Last checked at 12 Jan 2022 14:00
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 CLIA1 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;
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● | 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™;
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● | 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;
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● | Having accelerated its CLIA1 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;
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● | Receiving, ahead of schedule, the grant from the American Medical Association of CPT® Proprietary Laboratory Analyses codes2,3 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;
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● | 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;
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● | Agreement to provide access to de-identified patient samples used in the CTOT-19 study4 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
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● | 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 ClaravaTM and TutevaTM. 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/
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) 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.vericidx.com |
Sara Barrington, CEO | Via Walbrook PR |
Julian Baines, Chairman |
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Singer Capital Markets (Nominated Adviser & Broker) | Tel: 020 7496 3000 |
Aubrey Powell / Kailey Aliyar / Tom Salvesen |
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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
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.