Capitalised terms used in this announcement shall, unless the context provides otherwise, have the same meaning as defined in the Admission Document.
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that admission to trading on AIM ("Admission") will take place and dealings will commence at 8.00 a.m. today under the ticker VRCI and ISIN GB00BM8HZD43.
The Company’s Admission Document is available here.
The Company is an immuno-diagnostics development company, initially focussed on the kidney transplantation market. The Company's kidney transplant assays will use advanced next-generation sequencing that may define a personalised risk profile of each patient over the course of their transplant journey, and may also detect injury in advance of currently available clinical tests.
The Company develops tests to understand how a patient is likely to, and may be, responding to kidney transplant. There are two leading products for clinical validation and commercialisation:
In terms of validation trials, the Company is preparing to initiate a comprehensive multi-centre observational clinical study, commencing shortly after receipt of the net proceeds from the Fundraising. The primary study objective is to validate the clinical performance of gene expression immune-phenotyping signatures and associated algorithms for both Clarava™ and Tuteva™.
In terms of commercialisation, the Company intends to continue building its collaborative, multi-centre working group to further develop, validate and commercialise its products and technology platform.
In terms of reimbursement, the Company intends to seek coverage and reimbursement for Clarava™ and Tuteva™ products with Medicare Administrative Contractors of the Centers for Medicare & Medicaid Services (“CMS”) and major third-party private payors in the US.
Prior to full commercial scaling, the Company expects to focus its first revenues from a small number of early adopting sites. This is expected to be within 24 months of the Admission, subject to successful validation trials and approvals under CLIA certification.
Globally, there are approximately 95,000 transplants performed each year of which about 24,000 are performed in the US and some 25,000 in Europe. The comparatively low number in comparison to the waiting list in the US was recognised as an issue for patients waiting for a transplant for on average 3 to 5 years, even longer in some geographical locations.
It also formed part of the policy in the US Executive Order, Advancing American Kidney Health, where the agency was required to improve efficiencies in the transplant network and expand support for living donors, with the goal of doubling the number of available transplants by 2030.
It is estimated that about 37 to 50 per cent. of all grafts will experience a clinical (10 to 15 per cent.) or subclinical (27 to 40 per cent.) rejection condition in the first year following transplant and clinicians use immunosuppression therapy to try to manage the rejection risk. Despite that, the failure rate in the US has remained largely unchanged and is 16 per cent. (live donor) to 28 per cent. (cadaver) at 5 years. In the EU this is 13 to 21 per cent. respectively.
The net proceeds of the Fundraising of approximately £13.5 million will be used by the Company as follows:
The balance, being approximately £4.2 million, will be available as a contingency against delays in revenue or increased costs and providing additional working capital beyond the 21 month period following Admission.
“We are very grateful for the strong support shown by institutional and other investors to the Verici Dx IPO. Obtaining funding in a public market is a strong signal of quality to prospective partners and customers, raises the profile of the business and its innovative products considerably, and gives us a supportive platform as we advance our strategy. We look forward to providing further updates on the execution of our validation and commercialisation plans as we deploy the capital raised towards addressing a significant unmet clinical need.”
|Sara Barrington, CEO||
Via Walbrook PR
|Julian Baines, Chairman|
|N+1 Singer (Nominated Adviser & Broker)||
Tel: 020 7496 3000
|Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen / Ross Penney (Corporate Broking)
|Walbrook PR Limited||
Tel: 020 7933 8780 or email@example.com
|Paul McManus / Sam Allen||
Mob: 07980 541 893 / 07748 651 727
Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
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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