REG - Verici Dx PLC - Operational Update

Verici DxAnnouncement

22/03/2023 07:15

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RNS Number : 7803T  Verici Dx PLC  22 March 2023

Verici Dx plc

("Verici Dx" or the "Company")

 

Operational Update

 

First revenues from Tutivia™ following full commercial launch

 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for
organ transplant, provides an update on its operational progress made since
the release of its interim results in September 2022.

 

Verici Dx continues to execute the commercial introduction of Tutivia™, the
Company's first product for kidney transplant rejection, with first revenues
in FY 2023 and is exploring strategic options to increase sales distribution
and launch its second lead product, Clarava™ by the end of the year. The
Company retains sufficient funding to achieve further key milestones in 2023
and the first half of 2024, which will support commercial adoption including
the publication of additional data and obtaining both Medicare and private
payor pricing and coverage.

 

Data continues to support product differentiation and competitive advantages

Following a robust validation trial using a varied, 'all-comers' patient
population in a clinical setting, Tutivia™, a post-transplant prognostic
test for the assessment of risk of acute kidney rejection, was pilot-launched
in December 2022 ahead of its full commercial launch in January 2023. The
validation trial data showed a positive predictive value (PPV) of 60%, over
three times that was achieved by the closest comparative product in the market
when used in the same context, establishing a new industry standard.
Additionally, study data analysis of the clinical performance of Tutivia™
demonstrated a differentiation of high-risk and low-risk patient groups,
determining that patients of high risk were approximately six times more
likely to have a rejection than those of low risk. This represents a
significant demonstration of Tutivia(TM) as a predictive test capable of
informing a clear, actionable response from clinicians. The Directors believe
that no other comparable products have been validated to this degree.

 

Tutivia™ also has competitive advantages, as it can be run as early as the
first-week post-transplant, earlier than any other test. Tutivia™ enables
clinicians to act proactively, rather than reactively, to rejection events, as
well as not being confounded by other kidney health complications (such as the
BK virus), which need an alternative therapy protocol. This is because
Tutivia™ identifies RNA signatures that are specific to acute rejection, as
opposed to other tests that detect evidence of damage that may not necessarily
be caused by rejection alone.

 

In addition, following the positive initial data announced in September 2022
on Clarava™, the Company's pre-transplant prognostic test, the Company chose
to expand its validation trial for this lead product for a further six months.
This decision was taken to strengthen the publication appeal of the trial and
demonstrate a statistically robust and clinically compelling case in support
of the commercial rollout and adoption of the test. The full readout from this
trial is expected in Q2 2023, with the initial launch expected before the end
of the year.

 

Strong progress on rollout strategy

In line with its strategic plan, the Company is working with three leading US
transplant centres in the Tutivia™ commercial launch and is supporting them
with the adoption and integration of the test into the current clinical
pathway, to encourage consistent and recurring utilisation. This is providing
a valuable foundation for Verici Dx to make Tutivia™ as simple as possible
for clinicians to use and interpret.

 

Following the successful progression of the Company's laboratory registration
status to Compliance Certification by the Centers for Medicare & Medicaid
('CMS'), allowing its commercial operation for samples received from patients
in 45 US states, Verici Dx is ready to build on the initial rollout activity
over the course of 2023. Medicare and Medicaid account nationally for about
65% of all transplant patients and the Company is focused the initial rollout
of the test where the proportion of Medicare patients is higher than the
national average. To further drive adoption the Company has addressed the
pricing and coverage determinations under Medicare. This is administered by
the MolDx region of Palmetto given the Company's laboratory is based in
Tennesse. The Company submitted its pricing proposal in Q1 2023 and expects to
get the MolDx pricing recommendation by the end of Q2 2023. The Company is
currently preparing its submission for Medicare insurance reimbursement
coverage, under the Local Coverage Determination (LCD) offered in Palmetto and
a coverage determination is expected later this year. Registration for
Medicaid has been approved in three states and submitted in a further 11
states as well as with BlueCross Blue Shield of Tennessee, the largest health
benefit plan company in the state.

 

Prudent cash management and execution

As of 31 December 2022, the Company had a cash balance of $9.81m. The Company
has taken headcount reduction and clinical trial cost containment steps in
recent months and, as a result, has extended the current cash runway to last
until mid-2024. The Company is focused on early revenue generation during the
first half of this year and will seek to extend and broaden its revenue
streams from additional centres in the second half of 2023.

 

The Company expects to report its preliminary results for the year ended 31
December 2022 by the end of April 2023.

 

Sara Barrington, CEO of Verici Dx, said:

"We have continued to make significant progress in executing our strategy,
resulting in the full commercial launch of Tutivia™ in January, with
Clarava's™ initial launch expected before the end of this year.

 

"We achieved our internal target of attracting three key, leading US
transplant sites as early adopters for Tutivia™, a critical step that is
enabling us to demonstrate the adoption and integration process for
clinicians.

 

"Looking ahead to the rest of the year, we plan to accelerate the rollout of
Tutivia™ to other major transplant sites throughout the US, and to secure
pricing and health insurance coverage for this lead product. For Clarava™,
we expect to report validation shortly and to initiate its initial launch
before the end of the year, which will support the collation of further
evidence to enable a positive coverage determination. These pivotal milestones
will help refine our market positioning and further accelerate commercial
uptake of both of our lead products. Verici Dx looks forward to reporting on
its further progress."

 

 

Enquiries:

 

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

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

 Walbrook PR Limited                                      Tel: +44 20 7933 8780 or vericidx@walbrookpr.com
                                                          (mailto:renalytix@walbrookpr.com)
 Paul McManus / Stephanie Cuthbert /                      Mob: +44 7980 541 893 / +44 7796 794 663 /

 Sam Allen                                                07502 558 258

 

 

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 and 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.

 

Verici Dx's two lead products are Clarava™, a pre-transplant prognosis test
for the risk of early acute rejection, and Tutivia™, a post-transplant test
focused upon acute cellular rejection, including sub-clinical rejection. These
products seek to measure how a patient is likely to respond, and is
responding, to a kidney transplant. These products are underpinned by
extensive patented and published scientific research from the leading Mount
Sinai Medical Center, for which the Company holds an exclusive worldwide
licence.

 

 

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