REG - Verici Dx PLC - Progress and strategy update

Verici DxAnnouncement

12/01/2022 14:05

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RNS Number : 2523Y  Verici Dx PLC  12 January 2022

Verici Dx plc

("Verici Dx" or the "Company")

 

Progress and strategy update

 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for
organ transplant, provides the following corporate update for the year ended
31 December 2021.

 

Verici Dx has continued to make significant progress against the strategic
goals set out at IPO in November 2020. The Company has met all key milestones
to date, either ahead of time or on schedule, and remains on track for
commercial launch of the Company's two lead products through the Company's
CLIA(1) Laboratory in 2022.

 

The Company's two leading products, together with a third related product now
under development, aim to understand how a patient will respond and is
responding to kidney transplantation. The broadened portfolio is poised to
offer end-to-end testing for transplant patients and ultimately offer
integrated testing information giving a distinct competitive advantage:

 

·    Clarava™ is a pre-transplant prognosis test for the risk of early
acute rejection;

·    Tuteva™ is a post-transplant test focused upon acute cellular
rejection, including sub-clinical rejection as correlates to histopathology
findings; and

·    Protega™ is a liquid biopsy that aims to predict the risk of
fibrosis and long-term graft failure.

 

Milestone achievements

As previously announced, the Company has passed a number of key milestones
over the past twelve months including but not limited to:

 

 ●    Completion of the testing requirements of the multi-centre validation study
      for the two lead products, Clarava™ and Tuteva™, before the end of 2021,
      in-line with expectations;

 ●    Additionally, the studies exceeded their enrolment objectives in terms of
      numbers of sites and participants, assuring a robust data package for analysis
      and paving the way for efficient clinical validation work on the next study
      for Protega™;

 ●    Verici Dx is on track to conduct a full data analysis and clinical study
      report for its two lead products, with read-out of key findings in Q1 2022, as
      planned;

 ●    Having accelerated its CLIA(1) laboratory opening and approvals strategy, the
      Company obtained a Certification of Registration from the Centers for Medicare
      & Medicaid Services (CMS) for its newly established US clinical laboratory
      in Franklin, Tennessee, ahead of schedule, a significant commercial step at it
      allows Verici Dx to initiate operations as a diagnostic laboratory;

 ●    Receiving, ahead of schedule, the grant from the American Medical Association
      of CPT® Proprietary Laboratory Analyses codes(2,3) for Clarava™ and
      Tuteva™ which become effective on 1 April 2022 and support the commercial
      use and tracking of these products within the US healthcare system, including
      for health insurance purposes;

 ●    Extension of the Company's licence agreement with Mount Sinai to include an
      additional patent filing related to the analysis of gene expression in a
      liquid biopsy to predict risk of fibrosis and rejection of the graft over the
      longer term. This forms the basis of the Company's Protega™ product and
      broadens the Verici Dx portfolio;

 ●    Agreement to provide access to de-identified patient samples used in the
      CTOT-19 study(4) funded by the National Institutes of Health, to further
      validate the clinical performance of Clarava™ and Tuteva™ and providing
      data for an independent publication in 2022. The Company also agreed to
      provide full transcriptomic sequencing for all patient samples in the study to
      facilitate further studies and to increase the pace of innovation in
      transplantation; and

 ●    Collaboration with Illumina, Inc. (NASDAQ: ILMN), to expedite the operational
      launch of data analysis processing and predictive artificial intelligence
      component of Verici Dx's products using early access to ICA (Illumina
      Connected Analytics), a new software platform providing an environment for the
      clinical testing and further research collaborations arising from these large
      data sets.

 

Outlook

With strong progress on entering 2022, the Company remains focussed on
completing validation reporting from the validation study, continuing to
accelerate the regulatory and reimbursement pathways needed for commercial
launch of Clarava™ and Tuteva™, and to further advancing the work to
efficiently validate Protega™. Having already obtained a CPT code, the
Company will seek to determine pricing for both of its lead products, and
coverage determinations for Clarava™. Tuteva™ is expected to be eligible
for and covered by an existing local coverage determination issued by Palmetto
under the MolDX system. To support the commercialisation efforts, a health
economics model is expected to be completed by the end of Q1 2022, and to
engage in clinical utility and real-world evidence studies to support product
adoption. Verici Dx expects to accelerate the pathway to coverage
determination for Clarava™ through a series of utility training case studies
('vignettes') planned for 2022.

 

The generation of large data sets through the Company's approach to analysing
the whole transcriptome (RNA) will not only support the commercialisation of
Verici Dx's products with the potential to yield further innovation, it is
also considered valuable to third parties who may seek income-generating
collaborations with the Company in research, therapeutic development including
clinical trial enrichment, or longer term studies post approval. The recently
announced early-adopter deployment of the Illumina Connected Analytics
platform by the Company is expected to be a useful tool in being able to
assimilate, analyse and share data with and from such third parties.

 

Further potential growth opportunities

Verici Dx continues to look for licensing opportunities for complementary new
product technologies and tools to expand the Company's platform and data asset
generation. The Company believes there are complementary potential
opportunities to add new technology and AI capability to support and enhance
the use of Verici Dx product tests alongside histopathology imagery and in the
analysis of whole transcriptome and other data.

 

Notwithstanding the accelerated progress to date, the Company has carefully
managed funds to date to deliver an unaudited cash balance of $10.3m at 31
December 2021, in line with expectations after taking into account some
deferred capital expenditure which will occur this year. The Company wishes to
maintain momentum and take full advantage of the efficiency gains in the
initial development work associated with Protega™, as well as planned
improvements to the laboratory facilities in Tennessee and the commercial push
on Clarava(TM) and Tuteva(TM). Cash resources remain sufficient to continue
this expedited progress into early 2023 and Verici Dx will maintain close
control of expenditure and prioritise its investments in accordance with its
value creation strategy.

 

The Directors believe that Verici Dx has delivered on the foundation for the
longer-term vision to build and leverage its emergent data assets within and
beyond kidney transplant into other organs and auto-immune disease, while
commercialising the Company's well-differentiated core products and
capabilities.

 

Sara Barrington, CEO, commented:

"2022 is set up to be another exciting year for Verici Dx and by the end of
the year the Company will have firmly moved from being a Research and
Development organisation to one with commercial products. Our products have
strong differentiation and our ambition is to create a compelling platform for
clinicians to use as they seek to improve and optimise attainable outcomes.
With the expansion of our product portfolio to cover fibrosis, we aim to
address the patient's pre- and post-transplant journey and to bring further
understanding and innovation to healthcare challenges in transplant and other
immune-mediated areas. We look forward to a productive year of further
progress."

 

An updated Corporate Presentation, including a summary of the Company's
anticipated development and commercialisation timeline, will be made available
online later today at the following location:
https://vericidx.com/investors/documents-and-presentations/
(https://vericidx.com/investors/documents-and-presentations/)

Notes:

 

 1  Clinical Laboratory Improvement Amendments (CLIA) Certification of
    Registration under the Centers for Medicare & Medicaid Services (CMS)
 2  Current Procedural Terminology (CPT) codes are medical codes that are used to
    report medical, surgical, and diagnostic procedures and services to entities
    such as physicians, health insurance companies and accreditation
    organizations. CPT codes are also used for administrative management purposes
    such as claims processing and developing guidelines for medical care review.
 3  PLA codes are CPT codes including a corresponding descriptor for laboratories
    or manufacturers that want to identify their test more specifically.
 4  CTOT Home (ctotstudies.org)
    (https://urldefense.proofpoint.com/v2/url?u=https-3A__www.ctotstudies.org_index.htm&d=DwMFAg&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=1nMs9_ptZtfsK-kSZTRbZW-zBzR_4SSPiX1xvVa-xK0&m=fVFqavv4sO210snCgcrQQLQw1Mk0y9aDVmw-BOMz_5c&s=U4SOSpxiNI51psuHMZV9VqdSAt3gP2wgJgNYTNlEOMw&e=)
    CTOT is a cooperative research programme sponsored by the National Institute
    of Allergy and Infectious Diseases (NIAID). CTOT is an investigative
    consortium for conducting clinical and associated mechanistic studies that
    will lead to improved outcomes for transplant recipients. The purpose of these
    studies is to improve short and long-term graft and patient survival.

 

 

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: 020 7496 3000
 Aubrey Powell / Kailey Aliyar / Tom Salvesen

 Walbrook PR Limited                                      Tel: 020 7933 8780 or vericidx@walbrookpr.com
 Paul McManus / Sam Allen                                 Mob: 07980 541 893 / 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.

 

 

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