Half-year report

Continuing to build the foundations for commercial success.

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 2023.

Operational highlights (including post-period end)

• Initial revenues following the commercial launch of our first product, TutiviaTM, the Company’s post-transplant prognostic test for the assessment of risk of acute kidney rejection.
  • Full year revenues from TutiviaTM are likely to be less than expected although the Company has recently doubled the number of US transplant centers as early adopters of the test.
• The impact of lower Tutivia revenues is expected to be offset by higher than expected research-related revenues
  so that that cash runway expectations to mid-2024 are unchanged at this time.
• Successful clinical validation of our second product, ClaravaTM, the Company’s pre-transplant prognostic test, demonstrating a statistically significant result and capability to stratify patients based on their likely immune response to a transplanted kidney, informing a clear, actional response for clinicians.
  • ClaravaTM is on track for initial US commercial use by the end of 2023 under prospective real-world evidence studies.
• Completed patient enrolment for the multi-centre clinical validation study of the Company’s third product, ProtegaTM, assessing long-term outcomes for kidney transplant patients.
• Received preliminary gapfill median rate of $2,650 proposed for both ClaravaTM and TutiviaTM by the Centers for Medicare & Medicaid Services (“CMS”). These rates are due to be finalised later this year and represent a substantial uplift from the Company’s initial assumption for modelling purposes.
• Two key patents granted in the United States underpinning Verici Dx’s products.
• Achieved CLIA Certificate of Compliance for clinical laboratory in Nashville, TN, USA, a key requirement to obtaining insurance reimbursement coverage under Medicare and allowing for expanded commercial launch of TutiviaTM in 49 out of 50 US states to date.
• Submitted final responses to comments for our peer-reviewed publication on the Tutivia clinical validation. Final publication dependent on publishers.
• Initiated studies in our databank to facilitate product development and further research collaborations.
• Obtained Medicaid approvals in 15 States and a further 12 States pending.

Outstanding clinician feedback on TutiviaTM
We have been delighted with the feedback on TutiviaTM following its commercial launch at the start of 2023.

“In the first few months post-transplant there are many rejection events and yet in my opinion we have not really had a biomarker that can assist at this critical time. TutiviaTM is able to give the clinician reliable test results as soon as the first week post-transplant and so is an early biomarker test which addresses this critical need.”

Dr Nicolae Leca Professor, Medical Director, Kidney and Pancreas Transplant - University of Washington

Financial highlights

• Adjusted EBITDA loss of $4.8m (six months to 30 June 2022: loss of $5.0m), excluding share-based payments.
• $5.3m cash balance as at 30 June 2023 (31 December 2022: $9.8m).
• Net cash outflow from operating activities in the six months to 30 June 2023 was $4.7m (six months to 30 June
  2022: $5.0m) with investing activities consuming a further $0.1m (six months to 30 June 2022: $0.7m).

The full year revenues are expected to be lower than originally projected from Tutivia but offset by higher than expected revenues from research collaborations. Revenues and containment of total costs mean that cash runway expectations to mid-2024 are unchanged at this time.

Sara Barrington, Chief Executive Officer of Verici Dx, said:
“I am proud of the progress we have made in the first six months of this year. The clinician response to our first product, TutiviaTM, following its commercial launch at the start of the year clearly demonstrates how much they value the key benefits and recognise the strong differentiating features. We are also excited to have announced a second successful product, ClaravaTM, following the recently completed clinical validation study showing excellent results. This allows us to prepare for its initial launch in due course. We also completed enrolment for the validation study on our third product, ProtegaTM. Whilst this product has a much longer time frame, it completes the end-to-end testing for the portfolio as we look ahead.

“Although the timing effects on early adoption are frustrating, we have been able to make savings in other areas and are focused on research collaborations to help build a solid platform for future growth. At the same time, we are continuing to deliver on our strategy of transforming kidney transplant patient outcomes, as we move further into commercialisation.”

Investor briefing
Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the interim results via the Investor Meet Company platform on Thursday October 5 at 4.30pm BST.

This presentation is open to all existing and potential shareholders. Questions can be submitted 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 on the Investor Meet Company platform will automatically be invited.

A copy of the Company’s interim results report will shortly be made available on the Company’s website.