Verici Dx plc

("Verici Dx" or the "Company") 

Half-year report

Significant commercial progress with first revenues from Tutivia™ test sales

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its unaudited interim results for the six months ended 30 June 2025 ("H1 2025"). The first half was a period of significant commercial progress, with two products now fully validated and commercially available, and the first revenues from lead product Tutivia™ recognised.

Post period end the Company raised £6.35m (gross) to support the scale up of revenues, extending the expected cash runway into H2 2026.

Comparative unaudited data is for the six months ended 30 June 2024 ("H1 2024") unless stated otherwise.

Financial highlights

·    Revenue of $1.9m (H1 2024: $3.3m; FY 2024: $3.3m)

§ $1.16m from Tutivia™ testing revenues

§ $0.75m from Thermo Fisher licensing revenues

·    EBITDA loss of $2.8m (H1 2024: EBITDA loss of $1.1m; FY 2024: EBITDA loss of $5.4m)

·    $0.5m cash balance as at 30 June 2025 (31 December 2024: $4.1m) with cash balance as at 30 September of c.$5.3m

·    Net cash outflow from operating activities in H1 2025 was $3.5m (H1 2024: $3.2m outflow; FY 2024: $6.0m outflow)

Operational highlights

·    Two products now validated and commercially available

·    Lead product Tutivia™ attained Medicare coverage at $2,650 per test, covering a national estimate of 68% of all US transplant tests and commercial payor reimbursement applications are underway

·    Increasing test adoption: 591 Tutivia™ tests ordered in H1 2025 (334 for the whole of FY 2024)

·    In the period the Company reached a total of 21 transplant centres onboarded - representing 10% of annual US transplant volume

·    Continued progress with the Thermo Fisher Pre-Transplant Risk Assessment Test (PTRA) license

·    Well poised for growth: significant testing volume acceleration expected in H2 2025 and beyond

·    Commercial team expanded post period with the addition of two sales people in place and a director of clinical partnerships to join shortly

Commenting on Outlook, Sara Barrington, Chief Executive Officer of Verici Dx, said:

"As a Board we have no doubt that we have an exciting opportunity to deliver accelerated commercial growth in an approximate $900m addressable market. We have significantly de-risked the business, achieving all the milestones to enable two validated products to be commercialised. We have in place commercial requirements to support the business: our laboratories and logistical operations are set up, we have all the required regulatory approvals, and we have reimbursement. We are already seeing successful growth in the number of transplant centres onboarded and, funds are now in place to support further growth in testing volumes. Whilst growth financing was secured later in the year than hoped, we continue to target meeting market expectations for the full year, and we are confident that we can capitalise on the opportunity to address a significant unmet need."

Investor briefing

Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the interim results via the Investor Meet Company platform on 7 October at 10.00 am BST. This presentation is open to all existing and potential shareholders. Questions can be submitted at any time during the live presentation.

Investors can sign up to Investor Meet Company for free and add to meet VERICI DX PLC via:

https://www.investormeetcompany.com/verici-dx-plc/register-investor

Investors who already follow Verici Dx on the Investor Meet Company platform will automatically be invited.

A copy of the Company's interim results report will shortly be made available on the Company's website.

Enquiries:

About Verici Dx plc www.vericidx.com

Verici is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk, to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure, from pre-transplant to late stage. The Company also has a mission to accelerate the pace of innovation by research using the fully characterised] data from the underlying technology, including through collaboration with medical device, biopharmaceutical and data science partners.

The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.

Chief Executive Officer's Report

I am pleased to report that we made significant progress in H1 2025 as we transitioned from being a purely research stage business to a commercially focused enterprise with two products fully validated and commercially available. We believe we have a unique growth opportunity generating revenues both via license fees from our major strategic partner and through the rapid scale up of testing revenues from our lead product Tutivia™, a test for acute rejection post-transplant.

Post period end, we completed an equity fundraise of £6.35m (gross), with the support of both existing and new institutional investors. These funds have extended our cash runway into H2 2026 and will be used to support the commercial scale-up of a suite of next generation blood-based tests and improve patient outcomes for the 28,000 patients undergoing kidney transplants in the US each year.

We believe we are now very well-placed to exploit a large and growing commercial opportunity in circumstances where current testing technology may not provide accurate results and are not utilised, as well as potentially displace existing biomarker tests.

Our products

We have developed a suite of blood-based tests for kidney transplant patients assessing the risk of rejection along the patient journey from pre-transplant to long-term outcomes. Our technology is based upon RNA sequencing technology to utilise the messaging system of the body to deliver early and precise personalised information, comparable to an early warning system. By contrast, the current dominant technology offered in the market measures evidence of injury and is often referred to as a late biomarker.

§ Tutivia is a test for acute rejection post-transplant that reports the patient's risk of all forms of acute rejection, including borderline, T cell-mediated and antibody-mediated rejections. A single patient may require multiple tests. This is now commercially available with growing test revenue generation as we continue to work with the leading US transplant centres to increase utilisation.

§ Pre-Transplant Risk Assessment test ("PTRA") (Clarava), is a test for pre-transplant use to help define individual patient risk for acute rejection post-transplant. This can help clinicians to determine the level of immunosuppression for the patient in a more personalised manner. PTRA was licensed to Thermo Fisher for use with deceased donor kidneys in Q4 2023.

§ Protega is a test for longer term outcomes. The results may help clinicians determine the appropriate care pathways to delay or reduce progressive fibrosis or tissue scarring. The final visits for trial subjects have now been completed.

Tutivia - a unique commercial offering

Following the launch of Tutivia, and the successful fundraise to fund commercial scale up, we are now in a strong position to deliver significant acceleration in testing volumes in H2 2025 and beyond. In April we announced Medicare coverage for Tutivia™, which is fully reimbursed at a price of $2,650. Medicare is the largest payor in the US and provides coverage across c. 68% of all US transplant tests. This comprehensive coverage, without exclusions, will support the increased adoption of tests across the leading US transplant hospitals, offering both ease of process and credibility and status to our test.

A total of 591 Tutivia™ tests ordered were ordered in H1 2025, which compares favourably to the 334 ordered in the whole of FY 2024, and from Q4 2025 onwards we expect to see further scale up of Tutivia™ revenues as we invest our funds to accelerate commercial growth.

At the period we had 21 transplant centres onboarded, with these centres representing approximately 10% of annual kidney transplants in the US, and we are making good progress in on-boarding further centres. Through the deployment of additional headcount, we will provide direct sales support for the scale-up of Tutivia™ revenues, both in terms increasing test usage within existing order centres and expansion into new ordering centres. We will also fund additional direct sales support to raise awareness of Tutivia™, focussing on increasing interactions with Key Opinion Leaders, attendance and presentations at key industry conferences and events, and the production of educational content for a targeted clinical audience. We have already hired two new senior sales people and expect to see their impact in due course.

Tutivia - the addressable market and our strategy

We estimate that 28,000 kidney transplants take place each year in the US, and this number is growing. Under current clinical protocols we estimate that a weighted average of 12 testing points is used for each patient during their treatment pathway, which at a reimbursement price of $2,650, suggests a total addressable market of nearly $900m. Traditional biomarkers have been adopted in current US clinical protocols, but cannot be used with well over one third of the patient population, because these tests measure resulting kidney injury after rejection and a clear result is masked in cases of delayed graft function, BK nephropathy, belatacept conversion  or in cases where there has been a prior kidney transplant or multiple organ transplants. In all of these cases, Tutivia's RNA technology can be used for reliable, informative patient testing where competitive biomarker technology cannot be used, and this is a clear initial area of strong differentiation for our sales team to target. We are also confident, as adoption increases, testing centres will see that Tutivia can be used more comprehensively to replace a number of traditional biomarker tests.

PTRA (Clarava) license with Thermo Fisher

We continue to make good commercial progress with Thermo Fisher following the licensing of our PTRA test in Q4 2023. In 2024, we successfully completed the transfer of the technology and supported Thermo Fisher as they moved towards commercial launch in July last year. Thermo Fisher remains positive about the prospects for the One Lambda™ Pre-Transplant Risk Assessment (PTRA) Assay, investing in studies to support market adoption and raising awareness through key publications and key opinion leaders. At the end of February 2025, Verici Dx and Thermo Fisher jointly hosted an educational symposium at the Cutting Edge of Transplantation conference on the use of RNA signatures in the clinic, citing both PTRA and Tutivia.

Accordingly, we believe there remains significant potential from this strong ongoing relationship and expect to recognise further milestone payments related to sales volume, as well as ongoing royalty income.

Protega - a further unique competitive positioning opportunity.

The clinical validation study for Protega^TM, our test for longer term outcomes to help clinicians determine the appropriate care pathways to delay or reduce progressive fibrosis or tissue scarring, continues to progress in-line with our expectations. We have now completed the 24-month follow-up visits as part of the clinical validation study assessing long-term outcomes for kidney transplant patients and expect the study data to be available in the first half 2026.

Management and staff

At the end of June we were a team of 15, having taken steps to reduce headcount ahead of the fundraising. Following the fundraising, concluded in late July, we have successfully recruited two new sales people who have already started, and hired a director of clinical partnerships who is expected to join in mid-October.

Financials

We ended the period with a cash balance as of 30 June 2025 of $0.5m (31 December 2024: $4.1m), with the conclusion of the equity fundraise in July 2025 adding net $7.7m. Our cash balance as at 30 September 2025 is c.$5.3m.

In the period we recognised total revenues of $1.9m, being $0.75m from a further milestone with Thermo Fisher and $1.16m from testing revenues. This direct revenue is recognised at the point the test result is delivered to the ordering clinician and is reimbursed from one of two core payor types: Medicare and commercial payors. For Medicare patients we have a known and agreed price for the test. For commercial payors there are a number of factors which determine whether, and for how much, the test is reimbursed, which will also change depending upon each commercial payor. This requires a significant amount of judgement and estimation, particularly in this early period of revenue growth as we gather the information to be able to assess a reasonable average reimbursement from these commercial payors. While we consider that current working assumptions are reasonably conservative, they are subject to modification as further data emerges from payments for delivered test results.

Our largest item of expenditure remains employment costs, being $2.1m (H1 2024:  $1.9m). We began the year with 18 members of staff, we had one resignation in the period, exited three others from the business and made an additional hire into our bioinformatics team, ending the period with 15 members of staff.  As we have passed the peak of our clinical trial costs, our spend on research and development continues to fall, with the cost in the period of $0.65m (H1 2024: $1.0m) and we continue to manage costs carefully.

Cash outflow from operations was $3.5m (H1 2024 - $3.2m) leading to a cash balance at the end of the period of $0.5m (31 December 2024 - $4.1m). In late July we concluded an equity fundraise which generated net proceeds of $7.7m.

Outlook

As a Board we have no doubt that we have an exciting opportunity to deliver accelerated commercial growth in an approximate $900m addressable market. We have significantly de-risked the business, achieving all the milestones to enable two validated products to be commercialised. We have in place commercial requirements to support the business: our laboratories and logistical operations are set up, we have all the required regulatory approvals, and we have reimbursement. We are already seeing successful growth in the number of transplant centres onboarded and funds are now in place to support further growth in testing volumes. Whilst growth financing was secured later in the year than hoped, we continue to target meeting market expectations for the full year, and we are confident that we can maximise the opportunity to displace existing tests and address a significant unmet need.

On behalf of the Company, I would like to thank our shareholders for their ongoing support and look forward to providing further updates in due course.

Sara Barrington

Chief Executive Officer

30 September 2025

Consolidated condensed statement of profit or loss and other comprehensive income

for the six months ended 30 June 2025

The results reflected above relate to continuing operations.

Consolidated statement of financial position

as at 30 June 2025

Consolidated statement of cash flows

for the six months ended 30 June 2025