut. They act there first before they act systemically on other parts of the body. And it's a ginormous market. So 37 million people every year in the US alone seeing a doctor with these gastrointestinal issues spanning from severe diarrhea through to bloating, pain, irritable bowel syndrome or inflammatory bowel disease. And it is a huge unsolved problem. So looking at the chart on the right, historically only half of these patients suffering have achieved a resolution. So how do we help these patients? Well, many of the answers lie in their gut microbiome. So to address that, we've developed two tests, MetaPanel for diagnosing gastrointestinal pathogens, which launched just last year in Australia with Sonic Healthcare, and MetaExplore for diagnosing gastrointestinal disorders, which launched just the year prior. Now, our real world data here has shown that with our tests, we can get critical new diagnosis and treatment recommendations for over half of those patients, 52%, who have previously had no path to a resolution. So that's massive. We're very proud of the impact that we're already having on these patients. And we are only just at the start of this journey. So what's this first opportunity in gastrointestinal disease worth? It's a big market. We did some really great work with a Boston-based consulting firm and estimate the first, just the first slice of what we define as this new major diagnostic category in clinical microbiome testing. Just taking the first slice of that in gastrointestinal disease alone could be worthwhile in excess of $25 billion. I'm gonna, in the interest of time, skip a couple of the testimonial slides here. We have patient testimonials for people getting answers and resolution to GI symptoms that they've been suffering from for 10, 20, or in the case of this patient, for 35 years, now completely resolved. So perhaps then, not surprising, we are seeing strong sales and growth and it's accelerating. So this is a huge market with millions of patients suffering every day. And as I said before, we are just getting started. So now to dive into our therapeutics business for a moment. Mycroba is in a prime position at the forefront of microbiome therapeutics. And again, our primary focus is on gastrointestinal disease, specifically inflammatory bowel disease, which is a $23 billion treatment market. We have a drug development platform enabling us to deliver a pipeline of novel microbiome therapeutic assets. And we have successfully completed a phase one trial for inflammatory bowel disease lead candidate, which we call MAT 315 showing it was safe and well tolerated. And now I've now done significant preclinical and early clinical de-risking, which leads to our focus partnering and non-dilutive funding work. So after what I said before, five years of R&D heavy mode to develop these assets, We've now been able to shift into an R&D light, capital light, and partnering heavy and revenue-focused mode. And so there we have two commercial streams to value returned, which are stream one, live biotherapeutics, so traditional drug route disrupting and advancing the care for a range of chronic diseases, and stream two, that next generation probiotic stream disrupting that $79 billion probiotic market with new, novel, healthy human-derived products. And so what could assets in those two commercial streams be worth? So I've obviously put some indications there on the right based on previous precedent deal activity. But just to give it a little bit more air time, looking at recent transactions in inflammatory bowel disease, the appetite from Big Pharma in this category is strong, with five recent deals valued between $1.5 to $11 billion. And then if you look at recent activity in next-generation probiotics, you can see that things are heating up. So I hope that gives you an idea of the size and scale of the opportunities there with our therapeutics work. So on that, I'm going to close, as I always often do, in saying I'm incredibly excited about the opportunity, the impact and growth ahead for Microbah. We have an incredible world-class team, best-in-class technology and category-defining products. For patients, we're already changing lives and there are a lot of patients that need our help. So thank you all for listening and for your ongoing support.