Verici Dx plc

("Verici Dx" or the "Company") 

Significant Test Growth with Medicare Pending

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, provides an update on operations at quarter end.

In Q1 2025, Verici Dx recorded its highest Tutivia™ testing order rate of 292 tests. This represents a significant 68% increase in the testing order rate over the previous quarter (Q4 2024) and compares to a total test ordering figure of 334 for FY 2024. This is a highly encouraging ramp up in adoption and test ordering, even before the outcome of the Local Coverage Determination, and the Company expects continued growth in Tutivia™ testing for the remainder of the calendar reporting year.

Accounting recognition of revenues for Tutivia™ will continue to be pending a decision from Medicare contractor MolDX.  A decision on our MolDX Technical Assessment review for coverage is expected imminently, and a further announcement will be made at that time.  The price per test under Medicare is set at $2,650.

In addition, the Company notes that the milestone for a payment of $750k under the commercial contract for PTRA was achieved in Q1 2025 and has been invoiced to Thermo Fisher which we expect to receive in Q2 2025.

The Company has continued to demonstrate a highly disciplined approach to cost control, with further headcount reduction and other cost containment steps in recent months, including reducing external spend on product development. As of 31 March 2025, the Company held a cash position of $1.63 million. Cost controls are expected to provide sufficient cash runway, assuming receipt of the $750k milestone payment mentioned above, through to the end of June 2025. This funding should support the Company in reaching a MolDX insurance coverage decision before conducting an equity financing to continue its current commercial testing trajectory.

Sara Barrington, CEO of Verici Dx, said:

"I am extremely proud of the progress we have made since our last update, particularly when viewed in the context of limited resources and, ahead of the local coverage determination for Tutivia^TM. The significant increase in orders for Tutivia^TM in the last quarter reflects how it directly addresses areas of unmet need in transplant, as well as general utility, and demonstrates it is being very well received by clinicians who are passionate about improving their patient outcomes. 

"Verici has proven to lead the way in developing a new wave of technology for transplant with both Tutivia^TM and PTRA being clinically launched, and there is a high degree of interest in the progress in our other programs which have the potential to add significantly to the field.

"We previously said that adoption of innovative products is sensitive to establishing comprehensive insurance coverage and we recognise that the lack of coverage through 2024 slowed the pace of adoption. That said, we are pleased with the initial Tutivia^TM test ordering, the levels of repeat ordering, and we still expect volumes to further accelerate as insurance coverage is established."

Tutivia^TM update

The Company is currently working with 19 leading US transplant centres as they embed Tutivia^TM into their current clinical pathway which will further encourage consistent and recurring utilisation. We are pleased with the initial Tutivia^TM test ordering, and particularly to see the strong levels of repeat ordering as indicated above.

As previously announced, the Local Coverage Determination process remains ongoing. We submitted responses to questions to Medicare in support of a coverage determination for the Tutivia^TM test earlier in Q1 2025 and will provide further updates as and when appropriate.

PTRA update

Our collaboration with Thermo Fisher Scientific remains strong and we note that they continue to invest in the commercialization of PTRA. Verici and Thermo Fisher jointly hosted an educational symposium at CEoT conference at the end of February 2025 on the use of RNA signatures in the clinic, citing both PTRA and Tutivia^TM. Notably, Thermo Fisher is investing in new research related to PTRA aimed at identifying the earliest stage at which the test can be utilised before transplantation. Consequently, the second milestone originally anticipated for 2025 will be delayed as we continue to collaborate on publishing clinical validation data and Thermo Fisher pursues these additional research efforts to help broaden utility and adoption of the assay.  

Services and other product development update

In line with the Company's cost management, we expect a slowdown in licensing activity during 2025. As a result, the development timelines of Protega^TM and the urine product have been extended to the end of 2025.

Additionally, while the services business continues to generate interest and several collaborations are underway, broader market uncertainty following the introductions of tariffs has led the Board to take a more conservative approach to forecasting. Consequently, the licensing event previously forecasted for 2025 has been delayed to 2026 and the direct services revenue for 2025 have been reduced.

As such, the Board are revising the expected 2025 revenue for the Company's Services business from $5.9 million to $0.5 million.

Raising commercial awareness and understanding

The team is focused on raising industry awareness and understanding in RNA signature biomarkers and our assays, which will in turn support commercial adoption and growth. To this end, we attended key industry Q1 conferences aimed at 3 different customer segments.

·   We exhibited at the Cutting Edge of Transplantation (CEoT) summit from 28^th February to 1^st March 2025. The overarching goal of the CEoT 2025 was to discuss changes that have gone into effect and envision opportunities for the future. This theme resonated strongly with our mission, and it was exciting to hear how Tutivia is being successfully integrated into clinical practice by the Transplant Nephrologists and to see so much interest in PTRA, where we hosted a joint symposium with Thermo Fisher Scientific.

·    We also attended NATCO, the Organisation for Donation and Transplant Professionals, from 23^rd to 26^th February 2025 where we were able to highlight the advantages of Tutivia to the Transplant Coordinators.

·     Another highlight was our booth at the American Society of Transplant Surgeons (ASTS) Winter Symposium which ran from 16^th to 19^th January 2025 highlighting our technology to Transplant Surgeons

2024 Annual Results

As referred to above, the PTRA milestone payment of $750k which was expected to be recognized in 2024 will now be recognized in 2025. As a consequence, the Board now expects to report full year revenues of $3.3m, and adjusted EBITDA loss of $5.4m in line with expectations.

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About Verici Dx plc www.vericidx.com

Verici Dx 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.