In its inaugural audited results for the period ended 31 December 2020, Verici Dx (VRCI ) informed investors that it has been “very pleased” with the progress it has made in such a short time.
The Group, which develops advanced clinical diagnostics for use in organ transplants, was successfully admitted to AIM in November raising gross proceeds of c.$18.8m (£14.5m).
The proceeds are being used primarily to fund the clinical utility and validation studies for its lead products Clarava™ and Tuteva™ and other bioinformatics and health economic studies.
Clarava™ is a pre-transplant prognosis for the risk of early acute rejection while Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection. The Group said its initial focus on the kidney transplantation market reflects the urgent clinical need in this area.
Verici said it has already made good progress with three leading US centres in its multi-centre observational clinical validation study with plans to bring more US sites on board shortly while it is also progressing discussions to include a number of EU sites in order to ensure that the Group’s products are fully tested for validation by the end of 2021.
Post-period end, Verici expanded the scope of its licence agreement with Mount Sinai in January while in February it accelerated its CLIA laboratory opening and approvals strategy.
Verici reported adjusted EBITDA loss of $1.24m while cash by period-end stood at $17.8m. It said its financial performance reflects the initial acquisition of the FractalDX licence and related assets, costs incurred up to and including the IPO and operating costs since the IPO. As Verici is in the development phase, it is not yet generating revenues from its activities.
Julian Baines, Non-executive Chairman, said: "We have been very pleased with the progress of Verici in such a short time and our primary focus remains on the successful prosecution of our clinical trials, as the first key step in commercialising our innovative transplant products.”
Separately, Verici said today that it has entered into a Material Transfer Agreement ("MTA") to assess CTOT-19 (Clinical Trials in Organ Transplant) samples using Clarava™ and Tuteva™.
The trial is being conducted in an effort to validate the performance and development of commercial tests designed to improve short and long-term graft and patient survival.
Verici has entered into the MTA with the Icahn School of Medicine at Mount Sinai and Principal Investigator Dr. Peter Heeger to assess CTOT-19 samples generated from patients in the study, "Effects of Inhibiting at Early Inflammation in Kidney Transplant Patients."
Shares in Verici Dx have ticked up by 2.5% in value since the beginning of the year. As the Company remains within its development phase, it is not yet generating revenues from its activities. However, the company’s primary focus remains on the successful prosecution of our clinical trials, as the first key step in commercialising our innovative transplant products.
Verici is focused on the kidney transplantation market where urgent clinical attention is needed. According to the World Health Organisation, there are reports to suggest that between five and ten million people die annually from kidney disease about 300,000 people around the world are currently on a waiting list with this number expected to rise further.
Verici said it is on track with completing its clinical validation trial this year, alongside generating revenues in 2022. By period-end it had $17.7m cash while the Company also continues to expand its agreements with shareholder Mount Sinai Health System.
Reason to VRCI
Verici Dx is focused on developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants.
Leading IP
The Company’s work is 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.
Meanwhile, the company’s 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.
Verici Dx was admitted to trading on AIM on 3 November 2020, with the company also raising £12.05m through an oversubscribed fundraising, to primarily fund the development and commercialisation of its two leading clinical products in the kidney transplant space.
Significant Market Opportunity >$600m p.a.
The waiting list for transplants is significant at around 300,000 globally with US and European governments calling for an acceleration in the number of transplants undertaken each year.
Globally, there are approximately 95,000 transplants per annum, of which approximately 24,000 and 25,000 are performed in the US and Europe respectively.
In the US the average cost of a transplant is $0.44m per transplant and the average annual cost of dialysis is around $0.09m, with patients faced with being on dialysis from 3 to 5 years.
Positive Development Newsflow
Verici aims to commence a multi-centre validation study for each product in 4Q20, with studies expected to conclude in 4Q21. Clarava and Tuteva are then expected to be offered as Lab Developed Tests with regulatory approval with first revenues expected during 2022.
Verici expects supportive news flow throughout 2021 on commercial partnerships, regulatory news, reimbursement and results from test development programmes. Once approved, it aims to accelerate reimbursement coverage ahead of full clinical utility data in 4Q22.
Last month, Verici expanded the scope of an existing licence agreement to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft.
The development of a product that can predict risk of fibrosis and rejection using Verici’s core technological approach would extend its portfolio across the full course of a patient's transplant journey and complement its two in vitro diagnostic assays, Clarava and Tuteva.
The development of a product that can predict the risk of long-term graft failure, alongside our flagship products Clarava™ and Tuteva™, would establish an end-to-end solution for clinicians seeking to understand how a patient will and is responding to organ transplant.
There is a critical need for more personalised diagnostic information within transplant care, and in particular technologies informing earlier interventions with anti-fibrotic therapies in advance of irreversible organ damage,” commented Sara Barrington, CEO of the licence.
Verici said it will provide more information on its development and commercialisation plans in its results for the financial year ended 31 December 2020, which it expects to release in April.
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