Microba Life Sciences Limited

Good morning, everyone. Very pleased to share an update of our progress following close of the quarter ended 30 June 2024. Joining me on this call is our Head of Therapeutics, Trent Munro. Just moving past our standard disclaimer, Microva is a medical diagnostic and clinical stage therapeutics company, unlocking the medical application of the microbiome, which is the trillions of organisms that live in and on our body, which are critical to our health and development of disease, founded on world-leading metagenomic microbiome analysis technology with a clear vision that that technology would lead to new diagnostic testing solutions that become a routine part of healthcare and lead us to the discovery and development of novel drugs for major chronic diseases. We've invested over the last six years to get there, leveraging high-quality data, and initial revenues generated from the sale and delivery of over 50,000 non-diagnostic personal microbiome tests and the delivery of contract research services from companies and research institutes across the globe wanting to access our technology. From that work, we've amassed what we believe is one of the largest and most valuable microbiome data sets in the world. And that data set has enabled us to execute on the founding vision to unlock those diagnostic and therapeutic opportunities. Now, after many years of development, we've recently launched two diagnostic testing products, MetaPanel for diagnosing gastrointestinal pathogens, launched just a few months ago with Sonic Healthcare, and MetaExplore for diagnosing gastrointestinal disorders, launched just last year. In parallel from interrogating that dataset, We've invested in three therapeutic programs spanning inflammatory bowel disease, immuno-oncology and autoimmune disease. We've successfully completed a first in human phase one clinical trial for our inflammatory bowel disease lead candidate MAP315 and are at an advanced stage of setting up for a phase two trial and progressing a compelling pipeline of preclinical leads for our other indications. Firstly, let me take you through the strong numbers from the quarter and the close to the financial year. We delivered over 12 million in revenue for the full year, which is up 123% year on year. Underpinning that was 4.81 million in revenue for the quarter, which represents 20% quarter on quarter growth and 209% growth year on year. This was driven primarily by strong underlying growth of Microbe's core personal testing with accelerating growth of meta explore sales and revenue in Australia and our second full quarter of revenues from the United Kingdom through our in vivo clinical business. To really hone in on that core growth, here we've stripped out our research services revenue and new revenues in the United Kingdom So just looking at core microbial personal testing, we saw 4.61 million in revenue, which is up 50% year on year. A primary driver of this is the launch and progress of our diagnostic products meta-explorer meta-panel in Australia. And underpinning that, we're seeing strong clinical adoption metrics, including clinician retention, repeat referrals, and new ordering clinicians, which I'll go deeper on in a moment. So we have a strong core diagnostic testing business with accelerating growth. And we've now opened up the United Kingdom with our recent acquisition and kicking that into growth also. Aligned to this growth, there were a range of milestones and key highlights from the quarter. We've summarized the key highlights here for reading. But I'll take you through them in a little bit more detail on the following slides, covering our growth in Australia with our diagnostic tests, MetaExplore and MetaPanel, our progress in the United Kingdom, setting up to unlock growth in that region. And then I'll hand over to Trent to update on the advancement of our therapeutic assets. So first let's start with MetaExplore in Australia. Strong growth, really starting to gain some momentum following launch last year. So over 1800 tests sold during the quarter, representing 71% sales growth quarter on quarter. And aligned to that, we're seeing strong growth in clinician adoption with over 400 ordering clinicians for the quarter, which is up 41% quarter on quarter. And the team are focused on a range of growth activities directed to continuing this momentum. Next, MediPanel in Australia, making good progress since launch earlier in the year. Doctor referrals and sales continue to grow monthly, focused around the major East Coast states in New South Wales, Victoria, and Queensland. The MicroEver and Sonic teams in collaboration are active on targeted sales and marketing activities directed to gastroenterologists and general practitioners, clinician education, KOL engagement, and important utility studies and publications. Next, our business in the United Kingdom. In Vivo Clinical is delivering aligned to expectations. First full half of sales and revenue for the quarter, delivering 4.45 million in sales for the half. And we're executing here on our stage plan that we stated at the time of acquisition. Firstly, we want it to bed down and stabilize the acquisition. That's now done. And we're delivering those acquired revenues. There is then two steps to the growth plan. The InVivo team had light resourcing in sales and marketing with less than one full-time resource in sales for a company that was generating almost $9 million in revenue. Stage one of the growth plan was to sensibly add some firepower to that. And we're advanced in recruitment and looking to place those individuals in the weeks ahead. Then stage two of the growth plan was the core thesis to the acquisition. We have a leading position in GI microbiome testing for clinicians in the UK. And by adding our world-leading tests, we could multiply that business. Aligned to that, our plans to launch MetaExplore into the UK are well advanced and that is scheduled to occur in this financial year. So stay tuned for updates on that front. For microbus therapeutics business, I'll quickly hand over to our head of therapeutics, Trent Munro. So Trent, over to you for the update.

Thank you, Luke. Importantly for the quarter, for our autoimmune program, we announced that we successfully completed our two-year discovery initiative in partnership with Ginkgo Bioworks. This was delivered on time and on budget. Over the course of this program, we down-selected from over 200 leads to a small group of six leads, which demonstrated significant disease-relevant activity. And as a reminder, what's really important about this program is what sets microber apart is our ability to do this to . At the core of that, we have a true drug discovery pipeline that can be applied across a range of indications. The depth and the breadth of this discovery effort with Ginkgo has been huge. There were more than 3 million data points, and we believe this is a world-first microbiome therapeutic discovery effort. And we're not aware of anyone doing anything even close to this. As a result, we now have valuable new therapeutic intellectual property assets for the company with these six leads, and we're preparing for the next stage of preclinical validation. For our immuno-oncology program, we grew our clinical data and sample set to over 3,500 patients to support the overall preclinical package and lead candidate selection process. This spans the work we are doing as part of the Omico Consortium and the PROSPECT study with Garvin and others, and our world-leading microbiome artificial intelligence machine learning capabilities to find signals from these clinical data sets, which we will believe are useful in the treatment of cancer in the future. And finally, for our inflammatory bowel disease program, we continue to advance manufacturing and regulatory activities toward an IND submission to enable a phase two efficacy trial for our lead candidate, MAP315. We're very excited about the path ahead for our therapeutics programs, and the work here is really at the forefront of drug development, especially as it relates to the use of the microbiome. We are at the forefront also of using advances in data tools, spanning, as I mentioned, that artificial intelligence machine learning approach to drive unique insights into the therapeutic potential of the microbiome. So with that, a brief update, I'll hand you back to Luke for a deep dive into the diagnostics business. Thanks, Luke.

Thank you, Trent. All right, so let's do a deep dive on microbus diagnostics. With the launch of our first diagnostic product last year and our second a few months ago, we've taken that next step in our journey into a medical diagnostics company in a leading position at the forefront of the clinical application of microbiome testing with a clear vision to combat disease through microbiome health. So I'm going to take a moment to run you through the significant opportunity we're unlocking here for clinicians, patients, and our shareholders. Addressing that vision with the central impact that the microbiome plays in a range of disease settings, there is a lot of opportunity. Today, importantly, we're laser focused on applying our technology to help patients suffering from gastrointestinal disease. That is the area with the most clinical evidence and clinician readiness to adopt. Another reason we're focused on gastrointestinal disease is that it's a huge market with a large unmet need. On a per patient basis, a cancer patient certainly costs more, but the management of gastrointestinal disease is higher than people think. And there are just so many more patients. The real killer is that only half of them are getting a resolution. And this is from data that followed people for five years. A typical journey would be a patient with chronic diarrhea or severe bloating and associated pain. They go through a raft of standard of care molecular testing, no pathogen identified, nothing else measurable. They go through a colonoscopy to see if there's anything on the camera, but nothing to see. Symptoms persist. So they then try doctor shopping, integrated medicine, restrictive diet, supplements, anything that they can find at no resolution. Many of the answers lie in the microbiome. And it's a little painful for us because we've been able to see for years when there are concerning test results. But the question has always been, what can a doctor do about that to change the result and the outcome for the patient? And that has been the labour of the last several years to bring all of that together, to equip doctors with the clinical tools to assess, make decisions about how to intervene and change those results to get an outcome for the patient. So using our advanced metagenomic microbiome analysis technology, we've developed two tests. MetaPanel for diagnosing gastrointestinal pathogens launched just a few months ago nationwide, first here in Australia, together with Sonic Healthcare. And MetaExplore for diagnosing gastrointestinal disorders launched just last year, also first delivered here in Australia. What we're doing here is closing the gap on getting answers and resolutions for patients here. The best way to explain this is by taking a group of 100 people suffering from lower GI symptoms. 19 would get a pathogen diagnosis with standard of care, including qPCR, culture, and microscopy. But that standard of care only assesses less than 20% of the clinically known pathogens that could be infecting that patient. So with MediPanel, using our technology, we've said, let's test for all of them and comprehensively rule in or out a gastrointestinal pathogen as the cause of the patient's symptoms. And the real world data so far for MediPanel excitingly shows that we get a pathogen diagnosis for an additional 24 of those patients. So then for the remaining 60% of this group, we're now quite confident that they do not have a pathogenic cause of their symptoms, So what next? They sit in this complex heterogeneous population of people with what's classified as a functional gastrointestinal disorder of which some will lead to an irritable bowel syndrome diagnosis by exclusion. And this challenge for those patients sits at the intersection between the integrity of the gastrointestinal tract, the structure and function of the microbiome and the mental health status of that individual. with the signaling between the brain and the enteric nervous system via the vagus nerve. With MetaXplore, we've honed in on the integrity of the gastrointestinal tract with a range of biomarkers and the structure and function of the microbiome using our world-leading metagenomic technology. What we're showing is that with that test, we can get new answers a large portion of these people and are already having a significant impact with clinicians and their patients that are using meta explore. And we're preparing data to quantify and put those numbers up here for the meta explore test and expect to have that data out soon. So significantly closing the gap and getting answers for what is millions of people suffering from unresolved gastrointestinal disorders. So now quickly provide an insight into the impact that we're already having with these tests. For MediPanel, we've done some really outstanding work together with our partner, Sonic Healthcare, to demonstrate the performance of the MediPanel test in pathogen diagnosis. And I've shared that before when we launched the test. But importantly, what is the impact that we're already having here? So it's not coming from me. Here is a quote. from one of the country's leading clinical microbiologists, Dr. Mike Weyron from Sonic Healthcare. So safe to say, the first few months of MetaPanel test results have been compelling and importantly delivered diagnosis where standard of care would have missed. And as a result, the Sonic team are reasonably very excited. For MetaExplore, We've now had this test in the Australian market for over a year and starting to make a real impact. Again, rather than hearing it from me, here is a quote from a patient that was struggling with debilitating gastrointestinal symptoms that were causing extreme pain. After their test results with very clear findings and implementing a treatment plan, she's achieved complete resolution of her GI symptoms. Another one here is a lovely lady who's severely struggled with gastrointestinal symptoms for a long time, actually half her life. She was one of the first people to access the new test. It found problems that had never been identified before. And after implementing a treatment plan, she's achieved, I should say, full resolution from her symptoms for the first time in 35 years. That is why we are here. That's what we're here to do and what drives us every day. Safe to say, this is a significant market. We've been doing this work with a Boston-based consulting firm called Veronix, analyzing claims data in the US and then expanding that work into the UK, Australia, and key European markets. And what I'm presenting here is just the US data. We'll have the rest out very soon. But in the US alone, using the lowest predicate pricing band, we have a total addressable market here of over $15 billion for the US market. And we believe US pricing will actually be higher than this aligned to gap filling on a PLA code. But the basis of this work is not to do hand waving on a large total addressable market. What we've been doing with this work is drilling down to the serviceable addressable market, getting very specific about the core subsets of this patient population from immunocompromised to immunocompetent to inflammatory bowel disease diagnosed with flare, etc., and working out how do we sequentially work through these different subpopulations and particularly with respect to our reimbursement and aligned evidence generation strategy. We have a unique opportunity here in that many molecular diagnostic companies really have to wait to commercialize and start generating meaningful revenue until they get reimbursement and coverage. There's little opportunity for out-of-pocket pay based on a range of dynamics. But given the deficiency in standard of care and the chronic nature of these issues and the price point that we can come to market at, that means that a good part of the market is actually willing to pay out of pocket here to get a new answer. generates initial revenue, but perhaps more importantly, generates large volumes of real-world evidence data supporting the path to reimbursement and payer coverage. So the out-of-pocket pay strategy really is the focus for Australia and the UK. And it would be no surprise that then the focus in terms of reimbursement and coverage is centred around the US. We've been doing a lot of work here and expect to surface those plans at the appropriate time. We've been building up to this for many years. Done a huge amount in terms of regulatory positioning. So ISO 15189 accreditation in place here in Australia with an in-house IBD status, CE marking in Europe and a clear pathway into the UK. And we've been through clear cap in the United States for our non-diagnostic testing. So extremely well positioned to complete that work again for our diagnostic tests for a US laboratory developed test. And of course, we've been building evidence and you'll hear a lot more on this from Microbah. As at 30 June, 2024, we had $20.9 million in the bank with circa 6 million expected in the current half from Microbah's FY24 R&D tax incentive claim. So I'm gonna stop here and go to address some of the submitted questions. The first one is, what are you doing to protect and promote the share price? We're doing a lot. We take this very seriously and doing everything within our control to get the value of our incredible organization recognized in the share price. That includes active shareholder engagement via regular content, detailed announcements, quarterly presentations. active engagement with the investor community, spanning institutional investors, high net worths and retail via a whole range of channels. So we utilize the investment banking networks, engage deeply with the analysts, engage with high net worth investor groups. And I've got another one of those coming up in the next week. retail investor-related media opportunities. There's also been discussion around deep dive sessions and investor day type activities to provide further insights and engagement opportunities for shareholders. But most importantly, the best thing that we can do is build a great business that's solving real health problems for millions of patients using our world-leading technology. And that's exactly what we are doing and working tirelessly on every day. The next one here is scientific milestones need to answer the humanitarian question, so what? If I understand that question correctly, I believe what you're saying is that we need to better surface the patient impact from our products and the great scientific work of the company or how that relates to the great scientific work of the company, I should say. And what I would say is that everything that we do is directed to improving patient outcomes through our diagnostics and therapeutics. We see this every day through our direct feedback and outcomes from clinicians and patients. We have a range of studies and real-world evidence data, which is building and will also be published demonstrating this. And related to this topic, we've just included some key examples from patients in this quarterly presentation And we'll continue to show more and more of this to exemplify the impact that we're having on patients today, but also what that means in the opportunity we see to improve the lives of millions of patients across the globe. The next question here is, is there a reason you're planning to launch Metapanel in the US versus the UK through InVivo? what I'd say in response to that is we're focused right now on seeing that test be successful and delivering value to clinicians and patients in Australia. We'll then share the international commercialisation plan for Metapanel at the appropriate time. But I take the real essence of your question being let's make sure that the strategy is strategically sound, pragmatic and financially responsible. And I can guarantee it absolutely will be. The next one is, do you expect to have this phase two trial commencing this calendar year or is there further planning required? What I would say in response to that is we're not in a position yet to provide guidance on phase two commencement timing. We continue to actively explore all options to advance these assets through the key value inflection points to get these into the hands of clinicians and patients and importantly, deliver a return for shareholders. But to be clear, our strategy here remains unchanged to do initial preclinical and clinical de-risking and then partner with strategically aligned pharma partners for later development. We have multiple opportunities that we're progressing and we look forward to updating you all at the appropriate time. The next question here is, has the current FY24 R&D spend been similar to last year? And do you expect a similar sized incentive payment next year? So the R&D spend during FY24 was comparable to FY23. So we've continued to progress our three therapeutic programs in inflammatory bowel disease, autoimmune and immuno-oncology. Outlined in our quarterly report, we've said that we anticipate that our FY24 R&D tax incentive return will be around $6 million and that we expect for this amount to be received in the first half of this financial year in FY25. The next one is how does the metapanel sales process work? The sonic pay for the kit and then and resell to or rebuild the customer. No that's not not how it works, the doctor refers the test so a normal pathology form. The patient then pays via an online portal before collection of the specimen and is charged upon successful delivery of a report. So microbe then receives the revenue less the Commission for sonic. The next question is, is MediPanel a Medicare eligible test in Australia or is it a patient out-of-pocket cost? Currently, the test is out-of-pocket. We do have an opportunity here, as I outlined before, that many molecular diagnostic companies do not. Most have to wait for that reimbursement and coverage to be in place to commercialize and have clinical adoption. But as I said before, given the shortcomings or deficiencies in standard of care and the chronic nature of these issues, a portion of patients are willing to pay out of pocket to get an answer. Importantly, that not only generates initial revenue, but it generates a large amount of real world evidence data that then supports the utility and health economics of the test. which will in turn support the pursuit of reimbursement. So look forward to providing more information on the reimbursement strategy for Metapanel at the appropriate time. So that's all the questions for now. If I've missed any or any additional questions come in, I will ensure to respond as always via the Investor Hub platform or via email. I'm incredibly excited about the opportunity impacting growth ahead for Microbar. For patients, we're already changing lives, and there are a lot of people that need our help. And that is why two of the world's largest medical diagnostic companies in Sonic and SynLab are backing Microbar as the company to unlock the diagnostic application of microbiome testing. So I'll close there, and thank you, everyone, for tuning in.