Successful transition from a research to commercial-stage company
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its audited final results for the year ended 31 December 2022 and provides a progress update since year end.
Strategic progress (including post-period end)
- Achieved full commercial launch of TutiviaTM, the Company’s first product for the detection of acute
kidney transplant rejection, in January 2023, leading to first revenues being recognised in FY 2023.
- Expanded its validation trial on ClaravaTM, the Company's pre-transplant prognostic test, for a further six
months following positive initial data announced in September 2022. 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 remains on track to be announced by the end of June 2023, in line with previous guidance.
- Patient enrolment for the multi-centre clinical validation study of our third product, ProtegaTM, was
completed in the first quarter of 2023, assessing long-term outcomes for kidney transplant patients.
- Extended cash runway until mid-2024; the Company has retained 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. A
further commercial and operational update will be provided alongside the ClaravaTM data readout.
Operational highlights (including post-period end)
- Announced positive results from the TutiviaTM clinical validation study in June 2022, for the detection of
acute rejection following a kidney transplant.
- Granted CPT® Proprietary Laboratory Analyses ("PLA") codes for ClaravaTM and TutiviaTM tests by the
American Medical Association ("AMA"), providing the basis for coding and payment within the US
- In May 2023, a gapfill median rate of $2,650 was proposed for TutiviaTM for kidney transplant rejection
by the Centers for Medicare & Medicaid Services (“CMS”) in line with the Company’s application.
- Obtained Medicaid approvals in 14 States and a further 11 States are pending.
- Two key patents granted in the United States underpinning Verici Dx’s products.\
- Achieved CLIA Certificate of Compliance for laboratory in Nashville, TN, USA, a key requirement to
obtaining insurance reimbursement coverage under Medicare and allowing for expanded commercial
launch of TutiviaTM, in 45 US states.
- Completed analytical validation for ClaravaTM and TutiviaTM in February 2022, an essential element of
defining the performance characteristics and platform capabilities of in vitro diagnostic assays and a key
milestone towards commercialisation.
- Announced a collaboration with Illumina, Inc., for early access to the Illumina Connected Analytics (ICA)
platform to expedite the operational launch of data analysis processing and predictive artificial
intelligence component of Verici’s products in due course.
- Adjusted EBITDA1 loss of $10.5m (2021: loss of $7.1m).
- Cash balance at 31 December 2022 of $9.81m (2021: $10.3m).
- Raised gross proceeds of £10.0m in March 2022 via Placing and Subscription.
- Cash runway extended to mid-2024.
Commenting on the performance and outlook, Sara Barrington, Chief Executive Officer, said:
“2022 was a transformational year for Verici Dx; we began the year as an R&D-stage company, and have now
commercially launched our first product, TutiviaTM, following pleasing validation study results.
“We are well placed to deliver further progress against our strategy in 2023, building on the initial rollout of
TutiviaTM and we remain on track to announce the data read-out from the extended ClaravaTM trial by the end
of June. In addition, we are taking further steps towards reimbursement that will help accelerate commercial
uptake of our lead products.”
As previously announced, an investor meeting covering the FY22 financial results will be provided following
the data read-out from the extended ClaravaTM trial, expected to be announced by the end of June.
Sara Barrington, CEO Julian Baines, Chairman
www.vericidx.com Via Walbrook PR
N+1 Singer (Nominated Adviser & Broker) Aubrey Powell / Kailey Aliyar / Tom Salvesen
Tel: 020 7496 3000
Walbrook PR Limited Paul McManus / Sam Allen
Tel: 020 7933 8780 or email@example.com Mob: 07980 541 893 / 07748 651 727
Sara Barrington, CEO
Julian Baines, Chairman
Via Walbrook PR
N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen
Tel: 020 7496 3000
Walbrook PR Limited
Paul McManus / Sam Allen
Tel: 020 7933 8780 or firstname.lastname@example.org
Mob: 07980 541 893 / 07748 651 727
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 Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection and Clarava™, a pre-transplant prognosis test for the risk of early acute 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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