Further data from Tuteva™ clinical validation study presented

Performance in blinded multi-centre trial establishes new industry standard in detection of acute kidney transplant rejection and paves way for US commercial launch in 2022

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that the additional data from its blinded, international, multi-centre validation study for Tuteva™, the Company’s post-transplant blood test focused on acute rejection, has been presented at the American Transplant Congress (“ATC”) earlier this month.

The further data demonstrates a Positive Predictive Value (“PPV”) of 60% and Negative Predictive Value (“NPV”) of 80% for Tuteva™, a next-generation RNA sequencing assay. This and the ability to detect all types of rejection support improved clinical diagnosis compared to that currently available from other kidney transplant blood tests without enhancement from clinical features, and in a broad validation population. This data confirms that Tuteva™ demonstrates strong performance in the detection of acute rejection, following a kidney transplant. These clinically important results position Tuteva™ for an on-schedule commercial launch later this year to support the estimated c. 100,000 global patients who undergo kidney transplant procedures annually.

The study design and successful outcomes were well received at ATC and the poster, presented at the Congress and referenced during the closing session of the “What’s new / What’s hot” roundup, is now available on the Company website here: https://vericidx.com/clinical

Further details can be seen in the poster, but key conclusions from the study are outlined below:

• Validation in an all-comers cohort 1 that is independent of the training set and representing all forms and levels of rejection is essential to assessment of expected test performance in translational clinical care settings to support medical management decision making.
  ¹ The validation study utilised a generalised ‘all-comers’ patient population rather than a specific subgroup. The Tuteva™ study was purposefully designed this way to capture the clinical reality of all types of rejection, including sub-clinical, borderline, T Cell-mediated, and antibody-mediated rejection across 14 international transplant centres. The results reflect the wide clinical applicability of the test for comprehensive commercial adoption in a real-world setting.
• Prospective, multicenter, international studies allow for the inclusion of diverse populations and broad diversity in care management practices while allowing blinding to protect from introduction of biases; thereby producing robust and reliable results for clinical integration.
• Tuteva is a quantitative blood-based transcriptomic signature able to correlate an acute rejection risk score with rejection phenotype based on histopathology in the kidney biopsy, representing a level of evidence which has not yet not existed in biomarker transplant biology.

The trial continues for new validations of other pre and post-transplant tests which are included in the trial objectives, and patients will be monitored in-study at local sites for two years. Further data will be useful in supporting the utility of Tuteva TM and its apparent ability to also track changes in rejection status, as appeared to be shown by the test and biopsy results of a sub-group of 12 patients in the sample who received multiple biopsies. Should additional data support this finding in a larger sample over time, it will confirm that Tuteva TM is measuring relevant rejection markers reliably over time, which is important for clinical monitoring.

Sara Barrington, CEO, Verici Dx, said: “I’m delighted that the data shows that our underlying technology has the potential to be clinically groundbreaking, particularly as we focus on commercial launch later this year with the goal of making this much needed test available to all kidney transplant patients, so that an earlier clinical diagnosis can better inform their medical management.”

The publication of this data follows on from the recently announced senior appointments of Grant Harvey and Dr. Windy Tucci as Business Development Director and Medical Science Liaison Director respectively, to further strengthen the Verici Dx team ahead of planned commercial launch later this year.

In addition, Verici Dx expects to announce multi-centre clinical validation results for Clarava™, the pre-transplant prognostic test this summer, having completed additional tissue type matching analysis to support the data evaluation.

Enquiries:

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces the senior appointments of Grant Harvey and Dr. Windy Tucci as Business Development Director and Medical Science Liaison Director, respectively, with immediate effect.

Grant and Windy join the Verici Dx commercial team ahead of the planned commercial launch of Tuteva™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection, which is expected to commence in the latter part of 2022.

Grant Harvey, Business Development Director

Grant joined Verici Dx in June 2022 and brings more than 20 years of cross functional expertise in business development, sales leadership, marketing and training, as well as talent acquisition with a career portfolio of pharmaceuticals, medical services, and diagnostic products.

Prior to partnering with the Verci Dx team, Grant served as a Senior GI Specialty Manager for Exact Sciences, a molecular diagnostics company specializing in the detection of early-stage cancers. Before joining Exact Sciences, Grant served as the Southeast Regional Director with USWorldmeds in the Parkinson’s Disease space.

Grant also held numerous senior leadership roles with Horizon Therapeutics, a biopharmaceutical company focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. He also led national sales teams and key account managers in results-driven collaboration.

As director of business development with Fresenius Medical, a German healthcare company which provides kidney dialysis services, he worked with nephrology practices and health systems to overcome marketplace challenges and capitalize on opportunities to improve outcomes and services for dialysis patients.

Grant received his MBA from Elon University and his BS in Marketing from the University of North Carolina Wilmington.

Dr. Windy Tucci, Medical Science Liaison Director

Dr. Windy M. Tucci joined Verici Dx earlier in 2022 with over 15 years of ‘hands on’ clinical patient care and Pharmaceutical Industry experience in therapeutic areas focusing on Transplant, Gastroenterology, Oncology, Neurology, Cardiology and Nephrology.

She achieved her Doctorate in Pharmacy from the University of Florida, having previously graduated from Roger Williams University.

Prior to Joining Verici Dx, she was the Clinical Lead for the south with Otsuka America Pharmaceutical, and led the Medical Science Liaison team with Exact Sciences where she worked directly with Health Systems, Large Specialty Practices, Healthcare Providers and professional organizations. In these roles, Windy was instrumental in developing new approaches to expand business opportunities, implement sales team expansion and new collaborations, and support pipeline clinical research initiatives.

Sara Barrington, CEO, Verici Dx, said:

“We are delighted to welcome Grant and Windy to Verici’s commercial team. They bring 35 years of combined industry experience, which will be of great benefit to our team as we launch Tuteva™ commercially later this year.”

Enquiries:

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, confirms that the Annual Report and Accounts for the year ended 31 December 2021 (“2021 Annual Report”) and the Notice of the 2022 Annual General Meeting (“AGM”) have now been published on the Company’s website: https://vericidx.com/investors/.

The 2021 Annual Report, the Notice of AGM and details for voting by proxy will be posted to shareholders who have not consented to receive electronic communications today, on 25 May 2022.

The AGM is to be held at 3:00pm on 27 June 2022 at the Company’s registered offices, at Avon House, 19 Stanwell Road, Penarth, Cardiff, CF64 2EZ and will consider the Resolutions set out in the Notice of AGM.

The Company is providing a facility for shareholders to listen in to the AGM either online or telephonically (in a non-voting capacity) and there will be an opportunity for shareholders to ask questions. In order to facilitate the process, the Directors would request that shareholders register for the meeting and submit questions in advance, before 3:00pm on 24 June 2022. To register for dial-in details and to submit any questions please contact Walbrook PR via email at vericidx@walbrookpr.com or call +44 (0)20 7933 8780.

Proxy voting

Shareholders will not receive a hard copy form of proxy for the 2022 AGM in the post. Instead, Shareholders will be able to vote electronically using the link www.signalshares.com. Proxy votes must be received no later than 3:00pm on 23 June 2022.

Shareholders may request a hard copy form of proxy directly from the Registrars, Link Group, on Tel: 0371 664 0300. Calls are charged at the standard geographic rate and will vary by provider. Calls outside the United Kingdom will be charged at the applicable international rate. Lines are open between 09:00 – 17:30, Monday to Friday excluding public holidays in England and Wales. Alternatively, shareholders can vote by downloading the new app, LinkVote+, on Apple App Store or Google Play and follow the instructions.

Enquiries:

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.

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:

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.

Performance in blinded multi-centre trial establishes new industry standard in detection of acute kidney transplant rejection and paves way for commercial launch in United States in 2022

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces the successful outcomes from its blinded, international, multi-centre validation study for Tuteva™.

Tutivia™ is the Company’s post-transplant blood test focused on acute rejection, including sub-clinical rejection. The results of the validation study show that the test, a next-generation RNA sequencing assay, is demonstrating strong performance in the detection of acute rejection, following a kidney transplant.

The finalised data, to be presented at the American Transplant Congress in June 2022, demonstrates a significantly higher Positive Predictive Value (“PPV”) for Tuteva™ than currently available kidney transplant blood tests, without enhancement from clinical features, in a broad validation population. This successfully addresses the unmet need for actionable, novel (immune-pathway) biomarker data in this field which should assist clinicians in improving patient outcomes.  These clinically important results position Tuteva™ for a 2022 commercial launch to support the estimated c. 100,000 global patients who undergo kidney transplant procedures annually.

The strong results are particularly noteworthy given that the validation study utilised a generalised ‘all-comers’ patient population rather than a specific subgroup. The Tuteva™ study was purposefully designed this way to capture the clinical reality of all types of rejection, including sub-clinical, borderline, T Cell-mediated, and antibody-mediated rejection across 14 international transplant centres. The results reflect the wide clinical applicability of the test for comprehensive commercial adoption in a real-world setting.

Dr. Roslyn Mannon, Professor of Internal Medicine, the Vice Chair of Research Mentoring and Academic Development in Internal Medicine, and Associate Chief of Research, Division of Nephrology at University of Nebraska, said: “Clinicians value study results that are reflective of what they see in their patient base in their clinics.  Positive validation of Tuteva™ using a study design for that purpose gives clinicians confidence that this test can support critical clinician decision-making in the complex management of kidney transplant patients. With this positive predictive performance, Tuteva™ can now warn doctors in advance if kidney rejection is starting or likely to occur, allowing timely intervention to improve graft function and long-term survival.”  

Dr. Lorenzo Gallon, Medical Director of the Translational Medicine Programme, the Director of International Relations and the Director of the Renal Transplant Fellowship at Northwestern University, Chair, Science Advisory Board and Non-Executive Director for Verici Dx, said: “In the kidney transplant environment where the chance of a rejection event is high, the clinician needs early, accurate and actionable information to make key treatment decisions. Prior to Tuteva clinicians did not have the tools capable of positively predicting rejections with high performance.”

Sara Barrington, CEO, Verici Dx, said: “It is an honour to announce the validation results of the pioneering work of the late Dr. Barbara Murphy. Spun out of Renalytix (NASDAQ RNLX, LSE RENX), the underlying technology is proving to be clinically groundbreaking, and we remain focused upon making this generally available to transplant patients.   It is rewarding to see, in a blinded study, the validation of powerful tools that support improved clinical diagnosis of rejection allowing for more effective, earlier intervention. We look forward to presenting the full data at the American Transplant Congress in June.”

In addition to this positive read-out, Verici expects to announce multi-centre clinical validation results for Clarava™, the pre-transplant prognostic test within the coming weeks.

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

Enquiries:

Strategic decision to expand study without impacting commercial pathway

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that whilst it has met the study size criteria, a decision has been taken to expand its clinical validation study for its lead products, ClaravaTM and TutevaTM , by approximately four to six weeks to allow the inclusion of more verified data from European sites, and therein increase the robustness of the study. The Board does not expect this to have any impact on the Company’s recently outlined commercialisation pathway and the Company remains on track to present results to the clinical community at ATC (American Transplant Congress) in early June, as planned. Verici Dx believes it will be able to meet its launch plans within this year, as expected.

All the data from the validation study currently remains “blinded” and therefore the Company has not yet had access to the performance analysis of the study.

The reason for this decision is due to a delay in compliance visits from the Company’s European study sites. The inclusion of their data is significant as it contributes to ensuring an evenly distributed study population across all participating sites. This is an important aspect to ensure the robustness of the study for commercial launch. Unlike the US sites, where compliance monitoring can be undertaken remotely, the sites in Italy, France, and Spain require onsite in-person monitoring, which has recently been hampered by restrictions due to COVID-19, hence the delay
in inclusion of their data.

Sara Barrington, Chief Executive Officer, Verici Dx, said: “Our timelines are such that we have the scope to make a positive strategic choice to increase the robustness of the study and ensure strong representation from our European partners, as we initially intended, without impacting our commercial timelines. Importantly the study data remain blinded, and this decision has been made in line with the original study design for geographic diversity, with the added benefit of increasing the total number of patients in the study. We remain on track to present to the clinical community at ATC in early June, as planned, with Verici Dx on course to deliver on the launch plans for our two lead products by the year-end of the year.”

Enquiries:

1. Issuer Details

ISIN  GB0000654321

Issuer Name  VERICI DX PLC

UK or Non-UK Issuer  Non-UK

2. Reason for Notification

An acquisition or disposal of voting rights; An event changing the breakdown of voting

3. Details of person subject to the notification obligation

Name

Icahn School of Medicine at Mount Sinai

City of registered office (if applicable)

New York

Country of registered office (if applicable)

United States of America

4. Details of the shareholder

Full name of shareholder(s) if different from the person(s) subject to the notification obligation, above

 City of registered office (if applicable)

 Country of registered office (if applicable)

5. Date on which the threshold was crossed or reached

14-Mar-2022

6. Date on which Issuer notified

23-Mar-2022

7. Total positions of person(s) subject to the notification obligation

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached

8A. Voting rights attached to shares

8B1. Financial Instruments according to (DTR5.3.1R.(1) (a))

8B2. Financial Instruments with similar economic effect according to (DTR5.3.1R.(1) (b))

9. Information in relation to the person subject to the notification obligation

1. Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer.

10. In case of proxy voting

Name of the proxy holder

The number and % of voting rights held

The date until which the voting rights will be held

11. Additional Information

12. Date of Completion

23-Mar-2022

13. Place Of Completion

USA

1. Issuer Details

ISIN GB00BM8HZD43
Issuer Name VERICI DX PLC
UK or Non-UK Issuer UK

2. Reason for Notification

An acquisition or disposal of voting rights

3. Details of person subject to the notification obligation

Name Harwood Capital Management (Gibraltar) Limited
City of registered office (if applicable)  Gibraltar
Country of registered office (if applicable)  Gibraltar

4. Details of the shareholder

5. Date on which the threshold was crossed or reached

14-Mar-2022

6. Date on which Issuer notified

17-Mar-2022

7. Total positions of person(s) subject to the notification obligation

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached

8A. Voting rights attached to shares

8B1. Financial Instruments according to (DTR5.3.1R.(1) (a))

8B2. Financial Instruments with similar economic effect according to (DTR5.3.1R.(1) (b))

9. Information in relation to the person subject to the notification obligation

2.Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entities (please add additional rows as necessary)

10. In case of proxy voting

Name of the proxy holder

The number and % of voting rights held

The date until which the voting rights will be held

11. Additional Information

The position of previous notification, disclosed above as 20.01%, decreases to 18.70% once non-discretionary clients are excluded from the calculation.
The resulting total number of voting rights disclosed above (17.48%) reflects only the discretionary holdings of Harwood Capital LLP.

12. Date of Completion

18-Mar-2022

13. Place Of Completion

London Stock Exchange