Verici Dx plc

Good afternoon and welcome to the Verici DX PLC Business Update. Throughout the recorded update, investors will be in listen-only mode. Questions are encouraged and can be submitted at any time by the Q&A tab situated in the right-hand corner of your screen. Simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company can review all the questions submitted today and publish responses where it is appropriate to do so. Before we begin, I'd like to submit the following poll. I'd now like to hand you over to CEO, Sarah.

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. 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 for Arthur, early stage damage, post-transplant to tibia, late stage Protega. Collectively, those three tests have covered the end-to-end spectrum of testing in kidney transplants. And we have always maintained that there will be a movement from individual tests to more solutions based offering as we look at the integration of those three tests. Collectively and with other programs, we have called this the clinicians 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 of heart, liver and lung, and can be applied and extended into adjacent diseases such as autoimmune diseases. 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 and to demonstrate how that is now in three main revenue generating centers. Let's start off with Chlorava, 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 can see that aspects like that will be held under licensing revenues. Direct revenues reflect the next commercial product to Telia. 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 centre 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 to be determined is not uncertainty, it's choice. And again, those will feed into the centres 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 Centre. 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 thermos labs and that successful transfer was subject to the major milestones within that structure and those have now been achieved Underlying that, Thermo have been focused in 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 that 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 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 sales people 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, where it'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 recognise the revenue in 2024. We've now completed all states under the clear 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 investment 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 Leader is being able to explain our underlying technology, the applicability, the use of Tutiva, and sharing their experience. It's 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 Protego, 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. in 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 ongoing to cover the 24 month 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, etc. All of those are expected to yield products in the medium and longer term. And all of those programs are 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. It'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 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 oversight into that developed testing to our area of testing from the CLEAR process. That oversight was expected as REACHE is fully compliant and is able to offer the Tutivio test without any disruption. Future phase rollout has an improvement with the New York State process. The FDA are 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 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 Maldi X had given some guidance in terms of the interpretation of the LCD. that had caused some confusion. They did withdraw that guidance and instead turn 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 says that it will be very much in line with the guidance they already gave. And so we are not expecting any additional requirements. If they are some, we obviously have a process in place to deal with them. David, can I pass over to you for the numbers?

Thank you Sarah, good afternoon everybody. So pleasingly, the six months saw us record 3.3 million of revenue. That's revenue across our licensing business and the services business that Sarah 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 the end of the six month period was 7 million. That was obviously augmented by the which raised the net amount of £7.5 million. And therefore, with that cash balance and our assumptions for revenue for this year and beyond, we still have sight of cash going into 2026. Turning to the primary statements, so 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 million of the revenue in 2023, which was recognized in this period, so that impacted that cash outflow number. Minimal spend on CapEx and in February. Turning to the income statement, £4.4 million spent on expenses in the period. 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 raising funds in February. And 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 Thurlow 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 and that amount is currently standing at 745,000. Thank you. Back to you, Sarah. Thank you.