Welcome, everybody. Thanks for attending. This is the half year results and business update. Obviously, there is our disclosure slide. I'd like to kick off by presenting the slide that I have presented before, and then showing how we are translating this into our current view of the business. So this has been our vision slide for how we operate with the company. You can see the kidney transplant testing, the suite of products being pre-transplant, Clarava, early stage damage, post-transplant, Tutivia, late stage, Protega. Collectively, those three tests have covered the end-to-end spectrum of testing in kidney transplant.
And we have always maintained that there would be a movement from individual tests to more of a solution-based offering as we look at the integration of those three tests.
Collectively and with other programs, we have called this the Clinician's Platform and indicated that each area of those tests are and will be developed as applicable to other organs outside of kidney. The usual transplant organs are heart, liver, and lung, and can be applied and extended into adjacent diseases such as autoimmune. Behind that, we've talked about a research asset from both the physical samples that we generated as well as the data associated with that. If you recall, we sequenced, that's the entire transcriptome.
That's a wealth of information, so we have a big data aspect to this, and we have been referring to that as the research asset.
I'd like to reframe that vision picture to reflect our new stage of company, which is very much focused on revenue generation. To demonstrate how that is now in three main revenue generating centers. Let's start off with Clarava, the pre-transplant test. As previously disclosed, that was subject to a licensing arrangement with Thermo Fisher, and we will give an update on that. But you will see that aspects like that will be held under licensing revenues. Direct revenues reflect the next commercial product, Tutivia, that's early post-transplant, and that is subject to our direct sales force.
That is where we offer it directly to the company. And obviously, building on that, is as a center that we'll call direct revenues. Obviously, with a pipeline of products, we've covered that before.
We will give an update on status on that. For example, ProTega being the late stage. We have a choice whether that is offered through the licensing revenues model or with the direct. So that's to be determined, is not uncertainty, it's choice. So again, those will feed into the centers of direct and licensing. And then thirdly, the third source of revenue is what we're calling the services business. So that research asset, that cloud we had shown before, that is now being grouped together and offered to the market as a services business, and we'll give an update on that as well.
Let's start with the licensing revenue center. Back in 2023, November 2023, we discussed that we had signed an agreement with Thermo Fisher for the pre-transplant test.
That we had a number of milestones attached to that. And David will give the numbers later on in the presentation. And that there would be an ongoing royalty stream. That's the structure of the agreement there. The update is in the first half of the year is that we have completed that transfer. So the test is now up and running in Thermo's labs, and that successful transfer was subject to major milestones within that structure, and those have now been achieved. Underlying that, Thermo have been focused on gearing up for their commercial launch.
That will be announced in due course. But what we did see is, obviously, this being introduced to the clinical community at a major conference, which was called ATC, and that was done in June.
Looking forward with this agreement, we have some minor milestones to be achieved at the rest of the year and into next. And those are mostly subject to the launch plans of Thermo. We can report that we are on track, and we're, you know, focused on those for the rest of the year. Direct revenues, this is Tutivia. Tutivia is the early post-transplant test, and we have now three salespeople in our team that are focused at both opening new centers and exploring what we call recurring or repeat ordering within those centers.
We're now increased to 15 ordering centers, and we were able to, at the last conference, present new data in this field, a new subgroup called DGF, Delayed Graft Function patients.
There's an unmet clinical need in that area, and the presentation of the applicability of Tutivia within this subgroup was very well received and has resulted in an increase in orders behind that. The timing of the revenues in this area are subject to our coverage determination that we expect towards the end of the year. So whilst we are not recognizing any revenue at the moment, due to this process or being in review in this process, the technical assessment file process requires you to hold claims.
We do expect to be able to submit all of those claims at the end of the year with the coverage determination and retrospectively be able to record that revenue. That way, we should be able to recognize the revenue in 2024. We've now completed all states under the CLIA regulatory process.
New York State has some additional steps and data presentation requirements. We have completed those, and that is now submitted into New York State for review. We did expand the commercial team. We now have a total of five, three sales people and medical affairs. And we're also looking at deploying those for the rest of the year and into next year, hiring in terms of reaction to increased volumes that we would expect next year. So very much, the investm
ent in the sales force this year, and then any increases being in response to an increase in demand. Key Opinion Leader educational program is part of the increase in clinical awareness and outreach to the clinical community.
Key opinion leaders being able to explain our underlying technology, the applicability, the use of Tutivia, and sharing their experience is an important component in being able to get widespread adoption of our testing. The patient outreach was completed with the Patient Journey that was launched formally at the Transplant Games in July. But this is an educational tool that enables patients to navigate and understand their process all the way from the initial diagnosis of kidney disease through to completion and maintenance of the transplant.
And this is something that, in conjunction with centers, is an offering to patients to be able to understand their journey and the requirements of the transplant interaction with their teams. Other revenues.
In terms of product development, we spoke at the beginning of the year about ProTega, our third product in the core testing. We have completed the 12-month visit, and we do expect, after the data cleansing and analysis, to be able to issue the test out into the market in terms of validation and performance in the first half of next year. So we continue to be on track with that program. We did fundraise, request funds to be able to be applied to expanding that cohort right into the 24-month visits. And so that clinical trial is now going to cover the 24 months period.
That will be added to the test offering and provides us with a more robust test offering in terms of long-term outcomes.
Other programs funded and in the pipeline are the urine programs, applicability to other organs, et cetera. All of those are expected to yield products in the medium and longer term, and all of those programs are on track, on track. Turning to our third source of revenue, which is our services business. We did complete the transfer of the urine samples per the agreement. Some of that recognized last year, some of it this year. That is now complete, and fully recognized. We also announced a collaboration based with an academic institution in Sydney, Australia.
This is grant-funded, and enables us to demonstrate the ability of our tests being deployed internationally and within the environment of both education and standards elsewhere in the world. That's a very exciting collaboration.
We do have other opportunities in this area.... and they're all at various stages. But recognizing that we're having both, a lot of interest in this area, all the way from testing with wet lab capacity, all the way through to, the team's expertise. This enabled us to turn and look at outbound activities, and we do have a dedicated sales resource now employed in this revenue center. Market trends to be aware of. As some of you may have noted, the FDA did extend its ove
rsight, into lab developed testing, into our area of testing from the CLIA process. That oversight was expected, and Verici Dx is fully compliant, and is able to offer the Tutivia test, without any disruption.
Future phase rollout has an involvement with the New York State process, the FDA using that as a proxy in their oversight, and obviously, we are fully submitted there, and will simplify any future compliance needs. On the reimbursement front, we are, as noted, we submitted our application in Q1 of this year. And we are in an active review process, and are on track to meet the expectations of the determination before the end of the year. Industry-wide, we noted last year that MolDX had given some guidance in terms of the interpretation of the LCD, that had caused some confusion.
They did withdraw that guidance and instead turned to a process where they would amend and solidify that into an LCD.
We are expecting that this summer. We do have plenty of scope to be able to incorporate any unexpected changes within our process, but guidance is that it will be very much in line with the guidance they already gave. And so we are not expecting any additional requirements. If there are some, we obviously have a process in place to deal with that. David, can I pass over to you for the numbers?
Thank you, Sara. Good afternoon, everybody. Pleasingly, the six months saw us record $3.3 million of revenue. That's revenue across our licensing business and the services business that Sara has just spoken about. Our EBITDA loss for the period was $1.1 million. Again, referencing our tight control over costs. Cash balance at the end of the month, at end of the sixth month period, was $7 million. That was obviously augmented by the successful fundraise in February, which raised a net amount of $7.5 million.
And therefore, with that cash balance and our assumptions for revenue for this year and beyond, we still remain in sight of cash going into 2026. Turning to the primary statements. The cash flow statement for the six-month period.
Cash outflow from operations, $3.2 million. Notwithstanding the fact it was a $1.1 million EBITDA loss for the period, we received $1.5-
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Q&A can be accessed via your-
Turning to the income statement.
At this point, if I could maybe just hand over-
[Crosstalk ] . Our two biggest expenses remain staff costs and R&D expenditure. On staff costs, we started the period with 14 people in the business. At the end of June, we had 19 people in the business. That was three additional individuals hired into our commercial team and two individuals into our bioinformatics team. Again, both of those were as expected, as outlined to shareholders at the time of raising funds in February. Then finally, to the balance sheet. We have a large receivable of $1.5 million at the end of June.
This reflects the invoice that was issued to Thermo Fisher in June. And then on the payables, we continue to hold a prudent amount in terms of site accrual costs.
This is our estimate of costs which have been incurred by the site as part of a clinical trial, have yet to be invoiced, and that amount is currently standing at $745,000. Thank you. Back to you, Sara.
Thank you. So very much a message of on track and expanding, and I'd like to take a moment just to walk through, you know, the summary of the company. So far, in the four years since the IPO, we have obviously had a strong track record of delivering on time and to expectations. Part of that is that we have commercialized two tests, so been through the product development, validation, and right the way through to commercial. One being the licensing opportunity with the pre-transplant, and the other one representing the direct revenues.
And obviously, we have a clear pipeline of subsequent products, which we can be offering to either the licensing or the direct revenue lines.
Those diversified revenue streams also include the services business, recognizing that there is value not only in our underlying tangible assets, such as samples or the data, what we have been referring to as the research asset, but also the expertise within the company and the team, and giving a rich opportunity to have collaborations with other companies, other institutions, both in research and commercially, either on a fee for service or in a more grant-funded monetization. That obviously gives the company a little bit of security in terms of a diversified.
We're not a one-product company, we're not a one source of revenue company, and obviously, that enables us to expand on multiple fronts. We do have a large addressable market.
What is interesting is we had previously, you know, done our market sizing, particularly for the Tutivia, assuming that it would be 2 times a transplant patient. This has proven to be, in our experience in the marketplace, very conservative and perhaps over-conservative. We are seeing that, the numbers of testing being anywhere up to monthly, and that is obviously a much higher multiple on each transplant patient. We do offer, it's a happy phrase, the next generation of technology, but it is true.
So with the, RNA signature approach, we're able to offer, technology that is more personalized, it's more proactive, and in fact, is, able to be offered where there is still unmet need, in the marketplace.
With that, has been extended to our other products, where, for example, Clarava, there is not another similar offering, same as ProTega. And so at each point, we are addressing, in a very large addressable market, that critical need. It's not just enough to do product development within healthcare. You also have to understand you're operating within quite a structured, regulatory, and complex reimbursement environment.
And that is something that we're at an advanced stage, almost at completion with the regulatory with New York State, and obviously in the last stages of coverage with Tutivia under that LCD process. So all in all, you know, we're as we're looking to expand going forward, we have now moved from just a product development company into one that is quite clearly focused on revenues.
I think if you're looking at the growth of a company, that is what I would call stage two. Out of pre-revenues, we're now into revenues and building up that and obviously looking forward to the third stage of in the future profitability and cash flow breakeven stages. Definitely, firmly in the revenue. That's how we're seeing the company, that's how we're driving the expansion. We do aim to be at the center of RNA signature testing and are poised very well to do so. That concludes my presentation. Thank you. Thank you very much.
We're getting questions on obviously kind of short-term catalyst for share price appreciation. You know, obviously, I think that really refers to news flow for the rest of the year.
Obviously, the key aspects that I'm sure folks will be looking out for is the formal launch from Thermo on the Clarava. More news in terms of conclusions of the LCD process, and year-end figures on the results of the direct revenues approach, and any other kind of announceable information that we'll be able to make on the services business. Not all of those will be announceable, and that may be a discussion at year-end, but I would say that those are the major catalysts moving forward, very much revenue-focused there.
What are the next steps with regard to timescales? How near are you to commercialization? Hopefully, this presentation was helpful in terms of saying that we really are in commercialization right now.
We're very much in terms of looking at the business from a revenue center perspective. So obviously, the licensing we've had, you know, we've completed major milestones there. That's well underway and close to completion. Now, we're into the launch from Thermo. On the direct sales, where we have, I think it's almost doubled our centers in this period, and we continue to expand in that area and, you know, gain traction there.... Some comments on delisting. Yeah, I'd like to address that. I can't talk for other companies, obviously.
But I do note that many of those were because of funding requirements, and clearly, we closed around this year in the period. So that's not really a direct comparison.
I would like to say, I remain a huge supporter of AIM as an exchange. I do believe it has a unique role in the world. And it's one of the reasons that London's been at the forefront, traditionally, of being a financial center. I would like to see AIM is fully supported, maybe even expanded, and I remain committed to supporting it going forward. So hopefully that answers that question. Competition. There's different comments about competition as we think about each program.
So we have, in the end-to-end testing, the best served part of that journey for patients was in the first year post-transplant, and that is what we've offered with the two-year test. Now, in terms of competition, we offer quite different technology and an advancement in that area.
And you know, it's a hackneyed phrase to say that you're the next generation, but I do believe that that's appropriate in terms of looking at our approach to that area. There were a number of areas within that testing that competitors were not addressing, and we do. And to that point, I think we had some very clear differentiation. And we're priced competitively, and we're seeing that in the adoption of the test. The other two products in that end-to-end, the pre-transplant.
If I can just take a step back and say pre-transplant has been... You know, there are three aspects to the transplant equation when you're looking at rejection. There is the patient, there is the organ, and then there's the compatibility. It is the compatibility that has been best served to date.
There has been some measures of tests over the organs, but what had really not been addressed was the patient themselves. That is what Clarava does. It answers the clinical question, how aggressive or benign is the patient's immune system likely to react in the face of an organ, and therefore, was underserved. So if we say that there is no competition in that area, it is because it's a novel offering to the market, and there's a huge amount of interest from the clinical community in seeing such a test. ProTega is the same.
Long-term outcomes very poorly served in the environment. Fibrosis is a well-known condition, not only in kidney transplant, but other organs and other disease states. It is basically scarring of tissue and to long-term failure.
And the question there is: Are you progressing at a slow or a fast pace there? Will it lead to rejection? Are you likely to lose your graft in 5 years, which is problematic, or will you keep it for 30 or 40 years, which is the ideal? So clinicians don't have a good risk-based assessment tool there, and therefore, when I'm saying ProTega, it also doesn't have competition. It's because that is a unique offering and therefore is of interest. So hopefully that answers the question about competitors. I see that there is some questions about market sizing. I just want to return back to that point.
If you recall, in previous presentations, we had put the testing kidney testing market about $5 billion.
That looks to be too conservative because it was based on Tutivia being run only two times. We are seeing anywhere up to, let's say, nine times, you know, monthly after the first quarter post-transplant. There is a variety of protocols. Each center has its own protocol, but it looks like two times would be overly conservative. I've always said that when you get into the billions and you're saying, "Do I have a large addressable market?" The answer is just
yes. It is large, it is addressable, and, you know, I think one of our nearest competitors valued the kidney transplant market at about $10 billion. But and they're probably baking in the increased amount of testing that there is done.
But hopefully, you can see that, that there is, some very large revenue numbers to be had there. What steps have been taken to make the Thermo Fisher agreement a success? I think this is an opportunity to give a shout-out to both teams. To successfully transfer technology from one lab to another requires a high degree of cooperation, and a sharing of information, and to do it to time, you know, when everyone's got 100 other priorities... is a testament to how focused Thermo were, you know, and in their interest in being able to offer this test. So, we remain good friends.
We have a good working relationship with Thermo. We'll continue to support that team, and we were thrilled at the efficiency of both teams in getting that transferred.
As we move on, we had talked about supporting them commercially, with some joint presentations. Those have happened, and you should see news of where we jointly offer some educational programs. So there is a lot of reason to work together. The base technology of RNA signatures requires a certain amount of education and discussion in the clinical community. Obviously, those with pre-transplant are going to be interested in the post-transplant, and vice versa. So what we are seeing is a high degree of cooperation and sharing between the two teams, and that continues.
I'm asked for more details on the collaboration with the Westmead Institute, and other potential research partnerships. The research with the Australian group was important to us for many reasons.
One, it proved that we would be doing collaborations with high-profile academic centers, not only in the U.S. and Europe, but beyond. And I was thrilled to be able to give a nod to that international community. The details of the collaboration is that the government were interested in understanding, if you like, genetic-based testing within this environment and how that could be incorporated into national healthcare, and bringing on a new wave of education to the up-and-coming nephrologists. So that's it.
They funded this very large study, and we are part of that. So the result for that is that we are recognized and tested within the government environment, and also one where the education of the new generation of nephrologists will incorporate the results of that testing. So very important all the way around.
And the Westmead Institute is an organization that we're very proud to partner with, and they were actually in our clinical study, and they have a number of high-profile publications themselves. So I felt that this was a very high-quality example of a collaboration in the research environment with academia. The problem with research is everybody wants to keep it quiet. It's commercially sensitive, and we have the same issue, which is, you know, one doesn't always want to reveal what you're developing, what the pipeline is, and the details there.
And so where we are doing research partnerships, and we're not always able to disclose what they are, R&S contracts, et cetera, because of the sensitivity.
Where we are able to, where there is mutual interest in publicizing those collaborations, we will, and I hope to be able to do so within-
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Next question is, I'm sorry, I'm actually struggling to read that.
What strategy are you in place to further increase the adoption of Tutivia in transplant centers across the U.S.?
Okay. I don't think we need to change our strategies at all. We understand, first of all, there is the ability to recognize that when you're going into a new center, there is not only a clinician and a transplant team education-
Thank you. Thank you very much.
There's also a logistical element to it.
Can I please ask investors not to turn the session, as you know, we automatically redirect it, provide the feedback, and we'll be able to better understand your views and expectations. If you want to complete, which will be greatly valued by the company. Our financial team is reached yet. Jesse, we'd like to thank you for attending today's presentation and answering the team.
So that is all encompassed in what makes a center an ordering center. And we have have been working on that and have successfully opened 15 centers. Within that, then there is a focus that you don't want to spread your team too widely, just in opening centers. There's an amount of follow-up and encouragement to increase the and to look at recurring revenue, and that ordering from the, you know, clinical team, has a certain amount of habit forming. Is it easy to order? Do I know what it is? Can I understand where I'm using it with my patient care? So on and so forth.
All the way up to being fully baked into the IT systems and ultimately into protocols. So that's the approach there. For us-...
We asked for, you know, an investment in expansion of the sales team. We've divided into territories. We have the original, business development person working on that recurring revenue, setting up a model for what really helps clinicians feel comfortable with the test and putting it into their, their sort of business as normal in terms of testing for patients. But we also have made an investment into the, new salespeople, and we'd like to see those, you know, build out into their territories.
After that point, we have said we would hire in response to increased orders and be able to meet the demand with additional salespeople, and that would really be the strategy, which would be to build out that sales team until we've got national coverage and to extend beyond our initial target of centers into the full 180 that eventually we want to get to. What is the long-term vision for Verici in terms of the product portfolio and market presence? Hopefully, that's been covered with the presentation today.
I believe that we have offered up a vision where we started in kidney transplant testing, proven out the technology of RNA signatures and product development and validation, the utility of that testing within a discrete area of kidney transplant testing.
We then said, then you're able to sort of widen that field, and you build upon your own success. We've had two successful products, a third on the way. Those products are then translatable to other transplant areas, and ultimately, this idea of using the recognized expertise of the company and the team in terms of doing this product development and development of RNA signatures, which are widely applicable. We've seen them, you know, we've suggested that adjacent, you know, disease groups could be in the autoimmune, but in fact, it can be used very, very widely, oncology being a big area.
So when we say, right at the end of this presentation, we aim to be at the center of RNA Signature testing, it is a big new wave of technology that's being offered in testing in the medical community. And at the moment, we are demonstrating not only our success in, you know, validating signatures to the products, but we're also demonstrating that they have usefulness and that they are adopted commercially with all the wraparound in terms of the regulatory and reimbursement. And I do believe that we are well on our way for a long-term vision of being an RNA Signature company.
But that's not built overnight. We've always demonstrated how we would focus and build upon success, so that we don't get ahead of our skis.
I believe that we have delivered on that, and we continue to deliver on that, and over time, we'll be able to, you know, address and widen the disease groups, for a long-term vision. Thank you. I'd actually like to. In the period, obviously, we did a fundraise, and investors permitted us to, you know, really invest in the acceleration of previous success, to other product areas. It was a very successful fundraise when in a time when market conditions are perhaps not that conducive to raising funds. So I'd like to thank the shareholder base for their ongoing support.
I'm looking forward to reporting on that continued success as a faster pace, and we're very excited for the rest of the year.
Thank you, good afternoon.
Thank you.