Verici Dx’s post-transplant test, Tuteva, to be rebranded as Tutivia™
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 Tutivia™.
Tutivia™ (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:
- Clarava™, a pre-transplant prognosis test for the risk of early acute rejection;
- Tutivia™, a post-transplant test focused upon acute rejection, including sub-clinical rejection; and
- Protega™, a post-transplant test that aims to predict the risk of fibrosis and long-term graft failure
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.
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)
- Positive data from multi-centre, international validation study for Tuteva™ presented at American Transplant Congress (“ATC”) 2022, paving way for soft commercial launch of Tuteva™ in the United States in 2022
- 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
- Received, ahead of schedule, CPT® Proprietary Laboratory Analyses (“PLA”) codes for Clarava™ and Tuteva™
- 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 a key milestone towards commercialisation
- Raised gross proceeds of £10.0m in March 2022 via Placing and Subscription
- Appointed initial commercial team to support Tuteva™ launch
- Confirmed positive initial results, in September 2022, for Clarava™ from an international clinical validation study; an expanded cohort from the ongoing trial will be used to enrich the utility data for the assay and support a statistically robust and clinically meaningful case for its adoption in due course
Financial highlights
- Adjusted EBITDA loss of $4.91m (2021: loss of $2.52m), excluding share-based payments and costs of new share issue
- $15.7m cash balance as at 30 June 2022 (31 December 2021: $10.3m), augmented by the net proceeds of $12.5m from the issue of 28,571,429 new ordinary shares in March 2022
- Net cash outflow from operating activities in the six months to 30 June 2022 was $4.9m (excluding the share issue costs charged to the Income Statement) (six months to 30 June 2021: $2.8m) with investing activities consuming a further $0.7m (six months to 30 June 2021: $0.7m)
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:
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.
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:
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.
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:
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:
Capitalised terms in this announcement carry the same definitions as in the EKF announcement.
Enquiries:
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:
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/
