Final Results and Post Year-End Update

Well placed and funded to build on excellent progress to date
Positioned to have a commercial-stage product by end of 2022

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its audited final results for the period ended 31 December 2021. In addition, the Company provides a further update on its progress in 2022 to date and summarises expected next steps for the progression of its product portfolio, which now comprises:

• Clarava™, a pre-transplant prognosis test for the risk of early acute rejection;
• Tuteva™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection; and
• Protega™, a liquid biopsy that aims to predict the risk of fibrosis and long-term graft failure.

Strategic and operational highlights

• In January 2021, expanded the scope of licence agreement with Mount Sinai to include an additional patent filing; this formed the basis of the Company’s Protega™ product and broadened the Verici Dx portfolio;
• In July 2021, received CLIA-certification¹ from the Centres for Medicare & Medicaid Services (CMS) for the clinical laboratory in Franklin, Tennessee, ahead of schedule, allowing the Company to initiate operations as a diagnostic laboratory;
• In April 2021, entered into an agreement to allow access to de-identified samples from the CTOT-19 study², 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;
• Completed the testing requirements of the multi-centre validation study for the two lead products, Clarava™ and Tuteva™ in December 2021.
  • An extension in April 2022 ensured that the studies exceeded their enrolment objectives in terms of numbers of sites and participants, assuring a robust data package for analysis;
  • Successful recruitment is now paving the way for efficient clinical validation work on the next study for Protega™ and further studies on the integration of all products into an integrated suite of transplant testing.  ;

Financial highlights

• Adjusted EBITDA⁴ loss of $7.1m (2020: loss of $1.4m)
• Cash balance at 31 December 2021 of $10.3m (2020: $17.8m)
• On 11 March 2022 the Company closed a successful funding of gross GBP10.m by the issue of 28,571,429 new ordinary shares

Post-period end

• In January 2022, received, ahead of schedule, CPT® Proprietary Laboratory Analyses (“PLA”) codes³ for Clarava™ and Tuteva™;
• Announced a collaboration with Illumina, Inc., to expedite the operational launch of data analysis processing and predictive artificial intelligence component of our products, using early access to the Illumina Connected Analytics (ICA) platform;
• Completed analytical validation for Clarava™ and Tuteva™ in February 2022, an essential element of defining the performance characteristics and platform capabilities of in vitro diagnostic assays and milestone towards commercialisation;
• Raised gross proceeds of £10.0m in March 2022 via Placing and Subscription (the “Fundraise”).
• Successful headline results from multi-centre validation study for Tuteva™, establishing new industry standard in blood sample detection of acute kidney transplant rejection, positioning Tuteva™ for commercial launch later in 2022.

Commenting on the performance and outlook, Sara Barrington, Chief Executive Officer, said: “We have been delighted with the progress that Verici Dx has made, both during 2021 and at the start of 2022, either delivering strongly or exceeding against the expectations and strategic milestones set out at IPO. We are well placed to continue this momentum throughout the rest of the year, and by the end of 2022 we will have firmly moved from being a research and development company to one with a commercial product.

“Following our March 2022 fundraise, we have the necessary resources to not only commercialise our well-differentiated core products, but also progress the development of Protega™, and to find new exciting growth opportunities. Our recent announcement regarding the positive headline data from our international validation study for Tuteva™ was a significant milestone, as it demonstrated the significantly higher Positive Predictive Value (PPV) of Tuteva™ versus currently available blood tests.  This paves the way for a commercial launch in the United States later in 2022. We look forward to announcing the outcomes from the validation study for Clarava™ in the coming weeks. 

“Over the rest of the year, a health economics model is expected to be completed to help support our imminent commercial launches, and we will also work to engage in clinical utility and real-world evidence studies to support adoption of our two lead products.”

Notes:

1. 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.
2. 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.
3. PLA codes are CPT codes including a corresponding descriptor for laboratories or manufacturers wanting to identify a test more specifically.
4. Earnings before income tax, depreciation and amortisation, adjusted to exclude exceptional items.

Investor briefing

Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the Final Results and Post Year-End Update via the Investor Meet Company platform on Wednesday 25 May 2022 at 4.30pm (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 am 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:

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 vericidx@walbrookpr.com
Mob: 07980 541 893 / 07748 651 727

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.