Product rebranding as TutiviaTM

Verici Dx’s post-transplant test, Tuteva, to be rebranded as TutiviaTM

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that its post-transplant blood test focused on acute rejection, has been rebranded as TutiviaTM.

TutiviaTM (formerly known as Tuteva), is a blood-based RNA signature for a risk score for acute rejection, and will be the first test commercialised on the Verici transplant biomarker platform, with a soft commercial launch in the United States expected later in 2022.

The first three products on the platform are:


Enquiries:

Verici Dx
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 /
07502 558 258

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About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage. The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology, including through collaboration with medical device, biopharmaceutical and data science partners.

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.

Half-year report

Strong data in validation study for Tuteva™ paving the way for commercial launch

 

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 2022.

Operational highlights (including post-period end)

 

Financial highlights

 

Sara Barrington, Chief Executive Officer, said: “I have been delighted with the significant progress that we have made over this six-month period, as Verici Dx advances towards becoming a company with commercial products.

“The business is well funded following our March 2022 fundraise to advance all three of our products as well as potential new growth opportunities, including new partnerships such as our collaboration with Illumina. I am looking forward to making further progress over the rest of the year and beyond, as we move from being a purely research and development company to one with commercial products.”

 

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 today at 15:00 BST.

The 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.

 


 

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

About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage. The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.

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.

Positive results for Clarava™ from blinded multi-centre clinical validation study

Data validates Clarava’s ability to identify patients likely to experience future kidney transplant rejection

 

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 Clarava™, the Company’s pre-transplant blood-based prognostic test for the risk of early acute kidney transplant rejection.

Utilising a diverse validation population from 14 international transplant sites, the initial results of the validation study amongst the US kidney transplant patients followed up to date show that the Clarava™ diagnostic, which uses next-generation RNA sequencing, is an effective tool to identify patients likely to experience a future transplant rejection event prior to their surgery.

Clarava™ represents a novel pre-transplant approach to characterising a patient’s immune-profile using their RNA signature. This is expected to have wide-ranging implications regarding treatment plans for each patient ahead of transplant, post-operatively and in terms of monitoring patient response. The Directors believe that the available data on Clarava™ positions it as a viable and compelling product for a broader patient population and commercialisation, as it has no directly competing products. These initial results from the Clarava™ validation study therefore mark a further, important step toward clinical acceptance and commercialisation of the test.

To generate broad clinical acceptance within the diverse international transplant community, Verici Dx is extending enrolment in its ongoing clinical validation study for an additional six-month period, using its existing network of 14 international transplant centres across Europe as well as the US. The expansion of the Clarava™ validation cohort is designed to enrich the utility data for the assay and support a statistically robust and clinically meaningful case for its adoption in due course.

 

Sara Barrington, CEO, Verici Dx, said: “This new validating data demonstrates that Clarava™ can have a significant impact for transplant clinicians understanding of which patients could experience early acute rejection, pre-surgery. As a result, clinicians can make better decisions in advance that can help drive better outcomes post-transplant.”

The extension of the validation study has no material impact on the Company’s cash resources and runway, as the Clarava™ validation work is leveraging the ongoing, budgeted clinical validation study for Verici Dx’s third product, Protega™, as each patient’s sample can be used for multiple tests. Further updates on the Company’s progress will be provided shortly in its interim results announcement, which is due to be released on 7 September 2022.

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. The Directors named below take responsibility for the release of this information.

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

About Verici Dx plc

Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage. The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.

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.

Result of AGM and voting results

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that at the
Annual General Meeting (“AGM”) held earlier today, all resolutions were duly passed.
The voting results of the AGM were as follows:

  In Favour Against Withheld
Resolution Votes % Votes % Votes
1 62,212,695 100 0 0 0
2 62,212,118 100 577 0 0
3 62,212,545 100 0 0 150
4 52,879,826 85 9,332,869 15 0
5 51,490,878 83 10,720,067 17 1,750

 

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

Distribution of Verici Dx shares by EKF Diagnostics Holdings plc

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, notes the announcement made by EKF Diagnostics Holdings PLC (“EKF”) this morning (RNS 3845P), declaring the distribution of its Verici Dx Investment Shares to Relevant EKF Shareholders via a distribution in specie.

These shares comprise of 9,098,611 ordinary shares in Verici Dx of £0.001 each and are subject to a Lock-up Period of 365 days from transfer.

 

Full details can be seen in the EKF announcement here:

https://www.londonstockexchange.com/news-article/EKF/distribution-of-shares-in-verici-dx-plc/15501862

Capitalised terms in this announcement carry the same definitions as in the EKF announcement.

 


 

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

Investor Update

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that Sara Barrington, CEO, will provide a live presentation relating to positive data from the Tuteva™ clinical validation study via the Investor Meet Company platform on 17 June 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 9am 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.Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that an interview with Chief Executive, Sara Barrington, has been published this morning highlighting the positive performance data for Tuteva™, the Company’s post-transplant blood test focused on acute rejection. The interview can be viewed here: https://www.voxmarkets.co.uk/articles/verici-dx-interview-with-ceo-sara-barrington-c2bbfd2/

In the interview, Sara highlights that the data from its blinded, international, multi-centre validation study shows the superior clinical performance of Tuteva™ compared to existing diagnostics “by multiple times” and that the data received a very positive response at the American Transplant Congress (“ATC”) earlier this month.

The interview follows on from the news announced yesterday of further data demonstrating the effectiveness of the test in providing clinicians with actionable information to better inform the medical management of kidney transplant patients. Yesterday’s announcement can be seen here: https://vericidx.com/tuteva-clinical-validation-study/

The positive performance data establishes a new industry standard in detection of acute kidney transplant rejection and paves way for US commercial launch in 2022.

The headline result from the study was originally announced on 12 May, which can be seen here: https://vericidx.com/positive-results-for-tuteva/

 


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

Outlining positive data from Tuteva™ clinical validation study Test performance better than existing care “by multiple times”

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that an interview with Chief Executive, Sara Barrington, has been published this morning highlighting the positive performance data for Tuteva™, the Company’s post-transplant blood test focused on acute rejection. The interview can be viewed here: https://www.voxmarkets.co.uk/articles/verici-dx-interview-with-ceo-sara-barrington-c2bbfd2/

In the interview, Sara highlights that the data from its blinded, international, multi-centre validation study shows the superior clinical performance of Tuteva™ compared to existing diagnostics “by multiple times” and that the data received a very positive response at the American Transplant Congress (“ATC”) earlier this month.

The interview follows on from the news announced yesterday of further data demonstrating the effectiveness of the test in providing clinicians with actionable information to better inform the medical management of kidney transplant patients. Yesterday’s announcement can be seen here: https://vericidx.com/tuteva-clinical-validation-study/

The positive performance data establishes a new industry standard in detection of acute kidney transplant rejection and paves way for US commercial launch in 2022.

The headline result from the study was originally announced on 12 May, which can be seen here: https://vericidx.com/positive-results-for-tuteva/

 


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

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:

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:

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

Commercial Team Appointments

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:

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

Posting of Annual Report & Accounts and Notice of Annual General Meeting

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:

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.