REG - Verici Dx PLC - Significant Test Growth with Medicare Pending

Verici DxAnnouncement

07/04/2025 07:00

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RNS Number : 8177D  Verici Dx PLC  07 April 2025

 

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.

Enquiries:

 

 Verici Dx                                                www.v (http://www.vericidx.com) ericidx (http://www.vericidx.com) .com
                                                          (http://www.vericidx.com)
 Sara Barrington, CEO                                     investors@vericidx.com
 Julian Baines, Chairman

 Singer Capital Markets (Nominated Adviser & Broker)      Tel: +44 20 7496 3000
 Phil Davies / Sam Butcher

 

About Verici Dx plc www.vericidx.com (http://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.

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