Q&A with Verici Dx CEO, Sara Barrington & Chief Medical Officer, Dr Michael Donovan
Interims presentation
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, is aware of public statements and media reports relating to Silicon Valley Bank (“SVB”). The Company does not hold any cash at SVB nor does it have any banking relationship with SVB.
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
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.
The two lead products are Clarava™, a pre-transplant prognosis test for the risk of early acute rejection, and Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection. These products seek to measure how a patient is likely to respond, and is responding, to a kidney transplant. These products are underpinned by extensive patented and published scientific research from the leading Mount Sinai Medical Center, for which the Company holds an exclusive worldwide licence.
Intellectual property portfolio strengthened
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has been granted two key patents in the United States that support and protect the Company’s core technologies in RNA signature biomarker tests used for assessment of the prognostic risk pre-transplant (Clarava™) and post- transplant (Tutivia™) of acute kidney transplant rejection.
The patents cover broad molecular methods for predicting and diagnosing subclinical and clinical acute rejection, both pre- and post- kidney transplant by algorithmic analysis of gene sets and underpin both of Verici Dx’s lead products, TutiviaTM and ClaravaTM, and provide protection until 2036 and 2039 respectively. The patents underpinning TutiviaTM have also been previously granted in Europe, China and Australia.
These products use a weighted pattern of RNA biomarkers (signature) to assess the risk of rejection by the kidney transplant recipient and to assess rejection earlier and more reliably than other currently available methods. Verici Dx continues to file additional patents reflecting novel refinements to its predictive RNA signatures and methodologies driven by advanced machine learning techniques.
The protection of the Company’s intellectual property is fundamental to its strategy of amassing full transcriptomic data from the biological systems and interactions associated with transplant rejection and, over the longer term, informing transplant analysis in other organs and in the broader field of immune-mediated diseases.
Sara Barrington, CEO of Verici Dx, said:
“ClaravaTM and TutiviaTM address a significant unmet need and seek to improve outcomes for kidney transplant patients, by providing early, actionable information for clinicians to inform treatment plans. These significant new patents bolster our intellectual property portfolio and protect our proprietary methods of predicting and diagnosing sub-clinical and clinical acute kidney rejection.”
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
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.
Successful CMS review and inspection solidify commercial positioning and
represents a major milestone toward US Medicare reimbursement
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has successfully progressed its Registration status to Compliance Certification by the Centers for Medicare & Medicaid (“CMS’) for its commercial clinical operations to 45 US states. This follows the inspection by CMS of the Company’s US clinical laboratory based at the Innovation Park in Franklin, Tennessee.
The Company now intends to expand commercialisation of its advanced kidney transplant service offerings including Tutivia™. This milestone of certification is also a key requirement to obtaining insurance reimbursement coverage under Medicare under the Local Coverage Determination application being submitted this year.
The Company launched its first product, Tutivia™, for the detection of early acute rejection in kidney post-transplant patients, in January 2023. This CLIA certification increases the ease of ordering a Tutivia™ test from laboratories at transplant medical centres and provides further validation of Verici’s tests and services for transplant clinicians across the United States.
The Company will now proceed with its plan towards full accreditation in the remaining five states, including New York, which have further compliance requirements.
The CLIA certification further exemplifies Verici’s commitment to a quality-focused approach to providing advanced kidney transplant diagnostics services to clinicians and patients in need.
Sara Barrington, CEO of Verici Dx, said:
“This milestone is an enabling step in our ability to offer our two leading diagnostic tests, Tutivia™ and Clarava™, on a national basis to patients and their clinicians. We are well positioned to achieve additional milestones and progress commercial initiatives in 2023 that will support our growth in the United States.”
Verici Dx will give further progress and strategy updates later this month.
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
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’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:
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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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.
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.”
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.
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
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.
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
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 |
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
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.
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