American Medical Association grants Verici Dx two CPT^® Codes

CPT Codes facilitate reimbursement and represent first milestone on pathway to commercialisation

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces it has been granted CPT® Proprietary Laboratory Analyses (“PLA”) codes

1,2 for both its Clarava and Tuteva tests by the American Medical Association (“AMA”). The new codes have been approved and published by the AMA Editorial Panel and are scheduled to become effective on April 1, 2022.

Patti Connolly, Executive VP, Product Development of Verici Dx, said: “We were delighted with the AMA’s decision as CPT® codes are fundamental in the commercialisation of our lead products.”

Reimbursement in the US is comprised of three components: code, price and coverage. CPT^® codes offer health care professionals a uniform language for coding medical services and procedures, and the CPT^® PLA code allows clinical laboratories to more specifically identify their tests when billing Medicare and commercial insurers. The successful granting of a CPT® code marks the first step on the path for commercial reimbursement.

Notes:

1. Current Procedural Terminology (CPT) codes are medical codes that are used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation organizations. CPT codes are also used for administrative management purposes such as claims processing and developing guidelines for medical care review.
2. PLA codes are CPT codes including a corresponding descriptor for laboratories or manufacturers that want to identify their test more specifically.

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About The American Society of Nephrology

Since 1966, ASN has been creating a world without kidney diseases by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world. ASN has more than 21,000 members representing 131 countries. For more information, visit www.asn-online.org.

1. Issuer Details

ISIN: GB00BM8HZD43

Issuer Name: VERICI DX PLC

UK or Non-UK Issuer: UK

2. Reason for Notification

An acquisition or disposal of voting rights

3. Details of person subject to the notification obligation

Name

Harwood Capital Management (Gibraltar) Limited

City of registered office (if applicable)

Gibraltar

Country of registered office (if applicable)

Gibraltar

4. Details of the shareholder

5. Date on which the threshold was crossed or reached

16-Dec-2021

6. Date on which Issuer notified

17-Dec-2021

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

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

8A. Voting rights attached to shares

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

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

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

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

10. In case of proxy voting

Name of the proxy holder

–

The number and % of voting rights held

–

The date until which the voting rights will be held

–

11. Additional Information

–

12. Date of Completion

17-Dec-2021

13. Place Of Completion

London Stock Exchange

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Launch of lecture commemorating Verici Dx co-founder and former Board member with American Society of Nephrology supported by Verici Dx Plc, Renalytix plc and in conjunction with the American Society of Transplantation, starting at ASN Kidney Week 2022

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has signed an agreement with Renalytix plc (NASDAQ: RLNX AIM: RENX) and the American Society of Transplantation (“AST”), to establish and sponsor collectively the Barbara T. Murphy Endowed Lectureship (“The Murphy Lectureship”), commemorating Dr. Barbara T. Murphy, Verici Dx’s late co-founder and Board member.  Under the Murphy Lectureship, a lecture will be given each year in perpetuity during the American Society of Nephrology (“ASN”) Kidney Week.  Dr. Murphy was also a co-founder and Board member of Renalytix plc and a long serving member of the ASN, on whose Council she served and of which she was President-Elect; she was also a former president of the AST and former co-chair of its Public Policy committee.

The lectureship, which will begin at ASN Kidney Week being held in November 2022, will honour Dr. Murphy’s legacy as a renowned leader in transplant immunology and medicine by recognising advances in kidney transplantation.

Each lecture will feature a significant figure in kidney transplant immunology and medicine, focusing on kidney risk pre-transplant and transplant care. The lecturers may be physicians, scientists, or represent any other discipline provided they meet the award criteria.  During her career, Dr. Murphy catalysed considerable activity across multiple centers of excellence and this collaborative approach generated a significant body of insights into the immunological mechanisms involved in transplant rejection and the scope for improving transplant care.  The Murphy Lectureship in her honour is intended to foster continuing co-operation across different fields of expertise in support of further patient gains in transplant medicine and care.

Sara Barrington, CEO of Verici Dx, said: “We are proud and honoured to be able to sponsor and establish The Murphy Lectureship alongside ASN, Renalytix and the AST at ASN Kidney Week. It is a fitting tribute to Barbara as a former friend, colleague and inspirational leading nephrologist and specialist in kidney transplant immunology.

“Verici Dx is committed to following Barbara’s vision of improving patient outcomes and is on track to complete the clinical validation trial for the assessment of pre-transplant risk and the measurement of post-transplant rejection tests at the end of 2021.”

About Dr. Barbara T. Murphy

While attending medical school at the Royal College of Surgeons in Ireland, Dr. Murphy was inspired to pursue a career in treating and researching kidney diseases and transplant immunology by a young dialysis patient who received a second chance at life after a successful kidney transplant. This passion led Dr. Murphy to the United States, where she completed a nephrology fellowship at Harvard Medical School’s Brigham and Women’s Hospital in Boston, Massachusetts.

Dr. Murphy served as the Chair of the Department of Medicine from 2012 – 2021 at the Icahn School of Medicine at Mount Sinai, was the first female Chair of a Department of Medicine at an academic medical center in New York City and, at the time, was only the second female Chair of any Department at a top 20 medical school in the United States.  She was the Dean for Strategy and Innovation and the Murray M. Rosenberg Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and held a variety of leadership roles in national and international organisations, including AST President and ASN President-Elect at the time of her passing earlier this year.

Among Dr. Murphy’s many honours, she was named Nephrologist of the Year in 2011 by the American Kidney Fund, included in the Irish American “Healthcare and Life Science 50” in 2016, and identified as one of Crain’s New York’s “Notable Women in Health Care” in 2018. She received numerous honorary doctoral degrees from universities and medical schools.

Dr. Murphy was also the inaugural recipient of ASN’s new lifetime achievement Trailblazer Award. ASN launched the award in 2021 to honour leaders who strengthen the foundation of nephrology while advancing the field through innovation, creativity, inspiration, and tenacity.

Enquiries:

About Verici Dx plc

Verici Dx is an immuno-diagnostics company developing and commercialising tests to understand how a patient will respond 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 and those of other biological pathways enables the development of RNA signatures for prognostic and diagnostic tests. Our products and solutions are underpinned by extensive scientific research into the recipient’s RNA signatures and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These RNA signatures may 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 organ transplant diagnostics described above are based on technology developed by Mount Sinai faculty and licensed to Verici Dx. Mount Sinai has a financial interest in Verici Dx. Mount Sinai also has representation on the Verici Dx Board of Director

About The American Society of Nephrology

Since 1966, ASN has been creating a world without kidney diseases by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world. ASN has more than 21,000 members representing 131 countries. For more information, visit www.asn-online.org.

Grant in honour of Dr. Barbara T. Murphy, Verici Dx co-founder and former Board member

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has signed an agreement with the American Society of Transplantation (“AST”) to establish a Career Development Research Grant, commemorating Dr. Barbara T. Murphy, the Company’s late co-founder and Board member.

The grant will be awarded annually to a talented researcher in the fields of transplant science and immunology, enabling them to expand on preliminary research findings that have the potential to further the knowledge base in these areas.

Dr. Barbara T. Murphy, who passed away on 30 June 2021, was a leading nephrologist and specialist in kidney transplant immunology, with her research focusing on predicting and diagnosing the outcomes of kidney transplants.

The value of the initial grant is $50,000. The AST will be collecting the applications, with members of the AST Research Network Scientific Review Committee (SRC) choosing the recipient based on a scoring system reviewing the quality of the research. The grant recipient will be recognised during the 2022 American Transplant Congress, held from June 4-7, 2022, in Boston, MA, USA.

The AST is an organisation dedicated to advancing the field of transplantation and improving patient care by promoting research, education, advocacy, organ donation, and service to the community through a lens of equity and inclusion.

For more information on the grant and on how to apply:  www.myast.org/research-grants

Sara Barrington, Chief Executive Officer of Verici Dx, said:

“I am honoured to launch this research grant with the AST in memory of Barbara. She was an innovator, an entrepreneur and a mentor, and it is only befitting that this grant will enable promising, innovative researchers to further the research base within the transplant and immunology fields, within which Barbara was a leading voice. She was a valued colleague and a good friend, and she is missed greatly by all of us at Verici Dx.”

John Gill, President of the American Society of Transplantation, said:

“The AST is honored to partner with Verici on this award in tribute to Dr. Barbara T. Murphy. Dr. Murphy was a passionate supporter and inspiration to so many new investigators in the field of transplantation and it is particularly fitting that this generous award will be used to support the career development of a promising new investigator. As a past AST President, Dr. Murphy also understood the importance of our industry partners such as Verici in advancing innovation and I wish to thank Verici for their tremendous support.”

About Dr. Barbara T. Murphy

Dr. Murphy was the Murray M. Rosenberg Professor of Medicine, Chair of the Department of Medicine for the Mount Sinai Health System, and Dean for Clinical Integration and Population Health at the Icahn School of Medicine at Mount Sinai.

Dr. Murphy earned her M.B. B.A.O. B.Ch. from The Royal College of Surgeons in Ireland and went on to do an internship at Beaumont Hospital in Dublin. She completed a residency rotation at Beaumont Hospital followed by a fellowship in Clinical Nephrology also at Beaumont Hospital. Dr. Murphy completed her postdoctoral training with a fellowship in Nephrology at Brigham and Women’s Hospital, Harvard Medical School. As part of this she trained in transplant immunology at the Laboratory of Immunogenetics and Transplantation, Renal Division, Brigham and Women’s Hospital, Harvard Medical School. Dr. Murphy was recruited to Icahn Mount Sinai in 1997 as the Director of Transplant Nephrology and, just six years later, was named the Division’s Chief, becoming one of the youngest division chiefs in the United States as well as one of the few women at the time to hold the role. Among her many honours, Dr. Murphy was awarded the Young Investigator Award in Basic Science by the American Society of Transplantation in 2003. In 2005, Dr. Murphy became the Irene and Dr. Arthur M. Fishberg Professor of Medicine at the Mount Sinai School of Medicine. Then, in 2011, she was named Nephrologist of the Year by the American Kidney Fund. In 2012, she was named Chair of the Department of Medicine; at the time, she was only the second female chair of any department of medicine at a top 20 medical school in the United States.   She received the distinguished Jacobi Medallion in 2014. She also received an honorary degree from University College, Dublin, Ireland. In 2016, Dr. Murphy was honoured by The Annual Irish America Healthcare & Life Science 50. She was named in June 2021 as the recipient of the ASN’s first Lifetime Achievement Award.

Dr. Murphy belonged to a number of professional societies including the American Society of Transplantation and the American Society of Nephrology. Among her numerous achievements, she has held many leadership roles at a national level, including being a member of the board of the American Society of Transplantation, the executive committee of the American Transplant Congress, and chair of Education Committee of the American Society of Transplantation. In 2009 Dr. Murphy was the president of the American Society of Transplantation, and she was the president-elect of the American Society of Nephrology at the time of her death.

Her area of interest was transplant immunology, focusing on the use of high throughput genomic technologies as a means to understand the immune mechanisms that lead to graft injury and loss, with the aim of identifying gene expression profiles and or genetic variants that may be used to predict those at greatest risk.

Verici Dx was founded on intellectual property developed at Icahn Mount Sinai by Dr. Murphy and her colleagues. Icahn Mount Sinai and Mount Sinai faculty have financial interests in Verici Dx.

Enquiries:

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces the appointment of Lorenzo Gallon, MD, as Chair of the Company’s Science Advisory Board (SAB). Dr. Gallon was appointed to the Company’s Board as a Non-executive Director on 19 August 2021.

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

An expert in nephrology and hypertension as well as organ transplantation, Dr. Gallon’s primary research interests include: 

• The role of immunosuppressive medications in modulating the immune system, 
• Genomics of chronic renal allograft rejection, 
• Prednisone-free and calcineurin inhibitors-free immunosuppressive protocols,
• New immunosuppressive strategies,
• Focal segmental glomerulosclerosis (FSGS), and
• Aging and impact of physical exercise after kidney transplantation.

With nearly 20 years’ experience in the life sciences industry, focusing largely on nephrology and organ transplantation, Dr. Gallon is excellently placed to provide insight and guidance in the development of Verici’s two lead products, Clarava™ and Tuteva™.  He was a collaborator and co-author with Verici’s previous SAB Chair, Dr. Barbara Murphy, in the GoCar study¹ which was foundational in the development of Verici’s products. He has also been a member of the Editorial Board at the journal Nephron since 2019. 

In 2012, Dr Gallon was part the Northwestern Medicine transplant team that conducted the first successful removal and implantation of a kidney from one patient to another after the organ failed in the first recipient. The findings of the case were published in the New England Journal of Medicine.

Julian Baines, MBE, Non-executive Chairman of Verici Dx, said:

“I am delighted to welcome Lorenzo as the new Chair of Verici Dx’s Science Advisory Board. As a leading expert in nephrology and organ transplantation, he has been hugely valuable on the Board so far, and I’m sure will become even more so in this additional role, helping us accelerate development of our two lead products, Clarava™ and Tuteva™.”

Dr Lorenzo Gallon, Non-executive Director of Verici Dx, said:

“I am pleased to take on this additional role with Verici Dx, as Chair of the Science Advisory Board. I have been impressed with the progress of its product portfolio, which has the potential to really improve outcomes for kidney transplant patients, and look forward to working more closely with the team to provide advice and some experience to help advance the products.”

¹ – https://pubmed.ncbi.nlm.nih.gov/27452608/ 

Enquiries:

Strong progress made with key milestones towards commercialisation met ahead of schedule 

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 2021.

Strategic and Operational highlights for the period

• Partnered with five leading US centres to collaborate on clinical validation trial for lead products Clarava™ and Tuteva™.  
• Expanded scope of licence agreement with Icahn School of Medicine at Mount Sinai (“Mount Sinai”) in January 2021, 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 graft rejection.
• Entered into a Material Transfer Agreement (“MTA”) with Mount Sinai to allow access to CTOT-19 (Clinical Trials in Organ Transplant) samples, providing Verici Dx, in combination with the Company’s clinical validation study, with a large, well-characterised sample group.

Financial highlights

• Adjusted EBITDA¹ loss of $2.52m.
• Cash balance at 30 June 2021 of $14.5m (31 December 2020: $17.8m).
  • Strong cash position to expand the Verici Dx platform over time with additional innovative licensing opportunities that complement the existing offering.
  • Engage and build new alliances with patient groups and foundations alike focused on kidney research. 

Post-period end

• Obtained CLIA² Certification of Registration for the Company’s newly established US clinical laboratory in Tennessee ahead of schedule, authorising the Company to initiate commercial operations as a diagnostic laboratory, a key milestone towards the commercial launch of Clarava™ and Tuteva™.
• Expanded multi-centre clinical validation trial to a total of twelve US and EU sites. 
• Completion of patient enrolment to the clinical validation trial for lead products, ahead of schedule.
• Appointment of Lorenzo Gallon, MD, as Non-Executive Director.

Julian Baines, Non-Executive Chairman, said: “The Company has made strong progress over the past six months, with some key milestones reached ahead of schedule as we look to commercialise our innovative organ transplant products.

“We initially partnered with five leading US centres in our collaborative, multi-centre observational clinical validation study. We have since expanded to partner with a total of twelve US and European centres for the validation study and completed patient enrolment for Clarava™ and Tuteva™ ahead of schedule We remain on target for the validation study to be completed by the end of 2021 for lead products, in line with expectations set out at IPO, with the data to be submitted for publication in Q1 2022. 

“Post-period end, we obtained a CLIA Certification of Registration for our US clinical laboratory in Tennessee. Having a CLIA-certified lab will enable us to launch our two lead products commercially, subject to the successful conclusion of our analytical validation studies. I’d like to thank all of our employees and shareholders for their ongoing hard work and support over the past six months and into the next phases of commercialisation.”

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 13 September 2021 at 16:30hrs 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 plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it will release its unaudited results for the six-month period to 30 June 2021 on Monday 13 September 2021.

Investor briefing

Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the Half Year Results via the Investor Meet Company platform on Monday 13 September 2021 at 16:30hrs 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 09:00hrs 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:

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.

Verici Dx remains on track for completion of study end points by the end of 2021 for lead products

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that patient enrolment for a multi-centre observational clinical validation study for the Company’s lead products has concluded ahead of management expectations. Early completion of enrolment supports that the Company remains on track to complete the validation study for these products by the end of 2021, in line with expectations set out in the Company’s admission document.

Verici Dx has partnered with eleven leading US and EU centres to date to run a global, non-randomised study for the clinical validation of Verici Dx’s lead products, Clarava^TM and Tuteva^TM.

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

Over the longer term, the study will also provide validation for the Company’s fibrosis test, called Protega™. Patient enrolment continues for validation of Protega and is expected to complete by Q3 2022. The end points of the validation study for this product are expected to be reached up to two years after the completion of enrolment, with data expected shortly thereafter around year-end 2024.

Sara Barrington, CEO of Verici Dx, said: “I am delighted to have reached this key milestone ahead of our original expectations. Since IPO our primary focus has been on the successful prosecution of these clinical trials, as the first key step in commercialising our innovative transplant products.

“We remain on track to have our two lead products fully tested by the end of the year and look forward to reporting the data in Q1 2022.”

Enquiries:

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.