Half-year Report

Strong progress made with key milestones towards commercialisation met ahead of schedule 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its unaudited interim results for the six months ended 30 June 2021.

Strategic and Operational highlights for the period

• Partnered with five leading US centres to collaborate on clinical validation trial for lead products Clarava™ and Tuteva™.  
• Expanded scope of licence agreement with Icahn School of Medicine at Mount Sinai (“Mount Sinai”) in January 2021, 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 graft rejection.
• Entered into a Material Transfer Agreement ("MTA") with Mount Sinai to allow access to CTOT-19 (Clinical Trials in Organ Transplant) samples, providing Verici Dx, in combination with the Company’s clinical validation study, with a large, well-characterised sample group.

Financial highlights

• Adjusted EBITDA¹ loss of $2.52m.
• Cash balance at 30 June 2021 of $14.5m (31 December 2020: $17.8m).
  • Strong cash position to expand the Verici Dx platform over time with additional innovative licensing opportunities that complement the existing offering.
  • Engage and build new alliances with patient groups and foundations alike focused on kidney research. 

Post-period end

• Obtained CLIA² Certification of Registration for the Company’s newly established US clinical laboratory in Tennessee ahead of schedule, authorising the Company to initiate commercial operations as a diagnostic laboratory, a key milestone towards the commercial launch of Clarava™ and Tuteva™.
• Expanded multi-centre clinical validation trial to a total of twelve US and EU sites. 
• Completion of patient enrolment to the clinical validation trial for lead products, ahead of schedule.
• Appointment of Lorenzo Gallon, MD, as Non-Executive Director.

Julian Baines, Non-Executive Chairman, said: “The Company has made strong progress over the past six months, with some key milestones reached ahead of schedule as we look to commercialise our innovative organ transplant products.

“We initially partnered with five leading US centres in our collaborative, multi-centre observational clinical validation study. We have since expanded to partner with a total of twelve US and European centres for the validation study and completed patient enrolment for Clarava™ and Tuteva™ ahead of schedule We remain on target for the validation study to be completed by the end of 2021 for lead products, in line with expectations set out at IPO, with the data to be submitted for publication in Q1 2022. 

“Post-period end, we obtained a CLIA Certification of Registration for our US clinical laboratory in Tennessee. Having a CLIA-certified lab will enable us to launch our two lead products commercially, subject to the successful conclusion of our analytical validation studies. I’d like to thank all of our employees and shareholders for their ongoing hard work and support over the past six months and into the next phases of commercialisation.”

Notes:

1. Earnings before income tax, depreciation and amortisation, adjusted to exclude exceptional items and foreign exchange loss 
2. The CLIA (Clinical Laboratory Improvement Amendments) regime is used by the Center for Medicare and Medicaid Services (CMS) to regulate laboratory testing in the US, and requires all clinical laboratories to be certified before they can accept human samples for diagnostic testing

Investor briefing

Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the Final Results via the Investor Meet Company platform on 13 September 2021 at 16:30hrs BST.

The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9.00 a.m. the day before the meeting or at any time during the live presentation.

Investors can sign up to Investor Meet Company for free and add to meet VERICI DX PLC via:

https://www.investormeetcompany.com/verici-dx-plc/register-investor

Investors who already follow Verici Dx plc on the Investor Meet Company platform will automatically be invited.

Enquiries:

About Verici Dx plc

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.