Notice of Change of AGM Venue

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces a change in venue of its Annual General Meeting (‘AGM’), which will now take place at Harwood Capital, 6 Stratton Street, Mayfair, W1J 8LD on 19 May 2021 at 12.00pm.

 

As previously announced, the Company is providing a facility for shareholders to join the AGM either online or telephonically 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 10.30 a.m. 17 May 2021.

 

To register for dial-in details and to submit any questions please contact Walbrook PR via email at ekf@walbrookpr.com or call +44 (0)20 7933 8787

 

No other details have changed.

 

Shareholders are reminded that due to the UK Government restrictions on public gatherings as a consequence of the COVID-19 pandemic, it will not be possible for shareholders to attend the AGM in person. The Board, with this in mind and in accordance with the Corporate Insolvency and Governance Act 2020, has therefore decided that the AGM will be held as a ‘closed’ meeting with the minimum number of Directors and officers who hold shares, present, to form the necessary quorum. Regrettably, other shareholders will not be permitted to attend the meeting in person.

 

Copies of the Annual Report and Accounts and Notice of AGM are available on the Company’s website here:

https://vericidx.com/investors/documents-and-presentations/


 

Enquiries:

Verici Dx

www.vericidx.com

Sara Barrington, CEO

Via Walbrook PR

Julian Baines, Chairman  
N+1 Singer (Nominated Adviser & Broker)

Tel: 020 7496 3000

Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen / Ross Penney (Corporate Broking)
Walbrook PR Limited

Tel: 020 7933 8780 or vericidx@walbrookpr.com

Paul McManus / Sam Allen

Mob: 07980 541 893 / 07748 651 727

 


 

About Verici Dx plc

Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.

 

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.

 

About Mount Sinai Health System

The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.

 

For more information, visit https://www.mountsinai.org or find Mount Sinai on FacebookTwitter and YouTube.

Lease signed for laboratory as part of CLIA approval acceleration strategy

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces it has signed the lease for the premises intended to be the CLIA1-certified laboratory, situated at the Innovation Park2 in Franklin, Tennessee, US, which is within the Palmetto region for CMS Medicare governance. Palmetto GBA, LLC is one of the largest Medicare administration contractors in the US.

 

In January 2021, the Company appointed David Schultenover to accelerate the CLIA approval process to enable faster commercial launch of Verici Dx’s lead products, ClaravaTM and TutevaTM and setting up these premises is the first step in that accelerated pathway. The Company requires a CLIA-certified laboratory to be able to offer their diagnostic products to clinicians as a laboratory developed test (LDT) and approvals are expected by the end of the year. The Center for Medicare and Medicaid Services (CMS) regulates laboratory testing in the US through the CLIA regime, which requires all clinical laboratories to be certified before they can accept human samples for diagnostic testing.

 

David Schultenover, VP Quality and Regulatory Affairs at Verici Dx, commented: I joined the Company in January this year to help expedite the CLIA approval strategy and signing the lease to this space marks the first step towards achieving these CLIA approvals necessary for commercial launch of the Company’s leading products, ClaravaTM and TutevaTM. Innovation Park is an ideal location for the Company to establish operations and we are delighted with the quality of the premises which are well suited for our needs.” 

 

  1. CLIA - Clinical Laboratory Improvement Amendments
  2. Innovation Park is a 10 acre campus for growing start-ups or established companies. More information can be found here: http://www.theinnovationpark.com/#campus

 


 

Enquiries:

Verici Dx

www.vericidx.com

Sara Barrington, CEO

Via Walbrook PR

Julian Baines, Chairman  
N+1 Singer (Nominated Adviser & Broker)

Tel: 020 7496 3000

Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen / Ross Penney (Corporate Broking)
Walbrook PR Limited

Tel: 020 7933 8780 or vericidx@walbrookpr.com

Paul McManus / Sam Allen

Mob: 07980 541 893 / 07748 651 727

 


 

About Verici Dx plc

Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.

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.

Material Transfer Agreement secured to assess CTOT-19 samples using Clarava™ and Tuteva™

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces it has entered into a Material Transfer Agreement (“MTA”) with the Icahn School of Medicine at Mount Sinai and Principal Investigator Dr. Peter Heeger, to allow access to samples from the CTOT-19 (Clinical Trials in Organ Transplant1) trial in an effort to validate the performance and development of commercial tests designed to improve short and long-term graft and patient survival.

The Company has secured an agreement, providing access to de-identified samples generated from participants in the CTOT-19 study, titled: “Effects of Inhibiting at Early Inflammation in Kidney Transplant Patients.”2 This randomised controlled trial was initiated in November 2015 with the aim to enrol 300 kidney transplant recipients at 15 transplant centres in the US and Canada, with a primary completion date expected July 2021.

Access to samples from this important clinical trial, in addition to the Verici Dx clinical study already ongoing for the validation of Clarava™ and Tuteva™, provides the Company with a large and well-characterised sample group. The Company’s laboratory will conduct a blinded evaluation of samples in Clarava™ and Tuteva™ and work with investigators, including Dr. Peter Heeger, to characterise results following the data lock later this year.  The Company will further support this important CTOT programme by providing full transcriptomic sequencing to the investigators to augment ongoing research in mechanistic studies.

Dr. Barbara Murphy, Chair of Science Advisory Board of Verici Dx, commented: “We are extremely pleased for the opportunity this MTA represents and to collaborate with Dr. Peter Heeger and CTOT. We look forward to the assessment of the clinical performance validation of both Clarava and Tuteva as laboratory developed tests and to furthering research endeavours in organ transplant.”

The test described is based on technology developed by Mount Sinai faculty and licensed to Verici Dx. Mount Sinai and the Mount Sinai faculty who developed this technology, including Dr. Barbara Murphy, have a financial interest in Verici Dx.

 

References:

  1. 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.
  2. Effects of Inhibiting Early Inflammation in Kidney Transplant Patients - Full Text View - ClinicalTrials.gov

 


 

Enquiries:

Verici Dx

www.vericidx.com

Sara Barrington, CEO

Via Walbrook PR

Julian Baines, Chairman  
N+1 Singer (Nominated Adviser & Broker)

Tel: 020 7496 3000

Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen / Ross Penney (Corporate Broking)
Walbrook PR Limited

Tel: 020 7933 8780 or vericidx@walbrookpr.com

Paul McManus / Sam Allen

Mob: 07980 541 893 / 07748 651 727

 


 

About Verici Dx plc

Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.

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.

 

About Mount Sinai Health System

The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.

For more information, visit https://www.mountsinai.org or find Mount Sinai on FacebookTwitter and YouTube.

 

Final Results for the period ended 31 December 2020

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its inaugural audited results for the period ended 31 December 2020.


 

Strategic and Operational highlights

 

Financial highlights

 

Post-period end

 

Commenting on the outlook, Julian Baines, Non-executive Chairman, said: “We have been very pleased with the progress of the Company in such a short time and our primary focus remains on the successful prosecution of our clinical trials, as the first key step in commercialising our innovative transplant products.

“We are already making good progress, initially partnering with three leading US centres (Northwestern University Feinberg School of Medicine, Henry Ford Health System and University of Maryland, Baltimore) in our collaborative, multi-centre observational clinical validation study. We expect to bring more US sites on board shortly and are currently also progressing discussions to include a number of EU sites, to ensure that our products are fully tested for validation by the end of 2021, in line with our objectives set out at the time of our IPO.

“On behalf of the Board, I would like to thank our employees, stakeholders and shareholders for their support and we look forward to providing further updates on progress throughout the current year.”

Notes:

  1. Earnings before income tax, depreciation and amortisation, adjusted to exclude exceptional items and foreign exchange loss
  2. 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

 

Investor briefing

Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the Final Results via the Investor Meet Company platform on Wednesday 14 April 2021 at 5.00 p.m. (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 a.m. 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:

Verici Dx

www.vericidx.com

Sara Barrington, CEO

Via Walbrook PR

Julian Baines, Chairman  
N+1 Singer (Nominated Adviser & Broker)

Tel: 020 7496 3000

Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen / Ross Penney (Corporate Broking)
Walbrook PR Limited

Tel: 020 7933 8780 or vericidx@walbrookpr.com

Paul McManus / Sam Allen

Mob: 07980 541 893 / 07748 651 727

 


 

About Verici Dx plc

Verici Dx is an immuno-diagnostics company developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.

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.

 

Chairman’s statement

I am delighted to report on the first annual results for Verici Dx plc since admission to AIM in November 2020 and this report covers the period from the Company’s incorporation on 22 April 2020 to 31 December 2020.

A full description of our strategy and business model is provided in the Strategic Report below, however in summary Verici Dx is an immuno-diagnostics development company, initially focussed on the kidney transplantation market, incorporating the FractalDx technology and associated assets previously owned by Renalytix AI plc and licensed from the Icahn School of Medicine at Mount Sinai, New York.

We have two leading products which aim to understand how a patient will and is responding to kidney transplantation and these have started clinical validation trials:

Our kidney transplant assays use advanced next-generation sequencing that we believe can define a personalised risk profile for each patient over the course of their transplant journey and can detect injury in advance of currently available clinical tests, with a view to minimising risk of transplant rejection.

The initial focus of Verici Dx on the kidney transplantation market reflects the urgent clinical need in this area. According to the World Health Organisation (WHO), there are reports to suggest that between five and ten million people die annually from kidney disease (compared to 1.8m who die from the most prominent cancer, lung cancer) and about 300,000 people around the world are currently on a waiting list waiting for a kidney transplant and is expected to rise due to an increase in kidney disease. We believe we have unique kidney transplant diagnostic technology that enables accurate, data-driven support for clinical decisions, such as the most appropriate immunosuppressive therapy for that patient.  This has not only near-term scope to reduce the unnecessary and serious consequences from over- or under-dosing for immunosuppression, but also to improve the longevity of transplanted kidneys and, by reducing the risk and rate of transplant failure, much broader potential to deliver huge health economic benefits by improving transplant outcomes.

In early November last year, Verici Dx was successfully admitted to trading on AIM, raising gross proceeds of c.$18.8m (£14.5m). The fundraising was significantly oversubscribed by institutional and other investors, and the share price has appreciably outperformed the market in the period since then. The net proceeds are being used primarily to fund the clinical utility and validation studies for Clarava™ and Tuteva™, as well as other bioinformatics and health economic studies.

We are already making good progress initially partnering with three leading US centres (Northwestern University Feinberg School of Medicine, Henry Ford Health System and University of Maryland, Baltimore) in our collaborative, multi-centre observational clinical validation study. We expect to bring more US sites on board shortly and are currently also progressing discussions to include a number of EU sites, to ensure that our products are fully tested for validation by the end of 2021, in line with our objectives set out at the time of our IPO.

I am also very pleased that we have been able to announce further key milestones in the development of our strategy during the reporting period and post-period end:

First clinical trial sites initiated in US

Three leading US centres first to collaborate with Verici in clinical validation trial for lead products


Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has partnered with Lorenzo Gallon, MD, at Northwestern University Feinberg School of Medicine; Milagros Samaniego, MD, at Henry Ford Health System and Daniel G. Maluf, MD, at the University of Maryland, Baltimore to collaborate on Verici Dx’s clinical trial surrounding its two lead products, ClaravaTM and TutevaTM, and longer term, the validation of the fibrosis test.

The study uses next generation sequencing in the Verici Dx laboratory to create transcriptomic profiles to validate performance characteristics of the lead Verici Dx immune-phenotype signature tests.

Professor of Medicine (Nephrology and Hypertension) and Surgery (Organ Transplantation), Dr. Gallon is an alumnus of the University of Padua Medical School, Italy and is the Medical Director of the Translational Medicine Programme, the Director of International Relations and the Director of the Renal Transplant Fellowship at Northwestern University.

Dr. Samaniego is the Medical Director of Kidney and Kidney Pancreas Transplantation and Director of Research and Outreach Kidney Transplant Program the Henry Ford Transplant Institute with over 21 years of experience. She completed her residency at Baylor College of Medicine and her fellowship at Johns Hopkins Hospital. She is an American Society of Nephrology and American College of Physicians fellow, and her research has been focused on antibody-mediated rejection and studying new immunosuppression approaches to optimize the success of kidney transplants.

Dr. Maluf, Director of the Program in Transplantation at the University of Maryland School of Medicine, performs renal transplantation at the University of Maryland Medical Centre. He has clinical and scientific expertise in kidney and liver transplantation, including living donor liver transplantation. Dr. Maluf is nationally and internationally recognized for his work with the American Transplant Society and the International Liver Transplant Society.

 

Sara Barrington, CEO of Verici Dx, said:

“We are delighted at the level of global interest in our validation trial and highly appreciative that these centres were able to lead our first clinical trials in the United States. Lorenzo, Milagros and Daniel have excellent, demonstrable track records in the medical industry, and have collectively helped pioneer organ transplant research in the modern era. We are excited to be onboarding more US sites shortly and are currently progressing with a number of EU sites to ensure that the two leading products are fully tested for validation by the end of the year.”

 


 

Enquiries:

Verici Dx

www.vericidx.com

Sara Barrington, CEO

Via Walbrook PR

Julian Baines, Chairman  
N+1 Singer (Nominated Adviser & Broker)

Tel: 020 7496 3000

Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen / Ross Penney (Corporate Broking)
Walbrook PR Limited

Tel: 020 7933 8780 or vericidx@walbrookpr.com

Paul McManus / Sam Allen

Mob: 07980 541 893 / 07748 651 727

 


 

About Verici Dx plc

Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.

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.

 

Additional patent licence with Mount Sinai

Worldwide exclusive licence to liquid biopsy IP for predicting risk of fibrosis and chronic damage rejection
Strengthens patent portfolio covering the entire kidney transplant diagnostic pathway

 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has expanded the scope of its licence agreement with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”) to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft.

Interstitial fibrosis and tubular atrophy (IF/TA) is a significant complication in 50-65% of transplants at 12-24 months1 and a major cause of graft rejection in the first year after transplantation2.

The development of a product that can predict risk of fibrosis and rejection using the Company’s core technological approach would extend Verici Dx’s portfolio across the full course of a patient’s transplant journey and complement the Company’s two flagship in vitro diagnostic assays, Clarava™ and Tuteva™. Clarava™ is a pre-transplant prognosis test for the risk of early acute rejection, and Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection. A further product using this technological approach and focused on risk of fibrosis would support the diagnosis of risk of longer-term graft failure as well.

The development of a novel blood-based immune-phenotyping prognostic test for risk of fibrosis fits well with Verici Dx’s current laboratory capabilities, instrumentation and expertise. Liquid biopsy also allows for easier deployment in clinical care given the limited population of transplant centres that undertake tissue allograft surveillance biopsies and the lower risk and costs associated with blood-based biopsies.

The Company’s multi-centre observational clinical study to validate the clinical performance of Clarava™ and  Tuteva™ will also include patients being assessed for fibrosis for an extended study period beyond the initial end points for the first two products  in order to collect data in support of validation for this newly licensed test to predict risk of fibrosis.

 

Commenting Sara Barrington, CEO of Verici Dx, said:

“The development of a product that can predict the risk of long-term graft failure, alongside our flagship products Clarava™ and Tuteva™, would establish an end-to-end solution for clinicians seeking to understand how a patient will and is responding to organ transplant. There is a critical need for more personalised diagnostic information within transplant care, and in particular technologies informing earlier interventions with anti-fibrotic therapies in advance of irreversible organ damage.”

 

Notes

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4065724/#B41
  2. Nankivell et al. The Natural History of Chronic Allograft Nephropathy, NEJM 2003

 

 


Enquiries:

Verici Dx

www.vericidx.com

Sara Barrington, CEO

Via Walbrook PR

Julian Baines, Chairman  
N+1 Singer (Nominated Adviser & Broker)

Tel: 020 7496 3000

Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen / Ross Penney (Corporate Broking)
Walbrook PR Limited

Tel: 020 7933 8780 or vericidx@walbrookpr.com

Paul McManus / Sam Allen

Mob: 07980 541 893 / 07748 651 727

 

About Verici Dx plc www.vericidx.com

Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.

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 prognostic test described is based on technology developed by Mount Sinai faculty and licensed to Verici Dx. Mount Sinai has a financial interest in Verici Dx.

 

About the Mount Sinai Health System

The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.

 

For more information, visit https://www.mountsinai.org or find Mount Sinai on FacebookTwitter and YouTube.

 

Appointment of Senior Director of Clinical Trial Operations Preparatory phase for validation trials complete

23 December 2020
Verici Dx plc
(“Verici Dx” or the “Company”)

Appointment of Senior Director of Clinical Trial Operations
Preparatory phase for validation trials complete

Site initiation of transplant centres on track for January 2021

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has appointed Angela Rose as Senior Director, Clinical Trial Operations with immediate effect.

Angela, a senior clinical trial project management professional with over 15 years of experience in managing medical device, diagnostics, biologic and drug global clinical trial operations for regulatory approval, will be responsible for overseeing Verici Dx’s planned multi-centre observational clinical validation studies for its two flagship in vitro diagnostic assays, Clarava™ and Tuteva™. Clarava™ is a pre-transplant prognosis for the risk of early acute rejection, and Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection. These tests have the potential to define a personalised risk profile of kidney transplant patients over the course of their transplant journey and may also detect injury in advance of currently available clinical tests.

The preparatory phase for these validation studies has now been completed following the Company’s successful IPO fundraise in November 2020, and Angela will be instrumental in overseeing the clinical trial operations to the conclusion of the studies.

Angela joins Verici Dx from regenerative medicine biotech company Humacyte Inc., where she was responsible for global operational oversight and delivery of their clinical development projects and clinical trials. Angela’s extensive experience in clinical project management includes prior roles at biotech pharma company BioCryst Pharmaceuticals Inc., global contract research organisation Quintiles, biopharmaceutical firm Gilead Sciences, Inc., and infectious disease diagnostics company bioMérieux, Inc. Angela’s educational training at Duke University specialised in clinical laboratory science and, together with her industry experience in trials, positions her to engage in validation of diagnostic testing with deep understanding of the field in a commercial context.

Commenting on Angela’s appointment Sara Barrington, CEO of Verici Dx, said:
“We are delighted to have someone with Angela’s experience in clinical trial project management on board to oversee our clinical validation studies focused on Clarava™ and Tuteva™. We are on track to commence enrolment in transplant centres in the new year for trials to be conducted in 2021. Successful conclusion will validate our key products at the forefront of kidney transplant diagnostics.”

About the validation trials
The multi-centre observational clinical study will seek to validate the clinical performance of gene expression immune-phenotyping signatures and associated algorithms for the Company’s in vitro diagnostic assays. The study will allow clinico-pathologic data to be collected and studied while validating based on biopsy findings in central pathology and clinical outcomes. The study is expected to enrol approximately 200 subjects for the Clarava™ and Tuteva™ validation. Verici Dx expects enrolment in these validation trials to complete by the end of 2021.

Enquiries:
Verici Dx
www.vericidx.com

Sara Barrington, CEO Via Walbrook PR
Julian Baines, Chairman
N+1 Singer (Nominated Adviser & Broker)
Tel: 020 7496 3000

Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen (Corporate Broking)
Walbrook PR Limited
Tel: 020 7933 8780 or vericidx@walbrookpr.com
Paul McManus / Sam Allen
Mob: 07980 541 893 / 07748 651 727

About Verici Dx plc www.vericidx.com Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects. 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.

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS

(to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii: VERICI DX
1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)
Non-UK issuer
2. Reason for the notification (please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights YES
An acquisition or disposal of financial instruments
An event changing the breakdown of voting rights
Other (please specify)iii:
3. Details of person subject to the notification obligationiv
Name Harwood Capital Management (Gibraltar) Limited (as investment adviser/manager) to 1.Oryx International Growth Fund Limited

and

Harwood Capital LLP (as investment adviser/manager) to 2. North Atlantic Smaller Companies Investment Trust PLC and 3 Harwood Capital LLP

 

City and country of registered office (if applicable) 1.     Guernsey

2      & 3 London, United Kingdom

4. Full name of shareholder(s) (if different from 3.)v
Name
  1. Oryx International Growth Fund Limited
  2. North Atlantic Smaller Companies Investment Trust PLC
  3. Harwood Capital LLP

 

City and country of registered office (if applicable) As above
5. Date on which the threshold was crossed or reachedvi: 5 November 2020
6. Date on which issuer notified (DD/MM/YYYY): 9 November 2020
7. Total positions of person(s) subject to the notification obligation
% of voting rights attached to shares (total of 8. A) % of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)
Total of both in % (8.A + 8.B) Total number of voting rights of issuervii
Resulting situation on the date on which threshold was crossed or reached 1. 3.88%

2. 11.64%

3.  5.47%

1. 3.88%

2. 11.66%

3.  5.47%

141,747,816
Position of previous notification (if applicable) 1. 3.88%

2. 11.64%

3.  5.83%

 1. 3.88%

2. 11.66%

3.  5.83%

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii
A: Voting rights attached to shares
Class/type of
shares
ISIN code (if possible)
Number of voting rightsix % of voting rights
Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

GB00BM3HZD43

1.

2.

3.

 

5,500,000

16,500,000

7,758,572

3.88%

11.64%

5.47%

SUBTOTAL 8. A 29,758,572 20.99%
B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))
Type of financial instrument Expiration
date
x
Exercise/
Conversion Period
xi
Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights
SUBTOTAL 8. B 1
B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))
Type of financial instrument Expiration
date
x
Exercise/
Conversion Period
xi
Physical or cash

settlementxii

Number of voting rights % of voting rights
  SUBTOTAL 8.B.2

 

9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”)
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) issuerxiii
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 entityxiv (please add additional rows as necessary)
x
Namexv % of voting rights if it equals or is higher than the notifiable threshold % of voting rights through financial instruments if it equals or is higher than the notifiable threshold Total of both if it equals or is higher than the notifiable threshold
Christopher Harwood Bernard Mills 3.88 0 3.88
Harwood Capital Management Ltd
Harwood Capital LLP
Oryx International Growth Fund Ltd
Christopher Harwood Bernard Mills 11.64 0 11.64
Harwood Capital Management Ltd
Harwood Capital LLP
North Atlantic Smaller Companies Investment
Christopher Harwood Bernard Mills 5.47 0 5.47
Harwood Capital Management Ltd
Harwood Capital LLP
 
10. In case of proxy voting, please identify:
Name of the proxy holder
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional informationxvi

 

Place of completion London
Date of completion 9 November 2020

Enquiries:

Verici Dx

www.vericidx.com

Sara Barrington, CEO

Via Walbrook PR

Julian Baines, Chairman  
N+1 Singer (Nominated Adviser & Broker)

Tel: 020 7496 3000

Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen / Ross Penney (Corporate Broking)
Walbrook PR Limited

Tel: 020 7933 8780 or vericidx@walbrookpr.com

Paul McManus / Sam Allen

Mob: 07980 541 893 / 07748 651 727

 

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS

(to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii: VERICI DX
1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)
Non-UK issuer
2. Reason for the notification (please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights YES
An acquisition or disposal of financial instruments
An event changing the breakdown of voting rights
Other (please specify)iii:
3. Details of person subject to the notification obligationiv
Name Harwood Capital Management (Gibraltar) Limited (as investment adviser/manager) to 1.Oryx International Growth Fund Limited

and

Harwood Capital LLP (as investment adviser/manager) to 2. North Atlantic Smaller Companies Investment Trust PLC and 3 Harwood Capital LLP

City and country of registered office (if applicable)
  1. Guernsey
  2. & 3 London, United Kingdom
4. Full name of shareholder(s) (if different from 3.)v
Name
  1. Oryx International Growth Fund Limited
  2. North Atlantic Smaller Companies Investment Trust PLC
  3. Harwood Capital LLP

 

City and country of registered office (if applicable) As above
5. Date on which the threshold was crossed or reachedvi: 3 November 2020
6. Date on which issuer notified (DD/MM/YYYY): 9 November 2020
7. Total positions of person(s) subject to the notification obligation
% of voting rights attached to shares (total of 8. A) % of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)
Total of both in % (8.A + 8.B) Total number of voting rights of issuervii
Resulting situation on the date on which threshold was crossed or reached 1. 3.88%

2. 11.64%

3.  5.83%

1. 3.88%

2. 11.66%

3.  5.83%

141,747,816
Position of previous notification (if applicable)  

 

 

 

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii
A: Voting rights attached to shares
Class/type of
shares
ISIN code (if possible)
Number of voting rightsix % of voting rights
Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

GB00BM3HZD43

1.

2.

3.

 

    5,500,000

16,500,000

8,258,572

  3.88%

11.64%

5.83%

SUBTOTAL 8. A 30,258,572 21.35%
 

 

B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))
Type of financial instrument Expiration
date
x
Exercise/
Conversion Period
xi
Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights
SUBTOTAL 8. B 1
 
B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))
Type of financial instrument Expiration
date
x
Exercise/
Conversion Period
xi
Physical or cash

settlementxii

Number of voting rights % of voting rights
  SUBTOTAL 8.B.2

 

9. Information in relation to the person subject to the notification obligation
(please mark the applicable box with an “X”)
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) issuerxiii
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 entityxiv (please add additional rows as necessary)
x
Namexv % of voting rights if it equals or is higher than the notifiable threshold % of voting rights through financial instruments if it equals or is higher than the notifiable threshold Total of both if it equals or is higher than the notifiable threshold
Christopher Harwood Bernard Mills 3.88 0 3.88
Harwood Capital Management Ltd
Harwood Capital LLP
Oryx International Growth Fund Ltd
Christopher Harwood Bernard Mills 11.64 0 11.64
Harwood Capital Management Ltd
Harwood Capital LLP
North Atlantic Smaller Companies Investment
Christopher Harwood Bernard Mills 5.83 0 5.83
Harwood Capital Management Ltd
Harwood Capital LLP
 
10. In case of proxy voting, please identify:
Name of the proxy holder
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional informationxvi

 

Place of completion London
Date of completion 9 November 2020

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS

(to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:

            Verici DX Plc

1b. Please indicate if the issuer is a non-UK issuer
(please mark with an “X” if appropriate)
Non-UK issuer
2. Reason for the notification
(please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments
An event changing the breakdown of voting rights

X

Other (please specify)iii:
3. Details of person subject to the notification obligationiv
Name

Unicorn Asset Management Limited

City and country of registered office (if applicable)

London, United Kingdom

4. Full name of shareholder(s)
(if different from 3.)v
Name

Unicorn AIM VCT plc

City and country of registered office (if applicable)

Newton Abbot, United Kingdom

5. Date on which the threshold was crossed or reachedvi:

03 November 2020

6. Date on which issuer notified (DD/MM/YYYY):

05 November 2020

7. Total positions of person(s) subject to the notification obligation
% of voting rights attached to shares (total of 8. A) % of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)
Total of both in % (8.A + 8.B) Total number of voting rights of issuervii
Resulting situation on the date on which threshold was crossed or reached 3.17% 3.17% 141,747,816
Position of previous notification (if

applicable)

N/A N/A

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii
A: Voting rights attached to shares
Class/type of
shares
ISIN code (if possible)
Number of voting rightsix % of voting rights
Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

Ordinary shares
GB00BM8HZD43
4,500,000 3.17%
SUBTOTAL 8. A 4,500,000 3.17%
 

 

B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))
Type of financial instrument Expiration
date
x
Exercise/
Conversion Period
xi
Number of voting rights that may be acquired if the instrument is exercised/converted. % of voting rights
SUBTOTAL 8. B 1
Type of financial instrument Expiration
date
x
Exercise/
Conversion Period
xi
Physical or cash

settlementxii

Number of voting rights % of voting rights
  SUBTOTAL 8.B.2

 

9. Information in relation to the person subject to the notification obligation
(please mark the applicable box with an “X”)
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) issuerxiii X
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 entityxiv (please add additional rows as necessary)
Namexv % of voting rights if it equals or is higher than the notifiable threshold % of voting rights through financial instruments if it equals or is higher than the notifiable threshold Total of both if it equals or is higher than the notifiable threshold
10. In case of proxy voting, please identify:
Name of the proxy holder See Section 4
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional informationxvi
Figures are based on total voting rights of 141,747,816         

 

Place of completion Unicorn Asset Management Limited, Preachers Court, Charterhouse, Charterhouse Square, London, EC1M 6AU
Date of completion 05th November 2020

 


Enquiries:

Verici Dx

www.vericidx.com

Sara Barrington, CEO

Via Walbrook PR

Julian Baines, Chairman  
N+1 Singer (Nominated Adviser & Broker)

Tel: 020 7496 3000

Aubrey Powell / Justin McKeegan (Corporate Finance)
Tom Salvesen / Ross Penney (Corporate Broking)
Walbrook PR Limited

Tel: 020 7933 8780 or vericidx@walbrookpr.com

Paul McManus / Sam Allen

Mob: 07980 541 893 / 07748 651 727