Microba Life Sciences Limited (ASX:MAP)
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Earnings Call: Q2 2024

Jan 29, 2024

Luke Reid
CEO, Microba Life Sciences

Good morning, everyone. I'm very pleased to share an update of our progress following close of the quarter ended 31 December 2023. As always, I'll kick off by stating that our investment thesis at Microba remains unchanged, that the trillions of organisms that live in your gut, known as your gut microbiome, represent one of the biggest untapped opportunities to improve human health. This will see microbiome testing and therapeutics become a routine part of healthcare, and at Microba, we believe we have the best technology in the world to unlock this, and we're continuing to execute on establishing a dominant global position in both microbiome testing and in therapeutic development from the microbiome to capture this opportunity. This is our standard disclaimer. Quickly, for anyone new to Microba, our commercial model to capture this market opportunity is summarized here.

We deliver microbiome testing services globally to clinicians, consumers, and research clients, together with market-leading distribution partners. These services build our large proprietary microbiome data bank with consented and de-identified customer data, and we mine this large, large data bank to discover and develop novel therapeutics to ultimately execute pharma out-licensing transactions on those assets. Microba is a data-driven biotech company. We are commercial stage, delivering growing global revenues, and we've just expanded our international presence and revenues with a strategic acquisition in the United Kingdom. We've established partnerships with market leaders across our business, including global medical diagnostics leader, Sonic Healthcare, Europe's largest medical diagnostics company, SYNLAB, and New York Stock Exchange-listed synthetic biology leader, Ginkgo Bioworks.

We believe we have the most valuable microbiome data bank in the world, and from that proprietary data bank, we've established three therapeutic programs, with our first lead drug candidate, MAP 315, targeting ulcerative colitis, a major form of inflammatory bowel disease, having just completed a successful phase I first-in-human clinical trial, demonstrating it was both safe and well-tolerated. This is a fast-growth emerging market, which we're capturing with world-leading technology, supported by peer-reviewed publications and our two co-founders, who are leaders in the field. Underpinning this, we have a world-class team, including Deputy Chair and Chair of our Medical Advisory Board, Professor Ian Frazer, one of Australia's most distinguished clinical scientists and inventor of Gardasil, the cervical cancer vaccine, which now does over $7.7 billion in annual sales for Merck.

Our Head of Therapeutics, who joins me on this call today, Professor Trent Munro, who joined us from California-based multinational biopharmaceutical company, Amgen. Upfront, I want to highlight some of the recent milestones and key achievements from the quarter. Firstly, we successfully acquired a leading microbiome company in the United Kingdom, Invivo Healthcare. The U.K. is a key market in our international growth strategy. This provides us with a team and active customer base of over 1,700 healthcare professionals in the U.K. The business has multiple opportunities for growth, and we're expecting to accelerate that through equipping them with our world-leading microbiome testing technology. Secondly, we successfully completed the phase I clinical trial of Microba's lead therapeutic candidate, MAP 315, demonstrating it is safe and well-tolerated. No clinically significant safety signals, and fecal kinetics indicating successful delivery into the gastrointestinal tract.

Overall, the results provide strong, positive support for continuing to advance the clinical development of MAP 315 for the treatment of ulcerative colitis. Finally, we signed a second agreement with multinational probiotics leader, IFF, to develop novel microbiome-based treatments for multiple forms of allergy. The first agreement we signed with them in 2021 saw us apply our data-driven therapeutic platform to identify a number of potential therapeutic leads. IFF has now signed a second stage of that program, where we're taking multiple of their selected leads from Stage One, and we'll complete isolation and initial characterization of those leads. There's an upfront cash payment for this second stage of the program, and the objective is to develop an effective product for allergy treatment that leads to IFF taking up their option to license, commercializing a product and generating royalty payments back to Microba.

First, I'll provide an update on the progress of our testing services, which is driving our global revenue growth, then pass over to Trent to update on the advancement of our therapeutic programs. The key message is strong revenue growth. AUD 2.19 million in revenue for the quarter, up 79% year-on-year. AUD 3.21 million in revenue for the half, up 49% year-on-year. These results were principally driven by growth in MetaXplore test sales in Australia and international sales growth, particularly driven by sales growth with our major European partner, SYNLAB, Europe's largest medical diagnostics company, with revenues up 115% year-on-year. Closing out the acquisition of Invivo Healthcare, we also saw the first 26 days of revenues flow through from the United Kingdom, with the acquisition completing formally on the fifth of December.

We're excited about the quarters ahead, with expected continued growth of MetaXplore, national launch of our advanced infectious disease test MetaPanel, together with Sonic Healthcare, integration and growth of our United Kingdom business and capture of a full period of revenue, and continued international growth with our major partners. Zooming out, I want to put these milestones and growth into perspective of our strategy. To succeed in building a leading microbiome testing company, there are two core ingredients: product, delivering clinical utility, and sales and distribution execution. First, on product, MetaXplore launched last year as the most comprehensive gastrointestinal testing solution available, and is unlocking a large market in unresolved gastrointestinal disorders. We've seen strong growth now with over 2,700 tests delivered since launch last year, and over 1,000 healthcare professional accounts registered.

We're excited about the domestic and international growth opportunity ahead, the impact that the test is already having on patient management, and the opportunity to provide this test into the United Kingdom through our recent Invivo acquisition. The second product, MetaPanel, is scheduled for launch this quarter to bring the world's most comprehensive gastrointestinal pathogen test available to clinicians and patients. We believe the MetaPanel technology has the opportunity to create a new standard of care for gastrointestinal infectious disease pathology, and is expected to represent a significant commercial opportunity for the company. I look forward to sharing more about MetaPanel, the clinical and commercial opportunity it represents, and the commercial strategy shortly after we launch this test together with Sonic Healthcare.

We are at the forefront of this field, with market-leading testing products, positioned to deliver strong value and clinical utility to clinicians, and addressing large patient populations with significant unmet needs. Regarding sales and distribution execution, we have a leading international bench of distribution partners. Sonic, SYNLAB, Genova, G42 Healthcare provide us with strong access into major global healthcare markets. These distribution partners provide us with access into 35 countries. The acquisition of Invivo Healthcare has opened up the lucrative United Kingdom market to Microba, with an experienced team and active customer base. In total, we now have 17 countries operational, delivering Microba testing, many of which have only recently come online. I want to take a moment to talk more about our recent U.K. acquisition.

The United Kingdom is a key market for Microba, with an estimated 49,000 healthcare professionals in the U.K., which are positioned to employ Microba's microbiome testing into their practice. Invivo is a microbiome testing leader for healthcare professionals in the United Kingdom. The company has established a base of over 1,700 active healthcare professionals. In addition to its gastrointestinal microbiome testing services, Invivo has testing products spanning vaginal, oral, and urinary testing, together with a targeted set of evidence-based supplement formulations. The company has been self-funded from cash flow with no external capital, and the company's been consistently operating cash flow positive. The company is positioned for growth, with multiple growth opportunities, and we expect to accelerate that with the introduction of our world-leading microbiome testing technology. Invivo has provided gastrointestinal microbiome testing since 2015, and has established a leading position with healthcare professionals.

80% of Invivo's testing revenue is from their GI EcologiX product, which grew circa 20% last year. We can take that to the next level with our MetaXplore testing, which we expect to turbocharge that business. Both Microba and Invivo believe that MetaXplore can become the most favored microbiome test for healthcare professionals in the United Kingdom. For the H1 of the U.K. financial year, they generated GBP 4.39 million in sales, maintaining strong margins at 49%, driven by over 4,000 microbiome test sales and 62,000. We're excited about what's ahead for our new UK business, and I look forward to providing more updates over the coming quarters as we integrate and unlock the, this business and realize the growth, growth opportunities that it hold.

In addition to growing testing revenues, those services also generate high-value data, which enables us to deliver, discover and develop novel therapeutics. I'll now hand over to our Senior Vice President of Therapeutics, Professor Trent Munro, to provide the quarterly update on our therapeutics business and provide insight into the strong progress made across all three of our therapeutic programs. Trent, over to you.

Trent Munro
Senior Vice President of Therapeutics, Microba Life Sciences

Thanks very much, Luke. Great to be here and to provide an update on our progress in the last quarter, and more broadly, what's happening in the therapeutics part of the business. We're advancing three therapeutic programs spanning inflammatory bowel disease, immuno-oncology, and autoimmune disease. Our inflammatory bowel disease program is targeting a novel therapy for patients suffering from ulcerative colitis. During the quarter, we successfully completed the phase I first-in-human clinical trial of our lead drug candidate, MAP 315, importantly demonstrating that it was safe and well-tolerated, and we also generated data in the lab supporting a multimodal mechanism of action. For our immuno-oncology program, we are targeting the development of a therapeutic to improve response rates in cancer patients receiving immune checkpoint inhibitor therapy, which has become a standard of care in several cancer indications.

We know that these treatments can unleash the immune system to attack cancer, and they'll benefit from a combination of approaches to increase response rates. Emerging data indicates that the microbiome may represent a novel strategy to deliver this. Across the quarter, importantly, we generated further immunological activity data, demonstrating induction of a specific and targeted immune response underpinning the observed anti-tumor activity that we've reported recently. We are continuing to advance this preclinical program to enable lead candidate selection, which is being targeted before the end of the financial year. I'll move now to our autoimmune disease program, which is partnered with New York Stock Exchange-listed Ginkgo Bioworks. Here, we're targeting a range of indications, including lupus, psoriatic arthritis, and autoimmune liver disease. Again, there is strong evidence here that the microbiome is playing important roles in maintaining immune homeostasis.

An exciting time for this program as we completed stage 1 of our activity screening with Ginkgo in their labs in Boston, where we were able to take approximately 180 strains, conduct experiments, and down select to around 35, which have now moved into stage 2 functional screening, which is expected to be completed in Q4 of this year, and I'll show a snapshot of this data. In terms of the team and for people who are new to Microba, we're in a prime position at the forefront of microbiome drug development through our ability to pinpoint therapeutically relevant biology using our data-driven platform to develop precision microbiome therapeutics. We have a pipeline delivering compelling biology with distinct mechanisms, an oral delivery, excellent safety profile, and importantly, we've also demonstrated the ability to scale our underlying manufacturing.

To match this, we've built a strong multidisciplinary team, shown on the slide here, with experience across the globe, and we have a range of valuable global partners to help us deliver these development efforts. At Microba, the heart of all of this is our data-driven platform for drug discovery from the microbiome, which again, is underpinned by three factors. One, our world-leading microbiome analysis technology; two, our proprietary data bank; and three, the AI data-driven discovery methods that we employ. This platform is now generating multiple potent therapeutic candidates. Next slide. If we think about how this platform works, it enables us to go from this large proprietary population data bank through the data analysis to therapeutic leads for our preclinical assessment and advancement into human clinical trials.

We've decided that we needed to show a little bit more color on exactly how that works, within Microba. Here's some further details exemplifying how our global leading data position is enabling us to exactly pinpoint this therapeutic act-- therapeutically active biology. In terms of the platform and the pipeline, we've obviously spent a range of time focusing in on three primary programs, as I've described. If we think about the milestones and where they've moved, our inflammatory bowel disease program is now through phase I and advancing towards phase II clinical trials, our immuno-oncology program progressing rapidly through preclinical towards lead candidate, and our autoimmune disease program progressing through discovery and generating really valuable data, with Ginkgo Bioworks, which we believe is unparalleled in the microbiome drug development field.

Each of these programs represents a significant commercial opportunity for shareholders, and I'm excited by the data we're generating and the potential impact we can have for individuals suffering from these debilitating chronic conditions, diseases. Luke highlighted earlier that in November 2021, Microba signed a deal, a therapeutic partnership with IFF to develop novel treatments for multiple forms of allergy. Importantly, over the quarter, these partners, these parties have now signed a stage two agreement, where we can move into isolating key strains from the identified species list and complete primary characterization. The goal here is to leverage our data-driven, human-first approach to identify novel allergy treatments from the human gut microbiome. Success here would see a product developed in partnership with IFF, and that if IFF take up their option to license and commercialize the product, which will generate royalties back to Microba.

Quick further update on our inflammatory bowel disease program, which is obviously a chronic disease that affects millions of people globally. There's a desperate need here for novel and safe new drugs, with approximately 50% of patients unable to achieve sustained long-term remission. We've spent time trying to understand the activity of our lead candidate, MAP 315. We now have data in humans showing it's safe, and our preclinical data continues to highlight a range of mechanisms that involve mucosal healing and immune homeostasis, which are core components to achieving remission that's unaddressed by the current standard of care. I just wanted to give a highlight on what we actually saw in our phase II clinical trial for MAP 315 for everyone to reference.

With advent, in terms of, the details here, key, key parameters are that MAP 315 is safe and well-tolerated, and some of the metagenomic data that we're able to obtain, indicating our ability to detect the presence of this organism, within the intestine. With respect to further advancement of MAP 315 into phase I, here we are finalizing our clinical protocol and made great progress on our manufacturing readiness for that phase II program. We're also currently determining the final strategy and align timing on that, and we look forward to sharing more. In terms of our oncology program, some of the early biology that we saw, which indicated a specific anti-tumor activity, we've now been able to look at some of the immunological mechanism to support that.

What we see here is an increased number of T cells and natural killer cells, which are important immune cells, that provide the underpinning activity. These experiments, obviously, in the mouse studies that we reported on previously, and seeing this activity on top of immune checkpoint inhibitor activity provides an enhanced mechanism of action for tumor killing. So this is the type of activity that we've been looking for these leads that would support future development. In our autoimmune program, I also wanted to share a snapshot of what this stage one screening activity looked like, and just to highlight that these results really exceeded our expectations. Here we're showing the broad spectrum of immunomodulatory activity exhibited by our leads as it relates to dampening immune and inflammatory activity.

This data, along with a range of other parameters, has led us to select the potent leads to move into the stage 2 screening. Alongside our progress in the last 12 months, obviously we've seen the first 2 approvals of live microbiome drugs through the FDA. These include Rebyota from Ferring and VOWST from Seres Therapeutics. These live microbiome drugs, or as they're termed, live biotherapeutic product, live biotherapeutic products, or LBPs, are an entirely new class of drugs. These first 2 FDA-approved drugs are important to show a clear path to market and are both what we consider to be first generation, based on fecal donor materials. They're also targeting a specific unmet need in recurrent C. difficile infection.

At Microba, we believe the big opportunity is in rationally developed microbiome-derived drugs, which can be manufactured at scale to treat millions of patients globally and address major unmet needs in chronic disease settings, and our therapeutic assets are at the forefront of this. Our strategy here is to do initial preclinical and clinical de-risking, and then partner and transact with strategically aligned, pharma for later development. Importantly, we continue to build good relationships and have great discussions with the top-tier companies in the sector. So with a clear regulatory path to market and Microba progressing to Phase II with our next generation therapeutic assets, underpinned by data-driven discovery methods, I'm excited by the impact we can have on individuals suffering from chronic disease, and more broadly, the commercial opportunity for shareholders. I'll now hand back to Luke to talk about the milestones ahead. Thanks, Luke.

Luke Reid
CEO, Microba Life Sciences

Thank you, Trent. So closing out another quarter of growth and therapeutic advancement, what's ahead? We have a range of important milestones over the next quarter, which will advance the company and unlock value for shareholders, including the integration and advancement of our new United Kingdom business, Invivo Clinical; national launch of our MetaPanel test with Sonic; and advancement across all three of our therapeutic programs. As at 31 December 2023, we had AUD 28 million in the bank, and I'm very excited about what's ahead for 2024, and in particular, what will be unlocked for shareholders. I'll stop here and answer some of the questions that have come through during the session. Just give me a moment. So first question was: "You'd planned for first MetaPanel test to be available in December. Can you explain more about the update to the full national launch this quarter?" Absolutely.

Previous plans were to open early key opinion leader access in December 2023, setting up for an initial, New South Wales-specific launch in Q3, the current quarter. Sonic decided they wanted to upgrade their plans from a New South Wales launch to a full national launch. In particular, this starting with the East Coast of Australia in Victoria, New South Wales and Queensland, and then following on to additional states. So we decided to focus on that together, rather than, delivering that early KOL access in December, focus our attention on setting up for a much larger launch. This is very positive, and it demonstrates Sonic's excitement about the product and the opportunity ahead. The second question here was: "What is the next step with the United Kingdom Invivo acquisition?" Great question. We are activating a growth strategy.

Their CEO will be over here in Australia in a few weeks' time as we finalize the details on that plan. A quick win opportunity that was highlighted during the acquisition process was that they have a very small sales team relative to their revenues and sales, and so we have moved quickly to bolster that team, with one individual placed and another in recruitment. They're hungry to launch MetaXplore, and we're collectively working through the timing and strategy for that. So the message is, full steam ahead. Another question here is: "What is the next steps for the inflammatory bowel disease program?" Well, picking up on Trent's comments, the team are working quickly to get phase II ready post the completion of phase I. That includes finalizing the phase II protocol, which is well advanced, together with getting CMC ready.

It's designed as an adaptive patient study, looking to have between 140-200 participants in that trial, examining induction of remission. The team are active in market, exploring options in relation to the phase II strategy and will continue to update. Another question: "Following the first distribution agreement with Sonic in Australia, what can we expect next for the partnership?" We're very focused on the launch of MetaPanel here in Australia, to really get that partnership into commercial operation, and that happens this quarter. We're continuing now to plan for their other major markets, and are particularly focused on our conversations in the United Kingdom and the United States. Another question here: "The Meta product, MetaPanel product is opening up a new market.

What more can you say about that product and the opportunity?" To paint a bit of a picture, the current standard of care for infectious disease pathology is qPCR panels for pathogen detection and culture testing for antimicrobial resistance. The largest qPCR panel has around 22-25 common pathogen targets, which covers only a small fraction of potential pathogens that someone could be infected with. There are many patient settings, both outpatient and inpatient, which require broader coverage of pathogens to deliver the best care. They include people with unresolved diarrhea, people with unresolved abdominal pain, diarrhea in immunocompromised people, which I've spoken about before. These include cancer patients receiving chemotherapy, bone marrow transplant patients, solid organ transplant patients, dialysis, long-stay ICU.

It's a big market and a big opportunity for the company, and I look forward to revealing more about that commercial opportunity post-launch of the product together with Sonic. There's some additional questions here that I haven't had time to answer, but I will ensure that we respond to each of those over email. Closing out, for the H1 of the financial year, with our world-class team and technology, we've made significant progress in capturing this rapidly emerging microbiome testing market, and have made significant advancements in our therapeutic programs and the development of those assets. I'm excited about the milestones and value which will be created for shareholders over the months ahead, and thank you everyone for tuning in to the update.

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